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    Bulletin 04-10-2019

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    ARC 4382CMedicine Board[653]Notice of Intended Action

    Proposing rule making related to standards of practice for appropriate pain management and providing an opportunity for public comment

        The Board of Medicine hereby proposes to amend Chapter 13, “Standards of Practice and Principles of Medical Ethics,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code chapters 147, 148 and 272C and 2018 Iowa Acts, House File 2377.State or Federal Law Implemented    This rule making implements, in whole or in part, 2018 Iowa Acts, House File 2377.Purpose and Summary    This proposed rule making amends the standards of practice for appropriate pain management.  This rule making references the U.S. Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.  The proposed amendments require a physician to register with the Iowa Prescription Monitoring Program at the same time that the physician applies for registration or renews registration to prescribe controlled substances as required by the Iowa Board of Pharmacy. The proposed amendments also require a physician or the physician’s designated agent to utilize the Iowa Prescription Monitoring Program prior to issuing an opioid prescription and, beginning January 1, 2020, to transmit electronically as an electronic prescription every prescription issued for a controlled substance. This rule making makes it a ground for discipline if a physician prescribes opioids in dosage amounts exceeding what would be prescribed by a reasonably prudent physician in the state of Iowa acting in the same or similar circumstances. Fiscal Impact    This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 653—Chapter 3. Public Comment    Any interested person may submit written or oral comments concerning this proposed rule making. Written or oral comments in response to this rule making must be received by the Board no later than 4:30 p.m. on May 3, 2019. Comments should be directed to: Kent Nebel Iowa Board of Medicine 400 S.W. Eighth Street, Suite C Des Moines, Iowa 50309 Phone: 515.281.7088 Fax: 515.242.5908 Email: kent.nebel@iowa.govPublic Hearing    A public hearing at which persons may present their views orally or in writing will be held as follows: May 3, 2019 9 a.m. Board Office, Suite C 400 S.W. Eighth Street Des Moines, Iowa     Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.     Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making action is proposed:

        ITEM 1.    Amend rule 653—13.2(148,272C) as follows:

    653—13.2(124,148,272C) Standards of practice—appropriate pain management.  This rule establishes standards of practice for the management of acute and chronic pain. The board encourages the use ofnonpharmacologic therapy, including but not limited to adjunct therapies such as acupuncture, physical therapy and massage, and nonopioid pharmacologic therapy in the treatment of acute and chronic pain. This rule focuses on prescribing and administering controlled substances to provide relief and eliminate suffering for patients with acute or chronic pain.
    1. This rule is intended to encourage appropriate pain management, including the use of controlled substancesopioids for the treatment of pain, while stressing the need to establish safeguards to minimize the potential for substance abuse and drug diversion.
    2. The goal of pain management is to treat each patient’s pain in relation to the patient’s overall health, including physical function and psychological, social and work-related factors. At the end of life, the goals may shift to palliative care.
    3. The board recognizes that pain management, including the use of controlled substances, is an important part of general medical practice. Unmanaged or inappropriately treated pain impacts patients’ quality of life, reduces patients’ ability to be productive members of society, and increases patients’ use of health care services.
    4. Physicians should not fear board action for treating pain with controlled substancesopioids as long as the physicians’ prescribing is consistent with appropriate pain management practices. Dosage alone is not the sole measure of determining whether a physician has complied with appropriate pain management practices. The board recognizes the complexity of treating patients with chronic pain or a substance abuse history. Generally, the board is concerned about a pattern of improper pain management or a single occurrence of willful or gross overtreatment or undertreatment of pain.
    5. The board recognizes that the undertreatment of pain is a serious public health problem that results in decreases in patients’ functional status and quality of life, and that adequate access by patients to proper pain treatment is an important objective of any pain management policy.
    6. 6Inappropriate pain management may include nontreatment, undertreatment, overtreatment, and the continued use of ineffective treatments. Inappropriate pain management is a departure from the acceptable standard of practice in Iowa and may be grounds for disciplinary action.
        13.2(1) Definitions.  For the purposes of this rule, the following terms are defined as follows:        "Acute pain" means the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. Generally, acute pain is self-limited, lasting no more than a few weeks following the initial stimulus.        "Addiction" means a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.        "Chronic pain" means persistent or episodic pain of a duration or intensity that adversely affects the functioning or well-being of a patient when (1) no relief or cure for the cause of pain is possible; (2) no relief or cure for the cause of pain has been found; or (3) relief or cure for the cause of pain through other medical procedures would adversely affect the well-being of the patient. If pain persists beyond the anticipated healing period of a few weeks, patients should be thoroughly evaluated for the presence of chronic pain.pain that typically lasts longer than three months or past the time of normal tissue healing. Chronic pain can be the result of an underlying medical disease or condition, injury, medical treatment, inflammation, or an unknown cause.        "Opioid" means any U.S. Food and Drug Administration (FDA)-approved product or active pharmaceutical ingredient classified as a controlled substance that produces an agonist effect on opioid receptors and is indicated or used for the treatment of pain.        "Pain" means an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Pain is an individual, multifactorial experience influenced by culture, previous pain events, beliefs, mood and ability to cope.        "Physical dependence" means a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.        "Pseudoaddiction" means an iatrogenic syndrome resulting from the misinterpretation of relief-seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief-seeking behaviors resolve upon institution of effective analgesic therapy.        "Substance abuse" means the use of a drug, including alcohol, by the patient in an inappropriate manner that may cause harm to the patient or others, or the use of a drug for an indication other than that intended by the prescribing clinician. An abuser may or may not be physically dependent on or addicted to the drug.        "Tolerance" means a physiological state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.        "Undertreatment of pain" means the failure to properly assess, treat and manage pain or the failure to appropriately document a sound rationale for not treating pain.    13.2(2) Laws and regulations governing controlled substances.  Nothing in this rule relieves a physician from fully complying with applicable federal and state laws and regulations governing controlled substances.    13.2(3) Undertreatment of pain.  The undertreatment of pain is a departure from the acceptable standard of practice in Iowa. Undertreatment may include a failure to recognize symptoms and signs of pain, a failure to treat pain within a reasonable amount of time, a failure to allow interventions, e.g., analgesia, to become effective before invasive steps are taken, a failure to address pain needs in patients with reduced cognitive status, a failure to use controlled substancesopioids for terminal pain due to the physician’s concern with addicting the patient, or a failure to use an adequate level of pain management.    13.2(4) Assessment and treatment of acuteand chronic pain.  Appropriate assessment of the etiology of the pain is essential to the appropriate treatment of acuteand chronic pain. Acute pain is not a diagnosis; it is a symptom.    a.    Prescribing controlled substancesopioids for the treatment of acuteand chronic pain should be based on clearly diagnosed and documented pain. Appropriate management of acuteand chronic pain should include an assessment of the mechanism, type and intensity of pain. The patient’s medical record should clearly document a medical history, a pain history, a clinical examination, a medical diagnosis and a treatment plan.    b.    Prescribing opioids for the treatment of acute and chronic pain should only be accomplished within an established physician-patient relationship and should be based on clearly diagnosed and documented unrelieved pain.    c.    On March 15, 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 years of age and older in primary care settings. Recommendations focus on the use of opioids in treating chronic pain (pain lasting longer than three months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care. A physician who prescribes, dispenses or administers opioids to patients for the treatment of chronic pain should become familiar with the CDC Guideline for Prescribing Opioids for Chronic Pain.    13.2(5) Effective management of chronic pain.  Prescribing controlled substances for the treatment of chronic pain should only be accomplished within an established physician-patient relationship and should be based on clearly diagnosed and documented unrelieved pain. To ensure that chronic pain is properly assessed and treated, a physician who prescribes, dispenses or administers controlled substancesopioids to a patient for the treatment of chronic pain shall exercise sound clinical judgment and establish an effective pain management plan in accordance with the following:    a.    Patient evaluation.A patient evaluation that includes a physical examination and a comprehensive medical history shall be conducted prior to the initiation of treatment. The evaluation shall also include an assessment of the pain, physical and psychological function, diagnostic studies, previous interventions, including medication history, substance abuse history and any underlying or coexisting conditions. Consultation/referral to a physician with expertise in pain medicine, addiction medicine or substance abuse counseling or a physician who specializes in the treatment of the area, system, or organ perceived to be the source of the pain may be warranted depending upon the expertise of the physician and the complexity of the presenting patient. Interdisciplinary evaluation is strongly encouraged.    b.    Treatment plan.The physician shall establish a comprehensive treatment plan that tailors drug therapy to the individual needs of the patient. To ensure proper evaluation of the success of the treatment, the plan shall clearly state the objectives of the treatment, for example, pain relief or improved physical or psychosocial functioning. The treatment plan shall also indicate if any further diagnostic evaluations or treatments are planned and their purposes. The treatment plan shall also identify any other treatment modalities and rehabilitation programs utilized. The patient’s short- and long-term needs for pain relief shall be considered when drug therapy is prescribed. The patient’s ability to request pain relief as well as the patient setting shall be considered. For example, nursing home patients are unlikely to have their pain control needs assessed on a regular basis, making prn (on an as-needed basis) drugs less effective than drug therapy prescribed for routine administration that can be supplemented if pain is found to be worse. The patient should receive prescriptions for controlled substancesopioids from a single physician and a single pharmacy whenever possible.    c.    Informed consent.The physician shall document discussion of the risks and benefits of controlled substancesopioids with the patient or person representing the patient.    d.    Periodic review.The physician shall periodically review the course of drug treatment of the patient and the etiology of the pain. The physician should adjust drug therapy to the individual needs of each patient. Modification or continuation of drug therapy by the physician shall be dependent upon evaluation of the patient’s progress toward the objectives established in the treatment plan. The physician shall consider the appropriateness of continuing drug therapy and the use of other treatment modalities if periodic reviews indicate that the objectives of the treatment plan are not being met or that there is evidence of diversion or a pattern of substance abuse. Long-term opioid treatment is associated with the development of tolerance to its analgesic effects. There is also evidence that opioid treatment may paradoxically induce abnormal pain sensitivity, including hyperalgesia and allodynia. Thus, increasing opioid doses may not improve pain control and function.    e.    Consultation/referral.A specialty consultation may be considered at any time if there is evidence of significant adverse effects or lack of response to the medication. Pain, physical medicine, rehabilitation, general surgery, orthopedics, anesthesiology, psychiatry, neurology, rheumatology, oncology, addiction medicine, or other consultation may be appropriate. The physician should also consider consultation with, or referral to, a physician with expertise in addiction medicine or substance abuse counseling, if there is evidence of diversion or a pattern of substance abuse. The board encourages a multidisciplinary approach to chronic pain management, including the use of adjunct therapies such as acupuncture, physical therapy and massage.    f.    Documentation.The physician shall keep accurate, timely, and complete records that detail compliance with this subrule, including patient evaluation, diagnostic studies, treatment modalities, treatment plan, informed consent, periodic review, consultation, and any other relevant information about the patient’s condition and treatment.    g.    Pain management agreements.A physician who treats patients for chronic pain with controlled substancesopioids shall consider using a pain management agreement with each patient being treated that specifies the rules for medication use and the consequences for misuse. In determining whether to use a pain management agreement, a physician shall evaluate each patient, taking into account the risks to the patient and the potential benefits of long-term treatment with controlled substancesopioids. A physician who prescribes controlled substancesopioids to a patient for more than 90 days forthe treatment of chronic pain shall utilize a pain management agreement if the physician has reason to believe a patient is at risk of drug abuse or diversion. If a physician prescribes controlled substancesopioids to a patient for more than 90 days forthe treatment of chronic pain and chooses not to use a pain management agreement, then the physician shall document in the patient’s medical records the reason(s) why a pain management agreement was not used. Use of pain management agreements is not necessary for hospice or nursing home patients. A sample pain management agreement and prescription drug risk assessment tools may be found on the board’s website at www.medicalboard.iowa.gov.    h.    Substance abuse history or comorbid psychiatric disorder.A patient’s prior history of substance abuse does not necessarily contraindicate appropriate pain management. However, treatment of patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care and communication with the patient, monitoring, documentation, and consultation with or referral to an expert in the management of such patients. The board strongly encourages a multidisciplinary approach for pain management of such patients that incorporates the expertise of other health care professionals.    i.    Drug testing.A physician who prescribes controlled substancesopioids to a patient for more than 90 days for the treatment of chronic pain shall consider utilizing drug testing to ensure that the patient is receiving appropriate therapeutic levels of prescribed medications or if the physician has reason to believe that the patient is at risk of drug abuse or diversion.    j.    Termination of care.The physician shall consider termination of patient care if there is evidence of noncompliance with the rules for medication use, drug diversion, or a repeated pattern of substance abuse.    13.2(6) Pain management for terminal illness.  The provisions of this subrule apply to patients who are at the stage in the progression of cancer or other terminal illness when the goal of pain management is comfort care. When the goal of treatment shifts to comfort care rather than cure of the underlying condition, the board recognizes that the dosage level of opiates or controlled substancesopioids to control pain may exceed dosages recommended for chronic pain and may come at the expense of patient function. The determination of such pain management should involve the patient, if possible, and others the patient has designated for assisting in end-of-life care.    13.2(7) Prescription monitoring program.  The Iowa board of pharmacy has established a prescription monitoring program pursuant to Iowa Code sections 124.551 to 124.558 to assist prescribers and pharmacists in monitoring the prescription of controlled substances to patients. The board recommends that physiciansA physician shall register for the prescription monitoring program at the same time the physician applies for registration or renews registration to prescribe controlled substances as required by the Iowa board of pharmacy. A physician or the physician’s designated agent shall utilize the prescription monitoring program when prescribing controlled substances to patients if the physician has reason to believe that a patient is at risk of drug abuse or diversionprior to issuing an opioid prescription to assist the physician in determining appropriate treatment options and to improve the quality of patient care.A physician is not required to utilize the prescription monitoring program to assist in the treatment of a patient receiving inpatient hospice care or long-term residential facility patient care. An order issued in an inpatient hospital setting is not considered a prescription for the purposes of these rules. Patient safety is adequately protected in an inpatient hospital setting, and physicians caring for patients in an inpatient hospital setting do not prescribe. A link to the prescription monitoring program may be found at the board’s website at www.medicalboard.iowa.gov.    13.2(8) Electronic prescriptions.  Beginning January 1, 2020, every prescription issued for a controlled substance shall be transmitted electronically as an electronic prescription pursuant to Iowa Code section 124.308. The prescription shall be transmitted to a pharmacy by the physician or the physician’s authorized agent in compliance with federal law and regulation for electronic prescriptions of controlled substances.    13.(8) 13.2(9) Pain management resources.  The board strongly recommends that physicians consult the following resources regarding the proper treatment of chronic pain. This list is provided for the convenience of licensees, and the publications included are not intended to be incorporated in the rule by reference.    a.    American Academy of Hospice and Palliative Medicine or AAHPM is the American Medical Association-recognized specialty society of physicians who practice in hospice and palliative medicine in the United States. The mission of the AAHPM is to enhance the treatment of pain at the end of life.    b.    American Academy of Pain Medicine or AAPM is the American Medical Association-recognized specialty society of physicians who practice pain medicine in the United States. The mission of the AAPM is to enhance pain medicine practice by promoting a climate conducive to the effective and efficient practice of pain medicine.    c.    American Pain Society or APS is the national chapter of the International Association for the Study of Pain, an organization composed of physicians, nurses, psychologists, scientists and other professionals who have an interest in the study and treatment of pain. The mission of the APS is to serve people in pain by advancing research, education, treatment and professional practice.    d.    DEA Policy Statement: Dispensing Controlled Substances for the Treatment of Pain. On August 28, 2006, the Drug Enforcement Agency (DEA) issued a policy statement establishing guidelines for practitioners who dispense controlled substances for the treatment of pain. This policy statement may be helpful to practitioners who treat pain with controlled substances.    e.    Interagency Guideline on Prescribing Opioids for Pain. Developed by the Washington State Agency Medical Directors’ Group in collaboration with an expert advisory panel, actively practicing providers and public stakeholders, the guideline focuses on evidence-based treatment for chronic-pain patients. The guideline was published in 2007 and updated in 2015.    f.    Responsible Opioid Prescribing: A Physician’s Guide. In 2007, in collaboration with author Scott Fishman, M.D., the Federation of State Medical Boards’ (FSMB) Research and Education Foundation published a book on responsible opioid prescribing based on the FSMB Model Policy for the Use of Controlled Substances for the Treatment of Pain.    g.    World Health Organization: Pain Relief Ladder. Cancer pain relief and palliative care. Technical report series 804. Geneva: World Health Organization.    h.    CDC Guideline for Prescribing Opioids for Chronic Pain. On March 15, 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued a guideline to provide recommendations for the prescribing of opioid pain medication for patients 18 years of age and older in primary care settings. Recommendations focus on the use of opioids in treating chronic pain (pain lasting longer than three months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care.    13.2(10) Grounds for discipline.  A physician may be subject to disciplinary action for violation of these rules, the rules found in 653—Chapter 23, or any of the following:    a.    A physician who prescribes opioids in dosage amounts exceeding what would be prescribed by a reasonably prudent physician in the state of Iowa acting in the same or similar circumstances.    b.    A physician who knowingly fails to comply with the confidentiality requirements of Iowa Code section 124.553 or who delegates program information access to another individual except as provided in Iowa Code section 124.553.    c.    A physician who knowingly fails to comply with other requirements of Iowa Code chapter 124.    13.2(11) Unlawful access, disclosure, or use of information.  A person who intentionally or knowingly accesses, uses, or discloses information from the prescription monitoring program in violation of Iowa Code section 124.553, unless otherwise authorized by law, is guilty of a class “D” felony. This subrule shall not preclude a physician who requests and receives information from the prescription monitoring program consistent with the requirements of Iowa Code section 124.553 from otherwise lawfully providing that information to any other person for medical care purposes.       This rule is intended to implement Iowa Code chapters 124, 148 and 272C.    ARC 4391CPharmacy Board[657]Notice of Intended Action

    Proposing rule making related to pharmacist licensure and providing an opportunity for public comment

        The Board of Pharmacy hereby proposes to amend Chapter 2, “Pharmacist Licenses,” Chapter 4, “Pharmacist-Interns,” Chapter 25, “Child Support Noncompliance,” Chapter 31, “Student Loan Default or Noncompliance with Agreement for Payment of Obligation,” and Chapter 32, “Nonpayment of State Debt,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 147.10, 147.11, 147.34, 147.36, 147.44, 147.53, 147.76, 147.80, 155A.6, 155A.9, 155A.11, 155A.40, 155A.44 and 272C.2 to 272C.4.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code sections 147.2 to 147.5, 147.9 to 147.11, 147.34, 147.36, 147.44, 147.49, 147.53, 147.55, 147.76, 147.80, 155A.6 to 155A.9, 155A.11, 155A.12, 155A.19, 155A.40, 155A.44, 155A.46 and 272C.2 to 272C.4.Purpose and Summary    The Board conducted an overall five-year review of Chapter 2 pursuant to Iowa Code section 17A.7(2). Proposed amendments as a result of the review include:

  • Addition of rules identifying the purpose and scope and definitions for the chapter, consistent with other chapters of Board rules;
  • Addition of the word “nonrefundable” as it relates to the submission of fees, consistent with language added in other Board rules;
  • Updates to the licensure application, examination eligibility, and license transfer processes through the National Association of Boards of Pharmacy, to be consistent with current procedures;
  • Updates to the licensure application process for a foreign pharmacy graduate through the Foreign Pharmacy Graduate Examination Committee, to be consistent with current procedures;
  • Removal of language relating to a surcharge pursuant to 657—Chapter 30, because the Board discontinued assessing a surcharge several years ago;
  • Addition of a fee for a written license verification;
  • Expansion of the options for foreign pharmacy graduates to fulfill internship requirements at Iowa-licensed pharmacies to include pharmacies other than community or hospital pharmacies;
  • Removal of the option for a foreign pharmacy graduate to petition the Board for credit toward internship resulting from the pharmacy graduate’s pharmacy experience in a foreign country;
  • Updates to language relating to the continuing education requirements for pharmacists, to be consistent with more commonly used terminology;
  • Addition of an exemption for continuing education requirements for pharmacists who are not living or practicing in Iowa but who are licensed and practicing in another state, as well as for active duty military personnel;
  • Addition of a criminal history record check for pharmacist licensure candidates prior to initial licensure;
  • Addition of a requirement that a pharmacist notify the Board within 30 days of any criminal conviction, plea, or disciplinary action;
  • Removal of the requirement that a pharmacist notify the Board in advance of the pharmacist’s intent to complete a continuing professional development portfolio;
  • Updates to the language relating to the submission of a pharmacist-intern’s notarized affidavit of internship to the Board within six months of graduation;
  • Updates to cross references where appropriate; and
  • Other nonsubstantive changes and rearrangement of rules or subrules to provide consistency and clarification.
    • Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34. Public Comment    Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Sue Mears Board of Pharmacy 400 S.W. 8th Street, Suite E Des Moines, Iowa 50309 Email: sue.mears@iowa.govPublic Hearing     No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Renumber existing rules 657—2.1(147,155A) and 657—2.2(155A) as 657—2.4(147,155A) and 657—2.5(155A).

        ITEM 2.    Adopt the following new rule 657—2.1(147,155A):

    657—2.1(147,155A) Purpose and scope.  The purpose of this chapter is to set the minimum standards and application process for obtaining and maintaining pharmacist licensure in this state. The rules shall apply to pharmacists who seek or hold pharmacist licensure in Iowa.

        ITEM 3.    Adopt the following new rule 657—2.2(147,155A):

    657—2.2(147,155A) Definitions.  For the purposes of this chapter, the following definitions shall apply:        "Board" means the board of pharmacy.        "Continuing pharmacy education" "CPE" means a structured educational activity that is applicable to the practice of pharmacy, that promotes problem solving and critical thinking, and that is designed or intended to support the continuing development of pharmacists to maintain and enhance their competence in the practice of pharmacy.        "Continuing professional development" "CPD" means a self-directed, ongoing, systematic, and outcomes-focused approach to learning and professional development including active participation in learning activities that assist a pharmacist in developing and maintaining continuing competence in the practice of pharmacy, enhancing the pharmacist’s professional practice, and supporting achievement of the pharmacist’s career goals.        "CPE monitor" means the program administered by NABP to collect and store CPE data for pharmacy professionals.        "NABP" means the National Association of Boards of Pharmacy.        "Renewal period" means the 27-month period commencing April 1 prior to the previous license expiration and ending June 30, the date of current license expiration.

        ITEM 4.    Rescind rule 657—2.3(147,155A) and adopt the following new rule in lieu thereof:

    657—2.3(147,155A) License and criminal history record check required.      2.3(1) License required.  Prior to engaging in the practice of pharmacy in Iowa, a pharmacist shall have an active Iowa pharmacist license pursuant to rule 657—2.4(147,155A), 657—2.8(155A), or 657—2.9(147,155A).    2.3(2) Criminal history record check required.  Upon receipt of an initial licensure application pursuant to subrule 2.3(1), the board shall provide a fingerprint packet to the applicant, who shall submit to the board the completed fingerprint packet and a signed waiver form to facilitate a national criminal history background check of the applicant. The cost of the evaluation of the fingerprint packet and the Iowa division of criminal investigation and United States Federal Bureau of Investigation criminal history background checks will be assessed to the applicant.

        ITEM 5.    Renumber existing rules 657—2.4(155A) and 657—2.6(147) as 657—2.6(155A) and 657—2.7(147).

        ITEM 6.    Amend renumbered rule 657—2.4(147,155A) as follows:

    657—2.4(147,155A) Licensure by examination.  The board of pharmacy, in conjunction with the National Association of Boards of Pharmacy (NABP)NABP, shall provide for the administration of pharmacist licensure examinations.    2.4(1) Components.  Applicants shall take and pass the following components: the North American Pharmacist Licensure Examination (NAPLEX); the Multistate Pharmacy Jurisprudence Examination (MPJE), Iowa Edition. A total scaled score of no less than 75 is required to pass each examination.    2.4(2) Timeliness.  To be eligible for a license by examination, the candidate shall pass all components in Iowa within a period of one year beginning with the date the candidate passed an initial component. A candidate may request waiver or variance from this deadline pursuant to the procedures and requirements of 657—Chapter 34.    2.4(3) Examination results.  Examination scores and original license certificates shall be provided as soon after the examinations as possible.

        ITEM 7.    Rescind existing rules 657—2.5(155A) and 657—2.7(147).

        ITEM 8.    Amend renumbered rule 657—2.5(155A) as follows:

    657—2.5(155A) Application for examination—requirements.  Application for examination shall be on forms provided by the board, and all requested information shall be provided on or with such application. An applicant shall complete the NABP Computerized Examination Registration Form toadditionally apply for registrationeligibility to take the NAPLEXand the Multistate Pharmacy Jurisprudence Examination (MPJE), Iowa Edition, at nabp.pharmacy/programs. An applicant shall complete an additional registration form to apply for registration to take the MPJE, Iowa Edition.    2.5(1) Required information.  The application for examination shall require that the applicant provide, at a minimum, the following: name; address; telephone number; date of birth; social security number or individual tax identification number (ITIN); name and location of college of pharmacy and date of graduation; one current photograph of a quality at least similar to a passport photograph; and internship experience. If the applicant provides an ITIN in lieu of a social security number, the applicant shall also provide acceptable proof of lawful presence. Each applicant shall also declare the following: history of prior pharmacist licensure examinations and record of offenses including but not limited to charges, convictions, and fines which relate to the profession or that may affect the licensee’s ability to practice pharmacy.    2.5(2) Sworn statement.  The application for examination shall be made as a sworn statement before a notary public, and the notary public shall witness the signature of the applicant.    2.5(3) Fee.  The nonrefundable fee for examination shall consist of the biennial license fee, a processing fee, and an examination registration fee.    a.    The biennial license fee shall be $180, and the processing fee shall be $72. The nonrefundable biennial license fee and processing fee shall be submitted to the board with the application for licensure by examination.    b.    The examination registration fee shall be an amount determined by NABP and submitted pursuant to NABP direction at nabp.pharmacy/programs when submitting an application for eligibility to take the NAPLEX; the MPJE, Iowa Edition; or both.    2.5(4) College graduation certification.  Each applicant, with the exception of a foreign pharmacy graduate who shall comply with rule 657—2.10(155A), shall furnish a certificate from a recognized college of pharmacy stating that the applicant has successfully graduated from a college of pharmacy with either a bachelor of science degree in pharmacy or a doctor of pharmacy degree. Certification shall be completed by an individual authorized by the college on a form provided by the board. A recognized college of pharmacy is a United States institution that meets the minimum standards of the Accreditation Council for Pharmacy Education and appears on the list of accredited colleges of pharmacy published by the council as of July 1 of each year.    2.5(5) Foreign pharmacy graduates.  In addition to the requirements of this rule, except as provided in subrule 2.5(4), an applicant who is a graduate of a school or college of pharmacy located outside the United States that has not been recognized and approved by the board shall obtain certification by the Foreign Pharmacy Graduate Examination Committee (FPGEC) pursuant to rule 657—2.10(155A).

        ITEM 9.    Amend renumbered rule 657—2.6(155A) as follows:

    657—2.6(155A) Internship requirements.  Each applicant, except for an applicant for license transfer, shall furnish to the board evidence certifying completion of satisfactory internship experience. The board will not certify an applicant eligible to take any of the examination components prior to receipt of evidence of satisfactory completion of internship experience. Internship experience shall comply with the requirements in 657—Chapter 4. Internship experience completed in compliance with the requirements in 657—Chapter 4 shall be valid for application for licensure in Iowa by examination or score transfer for a period of three years following graduation from an approved college of pharmacy or as otherwise approved by the board on a case-by-case basis.

        ITEM 10.    Amend renumbered rule 657—2.7(147) as follows:

    657—2.7(147) Reexamination applications and fees.  A candidate who fails to pass either the NAPLEX or the MPJE, Iowa Edition, once shall be allowed to schedule a time to retake the examination as provided in this rule. To ensure the integrity of the examinations, no waiver or variance of the specified waiting period between reexaminations will be granted.    2.7(1)   NAPLEX. A candidate who fails to pass the NAPLEX once shall be allowed to schedule a time to retake the examination no less than 45 days following administration of the failed examination. The candidate may be approved to retake the NAPLEX no more than three times in a 12-month period.     2.7(2)   MPJE, Iowa Edition. A candidate who fails to pass the MPJE, Iowa Edition, once shall be allowed to schedule a time to retake the examination no less than 30 days following administration of the failed examination.     2.7(3)   Reexamination after two or more attempts. A candidate who fails to pass either examination following a second or subsequent examination may petition the board for permission to take the examination again. Determination of a candidate’s eligibility to take an examination more than two times shall be at the discretion of the board.    2.7(4)   Applications and fees. Each applicant for reexamination shall file an application on forms provided by the board. Anonrefundable processing fee of $36 will be charged for each NAPLEX or MPJE, Iowa Edition, reexamination and shall be paid to the board as provided in subrule 2.3(1). In addition, candidates will be required tothe applicant shall complete the appropriate examination registration application as provided in rule 657—2.2(155A) and to pay to NABP the registration and administration fees for each examination as provided in subrule 2.3(2)application process for reexamination and pay the required fee for reexamination as determined by NABP at nabp.pharmacy/programs. All applications, registration forms, and fees shall be submitted as provided in subrules 2.3(2) and 2.3(3).

        ITEM 11.    Amend rule 657—2.8(155A) as follows:

    657—2.8(155A) Transfer of examination scoresLicensure by score transfer.  The board of pharmacy participates in the NAPLEX score transfer program offered by NABP. This program allows candidates for pharmacist licensure to take the standardized NAPLEX in one state and have the score from that examination transferred to other participant states in which the candidate is seeking licensure. MPJE scores cannot be transferred.    2.8(1) Score transfer applicationApplication for score transfer.  The NAPLEX Score Transfer Form must be completed and submitted with the proper fee to NABP prior to, or postmarked no later than, the date on which the candidate takes the NAPLEX. The fee to NABP for score transfer is determined by NABP. Payment shall be made in the form of a money order or certified check payable to the National Association of Boards of Pharmacy. NABP makes no refunds of score transfer fees.To participate in the NABP score transfer program, an applicant shall complete all required application requirements and submit required fees as determined by NABP at nabp.pharmacy/programs.    2.8(2) Requirements and deadline.  Score transfer candidatesApplicants for licensure by score transfer shall meet the requirements established in rules 657—2.1(147,155A)657—2.4(147,155A) through 657—2.5(155A)657—2.6(155A) within 12 months of the date ofscore transfer. No refund of fees paid to the board will be made for failure to complete all licensure requirements within this one-year period.    2.8(3) Fees.  In addition to the score transfer fee identified in subrule 2.8(1), fees for licensure pursuant to the NABP score transfer program shall consist of the fees identified in rule 657—2.3(147,155A) excluding the NAPLEX examination registration and administration fees.paragraph 2.5(3)“a.”

        ITEM 12.    Amend rule 657—2.9(147,155A) as follows:

    657—2.9(147,155A) Licensure by license transfer/reciprocitytransfer.  An applicant for license transfer/reciprocitytransfer must be a pharmacist licensed by examination in a state or territory of the United States with which Iowa has a reciprocal agreement, and the license by examination upon which the transfer is based must be in good standing at the time of the application and license transfer. All candidates shall take and pass the MPJE, Iowa Edition, as provided in subrule 2.1(1)2.4(1). Any candidate who fails to pass the examination shall be eligible for reexamination as provided in rule 657—2.6(147)657—2.7(147).    2.9(1) Eligibility.  Each applicant for license transfer to this state who obtains the applicant’s original license after January 1, 1980, must have passed the NABP Licensure Examination (NABPLEX), the NAPLEX, or an equivalent examination as determined by NABP.    a.    Preliminary applicationApplication for license transfer.Each applicant for license transfer/reciprocitytransfer to Iowa shall complete and submit to NABP, with the appropriate fee as indicated on the application, the NABP Preliminary Application for Transfer of Pharmaceutic Licensure. Refunds of fees paid to NABP shall be at the discretion of NABPthe online application and pay the required fee as determined by NABP at nabp.pharmacy/programs.    b.    Foreign pharmacy graduates.If the applicant is a graduate of a school or college of pharmacy located outside the United States that has not been recognized and approved by the board, proof of qualifications shall include certification from the FPGEC pursuant to subrule 2.10(1).    2.9(2) Application requirements.  Application to the board shall consist of the final application for license transferthat is prepared by NABPand electronically submitted to the board pursuant to the NABP license transfer program. A foreign pharmacy graduate shall submit certification from the FPGEC as provided in subrule 2.10(1). Applications, together with other required information and fees, shall be submitted as provided in subrule 2.3(3).    2.9(3) MPJE required.  An applicant shall also be required to submit the registration application forsuccessfully pass the MPJE, Iowa Edition, as provided in rule 657—2.2(155A)subrule 2.4(1). The form and fees shall be submitted as provided in subrules 2.3(2) and 2.3(3).    2.9(4) Fees.  Thenonrefundable fee for license transfer shall consist of the biennial license fee established by rule 657—2.11(147,155A) including surchargeof $180 and a processing fee of $90. No refunds of the processing fee shall be made for cancellation or withdrawal of an application. The license fee and processing fee shall be payable to the Iowa Board of Pharmacy and may be remitted in the form of personal check, money order, cashier’s check, or certified check.    2.9(5) Timeliness.  A finalAn application for license transfer is valid for 12 months following the date of issuance by NABP. A candidateAn applicant for license transfer shall complete, within that one-year period, all licensure requirements established by this rule. No refund of fees will be made for failure to complete all licensure requirements within this one-year period.

        ITEM 13.    Amend rule 657—2.10(155A) as follows:

    657—2.10(155A) Foreign pharmacy graduates.      2.10(1) Education equivalency.  Any applicant who is a graduate of a school or college of pharmacy located outside the United States that has not been recognized and approved by the board shall be deemed to have satisfied the requirements of Iowa Code section 155A.8, subsection 1, by certification by the Foreign Pharmacy Graduate Examination Committee (FPGEC)FPGEC. Each applicant shall have successfully passed the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) given by the FPGEC established by the NABP. The FPGEE is hereby recognized and approved by the board. Each applicant shall also demonstrate proficiency in written English by passing the Test of English as a Foreign Language (TOEFL) and proficiency in spoken English by passing the Test of Spoken English (TSE) or proficiency in basic English language skills by passing the Internet Based TOEFLTest of English as a Foreign Language (TOEFL iBT)given by the FPGEC established by NABP. The TOEFL, TOEFL iBT, and TSE areis hereby recognized and approved by the board. Certification by the FPGEC shall be evidence of the applicant’s successfully passing the FPGEE, TSE, and TOEFL, or the FPGEE and TOEFL iBT, and certification is a prerequisite to taking the licensure examinations required in subrule 2.1(1)2.4(1).    2.10(2) Internship.  A foreign pharmacy graduate applicant shall also be required to obtain internship experience in one or more board-licensed community or hospital pharmacies as provided in rule 657—4.7(155A). Internship requirements shall, in all other aspects, meet the requirements established in 657—Chapter 4.

        ITEM 14.    Amend rule 657—2.11(147,155A) as follows:

    657—2.11(147,155A) License expiration and renewal.  A license to practice pharmacy shall expire on the second thirtieth day of June following the date of issuance of the license, with the exception that a new pharmacist license issued between April 1 and June 29 shall expire on the third thirtieth day of June following the date of issuance. The license renewal certificate shall be issued upon completion of the renewal application and timely payment of anonrefundable fee of $180 fee plus applicable surcharge pursuant to 657—30.8(155A).    2.11(1) Late paymentrenewal penalty.  Failure to renew the license before July 1 following expiration shall require payment of thenonrefundable renewal fee,and anonrefundable penalty fee of $180, and applicable surcharge pursuant to 657—30.8(155A). Failure to renew the license before August 1 following expiration shall require payment of thenonrefundable renewal fee,and anonrefundable penalty fee of $270, and applicable surcharge pursuant to 657—30.8(155A). Failure to renew the license before September 1 following expiration shall require payment of thenonrefundable renewal fee,and anonrefundable penalty fee of $360, and applicable surcharge pursuant to 657—30.8(155A). Failure to renew the license before October 1 following expiration may require an appearance before the board and shall require payment of the renewala nonrefundable reactivation fee, a penalty fee of $450, and applicable surcharge pursuant to 657—30.8(155A). In no event shall the combined fee and penalty fee for late renewal of the license exceedof $630 plus applicable surcharge pursuant to 657—30.8(155A). The provisions of Iowa Code section 147.11 shall apply to a license that is not renewed within five months of the expiration date.    2.11(2) Delinquent license.  If a license is not renewed before its expiration date, the license is delinquent and the licensee may not practice pharmacy in the state of Iowa until the licensee reactivates the delinquent license. Reactivation of a delinquent license shall include submission of a completed application and appropriatenonrefundable fees and may include requirements relating to the reactivation of an inactive license pursuant to subrule 2.13(2). A pharmacist who continues to practice pharmacy in Iowa without a current license may be subject to disciplinary sanctions pursuant to the provisions of 657—subrule 36.1(4)36.6(22).

        ITEM 15.    Amend rule 657—2.12(272C) as follows:

    657—2.12(272C) Continuing education requirements.  Pharmacists shall complete continuing education for license renewal pursuant to the requirements of this rule, except as provided in subrule 2.12(6) or rule 657—2.17(272C). For purposes of this rule, “continuing education” means a structured educational activity that is applicable to the practice of pharmacy, that promotes problem solving and critical thinking, and that is designed or intended to support the continuing development of pharmacists to maintain and enhance their competence in the practice of pharmacy. Nothing in these rules precludes the board from requiring an applicant forlicense renewalor reactivation to submit to a relicensure examination.    2.12(1) Continuingpharmacy education unit(CPE) required.  The nationally accepted measurement of continuing education is referred to as CEU (continuing education unit), and the board employs that measurement. Ten contact hours of approved continuing education are equivalent to one CEU.A pharmacist shall complete no less than 30 hours of CPE during each renewal period except as provided in subrule 2.12(6) or rule 657—2.17(272C).    a.    The board will require 3.0 CEUs each renewal period except as provided in subrule 2.12(5) or rule 657—2.17(272C). For purposes of this rule, “renewal period” means the 27-month period commencing April 1 prior to the previous license expiration and ending June 30, the date of current license expiration.    b.    a.    A pharmacist who fails to complete the required CEUsCPE hours within the renewal period shall be required to complete one and one-half times the number of delinquent CEUsCPE hours prior to reactivation of the license.    c.    b.    CEUsCPE hours that are used to satisfy the continuing educationCPE requirement for one renewal period shall not be used to satisfy the requirement for a subsequent renewal period.    d.    c.    Failure to receive a license renewal application or notice of license renewal shall not relieve the pharmacist of the responsibility of meeting continuing educationCPE requirements.    2.12(2) Continuing educationCPE activity completion.  Continuing education    a.    ACPE provider activity.CPEactivities that carry the seal of an Accreditation Council for Pharmacy Education (ACPE)-accredited provider will automatically qualify for continuing educationCPE credit. Successful completion and record of continuing educationCPE activities in CPE Monitor is mandated in order for a pharmacist to receive credit for ACPE-accredited provider continuing educationCPE activities.    a.    b.    Non-ACPE provider activity.A maximum of 1.3 CEUs (13 contact hours)13 CPE hours of the total 3.0 CEUs of continuing education credits30 CPE hours required pursuant to subrule 2.12(4) may be obtained through completion of non-ACPE provider activities if such activities are provided by an accredited health-professional continuing education provider, such as a continuing medical education (CME) provider, and if the activity content directly relates to the pharmacist’s professional practice. Non-ACPE provider activity completion shall be recorded, evaluated, and reported pursuant to the provisions of rule 657—2.17(272C) regarding continuing professional development.    (1)   The pharmacist is responsible for ensuring that the activity content directly relates to the pharmacist’s professional practice.    (2)   If one or more non-ACPE provider activities are intended to fulfill the requirement in paragraph 2.12(4)“c,” the pharmacist is responsible for ensuring the activity content relates to patient or medication safety.    (3)   If the non-ACPE provider is not able to transmit the activity record to CPE Monitor, the provider shall provide to the pharmacist a statement of credit that indicates the pharmacist’s participation in and successful completion of the continuing education activity. The statement of credit shall include all information identified in subrule 2.12(3), except for the pharmacist’s CPE Monitor e-profile identification number.    b.    Exemption for health-related graduate studies.A pharmacist who is continuing formal education in a health-related graduate program, including participation in a pharmacy residency program, may be exempted from meeting the continuing education requirements during the period of such enrollment or participation. As an alternative to requesting exemption from meeting the continuing education requirements, the pharmacist may complete a CPD portfolio pursuant to rule 657—2.17(272C).    (1)   An applicant for this exemption shall petition the board, as soon as possible following enrollment in the qualifying graduate program or commencement of the pharmacy residency program and prior to completion of the qualifying program, on forms provided by the board office.    (2)   At the discretion of the board, exemption during part-time or short-term enrollment in a health-related graduate program may be prorated for the actual period of such enrollment.    2.12(3) Continuing educationCPE activity record of credit.  An ACPE-accredited provider will be required to transmit to CPE Monitor information regarding an individual pharmacist’s participation in and successful completion of a continuing educationCPE activity. The record shall be accessible to the board and shall include the following information:    a.    Pharmacist’s full name and CPE Monitor e-profile identification number.    b.    Number of contact hours or CEUs awarded for activity completion.    c.    Date of live activity or date of completion of home study activity.    d.    Name of accredited provider.    e.    Activity title and universal activity number.    2.12(4) Continuing educationCPE activity topics.  Each pharmacist is required to obtain continuing educationCPE by completing activities in the topics specified in this subrule.    a.    Drug therapy.A minimum of 1.5 CEUs (15 contact hours)15 CPE hours of the pharmacist’s required 3.0 CEUs30 CPE hours shall be in ACPE-accredited provider activities dealing with drug therapy. Activities qualifying for the drug therapy requirement will include the ACPE topic designator “01” or “02” followed by the letter “P” at the end of the universal activity number.    b.    Pharmacy law.A minimum of 0.2 CEUs (2 contact hours)2 CPE hours of the pharmacist’s required 3.0 CEUs30 CPE hours shall be in ACPE-accredited provider activities dealing with pharmacy law. Activities qualifying for the pharmacy law requirement will include the ACPE topic designator “03” followed by the letter “P” at the end of the universal activity number.    c.    Patient or medication safety.A minimum of 0.2 CEUs (2 contact hours)2 CPE hours of the pharmacist’s required 3.0 CEUs30 CPE hours shall be in activities dealing with patient or medication safety. Activities completed to fulfill this requirement may be ACPE-accredited provider activities, in which case the universal activity number will end with the ACPE topic designator “05” followed by the letter “P.” A pharmacist may complete non-ACPE provider activities as provided in paragraph 2.12(2)“a”2.12(2)“b” to fulfill this topic requirement.    d.    Immunization.If the pharmacist is engaged in the administration of immunizations during the renewal period, a minimum of 1 CPE hour of the required 30 CPE hours shall be in ACPE-accredited provider activities dealing with immunization or vaccine administration. Activities qualifying for the immunization requirement will include the ACPE topic designator of “06” followed by the letter “P” at the end of the universal activity number.    2.12(5) New license holders licensed by examination.  After the initial license is issued by examination, the new license holder is exempt from meeting continuing education requirements for the first license renewal. However, if the licensee qualifies as a mandatory abuse reporter, the licensee shall not be exempt from mandatory training for identifying and reporting abuse pursuant to rule 657—2.16(235B,272C). Regardless of when the license is first issued, the new license holder will be required to obtain, prior to the second renewal, 30 contact hours (3.0 CEUs) of continuing education pursuant to subrules 2.12(1) through 2.12(4) or to complete a CPD portfolio pursuant to rule 657—2.17(272C).    2.12(6) New license holders licensed by license transfer/reciprocity.  After the initial license is issued by license transfer, the new license holder will be required to obtain, prior to the first license renewal, 30 contact hours (3.0 CEUs) of continuing education credits pursuant to subrules 2.12(1) through 2.12(4) or to complete a CPD portfolio pursuant to rule 657—2.17(272C).    2.(7) 2.12(5) Reporting continuing educationCPE credits.      a.    A pharmacist shall provide or report to the board, in the format specified on or with the pharmacist license renewal application, evidenceattestation that the continuing educationCPE requirements have been met.    b.    The board may require a pharmacist to submit activity statements of credit or other documented evidence of successful completion of the activities reported as fulfilling the continuing educationCPE requirements.    2.12(8) Physical disability or illness.  The board may, in individual cases involving physical disability or illness, grant waivers of the minimum continuing education requirements or extensions of time within which to fulfill the same or make the required reports. No waiver or extension of time shall be granted unless written application is made and signed by the licensee and the licensee’s physician. The board may grant waivers of the minimum continuing education requirements for physical disability or illness for any period of time not to exceed one renewal period. In the event that the physical disability or illness upon which a waiver has been granted continues beyond the period of the waiver, the licensee must reapply for an extension of the waiver. The board may, as a condition of any waiver granted, require the licensee to make up all or any portion of the waived continuing education requirements by any method prescribed by the board.    2.12(6) Exemptions and waivers to CPE requirements.      a.    Credit for health-related graduate studies.A pharmacist who is continuing formal education in a health-related graduate program, including participation in a pharmacy residency program, may be granted credit for health-related learning during the period of such enrollment or participation. As an alternative to requesting credit for health-related learning, the pharmacist may complete a CPD portfolio pursuant to rule 657—2.17(272C).    (1)   An applicant for credit for health-related learning shall petition the board, as soon as possible following enrollment in the qualifying graduate program or commencement of the pharmacy residency program and prior to completion of the qualifying program, on forms provided by the board.    (2)   At the discretion of the board, credit granted for health-related learning during part-time or short-term enrollment in a health-related graduate program may be prorated for the actual period of such enrollment.    b.    Exemption for new license holders licensed by examination.After the initial license is issued by examination, the licensee is exempt from meeting CPE requirements for the first license renewal. However, if the licensee qualifies as a mandatory abuse reporter, the licensee shall not be exempt from mandatory training for identifying and reporting abuse pursuant to rule 657—2.16(235B,272C).    c.    Waiver from CPE requirements due to physical disability or illness.The board may, in individual cases involving physical disability or illness, grant a waiver pursuant to 657—Chapter 34 of the minimum CPE requirements or an extension of time within which to fulfill the same or make the required reports. The board may grant a waiver of the minimum CPE requirements for physical disability or illness for any period of time not to exceed one renewal period. In the event that the physical disability or illness upon which a waiver has been granted continues beyond the period of the waiver, the licensee must reapply for an extension of the waiver. The board may, as a condition of any waiver granted, require the licensee to make up all or any portion of the waived CPE requirements by any method prescribed by the board. A waiver request pursuant to this paragraph and 657—Chapter 34 shall be signed by the licensee and the licensee’s physician.    d.    Active military duty.A licensee shall be deemed compliant with the CPE requirements of this rule during periods that the licensee serves honorably on active duty in the military services.    e.    Nonresident.A licensee who is not actively practicing in Iowa, is a resident of another state, and holds an active pharmacist license in the licensee’s home state during the renewal period shall be deemed compliant with the CPE requirements of this rule.

        ITEM 16.    Amend rule 657—2.13(272C) as follows:

    657—2.13(272C) Active and inactive license status.      2.13(1) Active license.  Active license status applies to a pharmacist who has submitted the renewal application andnonrefundable fee and has met Iowa requirements for continuing educationCPE or has completed a CPD portfolio pursuant to rule 657—2.17(272C). Active license status also applies to a pharmacist who has submitted the renewal application and fee and who is a resident of another state, is licensed to practice pharmacy in that state, and has met the continuing education requirements of that state. A pharmacist who meets the continuing education requirements of another state shall provide documentation on the renewal application of the pharmacist’s license status in that state. An Iowa licensee actively practicing in a state that does not require continuing education for license renewal shall be required to meet Iowa continuing education or CPD requirements.    2.13(2) Inactive license.  Failure of a pharmacist to comply with the continuing educationCPE or CPD requirements during the renewal period shall result in the issuance of a renewal card marked “inactive” upon submission of the renewal application andnonrefundable fee. Reactivation of an inactive pharmacist license shall be accomplished by the appropriate method described below. Internship, in each instance where internship is mentioned below, shall be in a pharmacy approved by the board. The pharmacist may be required to obtain a pharmacist-intern registration, including payment of the appropriatenonrefundable registration fee, and be issued an intern registration certificate.    a.    An inactive pharmacist who wishes to become active and who has been actively practicing pharmacy during the last five years in any state or states which required continuing education during that five-year period shall submit proof of continued licensure in good standing in the state or states of such practice.    b.    An inactive pharmacist who wishes to become active and who has been actively practicing pharmacy during the last five years in a state which does not require continuing education shall submit proof of continued licensure in good standing in the state or states of such practice. The pharmacist shall also complete one of the following options:    (1)   Take and successfully pass the MPJE, Iowa Edition, as provided in subrule 2.1(1)2.4(1);    (2)   Complete 160 hours of internship for each year the pharmacist was on inactive status (not to exceed 1,000 hours);     (3)   Obtain one and one-half times the number of continuing educationCPE credits required under subrule 2.12(1) for each renewal period the pharmacist was inactive; or    (4)   Complete a CPD portfolio pursuant to rule 657—2.17(272C) identifying a minimum of 45 learning outcomes for each renewal period the pharmacist was inactive.    c.    An inactive pharmacist who wishes to become active and who has not been actively practicing pharmacy during the past five years, and whose license has been inactive for not more than five years, shall complete one of the following options:    (1)   Successfully pass all components of the licensure examination as required in rule 657—2.1(147,155A)subrule 2.4(1);    (2)   Complete 160 hours of internship for each year the pharmacist was on inactive status;     (3)   Obtain one and one-half times the number of continuing educationCPE credits required under subrule 2.12(1) for each renewal period the pharmacist was inactive; or    (4)   Complete a CPD portfolio pursuant to rule 657—2.17(272C) identifying a minimum of 45 learning outcomes for each renewal period the pharmacist was inactive.    d.    An inactive pharmacist who wishes to become active and who has not been actively practicing pharmacy for more than five years shall petition the board for reactivation of the license to practice pharmacy under one or more of the following options:    (1)   Successfully pass all components of the licensure examination as required in rule 657—2.1(147,155A)subrule 2.4(1);    (2)   Complete 160 hours of internship for each year the pharmacist was on inactive status (not to exceed 1,000 hours);     (3)   Obtain one and one-half times the number of continuing educationCPE credits required under subrule 2.12(1) for each renewal period the pharmacist was inactive; or    (4)   Complete a CPD portfolio pursuant to rule 657—2.17(272C) identifying a minimum of 45 learning outcomes for each renewal period the pharmacist was inactive.

        ITEM 17.    Amend rule 657—2.14(155A) as follows:

    657—2.14(147,155A) Fees for additional license certificatesand verification.      2.14(1)   Only original license certificates issued by the board of pharmacy for licensed pharmacists are valid. Additional original license certificates for licensed pharmacists may be obtained from the board of pharmacy for a prepaidnonrefundable fee of $20 each. The fee shall be considered a repayment receipt as defined in Iowa Code section 8.2.    2.14(2)   The board may require the submission of a nonrefundable fee of $15 for written license verification.

        ITEM 18.    Amend rule 657—2.15(155A) as follows:

    657—2.15(155A) Notifications to the board.      2.15(1) Reporting licensee changes.  A pharmacistlicensee shall report to the board within ten days a change of the pharmacist’slicensee’s name, address,email address, or pharmacy employment.Except for a change in name, an update to the licensee’s personal online profile through the board’s online database shall satisfy this subrule.    2.15(2) Reporting criminal convictions and pleas.  A licensee who has been convicted of, or entered a plea of guilty, nolo contendere, or no contest to, a crime, other than a minor traffic offense, shall report such conviction or plea to the board within 30 days of adjudication.    2.15(3) Reporting of disciplinary action.  A licensee who has been the subject of disciplinary action in another state, to include but not be limited to citations, reprimands, fines, license restrictions, probation, or license surrender, suspension, or revocation, shall report such action to the board within 30 days of adjudication.

        ITEM 19.    Amend rule 657—2.17(272C) as follows:

    657—2.17(272C) Continuing professional development portfolio.  A pharmacist may complete and submit with the pharmacist’s license renewal a continuing professional development (CPD)CPD portfolio to fulfill the continuing educationCPE requirements in rule 657—2.12(272C). For purposes of these rules, “CPD” means a self-directed, ongoing, systematic, and outcomes-focused approach to learning and professional development including active participation in learning activities that assist a pharmacist in developing and maintaining continuing competence in the practice of pharmacy, enhancing the pharmacist’s professional practice, and supporting achievement of the pharmacist’s career goals. Definitions and descriptions of the terms “continuing education,” “CEU,” and “renewal period” included in rule 657—2.12(272C) shall apply to those terms as used in this rule.    2.17(1) Declaration of intent.  A pharmacist shall declare on or with the previous license renewal, or shall notify the board no later than January 1 of the year the pharmacist’s license is scheduled for renewal, of the pharmacist’s intent to complete a CPD portfolio for the next license renewal.    a.    The pharmacist’s declaration of intent shall be in writing. Oral declaration of intent to complete a CPD portfolio will not be accepted.    b.    A declaration of intent may be delivered to the board office via e-mail, facsimile transmission, or alternate hard-copy delivery.    2.(2) 2.17(1) Prerequisite.  A pharmacist, prior to submitting the pharmacist’s initial CPD portfolio, shall complete an ACPE-accredited provider activity regarding the objectives and processes relating to CPD. Record of the pharmacist’s participation in this prerequisite activity shall be included in the pharmacist’s initial CPD portfolio.    2.(3) 2.17(2) CPD portfolio requirements.  A pharmacist shall combine traditional continuing educationCPE activities with professional development activities. The pharmacist shall incorporate the record of completion and evaluation of any traditional continuing educationCPE activities into the CPD portfolio.    a.    The pharmacist is responsible for ensuring that the activity content identified in the CPD portfolio directly relates to the pharmacist’s professional practice and career goals.    b.    The pharmacist is responsible for ensuring that the activities identified in the CPD portfolio comply with the continuing educationCPE topic requirements identified in subrules 2.12(4) and 2.17(4)2.17(3).    2.(4) 2.17(3) CPD portfolio content.  In addition to the record of completion of the one-time prerequisite activity identified in subrule 2.17(2)2.17(1), a completed CPD portfolio shall include or identify the following:    a.    A minimum of 30 documented learning outcomes in the form of completed learning statements. The learning statement form or format shall beon forms provided by the board.    b.    Documented learning outcomes shall include a minimum of two outcomes relating to patient or medication safety, two outcomes relating to pharmacy law, and 15 outcomes relating to drug therapy, and if the pharmacist is engaged in the administration of immunizations or vaccines, one outcome relating to vaccine administration.    c.    Documented learning outcomes shall include any number of continuing educationCPE activities that carry the seal of an ACPE-accredited provider. Successful completion and record of these continuing educationCPE activities in CPE Monitor as provided in subrule 2.12(2)2.12(3), in addition to the documented CPD learning outcomes, is required for the pharmacist to receive credit for these activities.    d.    Documented learning outcomes shall include any continuing educationCPE activities provided by non-ACPE, accredited, health-professional continuing education providers pursuant to subrule 2.12(2).paragraph 2.12(2)“b.”    2.(5) 2.17(4) CPD portfolio review.  The board shall review or may contract for peer review of CPD portfolios submitted for pharmacist license renewal. The board shall respond to a submitting pharmacist with comments, suggestions, and recommendations regarding the pharmacist’s CPD portfolio and processes.

        ITEM 20.    Amend subrule 4.6(4) as follows:    4.6(4) Identification, reports, and notifications.  Credit for internship time will not be granted unless registration and other required records or affidavits are completed.    a.    The pharmacist-intern shall be so designated in all relationships with the public and health professionals. While on duty in the pharmacy, the intern shall wear visible to the public a name badge including the designation “pharmacist-intern” or “pharmacy student.”    b.    Registered interns shall notify the board office within ten days of a change of name or address.    c.    Notarized affidavits of experience in non-college-sponsored programs shall be filed withsubmitted to the board office after the successful completion of the internshipno later than six months following graduation from a school or college of pharmacy. These affidavits shall certify only the number of hours and dates of training obtained outside a college-based clinical program as provided in rule 657—4.3(155A). An individual registered as a pharmacist-intern while participating in an Iowa residency or fellowship program shall not be required to file affidavits of experience.

        ITEM 21.    Rescind subrule 4.7(3).

        ITEM 22.    Amend subrule 25.3(5) as follows:    25.3(5) Reinstatement following license suspension, revocation, or denial of renewal.  A licensee shall pay all board fees required for license renewal or license reinstatement, and all continuing education requirements shall be met, before a license will be reinstated after the board has suspended a license pursuant to the Act. A licensee whose license to practice pharmacy has been revoked shall complete the examination components as indicated in rule 657—2.1(147,155A)657—subrule 2.4(1) and shall pay all required examination fees pursuant to rule 657—2.3(147,155A)657—subrule 2.5(3). A licensee whose registration to practice as a pharmacist-intern, as a pharmacy technician, or as a pharmacy support person or whose registration to handle controlled substances under Iowa Code chapter 124 has been revoked shall complete the appropriate application and pay all board fees required for new registration.

        ITEM 23.    Amend subrule 31.3(5) as follows:    31.3(5) Reinstatement following license suspension, revocation, or denial of renewal.  All board fees required for license renewal or license reinstatement shall be paid by licensees, and all continuing education requirements shall be met, before a license will be renewed or reinstated after the board has suspended a license pursuant to the Act. A licensee whose license to practice pharmacy has been revoked shall complete the examination components as indicated in rule 657—2.1(147,155A)657—subrule 2.4(1) and shall pay all required examination fees pursuant to rule 657—2.3(147,155A)657—subrule 2.5(3). A licensee whose registration to practice as a pharmacist-intern, as a pharmacy technician, or as a pharmacy support person or whose registration to handle controlled substances under Iowa Code chapter 124 has been revoked shall complete the appropriate application and pay all board fees required for new registration.

        ITEM 24.    Amend subrule 32.3(5) as follows:    32.3(5) Reinstatement following license suspension, revocation, or denial of renewal.  All board fees required for license renewal or license reinstatement shall be paid by the licensee and all continuing education requirements shall be met before a license will be renewed or reinstated after the board has suspended a license pursuant to the Act. A licensee whose license to practice pharmacy has been revoked shall complete the examination components as indicated in rule 657—2.10(155A)657—subrule 2.4(1) and shall pay all required examination fees pursuant to rule 657—2.2(155A)657—subrule 2.5(3). A licensee whose registration to practice as a pharmacist-intern, as a pharmacy technician, or as a pharmacy support person or whose registration to handle controlled substances under Iowa Code chapter 124 has been revoked shall complete the appropriate application and pay all board fees required for new registration.    ARC 4386CPharmacy Board[657]Notice of Intended Action

    Proposing rule making related to exemptions to the electronic prescription mandate and providing an opportunity for public comment

        The Board of Pharmacy hereby proposes to amend Chapter 8, “Universal Practice Standards,” Chapter 10, “Controlled Substances,” and Chapter 21, “Electronic Data and Automated Systems in Pharmacy Practice,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 124.301, 124.308, 147.76 and 155A.27.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code sections 124.308 and 155A.27.Purpose and Summary    During the 2018 Legislative Session, the Iowa Code was amended to require the electronic transmission of all prescriptions as of January 1, 2020. The amendments to the Iowa Code provided exemptions for prescriptions which will not be required to be transmitted electronically. The amendments provided that a prescriber, medical group, institution, or pharmacy that is unable to comply with the electronic prescription mandate may petition the Board for an exemption. The amendments required the Board to adopt rules to establish the form and specific information to be included in a request for such an exemption and the specific criteria to be considered by the Board in determining whether to approve a request for exemption. This proposed rule making implements the electronic prescription mandate.Fiscal Impact    This rule making may have minimal fiscal impact to the State of Iowa. As noted in the legislation’s fiscal note submission, the Board anticipates an extra two days of meetings to review petitions for exemption to the mandate. This would result in an estimated $2,500 expense to the Board for the initiation of the mandate. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34. Public Comment    Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Sue Mears Board of Pharmacy 400 S.W. 8th Street, Suite E Des Moines, Iowa 50309 Email: sue.mears@iowa.govPublic Hearing    A public hearing at which persons may present their views orally or in writing will be held as follows: May 7, 2019 9 a.m. to 12 noon Shared Conference Room, Suite E 400 S.W. 8th Street Des Moines, Iowa     Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.     Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Adopt the following new rule 657—8.18(124,155A):

    657—8.18(124,155A) Electronic prescription mandate.  Beginning January 1, 2020, all prescriptions shall be transmitted electronically to a pharmacy pursuant to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A). A pharmacist who receives a written, oral, or facsimile prescription shall not be required to verify that the prescription is subject to an exception provided in rule 657—21.8(124,155A) and may dispense a prescription drug pursuant to an otherwise valid written, oral, or facsimile prescription pursuant to rule 657—8.19(124,126,155A).

        ITEM 2.    Amend rule 657—8.19(124,126,155A) as follows:

    657—8.19(124,126,155A) Manner of issuance of a prescription drug or medication order.  A prescription drug order or medication orderthat is issued prior to January 1, 2020, or that is exempt from the electronic prescription mandate pursuant to rule 657—21.8(124,155A) may be transmitted from a prescriber or a prescriber’s agent to a pharmacy in written form, orally including telephone voice communication, by facsimile transmission as provided in rule 657—21.9(124,155A)657—21.7(124,155A), or by electronic transmission in accordance with applicable federal and state laws, rules, and regulations. Any prescription drug order or medication order provided to a patient in written or printed form shall include the original, handwritten signature of the prescriber except as provided in rule 657—21.7(124,155A)657—21.6(124,155A).    8.19(1) Requirements for a prescription.  A valid prescription drug order shall be based on a valid patient-prescriber relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors and in subrule 8.19(8) for opioid antagonists.    a.    Written, electronic, or facsimile prescription.In addition to the electronic prescription application and pharmacy prescription application requirements of this rule, a written, electronic, or facsimile prescription shall include:    (1)   The date issued.    (2)   The name and address of the patient except as provided in subrule 8.19(7) for epinephrine auto-injectors and in subrule 8.19(8) for opioid antagonists.    (3)   The name, strength, and quantity of the drug or device prescribed.    (4)   The name and address of the prescriber and, if the prescription is for a controlled substance, the prescriber’s DEA registration number.    (5)   The written or electronic signature of the prescriber.    b.    Written prescription.In addition to the requirements of paragraph 8.19(1)“a,” a written prescription shall be manually signed, with ink or indelible pencil, by the prescriber. The requirement for manual signature shall not apply when an electronically prepared and signed prescription for a noncontrolled substance is printed on security paper as provided in 657—paragraph 21.7(3)“b.”21.6(2)“b.”    c.    Facsimile prescription.In addition to the requirements of paragraph 8.19(1)“a,” a prescription transmitted via facsimile shall include:    (1)   The identification number of the facsimile machine used to transmit the prescription to the pharmacy.    (2)   The time and date of transmission of the prescription.    (3)   The name, address, telephone number, and facsimile number of the pharmacy to which the prescription is being transmitted.    (4)   If the prescription is for a controlled substance and in compliance with DEA regulations, the manual signature of the prescriber.    d.    Electronic prescription.In addition to the requirements of paragraph 8.19(1)“a,” an electronically prepared prescription for a controlled or noncontrolled prescription drug or device that is electronically transmitted to a pharmacy shall include the prescriber’s electronic signature, except as provided herein.    (1)   An electronically prepared prescription for a controlled substance that is printed out or faxed by the prescriber or the prescriber’s agent shall be manually signed by the prescriber.    (2)   The prescriber shall ensure that the electronic prescription application used to prepare and transmit the electronic prescription complies with applicable state and federal laws, rules, and regulations regarding electronic prescriptions.    (3)   The prescriber or the prescriber’s agent shall provide verbal verification of an electronic prescription upon the request of the pharmacy.    (4)   An electronic prescription for a noncontrolled prescription drug or device that is transmitted by an authorized agent shall not be required to contain the prescriber’s electronic signature.    8.19(2) Verification.  The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of any prescription drug order or medication order consistent with federal and state laws, rules, and regulations. In exercising professional judgment, the prescriber and the pharmacist shall take adequate measures to guard against the diversion of prescription drugs and controlled substances through prescription forgeries.    8.19(3) Transmitting agent.  The prescriber may authorize an agent to transmit to the pharmacy a prescription drug order or medication order orally, by facsimile transmission, or by electronic transmission provided that the first and last names and title of the transmitting agent are included in the order.    a.    New order.A new written or electronically prepared and transmitted prescription drug or medication order shall be manually or electronically signed by the prescriber, except as provided in paragraph 8.19(1)“d.” If transmitted by the prescriber’s agent, the first and last names and title of the transmitting agent shall be included in the order. If the prescription is for a controlled substance and is written or printed from an electronic prescription application, the prescription shall be manually signed by the prescriber. An electronically prepared prescription shall not be electronically transmitted to the pharmacy if the prescription has been printed prior to the electronic transmission. An electronically prepared and electronically transmitted prescription that is printed following the electronic transmission shall be clearly labeled as a copy, not valid for dispensing.    b.    Refill order or renewal order.An authorization to refill a prescription drug or medication order, or to renew or continue an existing drug therapy, may be transmitted to professional pharmacy staff through oral communication, in writing, by facsimile transmission, or by electronic transmission initiated by or directed by the prescriber.    (1)   If the transmission is completed by the prescriber’s agent and the first and last names and title of the transmitting agent are included in the order, the prescriber’s signature is not required on the fax or alternate electronic transmission.    (2)   If the order differs in any manner from the original order, such as a change of the drug strength, dosage form, or directions for use, the prescriber shall sign the order as provided by paragraph 8.19(3)“a.”    8.19(4) Receiving agent.  Regardless of the means of transmission to a pharmacy, only professional pharmacy staff shall be authorized to receive a new prescription drug or medication order from a prescriber or the prescriber’s agent. A technician trainee may receive a refill or renewal order from a prescriber or the prescriber’s agent only if the technician’s supervising pharmacist has authorized that function.    8.19(5) Legitimate purpose.  The pharmacy and professional pharmacy staff shall ensure that the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by a prescriber acting in the usual course of the prescriber’s professional practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued solely on the basis of an Internet-based questionnaire.    8.19(6) Refills.  A refill is one or more dispensings of a prescription drug or device that result in the patient’s receipt of the quantity authorized by the prescriber for a single fill as indicated on the prescription drug order.    a.    Noncontrolled prescription drug or device.A prescription for a prescription drug or device that is not a controlled substance may authorize no more than 12 refills within 18 months following the date on which the prescription is issued.    b.    Controlled substance.A prescription for a Schedule III, IV, or V controlled substance may authorize no more than 5 refills within 6 months following the date on which the prescription is issued.    8.19(7) Epinephrine auto-injector prescription issued to school or facility.  A physician, an advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, or an accredited nonpublic school. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the facility, the school district, or the accredited nonpublic school in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.    a.    The pharmacy’s patient profile and record of dispensing of a prescription issued pursuant to this subrule shall be maintained in the name of the facility, school district, or accredited nonpublic school to which the prescription was issued and the drug was dispensed.    b.    The label affixed to an epinephrine auto-injector dispensed pursuant to this subrule shall identify the name of the facility, school district, or accredited nonpublic school to which the prescription is dispensed.    8.19(8) Opioid antagonist prescription issued to law enforcement, fire department, or service program.  A physician, an advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more opioid antagonists in the name of a law enforcement agency, fire department, or service program pursuant to Iowa Code section 147A.18 and rule 657—39.7(135,147A). The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the law enforcement agency, fire department, or service program in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.    a.    The pharmacy’s patient profile and record of dispensing of an opioid antagonist pursuant to this subrule shall be maintained in the name of the law enforcement agency, fire department, or service program to which the prescription was issued and the drug was dispensed.    b.    The label affixed to an opioid antagonist dispensed pursuant to this subrule shall identify the name of the law enforcement agency, fire department, or service program to which the prescription is dispensed and shall be affixed such that the expiration date of the drug is not rendered illegible.

        ITEM 3.    Amend rule 657—10.24(124,126,155A) as follows:

    657—10.24(124,126,155A) Prescription requirements.  All prescriptions for controlled substances shall be dated as of, and signed on, the day issued. Controlled substances prescriptions shall be valid for six months following date of issue. A prescription for a Schedule III, IV, or V controlled substance may include authorization to refill the prescription no more than five times within the six months following date of issue. A prescription for a Schedule II controlled substance shall not be refilled.Beginning January 1, 2020, all prescriptions for controlled substances shall be transmitted electronically to a pharmacy pursuant to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A).    10.24(1) Form of prescription.  All prescriptions for controlled substances shall bear the full name and address of the patient; the drug name, strength, dosage form, quantity prescribed, and directions for use; and the name, address, and DEA registration number of the prescriber. All prescriptions for controlled substances issued by individual prescribers shall include the legibly preprinted, typed, or hand-printed name of the prescriber as well as the prescriber’s written or electronic signature. A prescription for a controlled substance issued prior to January 1, 2020, or a prescription for a controlled substance that is exempt from the electronic prescription mandate pursuant to rule 657—21.8(124,155A), may be transmitted via nonelectronic methods as described in this rule.    a.    When an oral order is not permitted, or when a prescriber is unable to prepare and transmit an electronic prescription in compliance with DEA requirements for electronic prescriptions, prescriptions shall be written with ink, indelible pencil, or typed print and shall be manually signed by the prescriber. If the prescriber utilizes an electronic prescription application that meets DEA requirements for electronic prescriptions, the prescriber may electronically prepare and transmit a prescription for a controlled substance to a pharmacy that utilizes a pharmacy prescription application that meets DEA requirements for electronic prescriptions.     b.    A prescriber’s agent may prepare a prescription for the review, authorization, and manual or electronic signature of the prescriber, but the prescribing practitioner is responsible for the accuracy, completeness, and validity of the prescription.     c.    An electronic prescription for a controlled substance shall not be transmitted to a pharmacy except by the prescriber in compliance with DEA regulations.     d.    A prescriber shall securely maintain the unique authentication credentials issued to the prescriber for utilization of the electronic prescription application and authentication of the prescriber’s electronic signature. Unique authentication credentials issued to any individual shall not be shared with or disclosed to any other prescriber, agent, or individual.     e.    A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this rule.    10.24(2) Verification by pharmacist.      a.    The pharmacist shall verify the authenticity of the prescription with the individual prescriber or the prescriber’s agent in each case when a written or oral prescription for a Schedule II controlled substance is presented for filling and neither the prescribing individual practitioner issuing the prescription nor the patient or patient’s agent is known to the pharmacist. The pharmacist shall verify the authenticity of the prescription with the individual prescriber or the prescriber’s agent in any case when the pharmacist questions the validity of, including the legitimate medical purpose for, the prescription. The pharmacist is required to record the manner by which the prescription was verified and include the pharmacist’s name or unique identifier.    b.    A pharmacist who receives a written, oral, or facsimile prescription shall not be required to verify that the prescription is subject to an exception to the electronic prescription mandate provided in rule 657—21.8(124,155A) and may dispense a prescription drug pursuant to an otherwise valid written, oral, or facsimile prescription pursuant to this rule.    10.24(3) Intern, resident, foreign physician.  An intern, resident, or foreign physician exempt from registration pursuant to subrule 10.8(5) shall include on all prescriptions issued the hospital’s registration number and the special internal code number assigned by the hospital in lieu of the prescriber’s registration number required by this rule. Each prescription shall include the stamped or legibly printed name of the prescribing intern, resident, or foreign physician as well as the prescriber’s signature.    10.24(4) Valid prescriber/patient relationship.  Once the prescriber/patient relationship is broken and the prescriber is no longer available to treat the patient or to oversee the patient’s use of the controlled substance, a prescription shall lose its validity. A prescriber/patient relationship shall be deemed broken when the prescriber dies, retires, or moves out of the local service area or when the prescriber’s authority to prescribe is suspended, revoked, or otherwise modified to exclude authority for the schedule in which the prescribed substance is listed. The pharmacist, upon becoming aware of the situation, shall cancel the prescription and any remaining refills. However, the pharmacist shall exercise prudent judgment based upon individual circumstances to ensure that the patient is able to obtain a sufficient amount of the drug to continue treatment until the patient can reasonably obtain the service of another prescriber and a new prescription can be issued.    10.24(5) Facsimile transmission of a controlled substance prescription.  With the exception of an authorization for emergency dispensing as provided in rule 657—10.26(124), a prescription for a controlled substance in Schedules II, III, IV and V may be transmitted via facsimile from a prescriber to a pharmacy only as provided in rule 657—21.9(124,155A)657—21.7(124,155A).

        ITEM 4.    Amend subrule 10.29(3) as follows:    10.29(3) Dates and instructions.  Each prescription issued pursuant to this rule shall be dated as of and manuallyor electronically signed by the prescriber on the day the prescription is issued. Each separate prescription, other than the first prescription if that prescription is intended to be filled immediately, shall contain written instructions indicating the earliest date on which a pharmacist may fill each prescription.

        ITEM 5.    Amend rule 657—10.32(124) as follows:

    657—10.32(124) Schedule III, IV, or V prescription.  No prescription for a controlled substance listed in Schedule III, IV, or V shall be filled or refilled more than six months after the date on which it was issued nor be refilled more than five times.Beginning January 1, 2020, all prescriptions for controlled substances shall be transmitted electronically to a pharmacy pursuant to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A).    10.32(1) Record.  Each filling and refilling of a prescription shall be entered in a uniformly maintained and readily retrievable record in accordance with rule 657—10.25(124). If the pharmacist merely initials or affixes the pharmacist’s unique identifier and dates the back of the prescription, it shall be deemed that the full face amount of the prescription has been dispensed.    10.32(2) Oral refill authorization.  The prescribing practitioner may authorize additional refills of Schedule III, IV, or V controlled substances on the original prescription through an oral refill authorization transmitted to an authorized individual at the pharmacy provided the following conditions are met:    a.    The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issuance of the original prescription.    b.    The pharmacist, pharmacist-intern, or technician who obtains the oral authorization from the prescriber who issued the original prescription documents, on or with the original prescription, the date authorized, the quantity of each refill, the number of additional refills authorized, and the unique identification of the authorized individual.    c.    The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling of the original prescription.    d.    The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.    10.32(3) Partial fills.  The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible provided that each partial fill is recorded in the same manner as a refill pursuant to subrule 10.32(1). The total quantity dispensed in all partial fills shall not exceed the total quantity prescribed.    10.32(4) Medication order.  A Schedule III, IV, or V controlled substance may be administered or dispensed to institutionalized patients pursuant to a medication order as provided in 657—subrule 7.13(1) or rule 657—23.9(124,155A), as applicable.

        ITEM 6.    Adopt the following new definition of “CSA” in rule 657—21.2(124,155A):        "CSA" means the Iowa uniform controlled substances Act.

        ITEM 7.    Adopt the following new definition of “CSA registration” in rule 657—21.2(124,155A):        "CSA registration" means the registration issued by the board pursuant to the CSA that signifies the registrant’s authorization to engage in registered activities with controlled substances.

        ITEM 8.    Amend rule 657—21.6(124,155A) as follows:

    657—21.6(124,155A) Electronic prescription applications.   ABeginning January 1, 2020, each prescription for a controlled substance shall be transmitted electronically to a pharmacy except as provided in rule 657—21.8(124,155A). Prior to January 1, 2020, a prescriber may, but shall not be required to, initiate and authorize a prescription drug order utilizing an electronic prescription application that has been determined to maintain security and confidentiality of patient information and records and, if prescribing controlled substances via an electronic prescribing system, certified compliant with DEA regulations for electronic prescribing of controlled substances. The prescription drug order shall contain all information required by Iowa Code sections 155A.27 and 147.107(5). The receiving pharmacist shall be responsible for verifying the authenticity of an electronically prescribed prescription pursuant to rule 657—8.19(124,126,155A). A prescription that is electronically generatedprior to January 1, 2020, or subject to exemption as provided in rule 657—21.8(124,155A), may be transmitted to a pharmacy via electronic or facsimile transmission or printed in hard-copy format for delivery to the pharmacy. A prescription that is transmitted by a prescriber’s agent via electronic or facsimile transmission shall include the first and last names and title of the agent responsible for the transmission.    21.6(1) Electronic transmission.   ABeginning January 1, 2020, a prescription prepared pursuant to this rule mayshall be transmittedelectronically to a pharmacy via electronic transmission, unless exempt pursuant to rule 657—21.8(124,155A). A pharmacy shall be certified compliant with DEA regulations relating to electronic prescriptions prior to electronically receiving prescriptions for controlled substances. The electronic record shall serve as the original record and shall be maintained for two years from the date of last activity on the prescription. Any annotations shall be made and retained on the electronic record.    a.    An electronically prepared and transmitted prescription that is printed following transmission shall be clearly labeled as a copy, not valid for dispensing.    b.    The authenticity of a prescription transmitted via electronic transmission between a DEA-certified electronic prescription application and a DEA-certified electronic automated data processing system shall be deemed verified by virtue of the security processes included in those applications.    c.    A pharmacy shall ensure that no intermediary has the ability to change the content of the prescription drug order or compromise its confidentiality during the transmission process. The electronic format of the prescription drug order may be changed by the intermediary to facilitate the transmission between electronic applications as long as the content of the prescription drug order remains unchanged.    d.    In addition to the information requirements for a prescription, an electronically transmitted prescription shall identify the transmitter’s telephone number for verbal confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission as well as any other information required by federal or state laws, rules, or regulations.    e.    If the transmission of an electronic prescription fails, the prescriber may print the prescription, manually sign the printed prescription, and deliver the prescription to the pharmacy via facsimile transmission in accordance with subrule 21.6(2).    21.6(2) Printed (hard-copy) prescriptions.  An electronically generatedA prescriptionelectronically generated prior to January 1, 2020, or a prescription that is exempt from the electronic prescription mandate as provided in rule 657—21.8(124,155A), may be printed in hard-copy format for facsimile transmission or delivery to the pharmacy.    a.    A prescription for a controlled substance shall include the prescriber’s manualor electronic signature. Printed or hard-copy prescriptions for Schedule II controlled substances shall not be transmitted to a pharmacy via facsimile transmission, except as authorized in rule 657—21.7(124,155A).    b.    If the prescriber authenticates a prescription for a noncontrolled prescription drug utilizing an electronic signature, the printed prescription shall be printed on security paper. Security features of the paper shall ensure that prescription information is not obscured or rendered illegible when transmitted via facsimile or when scanned into an electronic record system.    c.    If the facsimile transmission of a printed prescription is a result of a failed electronic transmission, the facsimile shall indicate that it was originally transmitted to the named pharmacy, the date and time of the original electronic transmission, and the fact that the original transmission failed.

        ITEM 9.    Adopt the following new rule 657—21.8(124,155A):

    657—21.8(124,155A) Electronic prescription mandate and exemptions.  Beginning January 1, 2020, all prescriptions shall be transmitted electronically to a pharmacy except as provided in this rule.    21.8(1) Prescriptions exempt.  Prescriptions which shall be exempt from electronic transmission include:    a.    A prescription for a patient residing in a nursing home, long-term care facility, correctional facility, or jail.    b.    A prescription authorized by a licensed veterinarian.    c.    A prescription for a device.    d.    A prescription dispensed by a department of veterans affairs pharmacy.    e.    A prescription requiring information that makes electronic transmission impractical, such as complicated or lengthy directions for use or attachments.    f.    A prescription for a compounded preparation containing two or more components.    g.    A prescription issued in response to a public health emergency in a situation where a non-patient specific prescription would be permitted.    h.    A prescription issued for an opioid antagonist pursuant to Iowa Code section 135.190 or a prescription issued for epinephrine pursuant to Iowa Code section 135.185.    i.    A prescription issued during a temporary technical or electronic failure at the location of the prescriber or pharmacy, provided that a prescription issued pursuant to this paragraph shall indicate on the prescription that the prescriber or pharmacy is experiencing a temporary technical or electronic failure.    j.    A prescription issued pursuant to an established and valid collaborative practice agreement, standing order, or drug research protocol.    k.    A prescription issued in an emergency situation pursuant to federal law and regulation and rules of the board.    21.8(2) Prescriber, medical group, institution, or pharmacy exemption.  A prescriber, medical group institution, or pharmacy which has been granted an exemption to the electronic prescription mandate pursuant to rule 657—21.9(124,155A) shall be exempt from the electronic prescription mandate only for the duration of the approved exemption. Upon expiration of an approved exemption, the prescriber, medical group, institution, or pharmacy shall either comply with the electronic prescription mandate or timely petition the board for renewal of the exemption pursuant to rule 657—21.9(124,155A).

        ITEM 10.    Adopt the following new rule 657—21.9(124,155A):

    657—21.9(124,155A) Exemption from electronic prescription mandate—petition.  A prescriber, medical group, institution, or pharmacy that is unable to comply with the electronic prescription mandate in rule 657—21.8(124,155A) prior to January 1, 2020, may petition the board, on forms provided by the board, for an exemption from the requirements based upon economic hardship; technical limitations that the prescriber, medical group, institution, or pharmacy cannot control; or other exceptional circumstances. A prescriber, medical group, institution, or pharmacy seeking an exemption beginning January 1, 2020, shall submit a completed petition no later than October 1, 2019. A timely petition for renewal of a previously approved exemption shall be submitted at least 60 days in advance of the expiration of the previously approved exemption.    21.9(1) Petition information.  A petition for exemption from the electronic prescription mandate shall include, but not be limited to, all of the following:    a.    The name and address of the prescriber, medical group, institution, or pharmacy seeking the exemption. For medical groups and institutions, a list of the names, professional license numbers, and CSA registration numbers of all prescribers who would be covered by the exemption.    b.    Whether the petitioner is seeking an exemption for controlled substance prescriptions, non-controlled substance prescriptions, or both.    c.    The petitioner’s current electronic prescribing capabilities.    d.    The reason, such as economic hardship, technological limitations, or other exceptional circumstances, the petitioner is seeking exemption.    e.    Supporting documentation to justify the reason for the exemption, including the following mandatory documentation:    (1)   For economic hardship petitions, a copy of the petitioner’s most recent tax return showing annual income and at least two quotes documenting the cost of implementing electronic prescribing.    (2)   For technological limitation petitions, documentation showing the available Internet service providers, the speed and bandwidth available from each provider, and any data caps imposed by the Internet service provider, and documentation showing the minimum technological requirements from at least two electronic prescribing platform vendors.    f.    Anticipated date of compliance with the electronic prescription mandate.    g.    If the petition seeks renewal of a previously approved exemption, information relating to the petitioner’s actions during the previous exemption period to work toward compliance with the electronic prescription mandate or an explanation as to why no progress has been made.    21.9(2) Criteria for board consideration of a petition.  The board shall consider all information provided in a petition seeking exemption to the electronic prescription mandate and shall approve or deny a petition for exemption based on the following criteria:    a.    If the reason for exemption is economic hardship, whether the cost of compliance with the electronic prescription mandate would exceed 5 percent of the petitioner’s annual income as reported on the petitioner’s most recent tax return.    b.    If the reason for exemption is technological limitations, whether the Internet service providers available have the technological capabilities required by the electronic prescribing platform.    c.    If the reason for exemption is other exceptional circumstances, examples of exceptional circumstances include, but are not limited to, whether the petitioner is a free or low-income clinic, whether the petitioner had a bankruptcy in the previous year, whether the petitioner intends to discontinue practice in Iowa prior to December 31, 2020, and whether the petitioner has a disability that limits the ability to utilize an electronic prescribing platform. All other exceptional circumstances will be evaluated on a case-by-case basis.    d.    If the petition seeks renewal of a previous exemption to the electronic prescription mandate, the number of exemptions previously granted and updated information as it relates to the petitioner working toward compliance with the electronic prescription mandate or the explanation as to why no progress has been made.    21.9(3) Duration of approved exemption.  The board may approve an exemption, or the renewal of an exemption, to the electronic prescription mandate for a specified period of time not to exceed one year from the date of approval.    ARC 4388CPharmacy Board[657]Notice of Intended Action

    Proposing rule making related to statewide protocols and providing an opportunity for public comment

        The Board of Pharmacy hereby proposes to amend Chapter 39, “Expanded Practice Standards,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 147.76 and 155A.46.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 155A.46.Purpose and Summary    Following adoption of rule making relating to a pharmacist’s participation in statewide protocols (ARC 4270C, IAB 1/30/19), concern was raised relating to the term “prescribe” used in the applicable rules for the statewide protocols. To address the concern, amendments that replace “prescribe” with “order” consistent with language used in the Iowa Code were adopted and filed emergency and are published herein (ARC 4387C, IAB 4/10/19). Those amendments are included in this Notice to allow for public comment. Additional amendments are proposed in this Notice to clarify that, for the purpose of these rules, the order shall constitute a prescription to ensure that medications dispensed pursuant to a statewide protocol by a pharmacist’s order can be eligible for third-party reimbursement.Fiscal Impact    This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34. Public Comment     Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Sue Mears Board of Pharmacy 400 S.W. 8th Street, Suite E Des Moines, Iowa 50309 Email: sue.mears@iowa.govPublic Hearing     No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Amend rule 657—39.6(155A) as follows:

    657—39.6(155A) Statewide protocols.  A pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of public health and available on the board’s website at pharmacy.iowa.gov, prescribeorder and dispense medications pursuant to rules 657—39.8(155A), 657—39.9(155A), and 657—39.11(155A).For the purpose of this rule, the order shall constitute a prescription.

        ITEM 2.    Amend rule 657—39.8(155A) as follows:

    657—39.8(155A) Statewide protocol—naloxone.  An authorized pharmacist may prescribeorder and dispense naloxone to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of naloxone to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.For the purpose of this rule, the order shall constitute a prescription.    39.8(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has completed the training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered pharmacist-intern who has completed the training requirements of this rule and is working under the direct supervision of an authorized pharmacist.        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has completed the training requirements for an authorized pharmacist pursuant to this rule.        "Board" means the Iowa board of pharmacy.        "Patient" means an individual consulting with a pharmacist for drug therapy and may include an individual in a position to assist someone at risk of an opioid-related overdose.    39.8(2) Authorized pharmacist training.  An authorized pharmacist shall document successful completion of an ACPE-approved continuing education program of at least one-hour duration related to naloxone utilization prior to dispensing naloxone pursuant to the statewide protocol.    39.8(3) Assessment.  An authorized pharmacist shall assess a patient for eligibility to receive naloxone using criteria identified in the statewide protocol.    39.8(4) Patient education.  Upon assessment and determination that a patient is eligible to receive and possess naloxone pursuant to the statewide protocol, an authorized pharmacist shall, prior to dispensing naloxone pursuant to the statewide protocol, provide training and education to the patient including, but not limited to, the information identified in this subrule. An authorized pharmacist may provide to the patient written materials that include, but may not be limited to, the information identified in this subrule, but the written materials shall not be in lieu of direct pharmacist consultation with the patient.    a.    The signs and symptoms of opioid-related overdose as described in the statewide protocol.    b.    The importance of calling 911 as soon as possible and the potential need for rescue breathing.    c.    The appropriate use and directions for administration of the naloxone to be dispensed pursuant to the statewide protocol.    d.    Adverse reactions of naloxone as well as reactions resulting from opioid withdrawal following administration.    e.    The proper storage conditions, including temperature excursions, of the naloxone product being dispensed.    f.    The expiration date of the naloxone product being dispensed and the appropriate disposal of the naloxone product upon expiration.    g.    Information about substance abuse or behavioral health treatment programs, if applicable.    39.8(5) Labeling.  Naloxone dispensed pursuant to this rule shall be labeled in accordance with rule 657—6.10(126,155A), and the labeling shall not render the expiration date of the product illegible.    39.8(6) Reporting.  As soon as reasonably possible, the authorized pharmacist shall notify the patient’s primary health care provider of the naloxone product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the naloxone product provided to the patient and shall advise the patient to consult a physician.    39.8(7) Records.  An authorized pharmacist shall maintain records of naloxone prescribedordered and dispensed pursuant to the statewide protocol.

        ITEM 3.    Amend rule 657—39.9(155A) as follows:

    657—39.9(155A) Statewide protocol—nicotine replacement tobacco cessation products.  An authorized pharmacist may prescribeorder and dispense nicotine replacement tobacco cessation products to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of a nicotine replacement tobacco cessation product to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.For the purpose of this rule, the order shall constitute a prescription.    39.9(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has completed the training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered pharmacist-intern who has completed the training requirements of this rule and is working under the direct supervision of an authorized pharmacist.        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has completed the training requirements for an authorized pharmacist pursuant to this rule.        "Board" means the Iowa board of pharmacy.    39.9(2) Authorized pharmacist training.  An authorized pharmacist shall document successful completion of an ACPE-approved continuing education program of at least one-hour duration related to nicotine replacement tobacco cessation product utilization prior to dispensing such products under the statewide protocol.    39.9(3) Assessment.  An authorized pharmacist shall assess a patient for appropriateness of receiving a nicotine replacement tobacco cessation product pursuant to the statewide protocol.    39.9(4) Patient counseling and instructions.  Upon assessment and determination that provision of the nicotine replacement tobacco cessation product is appropriate pursuant to the statewide protocol, an authorized pharmacist shall, prior to dispensing such product, provide counseling and instructions to the patient pursuant to rule 657—6.14(155A).    39.9(5) Labeling.  Nicotine replacement tobacco cessation products dispensed pursuant to this rule shall be labeled in accordance with rule 657—6.10(126,155A), and the labeling shall not render the expiration date of the product illegible.    39.9(6) Reporting.  As soon as reasonably possible, the authorized pharmacist shall notify the patient’s primary health care provider of the nicotine replacement tobacco cessation product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the nicotine replacement tobacco cessation product provided to the patient and shall advise the patient to consult a physician.    39.9(7) Records.  An authorized pharmacist shall maintain records of nicotine replacement tobacco cessation products prescribedordered and dispensed pursuant to the statewide protocol.

        ITEM 4.    Amend rule 657—39.11(155A) as follows:

    657—39.11(155A) Vaccine administration by pharmacists—statewide protocol.  An authorized pharmacist may prescribeorder and administer vaccines and immunizations pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the prescribingordering and administration of a vaccine to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.For the purpose of this rule, the order shall constitute a prescription.    39.11(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACIP" means the CDC Advisory Committee on Immunization Practices.        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has met the requirements identified in subrule 39.11(3).        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has met the requirements for an authorized pharmacist identified in subrule 39.11(3).        "Board" means the Iowa board of pharmacy.        "CDC" means the United States Centers for Disease Control and Prevention.        "Immunization" shall have the same meaning as, and shall be interchangeable with, the term “vaccine.”        "Vaccine" means a specially prepared antigen administered to a person for the purpose of providing immunity.    39.11(2) Vaccines authorized by statewide protocol.  The vaccines authorized to be prescribedordered and administered pursuant to the statewide protocol shall include:    a.    To patients ages 18 years and older:    (1)   An immunization or vaccination recommended by ACIP in its approved vaccination schedule for adults.    (2)   An immunization or vaccination recommended by CDC for international travel.    (3)   A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application.    (4)   Other emergency immunizations or vaccinations in response to a public health emergency.    b.    To patients ages six months and older:    (1)   A vaccine or immunization for influenza.    (2)   Other emergency immunizations or vaccines in response to a public health emergency.    c.    To patients ages 11 years and older:    (1)   The final two doses in a course of vaccinations for human papillomavirus (HPV).    (2)   Reserved.    39.11(3) Authorized pharmacist training and continuing education.  An authorized pharmacist shall document successful completion of the requirements in paragraph 39.11(3)“a” and shall maintain competency by completing and maintaining documentation of the continuing education requirements in paragraph 39.11(3)“b.”    a.    Initial qualification.An authorized pharmacist shall have successfully completed an organized course of study in a college or school of pharmacy or an ACPE-accredited continuing education program on vaccine administration that:    (1)   Requires documentation by the pharmacist of current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.    (2)   Is an evidence-based course that includes study material and hands-on training and techniques for administering vaccines, requires testing with a passing score, complies with current CDC guidelines, and provides instruction and experiential training in the following content areas:    1.   Standards for immunization practices;    2.   Basic immunology and vaccine protection;    3.   Vaccine-preventable diseases;    4.   Recommended immunization schedules;    5.   Vaccine storage and management;    6.   Informed consent;    7.   Physiology and techniques for vaccine administration;    8.   Pre- and post-vaccine assessment, counseling, and identification of contraindications to the vaccine;    9.   Immunization record management; and    10.   Management of adverse events, including identification, appropriate response, documentation, and reporting.    b.    Continuing education.During any pharmacist license renewal period, an authorized pharmacist who engages in the administration of vaccines shall complete and document at least one hour of ACPE-approved continuing education with the ACPE topic designator “06” followed by the letter “P.”    c.    Certification maintained.During any period within which the pharmacist may engage in the administration of vaccines, the pharmacist shall maintain current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.    39.11(4) Assessment.  An authorized pharmacist shall assess a patient for appropriateness of receiving a vaccine pursuant to the statewide protocol.    39.11(5) Verification and reporting.  Prior to the prescribingordering and administration of an immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and review the statewide immunization registry or health information network. As soon as reasonably possible following administration of a vaccine, the pharmacist shall report such administration to the patient’s primary health care provider, primary physician, and a statewide immunization registry or health information network. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the vaccine administered to the patient and shall advise the patient to consult a physician.    ARC 4389CProfessional Licensure Division[645]Notice of Intended Action

    Proposing rule making related to behavior analysts and assistant behavior analysts and providing an opportunity for public comment

        The Board of Behavioral Science hereby proposes to amend Chapter 5, “Fees,” Chapter 31, “Licensure of Marital and Family Therapists and Mental Health Counselors,” and Chapter 33, “Discipline for Marital and Family Therapists and Mental Health Counselors,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 147.76 and 154D.3.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code chapter 154D.Purpose and Summary    The proposed amendments add licensing rules for two new professions, behavior analysts and assistant behavior analysts. The amendments also set license fees at $300 for the two new professions.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    A waiver provision is not included in this rule making because all administrative rules of the professional licensure boards in the Professional Licensure Division are subject to the waiver provisions accorded under 645—Chapter 18.Public Comment     Any interested person may submit written or oral comments concerning this proposed rule making. Written or oral comments in response to this rule making must be received by the Board no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Tony Alden Professional Licensure Division Lucas State Office Building 321 East 12th Street Des Moines, Iowa 50319 Phone: 515.281.4401 Fax: 515.281.3121 Email: tony.alden@idph.iowa.govPublic Hearing    A public hearing at which persons may present their views orally or in writing will be held as follows: April 30, 2019 8 to 8:30 a.m. Fifth Floor Conference Room 526 Lucas State Office Building Des Moines, Iowa     Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.    Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Emergency Rule Making Adopted by Reference    This proposed rule making is also published herein as an Adopted and Filed Emergency rule making (see ARC 4390C, IAB 4/10/19). The purpose of this Notice of Intended Action is to solicit public comment on that emergency rule making, whose subject matter is hereby adopted by reference.

    ARC 4381CRevenue Department[701]Notice of Intended Action

    Proposing rule making related to excise tax rate on motor fuels and providing an opportunity for public comment

        The Revenue Department hereby proposes to amend Chapter 68, “Motor Fuel and Undyed Special Fuel,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 421.14 and 452A.59.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 452A.3.Purpose and Summary    This proposed rule making amends subrule 68.2(1) to adjust the excise tax rate on gasoline from 30.7¢ per gallon (ending June 30, 2019) to 30.5¢ per gallon (beginning July 1, 2019) pursuant to the formula prescribed by Iowa Code section 452A.3. The ethanol distribution percentage for calendar year 2018 is between 60 percent and 65 percent, a decrease from 2017. As a result, pursuant to Iowa Code section 452A.3(1)“b”(4), in fiscal year 2020 the excise tax rate for ethanol blended gasoline will remain 29¢ per gallon, but the excise tax rate for gasoline will decrease from 30.7¢ per gallon to 30.5¢ per gallon.Fiscal Impact    Under the excise tax rates applicable for fiscal year 2020 as proposed in this rule making and as required by statute, it is estimated that, accounting for refunds, collections will be $435.3 million, resulting in a decrease of $1.1 million in revenues. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to rule 701—7.28(17A).Public Comment    Any interested person may submit written or oral comments concerning this proposed rule making. Written or oral comments in response to this rule making must be received by the Department no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Joe Fraioli Department of Revenue Hoover State Office Building P.O. Box 10457 Des Moines, Iowa 50306 Phone: 515.725.4057 Email: joe.fraioli@iowa.govPublic Hearing    No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making action is proposed:

        ITEM 1.    Amend subrule 68.2(1) as follows:    68.2(1)   The following rates of tax apply to the use of fuel in operating motor vehicles and aircraft:Gasoline20.3¢ per gallon (for July 1, 2003, through June 30, 2004) 20.5¢ per gallon (for July 1, 2004, through June 30, 2005) 20.7¢ per gallon (for July 1, 2005, through June 30, 2006) 21¢ per gallon (for July 1, 2006, through June 30, 2007) 20.7¢ per gallon (for July 1, 2007, through June 30, 2008) 21¢ per gallon (for July 1, 2008, through February 28, 2015) 31¢ per gallon (for March 1, 2015, through June 30, 2015) 30.8¢ per gallon (for July 1, 2015, through June 30, 2016) 30.7¢ per gallon (for July 1, 2016, through June 30, 2017) 30.5¢ per gallon (for July 1, 2017, through June 30, 2018) 30.7¢ per gallon (beginningfor July 1, 2018, through June 30, 2019) 30.5¢ per gallon (beginning July 1, 2019)Ethanol blended gasoline19¢ per gallon (for July 1, 2003, through February 28, 2015) 29¢ per gallon (for March 1, 2015, through June 30, 2015) 29.3¢ per gallon (for July 1, 2015, through June 30, 2016) 29¢ per gallon (beginning July 1, 2016)E-85 gasoline17¢ per gallon (for January 1, 2006, through June 30, 2007) 19¢ per gallon (for July 1, 2007, through February 28, 2015) 29¢ per gallon (for March 1, 2015, through June 30, 2015) 29.3¢ per gallon (for July 1, 2015, through June 30, 2016) 29¢ per gallon (beginning July 1, 2016)Aviation gasoline8¢ per gallon (beginning July 1, 1988)Diesel fuel other than B-11 or higher22.5¢ per gallon (on and before February 28, 2015) 32.5¢ per gallon (beginning March 1, 2015) Biodiesel blended fuel (B-11 orhigher)22.5¢ per gallon (on and before February 28, 2015) 32.5¢ per gallon (for March 1, 2015, through June 30, 2015) 29.5¢ per gallon (beginning July 1, 2015)Aviation jet fuel3¢ per gallon (on and before February 28, 2015) 5¢ per gallon (beginning March 1, 2015)L.P.G.20¢ per gallon (on and before February 28, 2015) 30¢ per gallon (beginning March 1, 2015)C.N.G.16¢ per 100 cu. ft. (on and before June 30, 2014) 21¢ per gallon (for July 1, 2014, through February 28, 2015) 31¢ per gallon (beginning March 1, 2015)L.N.G.22.5¢ per gallon (on and before February 28, 2015) 32.5¢ per gallon (beginning March 1, 2015)    ARC 4384CSecretary of State[721]Notice of Intended Action

    Proposing rule making related to voter registration age and providing an opportunity for public comment

        The Secretary of State hereby proposes to amend Chapter 23, “Voter Registration in State Agencies,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 17A.3 and 48A.19.State or Federal Law Implemented    This rule making implements, in whole or in part, 2017 Iowa Acts, House File 516.Purpose and Summary    2017 Iowa Acts, House File 516, division VIII, lowered the voter registration age from 17½ years of age to 17 years of age effective January 1, 2019. These proposed amendments bring the corresponding administrative rules into conformity with the law.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Secretary of State for a waiver of the discretionary provisions, if any, pursuant to 721—Chapter 10. Public Comment     Any interested person may submit written or oral comments concerning this proposed rule making. Written or oral comments in response to this rule making must be received by the Secretary of State no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Molly Widen Office of the Secretary of State Lucas State Office Building, First Floor 321 East 12th Street Des Moines, Iowa 50319 Phone: 515.281.5864 Email: molly.widen@sos.iowa.govPublic Hearing     No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Amend rule 721—23.3(48A) as follows:

    721—23.3(48A) Declination forms.  The offer of voter registration shall include a declination form in substantially the following form:STATE OF IOWAVoter Registration InformationYou can apply to register to vote when you apply for assistance. This agency is required to offer you the chance to register to vote.Registration Rules—You must be registered before you can vote in an election.To register to vote in Iowa you must—
  • be a citizen of the United States
  • be a resident of Iowa
  • be at least 17½17 years old (you must be 18years old by election day to vote)
  • not have been convicted of a felony (or have had your rights restored)
  • not currently be judged “mentally incompetent” by a court
  • give up the right to vote in any other place.
    • Help: If you would like help in filling out the voter registration form, we will help you. The decision whether to seek or accept help is yours. You may fill out the application form in private.Benefits: Applying to register or declining to register to vote will not affect the amount of assistance that you will be provided by this agency.Privacy: If you register to vote, the name of the office where you turn in the form will be kept private. If you do not register to vote, this fact will be kept private. This information will be used only for voter registration purposes.Complaints: If you believe that someone has interfered with your right to
  • register or to decline to register to vote,
  • privacy in deciding whether to register,
  • privacy in applying to register to vote,
  • choose your own political party or other political preference,
    • you may file a complaint with:Voter Registration CommissionOffice of the Secretary of StateLucas State Office BuildingDes Moines, Iowa 50319Telephone: (515)281-0145If you are not registered to vote where you live now, would you like to apply to register to vote here today?□ Yes, I want to register to vote.□ No, I do not want to register to vote.If you do not check either box, you will be considered to have decided not to register to vote at this time.Sign here: X Print your name: Date:

        ITEM 2.    Amend rule 721—23.10(48A) as follows:

    721—23.10(48A) Ineligible applicants.      23.10(1) Ineligible minor applicants.  An agency that has applicants who are ineligible to vote because they are minors shall not offer an opportunity to register to vote to applicants who the agency has validated are under the age of 17½17. The agency must still offer information about voter registration to all applicants.    23.10(2) All other ineligible applicants.  Except for those applicants specifically described in subrule 23.10(1), the opportunity to register to vote must be offered to every applicant. The applicant, not the agency, is responsible for determining the applicant’s eligibility to register to vote. The agency shall accept a registration form even if it is submitted by an applicant the agency believes to be ineligible to register to vote.Applicants who are not accepted for services or assistance by an agency shall be offered the opportunity to register to vote. Even if the applicant will not receive services or assistance from the agency, voter registration forms shall be processed and transmitted not later than the final working day of the week to the appropriate county commissioner of elections as required by Iowa Code section 48A.21.    ARC 4385CTransportation Department[761]Notice of Intended Action

    Proposing rule making related to funding for traffic safety improvements or studies and providing an opportunity for public comment

        The Department of Transportation hereby proposes to amend Chapter 164, “Traffic Safety Improvement Program,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code section 307.12.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 312.2(11).Purpose and Summary    This rule making proposes amendments to Chapter 164, which provides funding for traffic safety improvements or studies on public roads under county, city or state jurisdiction.  Generally, the proposed amendments will simplify the application process and review criteria by rearranging some of the rule language to make the chapter more reader-friendly, add and amend definitions, remove unnecessary language, and change the term “Traffic Safety Fund” to “Traffic Safety Improvement Program” to reflect the correct name of the program.    The Traffic Safety Improvement Program (TSIP), established by the Iowa Legislature in 1987, was created for the purpose of implementing traffic safety features that will aid in reducing fatalities and serious injuries on Iowa’s roadways.  The TSIP is funded using one-half of one percent of the Road Use Tax Fund in accordance with Iowa Code section 312.2(11).  The program has traditionally been available to only the Department, cities and counties.  The proposed amendments expand TSIP eligibility to include all public entities that are responsible for public roads and streets in any state park, state institution, or other state land as defined in Iowa Code section 306.3(10).  The proposed amendments allow public agencies, such as state universities and state schools, to apply for TSIP funding directly.  Currently, these entities must request that the appropriate underlying eligible governmental entity (usually a city or a district office of the Department) submit a TSIP project funding application on the entities’ behalf.  The proposed amendments eliminate the need for the extra layer of involvement.     The proposed amendments clarify program operations and submittal requirements to improve efficiency of the program’s administration. Potential applicants are directed to the Department’s website for TSIP application directions, forms, and worksheets.  In addition, TSIP applications will be submitted electronically, making the distribution of applications for review more efficient and saving on postage and a considerable amount of paper.     The proposed amendments state that the funds awarded by the Iowa Transportation Commission not used within the time specified in the project agreement will be retained for subsequent programming cycles.  This provision will improve the efficiency of the program and ensure available funds are being used to the maximum extent. Fiscal Impact    This rule making has no fiscal impact to the State of Iowa. As specified in Iowa Code section 312.2(11), the TSIP is funded each year by one-half of one percent of the Road Use Tax Fund. Funding levels for the program will not change. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the person’s circumstances meet the statutory criteria for a waiver may petition the Department for a waiver under 761—Chapter 11. Public Comment    Any interested person may submit written comments concerning this proposed rule making or may submit a written request to make an oral presentation at a public hearing. Written comments or requests to present oral comments in response to this rule making must be received by the Department no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Tracy George Department of Transportation DOT Rules Administrator, Strategic Communications and Policy 800 Lincoln Way Ames, Iowa 50010 Email: tracy.george@iowadot.usPublic Hearing    A public hearing to hear requested oral presentations will be held as follows: May 2, 2019 10 a.m. Department of Transportation Administration Building First Floor South Conference Room 800 Lincoln Way Ames, Iowa     Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rule making.    Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact Tracy George, the Department’s rules administrator, and advise of specific needs.     The public hearing will be canceled without further notice if no oral presentation is requested.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Amend rule 761—164.1(312) as follows:

    761—164.1(312) Definitions.          "Commission" means the Iowa transportation commission.        "Department" means the Iowa department of transportation.        "Jurisdiction" means the department, or thea county,ora cityor any other public agency having responsibility for and control over a road or street.        "Other public agency" means any board, commission or agency having jurisdiction and control over roads and streets in any state park, state institution and other state land. State park, state institution and other state land means as defined in Iowa Code section 306.3(10).        "Traffic safety fundimprovement program" means the fundfunding program created for traffic safety improvement projects pursuant to Iowa Code section 312.2312.2(11).

        ITEM 2.    Amend rule 761—164.2(312) as follows:

    761—164.2(312) Information and forms.  Information, instructions and application forms may be obtained from the Office of Traffic and Safety, Iowa Department of Transportation, 800 Lincoln Way, Ames, Iowa 50010; telephone (515)239-1557; or on the department’s website at www.iowadot.gov.

        ITEM 3.    Amend rule 761—164.3(312) as follows:

    761—164.3(312) Program administration.      164.3(1) Purpose.  The traffic safety fundimprovement program provides supplemental funding for traffic safety improvements or studies on public roads under county, city or state jurisdiction.    164.3(2) Local participation.  The department shall administer the traffic safety fundimprovement program as a statewide program and will encouragecoordinate local participation in the review and evaluation of applications for funding.    164.3(3) Funding.      a.    The commissionoffice of traffic and safety shall review all applications and be responsible to program selected projects, subject to the availability of fundsin order to make funding recommendations to the commission. The commission maychoose to fund all or part of a project and may make fundingor limit funding to specific work items. Funding may also be made dependent upon adherence to a time schedule or fulfillment of specified conditions.    b.    The commission need not commit all funds available during a fiscal year. Unexpended fundsFunds not committed by the commission shall be retained for subsequent programming cycles.Awarded funds not used within a specified period or remaining after project closure shall be retained for subsequent programming cycles.    c.    The maximum traffic safetyimprovement program funding for a site-specific projectimprovement shall generally not exceed $500,000. Total funding allotted for the traffic control device materials category shall not exceed $500,000 annually. Total funding allotted for all research,the studies and public information initiativesoutreach category shall not exceed $500,000 annually. All project costs exceeding the commitment of traffic safetyimprovement program funds shall be the responsibility of the applicant.

        ITEM 4.    Amend rule 761—164.4(312) as follows:

    761—164.4(312) Applicant eligibility.  The department, a county or an incorporated cityAny jurisdiction in the state of Iowa is eligible to apply for traffic safety funds. Joint applications are encouraged when applicable, but the applicantsimprovement program funding. Applicants shall designate one jurisdiction as the principal contactfor a project involving multiple jurisdictions.

        ITEM 5.    Amend rule 761—164.5(312) as follows:

    761—164.5(312) Project eligibility.  Projects located on a public roadway within the state of Iowa are eligible for funding. Projects located on a private road or for a private purpose are not eligible.    164.5(1) Types of projects.  Eligible applications shall address needs in one of three categories: construction or improvement of traffic operations at a specific site; purchase of materials for initial installation or replacement of obsolete traffic control signs; or transportation safety research, studies or public safety information initiatives.    164.5(2) Public roads.  Only applications involving a primary road, secondary road, or city street presently open to public use shall be considered. A project for a private purpose or road is not eligible.

        ITEM 6.    Amend rule 761—164.6(312) as follows:

    761—164.6(312) Eligible project costs.      164.6(1) Site-specific improvementscategory.  The costs of construction or improvements eligible for traffic safety fund reimbursementActivities considered eligible for funding are those required by, or integral to, the safety aspects of the project. Eligible activities include, but are not limited to, the following:    a.    Road modernization, upgrading or reconstruction.    b.    Bridge and culvert modernization, replacement or removalIntersection improvements.    c.    Road intersection and interchange improvement including channelization, traffic control devices or lighting.    d.    c.    Right-of-way required for a traffic safety projectpurchases.    e.    d.    Drainage and erosioncontrol measures which are an integral part of the project.    f.    e.    Traffic control devices required by the project.    g.    f.    GuardrailTraffic barriers and other roadside safety devices.    h.    g.    Tree removalRemoval of trees and other fixed objects.    i.    Other construction activities directly related to or required by the safety project.    164.6(2) Traffic control devicescategory.  The cost of materials purchased for initial installation of traffic control devices or replacement of obsolete traffic control devices tois considered eligible for funding. Devices shall comply with the applicable warrants in the Manual“Manual on Uniform Traffic Control DevicesDevices” (MUTCD)as adopted in rule 761—130.1(321), Iowa Administrative Code, shall be eligible for funding.    164.6(3) Research, studiesStudies and public information initiativesoutreach category.  Funding shall be available for research, studies or public information initiatives related to traffic operations safety.Activities considered eligible for funding include, but are not limited to, the following:    a.    Research shall addressaddressing statewide traffic safety concerns.    b.    A study shall address remedies forStudies addressing traffic operations safetyconcerns at a specific locationlocations. Study funds may be used to supplement federal Traffic Engineering Assistance Program (TEAP) funding.    c.    A public information initiative shall emphasizeInitiatives emphasizing or improving traffic safety techniques or policies, and should be of statewide interest. An initiative of local scope may also be considered.

        ITEM 7.    Amend rule 761—164.7(312) as follows:

    761—164.7(312) Ineligible project costs.      164.7(1)   Any and all costs incurred prior to commission approval of funding for a project are ineligible.    164.7(2)   Activities and costs not eligible for traffic safetyimprovement program funding as a portion of awithin the site-specific improvementimprovements category include, but are not limited to:    a.    Routine maintenance of a road, street, bridge, culvert or traffic control device.    b.    Safety-related activities associated with projects initiated for purposes other than traffic safety.    c.    b.    Contract administration costs.    d.    c.    Design and construction engineering and inspection.    e.    d.    Utility construction, reconstruction or adjustment, except as an integral part of a project.    f.    e.    Sidewalks, bicycleshared-use paths, or railroad-highway crossings, except as an integral part of a project.    g.    f.    Maintenance or energy costs for traffic control devices or lighting.    h.    g.    Expenditures for items not related to the roadway.    164.7(3)   Activities and costs not eligible for traffic safetyimprovement program funding as a part of an application forwithin the traffic control device materialsdevices category include, but mayare not be limited to:    a.    Maintenance or energy costs for traffic control devices or lighting.    b.    Installation costs.

        ITEM 8.    Amend rule 761—164.8(312) as follows:

    761—164.8(312) Applications.  Applications for funding shall address needs in one of three categories: site-specific improvements, traffic control devices, or studies and outreach.Application procedures for each funding category will be distinct.    164.8(1)   An application by a city or county for funding site-specific construction must be submitted on a departmental form specifically used for the traffic safety fund. Comparable information will be provided by the department for state-initiated projects.Applications in the site-specific improvements category shall be submitted electronically on forms provided on the department’s website. Required information shall include:    a.    The applicant’s name, mailing address, telephone number, and a designated contact person for the project.    b.    A preliminary project concept statement, including a location map and a sketch plan. The concept must be reasonable from a traffic engineering standpoint and detailed enough to generate project cost estimates.    c.    The justificationJustification for the proposed construction project. Justification may be based on a location’s inclusion in the department’s list of high accident locations, a TEAP-type study recommendation or a similarcrash history, a location’s crash risk, or recommendations from a traffic study generating a positive benefit/cost analysis for the proposed improvement.    d.    Data showing the anticipated effect of the project on traffic safety. Data shall include accidentcrash history frombased on the department’s Accident Location Analysis System (ALAS)current crash analysis software and the anticipated accidentcrash reduction, both in number and type, expected as a result of the project.    e.    An itemized cost estimate for the project including a list of the sources and amounts of supplementary funds for the project.Safety-related work items and quantities shall be listed separately.    f.    A time schedule for the project.    g.    The jurisdiction’s official endorsement, where applicable, of the project and written assurance that the improved site will be adequately maintainedfor a specified period of time.    164.8(2)   An application for funding to pay the cost of materials forApplications in the traffic control device installationdevices category shall be submitted in writing andelectronically on forms provided on the department’s website. Required information shall include:    a.    The applicant’s name, mailing address, telephone number, and a designated contact person.    b.    A list of the number and types of devices requested, and whether each is for initial placement or a replacement.    c.    An inventory or similar documentation providing justificationJustification for the requested devicedevices, including compliance with the applicable warrants in the “Manual on Uniform Traffic Control Devices” (MUTCD) as adopted in rule 761—130.1(321).    d.    A cost estimate.and    e.    A time schedule for installation after delivery.    e.    f.    The jurisdiction’s official endorsement of the traffic control device project and written assurance that the traffic control device will be adequately maintainedfor a specified period of time.    164.8(3)   Research, a study or a public information initiativeApplications in the studies and outreach category shall be proposed in writing andsubmitted electronically on forms provided on the department’s website. Required information shall include:    a.    The applicant’s name, mailing address, telephone number and a designated contact person.    b.    A description of the proposed subject matter and the goals or expected results of the effort.    c.    A cost estimate.    d.    A time schedule.

        ITEM 9.    Amend rule 761—164.9(312) as follows:

    761—164.9(312) Processing the application.      164.9(1) Submission.      a.    The jurisdiction shall submit an original and three copies of the complete applicationelectronically to the office of traffic and safety. An application may be submitted at any time and shall be dated when received by the office of traffic and safety.    b.    All completeComplete applications received before August 1516 of each year shall be evaluated for fundingin the following state fiscal year.    c.    If an application is incomplete, the department shall return the application to the applicant to be resubmitted when complete. A resubmitted application shall be dated when received by the office of traffic and safety.    d.    c.    An unfunded application may be resubmitted for consideration during a subsequent funding periodcycle.    e.    d.    An application may be withdrawn at any time.    164.9(2) Approval of projects.  Department staff shall prepare, with input from city and countylocal officials, a proposed program of projects for each funding category and submit the programs to the commission for approval. The criterion for determining funding priorities in each category is the demonstrated relationship of the project to traffic safety.

        ITEM 10.    Amend rule 761—164.10(312) as follows:

    761—164.10(312) Project agreement.      164.10(1)   After the commission has approved funding for a county or city project, a project agreement shall be negotiated and executed between the department and the local jurisdiction. The agreement shall specify the conditions for project funding, which may include such items as the responsibility for planning, design, right-of-way, contracting, construction, materials inspection, documentation and the criteria for each. The agreement shall also specify the funding level for the eligible work items.    164.10(2)   The department shall reimburse the county or cityjurisdiction for actual eligible project costs not to exceed the amounts authorized by the project agreement.    164.10(3)   Rescinded IAB 10/30/02, effective 12/4/02.

        ITEM 11.    Amend 761—Chapter 164, implementation sentence, as follows:       These rules are intended to implement Iowa Code section 312.2312.2(11).    ARC 4383CVoter Registration Commission[821]Notice of Intended Action

    Proposing rule making related to voter registration and providing an opportunity for public comment

        The Voter Registration Commission hereby proposes to amend Chapter 1, “Organization, Purpose, Procedures and Definitions,” and Chapter 2, “Voter Registration Forms, Acceptability, Registration Dates, and Effective Dates,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is proposed under the authority provided in Iowa Code sections 17A.4, 47.8 and 48A.18.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code sections 17A.7, 48A.5 and 48A.26.Purpose and Summary    The proposed amendment to rule 821—1.3(47) and adoption of new rule 821—1.8(17A) bring the Voter Registration Commission’s rules into conformity with Iowa Code section 17A.7.     The proposed amendment to rule 821—2.12(48A) is necessary due to technical changes made to Iowa’s voter registration laws by 2017 Iowa Acts, House File 516, effective January 1, 2019. Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Commission for a waiver of the discretionary provisions, if any. Public Comment     Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Commission no later than 4:30 p.m. on April 30, 2019. Comments should be directed to: Molly Widen State Registrar of Voters Lucas State Office Building, First Floor 321 East 12th Street Des Moines, Iowa 50319 Email: molly.widen@sos.iowa.govPublic Hearing     No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).    The following rule-making actions are proposed:

        ITEM 1.    Amend rule 821—1.3(47) as follows:

    821—1.3(47) General operating rules.      1.3(1)   The chair of the commission is the state commissioner of elections or the state commissioner’s designee.    1.3(2)   Any member of the commission, including the chair, may make and second any motion.    1.3(3)   To prevail, a motion, declaratory ruling, or ruling in a contested case must receive the votes of a majority of commissioners present and voting.    1.3(4)   Rescinded IAB 10/25/95, effective 10/6/95.    1.(5) 1.3(4)   A designee of a statutory member shall present a letter from the statutory member appointing the designee.    1.(6) 1.3(5)   A quorum of the commission is four members. No official action may be taken in the absence of a quorum.    1.3(7)   Any member of the public may petition the commission concerning any subject under the commission’s authority. Any member of the public may propose new rules or modifications to existing rules of the commission. Petitions or proposed rule changes may be in letter form, filed with the registrar and addressed to the commission. Any such letter must include a discussion of the problem or issue, addressing and supporting rationale for any proposed action by the commission. In addition, any such petition must state the legal authority which petitioner believes confers jurisdiction over the subject matter to the commission. Action on petitions received shall be taken not later than the second regular commission meeting following receipt of the petition. In the event a hearing is held on an issue, the hearing shall be scheduled within 90 days of receipt of the petition.

        ITEM 2.    Adopt the following new rule 821—1.8(17A):

    821—1.8(17A) Petition for rule making.  Any person or agency may file a petition for rule making with the voter registration commission at the Secretary of State’s Office, First Floor, State Capitol Building, Des Moines, Iowa 50319, or the Secretary of State’s Office, Lucas State Office Building, Des Moines, Iowa 50319. A petition is deemed filed when it is received in either office. The state registrar must provide the petitioner with a file-stamped copy of the petition if the petitioner provides the agency an extra copy for this purpose. The petition must be typewritten or legibly handwritten in ink and must substantially conform to the following form:VOTER REGISTRATION COMMISSION    Petition by (Name of Petitioner)for the (adoption, amendment, orrepeal) of rules relating to (statesubject matter). }    PETITION FORRULE MAKINGThe petition must provide the following information:
    1. A statement of the specific rule-making action sought by the petitioner including the text or a summary of the contents of the proposed rule or amendment to a rule and, if it is a petition to amend or repeal a rule, a citation to the particular portion or portions of the rule proposed to be amended or repealed, together with a quotation of the relevant language.
    2. A citation to any law deemed relevant to the commission’s authority to take the action urged or to the desirability of that action.
    3. A brief summary of petitioner’s arguments in support of the action urged in the petition.
    4. A brief summary of any data supporting the action urged in the petition.
    5. The names and addresses of other persons, or a description of any class of persons, known by petitioner to be affected by, or interested in, the proposed action which is the subject of the petition.
    6. Any request by petitioner for a meeting provided for by subrule 1.8(5).
        1.8(1)   The petition must be dated and signed by the petitioner or the petitioner’s representative. It must also include the name, mailing address, and telephone number of the petitioner and petitioner’s representative (if one is involved), and a statement indicating the person to whom communications concerning the petition should be directed.    1.8(2)   The commission may deny a petition because it does not substantially conform to the required form.    1.8(3)   The petitioner may attach a brief to the petition in support of the action urged in the petition. The commission may request a brief from the petitioner or from any other person concerning the substance of the petition.    1.8(4)   Inquiries concerning the status of a petition for rule making may be made to the Deputy Secretary of State, Lucas State Office Building, Des Moines, Iowa 50319.     1.8(5)   Upon receipt of a petition for rule making, the following steps shall be taken:    a.    Within 30 days after the filing of a petition, the state registrar must submit a copy of the petition and any accompanying brief to the administrative rules coordinator and to the administrative rules review committee. Upon request by petitioner in the petition, the agency must schedule a brief and informal meeting between the petitioner and a designee of the state registrar to discuss the petition. The commission may request the petitioner to submit additional information or argument concerning the petition. The commission may also solicit comments from any person on the substance of the petition. Also, comments on the substance of the petition may be submitted to the commission by any person.    b.    Within 90 days after the filing of the petition, or within any longer period agreed to by the petitioner, the commission must, in writing, deny the petition, and notify petitioner of its action and the specific grounds for the denial, or grant the petition and notify petitioner that it has instituted rule-making proceedings on the subject of the petition. Petitioner shall be deemed notified of the denial or grant of the petition on the date when a designee of the commission mails or delivers the required notification to petitioner.    c.    Denial of a petition because it does not substantially conform to the required form does not preclude the filing of a new petition on the same subject that seeks to eliminate the grounds for the agency’s rejection of the petition.

        ITEM 3.    Amend 821—Chapter 1, implementation sentence, as follows:       These rules are intended to implement Iowa Code sections17A.7,47.7 and 47.8.

        ITEM 4.    Amend rule 821—2.12(48A) as follows:

    821—2.12(48A) County registration date.  For the purposes of determining timeliness of an application to register to vote, the county registration date shall be determined as follows:    2.12(1)   The county registration date for an in-person applicant at least 18 years of age is the date the registration application is received by the commissioner or the commissioner’s designee. However, when preregistration is closed in the applicant’s precinct due to a pending election, the county registration date shall be the date of the day after the pending election unless the applicant registers pursuant to Iowa Code section 48A.7A.    2.12(2)   The county registration date for a by-mail applicant at least 18 years of age is the date the registration application is received by the commissioner, unless the application is postmarked on or before the worry-free postmark date established pursuant to Iowa Code section 48A.9, subsection 3. However, when preregistration is closed in the applicant’s precinct due to a pending election, the county registration date shall be the date of the day after the pending election unless the applicant registers pursuant to Iowa Code section 48A.7A.    2.12(3)   The county registration date for an application received from a source other than in person or by mail is the date the application is received by the commissioner or submitted to the office of driver services, department of transportation, or to a voter registration agency pursuant to Iowa Code section 48A.19, whichever is earlier.    2.12(4)   The county registration date for applicants aged 17 ½17 to 18 shall be the date of the applicant’s eighteenth birthday, except the county commissioner shall indicate that the person is registered and qualifies to vote at the pending primary election if the applicant will be at least 18 years of age on the date of the respective general election or city election. However, when preregistration is closed in the applicant’s precinct on the applicant’s eighteenth birthday, the county registration date shall be the date of the day after the pending election unless the applicant registers pursuant to Iowa Code section 48A.7A.    ARC 4387CPharmacy Board[657]Adopted and Filed Emergency

    Rule making related to statewide protocols

        The Board of Pharmacy hereby amends Chapter 39, “Expanded Practice Standards,” Iowa Administrative Code. Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 155A.46.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 155A.46.Purpose and Summary    Following adoption of rule making relating to a pharmacist’s participation in statewide protocols (ARC 4270C, IAB 1/30/19), concern was raised relating to the term “prescribe” used in the applicable rules for the statewide protocols. To address the concern, these amendments replace “prescribe” with “order” consistent with language used in the Iowa Code.Reason for Adoption of Rule Making Without Prior Notice and Opportunity for Public Participation    Pursuant to Iowa Code section 17A.4(3)“a,” the Board finds that notice and public participation are unnecessary or impractical because the Administrative Rules Review Committee, at its February 8, 2019, meeting, after placing a 70-day delay on the effective date of ARC 4270C, authorized the Board to file emergency rule making to change the language of ARC 4270C. Reason for Waiver of Normal Effective Date    Pursuant to Iowa Code section 17A.5(2)“b”(1)(b), the Board also finds that the normal effective date of this rule making, 35 days after publication, should be waived and the rule making made effective on April 5, 2019. These amendments confer a benefit on the public because the original rule making was set to become effective on March 6, 2019, allowing pharmacists and patients to utilize statewide protocols as soon as the Board adopted such protocols and the pharmacist met all minimum requirements. The Board has approved final versions of the protocols, and these protocols are ready for the public’s use as soon as the rules are in effect.Adoption of Rule Making    This rule making was adopted by the Board on March 12, 2019.Concurrent Publication of Notice of Intended Action    In addition to its adoption on an emergency basis, this rule making has been initiated through the normal rule-making process and is published herein under Notice of Intended Action as ARC 4388C to allow for public comment on these amendments in addition to other amendments to Chapter 39 that are proposed in ARC 4388C.Fiscal Impact    This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making became effective on April 5, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Amend rule 657—39.6(155A) as follows:

    657—39.6(155A) Statewide protocols.  A pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of public health and available on the board’s website at pharmacy.iowa.gov, prescribeorder and dispense medications pursuant to rules 657—39.8(155A), 657—39.9(155A), and 657—39.11(155A).

        ITEM 2.    Amend rule 657—39.8(155A) as follows:

    657—39.8(155A) Statewide protocol—naloxone.  An authorized pharmacist may prescribeorder and dispense naloxone to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of naloxone to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.    39.8(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has completed the training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered pharmacist-intern who has completed the training requirements of this rule and is working under the direct supervision of an authorized pharmacist.        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has completed the training requirements for an authorized pharmacist pursuant to this rule.        "Board" means the Iowa board of pharmacy.        "Patient" means an individual consulting with a pharmacist for drug therapy and may include an individual in a position to assist someone at risk of an opioid-related overdose.    39.8(2) Authorized pharmacist training.  An authorized pharmacist shall document successful completion of an ACPE-approved continuing education program of at least one-hour duration related to naloxone utilization prior to dispensing naloxone pursuant to the statewide protocol.    39.8(3) Assessment.  An authorized pharmacist shall assess a patient for eligibility to receive naloxone using criteria identified in the statewide protocol.    39.8(4) Patient education.  Upon assessment and determination that a patient is eligible to receive and possess naloxone pursuant to the statewide protocol, an authorized pharmacist shall, prior to dispensing naloxone pursuant to the statewide protocol, provide training and education to the patient including, but not limited to, the information identified in this subrule. An authorized pharmacist may provide to the patient written materials that include, but may not be limited to, the information identified in this subrule, but the written materials shall not be in lieu of direct pharmacist consultation with the patient.    a.    The signs and symptoms of opioid-related overdose as described in the statewide protocol.    b.    The importance of calling 911 as soon as possible and the potential need for rescue breathing.    c.    The appropriate use and directions for administration of the naloxone to be dispensed pursuant to the statewide protocol.    d.    Adverse reactions of naloxone as well as reactions resulting from opioid withdrawal following administration.    e.    The proper storage conditions, including temperature excursions, of the naloxone product being dispensed.    f.    The expiration date of the naloxone product being dispensed and the appropriate disposal of the naloxone product upon expiration.    g.    Information about substance abuse or behavioral health treatment programs, if applicable.    39.8(5) Labeling.  Naloxone dispensed pursuant to this rule shall be labeled in accordance with rule 657—6.10(126,155A), and the labeling shall not render the expiration date of the product illegible.    39.8(6) Reporting.  As soon as reasonably possible, the authorized pharmacist shall notify the patient’s primary health care provider of the naloxone product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the naloxone product provided to the patient and shall advise the patient to consult a physician.    39.8(7) Records.  An authorized pharmacist shall maintain records of naloxone prescribedordered and dispensed pursuant to the statewide protocol.

        ITEM 3.    Amend rule 657—39.9(155A) as follows:

    657—39.9(155A) Statewide protocol—nicotine replacement tobacco cessation products.  An authorized pharmacist may prescribeorder and dispense nicotine replacement tobacco cessation products to patients 18 years and older pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the dispensing of a nicotine replacement tobacco cessation product to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.    39.9(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has completed the training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered pharmacist-intern who has completed the training requirements of this rule and is working under the direct supervision of an authorized pharmacist.        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has completed the training requirements for an authorized pharmacist pursuant to this rule.        "Board" means the Iowa board of pharmacy.    39.9(2) Authorized pharmacist training.  An authorized pharmacist shall document successful completion of an ACPE-approved continuing education program of at least one-hour duration related to nicotine replacement tobacco cessation product utilization prior to dispensing such products under the statewide protocol.    39.9(3) Assessment.  An authorized pharmacist shall assess a patient for appropriateness of receiving a nicotine replacement tobacco cessation product pursuant to the statewide protocol.    39.9(4) Patient counseling and instructions.  Upon assessment and determination that provision of the nicotine replacement tobacco cessation product is appropriate pursuant to the statewide protocol, an authorized pharmacist shall, prior to dispensing such product, provide counseling and instructions to the patient pursuant to rule 657—6.14(155A).    39.9(5) Labeling.  Nicotine replacement tobacco cessation products dispensed pursuant to this rule shall be labeled in accordance with rule 657—6.10(126,155A), and the labeling shall not render the expiration date of the product illegible.    39.9(6) Reporting.  As soon as reasonably possible, the authorized pharmacist shall notify the patient’s primary health care provider of the nicotine replacement tobacco cessation product provided to the patient. If the patient does not have a primary health care provider, the authorized pharmacist shall provide the patient with a written record of the nicotine replacement tobacco cessation product provided to the patient and shall advise the patient to consult a physician.    39.9(7) Records.  An authorized pharmacist shall maintain records of nicotine replacement tobacco cessation products prescribedordered and dispensed pursuant to the statewide protocol.

        ITEM 4.    Amend rule 657—39.11(155A) as follows:

    657—39.11(155A) Vaccine administration by pharmacists—statewide protocol.  An authorized pharmacist may prescribeorder and administer vaccines and immunizations pursuant to a statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only delegate the prescribingordering and administration of a vaccine to an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.    39.11(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "ACIP" means the CDC Advisory Committee on Immunization Practices.        "ACPE" means the Accreditation Council for Pharmacy Education.        "Authorized pharmacist" means an Iowa-licensed pharmacist who has met the requirements identified in subrule 39.11(3).        "Authorized pharmacist-intern" means an Iowa-registered pharmacist-intern who has met the requirements for an authorized pharmacist identified in subrule 39.11(3).        "Board" means the Iowa board of pharmacy.        "CDC" means the United States Centers for Disease Control and Prevention.        "Immunization" shall have the same meaning as, and shall be interchangeable with, the term “vaccine.”        "Vaccine" means a specially prepared antigen administered to a person for the purpose of providing immunity.    39.11(2) Vaccines authorized by statewide protocol.  The vaccines authorized to be prescribedordered and administered pursuant to the statewide protocol shall include:    a.    To patients ages 18 years and older:    (1)   An immunization or vaccination recommended by ACIP in its approved vaccination schedule for adults.    (2)   An immunization or vaccination recommended by CDC for international travel.    (3)   A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application.    (4)   Other emergency immunizations or vaccinations in response to a public health emergency.    b.    To patients ages six months and older:    (1)   A vaccine or immunization for influenza.    (2)   Other emergency immunizations or vaccines in response to a public health emergency.    c.    To patients ages 11 years and older:    (1)   The final two doses in a course of vaccinations for human papillomavirus (HPV).    (2)   Reserved.    39.11(3) Authorized pharmacist training and continuing education.  An authorized pharmacist shall document successful completion of the requirements in paragraph 39.11(3)“a” and shall maintain competency by completing and maintaining documentation of the continuing education requirements in paragraph 39.11(3)“b.”    a.    Initial qualification.An authorized pharmacist shall have successfully completed an organized course of study in a college or school of pharmacy or an ACPE-accredited continuing education program on vaccine administration that:    (1)   Requires documentation by the pharmacist of current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.    (2)   Is an evidence-based course that includes study material and hands-on training and techniques for administering vaccines, requires testing with a passing score, complies with current CDC guidelines, and provides instruction and experiential training in the following content areas:    1.   Standards for immunization practices;    2.   Basic immunology and vaccine protection;    3.   Vaccine-preventable diseases;    4.   Recommended immunization schedules;    5.   Vaccine storage and management;    6.   Informed consent;    7.   Physiology and techniques for vaccine administration;    8.   Pre- and post-vaccine assessment, counseling, and identification of contraindications to the vaccine;    9.   Immunization record management; and    10.   Management of adverse events, including identification, appropriate response, documentation, and reporting.    b.    Continuing education.During any pharmacist license renewal period, an authorized pharmacist who engages in the administration of vaccines shall complete and document at least one hour of ACPE-approved continuing education with the ACPE topic designator “06” followed by the letter “P.”    c.    Certification maintained.During any period within which the pharmacist may engage in the administration of vaccines, the pharmacist shall maintain current certification in basic cardiac life support through a training program designated for health care providers that includes hands-on training.    39.11(4) Assessment.  An authorized pharmacist shall assess a patient for appropriateness of receiving a vaccine pursuant to the statewide protocol.    39.11(5) Verification and reporting.  Prior to the prescribingordering and administration of an immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and review the statewide immunization registry or health information network. As soon as reasonably possible following administration of a vaccine, the pharmacist shall report such administration to the patient’s primary health care provider, primary physician, and a statewide immunization registry or health information network. If the patient does not have a primary health care provider, the pharmacist shall provide the patient with a written record of the vaccine administered to the patient and shall advise the patient to consult a physician.        [Filed Emergency 3/17/19, effective 4/5/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4390CProfessional Licensure Division[645]Adopted and Filed Emergency

    Rule making related to behavior analysts and assistant behavior analysts

        The Board of Behavioral Science hereby amends Chapter 5, “Fees,” Chapter 31, “Licensure of Marital and Family Therapists and Mental Health Counselors,” and Chapter 33, “Discipline for Marital and Family Therapists and Mental Health Counselors,” Iowa Administrative Code. Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 154D.3.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code chapter 154D.Purpose and Summary    These amendments add licensing rules for two new professions, behavior analysts and assistant behavior analysts. The amendments also set license fees at $300 for the two new professions.Reason for Adoption of Rule Making Without Prior Notice and Opportunity for Public Participation    Pursuant to Iowa Code section 17A.4(3), the Board finds that notice and public participation are unnecessary or impractical because emergency adoption was approved by the Administrative Rules Review Committee. These amendments implement the provisions of 2018 Iowa Acts, chapter 1106, which became effective January 1, 2019, without appreciably adding to those provisions.     In compliance with Iowa Code section 17A.4(3)“a,” the Administrative Rules Review Committee at its March 8, 2019, meeting reviewed the Board’s determination and this rule making and approved the emergency adoption.Reason for Waiver of Normal Effective Date    Pursuant to Iowa Code section 17A.5(2)“b”(1)(b), the Board also finds that the normal effective date of this rule making, 35 days after publication, should be waived and the rule making made effective on March 22, 2019, because it allows the Board to start licensing individuals so they can practice and receive insurance reimbursement.Adoption of Rule Making    This rule making was adopted by the Board on March 14, 2019.Concurrent Publication of Notice of Intended Action    In addition to its adoption on an emergency basis, this rule making has been initiated through the normal rule-making process and is published herein under Notice of Intended Action as ARC 4389C to allow for public comment.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    A waiver provision is not included in this rule making because all administrative rules of the professional licensure boards in the Professional Licensure Division are subject to the waiver provisions accorded under 645—Chapter 18.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making became effective on March 22, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Adopt the following new subrule 5.3(10):    5.3(10)   License fee for license to practice as a behavior analyst or assistant behavior analyst is $300.

        ITEM 2.    Amend 645—Chapter 31, title, as follows:LICENSURE OF MARITAL AND FAMILY THERAPISTS, AND MENTAL HEALTH COUNSELORS, BEHAVIOR ANALYSTS, AND ASSISTANT BEHAVIOR ANALYSTS

        ITEM 3.    Amend rule 645—31.1(154D), definitions of “Licensee” and “License expiration date,” as follows:        "Licensee" means any person licensed to practice as a marital and family therapist,or mental health counselor, behavior analyst, or assistant behavior analyst in the state of Iowa.        "License expiration date" means September 30 of even-numbered yearsfor marital and family therapists and mental health counselors, and means the expiration date of the certification issued by the Behavior Analyst Certification Board for behavior analysts and assistant behavior analysts.

        ITEM 4.    Adopt the following new definition of “BACB” in rule 645—31.1(154D):        "BACB" means the Behavior Analyst Certification Board.

        ITEM 5.    Amend rule 645—31.2(154D), introductory paragraph, as follows:

    645—31.2(154D) Requirements for permanent and temporary licensureas a mental health counselor or marriage and family therapist.  The following criteria shall apply to licensure:

        ITEM 6.    Amend rule 645—31.3(154D), introductory paragraph, as follows:

    645—31.3(154D) Examination requirementsfor mental health counselors and marital and family therapists.  The following criteria shall apply to the written examination(s):

        ITEM 7.    Amend rule 645—31.8(154D), introductory paragraph, as follows:

    645—31.8(154D) Licensure by endorsementfor mental health counselors and marital and family therapists.  An applicant who has been a licensed marriage and family therapist or mental health counselor under the laws of another jurisdiction may file an application for licensure by endorsement with the board office.

        ITEM 8.    Adopt the following new rule 645—31.9(147):

    645—31.9(147) Licensure of behavior analysts and assistant behavior analysts.      31.9(1)   The applicant shall complete a board-approved application. Application forms may be obtained from the board’s website (www.idph.iowa.gov/licensure) or directly from the board office. All paper applications shall be sent to the Board of Behavioral Science, Professional Licensure Division, Fifth Floor, Lucas State Office Building, Des Moines, Iowa 50319-0075.    31.9(2)   The applicant shall complete the application form according to the instructions contained in the application. If the application is not completed according to the instructions, the application will not be reviewed by the board.    31.9(3)   Each application shall be accompanied by the appropriate fees payable to the board of behavioral science. The fees are nonrefundable.    31.9(4)   For licensure as a behavior analyst, the applicant shall submit proof of current BACB certification as a board-certified behavior analyst or board-certified behavior analyst-doctoral. For licensure as an assistant behavior analyst, the applicant shall submit proof of current BACB certification as a board-certified assistant behavior analyst.

        ITEM 9.    Amend rule 645—31.10(147), catchwords, as follows:

    645—31.10(147) License renewalfor mental health counselors and marriage and family therapists.  

        ITEM 10.    Adopt the following new rule 645—31.11(272C):

    645—31.11(272C) Initial licensing, reactivation, and license renewal for behavior analysts and assistant behavior analysts.      31.11(1)   An initial license for a behavior analyst or assistant behavior analyst shall be issued with the same expiration date as the applicant’s current certification issued by BACB.    31.11(2)   The biennial license renewal period for a behavior analyst or assistant behavior analyst shall run concurrent with the licensee’s BACB certification. Each license renewed shall be given the expiration date that is on the licensee’s current BACB certification. The licensee is responsible for renewing the license prior to its expiration. Failure of the licensee to receive notice from the board does not relieve the licensee of the responsibility for renewing the license.    31.11(3)   A licensee seeking renewal shall:    a.    Meet the continuing education requirements required by BACB to renew a certification.    b.    Maintain current certification as a board-certified behavior analyst, board-certified behavior analyst-doctoral, or board-certified assistant behavior analyst issued by BACB.    c.    Submit the completed renewal application and renewal fee before the license expiration date.    31.11(4)   Upon receiving the information required by this rule and the required fee, board staff shall administratively issue a license. In the event the board receives adverse information on the renewal application, the board shall issue the renewal license but may refer the adverse information for further consideration or disciplinary investigation.    31.11(5)   A person licensed as a behavior analyst or assistant behavior analyst shall keep the person’s license certificate and wallet card displayed in a conspicuous public place at the primary site of practice.    31.11(6)   Late renewal. The license shall become late when the license has not been renewed by the expiration date on the wallet card. The licensee shall be assessed a late fee as specified in 645—subrule 5.3(4). To renew a late license, the licensee shall complete the renewal requirements and submit the late fee within the grace period.    31.11(7)   Inactive license. A licensee who fails to renew the license by the end of the grace period has an inactive license. A licensee whose license is inactive continues to hold the privilege of licensure in Iowa, but may not engage in the practice of applied behavior analysis for which a license is required in Iowa until the license is reactivated. A licensee who practices applied behavior analysis in a capacity that requires licensure in the state of Iowa with an inactive license may be subject to disciplinary action by the board, injunctive action pursuant to Iowa Code section 147.83, criminal sanctions pursuant to Iowa Code section 147.86, and other available legal remedies.    31.11(8)   Reactivation. To apply for reactivation of an inactive license, a licensee shall submit a completed renewal application and proof of current certification and shall be assessed a reactivation fee as specified in 645—subrule 5.3(5).

        ITEM 11.    Amend rule 645—31.16(17A,147,272C), introductory paragraph, as follows:

    645—31.16(17A,147,272C) License reactivationfor mental health counselors and marital and family therapists.  To apply for reactivation of an inactive license, a licensee shall:

        ITEM 12.    Amend rule 645—31.17(17A,147,272C) as follows:

    645—31.17(17A,147,272C) License reinstatement.  A licensee whose license has been revoked, suspended, or voluntarily surrendered must apply for and receive reinstatement of the license in accordance with 645—11.31(272C) and must apply for and be granted reactivation of the license in accordance with 645—31.16(17A,147,272C)or subrule 31.11(8) prior to practicing mental health counseling,or marital and family therapy, or applied behavior analysis in this state.

        ITEM 13.    Amend 645—Chapter 33, title, as follows:DISCIPLINE FOR MARITAL AND FAMILY THERAPISTS, AND MENTAL HEALTH COUNSELORS, BEHAVIOR ANALYSTS, AND ASSISTANT BEHAVIOR ANALYSTS

        ITEM 14.    Amend rule 645—33.1(154D), definition of “Licensee,” as follows:        "Licensee" means a person licensed to practice as a marital and family therapist,or mental health counselor, behavior analyst, or assistant behavior analyst in Iowa.

        ITEM 15.    Adopt the following new paragraph 33.2(1)"c":    c.    Behavior analysts and assistant behavior analysts.Failure to comply with the current Behavior Analyst Certification Board (BACB) Professional and Ethical Compliance Code for Behavior Analysts, which is hereby adopted by reference. Copies of the Professional and Ethical Compliance Code may be obtained from the BACB website.

        ITEM 16.    Amend subrule 33.2(14) as follows:    33.2(14)   Revocation, suspension, or other disciplinary action taken by a licensing authorityor professional certifying entity of this state, another state, territory, or country; or failure by the licensee to report in writing to the board revocation, suspension, or other disciplinary action taken by a licensing authorityor certifying entity within 30 days of the final action. A stay by an appellate court shall not negate this requirement; however, if such disciplinary action is overturned or reversed by a court of last resort, the report shall be expunged from the records of the board.

        ITEM 17.    Amend subrule 33.2(24) as follows:    33.2(24)   Knowingly aiding, assisting, procuring, or advising a person to unlawfully practice as a marital and family therapist, or a mental health counselor, behavior analyst, or assistant behavior analyst.

        ITEM 18.    Amend subrule 33.2(26) as follows:    33.2(26)   Representing oneself as a licensed marital and family therapist,or mental health counselor, behavior analyst, or assistant behavior analyst when one’s license has been suspended or revoked, or when one’s license is on inactive status.    [Filed Emergency 3/22/19, effective 3/22/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4392CHuman Services Department[441]Adopted and Filed

    Rule making related to primary care providers

        The Human Services Department hereby amends Chapter 73, “Managed Care,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 249A.4 and 2018 Iowa Acts, Senate File 2418.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 249A.4 and 2018 Iowa Acts, Senate File 2418, section 128.Purpose and Summary    This amendment allows advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to be primary care providers with a managed care organization (MCO).Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 30, 2019, as ARC 4258C. The Department received a comment from one respondent supporting the proposed change in administrative rule during the public comment period. No changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Council on Human Services on March 13, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to rule 441—1.8(17A,217).Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on June 1, 2019.    The following rule-making action is adopted:

        ITEM 1.    Adopt the following new subrule 73.8(5):    73.8(5)   An enrollee’s primary care provider shall be responsible for providing preventative and primary health care to the enrollee; for initiating referrals for specialist care, where appropriate; and for maintaining the continuity of patient care. Primary care providers may be physicians, advanced registered nurse practitioners, or physician assistants, licensed and practicing in accordance with state law.    [Filed 3/13/19, effective 6/1/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4393CHuman Services Department[441]Adopted and Filed

    Rule making related to updates of forms and information

        The Human Services Department hereby amends Chapter 176, “Dependent Adult Abuse,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 234.6.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 234.6.Purpose and Summary    The purpose of these amendments is to streamline required maintenance of administrative rules related to dependent adult abuse by removing form numbers from the administrative rules.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 16, 2019, as ARC 4239C. No public comments were received. No changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Council on Human Services on March 13, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to rule 441—1.8(17A,217).Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on June 1, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Amend subrule 176.4(2) as follows:    176.4(2)   The reporter may usea form prescribed by the department’s Form 470-2441, Suspected Dependent Adult Abuse Report,department or may use a form developed by the reporter that meets the requirements of Iowa Code section 235B.3.

        ITEM 2.    Amend subrule 176.6(5) as follows:    176.6(5)   Completion of evaluation or assessment report. Upon completion of its evaluation or assessment, the department shall complete a report that describes its findings and includes all actions taken or contemplated.    a.    The department shall complete its report within 20 working days of the receipt of the abuse allegations, unless the worker’s supervisor grants an extension of time for good cause shown. The worker’s supervisor may grant an extension for a maximum of 30 working days. No more than three extensions shall be granted.    b.    Upon completion of an evaluation, the department shall enter its report into the system on dependent adults (SODA)dependent adult reporting and evaluation system (DARES).    c.    Upon completion of an assessment when the alleged abuse is the result of the acts or omissions of the dependent adult, the department shall place the report in the case file of the dependent adult and on SODAenter the information into DARES.

        ITEM 3.    Amend subrule 176.6(14), introductory paragraph, as follows:    176.6(14)   Assessment of dependency and risk. After the first visit to a dependent adult who is alleged to be abused, the department shall complete an assessment of the adult using Form 470-3246, Dependent Adult Assessment Toola form prescribed by the department. The department shall assess:

        ITEM 4.    Amend subrule 176.6(15) as follows:    176.6(15)   Follow-up for at-risk adults. When it has not been possible or necessary to obtain a court order for services to an at-risk adult, the department shall attempt to persuadeempower the at-risk adult to agree to accept services and to participate in preparing a safety plan. If the adult refuses to sign Form 470-4835, Safety Plan for At-Risk Adult,a safety plan for an at-risk adult and to acceptrecommended services, the department shall provide periodic visits.    a.    Purpose.The purpose of the visits shall be to:    (1)   Assess the adult for increased risk or impairment,    (2)   Monitor the adult’s situation to determine the feasibility of intervening with protective services, and    (3)   PersuadeEmpower the adult to acceptrecommended services and to sign Form 470-4835, Safety Plan for At-Risk Adultengage in safety planning.    b.    Exemption.If it has been determined there is a physical threat to the safety of the department employee who is attempting to visit an at-risk adult, the department shall not attempt a periodic visit unless the physical threat to safety has been removed.    c.    Criteria to continue visits.Periodic visits shall continue if:    (1)   The adult’s health or safety has deteriorated somewhat but not to the point that a court order is necessary; or    (2)   The adult’s health or safety has remained the same and there is a possibility the adult may in the future agree to services and to participating in preparing a safety plan.    d.    Criteria to end visits.Periodic visits shall be terminated when:    (1)   The adult agrees to services and services are arranged; or     (2)   The adult’s health or safety has deteriorated to the point that the department has requested court action pursuant to subrule 176.6(8); or    (3)   The adult’s health or safety has not changed six months after the initial report of alleged abuse; there appears no possibility the adult will ever agree to services; and the adult is competent to make decisions.

        ITEM 5.    Amend subrule 176.10(10) as follows:    176.10(10) Mandatory reporter notification.  The department shall attempt to notify orally the mandatory reporter who made the report in a dependent adult abuse case of the results of the evaluation or assessment and of the confidentiality provisions of Iowa Code sections 235B.6 and 235B.12. The department shall subsequently transmit a written notice on Form 470-2444, Adult Protective Notification,adult protective notification on a form prescribed by the department to theeach mandatory reporter who made the report. The form shall include information regarding the results of the evaluation or assessment and confidentiality provisions. A copy of the written notice shall be transmitted to the registry and shall be maintained by the registry as provided in Iowa Code section 235B.8.

        ITEM 6.    Amend subrule 176.15(2), introductory paragraph, as follows:    176.15(2) Execution of team agreement.  When the team is established, the service area manager or designee and all team members shall execute an agreement on Form 470-2328, Dependent Adult Abuse Multidisciplinary Team Agreementa form prescribed by the department. ThisThe multidisciplinary team agreement specifiesshall specify:    [Filed 3/13/19, effective 6/1/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4394CInsurance Division[191]Adopted and Filed

    Rule making related to Medicare supplement policies

        The Insurance Division hereby rescinds Chapter 37, “Medicare Supplement Insurance,” Iowa Administrative Code, and adopts a new Chapter 37 with the same title.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code chapter 514D.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code chapter 514D.Purpose and Summary    This rule making rescinds the current Chapter 37 and replaces it with a new version. The new chapter is based on the Model Regulation to Implement the NAIC Medicare Supplement Insurance Minimum Standards Model Act, 2017, (the NAIC Model) and the model regulation for advertising adopted by the National Association of Insurance Commissioners (NAIC). The new chapter includes new requirements for Medicare Supplement policies to be offered and issued on or after January 1, 2020. This rule making also serves as furtherance of the Insurance Division’s compliance with Iowa Code section 17A.7(2).Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on February 13, 2019, as ARC 4282C. A public hearing was held on March 8, 2019, at 10 a.m. in the Division’s offices on the fourth floor of Two Ruan Center, 601 Locust Street, Des Moines, Iowa. Two persons attended the public hearing. Both written and oral public comments were received at the public hearing. Four public comment letters were also received. Comments received and changes made from the Notice are summarized here:    For this Adopted and Filed rule making, the Division made nonmaterial changes to the Noticed rules, both in response to the comments received and based on the Division’s own review of the Noticed rules, as follows:

    1. Comments were received regarding the differences between the definitions in the proposed rule making and the definitions in the NAIC Model. The Division declined to make additional changes in response to these comments because, during its review of the new NAIC Model, the Division found that terms used within the NAIC Model were inconsistent and confusing, so the Division attempted to use uniform terms throughout the chapter. The Division did not intend to change the substantive meaning of the NAIC Model.
        An exception was made for terms in certain of the required documents in the appendices to the chapter: If a required document was intended for use by the public, the Division generally left the more commonly used term in the document, even if the term differed from a definition in the rule making. The definitions in the rule making would not be readily available to members of the public to assist them in interpreting the required documents.
    1. For the version of the rules in the Notice, the Division added the clause “and with an effective date of coverage prior to January 1, 2020” to the end of the definition, from the NAIC Model, of “2010 standardized Medicare supplement benefit plan.” This clause was also added to the catchwords of rule 191—37.8(514D). This was done to mirror the definition of “1990 standardized Medicare supplement benefit plan.” However, the addition is not correct, and the clauses have been deleted from these adopted rules.
    2. Comments suggested the rules should not include a definition of “2020 standardized Medicare supplement benefit plan” because the standardized plans were not changed in the same way for 2020 as they had been in the past and using a different term could lead to more confusion. The Division made this suggested change. The Division also added the words “newly eligible” to the catchwords of subrule 37.9(2) to allow readers to more easily find what “newly eligible individuals” means.
    3. A comment was received requesting the addition of language that would allow the Commissioner to approve of instances when guaranteed renewability would be administratively challenging, such as when an issuer exits the market or seeks to discontinue a product. The suggestions were to add such language to the following paragraphs and subparagraphs: 37.6(1)“d”(1), 37.6(1)“e,” 37.7(1)“h”(2), and 37.8(1)“h”(2).
        The Division believes guaranteed renewability is a substantial element of Medicare Supplement policies that should be maintained except in extreme circumstances, in which case an issuer can apply for the waiver of the rule under 191—Chapter 4. In addition, the Division believes such a change is outside of the scope of this rule making. The Division declined to add the suggested language.
    1. A comment was received regarding proposed rule 191—37.26(514D) in which the NAIC Model language had been reworded. The Division did not intend substantive changes. The Division changed the passive voice, reworded some language, and made some divisions for clarity.
        The comment also noted that the citation to 37.17(4)“a” in subrule 37.26(2) was incorrect. The Division has corrected the citation to 37.26(1)“c.”
    1. Based on the Division’s own continued review, the word “standard” was changed to “standardized” in reference to benefit plans. This change was made in the definition for “SMSBP” in rule 191—37.3(514D); paragraph 37.8(1)“b”; paragraph 37.23(3)“a”; and Appendix E, both in the first paragraph of the appendix and in the first paragraph after the heading “Benefit Chart of Medicare Supplement Plans Sold On or After January 1, 2020.”
    2. Based on comments received and on the Division’s own continued review, in Appendix E, in the second chart (“Benefit Chart of Medicare Supplement Plans Sold On or After January 1, 2020”):
  • In the column heading “Medicare first eligible before 2020,” the word “only” was added at the end, in keeping with the model.
  • In the column now with the heading “Medicare first eligible before 2020 only,” in the subcolumn with the heading “C,” in the row for “Medicare Part B excess charges,” the checkmark was deleted, in keeping with the model. A checkmark should only appear in this row under subcolumn “F” of the column.
  • In the column now with the heading “Medicare first eligible before 2020 only,” in the subcolumn with the heading “C,” in the row for “Foreign travel emergency (up to plan limits),” a checkmark was added, in keeping with the model. In the column, both subcolumns “C” and “F” should contain checkmarks in this row.
  • In the column with the heading “Benefits,” the heading for the row “out-of-pocket limit [2017]” was changed to “out-of-pocket limit [2019].”
  • The first word in footnote 1, “Medicare,” was deleted, in accordance with the NAIC Model.
    1. Based on the Insurance Division’s continued review, references to the guide called “Guide to Health Insurance for People with Medicare” in many of the notices in the appendices and in paragraph 37.26(1)“b” were changed to bracketed instructions to the issuer to insert the name of the most recent version of the guide, because the name of the guide may change, as it did for the 2019 version.
    1. Paragraph 37.36(6)“b” was revised by the Division to use the singular form of “policy” and “certificate” throughout, with the appropriate verb tenses.
    Adoption of Rule Making    This rule making was adopted by Doug Ommen, Iowa Insurance Commissioner, on March 22, 2019.Fiscal Impact    This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    The Insurance Division’s general waiver provisions of 191—Chapter 4 apply to these rules.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making action is adopted:

        ITEM 1.    Rescind 191—Chapter 37 and adopt the following new chapter in lieu thereof: CHAPTER 37MEDICARE SUPPLEMENT INSURANCE

    191—37.1(514D) Purpose and authority.  The purpose of this chapter is to provide for the reasonable standardization of coverage and simplification of terms and benefits of Medicare supplement policies; to facilitate public understanding and comparison of such policies; to eliminate provisions contained in such policies which may be misleading or confusing in connection with the purchase of such policies or with the settlement of claims; and to provide for full disclosures in the sale of accident and sickness insurance coverages to persons eligible for Medicare. This chapter is issued pursuant to the authority vested in the commissioner under Iowa Code chapter 514D.

    191—37.2(514D) Applicability, scope, and appendices.      37.2(1) Applicability and scope.      a.    Except as otherwise specifically provided in rules 191—37.6(514D), 191—37.22(514D), 191—37.23(514D), 191—37.28(514D) and 191—37.32(514D), this chapter shall apply to:    (1)   All Medicare supplement individual or group policies delivered or issued for delivery in this state on or after May 15, 2019, unless otherwise stated; and    (2)   All certificates issued under group Medicare supplement policies, which certificates have been delivered or issued for delivery in this state on or after May 15, 2019, unless otherwise stated.    b.    This chapter shall not apply to a policy or contract of one or more employers or labor organizations, or of the trustees of a fund established by one or more employers or labor organizations, or combination thereof; for employees or former employees, or a combination thereof; or for members or former members, or a combination thereof, of the labor organizations.    37.2(2) Appendices.  The following appendices can be found at the end of this chapter:    a.    Appendix A: Medicare Supplement Refund Calculation Form. This form is to be completed pursuant to subrule 37.23(3).    b.    Appendix B: Disclosure Statements. The applicable notice from the choices in Appendix B shall be used on Medicare supplement applications, pursuant to subrule 37.26(2).    c.    Appendix C: Statements and Questions for Application Forms Related to Duplicate or Replacement Coverage. The statements and questions in Appendix C shall be included with the outline of coverage and delivered with any application form for Medicare supplement policies or certificates to an applicant, as required by subrules 37.27(1) and 37.27(2).    d.    Appendix D: Notice to Applicant Regarding Replacement of Medicare Supplement Insurance or Medicare Advantage. The notice form of Appendix D shall be provided as required by subrules 37.27(4) and 37.27(5).    e.    Appendix E: Outline of Coverage: Benefit Charts. The items in the applicable tables in this Appendix E, displaying the features of each benefit plan offered by the issuer, shall be included in the outline of coverage in the order prescribed, pursuant to subrule 37.28(4).    f.    Appendix F: Form for Reporting Medicare Supplement Policies or Certificates. This form is to be completed pursuant to subrule 37.32(1).

    191—37.3(514D) Definitions.  For purposes of this chapter, in addition to the definitions in Iowa Code section 514D.2, the following definitions shall apply, unless otherwise specified:        "1990 standardized Medicare supplement benefit plan" "1990 plan" means a group or individual Medicare supplement policy issued on or after January 1, 1992, and with an effective date for coverage prior to June 1, 2010, and includes Medicare supplement insurance policies and certificates renewed on or after June 1, 2010, which are not replaced by the issuer at the request of the insured.        "2010 standardized Medicare supplement benefit plan" "2010 plan" means a group or individual Medicare supplement policy issued with an effective date for coverage on or after June 1, 2010.        "Applicant" means:
    1. In the case of an individual Medicare supplement policy, the person who seeks to contract for insurance benefits; and
    2. In the case of a group Medicare supplement policy, the proposed covered individual, unless stated otherwise.
            "Basic core benefits" are benefits defined in subrule 37.7(2) for 1990 plans, subrule 37.8(2) for 2010 plans, and subrule 37.9(1) for Medicare supplement policies or certificates delivered or issued for delivery to individuals newly eligible for Medicare on or after January 1, 2020.        "Certificate" means any certificate of coverage delivered or issued for delivery in this state to a covered individual under a group Medicare supplement policy.        "Certificate form" means the form (as defined in Iowa Code section 514D.2(2)) on which the certificate is delivered or issued for delivery by the issuer.        "Certificate holder" means the named individual to whom the certificate of coverage under a group policy is issued, or a spouse, if applicable.        "CMS" means the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services.        "Commissioner" means the Iowa insurance commissioner, and includes the insurance division as delegated.        "Covered individual" means an individual who may receive benefits under an individual or group Medicare supplement policy because the individual is one of the following: the named insured under an individual Medicare supplement policy; the named certificate holder under a group Medicare supplement policy; or an individual such as a spouse covered by way of the named certificate holder’s group Medicare supplement policy. For purposes of rule 191—37.20(514D), “covered individual” means an individual who may receive benefits under an individual or group Medicare Select policy because the individual is one of the following: the named insured under an individual Medicare Select policy; the named certificate holder under a group Medicare Select policy; or an individual such as a spouse covered by way of the named certificate holder’s group Medicare Select policy.        "Creditable coverage."
    1. “Creditable coverage” means, with respect to an individual, health coverage of the individual provided under any of the following:
  • A group health plan;
  • Health insurance coverage;
  • Part A or Part B of Title XVIII of the Social Security Act (Medicare);
  • Title XIX of the Social Security Act (Medicaid), other than coverage consisting solely of benefits under Section 1928;
  • Chapter 55 of Title 10, United States Code (CHAMPUS);
  • A medical care program of the Indian Health Service or of a tribal organization;
  • A state health benefits risk pool;
  • A health plan offered under Chapter 89 of Title 5, United States Code (Federal Employees Health Benefits Program);
  • A public health plan as defined in federal regulation; and
  • A health benefit plan under Section 5(e) of the Peace Corps Act (22 United States Code 2504(e)).
    1. “Creditable coverage” shall not include one or more of, or any combination of, the following:
  • Coverage only for accident or disability income insurance, or any combination thereof;
  • Coverage issued as a supplement to liability insurance;
  • Liability insurance, including general liability insurance and automobile liability insurance;
  • Workers’ compensation or similar insurance;
  • Automobile medical payment insurance;
  • Credit-only insurance;
  • Coverage for on-site medical clinics; and
  • Other similar insurance coverage, specified in federal regulations, under which benefits for medical care are secondary or incidental to other insurance benefits.
    1. “Creditable coverage” shall not include the following benefits if they are provided under a separate policy, certificate or contract of insurance or are otherwise not an integral part of the plan:
  • Limited scope dental or vision benefits;
  • Benefits for long-term care, nursing home care, home health care, community-based care, or any combination thereof; and
  • Such other similar limited benefits as are specified in federal regulations.
    1. “Creditable coverage” shall not include the following benefits if offered as independent, noncoordinated benefits:
  • Coverage only for a specified disease or illness; and
  • Hospital indemnity or other fixed indemnity insurance.
    1. “Creditable coverage” shall not include the following if it is offered as a separate policy, certificate or contract of insurance:
  • Medicare supplemental health insurance as defined under Section 1882(g)(1) of the Social Security Act;
  • Coverage supplemental to the coverage provided under Chapter 55 of Title 10, United States Code; and
  • Similar supplemental coverage provided to the coverage under a group health plan.
    •         "File" "filing," when used in reference to filing information with the commissioner or with the insurance division, means submitting information as set forth in these rules through the System for Electronic Rate and Form Filing (SERFF), www.serff.com, or as otherwise directed by the insurance division through its website, iid.iowa.gov.         "Group member" means the individual who is a member of the group entity to which the group policy is issued.        "Group policyholder" means the group entity to which a group Medicare supplement policy is issued.        "Insolvency" means that an issuer, licensed to transact the business of insurance in this state, has had a final order of liquidation entered against it with a finding of insolvency by a court of competent jurisdiction in the issuer’s state of domicile.        "Insurance division" means the Iowa insurance division.        "Issuer" includes insurance companies, fraternal benefit societies, health care service plans, health maintenance organizations, and any other entity delivering or issuing for delivery in this state Medicare supplement policies or certificates.        "Medicare" means the Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965, as then constituted or later amended.        "Medicare Advantage plan" means a plan of coverage for health benefits under Medicare Part C (as defined in 42 U.S.C. 1395w-28(b)(1)), and includes:
    1. Coordinated care plans which provide health care services, including but not limited to health maintenance organization plans (with or without a point-of-service option), plans offered by provider-sponsored organizations, and preferred provider organization plans;
    2. Medical savings account plans coupled with a contribution into a Medicare Advantage medical savings account; and
    3. Medicare Advantage private fee-for-service plans.
            "Medicare Select policy," “Medicare Select certificate,” “Medicare Select issuer,” and “Medicare Select network provider” are defined in subrule 37.20(2).        "Medicare supplement policy" means a group or individual policy of accident and sickness insurance or a subscriber contract of hospital and medical service associations or health maintenance organizations, other than a policy issued pursuant to a contract under Section 1876 of the federal Social Security Act (42 U.S.C. Section 1395 et seq.) or an issued policy under a demonstration project specified in 42 U.S.C. Section 1395ss(g)(1), which is advertised, marketed or designed primarily as a supplement to reimbursements under Medicare for the hospital, medical or surgical expenses of persons eligible for Medicare. “Medicare supplement policy” does not include Medicare Advantage plans, outpatient prescription drug plans established under Medicare Part D, or any health care prepayment plan (HCPP) that provides benefits pursuant to an agreement under Section 1833(a)(1)(A) of the Social Security Act.        "MMA" means the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066.        "PACE program" means a program of all-inclusive care for the elderly, operated by an approved PACE organization (an entity that is approved as a PACE program by the Iowa department of human services and that has in effect a PACE program agreement between the entity, CMS, and the Iowa department of human services to operate a PACE program) that provides comprehensive health care services to enrollees in Iowa, pursuant to Section 1894 of the Social Security Act (42 U.S.C. 1395eee) and Iowa Administrative Code rules 441—88.21(249A) through 441—88.28(249A).        "Person" means any individual, corporation, association, or partnership.        "Policy form" means the form (as defined by Iowa Code section 514D.2(2)) on which the policy (as defined by Iowa Code section 514D.2(4)) is delivered or issued for delivery by the issuer.        "Policyholder" means the individual person to whom or group entity to which an individual or group Medicare supplement policy is issued.        "PPS" means prospective payment system.        "Prestandardized Medicare supplement benefit plan" "prestandardized plan" means a group or individual Medicare supplement policy issued prior to January 1, 1992.        "Producer" means a person licensed in this state pursuant to Iowa Code chapter 522B and Iowa Administrative Code 191—Chapter 10 to sell, solicit, negotiate, effect, procure, deliver, renew, continue or bind policies of insurance for persons residing or located, or for policies to be performed, in this state.        "Secretary" means the Secretary of the U.S. Department of Health and Human Services.        "SMSBP" "standardized Medicare supplement benefit plan" means a 1990 plan, a 2010 plan, or a plan described in subrule 37.9(1) for Medicare supplement policies or certificates delivered or issued for delivery to individuals newly eligible for Medicare on or after January 1, 2020.

    191—37.4(514D) Policy definitions and terms.  No policy or certificate may be advertised, solicited or issued for delivery in this state as a Medicare supplement policy or certificate unless such policy or certificate contains definitions or terms which conform to the requirements of this rule.        "Accident," “accidental injury,” or “accidental means” shall be defined to employ “result” language and shall not include words which establish an accidental means test or use words such as “external, violent, visible wounds” or similar words of description or characterization.
    1. The definition shall not be more restrictive than the following: “Injury or injuries for which benefits are provided means accidental bodily injury sustained by the covered individual which is the direct result of an accident, independent of disease or bodily infirmity or any other cause, and occurs while insurance coverage is in force.”
    2. Such definition may provide that injuries shall not include injuries for which benefits are provided or available under any workers’ compensation, employer’s liability or similar law, or motor vehicle no-fault plan, unless prohibited by law.
            "Benefit period" "Medicare benefit period" shall not be defined more restrictively than as defined by Medicare.        "Convalescent nursing home," “extended care facility,” or “skilled nursing facility” shall not be defined more restrictively than as defined by Medicare.        "Hospital" may be defined in relation to its status, facilities and available services or to reflect its accreditation by the Joint Commission on Accreditation of Hospitals, but not more restrictively than as defined by Medicare.        "Medicare" shall be defined in the policy and certificate. Medicare may be substantially defined as “The Health Insurance for the Aged Act, Title XVIII of the Social Security Amendments of 1965 as then constituted or later amended,” or “Title I, Part I of Pub. L. No. 89-97, as Enacted by the Eighty-Ninth Congress of the United States of America and popularly known as the Health Insurance for the Aged Act, as then constituted and any later amendments or substitutes thereof,” or words of similar import.        "Medicare-eligible expenses" shall mean expenses of the kinds covered by Medicare Parts A and B, to the extent recognized as reasonable and medically necessary by Medicare.        "Physician" shall not be defined more restrictively than as defined by Medicare.        "Sickness" shall not be defined to be more restrictive than the following: “Sickness means illness or disease of a covered individual which first manifests itself after the effective date of insurance and while the insurance is in force.” The definition may be further modified to exclude sicknesses or diseases for which benefits are provided under any workers’ compensation, occupational disease, employer’s liability or similar law.

    191—37.5(514D) Policy provisions.      37.5(1) Coverage restrictions related to Medicare.  Except for permitted preexisting condition clauses as described in paragraphs 37.6(1)“a,” 37.7(1)“d,” and 37.8(1)“d,” no policy or certificate may be advertised, solicited or issued for delivery in this state as a Medicare supplement policy or certificate if such Medicare supplement policy or certificate contains limitations or exclusions on coverage that are more restrictive than those permitted by Medicare.    37.5(2) Waivers of preexisting conditions.  No Medicare supplement policy or certificate may use waivers to exclude, limit or reduce coverage or benefits for specifically named or described preexisting diseases or physical conditions.    37.5(3) Duplicate benefits.  No Medicare supplement policy or certificate in force in the state shall contain benefits which duplicate benefits provided by Medicare insurance.    37.5(4) Renewal of pre-2006 coverage.  Subject to paragraphs 37.6(1)“d,” “e,” and “g” and 37.7(1)“d” and “e,” a Medicare supplement policy or certificate with benefits for outpatient prescription drugs in existence prior to January 1, 2006, shall, at the option of a currently covered individual who does not enroll in Medicare Part D, be renewed for that covered individual.    37.5(5) Coverage of prescription drugs after 2005.  A Medicare supplement policy or certificate with benefits for outpatient prescription drugs shall not be issued after December 31, 2005.    37.5(6) Renewal of coverage of prescription drugs after 2005 for enrollees of Part D.  After December 31, 2005, a Medicare supplement policy or certificate with benefits for outpatient prescription drugs may not be renewed after the covered individual enrolls in Medicare Part D unless:    a.    The policy or certificate is modified to eliminate outpatient prescription coverage for expenses of outpatient prescription drugs incurred after the effective date of the covered individual’s coverage under a Medicare Part D plan; and    b.    Premiums are adjusted to reflect the elimination of outpatient prescription drug coverage at the time of Medicare Part D enrollment, accounting for any claims paid, if applicable.

    191—37.6(514D) Minimum benefit standards for prestandardized Medicare supplement benefit plan policies or certificates issued for delivery prior to January 1, 1992 (prestandardized plans).  No policy or certificate may be advertised, solicited or issued for delivery in this state as a prestandardized plan policy or certificate unless it meets or exceeds the following minimum standards. These are minimum standards and do not preclude the inclusion of other provisions or benefits which are not inconsistent with these standards.    37.6(1) General standards.  The following standards apply to prestandardized plans and are in addition to all other requirements of this chapter.    a.    A prestandardized plan shall not exclude or limit benefits for losses incurred more than six months from the effective date of coverage because it involved a preexisting condition. The prestandardized plan shall not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within six months before the effective date of coverage.    b.    A prestandardized plan shall not indemnify against losses resulting from sickness on a different basis than losses resulting from accidents.    c.    A prestandardized plan shall provide that benefits designed to cover cost-sharing amounts under Medicare will be changed automatically to coincide with any changes in the applicable Medicare deductible, copayment, or coinsurance amounts. Premiums may be modified to correspond with such changes.    d.    A “noncancelable,” “guaranteed renewable,” or “noncancelable and guaranteed renewable” prestandardized plan shall not:    (1)   Provide for termination of coverage of a spouse of a group member solely because of the occurrence of an event specified for termination of coverage of the group member, other than the nonpayment of premium; or    (2)   Be canceled or nonrenewed by the issuer solely on the grounds of deterioration of health.    e.    Except as authorized by the commissioner, an issuer shall neither cancel nor nonrenew a prestandardized plan policy or certificate for any reason other than nonpayment of premium or material misrepresentation.    f.    Group Medicare supplement policies.    (1)   If a group prestandardized plan is terminated by the group policyholder and not replaced as provided in subparagraph 37.6(1)“f”(3), the issuer shall offer to each of the covered individuals under the group prestandardized plan an individual Medicare supplement policy. The issuer shall offer each of the group prestandardized plan’s covered individuals at least the following choices:    1.   An individual Medicare supplement policy currently offered by the issuer having comparable benefits to those contained in the terminated group prestandardized plan; and    2.   An individual Medicare supplement policy which provides only such benefits as are required to meet the basic core benefits minimum standards as defined in subrule 37.7(2).    (2)   If a covered individual’s membership with the group entity that is the group policyholder is terminated, the issuer shall:    1.   Offer the covered individual such conversion opportunities as are described in subparagraph 37.6(1)“f”(1); or    2.   At the option of the group policyholder, offer the covered individual continuation of coverage under the group prestandardized plan.    (3)   If a group prestandardized plan is replaced by another group Medicare supplement policy purchased by the same group policyholder, the issuer of the replacement group Medicare supplement policy shall offer coverage to all covered individuals under the replaced group prestandardized plan on its date of termination. Coverage under the new replacement group Medicare supplement policy shall not result in any exclusion for preexisting conditions that would have been covered under the replaced group prestandardized plan.    (4)   If a prestandardized plan eliminates an outpatient prescription drug benefit as a result of requirements imposed by the MMA, the modified policy shall be deemed to satisfy the guaranteed renewal requirements of this subrule.    g.    Termination of a prestandardized plan policy or certificate shall be without prejudice to any continuous loss which commenced while the prestandardized plan policy or certificate was in force, but the extension of benefits beyond the period during which the prestandardized plan policy or certificate was in force may be predicated upon the continuous total disability of the covered individual, limited to the duration of the prestandardized plan policy or certificate benefit period, if any, or to payment of the maximum benefits. Receipt of Medicare Part D benefits will not be considered in determining a continuous loss.    37.6(2) Minimum benefit standards.  The following are minimum benefit standards for prestandardized plans:    a.    Coverage of Part A Medicare-eligible expenses for hospitalization to the extent not covered by Medicare from the sixty-first day through the ninetieth day in any Medicare benefit period;    b.    Coverage for either all or none of the Medicare Part A inpatient hospital deductible amount;    c.    Coverage of Part A Medicare-eligible expenses which are incurred as daily hospital charges during the covered individual’s use of Medicare’s lifetime hospital inpatient reserve days;    d.    Upon exhaustion of all Medicare hospital inpatient coverage including the lifetime reserve days, coverage of 90 percent of all Medicare Part A eligible expenses for hospitalization not covered by Medicare subject to a lifetime maximum benefit of an additional 365 days;    e.    Coverage under Medicare Part A for the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations) unless replaced in accordance with federal regulations or already paid for under Part B;    f.    Coverage for the coinsurance amount, or in the case of hospital outpatient department services paid under a PPS, the copayment amount, of Medicare-eligible expenses under Part B regardless of hospital confinement, subject to a maximum calendar year out-of-pocket amount equal to the Medicare Part B deductible;    g.    Effective January 1, 1990, coverage under Medicare Part B for the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations), unless replaced in accordance with federal regulations or already paid for under Part A, subject to the Medicare deductible amount.

    191—37.7(514D) Benefit standards for 1990 standardized Medicare supplement benefit plan policies or certificates issued for delivery on or after January 1, 1992, and with an effective date for coverage prior to June 1, 2010 (1990 plans).  The following standards are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this state on or after January 1, 1992, and with an effective date for coverage prior to June 1, 2010. No policy or certificate may be advertised, solicited, delivered or issued for delivery in this state as a Medicare supplement policy or certificate unless it complies with these benefit standards. No issuer may offer any prestandardized Medicare supplement benefit plan for sale on or after January 1, 1992. Benefit standards applicable to Medicare supplement policies and certificates issued before January 1, 1992, remain subject to the requirements of rule 191—37.6(514D).    37.7(1) General standards.  The following standards apply to 1990 plans and are in addition to all other requirements of this chapter.    a.    Combinations of benefits other than standard not allowed.No groups, packages or combinations of Medicare supplement benefits other than those listed in this rule shall be offered for sale in this state, except as may be permitted in subrule 37.7(6) and in rule 191—37.20(514D).    b.    Uniformity and conformity.All 1990 plans shall be uniform in structure, language, designation and format to the standardized Medicare supplement benefit plans A through L listed in subrule 37.7(4) and shall conform to the definitions in rules 191—37.3(514D) and 191—37.4(514D). Each benefit shall be structured in accordance with the format provided in this rule and list the benefits in the order shown in this rule. For purposes of this rule, “structure, language, and format” means style, arrangement and overall content of a benefit.    c.    Other designations may be used.An issuer may use, in addition to the benefit plan designations required in paragraph 37.7(1)“b,” other designations to the extent permitted by law.    d.    Preexisting conditions.A 1990 plan shall not exclude or limit benefits for losses incurred more than six months from the effective date of coverage because the claim involved a preexisting condition. The 1990 plan may not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within six months before the effective date of coverage.    e.    Sickness same as accident.A 1990 plan shall not indemnify against losses resulting from sickness on a different basis than losses resulting from accidents.    f.    Automatic change of cost sharing.A 1990 plan shall provide that benefits designed to cover cost-sharing amounts under Medicare will be changed automatically to coincide with any changes in the applicable deductible, copayment, or coinsurance amounts set by Medicare. Premiums may be modified to correspond with such changes.    g.    Termination of coverage of spouse.No 1990 plan shall provide for termination of coverage of a spouse solely because of the occurrence of an event specified for termination of coverage of the insured, other than the nonpayment of premium.    h.    Guaranteed renewability.Each 1990 plan shall be guaranteed renewable.    (1)   The issuer shall not cancel or nonrenew a 1990 plan solely on the ground of health status of the covered individual.    (2)   The issuer shall not cancel or nonrenew a 1990 plan for any reason other than nonpayment of premium or material misrepresentation.    (3)   If the 1990 plan is terminated by the group policyholder and is not replaced as provided under subparagraph 37.7(1)“h”(5), the issuer shall offer to the covered individual a conversion opportunity of an individual Medicare supplement policy which, at the option of the covered individual, either:    1.   Provides for continuation of the benefits contained in the group 1990 plan; or    2.   Provides for such benefits as otherwise meet the requirements of this subrule.    (4)   If a covered individual under a group 1990 plan terminates membership in the group, the issuer shall either:    1.   Offer the covered individual the conversion opportunity described in subparagraph 37.7(1)“h”(3); or    2.   At the option of the group policyholder, offer the covered individual continuation of coverage under the group Medicare supplement policy.    (5)   If a group 1990 plan is replaced by another group Medicare supplement policy purchased by the same group policyholder, the issuer of the replacement group Medicare supplement policy shall offer coverage under the replacement group Medicare supplement policy to all covered individuals of the replaced group 1990 plan effective on the date of termination of the replaced group 1990 plan. Coverage under the replacement group Medicare supplement policy shall not result in any exclusion of any covered individual’s preexisting conditions that would have been covered under the replaced group 1990 plan.    (6)   If a 1990 plan eliminates an outpatient prescription drug benefit as a result of requirements imposed by the MMA, the modified 1990 plan shall be deemed to satisfy the guaranteed renewal requirements of this paragraph.    i.    Termination involving continuous loss.Termination of a 1990 plan shall be without prejudice to any continuous loss which commenced while the 1990 plan was in force, but the extension of benefits beyond the period during which the 1990 plan was in force may be conditioned upon the continuous total disability of the covered individual, limited to the duration of the 1990 plan benefit period, if any, or payment of the maximum benefits. Receipt of Medicare Part D benefits will not be considered in determining a continuous loss.    j.    Suspension for Title XIX coverage.    (1)   A 1990 plan shall provide that benefits and premiums under the 1990 plan shall be suspended at the request of the covered individual for the period (not to exceed 24 months) in which the covered individual has applied for and is determined to be entitled to medical assistance under Title XIX of the Social Security Act, but only if the covered individual notifies the issuer of such 1990 plan within 90 days after the date the covered individual becomes entitled to such assistance.    (2)   If such suspension occurs and if the covered individual loses entitlement to such medical assistance, such 1990 plan shall be automatically reinstituted (effective as of the date of termination of such entitlement) if the covered individual provides notice of loss of such entitlement within 90 days after the date of such loss and pays the premium attributable to the period, effective as of the date of termination of such entitlement.    (3)   Each 1990 plan shall provide that benefits and premiums under the 1990 plan shall be suspended for the period provided by federal regulation at the request of the covered individual if the covered individual is entitled to benefits under Section 226(b) of the Social Security Act and is covered under a group health plan as defined in Section 1862(b)(1)(A)(v) of the Social Security Act. If suspension occurs and if the covered individual loses coverage under the group health plan, the 1990 plan shall be automatically reinstituted effective as of the date of loss of coverage if the covered individual provides notice to the issuer of loss of coverage within 90 days after the date of such loss and pays the premium attributable to the period, effective as of the date of termination of enrollment in the group health plan.    (4)   Reinstitution of coverage as described in subparagraphs 37.7(1)“j”(2) and (3):    1.   Shall not provide for any waiting period with respect to treatment of preexisting conditions;    2.   Shall provide for resumption of coverage that is substantially equivalent to coverage in effect before the date of suspension. If the suspended 1990 plan provided coverage for outpatient prescription drugs, reinstitution of the 1990 plan for Medicare Part D enrollees shall be without coverage for outpatient prescription drugs and shall otherwise provide substantially equivalent coverage to the coverage in effect before the date of suspension; and    3.   Shall provide for classification of premiums on terms at least as favorable to the covered individual as the premium classification terms that would have applied to the covered individual had the coverage not been suspended.    k.    Exchange of 1990 plan to 2010 plan.If an issuer makes a written offer to a covered individual covered by one or more of the issuer’s 1990 plans (as described in this rule) to allow, during a specified period, the covered individual to exchange coverage from the covered individual’s 1990 plan (as described in this rule) to a 2010 plan (as described in rule 191—37.8(514D)), the offer and subsequent exchange shall comply with the following requirements:    (1)   An issuer need not provide justification to the commissioner or comply with 191—Chapter 16 or rule 191—37.27(514D) if the covered individual exchanges a 1990 plan policy or certificate for an issue-age-rated 2010 plan policy or certificate using the same issue age and duration as was used for the covered individual’s 1990 plan policy or certificate to be exchanged. If a covered individual’s 1990 plan policy or certificate to be exchanged is priced on an issue-age-rate schedule at the time of such offer, the rate charged to the covered individual for the exchanged 2010 plan policy or certificate shall recognize the policy reserve buildup, due to the prefunding inherent in the use of an issue-age-rate basis, for the benefit of the covered individual. The rating method proposed to be used by an issuer must be filed with the commissioner pursuant to rule 191—37.24(514D).    (2)   The rating class of the new exchanged 2010 plan policy or certificate shall be the class closest to the covered individual’s rating class of the exchanged 1990 plan.    (3)   An issuer may not apply new preexisting condition limitations or a new incontestability period to the covered individual’s exchanged 2010 plan for those benefits contained in the exchanged 1990 plan, but may apply preexisting condition limitations of no more than six months to any added benefits contained in the exchanged 2010 plan that were not contained in the exchanged 1990 plan.    (4)   The exchanged 2010 plan shall be offered to all covered individuals within a given 1990 plan, except where the offer or issue would be in violation of state or federal law.    37.7(2) Standards for basic core benefits common to 1990 standardized Medicare supplement benefit plans A through J (1990 plans).  Every issuer shall make available a 1990 plan including only the following basic core benefits to each prospective covered individual. An issuer may make available to prospective covered individuals any of the issuer’s other standardized Medicare supplement benefit plans in addition to the basic core benefits, but not in lieu thereof. The 1990 basic core benefits are the following:    a.    Coverage of Part A Medicare-eligible expenses for hospitalization, to the extent not covered by Medicare, from the sixty-first day through the ninetieth day in any Medicare benefit period;    b.    Coverage of Part A Medicare-eligible expenses incurred for hospitalization, to the extent not covered by Medicare, for each Medicare lifetime inpatient reserve day used;    c.    Upon exhaustion of the Medicare hospital inpatient coverage including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization, paid at the applicable PPS rate or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days. Medicare requires that the provider shall accept the issuer’s payment as payment in full and that the provider may not bill the covered individual for any balance;    d.    Coverage under Medicare Parts A and B for the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations) unless replaced in accordance with federal regulations;    e.    Coverage for the coinsurance amount or, in the case of hospital outpatient department services paid under a PPS, the copayment amount of Medicare Part B eligible expenses regardless of hospital confinement, subject to the Medicare Part B deductible.    37.7(3) Standards for additional benefits for plans B through J.  The following benefit descriptions apply to the additional benefits specified for 1990 plans B through J in subrule 37.7(4):    a.    Medicare Part A deductible: coverage for all of the Medicare Part A inpatient hospital deductible amount per benefit period.    b.    Skilled nursing facility care: coverage for the actual billed charges up to the coinsurance amount from the twenty-first day through the one hundredth day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A.    c.    Medicare Part B deductible: coverage for all of the Medicare Part B deductible amount per calendar year regardless of hospital confinement.    d.    Eighty percent of the Medicare Part B excess charges: coverage for 80 percent of the difference between the actual Medicare Part B charge as billed, not to exceed any charge limitation established by Medicare or by state law, and the Medicare-approved Part B charge.    e.    One hundred percent of the Medicare Part B excess charges: coverage for all of the difference between the actual Medicare Part B charge as billed, not to exceed any charge limitation established by Medicare or by state law, and the Medicare-approved Part B charge.    f.    Basic outpatient prescription drug benefit: coverage for 50 percent of outpatient prescription drug charges, after a $250 calendar year deductible, to a maximum of $1,250 in benefits received by the covered individual per calendar year, to the extent not covered by Medicare. The outpatient prescription drug benefit may be included for sale or issuance in a Medicare 1990 plan until January 1, 2006.    g.    Extended outpatient prescription drug benefit: coverage for 50 percent of outpatient prescription drug charges, after a $250 calendar year deductible to a maximum of $3,000 in benefits received by the covered individual per calendar year, to the extent not covered by Medicare. The outpatient prescription drug benefit may be included for sale or issuance in a Medicare 1990 plan until January 1, 2006.    h.    Medically necessary emergency care in a foreign country: coverage to the extent not covered by Medicare for 80 percent of the billed charges for Medicare-eligible expenses for medically necessary emergency hospital, physician and medical care received in a foreign country, which care would have been covered by Medicare if provided in the United States and which care began during the first 60 consecutive days of each trip outside the United States, subject to a calendar year deductible of $250 and a lifetime maximum benefit of $50,000. For purposes of this benefit, “emergency care” shall mean care needed immediately because of an injury or an illness of sudden and unexpected onset.    i.    Preventive medical care benefit:    (1)   Coverage for the following preventive health services not covered by Medicare:    1.   An annual clinical preventive medical history and physical examination that may include tests and services from numbered paragraph “2” and patient education to address preventive health care measures.    2.   Preventive screening tests or preventive services, the selection and frequency of which is determined to be medically appropriate by the attending physician.    (2)   Reimbursement shall be for the actual charges up to 100 percent of the Medicare-approved amount for each service, as if Medicare were to cover the service as identified in American Medical Association current procedural terminology (AMA CPT) codes, to a maximum of $120 annually under this benefit. This benefit shall not include payment for any procedure covered by Medicare.    j.    At-home recovery benefit: coverage for services to provide short-term, at-home assistance with activities of daily living for those recovering from an illness, injury or surgery.    (1)   For purposes of this benefit, the following definitions shall apply:“Activities of daily living” includes, but is not limited to, bathing, dressing, personal hygiene, transferring, eating, ambulating, assistance with drugs that are normally self-administered, and changing bandages or other dressings.“At-home recovery visit” means the period of a visit required to provide at-home recovery care, without limit on the duration of the visit, except each consecutive four hours in a 24-hour period of services provided by a care provider is one visit.“Care provider” means a duly qualified or licensed home health aide or homemaker, personal care aide or nurse provided through a licensed home health care agency or referred by a licensed referral agency or licensed nurses registry.“Home” shall mean any place used by the covered individual as a place of residence, provided that such place would qualify as a residence for home health care services covered by Medicare. A hospital or skilled nursing facility shall not be considered the covered individual’s place of residence.    (2)   Coverage requirements and limitations.    1.   At-home recovery services provided must be primarily services which assist in activities of daily living.    2.   The covered individual’s attending physician must certify that the specific type and frequency of at-home recovery services are necessary because of a condition for which a home care plan of treatment was approved by Medicare.    3.   Coverage is limited to:
  • No more than the number and type of at-home recovery visits certified as necessary by the covered individual’s attending physician. The total number of at-home recovery visits shall not exceed the number of Medicare-approved home health care visits under a Medicare-approved home care plan of treatment.
  • The actual charges for each visit up to a maximum reimbursement of $40 per visit.
  • One thousand six hundred dollars per calendar year.
  • Seven visits in any one week.
  • Care furnished on a visiting basis in the covered individual’s home.
  • Services provided by a care provider as defined in this paragraph 37.7(3)“j.”
  • At-home recovery visits while the covered individual is covered under the policy or certificate and not otherwise excluded.
  • At-home recovery visits received during the period the covered individual is receiving Medicare-approved home care services or no more than eight weeks after the service date of the last Medicare-approved home health care visit.
    •     (3)   Coverage is excluded for:    1.   Home care visits paid for by Medicare or other government programs; and    2.   Care provided by family members, unpaid volunteers or providers who are not care providers.        37.7(4) Elements required in standardized 1990 Medicare supplement benefit plans.  The additional benefits described in subrule 37.7(3) shall be included in 1990 Medicare supplement benefit plans as specified for each 1990 plan as follows:    a.    Plan A shall be limited to the basic core benefits, as defined in subrule 37.7(2).    b.    Plan B shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible as defined in paragraph 37.7(3)“a.”    c.    Plan C shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, Medicare Part B deductible, and medically necessary emergency care in a foreign country as defined in paragraphs 37.7(3)“a,”“b,”“c,” and “h,” respectively.    d.    Plan D shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, medically necessary emergency care in a foreign country, and the at-home recovery benefit as defined in paragraphs 37.7(3)“a,”“b,”“h,” and “j,” respectively.    e.    Plan E shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, medically necessary emergency care in a foreign country, and preventive medical care as defined in paragraphs 37.7(3)“a,”“b,”“h,” and “i,” respectively.    f.    Plan F shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, the Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, and medically necessary emergency care in a foreign country as defined in paragraphs 37.7(3)“a,”“b,”“c,”“e,” and “h,” respectively.    g.    Plan G shall include only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, 80 percent of the Medicare Part B excess charges, medically necessary emergency care in a foreign country, and the at-home recovery benefit as defined in paragraphs 37.7(3)“a,”“b,”“d,”“h,” and “j,” respectively.    h.    Plan H shall consist of only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, basic prescription drug benefit, and medically necessary emergency care in a foreign country as defined in paragraphs 37.7(3)“a,”“b,”“f,” and “h,” respectively. The outpatient prescription drug benefit shall not be included in a 1990 plan sold after December 31, 2005.    i.    Plan I shall consist of only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, 100 percent of the Medicare Part B excess charges, basic prescription drug benefit, medically necessary emergency care in a foreign country, and at-home recovery benefit as defined in paragraphs 37.7(3)“a,”“b,”“e,”“f,”“h,” and “j,” respectively. The outpatient prescription drug benefit shall not be included in a 1990 plan sold after December 31, 2005.    j.    Plan J shall consist of only the following: basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, extended prescription drug benefit, medically necessary emergency care in a foreign country, preventive medical care, and at-home recovery benefit as defined in paragraphs 37.7(3)“a,”“b,”“c,”“e,”“g,”“h,”“i,” and “j,” respectively. The outpatient prescription drug benefit shall not be included in a 1990 plan sold after December 31, 2005.    k.    High deductible Plan F shall include only the following: 100 percent of covered expenses following the payment of the annual high deductible Plan F deductible. The covered expenses include the basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, the Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, and medically necessary emergency care in a foreign country as defined in paragraphs 37.7(3)“a,”“b,”“c,”“e,” and “h,” respectively. The annual high deductible Plan F deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by the Plan F policy, and shall be in addition to any other specific benefit deductibles. The annual high deductible Plan F deductible shall be $1,500 for 1998 and 1999, and shall be based on the calendar year. It shall be adjusted annually thereafter by the Secretary to reflect the change in the consumer price index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10.    l.    High deductible Plan J shall consist of only the following: 100 percent of covered expenses following the payment of the annual high deductible Plan J deductible. The covered expenses include the basic core benefits as set forth in subrule 37.7(2), plus the Medicare Part A deductible, skilled nursing facility care, Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, extended outpatient prescription drug benefit, medically necessary emergency care in a foreign country, preventive medical care benefit, and at-home recovery benefit as defined in paragraphs 37.7(3)“a,”“b,”“c,”“e,”“g,”“h,”“i,” and “j,” respectively. The annual high deductible Plan J deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by the Medicare supplement Plan J policy, and shall be in addition to any other specific benefit deductibles. The annual deductible shall be $1,500 for 1998 and 1999, and shall be based on a calendar year. It shall be adjusted annually thereafter by the Secretary to reflect the change in the consumer price index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10. The outpatient prescription drug benefit shall not be included in a 1990 plan sold after December 31, 2005.    m.    Plan K shall consist of the following:    (1)   Coverage of 100 percent of the Part A hospital coinsurance amount for each day used from the sixty-first day through the ninetieth day in any Medicare benefit period;    (2)   Coverage of 100 percent of the Part A hospital coinsurance amount for each Medicare lifetime inpatient reserve day used from the ninety-first day through the one hundred fiftieth day in any Medicare benefit period;    (3)   Upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable PPS rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days. The provider shall accept the issuer’s payment in full and may not bill the covered individual for any balance;    (4)   Medicare Part A deductible: coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period until the out-of-pocket limitation is met as described in subparagraph 37.7(4)“m”(10);    (5)   Skilled nursing facility care: coverage for 50 percent of the coinsurance amount for each day used from the twenty-first day through the one hundredth day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A until the out-of-pocket limitation is met as described in subparagraph 37.7(4)“m”(10);    (6)   Hospice care: coverage for 50 percent of cost sharing for all Part A Medicare-eligible expenses and respite care until the out-of-pocket limitation is met as described in subparagraph 37.7(4)“m”(10);    (7)   Coverage for 50 percent, under Medicare Part A or B, of the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations) unless replaced in accordance with federal regulations until the out-of-pocket limitation is met as described in subparagraph 37.7(4)“m”(10);    (8)   Except for coverage provided in subparagraph 37.7(4)“m”(9), coverage for 50 percent of the cost sharing otherwise applicable under Medicare Part B after the covered individual pays the Part B deductible until the out-of-pocket limitation is met as described in subparagraph 37.7(4)“m”(10);    (9)   Coverage of 100 percent of the cost sharing for Medicare Part B preventive services after the covered individual pays the Part B deductible; and    (10)   Coverage of 100 percent of all cost sharing under Medicare Parts A and B for the balance of the calendar year after the individual has reached the out-of-pocket limitation on annual expenditures under Medicare Parts A and B of $4,000 in 2006, indexed each year by the appropriate inflation adjustment specified by the Secretary.    n.    Plan L shall consist of the following:    (1)   The benefits described in subparagraphs 37.7(4)“m”(1), (2), (3), and (9);    (2)   The benefits described in subparagraphs 37.7(4)“m”(4), (5), (6), (7) and (8), but substituting 75 percent for 50 percent in each subparagraph; and    (3)   The benefit described in paragraph 37.7(4)“m”(10), but substituting $2,000 for $4,000.    37.7(5) Elements required in Medicare supplement plans mandated by the MMA.  The 1990 plans mandated by the MMA, Plans K and L, shall include the benefits described for each plan, as follows:    a.    Plan K mandated by the MMA shall consist of only those benefits described in paragraph 37.7(4)“m.”    b.    Plan L mandated by the MMA shall consist of only those benefits described in paragraph 37.7(4)“n.”    37.7(6) New or innovative benefits.  An issuer may, with the prior approval of the commissioner, offer policies or certificates with new or innovative benefits in addition to the benefits provided in a policy or certificate that otherwise complies with the applicable standards. The new or innovative benefits may include benefits that are appropriate to Medicare supplement insurance, new or innovative, not otherwise available, cost-effective, and offered in a manner which is consistent with the goal of simplification of Medicare supplement policies. After December 31, 2005, the innovative benefit shall not include an outpatient prescription drug benefit.

    191—37.8(514D) Benefit standards for 2010 standardized Medicare supplement benefit plan policies or certificates issued for delivery with an effective date for coverage on or after June 1, 2010 (2010 plans).  The following standards are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this state with an effective date for coverage on or after June 1, 2010. No policy or certificate was to be advertised, solicited, delivered, or issued for delivery in this state as a Medicare supplement policy or certificate during that time period unless it complied with the benefit standards set forth in this rule. No issuer may offer any 1990 standardized Medicare supplement benefit plan for sale on or after June 1, 2010. Benefit standards applicable to Medicare supplement policies and certificates issued before June 1, 2010, remain subject to the requirements of rule 191—37.6(514D) or 191—37.7(514D).    37.8(1) General standards.  The following standards apply to 2010 plans and are in addition to all other requirements of this chapter.    a.    Combinations of benefits other than standard not allowed.No groups, packages or combinations of Medicare supplement benefits other than those listed in this rule shall be offered for sale in this state, except as may be permitted in subrule 37.8(5) and rule 191—37.20(514D).    b.    Uniformity and conformity.All 2010 plans shall be uniform in structure, language, designation and format to the standardized benefit plans listed in subrule 37.8(4), and shall conform to the definitions in rules 191—37.3(514D) and 191—37.4(514D). Each benefit plan shall be structured in accordance with the format provided in subrules 37.8(2), 37.8(3) and 37.8(4), or in the case of Plan K or L, each benefit plan shall be structured in accordance with the format provided in paragraph 37.8(4)“h” or “i.” Each plan shall list the benefits in the order shown. For purposes of this rule, “structure, language, and format” means style, arrangement and overall content of a benefit.    c.    Other designations may be used.An issuer may use, in addition to the benefit plan designations required in paragraph 37.8(1)“b,” other designations to the extent permitted by law.    d.    Preexisting conditions.A 2010 plan shall not exclude or limit benefits for losses incurred more than six months from the effective date of coverage because the losses involved a preexisting condition. The 2010 plan may not define a preexisting condition more restrictively than a condition for which medical advice was given or treatment was recommended by or received from a physician within six months before the effective date of coverage.    e.    Sickness same as accident.A 2010 plan shall not indemnify against losses resulting from sickness on a different basis than losses resulting from accidents.    f.    Automatic change of cost sharing.A 2010 plan shall provide that benefits designed to cover cost-sharing amounts under Medicare will be changed automatically to coincide with any changes in the applicable Medicare deductible, copayment, or coinsurance amounts. Premiums may be modified to correspond with such changes.    g.    Termination of coverage of spouse.No 2010 plan shall provide for termination of coverage of a spouse solely because of the occurrence of an event specified for termination of coverage of the named insured or group member, other than the nonpayment of premium.    h.    Guaranteed renewability.Each 2010 plan shall be guaranteed renewable.    (1)   The issuer shall not cancel or nonrenew the policy or certificate solely on the ground of health status of the covered individual.    (2)   The issuer shall not cancel or nonrenew the 2010 plan for any reason other than nonpayment of premium or material misrepresentation.    (3)   If a group 2010 plan is terminated by the group policyholder and is not replaced as provided under subparagraph 37.8(1)“h”(5), the issuer shall offer covered individuals a conversion opportunity to an individual 2010 plan which, at the option of the covered individual, either:    1.   Provides for continuation of the benefits contained in the group 2010 plan; or    2.   Provides for benefits that otherwise meet the requirements of this subrule.    (4)   If a covered individual under a group 2010 plan terminates membership in the group, the issuer shall:    1.   Offer the covered individual the conversion opportunity described in subparagraph 37.8(1)“h”(3); or    2.   At the option of the group policyholder, offer the covered individual continuation of coverage under the group 2010 plan.    (5)   If a group 2010 plan is replaced by another group Medicare supplement policy purchased by the same group policyholder, the issuer of the replacement group Medicare supplement policy shall offer coverage under the replacement group Medicare supplement policy to all covered individuals of the replaced group 2010 plan on the effective date of termination of the replaced group 2010 plan. Coverage under the replacement group Medicare supplement policy shall not result in any exclusion for any covered individual’s preexisting conditions that would have been covered under the replaced group 2010 plan.    i.    Termination involving continuous loss.Termination of a 2010 plan policy or certificate shall be without prejudice to any continuous loss which commenced while the policy or certificate was in force, but the extension of benefits beyond the period during which the policy or certificate was in force may be conditioned upon the continuous total disability of the covered individual, limited to the duration of the policy or certificate benefit period, if any, or payment of the maximum benefits. Receipt of Medicare Part D benefits will not be considered in determining a continuous loss.    j.    Suspension for Title XIX coverage.    (1)   A 2010 plan shall provide that benefits and premiums under the policy or certificate shall be suspended at the request of the covered individual for the period (not to exceed 24 months) in which the covered individual has applied for and is determined to be entitled to medical assistance under Title XIX of the Social Security Act, but only if the covered individual notifies the issuer of the policy or certificate within 90 days after the date the covered individual becomes entitled to assistance.    (2)   If such suspension occurs and if the covered individual loses entitlement to medical assistance, the policy or certificate shall be automatically reinstituted effective as of the date of termination of entitlement if the covered individual provides notice of loss of entitlement within 90 days after the date of loss and pays the premium attributable to the period, effective as of the date of termination of entitlement.    (3)   Each 2010 plan shall provide that benefits and premiums under the 2010 plan shall be suspended (for any period that may be provided by federal regulation) at the request of the covered individual if the covered individual is entitled to benefits under Section 226(b) of the Social Security Act and is covered under a group health plan as defined in Section 1862(b)(1)(A)(v) of the Social Security Act. If suspension occurs and if the covered individual loses coverage under the group health plan, the 2010 plan policy or certificate shall be automatically reinstituted effective as of the date of loss of coverage if the covered individual provides notice to the issuer of loss of coverage within 90 days after the date of the loss and pays the premium attributable to the period, effective as of the date of termination of such entitlement.    (4)   Reinstitution of coverage as described in subparagraphs 37.8(1)“j”(2) and (3):    1.   Shall not provide for any waiting period with respect to treatment of preexisting conditions;    2.   Shall provide for resumption of coverage that is substantially equivalent to coverage in effect before the date of suspension; and    3.   Shall provide for classification of premiums on terms at least as favorable to the covered individual as the premium classification terms that would have applied to the covered individual had the coverage not been suspended.    37.8(2) Standards for basic core benefits common to 2010 standardized Medicare supplement benefit Plans A, B, C, D, F, F with high deductible, G, M, and N (2010 basic core benefits).      a.    Availability of basic core benefits required.Every issuer of 2010 plans shall make available to each prospective covered individual a 2010 plan including only the following 2010 basic core benefits. An issuer may make available to a prospective covered individual any of the issuer’s other Medicare supplement benefit plans in addition to the 2010 plan of basic core benefits, but not in lieu thereof.    b.    When issuer must make certain plans available.If an issuer makes available any of the additional benefits described in subrule 37.8(3) or offers standardized benefit Plans K or L (as described in paragraphs 37.8(4)“h” and “i”), then the issuer shall make available to each prospective covered individual, in addition to a policy form or certificate form with only the 2010 plan basic core benefits as set forth in paragraph 37.8(2)“c,” a policy form or certificate form containing either standardized benefit Plan C (as described in paragraph 37.8(4)“c”) or a standardized benefit Plan F (as described in paragraph 37.8(4)“e”).    c.    2010 plan basic core benefits.The 2010 plan basic core benefits shall include the following:    (1)   Hospitalization days 61 through 90: coverage of Part A Medicare-eligible expenses for hospitalization, to the extent not covered by Medicare, from the sixty-first day through the ninetieth day in any Medicare benefit period;    (2)   Hospitalization for reserve days: coverage of Part A Medicare-eligible expenses incurred for hospitalization to the extent not covered by Medicare for each Medicare lifetime inpatient reserve day used;    (3)   Hospitalization for additional 365 days: upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable PPS rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days. Medicare requires that the provider shall accept the issuer’s payment as payment in full and that the provider may not bill the covered individual for any balance;    (4)   Blood: coverage under Medicare Parts A and B for the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations) unless replaced in accordance with federal regulations;    (5)   Coinsurance: coverage for the coinsurance amount or, in the case of hospital outpatient department services paid under a PPS, the copayment amount of Medicare-eligible expenses under Part B regardless of hospital confinement, subject to the Medicare Part B deductible; and    (6)   Hospice care: coverage of cost sharing for all Part A Medicare-eligible hospice care and respite care expenses.    37.8(3) Standards for 2010 plan additional benefits.  The following additional benefits shall be included in 2010 plan Plans B, C, D, F, F with high deductible, G, M, and N as provided by subrule 37.8(4):    a.    Medicare Part A deductible: coverage for 100 percent of the Medicare Part A inpatient hospital deductible amount per benefit period;    b.    Medicare Part A deductible: coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period;    c.    Skilled nursing facility care: coverage for the actual billed charges up to the coinsurance amount from the twenty-first day through the one hundredth day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A;    d.    Medicare Part B deductible: coverage for 100 percent of the Medicare Part B deductible amount per calendar year regardless of hospital confinement;    e.    One hundred percent of the Medicare Part B excess charges: coverage for all of the difference between the actual Medicare Part B charges as billed, not to exceed any charge limitation established by the Medicare program or state law, and the Medicare-approved Part B charge; and    f.    Medically necessary emergency care in a foreign country: coverage to the extent not covered by Medicare for 80 percent of the billed charges for Medicare-eligible expenses for medically necessary emergency hospital, physician and medical care received in a foreign country, which care would have been covered by Medicare if provided in the United States and which care began during the first 60 consecutive days of each trip outside the United States, subject to a calendar year deductible of $250 and a lifetime maximum benefit of $50,000. For purposes of this benefit, “emergency care” shall mean care needed immediately because of an injury or an illness of sudden and unexpected onset.    37.8(4) Elements required in standardized 2010 Medicare supplement benefit plans.  The 2010 plans shall include the benefits, as described for each plan, as follows:    a.    Plan A shall include only the following: the basic core benefits as set forth in subrule 37.8(2).    b.    Plan B shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible as defined in paragraph 37.8(3)“a.”    c.    Plan C shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, 100 percent of the Medicare Part B deductible, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,”“d,” and “f,” respectively.    d.    Plan D shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,” and “f,” respectively.    e.    Plan F shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, 100 percent of the Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,”“d,”“e,” and “f,” respectively.    f.    Plan F with high deductible.    (1)   Plan F with high deductible shall include only the following:    1.   One hundred percent of covered expenses following the payment of the annual deductible set forth in subparagraph 37.8(4)“f”(2).    2.   The basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, 100 percent of the Medicare Part B deductible, 100 percent of the Medicare Part B excess charges, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,”“d,”“e,” and “f,” respectively.    (2)   The annual deductible in Plan F with high deductible shall consist of out-of-pocket expenses, other than premiums, for services covered by (regular) Plan F, and shall be in addition to any other specific benefit deductibles. The basis for the deductible shall be $1,500 and shall be adjusted annually from 1999 by the Secretary to reflect the change in the consumer price index for all urban consumers for the 12-month period ending with August of the preceding year, and rounded to the nearest multiple of $10.    g.    Plan G shall include only the following: the core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, 100 percent of the Medicare Part B excess charges, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,”“e,” and “f,” respectively.     h.    Plan K is mandated by the MMA and shall include only the following:    (1)   Medicare Part A hospital coinsurance from the sixty-first day through the ninetieth day: coverage of 100 percent of the Part A hospital coinsurance amount for each day used from the sixty-first day through the ninetieth day in any Medicare benefit period;    (2)   Medicare Part A hospital coinsurance from the ninety-first day through the one hundred fiftieth day: coverage of 100 percent of the Part A hospital coinsurance amount for each Medicare lifetime inpatient reserve day used from the ninety-first day through the one hundred fiftieth day in any Medicare benefit period;    (3)   Medicare Part A hospitalization after lifetime reserve days are exhausted: upon exhaustion of the Medicare hospital inpatient coverage, including the lifetime reserve days, coverage of 100 percent of the Medicare Part A eligible expenses for hospitalization paid at the applicable PPS rate, or other appropriate Medicare standard of payment, subject to a lifetime maximum benefit of an additional 365 days. The provider shall accept the issuer’s payment as payment in full and may not bill the covered individual for any balance;    (4)   Medicare Part A deductible: coverage for 50 percent of the Medicare Part A inpatient hospital deductible amount per benefit period until the out-of-pocket limitation is met as described in subparagraph 37.8(4)“h”(10);    (5)   Skilled nursing facility care: coverage for 50 percent of the coinsurance amount for each day used from the twenty-first day through the one hundredth day in a Medicare benefit period for post-hospital skilled nursing facility care eligible under Medicare Part A until the out-of-pocket limitation is met as described in subparagraph 37.8(4)“h”(10);    (6)   Hospice care: coverage for 50 percent of cost sharing for all Medicare Part A eligible expenses and respite care until the out-of-pocket limitation is met as described in subparagraph 37.8(4)“h”(10);    (7)   Blood: coverage for 50 percent, under Medicare Part A or B, of the reasonable cost of the first three pints of blood (or equivalent quantities of packed red blood cells, as defined under federal regulations) unless replaced in accordance with federal regulations until the out-of-pocket limitation is met as described in subparagraph 37.8(4)“h”(10);    (8)   Medicare Part B cost sharing: except for coverage provided in subparagraph 37.8(4)“h”(9), coverage for 50 percent of the cost sharing otherwise applicable under Medicare Part B after the covered individual pays the Part B deductible until the out-of-pocket limitation is met as described in subparagraph 37.8(4)“h”(10);    (9)   Medicare Part B preventive services: coverage of 100 percent of the cost sharing for Medicare Part B preventive services after the covered individual pays the Medicare Part B deductible; and    (10)   Cost sharing after out-of-pocket limits reached: coverage of 100 percent of all cost sharing under Medicare Parts A and B for the balance of the calendar year after the individual has reached the out-of-pocket limitation on annual expenditures under Medicare Parts A and B of $4,000 in 2006, indexed each year by the appropriate inflation adjustment specified by the Secretary.    i.    Plan L is mandated by the MMA and shall include only the following:    (1)   The benefits described in subparagraphs 37.8(4)“h”(1), (2), (3) and (9);    (2)   The benefits described in subparagraphs 37.8(4)“h”(4), (5), (6), (7) and (8), but substituting 75 percent for 50 percent; and    (3)   The benefit described in subparagraph 37.8(4)“h”(10), but substituting $2,000 for $4,000.    j.    Plan M shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 50 percent of the Medicare Part A deductible, skilled nursing facility care, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“b,”“c,” and “f,” respectively.    k.    Plan N shall include only the following: the basic core benefits as set forth in subrule 37.8(2), plus 100 percent of the Medicare Part A deductible, skilled nursing facility care, and medically necessary emergency care in a foreign country as defined in paragraphs 37.8(3)“a,”“c,” and “f,” respectively, with copayments in the following amounts:    (1)   The lesser of $20 or the Medicare Part B coinsurance or copayment for each covered provider office visit (including visits to medical specialists); and    (2)   The lesser of $50 or the Medicare Part B coinsurance or copayment for each covered emergency room visit; however, this copayment shall be waived if the covered individual is admitted to any hospital and the emergency visit is subsequently covered as a Medicare Part A expense.    37.8(5) New or innovative benefits.  An issuer may, with the prior approval of the commissioner, offer policies or certificates with new or innovative benefits, in addition to the standardized benefits provided in a policy or certificate that otherwise complies with the applicable standards. The new or innovative benefits shall include only benefits that are appropriate to Medicare supplement insurance, are new or innovative, are not otherwise available, and are cost-effective. Approval of new or innovative benefits must not adversely impact the goal of Medicare supplement simplification. New or innovative benefits shall not include an outpatient prescription drug benefit. New or innovative benefits shall not be used to change or reduce benefits, including a change of any cost-sharing provision, in any standardized plan.

    191—37.9(514D) Standard Medicare supplement benefit plans for 2020 standardized Medicare supplement benefit plan policies or certificates issued for delivery to individuals newly eligible for Medicare on or after January 1, 2020.  The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) requires that the following standards are applicable to all Medicare supplement policies or certificates delivered or issued for delivery in this state to individuals newly eligible for Medicare on or after January 1, 2020. No policy or certificate that provides coverage of the Medicare Part B deductible may be advertised, solicited, delivered or issued for delivery in this state as a Medicare supplement policy or certificate to individuals newly eligible for Medicare on or after January 1, 2020. All policies must comply with the following benefit standards. Benefit plan standards applicable to Medicare supplement policies and certificates issued to individuals eligible for Medicare before January 1, 2020, remain subject to the requirements of rules 191—37.6(514D), 191—37.7(514D) and 191—37.8(514D).    37.9(1) Benefit requirements.  The standards and requirements of rule 191—37.8(514D) shall apply to all Medicare supplement policies or certificates delivered or issued for delivery to individuals newly eligible for Medicare on or after January 1, 2020, with the following exceptions:    a.    Plan C is redesignated as Plan D and shall provide the benefits contained in paragraph 37.8(4)“c” but shall not provide coverage for 100 percent or any portion of the Medicare Part B deductible.    b.    Plan F is redesignated as Plan G and shall provide the benefits contained in paragraph 37.8(4)“e” but shall not provide coverage for 100 percent or any portion of the Medicare Part B deductible.    c.    Plans C, F, and F with high deductible may not be offered to individuals newly eligible for Medicare on or after January 1, 2020.     d.    Plan F with high deductible is redesignated as Plan G with high deductible and shall provide the benefits contained in paragraph 37.8(4)“f,” but shall not provide coverage for 100 percent or any portion of the Medicare Part B deductible; provided further that the Medicare Part B deductible paid by the covered individual shall be considered an out-of-pocket expense in meeting the annual high deductible.    e.    The reference to Plan C or F contained in paragraph 37.8(2)“b” is deemed a reference to Plan D or G for purposes of this rule.    37.9(2) Applicability to certain newly eligible individuals.  This rule applies only to individuals who are newly eligible for Medicare on or after January 1, 2020, by reason of:    a.    Attaining age 65 on or after January 1, 2020; or    b.    Entitlement to benefits under Medicare Part A pursuant to Section 226(b) or 226A of the Social Security Act, or who are deemed to be eligible for benefits under Section 226(a) of the Social Security Act on or after January 1, 2020.    37.9(3) Guaranteed issue for eligible persons.  For purposes of rule 191—37.36(514D), in the case of any individual newly eligible for Medicare on or after January 1, 2020, any reference to a Medicare supplement Plan C or F (including Plan F with high deductible) shall be deemed to be a reference to Medicare supplement Plan D or G (including Plan G with high deductible), respectively, that meets the requirements of this rule.    37.9(4) Offer of redesignated plans to individuals other than newly eligible.  On or after January 1, 2020, the standardized benefit plans described in paragraph 37.9(1)“d” may be offered to any individual who was eligible for Medicare prior to January 1, 2020, in addition to the standardized plans described in subrule 37.8(4).

    191—37.10()    Reserved.

    191—37.11()    Reserved.

    191—37.12()    Reserved.

    191—37.13()    Reserved.

    191—37.14()    Reserved.

    191—37.15()    Reserved.

    191—37.16()    Reserved.

    191—37.17()    Reserved.

    191—37.18()    Reserved.

    191—37.19()    Reserved.

    191—37.20(514D) Medicare Select policies and certificates.      37.20(1) Applicability of this rule.      a.    Rule 191—37.20(514D) shall apply to Medicare Select policies and certificates, as defined in this rule.    b.    No policy or certificate may be advertised as a Medicare Select policy or certificate unless it meets the requirements of this rule.    37.20(2) Definitions.  For the purposes of this rule, in addition to the definitions of Iowa Code section 514D.2, and of rules 191—37.3(514D) and 191—37.4(514D), the following definitions shall apply:        "Complaint" means any dissatisfaction expressed by a covered individual concerning a Medicare Select issuer or a Medicare Select network provider.        "Grievance" means dissatisfaction expressed in writing by a covered individual under a Medicare Select policy or certificate with the administration, claims practices, or provision of services concerning a Medicare Select issuer or its Medicare Select network providers.        "Medicare Select issuer" means an issuer offering, or seeking to offer, a Medicare Select policy or certificate.        "Medicare Select network provider" means a provider of health care, or a group of providers of health care, which has entered into a written agreement with a Medicare Select issuer to provide benefits insured under a Medicare Select policy or certificate.        "Medicare Select policy" means a Medicare supplement individual policy that contains a restricted network provision; “Medicare Select certificate” means an individual’s certificate of coverage under a group Medicare supplement policy that contains restricted network provisions; and “Medicare Select policy or certificate” means either a Medicare Select policy or a Medicare Select certificate.        "Restricted network provision" means any provision in a Medicare Select policy or certificate which conditions the payment of benefits, in whole or in part, on the use of Medicare Select network providers belonging to a network specified by the Medicare Select policy or certificate.        "Service area" means the geographic area, approved by the commissioner as part of the Medicare Select issuer’s plan of operation, within which the Medicare Select issuer is authorized to offer a Medicare Select policy or certificate.    37.20(3) Authorization to offer Medicare Select policies or certificates.  The commissioner may authorize an issuer to offer a Medicare Select policy or certificate, pursuant to this rule and Section 4358 of the Omnibus Budget Reconciliation Act (OBRA) of 1990, if the commissioner finds, upon review and approval of the plan of operation filed in accordance with subrule 37.20(5), that the issuer has satisfied all of the requirements of this chapter.    37.20(4) Prohibition against offering Medicare Select policies or certificates without approved plan of operation.  A Medicare Select issuer shall not issue a Medicare Select policy or certificate in this state until its plan of operation has been approved by the commissioner, and the commissioner has authorized the issuer to offer Medicare Select policies or certificates, pursuant to subrule 37.20(3).    37.20(5) Medicare Select issuer shall file a proposed plan of operation.  An issuer shall file a proposed plan of operation with the commissioner in a format prescribed by the commissioner and receive approval of the proposed plan from the commissioner prior to offering Medicare Select policies or certificates. The plan of operation shall contain at a minimum all of the information required by paragraphs 37.20(5)“a” through “g” as follows:    a.    Evidence that all services covered under the Medicare Select policies or certificates that are subject to restricted network provisions are available and accessible through Medicare Select network providers, including a demonstration that the issuer has met all of the conditions in subparagraphs 37.20(5)“a”(1) through (5) as follows:    (1)   Such services can be provided by Medicare Select network providers with reasonable promptness with respect to geographic location, hours of operation and after-hours care. The hours of operation and availability of after-hours care shall reflect usual practice in the local area. Geographic availability shall reflect the usual travel times within the community.    (2)   The number of Medicare Select network providers in the service area is sufficient, with respect to current and expected covered individuals, either:    1.   To adequately deliver all services that are subject to a restricted network provision; or    2.   To make appropriate referrals.    (3)   There are written agreements with Medicare Select network providers describing specific responsibilities.    (4)   Emergency care is available 24 hours per day and seven days per week.    (5)   In the case of covered services that are subject to a restricted network provision and are provided on a prepaid basis, there are written agreements with Medicare Select network providers prohibiting such Medicare Select network providers from billing or otherwise seeking reimbursement from or recourse against any covered individual under a Medicare Select policy or certificate. This paragraph shall not apply to supplemental charges or coinsurance amounts as stated in the Medicare Select policy or certificate.    b.    A statement or map providing a clear description of the service area.    c.    A description of the grievance procedure to be utilized, that is compliant with subrule 37.20(11).    d.    A description of the quality assurance program, including:    (1)   The formal organizational structure;    (2)   The written criteria for selection, retention and removal of Medicare Select network providers; and    (3)   The procedures for evaluating quality of care provided by Medicare Select network providers, and the process to initiate corrective action when warranted.    e.    A list and description, by specialty, of the Medicare Select network providers.    f.    Copies of the written information proposed to be used by the Medicare Select issuer to comply with subrule 37.20(9).    g.    Any other information requested by the commissioner.    37.20(6) Filing of changes and updates to Medicare Select issuer’s plan of operations.      a.    A Medicare Select issuer shall file any proposed changes to the plan of operation, except for changes to the list of Medicare Select network providers, with the commissioner prior to implementing such changes. Such changes shall be considered approved by the commissioner after 30 days unless specifically disapproved.    b.    An updated list of Medicare Select network providers shall be filed with the commissioner at least quarterly.    37.20(7) Use of restricted network provision prohibited under certain circumstances.  A Medicare Select policy or certificate issuer shall not apply a restricted network provision to limit a payment amount for covered services provided by providers that are not restricted network providers if:    a.    The services are for symptoms requiring emergency care or are immediately required for an unforeseen illness, injury or a condition; and    b.    It is not reasonable to obtain such services through a Medicare Select network provider.    37.20(8) Full coverage for services required under certain circumstances.  A Medicare Select policy or certificate shall provide payment for full coverage under the Medicare Select policy for covered services that are not available through Medicare Select network providers.    37.20(9) Content of required disclosure.  A Medicare Select issuer shall make full and fair disclosure in writing of the provisions, restrictions, and limitations of the Medicare Select policy or certificate to each applicant. This disclosure shall include at a minimum all of the information described in paragraphs 37.20(9)“a” through “g” as follows:    a.    An outline of coverage sufficient to permit the applicant to compare the coverage and premiums of the Medicare Select policy or certificate with:    (1)   Other Medicare supplement policies or certificates offered by the Medicare Select issuer; and    (2)   Other Medicare Select policies or certificates.    b.    A description (including address, telephone number and hours of operation) of the Medicare Select network providers, including primary care physicians, specialty physicians, hospitals and other providers.    c.    A description of the restricted network provisions, including payments for coinsurance and deductibles when providers other than Medicare Select network providers are utilized. Except to the extent specified in the Medicare Select policy or certificate, expenses incurred when using out-of-network providers do not count toward the out-of-pocket annual limit contained in Medicare Select Plans K and L.    d.    A description of coverage for emergency and urgently needed care and other out-of-service area coverage.    e.    A description of limitations on referrals to Medicare Select network providers and to other providers.    f.    A description of the covered individual’s rights to purchase any other Medicare supplement policy or certificate otherwise offered by the Medicare Select issuer.    g.    A description of the Medicare Select issuer’s quality assurance program and grievance procedure.    37.20(10) Acknowledgment.  Prior to the sale of a Medicare Select policy or certificate, a Medicare Select issuer shall obtain from the applicant a signed and dated form stating that the applicant has received the information provided pursuant to subrule 37.20(9) and that the applicant understands the restrictions of the Medicare Select policy or certificate.    37.20(11) Complaint and grievance procedures.  A Medicare Select issuer shall have and use procedures for hearing complaints and resolving written grievances from the covered individuals. Such procedures shall be aimed at mutual agreement for settlement and may include arbitration procedures.    a.    The grievance procedure shall be described in the Medicare Select policy or certificate and in the outline of coverage.    b.    At the time the Medicare Select policy or certificate is issued, the Medicare Select issuer shall provide detailed information to the covered individual describing how a grievance may be registered with the Medicare Select issuer.    c.    The Medicare Select issuer shall consider grievances in a timely manner and shall transmit them to appropriate decision makers who have authority to fully investigate the issue and take corrective action.    d.    If a grievance is found to be valid, corrective action shall be taken promptly.    e.    All concerned parties shall be notified by the Medicare Select issuer about the results of a grievance.    f.    The Medicare Select issuer shall report no later than each March 31 to the commissioner regarding its grievance procedure. The report shall be in a format prescribed by the commissioner and shall contain the number of grievances filed in the prior calendar year and a summary of the subject, nature and resolution of such grievances.    37.20(12) Opportunity to purchase another policy at time of purchase.  At the time of initial purchase, a Medicare Select issuer shall make available to each applicant for a Medicare Select policy or certificate the opportunity to purchase any Medicare supplement policy or certificate otherwise offered by the Medicare Select issuer.    37.20(13) Opportunity to purchase another policy after issue.      a.    At the request of a covered individual under a Medicare Select policy or certificate, a Medicare Select issuer shall make available to the covered individual the opportunity to purchase a Medicare supplement policy or certificate offered by the Medicare Select issuer which has comparable or lesser benefits and which does not contain a restricted network provision. The Medicare Select issuer shall make such policies or certificates available without requiring evidence of insurability after the Medicare Select policy or certificate has been in force for six months.    b.    For the purposes of this subrule, a Medicare supplement policy or certificate will be considered to have comparable or lesser benefits unless it contains one or more significant benefits not included in the Medicare Select policy or certificate being replaced. For the purposes of this paragraph, a significant benefit means coverage for the Medicare Part A deductible, coverage for at-home recovery services or coverage for Medicare Part B excess charges.    37.20(14) Continuation of coverage.  Medicare Select policies and certificates shall provide for continuation of coverage in the event the Secretary determines that Medicare Select policies and certificates issued pursuant to this rule should be discontinued due to either the failure of the Medicare Select program to be reauthorized under law or the substantial amendment of the Medicare Select program.    a.    Each Medicare Select issuer shall make available to each insured individual under a Medicare Select policy or certificate the opportunity to purchase any Medicare supplement policy or certificate offered by the Medicare Select issuer which has comparable or lesser benefits and which does not contain a restricted network provision. The Medicare Select issuer shall make such policies and certificates available without requiring evidence of insurability.    b.    For the purposes of this subrule, a Medicare supplement policy or certificate will be considered to have comparable or lesser benefits unless it contains one or more significant benefits not included in the Medicare Select policy or certificate being replaced. For the purposes of this paragraph, a significant benefit means coverage for the Medicare Part A deductible, coverage for at-home recovery services or coverage for Medicare Part B excess charges.    37.20(15) Compliance with data requests.  A Medicare Select issuer shall comply with reasonable requests for data made by state or federal agencies, including the U.S. Department of Health and Human Services, for the purpose of evaluating the Medicare Select program.

    191—37.21(514D) Open enrollment.      37.21(1) Denial of policy for health reason prohibited.  No issuer shall deny or condition the issuance or effectiveness of any Medicare supplement policy or certificate available for sale in this state, or discriminate in the pricing of such a Medicare supplement policy or certificate, because of the health status, claims experience, receipt of health care, or medical condition of an applicant in the case of an application for a Medicare supplement policy or certificate that is submitted prior to or during the six-month period beginning with the first day of the first month in which an individual is both 65 years of age or older and is enrolled for benefits under Medicare Part B. Each Medicare supplement policy and certificate currently available from an issuer shall be made available to all applicants who qualify under this subrule without regard to age.    37.21(2) When preexisting condition exclusion cannot be applied.      a.    Definition of “continuous period of creditable coverage.”For purposes of this subrule, “continuous period of creditable coverage” means the period during which a covered individual was covered by creditable coverage, if during the period of the coverage the covered individual had no breaks in coverage greater than 63 days.    b.    No preexisting condition exclusion.If an applicant under subrule 37.21(1) submits an application during the time period referenced in subrule 37.21(1) and, as of the date of application, has had a continuous period of creditable coverage of at least six months, the issuer shall not exclude benefits based on a preexisting condition.    c.    Reduced time of preexisting condition exclusion.If the applicant qualifies under subrule 37.21(1) and submits an application during the time period referenced in subrule 37.21(1) and, as of the date of application, has had a continuous period of creditable coverage that is less than six months, the Medicare Select issuer shall reduce the period of any preexisting condition exclusion by the aggregate of the period of creditable coverage applicable to the applicant as of the enrollment date. The Secretary shall specify the manner of the reduction under this subrule.    37.21(3) When benefits can be excluded because of preexisting condition.  Subrule 37.21(1) shall not be construed, except as provided in rule 191—37.33(514D) or 191—37.36(514D), as preventing the exclusion of benefits under a policy, during the first six months, based on a preexisting condition for which the covered individual received treatment or was otherwise diagnosed during the six months before the coverage became effective.

    191—37.22(514D) Standards for claims payment.      37.22(1) Compliance with OBRA.  An issuer shall comply with Section 1882(c)(3) of the Social Security Act (as enacted by Section 4081(b)(2)(C) of the Omnibus Budget Reconciliation Act of 1987 (OBRA) 1987, Pub. L. No. 100-203) by:    a.    Accepting a notice from an issuer on dually assigned claims submitted by participating providers and suppliers as a claim for benefits in place of any other claim form otherwise required and making a payment determination on the basis of the information contained in that notice;    b.    Notifying the participating provider or supplier and the beneficiary of the payment determination;    c.    Paying the participating provider or supplier directly;    d.    Furnishing, at the time of enrollment, each covered individual with a card listing the policy name, number and a central mailing address to which notices from an issuer may be sent;    e.    Paying user fees for claim notices that are transmitted electronically or otherwise; and    f.    Providing to the Secretary, at least annually, the issuer’s central mailing address to which all claims may be sent by other issuers.    37.22(2) Certification of compliance with OBRA.  Compliance with the requirements set forth in 37.22(1) shall be certified on the Medicare supplement insurance experience reporting form.

    191—37.23(514D) Loss ratio standards and refund or credit of premium.      37.23(1) Definitions.  For the purposes of this rule:        "Health care expenses" means expenses of health maintenance organizations associated with the delivery of health care services, which expenses are analogous to incurred losses of issuers.        "Type" means one of the following: an individual policy, a group policy, an individual Medicare Select policy, or a group Medicare Select policy.    37.23(2) Loss ratio standards.      a.    Calculations.    (1)   A Medicare supplement policy form or certificate form shall not be delivered or issued for delivery unless the Medicare supplement policy form or certificate form can be expected, as estimated for the entire period for which rates are computed to provide coverage, to return to covered individuals one of the following amounts in the form of aggregate benefits (not including anticipated refunds or credits) provided under the policy form or certificate form:    1.   At least 75 percent of the aggregate amount of premiums earned in the case of group Medicare supplement policies, or    2.   At least 65 percent of the aggregate amount of premiums earned in the case of individual Medicare supplement policies.    (2)   The percentages in subparagraph 37.23(2)“a”(1) are to be calculated on the basis of incurred claims experience or incurred health care expenses where coverage is provided by a health maintenance organization on a service rather than reimbursement basis and earned premiums for such period and in accordance with accepted actuarial principles and practices.    (3)   For purposes of subparagraph 37.23(2)“a”(2), “incurred health care expenses where coverage is provided by a health maintenance organization” shall not include:    1.   Home office and overhead costs;    2.   Advertising costs;    3.   Commissions and other acquisition costs;    4.   Taxes;    5.   Capital costs;    6.   Administrative costs; and    7.   Claims processing costs.    b.    Filing demonstration of compliance.All filings of rates and rating schedules shall demonstrate that expected claims in relation to premiums comply with the requirements of this rule when combined with actual experience to date. Filings of rate revisions shall also demonstrate that the anticipated loss ratio over the entire future period for which the revised rates are computed to provide coverage can be expected to meet the appropriate loss ratio standards.    c.    Certain direct sales.For purposes of applying paragraph 37.23(2)“a” only, policies issued as a result of solicitations of individuals through the mails or by mass media advertising (including both print and broadcast advertising) shall be deemed to be individual policies.    d.    Prestandardized plans.For all policies issued prior to January 1, 1992, expected claims in relation to premiums shall meet:    (1)   The originally filed anticipated loss ratio when combined with the actual experience from inception;    (2)   The appropriate loss ratio requirement from paragraphs “1” and “2” of subparagraph 37.23(1)“a”(1) when combined with actual experience beginning with January 1, 1996, to date; and    (3)   The appropriate loss ratio requirement from paragraphs “1” and “2” of subparagraph 37.23(1)“a”(1) over the entire future period for which rates are computed to provide coverage.    37.23(3) Refund or credit calculation.      a.    An issuer shall collect and file with the commissioner by May 31 of each year the data contained in the reporting form contained in Appendix A for each type in a standardized Medicare supplement benefit plan (SMSBP).    b.    If, on the basis of the experience as reported, the benchmark ratio since inception (Appendix A, ratio 1) exceeds the adjusted experience ratio since inception (Appendix A, ratio 3), then a refund or credit calculation is required. The refund calculation shall be done on a statewide basis for each type in an SMSBP. For purposes of the refund or credit calculation, experience on SMSBP policies issued within the reporting year shall be excluded.    c.    For purposes of this rule, for SMSBP policies or certificates issued prior to January 1, 1992, the issuer shall make the refund or credit calculation separately for all individual SMSBP policies (including all group SMSBP policies subject to an individual loss ratio standard when issued) combined and all other group SMSBP policies combined for experience after January 1, 1996. The first report shall be due May 31, 1998.    d.    A refund or credit shall be made only when the benchmark loss ratio exceeds the adjusted experience loss ratio and the amount to be refunded or credited exceeds a de minimis level. Such refund shall include interest from the end of the calendar year to the date of the refund or credit at a rate specified by the Secretary, but in no event shall it be less than the average rate of interest for 13-week Treasury notes. A refund or credit against premiums due shall be made by September 30 following the experience year upon which the refund or credit is based.    37.23(4) Annual filing of premium rates.  An issuer of Medicare supplement policies and certificates issued before or after the effective date of January 1, 1992, in this state shall file annually its rates, rating schedule and supporting documentation including ratios of incurred losses to earned premiums by SMSBP policy duration for approval by the commissioner in accordance with the filing requirements and procedures prescribed by the commissioner.    a.    The supporting documentation shall also demonstrate in accordance with actuarial standards of practice using reasonable assumptions that the appropriate loss ratio standards can be expected to be met over the entire period for which rates are computed.    (1)   Such demonstration shall exclude active life reserves.    (2)   An expected third-year loss ratio which is greater than or equal to the applicable percentage shall be demonstrated for SMSBP policies or certificates in force less than three years.    b.    As soon as practicable, but prior to the effective date of enhancements in Medicare benefits, every issuer of Medicare supplement policies or certificates in this state shall file with the commissioner, in accordance with the applicable filing procedures of this state, the following:    (1)   Such supporting documents as necessary to justify that the adjustments are appropriate.    1.   Appropriate premium adjustments shall be those which:
  • Are necessary to produce loss ratios as anticipated for the current premium for the applicable SMSBP policies or certificates;
  • Are necessary to produce an expected loss ratio under such SMSBP policies or certificates as will conform with minimum loss ratio standards for SMSBP policies or certificates; and
  • Are expected to result in a loss ratio at least as great as that originally anticipated in the rates used to produce current premiums by the issuer for such SMSBP policies or certificates.
    •     2.   No premium adjustment which would modify the loss ratio experience under the SMSBP policy other than the adjustments described herein shall be made with respect to an SMSBP policy at any time other than upon its renewal date or anniversary date.    3.   If an issuer fails to make premium adjustments acceptable to the commissioner, the commissioner may order premium adjustments, refunds or premium credits deemed necessary to achieve the loss ratio required by this rule.        (2)   Any appropriate riders, endorsements or policy forms needed to accomplish the SMSBP policy or certificate modifications necessary to eliminate benefit duplications with Medicare. Such riders, endorsements or policy forms shall provide a clear description of the Medicare supplement benefits provided by the SMSBP policy or certificate.        37.23(5) Public hearings.  The commissioner may conduct a public hearing to gather information concerning a request by an issuer for an increase in a rate for an SMSBP policy form or certificate form issued before or after the effective date of January 1, 1992, if the experience of the form for the previous reporting period is not in compliance with the applicable loss ratio standard. The determination of compliance is to be made without consideration of any refund or credit for such reporting period. Public notice of such hearing shall be furnished in a manner deemed appropriate by the commissioner.

    191—37.24(514D) Filing and approval of policies and certificates and premium rates.      37.24(1) Definition.  For the purposes of this rule:        "Type" means one of the following: an individual policy, a group policy, an individual Medicare Select policy, or a group Medicare Select policy.    37.24(2) Form filing and approval required.  An issuer shall not deliver or issue for delivery a policy or certificate to a resident of this state unless the SMSBP policy form or certificate form has been filed pursuant to rule 191—20.1(505,509,514A,515,515A,515F) and approved by the commissioner.    37.24(3) MMA requirements to be filed with state of issue.  An issuer shall file any riders or amendments to SMSBP policy or certificate forms to delete outpatient prescription drug benefits as required by the MMA only with the commissioner in the state in which the policy or certificate was issued.    37.24(4) Rate filing and approval required.  An issuer shall not use or change premium rates for a Medicare supplement policy or certificate unless the rates, rating schedule and supporting documentation have been filed with and approved by the commissioner in accordance with the filing requirements and procedures prescribed by the commissioner.    37.24(5) One form per type.      a.    Except as provided in paragraph 37.24(5)“b,” an issuer shall not file for approval more than one form of a policy or certificate of each type for each SMSBP.    b.    An issuer may offer, with the approval of the commissioner, up to four additional policy forms or certificate forms of the same type for the same SMSBP, one for each of the following cases:    (1)   The inclusion of new or innovative benefits;    (2)   The addition of either direct response or producer marketing methods;    (3)   The addition of either guaranteed issue or underwritten coverage;    (4)   The offering of coverage to individuals eligible for Medicare by reason of disability.    37.24(6) Forms to be kept available once approved.      a.    Except as provided in subparagraph 37.24(6)“a”(1), an issuer shall continue to make available for purchase any SMSBP policy form or certificate form issued after January 1, 1992, that has been approved by the commissioner. An SMSBP policy form or certificate form shall not be considered to be available for purchase unless the issuer has actively offered it for sale in the previous 12 months.    (1)   An issuer may discontinue the availability of an SMSBP policy form or certificate form if the issuer provides to the commissioner in writing its decision at least 30 days prior to discontinuing the availability of the form of the SMSBP policy or certificate. After receipt of the notice by the commissioner, the issuer shall no longer offer for sale the SMSBP policy form or certificate form in this state.    (2)   An issuer that discontinues the availability of an SMSBP policy form or certificate form pursuant to subparagraph 37.24(6)“a”(1) shall not file for approval of a new SMSBP policy form or certificate form of the same type for the same SMSBP as the discontinued form for a period of five years after the issuer provides notice to the commissioner of the discontinuance. The period of discontinuance may be reduced if the commissioner determines that a shorter period is appropriate.    b.    The sale or other transfer of Medicare supplement business to another issuer shall be considered a discontinuance for the purposes of this subrule.    c.    A change in the rating structure or methodology shall be considered a discontinuance under paragraph 37.24(6)“a” unless the issuer complies with the following requirements:    (1)   The issuer provides an actuarial memorandum, in a form and manner prescribed by the commissioner, describing the manner in which the revised rating methodology and resultant rates differ from the existing rating methodology and resultant rates.    (2)   The issuer does not subsequently put into effect a change of rates or rating factors that would cause the percentage differential between the discontinued and subsequent rates as described in the actuarial memorandum to change. The commissioner may approve a change to the differential which is in the public interest.    37.24(7) Experience under forms of same type to be combined for calculations.      a.    Except as provided in paragraph 37.24(7)“b,” the experience under all SMSBP policy forms or certificate forms of the same type in an SMSBP shall be combined for purposes of the refund or credit calculation prescribed in rule 191—37.23(514D).    b.    Forms assumed under an assumption reinsurance agreement shall not be combined with the experience of other policy or certificate forms for purposes of the refund or credit calculation.

    191—37.25(514D) Permitted compensation arrangements.      37.25(1) Definition of “compensation.”  For purposes of this rule:        "Compensation" includes pecuniary or nonpecuniary remuneration of any kind relating to the sale or renewal of the Medicare supplement or Medicare Select policy or certificate including, but not limited to, bonuses, gifts, prizes, awards and finder’s fees.    37.25(2) Compensation to producer for sales.  An issuer or other entity may provide a commission or other compensation to a producer or other representative for the sale of a Medicare supplement policy or certificate only if the first-year commission or other first-year compensation is no more than 200 percent of the commission or other compensation paid for selling or servicing the Medicare supplement policy or certificate in the second year or period.    37.25(3) Compensation to producer for renewals.  The commission or other compensation provided in subsequent (renewal) years must be the same as that provided in the second year or period and must be provided for no fewer than five renewal years.    37.25(4) Compensation for renewals involving replacement.  No issuer or other entity shall provide compensation to its producers and no producer shall receive compensation greater than the renewal compensation payable by the replacing issuer on renewal Medicare supplement policies or certificates if an existing Medicare supplement policy or certificate is replaced.

    191—37.26(514D) Required notice regarding policies or certificates which are not Medicare supplement policies or certificates.      37.26(1) Issuer required to disclose that a policy is not a Medicare supplement policy.  An issuer of any accident and sickness insurance policy or certificate issued for delivery in this state to a person eligible for Medicare shall notify the insured under the policy that the policy is not a Medicare supplement policy or certificate, if the policy or certificate is not a Medicare supplement policy or certificate.     a.    The notice shall either be printed or attached to the first page of the outline of coverage delivered to the insured under the accident and sickness policy or, if no outline of coverage is delivered, to the first page of the policy or certificate delivered to the insured.    b.    The notice shall be in no less than 12-point type and shall contain the following language:“THIS [POLICY OR CERTIFICATE] IS NOT A MEDICARE SUPPLEMENT [POLICY OR CONTRACT]. If you are eligible for Medicare, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services] available from the company.”    c.    The notice requirement of this subrule 37.26(1) shall not apply to an accident and sickness insurance policy or certificate that is a Medicare supplement policy or certificate, a policy issued pursuant to a contract under Section 1876 of the federal Social Security Act (42 U.S.C. Section 1395 et seq.), a disability income policy, or any other policy excepted by rule 191—37.2(514D).    37.26(2) Issuer required to disclose extent of duplication of Medicare.  When providing an application to persons eligible for Medicare for the health insurance policies or certificates described in subrule 37.26(1), except for policies or certificates excluded by paragraph 37.26(1)“c,” issuers shall disclose the extent to which a policy duplicates Medicare. The disclosure shall use the applicable statement in Appendix B and shall be provided as a part of, or together with, the application for the policy or certificate.

    191—37.27(514D) Requirements for application forms and replacement coverage.      37.27(1) Application to include Appendix C.  Application forms for Medicare supplement policies or certificates shall include in the outline of coverage the “statements and questions for application forms related to duplicate or replacement coverage” set forth in Appendix C, in the order prescribed in Appendix C, designed to elicit the following information, as of the date of the application: whether the applicant currently has a Medicare supplement policy or certificate, a Medicare Advantage policy or certificate, or other Medicaid coverage; whether the applicant has another health insurance policy or certificate in force; or whether the applicant intends a Medicare supplement policy or certificate to replace any other accident and sickness policy or certificate presently in force. An additional page or form containing such questions and statements and the applicant’s responses may be used, but it must be signed by the applicant and producer, attached to the application, and kept together with the issuer’s records.    37.27(2) List of policies sold to applicant.  Producers shall list on the form or on an attachment to the form of Appendix C any other health insurance policies they have sold to the applicant, including the following:    a.    Policies sold which are still in force.    b.    Policies sold in the prior five years which are no longer in force.    37.27(3) Direct response sales.  In the case of a direct response issuer, a copy of the application or additional page or form, signed by the applicant and acknowledged by the issuer, shall be returned to the applicant by the issuer upon delivery of the policy and shall include the notice regarding replacement of Medicare supplement coverage required of direct response issuers by subrule 37.27(4).    37.27(4) Required notice regarding replacement.  Upon determining that a sale will involve replacement of Medicare supplement coverage, any issuer, other than a direct response issuer, or its producer, shall furnish the applicant, prior to issuance or delivery of the Medicare supplement policy or certificate, a notice regarding replacement of Medicare supplement coverage. The notice shall be provided in the format described in subrule 37.27(5). One copy of such notice signed by the applicant and the producer, except where the coverage is sold without a producer, shall be provided to the applicant, and an additional signed copy shall be retained by the issuer. A direct response issuer shall deliver to the applicant at the time of the issuance of the policy the notice regarding replacement of Medicare supplement coverage.    37.27(5) Required format of notice regarding replacement.  The notice required by subrule 37.27(4) for an issuer shall be provided in substantially the form and language of the Notice to Applicant regarding Replacement of Medicare Supplement Insurance or Medicare Advantage, as set forth in Appendix D, in no less than 12-point type. Statements 1 and 2 of the replacement notice of Appendix D (applicable to preexisting conditions) may be deleted by an issuer if the replacement does not involve application of a new preexisting condition limitation.

    191—37.28(514D) Required disclosure provisions.      37.28(1) General rules.      a.    A Medicare supplement policy or certificate shall include renewal or continuation provisions. The language or specifications of such provisions shall be consistent with the type of Medicare supplement policy issued. Such provisions shall be appropriately captioned and shall appear on the first page of the Medicare supplement policy or certificate, and shall include any reservations by the issuer of the right to change premiums and any automatic renewal premium increases based on the covered individual’s age.    b.    Except for a rider or an endorsement by which the issuer effectuates a request made in writing by the covered individual, exercises a specifically reserved right under a Medicare supplement policy or certificate, or is required to reduce or eliminate benefits to avoid duplication of Medicare benefits, any rider or endorsement added to a Medicare supplement policy or certificate after the date the policy or certificate is issued, or at reinstatement or renewal, which reduces or eliminates benefits or coverage in the policy or certificate shall require a signed acceptance by the covered individual. After the date of issue of a Medicare supplement policy or certificate, any rider or endorsement which increases benefits or coverage with a concomitant increase in premium during the policy term shall be agreed to in writing signed by the covered individual, unless the benefits are required by the minimum standards for Medicare supplement policies or certificates, or if the increased benefits or coverage is required by law. Where a separate additional premium is charged for benefits provided in connection with a rider or endorsement, such premium charge shall be set forth in the Medicare supplement policy or certificate.    c.    Medicare supplement policies or certificates shall not provide for the payment of benefits based on standards described as “usual and customary,” “reasonable and customary” or words of similar import.    d.    If a Medicare supplement policy or certificate contains any limitations with respect to preexisting conditions, such limitations shall appear as a separate paragraph of the Medicare supplement policy or certificate and be labeled as “Preexisting Condition Limitations.”    e.    A Medicare supplement policy or certificate shall have a notice prominently printed on the first page of the policy or certificate, or attached thereto, stating in substance that the covered individual shall have the right to return the Medicare supplement policy or certificate within 30 days of its delivery and to have the premium refunded if, after examination of the Medicare supplement policy or certificate, the covered individual is not satisfied for any reason.    f.    An issuer of an accident or sickness policy or certificate which provides hospital or medical expense coverage on an expense-incurred or indemnity basis to an individual eligible for Medicare shall provide to any applicant for such policy or certificate the most recent version of Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services (“guide”), developed jointly by the National Association of Insurance Commissioners and CMS, using the same language, format, type size (no less than 12 point), type-proportional spacing, bold characters and line spacing. Delivery of the guide shall be made whether or not such policy or certificate was advertised, solicited or issued as a Medicare supplement policy or certificate as defined in this chapter. Except in the case of a direct response issuer, delivery of the guide shall be made to the applicant at the time of application and acknowledgment of receipt of the guide shall be obtained by the issuer. A direct response issuer shall deliver the guide to the applicant upon request but not later than at the time the Medicare supplement policy is delivered.    37.28(2) Notice requirements.      a.    As soon as practicable, but no later than 30 days prior to the annual effective date of any Medicare benefit changes, an issuer shall notify its covered individuals of modifications it has made to Medicare supplement policies or certificates in a format acceptable to the commissioner. The notice shall:    (1)   Include a description of revisions to the Medicare program and a description of each modification made to the coverage provided under the Medicare supplement policy or certificate; and    (2)   Inform each covered individual as to when any premium adjustment is to be made due to changes in Medicare.    b.    The notice of benefit modifications and any premium adjustments shall be in outline form and in clear and simple terms so as to facilitate comprehension.    c.    Such notices shall not contain or be accompanied by any solicitation.    37.28(3) MMA notice requirements.  Issuers shall comply with any notice requirements of the MMA.    37.28(4) Outline of coverage requirements for Medicare supplement policies.      a.    An issuer shall provide an outline of coverage to any applicant for a Medicare supplement policy or certificate at the time application is presented to the prospective applicant and, except for a direct response policy, shall obtain an acknowledgment of receipt of such outline of coverage from the applicant.    b.    If an outline of coverage is provided at the time of application and the Medicare supplement policy or certificate is issued on a basis which would require revision of the outline, the issuer shall provide a substitute outline of coverage properly describing the Medicare supplement policy or certificate to accompany such Medicare supplement policy or certificate when it is delivered to the covered individual, and the substitute outline of coverage shall contain the following statement, in no less than 12-point type, immediately above the issuer’s company name:“NOTICE: Read this outline of coverage carefully. It is not identical to the outline of coverage provided upon application and the coverage originally applied for has not been issued.”    c.    The outline of coverage provided to an applicant pursuant to this rule shall consist of the following four parts: a cover page; premium information; disclosure pages; and charts displaying the features of each Medicare supplement benefit plan offered by the issuer. The outline of coverage shall be in the language and format prescribed in this rule and in Appendix E in no less than 12-point type. All plans shall be shown on the cover page, and the plans that are offered by the issuer shall be prominently identified. Premium information for plans that are offered by the issuer shall be shown on the cover page or immediately following the cover page and shall be prominently displayed. The premium and mode shall be stated for all plans that are offered to the prospective applicant. All possible premiums for the prospective applicant shall be illustrated.    d.    The items in Appendix E shall be included in the outline of coverage in the order prescribed in Appendix E.

    191—37.29()    Reserved.

    191—37.30(514D) Standards for marketing.      37.30(1) Requirements for marketing.  An issuer, directly or through its producers, shall:    a.    Establish marketing procedures to ensure that any comparison of policies or certificates by its producers will be fair and accurate.    b.    Establish marketing procedures to ensure excessive insurance is not sold or issued.    c.    Display prominently by type, stamp or other appropriate means, on the first page of the policy or certificate, the following:“Notice to buyer: This policy may not cover all of your medical expenses.”    d.    Inquire and otherwise make every reasonable effort to identify whether a prospective covered individual for Medicare supplement policy or certificate already has accident and sickness insurance and the types and amounts of any such insurance.    e.    Establish auditable procedures for certifying compliance with this subrule.    f.    At solicitation, provide written notice to the prospective covered individual of the name, address, and telephone number of the senior health insurance information program, part of the insurance division. The written notice shall be in a form prescribed by the commissioner.    37.30(2) Prohibitions in marketing.  In addition to the practices prohibited in Iowa Code chapter 507B, 191—Chapter 15 and other rules promulgated under Iowa Code chapter 507B, and rule 191—37.50(514D), the following acts and practices are prohibited:    a.    Twisting.Knowingly making any misleading representation or incomplete or fraudulent comparison of any insurance policies or certificates, or of any issuers, for the purpose of inducing, or tending to induce, any person to lapse, forfeit, surrender, terminate, retain, pledge, assign, borrow on, or convert any insurance policy or certificate or to take out a policy or certificate of insurance with another issuer.    b.    High-pressure tactics.Employing any method of marketing having the effect of or tending to induce the purchase of insurance through force, fright, threat, whether explicit or implied, or undue pressure to purchase or recommend the purchase of insurance.    c.    Cold-lead advertising.Making use directly or indirectly of any method of marketing which fails to disclose in a conspicuous manner that a purpose of the method of marketing is solicitation of insurance and that contact will be made by an insurance producer or insurance company.    37.30(3) Prohibited terms in noncompliant policies or certificates.  The terms “Medicare supplement,” “Medigap,” “Medicare wrap-around” and words of similar import shall not be used unless the policy or certificate is issued in compliance with this chapter.

    191—37.31(514D) Appropriateness of recommended purchase and excessive insurance.      37.31(1) Appropriateness.  In recommending the purchase or replacement of any Medicare supplement policy or certificate, a producer shall make reasonable efforts to determine the appropriateness of a recommended purchase or replacement.    37.31(2) No duplication.  Any sale of a Medicare supplement policy or certificate that will provide an individual more than one Medicare supplement policy or certificate is prohibited.    37.31(3) No Medicare supplement for enrollee in Part C.  An issuer shall not issue a Medicare supplement policy or certificate to an individual enrolled in Medicare Part C unless the effective date of the coverage is after the termination date of the individual’s Medicare Part C coverage.

    191—37.32(514D) Reporting of multiple policies.      37.32(1) Report of in-force Medicare supplement covered individuals.  On or before March 1 of each year, an issuer shall report, using the format of Appendix F, the following information for every covered individual resident of this state for which the issuer has in force more than one Medicare supplement policy or certificate:    a.    Policy and certificate number; and    b.    Date of issuance.    37.32(2) Grouping of items.  The items set forth in subrule 37.21(1) must be grouped by covered individual.

    191—37.33(514D) Prohibition against preexisting conditions, waiting periods, elimination periods and probationary periods in replacement policies or certificates.      37.33(1) Time credited from prior policy or certificate.  If a Medicare supplement policy or certificate replaces another Medicare supplement policy or certificate, the replacing issuer shall waive any time periods applicable to preexisting conditions, waiting periods, elimination periods and probationary periods in the new replacing Medicare supplement policy or certificate to the extent such time was spent under the replaced policy.    37.33(2) Similar benefits credited from prior policy or certificate.  If a Medicare supplement policy or certificate replaces another Medicare supplement policy or certificate which has been in effect for at least six months, the replacing Medicare supplement policy or certificate shall not provide any time period applicable to preexisting conditions, waiting periods, elimination periods and probationary periods for benefits similar to those contained in the replaced policy or certificate.

    191—37.34(514D) Prohibitions against use of genetic information and against requests for genetic testing.  This rule applies to all Medicare supplement policies or certificates with policy years beginning on or after May 21, 2009.    37.34(1) Definitions.  For the purposes of this rule, the following definitions shall apply:        "Family member" means, with respect to an individual, any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of such individual.        "Genetic information" means, with respect to any individual, information about such individual’s genetic tests, the genetic tests of family members of such individual, and the manifestation of a disease or disorder in family members of such individual. “Genetic information” includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual. Any reference to genetic information concerning an individual or family member of an individual who is a pregnant woman includes genetic information of any fetus carried by such pregnant woman or, with respect to an individual or family member utilizing reproductive technology, includes genetic information of any embryo legally held by an individual or family member. The term “genetic information” does not include information about the sex or age of any individual.        "Genetic services" means a genetic test, genetic counseling (including obtaining, interpreting, or assessing genetic information), or genetic education.        "Genetic test" means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. The term “genetic test” does not mean:
    1. An analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or
    2. An analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.
            "Issuer of a Medicare supplement policy or certificate" means the same as “issuer” as defined in rule 191—37.3(514D) and includes a third-party administrator, or other person acting for or on behalf of such issuer.        "Underwriting purposes" means:
    1. Rules for or determination of eligibility (including enrollment and continued eligibility) for benefits under the Medicare supplement policy or certificate;
    2. The computation of premium or contribution amounts under the Medicare supplement policy or certificate;
    3. The application of any preexisting condition exclusion under the Medicare supplement policy or certificate; and
    4. Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
        37.34(2) Use of genetic information by issuer prohibited.  An issuer of a Medicare supplement policy or certificate:    a.    Shall not deny or condition the issuance or effectiveness of the Medicare supplement policy or certificate (including the imposition of any exclusion of benefits under the policy based on a preexisting condition) of an individual on the basis of the genetic information with respect to such individual; and    b.    Shall not discriminate in the pricing of the Medicare supplement policy or certificate (including the adjustment of premium rates) of an individual on the basis of the genetic information with respect to such individual.    37.34(3) What prohibition does not include.  Nothing in subrule 37.34(2) shall be construed to limit the ability of an issuer of a Medicare supplement policy or certificate, to the extent otherwise permitted by law, from:    a.    Denying or conditioning the issuance or effectiveness of the Medicare supplement policy or certificate or increasing the premium for a group plan based on the manifestation of a disease or disorder of a covered individual or applicant; or    b.    Increasing the premium for any Medicare supplement policy or certificate issued to an individual based on the manifestation of a disease or disorder of another individual who is covered under the Medicare supplement policy. In such case, the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other group members and to further increase the premium for the insured group.    37.34(4) Issuer prohibited from requiring genetic testing.  An issuer of a Medicare supplement policy or certificate shall not request or require an individual or a family member of such individual to undergo a genetic test.    37.34(5) Obtaining and using test results to determine payment.  Subrule 37.34(4) shall not be construed to preclude an issuer of a Medicare supplement policy or certificate from obtaining and using the results of a genetic test in making a determination regarding payment (as defined for the purposes of applying the regulations promulgated under Medicare Part C of Title XI and Section 264 of the Health Insurance Portability and Accountability Act of 1996, as may be revised from time to time) and consistent with subrule 37.34(2). However, for purposes of carrying out this subrule, an issuer of a Medicare supplement policy or certificate may request only the minimum amount of information necessary to accomplish the intended purpose.    37.34(6) Conditions when issuer may request a genetic test.  Notwithstanding subrule 37.34(4), an issuer of a Medicare supplement policy or certificate may request, but not require, that an individual or a family member of such individual undergo a genetic test if each of the following conditions is met:    a.    The request is made pursuant to research that complies with Part 46 of Title 45, Code of Federal Regulations, or equivalent federal regulations, and any applicable state or local law or regulations for the protection of human subjects in research.    b.    The issuer of a Medicare supplement policy or certificate clearly indicates to each individual, or in the case of a minor child, to the legal guardian of such child, to whom the request is made that:    (1)   Compliance with the request is voluntary; and    (2)   Noncompliance will have no effect on enrollment status or premium or contribution amounts.    c.    No genetic information collected or acquired under this subrule shall be used for underwriting, determination of eligibility to enroll or maintain enrollment status, premium rates, or the issuance, renewal, or replacement of a Medicare supplement policy or certificate.    d.    The issuer of a Medicare supplement policy or certificate notifies the Secretary in writing that the issuer of a Medicare supplement policy or certificate is conducting activities pursuant to the exception provided for under this subrule, including a description of the activities conducted.    e.    The issuer of a Medicare supplement policy or certificate complies with such other conditions as the Secretary may by regulation require for activities conducted under this subrule.    37.34(7) Issuer prohibited from actively obtaining genetic information for underwriting.  An issuer of a Medicare supplement policy or certificate shall not request, require, or purchase genetic information for underwriting purposes.    37.34(8) Issuer prohibited from actively obtaining genetic information for enrollment.  An issuer of a Medicare supplement policy or certificate shall not request, require, or purchase genetic information with respect to any individual prior to such individual’s enrollment under the policy in connection with such enrollment.    37.34(9) Obtaining information incidentally not a violation.  If an issuer of a Medicare supplement policy or certificate obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation of subrule 37.34(8) if such request, requirement, or purchase is not in violation of subrule 37.34(7).

    191—37.35(514D) Prohibition against using materials prepared by SHIIP.  The Senior Health Insurance Information Program (SHIIP) may prepare a consumer Medicare supplement insurance premium guide and benefits comparison guide. This guide and the SHIIP name or logo shall not be used in the solicitation or sale of health insurance products. Violation of this rule shall be deemed an unfair trade practice under Iowa Code chapter 507B.

    191—37.36(514D) Guaranteed issue for eligible persons.      37.36(1) Definition of “Medicare Advantage organization.”  For purposes of this rule:        "Medicare Advantage organization" means a private company that has a contract with Medicare to provide Medicare Advantage plans and benefits to individuals.    37.36(2) Guaranteed issue.      a.    Eligible persons for guaranteed issue of a Medicare supplement policy or certificate are those individuals described in subrule 37.36(3) who seek to enroll under the Medicare supplement policy during the period specified in subrule 37.36(4) and who submit evidence of the date of termination, disenrollment, or Medicare Part D enrollment with the application for a Medicare supplement policy or certificate.    b.    With respect to eligible individuals for guaranteed issue of a Medicare supplement policy or certificate, an issuer: shall not deny or condition the issuance or effectiveness of a Medicare supplement policy or certificate described in subrule 37.36(6) that is offered by the issuer and is available for issuance to new enrollees; shall not discriminate in the pricing of such Medicare supplement policy or certificate because of health status, claims experience, receipt of health care, or medical condition; and shall not impose an exclusion of benefits based on a preexisting condition under such Medicare supplement policy or certificate.    37.36(3) Eligible persons.  An eligible person is an individual described in any of the following paragraphs 37.36(3)“a” through “g”:    a.    The individual is enrolled under an employee welfare benefit plan that provides health benefits that supplement benefits under Medicare, and the plan terminates or the plan ceases to provide some or all such supplemental health benefits to the individual (for purposes of this paragraph, “employee welfare benefit plan” means a plan, fund or program of employee benefits as defined in 29 U.S.C. Section 1002 Employee Retirement Income Security Act).    b.    The individual is enrolled with a Medicare Advantage organization under a Medicare Advantage plan and any of the following circumstances apply, or the individual is 65 years of age or older and is enrolled with a PACE provider and circumstances exist similar to one of the circumstances described in subparagraphs 37.36(3)“b”(1) through (5) that would permit discontinuance of the individual’s enrollment with such a provider if such individual were enrolled in a Medicare Advantage plan:    (1)   The certification of the Medicare Advantage organization or Medicare Advantage plan has been terminated.    (2)   The Medicare Advantage organization has terminated or otherwise discontinued providing the Medicare Advantage plan in the area in which the individual resides.    (3)   The individual is no longer eligible to elect the Medicare Advantage plan because of a change in the individual’s place of residence or other change in circumstances specified by the Secretary, but not including termination of the individual’s enrollment on the basis described in Section 1851(g)(3)(B) of the federal Social Security Act (where the individual has not paid premiums on a timely basis or has engaged in disruptive behavior as specified in standards under Section 1856), or the Medicare Advantage plan is terminated for all individuals within a residence area.    (4)   The individual demonstrates, in accordance with guidelines established by the Secretary, that:    1.   The Medicare Advantage organization offering the Medicare Advantage plan substantially violated a material provision of the Medicare Advantage organization’s contract under this part in relation to the individual, including the failure to provide an enrollee on a timely basis medically necessary care for which benefits are available under the Medicare Advantage plan or the failure to provide such covered care in accordance with applicable quality standards; or    2.   The Medicare Advantage organization, or agent, producer or other entity acting on the Medicare Advantage organization’s behalf, materially misrepresented the Medicare Advantage plan’s provisions in marketing the Medicare Advantage plan to the individual.    (5)   The individual meets such other exceptional conditions as the Secretary may provide.    c.    The individual is one for whom both subparagraphs 37.36(3)“c”(1) and (2) are true:    (1)   The individual is enrolled with one of the following organizations:    1.   An eligible organization under a contract under Section 1876 of the Social Security Act (Medicare cost);    2.   A similar organization operating under demonstration project authority, effective for periods before April 1, 1999;    3.   An organization operating under an agreement under Section 1833(a)(1)(A) of the Social Security Act (Health Care Prepayment Plan (HCPP)); or    4.   An organization under a Medicare Select policy.    (2)   The enrollment ceases under the same circumstances that would permit discontinuance of an individual’s election of coverage under paragraph 37.36(3)“b.”    d.    The individual is enrolled under a Medicare supplement policy or certificate, and the enrollment ceases because:    (1)   Of the insolvency or rehabilitation of the issuer (pursuant to Iowa Code chapter 507C) or the bankruptcy of the Medicare Advantage organization; or of other involuntary termination of coverage or enrollment under the policy (for purposes of this subparagraph, “bankruptcy” means when a Medicare Advantage organization that is not an issuer has filed, or has had filed against it, a petition for declaration of bankruptcy, and has ceased doing business in the state); or    (2)   The issuer of the policy substantially violated a material provision of the policy; or    (3)   The issuer, or an agent, producer or other entity acting on the issuer’s behalf, materially misrepresented the policy’s provisions in marketing the policy to the individual.    e.    The individual was enrolled under a Medicare supplement policy or certificate and terminated enrollment and subsequently enrolls, for the first time, with any Medicare Advantage organization under a Medicare Advantage plan, any eligible organization under a contract under Section 1876 of the Social Security Act (Medicare cost), any similar organization operating under demonstration project authority, any PACE provider, or a Medicare Select policy; and the subsequent enrollment under this paragraph 37.36(3)“e” was terminated by the enrollee during any period within the first 12 months of such subsequent enrollment (during which the enrollee is permitted to terminate such subsequent enrollment under Section 1851(e) of the federal Social Security Act).    f.    The individual, upon first becoming enrolled for benefits under Medicare Part B at age 65 or older, enrolls in a Medicare Advantage plan under Medicare Part C, or with a PACE provider, and disenrolls from the plan or program by no later than 12 months after the effective date of enrollment.    g.    The individual enrolls in a Medicare Part D plan during the initial enrollment period and, at the time of enrollment in Medicare Part D, was enrolled under a Medicare supplement policy or certificate that covers outpatient prescription drugs and the individual terminates enrollment in the Medicare supplement policy or certificate and submits evidence of enrollment in Medicare Part D along with the application for a policy described in paragraph 37.36(6)“e.”    37.36(4) Guaranteed issue time periods.      a.    In the case of an individual described in paragraph 37.36(3)“a,” the guaranteed issue period:    (1)   Begins on the later of:     1.   The date the individual receives a notice of termination or cessation of some or all supplemental health benefits (or, if a notice is not received, notice that a claim has been denied because of such a termination or cessation); or    2.   The date that the applicable coverage terminates or ceases; and     (2)   Ends 63 days thereafter.    b.    In the case of an individual described in paragraph 37.36(3)“b,”“c,”“e” or “f” whose enrollment is terminated involuntarily, the guaranteed issue period begins on the date that the individual receives a notice of termination and ends 63 days after the date the applicable coverage is terminated.    c.    In the case of an individual described in subparagraph 37.36(3)“d”(1), the guaranteed issue period:    (1)   Begins on the earlier of:    1.   The date that the individual receives a notice of termination, a notice that the issuer is insolvent or in rehabilitation (pursuant to Iowa Code chapter 507C), or other such similar notice, if any; and    2.   The date that the applicable coverage is terminated; and     (2)   Ends on the date that is 63 days after the date the coverage is terminated.    d.    In the case of an individual described in paragraph 37.36(3)“b,”subparagraph 37.36(3)“d”(2) or (3), or paragraph 37.36(3)“e” or “f” who disenrolls voluntarily, the guaranteed issue period begins on the date that is 60 days before the effective date of the disenrollment and ends on the date that is 63 days after the effective date.    e.    In the case of an individual described in paragraph 37.36(3)“g,” the guaranteed issue period begins on the date the individual receives notice pursuant to Section 1882(v)(2)(B) of the Social Security Act from the Medicare supplement or certificate issuer during the 60-day period immediately preceding the initial Medicare Part D enrollment period and ends on the date that is 63 days after the effective date of the individual’s coverage under Medicare Part D.    f.    In the case of an individual described in subrule 37.36(3) but not described in the preceding paragraphs 37.36(4)“a” to “e,” the guaranteed issue period begins on the effective date of disenrollment and ends on the date that is 63 days after the effective date.    37.36(5) Extended Medigap access for interrupted trial periods.      a.    In the case of an individual described in subrule 37.36(3) (or deemed to be so described pursuant to this paragraph 37.36(5)“a”) whose enrollment with an organization or provider described in paragraph 37.36(3)“e” is involuntarily terminated within the first 12 months of enrollment and who, without an intervening enrollment, enrolls with another such organization or provider, the subsequent enrollment shall be deemed to be an initial enrollment as described in paragraph 37.36(3)“e.”    b.    In the case of an individual described in paragraph 37.36(3)“f” (or deemed to be so described pursuant to this paragraph 37.36(5)“b”) whose enrollment with a plan or in a program described in paragraph 37.36(3)“f” is involuntarily terminated within the first 12 months of enrollment and who, without an intervening enrollment, enrolls in another such plan or program, the subsequent enrollment shall be deemed to be an initial enrollment as described in paragraph 37.36(3)“f.”    c.    For purposes of paragraphs 37.36(3)“e” and “f,” no enrollment of an individual with an organization or provider described in paragraph 37.36(3)“e,” or with a plan or in a program described in paragraph 37.36(3)“f,” may be deemed to be an initial enrollment under this paragraph 37.36(5)“c” after the two-year period beginning on the date on which the individual first enrolled with such an organization, provider, plan or program.    37.36(6) Products to which eligible persons are entitled.      a.    If an individual meets the requirements of paragraph 37.36(3)“a,”“b,”“c,” or “d,” the individual may be issued a Medicare supplement policy or certificate which has a benefit package classified as Plan A, B, C, F (including F with a high deductible), K or L offered by any issuer.    b.    The Medicare supplement policy or certificate to which eligible persons are entitled under paragraph 37.36(3)“e,” subject to paragraph 37.36(6)“c,” is the same Medicare supplement policy or certificate in which the individual was most recently previously enrolled if available from the same issuer, or, if not so available, a policy described in paragraph 37.36(6)“a.”    c.    After December 31, 2005, if the individual was most recently enrolled in a Medicare supplement policy or certificate with an outpatient prescription drug benefit, a Medicare supplement policy or certificate described in this subrule is:    (1)   The policy available from the same issuer but modified to remove outpatient prescription drug coverage; or    (2)   At the election of the individual, an A, B, C, F (including F with a high deductible), K or L policy that is offered by any issuer.    d.    The Medicare supplement policy or certificate to which eligible persons are entitled under paragraph 37.36(3)“f” shall include any Medicare supplement policy or certificate offered by any issuer.    e.    The Medicare supplement policy or certificate to which eligible persons are entitled under paragraph 37.36(3)“g” is a Medicare supplement policy or certificate that has a benefit package classified as Plan A, B, C, F (including F with a high deductible), K or L, and that is offered and is available for issuance to new enrollees by the same issuer that issued the individual’s Medicare supplement policy or certificate with outpatient prescription drug coverage.     37.36(7) Notification of provisions.      a.    At the time of an event described in subrule 37.36(3) because of which an individual loses coverage or benefits due to the termination or change of a contract or agreement, policy, or plan, the organization that terminates or changes the contract or agreement, the issuer terminating or changing the policy, or the administrator of the plan being terminated or changed, respectively, shall notify the individual of the individual’s rights under this rule and of the obligations of issuers of Medicare supplement policies or certificates under subrule 37.36(2). Such notice shall be communicated contemporaneously with the notification of termination.    b.    At the time of an event described in subrule 37.36(3) because of which an individual ceases enrollment under a contract or agreement, policy, or plan, the organization that offers the contract or agreement, regardless of the basis for the cessation of enrollment, the issuer offering the policy, or the administrator of the plan, respectively, shall notify the individual of the individual’s rights under this rule and of the obligations of issuers of Medicare supplement policies or certificates under subrule 37.36(3). Such notice shall be communicated within ten working days of the issuer receiving notification of the disenrollment.

    191—37.37()    Reserved.

    191—37.38()    Reserved.

    191—37.39()    Reserved.

    191—37.40()    Reserved.

    191—37.41()    Reserved.

    191—37.42()    Reserved.

    191—37.43()    Reserved.

    191—37.44()    Reserved.

    191—37.45()    Reserved.

    191—37.46()    Reserved.

    191—37.47()    Reserved.

    191—37.48()    Reserved.

    191—37.49()    Reserved.

    191—37.50(507B,514D) Medicare supplement advertising.      37.50(1) Purpose.  The purpose of this rule is to provide prospective purchasers with clear and unambiguous statements in the advertisement of Medicare supplement insurance and to ensure the clear and truthful disclosure of the benefits, limitations and exclusions of policies sold as Medicare supplement insurance. This purpose is intended to be accomplished by the establishment of guidelines and permissible and impermissible standards of conduct in the advertising of Medicare supplement insurance in a manner which prevents unfair, deceptive and misleading advertising and which is conducive to accurate presentation and description to the insurance-buying public through the advertising media and material used by producers and companies.    37.50(2) Applicability.      a.    This rule shall apply to any “advertisement” of Medicare supplement insurance, as that term is defined in subrule 37.50(3), unless otherwise specified in this rule, that the issuer or producer knows or reasonably should know is intended for presentation, distribution or dissemination in this state when the presentation, distribution or dissemination is made either directly or indirectly by or on behalf of an issuer or producer.    b.    The requirements of Iowa Code chapter 507B and 191—Chapter 15 also shall apply to issuers and producers to which this rule 191—37.50(507B,514D) applies, unless specifically exempted therein.    37.50(3) Definitions.  In addition to the definitions in Iowa Code sections 507B.2 and 514D.2 and rules 191—15.2(507B) and 191—37.3(514D), the following definitions shall apply to this rule 191—37.50(507B,514D). When a term defined in this rule is also defined in Iowa Code section 507B.2 or 514D.2 or rule 191—15.2(507B) or 191—37.3(514D), the definition of the term in this rule shall take precedence.        "Advertisement"
    1. Includes the definition of “advertisement” in rule 191—15.2(507B).
    2. Includes advertising material included with a Medicare supplement policy or certificate when the Medicare supplement policy or certificate is delivered and the advertising material is used in the solicitation of Medicare supplement policy renewals and reinstatements.
    3. Does not include:
  • The items excluded in paragraph “2” of the definition of “advertisement” in rule 191—15.2(507B).
  • Material to be used solely for the training and education of an issuer’s employees, producers, agents or brokers.
  • Material used in-house by issuers.
  • Communications within an issuer’s own organization not intended for dissemination to the public.
  • Individual communications of a personal nature with current covered individuals other than material urging the covered individuals to increase or expand coverage.
  • Correspondence between a prospective group or blanket policyholder and an issuer in the course of negotiating a group or blanket Medicare supplement policy.
  • Court-approved material ordered by a court to be disseminated to covered individuals or group policyholders of Medicare supplement policies.
  • A general announcement from a group or blanket Medicare supplement policyholder to eligible individuals on an employment or membership list that a Medicare supplement policy has been written or arranged; provided the announcement clearly indicates that it is preliminary to the issuance of a booklet.
    •         "Certificate" means any certificate issued under a group Medicare supplement policy, which certificate has been delivered or issued for delivery in this state.        "Exception" means any provision in a Medicare supplement policy whereby coverage for a specified hazard is entirely eliminated; it is a statement of a risk not assumed under the Medicare supplement policy or certificate.        "Institutional advertisement" means an advertisement having as its sole purpose the promotion of the reader’s, viewer’s or listener’s interest in the concept of Medicare supplement insurance, or the promotion of the issuer as a seller of Medicare supplement insurance.        "Invitation to contract" means an advertisement that is neither an institutional advertisement nor an invitation to inquire (defined in paragraph 37.50(8)“d”).         "Issuer" shall include any entity which is defined as an “issuer” in rule 191—37.3(514D) and is engaged in the advertisement of itself, or of Medicare supplement insurance.        "Lead-generating device" means any communication directed to the public that, regardless of form, content or stated purpose, is intended to result in the compilation or qualification of a list containing names and other personal information to be used to solicit residents of this state for the purchase of Medicare supplement insurance.        "Limitation" means any provision other than an exception or a reduction that restricts coverage under a Medicare supplement policy.        "Medicare supplement insurance" means a group or individual policy of accident and sickness insurance or a contract of hospital and medical service associations or health maintenance organizations that is advertised, marketed or designed primarily as a supplement to reimbursements under Medicare for the hospital, medical, or surgical expenses of persons eligible for Medicare by reason of age.        "Person" means a natural person, association, organization, partnership, trust, group, discretionary group, corporation or any other entity.        "Reduction" means any provision that reduces the amount of the benefit; a risk of loss is assumed but payment upon the occurrence of the loss is limited to some amount or period less than would be otherwise payable had the reduction not been used.        37.50(4) Form and content of advertisements.      a.    An issuer shall clearly identify its Medicare supplement insurance as an insurance policy or certificate. A Medicare supplement policy or certificate trade name must be followed by the words “Insurance Policy” or similar words clearly identifying the fact that an insurance policy or certificate or health benefits product (in the case of health maintenance organizations, prepaid health plans and other direct service organizations) is being offered.    b.    Medicare supplement insurance advertising materials that are reproduced in quantity shall be identified by form numbers or other identifying means. The identification shall be sufficient to distinguish an advertisement from any other advertising materials, policies, applications or other materials used by the issuer.    37.50(5) Testimonials or endorsements by third parties.  In addition to complying with 191—subrule 15.3(7), when a testimonial refers to benefits received under a Medicare supplement policy or certificate, the issuer shall retain for examination by the commissioner the specific claim data, including claim number, date of loss, and other pertinent information, for a period of four years or until the filing of the next regular report of examination of the issuer, whichever is the longer period of time. The use of testimonials that do not correctly reflect the present practices of the issuer or that are not applicable to the Medicare supplement policy or certificate or benefit being advertised is not permissible.    37.50(6) Use of statistics; jurisdictional licensing; status of insurer.  Medicare supplement insurance advertisements shall be in compliance with 191—subrule 15.3(5) and with the following:    a.    A Medicare supplement insurance advertisement shall specifically identify the Medicare supplement policy or certificate to which statistics relate and, where statistics are given which are applicable to a different policy or certificate, the advertisement shall state clearly that the data do not relate to the Medicare supplement policy or certificate being advertised.    b.    A Medicare supplement insurance advertisement that is intended to be seen or heard beyond the limits of the jurisdiction in which the issuer is licensed shall not imply licensing beyond those limits.    c.    A Medicare supplement insurance advertisement shall not create the impression directly or indirectly that the issuer, the issuer’s financial condition or status, the issuer’s payment of its claims, or the merits, desirability or advisability of the issuer’s policy forms or kinds of plans of insurance are approved, endorsed or accredited by any division or agency of this state or of the United States government.    d.    A Medicare supplement insurance advertisement shall not imply that approval, endorsement or accreditation of policy forms or advertising has been granted by any division or agency of this state or of the United States government. “Approval” of either policy forms or advertising shall not be used by an issuer to imply or state that a governmental agency has endorsed or recommended the issuer, its policies, its advertising or its financial condition.    37.50(7) Identity of issuer.  Advertisements shall be in compliance with 191—subrule 15.3(9) and with the following:    a.    Advertisements, stationery or envelopes that employ words, letters, initials, symbols or other devices are not permitted if they are so similar to those used by governmental agencies or other issuers that they may lead the public to believe:    (1)   The advertised Medicare supplement insurance coverages are somehow provided by or are endorsed by the governmental agencies or the other issuers;    (2)   The Medicare supplement insurance advertiser is the same as, is connected with or is endorsed by the governmental agencies or the other issuers.    b.    No Medicare supplement insurance advertisement shall use the name of a state or political subdivision thereof in a policy name or description.    c.    No Medicare supplement insurance advertisement in the form of envelopes or stationery of any kind may use any name, service mark, slogan, symbol or any device in such a manner that implies that the issuer or the policy advertised, or that any producer who may call upon the consumer in response to the advertisement, is connected with a governmental agency, such as the Social Security Administration.    d.    No Medicare supplement insurance advertisement may incorporate the word “Medicare” in the title of the plan or policy being advertised unless, wherever it appears, the word is qualified by language differentiating the plan or policy from Medicare. Such an advertisement, however, shall not use the phrase “_____________ Medicare Department of the _________________ Insurance Company,” or language of similar import.    e.    No Medicare supplement insurance advertisement shall be used that fails to include a disclaimer to the effect of “Not connected with or endorsed by the U.S. government or the federal Medicare program.”    f.    No Medicare supplement insurance advertisement may imply that the reader may lose a right, privilege or benefit under federal, state or local law if the reader fails to respond to the advertisement.    g.    No issuer may use, in the trade name of its Medicare supplement insurance policy, any terminology or words so similar to the name of a governmental agency or governmental program as to have the tendency to confuse, deceive or mislead the prospective purchaser.    h.    All Medicare supplement insurance advertisements used by producers or solicitors of an issuer shall have prior written approval of the issuer before the advertisements may be used.    i.    A producer who makes contact with a consumer as a result of acquiring that consumer’s name from a lead-generating device shall disclose that fact in the initial contact with the consumer.    37.50(8) Introductory, initial or special offers.      a.    Enrollment periods.    (1)   An advertisement of an individual Medicare supplement insurance policy shall not directly or by implication represent that a contract or combination of contracts is an introductory, initial or special offer, or that applicants will receive substantial advantages not available at a later date, or that the offer is available only to a specified group of individuals, unless such representation is true. A Medicare supplement insurance advertisement shall not contain phrases describing an enrollment period as “special,” “limited,” or similar words or phrases when the issuer uses such enrollment periods as the usual method of advertising Medicare supplement insurance.    (2)   An enrollment period during which a particular Medicare supplement insurance product may be purchased on an individual basis shall not be offered within this state unless there has been a lapse of not less than six months between the close of the immediately preceding enrollment period for the same product and the opening of the new enrollment period. The Medicare supplement insurance advertisement shall indicate the date by which the applicant must mail the application, which shall be not fewer than 10 days and not more than 40 days from the date that the enrollment period is advertised for the first time. This rule applies to all advertising media, e.g., mail, newspapers, electronic mail, websites, radio, television, magazines and periodicals, used by any one issuer. This rule is not applicable to solicitations of employees or members of a particular group or association that otherwise would be eligible for group, blanket or franchise insurance. The phrase “any one issuer” in this subparagraph includes all the affiliated companies of a group of insurance companies under common management or control. The phrase “a particular Medicare supplement insurance product” in this subparagraph means an insurance policy that provides benefits substantially different from those contained in any other policy. Different terms of renewability, an increase or decrease in the dollar amounts of benefits, or an increase or decrease in any elimination period or waiting period from those available during an enrollment period for another policy shall not be sufficient to constitute the product’s being offered as a different product eligible for concurrent or overlapping enrollment periods.    (3)   This rule prohibits any statement or implication to the effect that only a specific number of Medicare supplement policies will be sold, or that a time is fixed for the discontinuance of the sale of the particular Medicare supplement policy advertised because of special advantages available in the policy, unless either representation is true.    b.    An advertisement shall not offer a Medicare supplement policy that utilizes a reduced initial premium rate in a manner that overemphasizes the availability and the amount of the initial reduced premium. When an issuer charges an initial premium that differs in amount from the amount of the renewal premium payable on the same mode, the advertisement shall not display the amount of the reduced initial premium either more frequently or more prominently than the renewal premium, and both the initial reduced premium and the renewal premium shall be stated in juxtaposition in each portion of the advertisement where the initial reduced premium appears. The term “juxtaposition” means side by side or immediately above or below.    c.    Special awards, such as a “safe driver’s award,” shall not be used in connection with advertisements of Medicare supplement insurance.    d.    An invitation to inquire, which means an advertisement having as its objective the creation of a desire to inquire further about Medicare supplement insurance that is limited to a brief description of coverage, shall contain a provision in the following or substantially similar form:“This policy has [exclusions] [limitations] [reductions of benefits] [terms under which the policy may be continued in force or discontinued]. For costs and complete details of the coverage, call [or write] your producer or the company [whichever is applicable].”    37.50(9) Enforcement procedures—certificate of compliance.  Each issuer required to file an annual statement which is now or which hereafter becomes subject to the provisions of this chapter must file with the insurance division, with the issuer’s annual statement, a certificate of compliance executed by an authorized officer of the issuer wherein it is stated that, to the best of the authorized officer’s knowledge, information and belief, the Medicare supplement insurance advertisements that were disseminated by the issuer during the preceding statement year complied with or were made to comply in all respects with the provisions of this chapter and the laws of this state as implemented and interpreted by this chapter.    37.50(10) Filing for prior review.  The commissioner may, at the commissioner’s discretion, require the filing with the insurance division, for review prior to use, of any Medicare supplement insurance advertising material.

    191—37.51(514D) Severability.  If any provisions of this chapter or the application thereof to any person or circumstance is for any reason held to be invalid, the remainder of the chapter and the application of such provision to other persons or circumstances shall not be affected thereby.       These rules are intended to implement Iowa Code chapters 507B and 514D.     APPENDIX AMEDICARE SUPPLEMENT REFUND CALCULATION FORMFOR CALENDAR YEAR ______TYPE1SMSBP2For the State ofCompany Name NAIC Group CodeNAIC Company CodeAddressPerson Completing This ExhibitTitleTelephone NumberLine    (a)Earned Premium3    (b)Incurred Claims41.Current Year’s Experience     a. Total (all policy years)     b. Current year’s issues5     c. Net (for reporting purposes = 1a – 1b)2.Past Years’ Experience (all policy years)3.    Total Experience(Net Current Year + Past Year)4.Refunds Last Year (excluding interest)5.Previous Since Inception (excluding interest)6.Refunds Since Inception (excluding interest)7.Benchmark Ratio Since Inception (see worksheet for Ratio 1)8.    Experienced Ratio Since Inception (Ratio 2)Total Actual Incurred Claims (line 3, col. b) Total Earned Prem. (line 3, col. a) – Refunds Since Inception (line 6)9.    Life Years Exposed Since InceptionIf the Experienced Ratio is less than the Benchmark Ratio, and there are more than 500 life years exposure, then proceed to calculation of refund.10.Tolerance Permitted (obtained from credibility table)1 Individual, Group, Individual Medicare Select, or Group Medicare Select only.2 “SMSBP” = Standardized Medicare Supplement Benefit Plan – Use “P” for prestandardized Medicare supplement benefit plans.3 Includes Modal Loadings and Fees Charged.4 Excludes Active Life Reserves.5 This is to be used as “Issue Year Earned Premium” for Year 1 of next year’s “Worksheet for Calculation of Benchmark Ratios.” Medicare Supplement Credibility TableLife Years Exposed    Since InceptionTolerance    10,000 +0.0%    5,000 - 9,9995.0%    2,500 - 4,9997.5%    1,000 - 2,49910.0%    500 - 99915.0%If less than 500, no credibility. MEDICARE SUPPLEMENT REFUND CALCULATION FORMFOR CALENDAR YEAR ______TYPE1 SMSBP2For the State ofCompany NameNAIC Group CodeNAIC Company CodeAddressPerson Completing This Exhibit TitleTelephone Number11.Adjustment to Incurred Claims for CredibilityRatio 3 = Ratio 2 + ToleranceIf Ratio 3 is more than Benchmark Ratio (Ratio 1), a refund or credit to premium is not required.If Ratio 3 is less than the Benchmark Ratio, then proceed.12.Adjusted Incurred Claims[Total Earned Premiums (line 3, col. a) – Refunds Since Inception (line 6)] × Ratio 3 (line 11)13.Refund =Total Earned Premiums (line 3, col. a) – Refunds Since Inception (line 6) – [Adjusted Incurred Claims (line 12) / Benchmark Ratio (Ratio 1)]If the amount on line 13 is less than .005 times the annualized premium in force as of December 31 of the reporting year, then no refund is made. Otherwise, the amount on line 13 is to be refunded or credited, and a description of the refund or credit against premiums to be used must be attached to this form.I certify that the above information and calculations are true and accurate to the best of my knowledge and belief.SignatureName (Please type.)Title (Please type.)Date1 Individual, Group, Individual Medicare Select, or Group Medicare Select only.2 “SMSBP” = Standardized Medicare Supplement Benefit Plan – Use “P” for prestandardized plans. REPORTING FORM FOR THE CALCULATION OFBENCHMARK RATIO SINCE INCEPTION FOR GROUP POLICIESFOR CALENDAR YEAR _____TYPE1 SMSBP2For the State ofCompany NameNAIC Group CodeNAIC Company CodeAddressPerson Completing This Exhibit TitleTelephone Number(a)3(b)4(c)(d)(e)(f)(g)(h)(i)(j)(o)5    Year    EarnedPremium    Factor    (b) × (c)    CumulativeLoss Ratio    (d) × (e)    Factor    (b) × (g)    CumulativeLoss Ratio    (h) × (i)    Policy YearLoss Ratio12.7700.5070.0000.0000.4624.1750.5670.0000.0000.6334.1750.5671.1940.7590.7544.1750.5672.2450.7710.7754.1750.5673.1700.7820.8064.1750.5673.9980.7920.8274.1750.5674.7540.8020.8484.1750.5675.4450.8110.8794.1750.5676.0750.8180.88104.1750.5676.6500.8240.88114.1750.5677.1760.8280.88124.1750.5677.6550.8310.88134.1750.5678.0930.8340.89144.1750.5678.4930.8370.8915+64.1750.5678.6840.8380.89Total:(k):(l):(m):(n):Benchmark Ratio Since Inception: (l + n)/(k + m): __________1 Individual, Group, Individual Medicare Select, or Group Medicare Select only.2 “SMSBP” = Standardized Medicare Supplement Benefit Plan – Use “P” for prestandardized Medicare supplement benefit plans.3 Year 1 is the current calendar year - 1. Year 2 is the current calendar year - 2 (etc.). (Example: If the current year is 1991, then: Year 1 is 1990; Year 2 is 1989, etc.)4 For the calendar year on the appropriate line in column (a), the premium earned during that year for policies issued in that year.5 These loss ratios are not explicitly used in computing the benchmark loss ratios. They are the loss ratios, on a policy year basis, which result in the cumulative loss ratios displayed on this worksheet. They are shown here for informational purposes only.6 To include the earned premium for all years prior to as well as the 15th year prior to the current year. REPORTING FORM FOR THE CALCULATION OFBENCHMARK RATIO SINCE INCEPTION FOR INDIVIDUAL POLICIESFOR CALENDAR YEAR _____TYPE1 SMSBP2For the State ofCompany NameNAIC Group CodeNAIC Company CodeAddress Person Completing This ExhibitTitleTelephone Number(a)3(b)4(c)(d)(e)(f)(g)(h)(i)(j)(o)5    Year    EarnedPremium    Factor    (b) × (c)    CumulativeLoss Ratio    (d) × (e)    Factor    (b) × (g)    CumulativeLoss Ratio    (h) × (i)    Policy YearLoss Ratio12.7700.4420.0000.0000.4024.1750.4930.0000.0000.5534.1750.4931.1940.6590.6544.1750.4932.2450.6690.6754.1750.4933.1700.6780.6964.1750.4933.9980.6860.7174.1750.4934.7540.6950.7384.1750.4935.4450.7020.7594.1750.4936.0750.7080.76104.1750.4936.6500.7130.76114.1750.4937.1760.7170.76124.1750.4937.6550.7200.77134.1750.4938.0930.7230.77144.1750.4938.4930.7250.7715+64.1750.4938.6840.7250.77Total:(k):(l):(m):(n):Benchmark Ratio Since Inception: (l + n)/(k + m): _______1 Individual, Group, Individual Medicare Select, or Group Medicare Select only.2 “SMSBP” = Standardized Medicare Supplement Benefit Plan – Use “P” for prestandardized Medicare supplement benefit plans.3 Year 1 is the current calendar year - 1. Year 2 is the current calendar year - 2 (etc.). (Example: If the current year is 1991, then: Year 1 is 1990; Year 2 is 1989, etc.)4 For the calendar year on the appropriate line in column (a), the premium earned during that year for policies issued in that year.5 These loss ratios are not explicitly used in computing the benchmark loss ratios. They are the loss ratios, on a policy year basis, which result in the cumulative loss ratios displayed on this worksheet. They are shown here for informational purposes.6 To include the earned premium for all years prior to as well as the 15th year prior to the current year.     APPENDIX BDISCLOSURE STATEMENTSInstructions for Use of the Disclosure Statements for Health Insurance PoliciesSold to Medicare Beneficiaries that Duplicate Medicare Benefits1. Section 1882(d) of the federal Social Security Act [42 U.S.C. 1395ss] prohibits the sale of a health insurance policy (the term policy includes certificate) to a Medicare beneficiary that duplicates Medicare benefits unless it will pay benefits without regard to a beneficiary’s other health coverage and it includes the prescribed disclosure statement on or together with the application for the policy.2. All types of health insurance policies that duplicate Medicare benefits shall include one of the attached disclosure statements, according to the particular policy type involved, on the application or together with the application. The disclosure statement may not significantly or materially vary from the attached statements in terms of language or format (using not less than 12-point type size, type-proportional spacing, bold characters, line spacing, and boxes around text).3. State and federal law prohibits issuers from selling a Medicare supplement policy or certificate to a person that already has a Medicare supplement policy or certificate except as a replacement policy.4. Property/casualty and life insurance policies are not considered health insurance.5. Disability income policies are not considered to provide benefits that duplicate Medicare.6. Long-term care insurance policies that coordinate with Medicare and other health insurance are not considered to provide benefits that duplicate Medicare.7. The federal law does not preempt state laws that are more stringent than the federal requirements.8. The federal law does not preempt existing state form filing requirements.9. Section 1882 of the federal Social Security Act was amended in Subsection (d)(3)(A) to allow for alternative disclosure statements. The disclosure statements already in Appendix B remain. An issuer may use either disclosure statement with the requisite insurance product. However, issuers should use either the original disclosure statements or the alternative disclosure statements and not use both simultaneously. [Original disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance provides limited benefits, if you meet the policy conditions, for hospital or medical expenses that result from accidental injury. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits when it pays:
  • Hospital or medical expenses up to the maximum stated in the policy
    • Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for policies that provide benefits for specified limited services.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance provides limited benefits, if you meet the policy conditions, for expenses relating to the specific services listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance. This insurance duplicates Medicare benefits when:
  • Any of the services covered by the policy are also covered by Medicare
    • Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for policies that reimburse expenses incurred for specified diseases or other specified impairments. This includes expense-incurred cancer, specified disease and other types of health insurance policies that limit reimbursement to named medical conditions.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance provides limited benefits, if you meet the policy conditions, for hospital or medical expenses only when you are treated for one of the specific diseases or health conditions listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits when it pays:
  • Hospital or medical expenses up to the maximum stated in the policy
    • Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance pays a fixed amount, regardless of your expenses, if you meet the policy conditions, for one of the specific diseases or health conditions named in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits because Medicare generally pays for most of the expenses for the diagnosis and treatment of the specific conditions or diagnoses named in the policy.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance pays a fixed dollar amount, regardless of your expenses, for each day you meet the policy conditions. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits when:
  • Any expenses or services covered by the policy are also covered by Medicare
    • Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Hospice
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for policies that provide benefits upon both an expense-incurred and fixed indemnity basis.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance pays limited reimbursement for expenses if you meet the conditions listed in the policy. It also pays a fixed amount, regardless of your expenses, if you meet other policy conditions. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits when:
  • Any expenses or services covered by the policy are also covered by Medicare; or
  • It pays the fixed dollar amount stated in the policy and Medicare covers the same event.
    • Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice care
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Original disclosure statement for other health insurance policies not specifically identified in the preceding statements.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS INSURANCE DUPLICATES SOME MEDICARE BENEFITSThis is not Medicare Supplement InsuranceThis insurance provides limited benefits if you meet the conditions listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.This insurance duplicates Medicare benefits when it pays:
  • The benefits stated in the policy and coverage for the same event is provided by Medicare
    • Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for policies that provide benefits for expenses incurred for an accidental injury only.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy.This insurance provides limited benefits, if you meet the policy conditions, for hospital or medical expenses that result from accidental injury. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for policies that provide benefits for specified limited services.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits under this policy.This insurance provides limited benefits, if you meet the policy conditions, for expenses relating to the specific services listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for policies that reimburse expenses incurred for specified diseases or other specified impairments. This includes expense-incurred cancer, specified disease and other types of health insurance policies that limit reimbursement to named medical conditions.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy. Medicare generally pays for most or all of these expenses.This insurance provides limited benefits, if you meet the policy conditions, for hospital or medical expenses only when you are treated for one of the specific diseases or health conditions listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for policies that pay fixed dollar amounts for specified diseases or other specified impairments. This includes cancer, specified disease, and other health insurance policies that pay a scheduled benefit or specific payment based on diagnosis of the conditions named in the policy.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy.This insurance pays a fixed amount, regardless of your expenses, if you meet the policy conditions, for one of the specific diseases or health conditions named in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for indemnity policies and other policies that pay a fixed dollar amount per day, excluding long-term care policies.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy.This insurance pays a fixed dollar amount, regardless of your expenses, for each day you meet the policy conditions. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance. Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for policies that provide benefits upon both an expense-incurred and fixed indemnity basis.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy.This insurance pays limited reimbursement for expenses if you meet the conditions listed in the policy. It also pays a fixed amount, regardless of your expenses, if you meet other policy conditions. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice care
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    • [Alternative disclosure statement for other health insurance policies not specifically identified in the preceding statements.]    IMPORTANT NOTICE TO PERSONS ON MEDICARETHIS IS NOT MEDICARE SUPPLEMENT INSURANCESome health care services paid for by Medicare may also trigger the payment of benefits from this policy.This insurance provides limited benefits if you meet the conditions listed in the policy. It does not pay your Medicare deductibles or coinsurance and is not a substitute for Medicare Supplement insurance.Medicare generally pays for most or all of these expenses.Medicare pays extensive benefits for medically necessary services regardless of the reason you need them. These include:
  • Hospitalization
  • Physician services
  • Hospice
  • Outpatient Prescription Drugs if you are enrolled in Medicare Part D
  • Other approved items and services
    • This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.Before You Buy This Insurance
  • Check the coverage in all health insurance policies you already have.
  • For more information about Medicare and Medicare Supplement insurance, review the [insert name of most recent version of 2019 Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services], available from the insurance company.
  • For help in understanding your health insurance, contact the Senior Health Insurance Information Program (SHIIP) of the Iowa Insurance Division.
    •     APPENDIX CSTATEMENTS AND QUESTIONS FOR APPLICATION FORMS RELATED TO DUPLICATE OR REPLACEMENT COVERAGEStatements(1) You do not need more than one Medicare supplement policy.(2) If you purchase this [policy or certificate], you may want to evaluate your existing health coverage and decide if you need multiple coverages.(3) You may be eligible for benefits under Medicaid and may not need a Medicare supplement [policy or certificate].(4) If, after purchasing this [policy or certificate], you become eligible for Medicaid, the benefits and premiums under your Medicare supplement [policy or certificate] can be suspended, if requested, during your entitlement to benefits under Medicaid for 24 months. You must request this suspension within 90 days of becoming eligible for Medicaid. If you are no longer entitled to Medicaid, your suspended Medicare supplement [policy or certificate] (or, if that is no longer available, a substantially equivalent [policy or certificate]) will be reinstituted if requested within 90 days of losing your Medicaid eligibility. If the Medicare supplement [policy or certificate] provided coverage for outpatient prescription drugs and you enrolled in Medicare Part D while your [policy or certificate] was suspended, the reinstituted [policy or certificate] will not have outpatient prescription drug coverage, but will otherwise be substantially equivalent to your coverage before the date of the suspension.(5) If you are eligible for and have enrolled in a Medicare supplement [policy or certificate] by reason of disability and you later become covered by an employer or union-based group health plan, the benefits and premiums under your Medicare supplement [policy or certificate] can be suspended, if requested, while you are covered under the employer or union-based group health plan. If you suspend your Medicare supplement [policy or certificate] under these circumstances, and later lose your employer or union-based group health plan, your suspended Medicare supplement [policy or certificate] (or, if that is no longer available, a substantially equivalent [policy or certificate],) will be reinstituted if requested within 90 days of losing your employer or union-based group health plan. If the Medicare supplement [policy or certificate] provided coverage for outpatient prescription drugs and you enrolled in Medicare Part D while your [policy or certificate] was suspended, the reinstituted [policy or certificate] will not have outpatient prescription drug coverage, but will otherwise be substantially equivalent to your coverage before the date of the suspension.(6) Counseling services may be available in your state to provide advice concerning your purchase of Medicare supplement insurance and concerning medical assistance through the state Medicaid program, including benefits as a Qualified Medicare Beneficiary (QMB) and a Specified Low-Income Medicare Beneficiary (SLMB).QuestionsIf you lost or are losing other health insurance coverage and received a notice from your prior insurance company saying you were eligible for guaranteed issue of a Medicare supplement insurance [policy or certificate], or that you had certain rights to buy such a [policy or certificate], you may be guaranteed acceptance in one or more of our Medicare supplement plans. Please include a copy of the notice from your prior insurance company with your application.PLEASE ANSWER ALL QUESTIONS.(Please mark Yes or No below with an “X”.)To the best of your knowledge,(1) (a) Did you turn age 65 in the last 6 months?Yes____No____(b) Did you enroll in Medicare Part B in the last 6 months?Yes____No____(c) If yes, what is the effective date? ____________________________(2) Are you covered for medical assistance through the state Medicaid program?(NOTE TO APPLICANT: If you are participating in a “Spend-Down Program” and have not met your “Share of Cost,” please answer NO to this question.)Yes____No____If yes,(a) Will Medicaid pay your premiums for this Medicare supplement [policy or certificate]?Yes____No____(b) Do you receive any benefits from Medicaid OTHER THAN payments toward your Medicare Part B premium?Yes____No____(3) (a) If you had coverage from any Medicare plan other than original Medicare within the past 63 days (for example, a Medicare Advantage plan, or a Medicare HMO or PPO), fill in your start and end dates below. If you are still covered under this plan, leave “END” blank.START __/__/__ END __/__/__(b) If you are still covered under the Medicare plan, do you intend to replace your current coverage with this new Medicare supplement [policy or certificate]?Yes____No____(c) Was this your first time in this type of Medicare plan?Yes____No____(d) Did you drop a Medicare supplement policy or certificate to enroll in this plan?Yes____No____(4) (a) Do you have another Medicare supplement policy or certificate in force?Yes____No____(b) If so, with what company, and what plan do you have [optional for direct mailers]? ______________________________________________________________________(c) If so, do you intend to replace your current Medicare supplement policy or certificate with this [policy or certificate]?Yes____No____(5) Have you had coverage under any other health insurance within the past 63 days? (For example, an employer, union, or individual plan)Yes____No____(a) If so, with what company and what kind of policy or certificate?____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________(b) What are your dates of coverage under the other policy or certificate?START __/__/__ END __/__/__(If you are still covered under the other policy or certificate, leave “END” blank.)     APPENDIX DNOTICE TO APPLICANT REGARDING REPLACEMENT OF MEDICARE SUPPLEMENT INSURANCE OR MEDICARE ADVANTAGE[Insurance company’s name and address]SAVE THIS NOTICE! IT MAY BE IMPORTANT TO YOU IN THE FUTURE.According to [your application] [information you have furnished], you intend to terminate an existing Medicare supplement policy or certificate or Medicare Advantage policy or certificate and replace it with a policy to be issued by [Company Name] Insurance Company. Your new policy will provide thirty (30) days within which you may decide without cost whether you desire to keep the policy. You should review this new coverage carefully. Compare it with all accident and sickness coverage you now have. If, after due consideration, you find that purchase of this Medicare supplement [policy or certificate] is a wise decision, you should terminate your present Medicare supplement policy or certificate or Medicare Advantage policy or certificate. You should evaluate the need for other accident and sickness coverage you have that may duplicate this policy.STATEMENT TO APPLICANT BY ISSUER, PRODUCER [BROKER OR OTHER REPRESENTATIVE]:I have reviewed your current medical or health insurance coverage. To the best of my knowledge, this Medicare supplement policy or certificate will not duplicate your existing Medicare supplement policy or certificate or, if applicable, Medicare Advantage policy or certificate because you intend to terminate your existing Medicare supplement policy or certificate or Medicare Advantage policy or certificate. The replacement [policy or certificate] is being purchased for the following reason (check one):____ Additional benefits.____ No change in benefits, but lower premiums.____ Fewer benefits and lower premiums.____ My plan has outpatient prescription drug coverage and I am enrolling in Part D.____ Disenrollment from a Medicare Advantage policy or certificate. Please explain reason for disenrollment. [optional only for direct mailers]____ Other. (Please specify.)________________________________________________________
    1. Note: If the issuer of the Medicare supplement policy or certificate being applied for does not impose, or is otherwise prohibited from imposing, preexisting condition limitations, please skip to statement 2 below. Health conditions which you may presently have (preexisting conditions) may not be immediately or fully covered under the new policy. This could result in denial or delay of a claim for benefits under the new [policy or certificate], whereas a similar claim might have been payable under your present policy or certificate.
    2. State law provides that your replacement policy or certificate may not contain new preexisting conditions, waiting periods, elimination periods or probationary periods. The insurance company will waive any time periods applicable to preexisting conditions, waiting periods, elimination periods or probationary periods in the new policy or certificate (or coverage) for similar benefits to the extent such time was spent (depleted) under the original policy or certificate.
    3. If you still wish to terminate your present policy or certificate and replace it with new coverage, be certain to truthfully and completely answer all questions on the application concerning your medical and health history. Failure to include all material medical information on an application may provide a basis for the company to deny any future claims and to refund your premium as though your policy or certificate had never been in force. After the application has been completed and before you sign it, review it carefully to be certain that all information has been properly recorded. [If the policy or certificate is guaranteed issue, this paragraph need not appear.]
    Do not cancel your present policy or certificate until you have received your new [policy or certificate] and are sure that you want to keep it.____________________________________________________________________(Signature of Producer, Broker or Other Representative)*[Typed Name and Address of Issuer, and of Producer or Broker]____________________________________________________________________(Applicant’s Signature)______________________________(Date)*Signature not required for direct response sales.     APPENDIX EOUTLINE OF COVERAGE: BENEFIT CHARTS[Any amount in brackets in this Appendix E shall be changed to coincide with any change in amount made by the Secretary of the U.S. Department of Health and Human Services.]Benefit Chart of Medicare Supplement Plans Sold for Effective Dates On or After June 1, 2010This chart shows the benefits included in each of the standardized Medicare Supplement plans. Every company must make Plan “A” available. Some plans may not be available in your state.Basic Benefits:
  • Hospitalization – Part A coinsurance plus coverage for 365 additional days after Medicare benefits end.
  • Medical Expenses – Part B coinsurance (generally 20% of Medicare-approved expenses) or copayments for hospital outpatient services. Plans K, L and N require insureds to pay a portion of Part B coinsurance or copayments.
  • Blood – First three pints of blood each year.
  • Hospice – Part A coinsurance.
    • ABCDFF*G KLMNBasic, including 100% Part B coinsuranceBasic, including 100% Part B coinsuranceBasic, including 100% Part B coinsuranceBasic, including 100% Part B coinsuranceBasic, including 100% Part B co- insurance*Basic, including 100% Part B coinsurance Hospitali- zation and preven- tive care paid at 100%; other basic benefits paid at 50%Hospitali- zation and preven- tive care paid at 100%; other basic benefits paid at 75%Basic, including 100% Part B coinsuranceBasic, including 100% Part B coinsurance, except up to $20 copayment for office visit, and up to $50 copay- ment for ERSkilled Nursing Facility CoinsuranceSkilled Nursing Facility CoinsuranceSkilled Nursing Facility CoinsuranceSkilled Nursing Facility Coinsurance 50% Skilled Nursing Facility Coinsurance75% Skilled Nursing Facility CoinsuranceSkilled Nursing Facility CoinsuranceSkilled Nursing Facility CoinsurancePart A DeductiblePart A DeductiblePart A DeductiblePart A DeductiblePart A Deductible 50% Part A Deductible75% Part A Deductible50% Part A DeductiblePart A DeductiblePart B DeductiblePart B Deductible     Part BExcess (100%)    Part BExcess(100%) Foreign Travel Emer- gencyForeign Travel Emer- gencyForeign Travel EmergencyForeign Travel Emer- gency Foreign Travel Emer- gencyForeign Travel Emer- gency Out-of- pocket limit $[5560]; paid at 100% after limit reached Out-of- pocket limit $[2780]; paid at 100% after limit reached * Plan F also has an option called a high deductible Plan F. This high deductible plan pays the same benefits as Plan F after one has paid a calendar year $[2300] deductible. Benefits from high deductible Plan F will not begin until out-of-pocket expenses exceed $[2300]. Out-of-pocket expenses for this deductible are expenses that would ordinarily be paid by the policy. These expenses include the Medicare deductibles for Part A and Part B, but do not include the plan’s separate foreign travel emergency deductible. PREMIUM INFORMATION [Boldface Type]We, [insert issuer’s name], can only raise your premium if we raise the premium for all policies like yours in this state. [If the premium is based on the increasing age of the insured individual, include information specifying when premiums will change.]READ YOUR POLICY VERY CAREFULLY [Boldface Type]This is only an outline describing your policy’s most important features. The policy is your insurance contract. You must read the policy itself to understand all of the rights and duties of both you and your insurance company.RIGHT TO RETURN POLICY [Boldface Type]If you find that you are not satisfied with your policy, you may return it to [insert issuer’s address]. If you send the policy back to us within 30 days after you receive it, we will treat the policy as if it had never been issued and return all of your payments.POLICY REPLACEMENT [Boldface Type]If you are replacing another health insurance policy, do NOT cancel it until you have actually received your new policy and are sure you want to keep it.NOTICE [Boldface Type]This policy may not fully cover all of your medical costs.[for producers:]Neither [insert company’s name] nor its producers are connected with Medicare.[for direct response:][Insert company’s name] is not connected with Medicare.This outline of coverage does not give all the details of Medicare coverage. Contact your local Social Security office or consult “Medicare and You” for more details.COMPLETE ANSWERS ARE VERY IMPORTANT [Boldface Type]When you fill out the application for the new policy, be sure to answer truthfully and completely all questions about your medical and health history. The company may cancel your policy and refuse to pay any claims if you leave out or falsify important medical information. [If the policy or certificate is guaranteed issue, this paragraph need not appear.]Review the application carefully before you sign it. Be certain that all information has been properly recorded.[Include for each plan prominently identified in the cover page a chart showing the services, Medicare payments, plan payments and insured payments, using the same language, in the same order, using uniform layout and format as shown in the charts below. No more than four plans may be shown on one chart. For purposes of illustration, charts for each plan are included in this Appendix E: Outline of Coverage. An issuer may use additional benefit plan descriptions on these charts pursuant to paragraph 37.8(1)“c.”][Include an explanation of any innovative benefits on the cover page and in the chart, in a manner approved by the commissioner.] Benefit Chart of Medicare Supplement Plans Sold On or After January 1, 2020This chart shows the benefits included in each of the standardized Medicare supplement plans. Some plans may not be available. Only applicants first eligible for Medicare before 2020 may purchase Plans C, F, and high deductible F.Note: A ü means 100% of the benefit is paid. Benefits Plans Available to All ApplicantsMedicare first eligible before 2020 only A B D G1 K L M NCF 1 Medicare Part A coinsurance and hospital coverage (up to an additional 365 days after Medicare benefits are used up) ü ü ü ü ü ü ü ü ü ü Medicare Part B coinsurance or copayment ü ü ü ü 50%75% ü ü Copays apply3 ü ü Blood (first three pints) ü ü ü ü 50%75% ü ü ü ü Medicare Part A hospice care coinsurance or copayment ü ü ü ü 50%75% ü ü ü ü Skilled nursing facility coinsurance ü ü 50%75% ü ü ü ü Medicare Part A deductible ü ü ü 50%75%50% ü ü ü Medicare Part B deductible ü ü Medicare Part B excess charges ü ü Foreign travel emergency (up to plan limits) ü ü ü ü ü ü Out-of-pocket limit in [2019]2[$5560]2[$2780]21Plans F and G also have high deductible options which require first paying the plans’ deductibles of [$2300] before the plans begin to pay. Once the plans’ deductibles are met, the plans pay 100% of covered services for the rest of the calendar year. High deductible Plan G does not cover the Medicare Part B deductible. However, high deductible Plans F and G count your payments of the Medicare Part B deductible toward meeting the plan deductibles.2Plans K and L pay 100% of covered services for the rest of the calendar year once you meet the out-of-pocket yearly limits.3Plan N pays 100% of the Medicare Part B coinsurance, except for copayments of up to $20 for some office visits and up to $50 copayments for emergency room visits that do not result in inpatient admissions. PLAN AMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIOD* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.SERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$0$[1364] (Part A deductible)   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.               First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a day$0Up to $[170.50] a day   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN AMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0PLAN AMEDICARE PARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care servicesand medical supplies100%$0$0—Durable medical equipment          First $[185] of Medicare-ApprovedAmounts*$0$0$[185] (Part B deductible)         Remainder of Medicare-ApprovedAmounts80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Medicare Part B deductible will have been met for the calendar year. MEDICARE PLAN BMEDICARE PART A—HOSPITAL SERVICES—PER BENEFIT PERIOD* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.SERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a day$0Up to $[170.50] a day   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN BMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0PLAN BPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies100%$0$0—Durable medical equipment          First $[185] of Medicare-ApprovedAmounts*$0$0$[185] (Part B deductible)         Remainder of Medicare-ApprovedAmounts80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year. PLAN CMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN CMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$[185] (Part B deductible)$0    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$[185] (Part B deductible)$0Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0PLAN CPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies100%$0$0—Durable medical equipment         First $[185] of Medicare-ApprovedAmounts*$0$[185] (Part B deductible)$0         Remainder of Medicare-ApprovedAmounts*80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.PLAN COTHER BENEFITS—NOT COVERED BY MEDICARESERVICESMEDICARE PAYSPLAN PAYSYOU PAY    FOREIGN TRAVEL—NOT COVERED BY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum PLAN DMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN DMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0PLAN DPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies100%$0$0—Durable medical equipment         First $[185] of Medicare-ApprovedAmounts*$0$0$[185] (Part B deductible)         Remainder of Medicare-ApprovedAmounts80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.PLAN DOTHER BENEFITS—NOT COVERED BY MEDICARESERVICESMEDICARE PAYSPLAN PAYSYOU PAY    FOREIGN TRAVEL—NOT COVEREDBY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum PLAN F or HIGH DEDUCTIBLE PLAN FMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIOD    SERVICES    MEDICARE PAYS    [AFTER YOU PAY $[2300] DEDUCTIBLE,**]PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0***     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.[** This high deductible plan pays the same benefits as Plan F after you have paid a calendar year $[2300] deductible. Benefits from the high deductible Plan F will not begin until out-of-pocket expenses are $[2300]. Out-of-pocket expenses for this deductible are expenses that would ordinarily be paid by the policy. This includes the Medicare deductibles for Part A and Part B, but does not include the plan’s separate foreign travel emergency deductible.]*** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN F or HIGH DEDUCTIBLE PLAN FMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEAR    SERVICES    MEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$[185] (Part B deductible)$0    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    100%    $0BLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$[185] (Part B deductible)$0Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.[** This high deductible plan pays the same benefits as Plan F after you have paid a calendar year $[2300] deductible. Benefits from the high deductible Plan F will not begin until out-of-pocket expenses are $[2300]. Out-of-pocket expenses for this deductible are expenses that would ordinarily be paid by the policy. This includes the Medicare deductibles for Part A and Part B, but does not include the plan’s separate foreign travel emergency deductible.] PLAN F or HIGH DEDUCTIBLE PLAN FPARTS A & B    SERVICES    MEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care servicesand medical supplies100%$0$0—Durable medical equipment         First $[185] of Medicare-ApprovedAmounts*$0$[185] (Part B deductible)$0         Remainder of Medicare-ApprovedAmounts80%20%$0PLAN F or HIGH DEDUCTIBLE PLAN FOTHER BENEFITS—NOT COVERED BY MEDICARE    SERVICES    MEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    FOREIGN TRAVEL—NOT COVERED BY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.[** This high deductible plan pays the same benefits as Plan F after you have paid a calendar year $[2300] deductible. Benefits from the high deductible Plan F will not begin until out-of-pocket expenses are $[2300]. Out-of-pocket expenses for this deductible are expenses that would ordinarily be paid by the policy. This includes the Medicare deductibles for Part A and Part B, but does not include the plan’s separate foreign travel emergency deductible.] PLAN G or HIGH DEDUCTIBLE PLAN GMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0***     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.[** This high deductible plan pays the same benefits as Plan G after you have paid a calendar year [$2300] deductible. Benefits from the high deductible Plan G will not begin until out-of-pocket expenses are [$2300]. Out-of-pocket expenses for this deductible include expenses for the Medicare Part B deductible, and expenses that would ordinarily be paid by the policy. This does not include the plan’s separate foreign travel emergency deductible.]*** NOTICE: When your Medicare Part A hospital benefits are exhausted, the issuer stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN G or HIGH DEDUCTIBLE PLAN GMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Unless Part B deductible has been met)     Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%$0    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    100%    0%BLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Unless Part B deductible has been met) Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.[**This high deductible plan pays the same benefits as Plan G after you have paid a calendar year $[2300] deductible. Benefits from the high deductible Plan G will not begin until out-of-pocket expenses are $[2300]. Out-of-pocket expenses for this deductible include expenses for the Medicare Part B deductible, and expenses that would ordinarily be paid by the policy. This does not include the plan’s separate foreign travel emergency deductible.] PLAN G or HIGH DEDUCTIBLE PLAN GPARTS A & BSERVICESMEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies100%$0$0—Durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Unless Part B deductible has been met)     Remainder of Medicare-Approved Amounts80%20%$0PLAN G or HIGH DEDUCTIBLE PLAN GOTHER BENEFITS—NOT COVERED BY MEDICARESERVICESMEDICARE PAYS[AFTER YOU PAY $[2300] DEDUCTIBLE,**] PLAN PAYS[IN ADDITION TO $[2300] DEDUCTIBLE,**] YOU PAY    FOREIGN TRAVEL—NOT COVERED BY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.[**This high deductible plan pays the same benefits as Plan G after you have paid a calendar year $[2300] deductible. Benefits from the high deductible Plan G will not begin until out-of-pocket expenses are $[2300]. Out-of-pocket expenses for this deductible include expenses for the Medicare Part B deductible, and expenses that would ordinarily be paid by the policy. This does not include the plan’s separate foreign travel emergency deductible.] PLAN KMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    HOSPITALIZATION**Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[682] (50% of Part A deductible)$[682] (50% of Part A deductible)♦   61st through 90th dayAll but $[341] a day$[341] a day $0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day $0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0***     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE**You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[85.25] a dayUp to $[85.25] a day ♦   101st day and after$0$0All costsBLOODFirst 3 pints$050%50%♦Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    50% of copayment/ coinsurance     50% of Medicare copayment/ coinsurance♦* You will pay half the cost sharing of some covered services until you reach the annual out-of-pocket maximum of $[5560] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual maximum, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.** A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.*** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN KMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts****$0$0$[185] (Part B deductible)**** ♦    Preventive Benefits for Medicare-Covered Services    Generally 80% or more of Medicare-Approved AmountsRemainder of Medicare-Approved Amounts All costs above Medicare-Approved Amounts    Remainder of Medicare-Approved AmountsGenerally 80%Generally 10%Generally 10% ♦    Part B Excess Charges(Above Medicare-Approved Amounts)$0$0All costs (and they do not count toward annual out-of-pocket limit of $[5560])*BLOODFirst 3 pints$050%50%♦Next $[185] of Medicare-Approved Amounts****$0$0$[185] (Part B deductible)**** ♦Remainder of Medicare-Approved AmountsGenerally 80%Generally 10%Generally 10% ♦CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* You will pay half the cost sharing of some covered services until you reach the annual out-of-pocket maximum of $[5560] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual maximum, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.**** Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year. PLAN KPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies100%$0$0    —Durable medical equipment   First $[185] of Medicare-ApprovedAmounts*****    $0    $0    $[185] (Part B deductible) ♦   Remainder of Medicare-Approved Amounts80%10%10%♦Medicare benefits are subject to change. Please consult the latest [Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services].* You will pay half the cost sharing of some covered services until you reach the annual out-of-pocket maximum of $[5560] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual maximum, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.***** This plan limits your annual out-of-pocket payments for Medicare-approved amounts to $[5560] per year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service. PLAN LMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    HOSPITALIZATION**Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1023] (75% of Part A deductible)$[341] (25% of Part A deductible)♦   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0***     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE**You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[127.88] a day (75% of Part A Coinsurance)Up to $[42.63] a day (25% of Part A Coinsurance)♦   101st day and after$0$0All costsBLOODFirst 3 pints$075%25%♦Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care     75% of copayment/ coinsurance    25% of copayment/ coinsurance♦* You will pay one-fourth of the cost sharing of some covered services until you reach the annual out-of-pocket limit of $[2780] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual limit, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.** A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.*** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN LMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts****$0$0$[185] (Part B deductible)****♦    Preventive Benefits for Medicare-Covered Services    Generally 75% or more of Medicare-Approved AmountsRemainder of Medicare-Approved AmountsAll costs above Medicare-Approved Amounts    Remainder of Medicare-Approved AmountsGenerally 80%Generally 15%Generally 5%♦    Part B Excess Charges(Above Medicare-Approved Amounts)$0$0All costs (and they do not count toward annual out-of-pocket limit of $[2780])*BLOODFirst 3 pints$075%25%♦Next $[185] of Medicare-Approved Amounts****$0$0$[185] (Part B deductible)♦Remainder of Medicare-Approved AmountsGenerally 80%Generally 15%Generally 5%♦CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* You will pay one-fourth of the cost sharing of some covered services until you reach the annual out-of-pocket limit of $[2780] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual limit, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.**** Once you have been billed $[185] of Medicare-approved amounts for covered services (which are noted with an asterisk), your Part B deductible will have been met for the calendar year. PLAN LPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY*    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies 100%$0$0    —Durable medical equipment     First $[185] of Medicare-ApprovedAmounts****    $0    $0    $[185] (Part B deductible)♦         Remainder of Medicare-Approved Amounts80%15%5%♦Medicare benefits are subject to change. Please consult the latest [Choosing a Medigap Policy: Guide to Health Insurance for People with Medicare, issued by Centers for Medicare and Medicaid Services].* You will pay one-fourth of the cost sharing of some covered services until you reach the annual out-of-pocket limit of $[2780] each calendar year. The amounts that count toward your annual limit are noted with diamonds (♦) in the chart above. Once you reach the annual limit, the plan pays 100% of your Medicare copayment and coinsurance for the rest of the calendar year. However, this limit does NOT include charges from your provider that exceed Medicare-approved amounts (these are called “Excess Charges”), and you will be responsible for paying this difference in the amount charged by your provider and the amount paid by Medicare for the item or service.**** Once you have been billed $[185] of Medicare-approved amounts for covered services (which are noted with an asterisk), your Part B deductible will have been met for the calendar year. PLAN MMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[682] (50% of Part A deductible)$[682] (50% of Part A deductible)   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN MMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)    Remainder of Medicare-Approved AmountsGenerally 80%Generally 20%0%    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year. PLAN MPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies 100%$0$0    —Durable medical equipmentFirst $[185] of Medicare-Approved Amounts*    $0    $0    $[185] (Part B deductible)   Remainder of Medicare-Approved Amounts80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.PLAN MOTHER BENEFITS—NOT COVERED BY MEDICARESERVICESMEDICARE PAYSPLAN PAYSYOU PAY    FOREIGN TRAVEL—NOT COVEREDBY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum PLAN NMEDICARE (PART A)—HOSPITAL SERVICES—PER BENEFIT PERIODSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOSPITALIZATION*Semiprivate room and board, general nursing and miscellaneous services and supplies   First 60 daysAll but $[1364]$[1364] (Part A deductible)$0   61st through 90th dayAll but $[341] a day$[341] a day$0   91st day and after:   —While using 60 lifetime reserve daysAll but $[682] a day$[682] a day$0   —Once lifetime reserve days are used:     —Additional 365 days$0100% of Medicare eligible expenses$0**     —Beyond the additional 365 days$0$0All costs    SKILLED NURSING FACILITY CARE*You must meet Medicare’s requirements, including having been in a hospital for at least 3 days and entered a Medicare-approved facility within 30 days after leaving the hospital.   First 20 daysAll approved amounts$0$0   21st through 100th dayAll but $[170.50] a dayUp to $[170.50] a day$0**   101st day and after$0$0All costsBLOODFirst 3 pints$03 pints$0Additional amounts100%$0$0    HOSPICE CAREYou must meet Medicare’s requirements, including a doctor’s certification of terminal illness.    All but very limited copayment/ coinsurance for outpatient drugs and inpatient respite care    Medicare copayment/ coinsurance    $0* A benefit period begins on the first day you receive service as an inpatient in a hospital and ends after you have been out of the hospital and have not received skilled care in any other facility for 60 days in a row.** NOTICE: When your Medicare Part A hospital benefits are exhausted, the insurance company stands in the place of Medicare and will pay whatever amount Medicare would have paid for up to an additional 365 days as provided in the policy’s basic core benefits (“basic core benefits” are the equivalent of what is provided under Medicare Part A). During this time, the hospital is prohibited from billing you for the balance based on any difference between its billed charges and the amount Medicare would have paid. PLAN NMEDICARE (PART B)—MEDICAL SERVICES—PER CALENDAR YEARSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    MEDICAL EXPENSES—IN OR OUT OF THE HOSPITAL AND OUTPATIENT HOSPITAL TREATMENT, such as physician’s services, inpatient and outpatient medical and surgical services and supplies, physical and speech therapy, diagnostic tests, durable medical equipment    First $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)    Remainder of Medicare-Approved AmountsGenerally 80%Balance, other than up to $[20] per office visit and up to $[50] per emergency room visit. The copayment of up to $[50] is waived if the insured individual is admitted to any hospital and the emergency visit is covered as a Medicare Part A expense.Up to $[20] per office visit and up to $[50] per emergency room visit. The copayment of up to $[50] is waived if the insured individual is admitted to any hospital and the emergency visit is covered as a Medicare Part A expense.    Part B Excess Charges(Above Medicare-Approved Amounts)    $0    $0    All costsBLOODFirst 3 pints$0All costs$0Next $[185] of Medicare-Approved Amounts*$0$0$[185] (Part B deductible)Remainder of Medicare-Approved Amounts80%20%$0CLINICAL LABORATORY SERVICES— TESTS FOR DIAGNOSTIC SERVICES    100%    $0    $0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year. PLAN NPARTS A & BSERVICESMEDICARE PAYSPLAN PAYSYOU PAY    HOME HEALTH CAREMEDICARE-APPROVED SERVICES    —Medically necessary skilled care services andmedical supplies 100%$0$0    —Durable medical equipmentFirst $[185] of Medicare-Approved Amounts*    $0    $0    $[185] (Part B deductible)   Remainder of Medicare-Approved Amounts80%20%$0* Once you have been billed $[185] of Medicare-approved amounts for covered services, your Part B deductible will have been met for the calendar year.PLAN NOTHER BENEFITS—NOT COVERED BY MEDICARESERVICESMEDICARE PAYSPLAN PAYSYOU PAY    FOREIGN TRAVEL—NOT COVEREDBY MEDICAREMedically necessary emergency care services beginning during the first 60 days of each trip outside the USA   First $250 each calendar year$0$0$250   Remainder of charges$080% to a lifetime maximum benefit of $50,00020% and amounts over the $50,000 lifetime maximum     APPENDIX F FORM FOR REPORTINGMEDICARE SUPPLEMENT POLICIES OR CERTIFICATESPursuant to Iowa Administrative Code rule 191—37.32(514D)Company Name:Address:Phone Number: Due March 1, annuallyThe purpose of this form is to report the following information on each resident of this state who has in force more than one Medicare supplement policy or certificate. The information is to be grouped by covered individual.Policy and Certificate #Date of IssuanceSignatureName and Title (please type)Date        [Filed 3/22/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4396CNatural Resource Commission[571]Adopted and Filed

    Rule making related to camping, rental facility, vessel storage, and other special privilege fees

        The Natural Resource Commission hereby amends Chapter 61, “State Parks, Recreation Areas, and State Forest Camping,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 455A.5(6)“a.”State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 455A.14.Purpose and Summary    The rule making amends portions of Chapter 61 by adding references to new 561—Chapter 16 (ARC 4395C, IAB 4/10/19) and removes provisions that are no longer needed. This is because the Department of Natural Resources (Department) is authorized, pursuant to Iowa Code section 455A.14 as enacted by 2018 Iowa Acts, Senate File 2389 (signed by Governor Reynolds on April 26, 2018), to set and publish camping, rental facility, vessel storage, and other special privilege fees on the Department’s website. Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 16, 2019, as ARC 4225C. Six public hearings were held on February 7, 2019, from 12 noon to 2:00 p.m. at the following locations:Wallace State Office Building Conference Room 4E/4W Des Moines, IowaClear Lake State Park Office 2730 South Lakeview Drive Clear Lake, IowaLake Darling State Park Lodge 111 Lake Darling Road Brighton, IowaDelaware County Conservation Board Conference Room 2379 Jefferson Road Manchester, IowaCold Springs District Office Conference Room 57744 Lewis Road Lewis, IowaVisitor Center Banquet Room Lewis and Clark State Park 21914 Park Loop Onawa, Iowa    Three people attended the public hearings. A total of eight comments were received from the public, all in general support of the rule making. To clarify that the methodology for fees is set forth in 561—Chapter 16, the word “in” was changed to “pursuant to” in paragraph 61.4(4)“b.” No other changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Commission on March 14, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. A copy of the impact statement is available from the Department upon request. Jobs Impact    After analysis and review of this rule making, the Commission does not anticipate any impact to private sector jobs or employment in the state from this rule making. In fact, the public’s use of state parks and recreation areas provides important economic support to nearby cities and towns, with guests supporting local businesses and camping and rental fees resulting in sales tax revenue. This is expected to continue, and possibly at times even increase, due to the dynamic pricing strategies that will be made possible by this rule making and its companion rule making to adopt 561—Chapter 16. A copy of the impact statement is available from the Department upon request.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to 571—Chapter 11.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Rescind the definition of “Reservation transaction fees” in rule 571—61.2(461A).

        ITEM 2.    Rescind subrule 61.3(3) and adopt the following new subrule in lieu thereof:    61.3(3) Reservation transaction fees.  Fees to process a reservation, change a reservation or cancel a reservation shall be set contractually with the reservation system vendor and published on the department’s website with the camping, rental facility and other special privilege fees set by the department pursuant to 561—Chapter 16.

        ITEM 3.    Rescind subrule 61.4(1) and adopt the following new subrule in lieu thereof:    61.4(1) Fees.  Camping fees shall be set by the department pursuant to 561—Chapter 16.

        ITEM 4.    Rescind and reserve subrule 61.4(2).

        ITEM 5.    Amend paragraph 61.4(4)"b" as follows:    b.    Chaperoned, organized youth groups may choose to occupy campsites not designated as organized youth group campsites. However, the group is subject to all fees and rules in 61.4(1), 61.4(3) and 61.4(5) pertaining to the campsite the group wishes to occupy, as well as all fees as set by the department pursuant to 561—Chapter 16.

        ITEM 6.    Amend rule 571—61.5(461A), introductory paragraph, as follows:

    571—61.5(461A) Rental facilities.  The following are maximum fees for facility use in state parks and recreation areas. The fees may be reduced or waived by the director for special events or special promotional efforts sponsored by the department. Special events or promotional efforts shall be conducted so as to give all park facility users equal opportunity to take advantage of reduced or waived fees. Reductions or waivers shall be on a statewide basis covering like facilities. In the case of promotional events, prizes shall be awarded by random drawing of registrations made available to all park visitors during the event.

        ITEM 7.    Rescind subrule 61.5(1) and adopt the following new subrule in lieu thereof:    61.5(1) Rental facility fees.  Rental facility fees shall be set by the department pursuant to 561—Chapter 16.

        ITEM 8.    Rescind and reserve subrule 61.5(2).

        ITEM 9.    Rescind rule 571—61.6(461A) and adopt the following new rule in lieu thereof:

    571—61.6(461A) Vessel storage fees.  Vessel storage fees shall be set by the department pursuant to 561—Chapter 16.       This rule is intended to implement Iowa Code section 455A.14.

        ITEM 10.    Amend paragraph 61.22(1)"b" as follows:    b.    The fees for camping in established state forest campgrounds shall be the same as those cited in paragraphs 61.4(1)“a” and “b” for all other nonmodern camping areas managed by the department where fees are chargedset by the department pursuant to 561—Chapter 16.    [Filed 3/15/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4395CNatural Resources Department[561]Adopted and Filed

    Rule making related to state park and recreation area fees

        The Natural Resources Department hereby adopts Chapter 16, “State Park and Recreation Area Fees,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 455A.14.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 455A.14.Purpose and Summary    Iowa Code section 455A.14 explicitly directs the Department to promulgate in rule a methodology for establishing base fees for park and recreation area camping, rental facilities, vessel storage, and other special privileges. This rule making establishes this methodology. The methodology reflects the parameters of rate setting contained in the statute, namely to ensure fees are competitive with those charged at other parks and recreation areas within a 60-mile radius for the same or similar privileges and to strategically adjust these fees in response to, or so as to stimulate, user demand. This rule making does not directly establish any fees but rather outlines the criteria that will determine what those fees will be. Once set, those fees shall be published on the Department’s website.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 16, 2019, as ARC 4226C. Six public hearings were held on February 7, 2019, from 12 noon to 2:00 p.m. at the following locations:Delaware County Conservation Board Conference Room 2379 Jefferson Road Manchester, IowaCold Springs District Office Conference Room 57744 Lewis Road Lewis, IowaClear Lake State Park Office 2730 South Lakeview Drive Clear Lake, IowaLake Darling State Park Lodge 111 Lake Darling Road Brighton, IowaVisitor Center Banquet Room Lewis and Clark State Park 21914 Park Loop Onawa, IowaWallace State Office Building Conference Room 4E/4W Des Moines, Iowa    Three people attended the public hearings. A total of eight comments were received from the public, all in general support of the rule making. To clarify that the methodology for fees is set forth in Chapter 16, the word “by” was changed to “pursuant to” in rule 561—16.3(455A). No other changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Department on March 14, 2019.Fiscal Impact    The fiscal impact of this rule making would be a possible increase in revenue for the state’s conservation fund, which is required by law to support Iowa’s state parks system among other public lands and waters. See Iowa Code section 456A.17. This rule making does not directly establish what camping, rental facility, vessel storage, and other special privilege base fees will be. Instead, it defines the methodology used by the Director to set those fees; nonetheless, the ultimate impact of this rule making is state park and recreation area fees. Accordingly, the Department associates all speculated revenues with this rule making.    Importantly, these revenues are necessarily speculative due to the data collection required by 2018 Iowa Acts, Senate File 2389, that is still ongoing. Senate File 2389 requires the Department to survey a 60-mile radius around each state park and recreation area and catalog prices assessed at other public areas within each radius. The information gained from the survey is to guide the Department in establishing base fees to ensure rates remain competitive. A final assessment is not expected until sometime next year. As such, the Department does not anticipate many fee changes in 2019. That said, the surveying completed so far reveals a wide variety of prices, some much higher and some less than those currently charged at certain parks and recreation areas, so a few fee modifications are likely. The Department does not anticipate that the possible modifications will result in significantly higher fee amounts.    One possible example of a modification to fees for 2019 would be extending peak season pricing for fall destination parks. The peak season for camping is typically May 1 through September 30. During this period, the camping rates are at the highest amount of the year. The winter season rates typically begin October 1 and run through April 30. The Department anticipates that it will drop its winter season camping rate by $5/night for all campsite types (electric, nonelectric, full hook-up) in a modern campground and by $3/night for all campsite types (electric, nonelectric, full hook-up) in a nonmodern campground. However, several state parks and recreation areas around the state are popular camping destinations during the fall, including the month of October, while shower and restroom facilities are still open and water is available. Water is turned off and facilities shut down sometime in mid-October due to the potential of freezing temperatures. The Department is reviewing the occupancy rates of campgrounds in the month of October to determine which campgrounds could justifiably maintain the peak season rates. For example, Pikes Peak State Park is situated on the bluffs overlooking the Mississippi and Wisconsin Rivers. It is a destination area for fall foliage visits. In 2017, the campground’s overall occupancy for electric campsites was 56 percent (62 percent on weekends) and 27.57 percent for nonelectric sites (52 percent on weekends). If the peak season for this park was extended to include October 1 to 31, an additional $5,100 in new revenue could be generated for the conservation fund.    The Department is considering a strategic reduction in camping fees during pre- and post-peak season times to increase use and occupancy. Under the current rules, peak season pricing begins on May 1, but campground use really picks up around Memorial Day. Likewise, peak season pricing stays in effect until September 30, but camping starts to taper off after Labor Day, except in the fall destination parks noted above. To drive use and occupancy during these less popular times, the Department may strategically reduce rates through the use of short-term discount promotions or create a lower pre- and post-season rate. Estimations on revenue generation are necessarily speculative, but even a $10/night price (for example) for an otherwise unoccupied campsite is positive revenue to the conservation fund.    Finally, the Department may strategically increase peak season rental fees at several high-demand and unique facilities around the state, with Gull Point State Lodge being one example. This large stone and timber day-use lodge was built by the Civilian Conservation Corps. It sits on the shore of West Okoboji, has seating for 200 guests and a patio that seats an additional 30, and has a full kitchen, a modern restroom, and two fireplaces. It is a high-demand venue for weddings, reunions, and other group activities. It currently rents for $200/day on Fridays, Saturdays, and major holidays, and $100/day on weekdays. There are no similarly situated or sized public comparables in a 60-mile radius, and notably, the comparable private facilities rent for several hundred to several thousand dollars a day. Therefore, the Department is likely to increase its rate, and even doubling the rate would still result in an extraordinarily low and affordable fee for the venue’s size, location, and amenities and would generate several thousand dollars for the conservation fund.    However, consistent with the criteria in this rule making, the Director would be able to strategically decrease or increase all fees depending on the listed factors. The scenarios above are just examples of speculated future revenues based on the dynamic pricing made possible by 2018 Iowa Acts, Senate File 2389, and this rule making, and no final fee decisions for 2019 have been made. A copy of the impact statement is available from the Department upon request. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found. If anything, the public’s use of state parks and recreation areas provides important economic support to nearby cities and towns, with guests supporting local businesses and camping and rental fees resulting in sales tax revenue. This is expected to continue, and possibly at times even increase, due to the dynamic pricing strategies that will be made possible by this rule making. A copy of the impact statement is available from the Department upon request.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to 561—Chapter 10.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making action is adopted:

        ITEM 1.    Adopt the following new 561—Chapter 16: CHAPTER 16STATE PARK AND RECREATION AREA FEES

    561—16.1(455A) Definitions.          "Commission" means the natural resource commission.        "Department" means the department of natural resources.        "Director" means the director of the department of natural resources.

    561—16.2(455A) Camping, rental facilities, vessel storage, and other special privileges—fees.      16.2(1) Fee methodology.  The director or the director’s designee shall fix and publish on the department’s website base fees for camping, the use of rental facilities, vessel storage and other special privileges at state parks and recreation areas under the jurisdiction of the department and the commission. The director or the director’s designee may increase, reduce, or waive the base fees on a case-by-case basis in order to take advantage of marketing opportunities so as to encourage maximum use of state facilities. The director or the director’s designee may consider the following factors when establishing and when adjusting base fees:    a.    The specific park’s or recreation area’s amenities.    b.    The size and features of a particular campsite or rental facility.    c.    Use of campsites, rental facilities, or other special privileges.    d.    Day of the week, season of the year, holidays, or other noteworthy occasions or special events.    e.    Cost of operations.    f.    Other considerations that the director or the director’s designee deems appropriate.    16.2(2) Fees honored.  The fee to be charged shall be the fee currently in effect at the time the reservation is made and paid for. Any change to a reservation shall be subject to the fees applicable to the campsite or rental facility, along with any applicable reservation change fee, at the time the reservation is modified.

    561—16.3(455A) Areas under management—varying fees.  Fees charged for like services in state-owned areas under management by political subdivisions may vary from those established pursuant to this chapter.       These rules are intended to implement Iowa Code section 455A.14.        [Filed 3/15/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4397CPharmacy Board[657]Adopted and Filed

    Rule making related to prescription monitoring program

        The Board of Pharmacy hereby rescinds Chapter 37, “Iowa Prescription Monitoring Program,” Iowa Administrative Code, and adopts a new Chapter 37 with the same title.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 124.554.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code sections 124.550 to 124.558.Purpose and Summary    During the 2018 Legislative Session, changes were made to the Iowa Code which affect the Iowa Prescription Monitoring Program (PMP), including a requirement that prescribing practitioners register with the PMP simultaneous to Iowa uniform controlled substances Act (CSA) registration, authorization for the Board to assess up to a 25 percent surcharge on CSA registrations to be deposited into the PMP fund, a requirement that dispensing of controlled substances by prescribers be reported to the PMP, and a requirement that administration of an opioid antagonist by a first responder be reported to the PMP.    The Board and the PMP Advisory Council also took the opportunity to conduct an overall review of the chapter as required by Iowa Code section 17A.7(2) and made changes as reflected in the new chapter to provide clarity where needed and to reorganize and simplify where appropriate.    To further the goal of program utilization, the Board and the PMP Advisory Council require that pharmacists who are involved in direct patient care register with the PMP simultaneous to licensure or renewal. Also, the specific number of authorized delegates has been removed from the rules to allow practitioners the ability to designate delegates according to practitioners’ individual practice settings.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 2, 2019, as ARC 4205C.     The Board received comments from the Iowa Pharmacy Association and UnityPoint Health. The Association was supportive of the proposed rule making and had no suggested changes. UnityPoint expressed concern about the reporting requirements by hospital pharmacies as the requirements relate to reporting the dispensing of controlled substances at discharge or from the emergency department, citing increased costs and administrative burdens. The health care system’s comments included a request for the Board to retain the exemptions which exist in the current rules relating to dispensing of discharge medications from the emergency department for the patient’s home use. The Board’s reasoning for removing these exemptions, and thus requiring the reporting of such dispensing, was based on the legislative intent of the program to capture and identify to the extent reasonable and functional all controlled substances that are dispensed to a patient to be used in the patient’s personal setting. The health care system’s comment also included a request to add a definition of “outpatient procedure” and to update the definition of “reportable prescription” to avoid confusion or conflicting interpretations. The Board determined that adding definitions for “administer” and “dispense” will sufficiently resolve confusion about the reporting requirements and exemptions. The health care system’s comment further requested additional time to implement systems and workflow to comply with the new reporting requirements. The Board declined this request as the dispensing of medications, including controlled substances, at the time of a patient’s discharge from the hospital or pursuant to an evaluation in the emergency department is not mandated. The health care system can issue prescriptions to a patient to be filled at the pharmacy of the patient’s choice, and these prescriptions can be dispensed and will be reported accordingly to the PMP if the hospital system does not have the capability to report to the PMP as required.    As identified above, one change made to the rule making since publication of the Notice includes the addition of definitions for “administer” and “dispense.” Definitions of “health care facility” and “opioid antagonist” were also added for clarification. To provide further opportunities for a practitioner to report the administration of a controlled substance when determined appropriate by the practitioner, the language “emergency department” has been removed from paragraph “2” of the definition of “reportable prescription.” In subrule 37.16(1), the term “report card” has been changed to “activity report” to better align with the Iowa Code. In subrule 37.3(1), language was added to clarify that practitioners must also have U.S. Drug Enforcement Administration (DEA) registration when registering for the PMP. In subrule 37.16(5), the reference to access to PMP records for law enforcement officials, when requested pursuant to a subpoena as part of an investigation, was clarified to include a practitioner’s prescribing or dispensing records. Other nonsubstantive changes were made for clarification.    Pursuant to Iowa Code sections 124.554 and 124.556 as amended by 2018 Iowa Acts, House File 2377, sections 13 through 16, rule 657—37.19(124) has been added to the rule making to identify procedures relating to the issuance of prescriber activity reports.    Pursuant to Iowa Code sections 124.553 and 124.554 as amended by 2018 Iowa Acts, House File 2377, sections 17 through 20, rule 657—37.20(124) has been added to the rule making to identify procedures relating to the issuance of proactive notifications, and rule 657—37.21(124) has been revised to add information distributed to prescribing practitioners and dispensing pharmacists in proactive notifications to the list of information and records retained by the PMP.Adoption of Rule Making    This rule making was adopted by the Board on March 12, 2019.Fiscal Impact     The Board is in the process of seeking a format by which first responders can submit data relating to the administration of an opioid antagonist. As stated in the Fiscal Note on 2018 Iowa Acts, House File 2377, this change is anticipated to cost upwards of $75,000. With respect to the surcharge, the Board is not anticipating implementation of the surcharge at this time. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 657—Chapter 34.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making action is adopted:

        ITEM 1.    Rescind 657—Chapter 37 and adopt the following new chapter in lieu thereof: CHAPTER 37IOWA PRESCRIPTION MONITORING PROGRAM

    657—37.1(124) Purpose and scope.  These rules establish a prescription monitoring program (PMP) that compiles a central database of reportable prescriptions dispensed to patients in Iowa. An authorized health care practitioner shall access PMP information when mandated by the practitioner’s licensing authority regarding the practitioner’s patient to assist in determining appropriate treatment options and to improve the quality of patient care. The PMP is intended to provide a practitioner with a resource for information regarding a patient’s use of controlled substances and to serve as a tool to assess a prescriber’s prescribing practices. This database will assist the practitioner in identifying any potential diversion, misuse, or abuse of controlled substances without impeding the appropriate medical use of controlled substances.

    657—37.2(124) Definitions.  For the purposes of this chapter, the following definitions shall apply.        "Administer" means to provide or apply a controlled substance to a patient for immediate use within the prescribing practitioner’s practice location. Administration does not include dispensing.        "Board" means the Iowa board of pharmacy.        "Controlled substance" means a drug in Schedules II through IV set forth in Iowa Code chapter 124, division II.        "Council" means the PMP advisory council established pursuant to Iowa Code section 124.555 to provide oversight and to co-manage PMP activities with the board.        "CSA registration" means registration with the board under the Iowa uniform controlled substances Act pursuant to 657—Chapter 10.        "DEA number" means the registration number issued to an individual or pharmacy by the U.S. Department of Justice, Drug Enforcement Administration (DEA), authorizing the individual or pharmacy to engage in the prescribing, dispensing, distributing, or procuring of a controlled substance.        "Dispense" means to provide a controlled substance to a patient for self-use outside of the prescribing practitioner’s practice location. Dispensing does not include administration.        "Dispenser" means a pharmacy or prescriber, regardless of location, who delivers to the ultimate user a substance required to be reported to the PMP. “Dispenser” does not include a person exempt from reporting pursuant to subrule 37.7(2).        "First responder" means an emergency medical care provider, a registered nurse staffing an authorized service program under Iowa Code section 147A.12, a physician assistant staffing an authorized service program under Iowa Code section 147A.13, a firefighter, or a peace officer as defined in Iowa Code section 801.4, who is trained and authorized to administer an opioid antagonist.        "Health care facility" means a residential care facility, a nursing facility, an intermediate care facility for persons with mental illness, or an intermediate care facility for persons with an intellectual disability.        "Health care professional" means a person who, by education, training, certification, or licensure, is qualified to provide and is engaged in providing health care to patients. “Health care professional” does not include clerical or administrative staff. A health care professional shall be licensed, registered, certified, or otherwise credentialed in a manner that permits verification of the health care professional’s credentials.         "Health care system" means an organization that includes at least one hospital or at least one group of practitioners that provides comprehensive care that are connected with each other through common ownership or management.        "HIPAA" means the Health Insurance Portability and Accountability Act.        "Law enforcement" means an entity or agency with jurisdiction to investigate or prosecute violations of criminal law. “Law enforcement” includes, but is not limited to, such agencies as police departments, United States attorneys, the DEA, county attorneys, and the Medicaid fraud control unit.        "Licensing authority" means an agency that licenses or registers health care professionals and has jurisdiction to enforce governing laws over those individuals who are licensed or registered. “Licensing authority” includes, but is not limited to, professional licensing boards and the DEA.        "NarxCare" means an analytics tool and care management platform that helps practitioners analyze real-time data from the PMP. The platform analyzes patient data and history to provide a patient risk score and usage patterns to help practitioners identify potential risk factors.        "NDC number" means the universal product identifier used in the United States to identify a specific human drug.        "Opioid antagonist" means a drug that binds to opioid receptors and blocks or inhibits the effects of opioids acting on those receptors, including but not limited to naloxone hydrochloride or any other similarly acting drug approved by the United States Food and Drug Administration.         "PMP administrator" means staff persons designated to manage and administer the PMP under the direction and oversight of the board and the council.        "Practitioner" means a prescriber or a pharmacist.        "Practitioner’s delegate" means a health care professional who is under the supervision of a PMP-registered practitioner and who is authorized by the practitioner to access PMP information on the practitioner’s behalf.        "Prescriber" means an individual with an active CSA registration who has the authority to prescribe controlled substances. For the purposes of this chapter, “prescriber” does not include a licensed veterinarian.        "Prescription monitoring program" "PMP" means the program established pursuant to these rules for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.        "Reportable prescription" means the record of a controlled substance administered or dispensed by a practitioner and the record of an opioid antagonist dispensed by a practitioner or administered by a first responder. “Reportable prescription” shall not include records identified in subrule 37.7(1). “Reportable prescription” shall include, but not be limited to:
    1. The dispensing of a controlled substance to an emergency department patient;
    2. The administration of a controlled substance to a patient at the discretion of the treating practitioner;
    3. The administration or dispensing of an opioid antagonist to an emergency department patient;
    4. The dispensing of a controlled substance sample; and
    5. The dispensing of a controlled substance or opioid antagonist to a patient upon discharge from a hospital or care facility.

    657—37.3(124) Registration.  Registration for the PMP pursuant to this rule shall be via the Iowa PMP AWARxE website at iowa.pmpaware.net.     37.3(1) Prescribers.   A prescriber shall register for the PMP at the same time the prescriber registers or renews a CSA registration pursuant to 657—Chapter 10. A licensed veterinarian with an active CSA registration may register for the PMP. Registration for the PMP shall also require the prescriber’s DEA number.    37.3(2) Pharmacists.  A pharmacist who is involved in patient care shall register for the PMP at the same time the pharmacist becomes licensed or renews a license pursuant to 657—Chapter 2.    37.3(3) Practitioner’s delegates.  A practitioner may authorize an adequate number of health care professionals who actively work with the practitioner to act as the practitioner’s delegates for the purpose of requesting PMP information. A practitioner’s delegate shall be licensed, registered, certified, or otherwise credentialed as a health care professional in a manner that permits verification of the health care professional’s credentials. The practitioner shall be responsible for the PMP information access of the practitioner’s delegates.    37.3(4) Law enforcement officials.  A law enforcement official may register for the PMP to access information by order, subpoena, or other means of legal compulsion relating to a specific investigation and supported by a determination of probable cause.    37.3(5) Licensing authority.  A licensing authority official may register for the PMP to access information by order, subpoena, or other means of legal compulsion relating to a specific investigation and supported by a determination of probable cause.    37.3(6) Medical examiners and medical examiner investigators.  A medical examiner or a medical examiner investigator may register for the PMP to access information when the information relates to an investigation being conducted by the examiner or investigator.

    657—37.4()   Reserved.

    657—37.5()   Reserved.

    657—37.6(124) Security of PMP credentials.  Each user registered to access PMP information shall securely maintain and use the login and password and any other secure access credentials assigned to the individual user. Except in an emergency when a patient would be placed in greater jeopardy by restricting PMP information access to the user, a registered user shall not share the user’s secure access credentials.

    657—37.7(124) PMP reporting—exemptions.      37.7(1) Exempted dispensing or administration.  The dispensing or administration of a controlled substance as described in this subrule shall not be considered a reportable prescription. A pharmacy engaged in the distribution of controlled substances solely pursuant to one or more of the practices identified in this subrule shall notify the PMP administrator of the exempted practice, and the pharmacy shall not be required to report to the PMP.    a.    The dispensing by a licensed hospital pharmacy for the purposes of inpatient hospital care.    b.    The dispensing by a licensed pharmacy for a patient residing in a health care facility or inpatient hospice facility.    c.    The administration by a prescriber of a controlled substance for the purposes of outpatient procedures and treatment.    37.7(2) Exempted practitioners.  The following entities or individuals shall not be required to report to the PMP and shall not be required to notify the PMP administrator of their exempted status:    a.    A licensed pharmacy that does not have a CSA registration and does not dispense controlled substances in or into Iowa.    b.    A licensed veterinarian who administers or dispenses a controlled substance in the normal course of the veterinarian’s professional practice.    c.    A DEA-registered narcotic treatment program which is subject to the record-keeping provisions of 21 CFR Section 1304.24.

    657—37.8(124) PMP reporting—dispensing prescribers.  Each dispensing prescriber, unless exempt pursuant to rule 657—37.7(124), shall submit to the PMP a record of each reportable prescription dispensed during a reporting period pursuant to subrule 37.12(2). For purposes of prescriber dispensing, the prescriber shall also be identified as the dispenser or pharmacy.

    657—37.9(124) PMP reporting—pharmacies.  Each pharmacy, unless exempt pursuant to rule 657—37.7(124), shall submit to the PMP either a record of each reportable prescription dispensed or administered during a reporting period pursuant to subrule 37.12(2) or a zero report pursuant to subrule 37.12(4), as appropriate.

    657—37.10()   Reserved.

    657—37.11()   Reserved.

    657—37.12(124) Reporting requirements.      37.12(1) Data elements.  The information submitted to the PMP for each reportable prescription shall be accurate and shall include, at a minimum, the following data elements:    a.    Dispenser DEA number.    b.    Date the prescription is dispensed or administered.    c.    Prescription number or unique identification number.    d.    NDC number of the drug dispensed or administered.    e.    Quantity of the drug dispensed or administered.    f.    Number of days of drug therapy provided by the drug dispensed or administered.    g.    Patient legal first and last names.    h.    Patient address including street address, city, state, and ZIP code.    i.    Patient phone number.    j.    Patient date of birth.    k.    Patient gender.    l.    Prescriber name and DEA number.    m.    Date the prescription was issued by the prescriber.    n.    Method of payment.    o.    Form of transmission of prescription origin.    p.    Refill number.    q.    Number of refills authorized.    r.    Indication as to whether the prescription is new or a refill.    37.12(2) Reporting periods.  A record of each reportable administration or prescription dispensed shall be submitted by each dispenser no later than the next business day following administration or dispensing.    37.12(3) Transmission.  Prescription dispensing and administration information shall be transmitted via the PMP’s current version of data upload or electronic submission.    37.12(4) Zero reports.  If a pharmacy did not dispense or administer any reportable prescriptions during a reporting period, the dispenser shall submit a zero report no later than the next business day.

    657—37.13(124) Opioid antagonist administration by first responders.       37.13(1)   The administration of an opioid antagonist by a first responder shall be reported to the PMP, unless such administration was reported to the Iowa department of public health bureau of emergency and trauma services.     37.13(2)   The reporting of the administration of an opioid antagonist by a first responder shall include the following data elements:    a.    Patient first and last names.    b.    First and last names of the individual who administered the opioid antagonist.    c.    Date of administration.    d.    Quantity of the opioid antagonist administered.

    657—37.14()   Reserved.

    657—37.15()   Reserved.

    657—37.16(124) Access to PMP information.  All information contained in the PMP is confidential and shall only be accessed as provided in this rule. All requests for PMP information must comply with the format specified by the board for the particular type of request. Once information is accessed, further dissemination or use of that information is governed by applicable federal and state laws governing the person who accessed the information. The board may charge a fee to recover the actual costs associated with responding to any request by a person other than a practitioner or a practitioner’s delegate. Any fees or costs assessed by the board shall be considered repayment receipts as defined in Iowa Code section 8.2.    37.16(1) Prescribers.  A prescriber may access a patient’s prescription history report; the prescriber’s activity report; proactive alerts or system user notes, such as peer-to-peer communication; and NarxCare reports.    37.16(2) Pharmacists.  A pharmacist may access a patient’s prescription history report; proactive alerts or system user notes, such as peer-to-peer communication; and NarxCare reports.    37.16(3) Practitioner’s delegates.  A practitioner’s delegate may access a patient’s prescription history report; proactive alerts or system user notes, such as peer-to-peer communication; and NarxCare reports.     37.16(4) Licensing authority officials.       a.    A licensing authority with jurisdiction over a practitioner may obtain the following information, if the request is accompanied by a subpoena compelling disclosure of such information for a specific investigation into the prescribing or dispensing practices of the licensee: prescription history reports; proactive alerts or system user notes, such as peer-to-peer communication; PMP access logs and login records; and NarxCare reports.     b.    A licensing authority with jurisdiction over a health care professional may obtain the following information, if the request is accompanied by a subpoena compelling disclosure of such information for a specific investigation into the licensee’s misuse of controlled substances: the licensee’s prescription history report.    37.16(5) Law enforcement officials.  A law enforcement official may obtain a patient’s prescription history report and the prescribing or dispensing practices of a prescriber if the request is accompanied by a subpoena or other means of legal compulsion compelling disclosure of such information for use in a specific investigation.    37.16(6) Medical examiners and medical examiner investigators.  A medical examiner or medical examiner investigator may obtain a decedent’s prescription history report for use in a specific investigation.    37.16(7) Patients.  A patient or the patient’s agent may request the patient’s own prescription history report by using the board’s patient request form. The request can be personally delivered to the board office where the patient will be required to present current government-issued photo identification at the time of the delivery of the request. A patient who is unable to personally deliver the request to the board office may submit a notarized request, along with a certified copy of the patient’s government-issued photo identification, via mail or commercial delivery service. The following agents may submit a request on behalf of a patient: an individual with a medical power of attorney for the patient, a patient’s attorney, or an executor of the patient’s estate. In addition to the patient’s information, the patient’s agent shall be identified by name, current address, and telephone number. In lieu of the patient’s signature and identification, the patient’s agent shall sign the request and the government-issued photo identification shall identify the patient’s agent. The patient’s agent shall include a copy of the legal document that establishes the agency relationship with the patient.

    657—37.17(124) Integrated systems.  A practitioner or a health care system may integrate its electronic health record system or a pharmacy may integrate its automated data processing system with the PMP using an application programming interface. Use of an integrated system shall comply with all of the following:    37.17(1)   The integrated system shall log each user’s access to PMP information. Access logs shall be retained by the practitioner, health care system, or pharmacy for a minimum of four years from the date of access and shall be provided to the board upon request.    37.17(2)   If the user identified in access logs is not the practitioner, the integrated system shall clearly identify on which practitioner’s behalf the user was accessing PMP information. A practitioner’s delegate using an integrated system is required to maintain active PMP registration.    37.17(3)   The integrated system shall maintain appropriate administrative, technical, and physical security measures to safeguard against unauthorized access, disclosure, or theft of PMP information and shall meet all HIPAA requirements for safeguarding protected health information.    37.17(4)   The practitioner, health care system, or pharmacy shall notify the PMP administrator of any breach in the electronic health record system that may have included PMP information within 72 hours of making the determination that a breach occurred.    37.17(5)   An integrated system shall comply with all requirements in subchapter VI of Iowa Code chapter 124 and all requirements of this chapter.

    657—37.18(124) PMP administrator access.      37.18(1) PMP staff.  The board may designate PMP administrators who may access any PMP information needed to perform the functions of the job.    37.18(2) Statistical data.  The PMP administrator or designee may provide summary, statistical, or aggregate data to public or private entities for statistical, public research, public policy, or educational purposes. The board may charge a fee to recover the actual costs associated with responding to a request for PMP data pursuant to this subrule. Any fees or costs assessed by the board shall be considered repayment receipts as defined in Iowa Code section 8.2.

    657—37.19(124) Prescriber activity reports.  The PMP administrator shall, at least annually, electronically issue to each prescriber who prescribed a controlled substance that was reported to the program as dispensed in or into this state during the preceding reporting period an activity report which shall include, at a minimum, the following:
    1. A summary of the prescriber’s history of prescribing controlled substances,
    2. A comparison of the prescriber’s history of prescribing controlled substances with the history of other prescribers of the same profession or specialty,
    3. The prescriber’s history of program use,
    4. General patient risk factors, and
    5. Educational updates.

    657—37.20(124) Proactive notifications.   The PMP administrator shall provide notification to a practitioner when a patient may be practitioner shopping or at risk of abusing or misusing a controlled substance based on criteria and thresholds determined by the board and the advisory council. A proactive notification pursuant to this rule will be initiated when a patient obtains prescriptions for controlled substances from a minimum number of prescribing practitioners and from a minimum number of pharmacies within a maximum number of days which exceed the thresholds established by the board and advisory council. The notification will suggest review of the patient’s prescription history.

    657—37.21(124) Record retention.  The PMP shall retain all reported prescriptions, all records of access to or query of PMP information, and all information distributed to practitioners in proactive notifications for a minimum of four years from the date of the record.

    657—37.22(124) Information errors.  Any person who believes that PMP information is erroneous shall notify the pharmacy or dispensing practitioner. Upon notification of a potential error in PMP information, the pharmacy or dispensing practitioner shall promptly correct erroneous information in the record.

    657—37.23(124) Discipline.  Any licensee who fails to comply with the provisions of the law or these rules is subject to disciplinary action by the board and may be subject to criminal prosecution.       These rules are intended to implement Iowa Code sections 124.550 to 124.558.        [Filed 3/20/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4398CPublic Health Department[641]Adopted and Filed

    Rule making related to vital records

        The Public Health Department hereby amends Chapter 95, “Vital Records: General Administration,” Chapter 96, “Birth Registration,” Chapter 98, “Marriage Registration,” and Chapter 99, “Vital Records Modifications,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 144.3.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code chapter 144.Purpose and Summary    These amendments will affect persons who are seeking to establish a vital record event or amend a vital record on file. Outlining in rule the process to amend or establish vital records will also assist a judge when issuing an order in a court of competent jurisdiction. Also, midwives or other persons who provide guidance and support to a pregnant woman during labor and delivery will be required to report the home birth event. The amendments will better allow the Department to support the public and protect the integrity of vital records. The following paragraphs describe the amendments in more detail:    The amendments to Chapter 95 will ensure that vital record fees are being assessed per record issued and not per search performed. In addition, language is added to protect the registrant of vital records to ensure that entitlement to a certified copy of any vital record is for the benefit of the person listed on the vital record. Entitlement to a certified copy of a vital record by legal representatives must be on behalf of an entitled family member and also for the benefit of the person on the record.    The amendment to Chapter 96 adds the requirement that a midwife or any person providing assistance with the birth must report a home birth.    The amendment to Chapter 98 outlines the process to establish a delayed marriage record through the court system.    The amendments to Chapter 99 outline the process to amend a certificate of vital record through the court system and to allow for a person to amend a vital record using an established vital record on file.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on November 21, 2018, as ARC 4127C. No public comments were received.    Based on comments from the State Board of Health and members of the Administrative Rules Review Committee, small changes from the Notice were made for clarification.    The first change in rule 641—95.3(144) changes a sentence from “Forms used for the purpose of creating a vital record event shall not be accessible to the general public” to “Official designated forms used for the express purpose of creating a vital record event shall not be accessible to the general public unless authorized by rule.”    The second change strikes the wording “the search and” from paragraph 95.6(1)“b.” This was an oversight of wording that should have been stricken in the Notice.    The third change clarifies the requirement of persons to report a non-institution Iowa live birth. A definition of “doula” that was proposed in Item 1 of the Notice was not adopted, so Item 1 has been removed. The remaining Items have been renumbered.    The last changes clarify the reporting requirement by removing the word “doula” and replacing it with “any person providing assistance with the birth” in paragraph 96.7(1)“b” and by removing the word “doula” and adding the words “who is” for the same type of clarification in subrule 96.7(4).Adoption of Rule Making    This rule making was adopted by the State Board of Health on March 13, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to the Department’s variance and waiver provisions contained in 641—Chapter 178. Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Amend rule 641—95.3(144), introductory paragraph, as follows:

    641—95.3(144) Forms—property of department.  All forms, certificates and reports pertaining to the registration of vital events are the property of the department and shall be surrendered to the state registrar upon demand.Official designated forms used for the express purpose of creating a vital record event shall not be accessible to the general public unless authorized by rule.

        ITEM 2.    Amend subrules 95.6(1) and 95.6(2) as follows:    95 95.6 6(1) Fees for services provided by state registrar or county registrar.  The following fees shall be charged and remitted for the various services provided by the state registrar or the county registrar.    a.    The state registrar or county registrar, as applicable, shall charge a fee of $20 to conduct a search for a record. On and after July 1, 2019, this fee will revert to $15for a certified copy of a vital record.    (1)   The search fee shall include one certified copy of the record.    (2)   For each additional certified copy of the same record, a $20 fee shall be charged. On and after July 1, 2019, this fee will revert to $15.(3)   If, following a search, no record is found and no certified copy is printed, the $20 fee may be retained. On and after July 1, 2019, this fee will revert to $15.    b.    The state registrar shall charge a fee of $20 to prepare an adoption certificate, to amend a certificate, to amend a certificate of live birth to reflect a legal change of name, to prepare a delayed certificate, to process other administrative or legal actions, or for the search and preparation of copies of supporting documents on file in the state registrar’s office. On and after July 1, 2019, this fee will revert to $15. No fee shall be charged for establishment of paternity.    c.    The state registrar shall charge a fee of $25 to file a completed application for the mutual consent voluntary adoption registry.    d.    The state registrar shall charge a fee of $5 to update applicant information maintained in the mutual consent voluntary adoption registry and the declaration of paternity registry.    e.    The state registrar shall charge a fee of $20 to amend an abstract or other legal documentation in support of the preparation of a new certificate. On and after July 1, 2019, this fee will revert to $15.    f.    The state registrar shall charge a fee of $35 to conduct a search for a record for the purpose of issuingissue a commemorative copy of a certificate of birth or a certificate of marriage pursuant to Iowa Code section 144.45A. Fees collected shall be deposited in the emergency medical services fund established in Iowa Code section 135.25.    g.    The state registrar shall charge a fee of $20 to conduct a search for a certificate of fetal death for the purpose of issuing an uncertified copy of a certificate of birth resulting in stillbirth pursuant to Iowa Code section 144.31A. On and after July 1, 2019, this fee will revert to $15.    95 95.6 6(2) Overpayments.  Any overpayment of $5 or less received by the state registrar for the copying of or search for vital records or for the preparation or amending of a certificate shall not be refunded and shall be retained by the department.

        ITEM 3.    Amend paragraph 95.8(1)"d" as follows:    d.    Other persons who demonstrate a direct tangible interest and entitlement when it is shown that the certified copy is needed to determine or protect a personal or property interestand the interest is for the benefit of the registrant.

        ITEM 4.    Amend paragraph 95.8(2)"d" as follows:    d.    Commercial firms or agencies requesting lists of vital record events, or lists of names, or lists of addresses, or that are not legal representatives requesting records on behalf of entitled individuals.

        ITEM 5.    Amend rule 641—96.7(144) as follows:

    641—96.7(144) Non-institution birth.      96.7(1)   In case of a non-institution Iowa live birth, the official non-institution birth worksheet shall be completed and filed with the state registrar by one of the following in the indicated order of priority:    a.    The physician in attendance at or immediately after the live birth.    b.    Any other person, including a certified nurse midwife or any person providing assistance with the birth, in attendance at or immediately after the live birth.    c.    The mother or her legal spouse.    d.    The person in charge of the premises where the live birth occurred.    96.7(2)   Evidence in support of the facts of live birth shall be included in a cover letter, which shall contain the notarized signature of the person responsible for registering the birth. A certificate of live birth shall be completed and filed upon presentation of the following clear and convincing evidence by the individual responsible for filing the certificate:    a.    Evidence of pregnancy including:    (1)   Prenatal record;    (2)   A statement from a physician, certified nurse midwife, or other health care provider qualified to determine pregnancy;    (3)   A statement from a public health nurse or other health care provider documenting a prenatal home visit; or    (4)   Other evidence acceptable to the state registrar.     b.    Evidence the infant was born alive including:    (1)   A statement from the physician, certified nurse midwife or other health care provider who saw or examined the infant;    (2)   A statement from a public health nurse or other health care provider documenting a postnatal home visit; or    (3)   Other evidence acceptable to the state registrar.    c.    Clear and convincing evidence acceptable to the state registrar of the mother’s presence in this state at the reported place and date of the live birth.    96.7(3)   An Iowa-licensed certified nurse midwife may preregister with the state registrar by submitting a dated statement on business letterhead identifying the midwife’s business name, if applicable, printed full name and original signature of the midwife, professional title, license number, address and telephone numbercompleted Iowa-Licensed CNM Pre-Registration Application For Home Births and a clear photocopy of that person’s current government-issued photo identification.    a.    CertifiedTo register a live birth, certified nurse midwives who are preregistered shall submit to the state registrar for registration of the live birth at a minimum the following:    (1)   A cover letter that is on the business letterhead, that identifies the live birth submitted for registration, that supports the facts of the live birth, and that contains the original signature of the person responsible for registering the live birth;    (2)   The original official non-institution birth worksheet completed and signed pursuant to subrule 96.7(5) or as directed by the state registrar; and    (3)   Payment of fees, which shall be included with the birth worksheet.; and    (4)   Other evidence acceptable to the state registrar as requested.    b.    It is the responsibility of the individual preregistering to update any information provided in the individual’s original registration.    96.7(4)   Certified nurse midwivesA certified nurse midwife, or any person providing assistance with the birth, who is not preregistered prior to submitting a certificate of live birth for registration shall follow subrules 96.7(1), 96.7(2) and 96.7(5) for all live births the midwives attendperson attends outside a birthing institution.    96.7(5)   The official non-institution birth worksheet shall include a notarized signature of the mother or her legal spouse and shall be accompanied by a clear photocopy of that person’s current government-issued photo identification. If photo identification is unavailable, other identifying documentation may be acceptable to the state registrar.

        ITEM 6.    Amend subrule 98.7(6) as follows:    98.7(6) Denial of registration.  In the absence of adequate substantiating evidence or if the state registrar finds reason to question the validity or adequacy of the evidence required to establish a delayed certificate of marriage, the state registrar shall not register the delayed record.    a.    The written notice of rejection from the state registrar shall include:    (1)   The Delayed Certificate of Marriage form stamped “rejected”; and    (2)   The Delayed Evidence Refusal form.    b.    Applications for delayed certificates which have not been completed within one year from the date of application may be dismissed at the discretion of the state registrar. Upon dismissal, the state registrar shall advise the applicant, and all documents submitted in support of such registration shall be returned to the applicant.The state registrar shall provide information related to the applicant’s right of appeal to the district court.    c.    If a request to establish a delayed certificate of marriage is rejected under the provisions of Iowa Code section 144.16, a petition may be filed with the district court for an order to establish a delayed certificate of marriage. The petition shall:    (1)   Be made on a form prescribed and furnished by the state registrar.    (2)   Allege that diligent efforts by the petitioner have failed to obtain the evidence required in accordance with Iowa Code section 144.16.    (3)   Allege that the state registrar has refused to establish the delayed certificate of marriage.    (4)   Include such other allegations as may be required.    (5)   Be accompanied by a statement of the registration official made in accordance with Iowa Code section 144.16 and all documentary evidence which was submitted to the registration official in support of such registration.    (6)   Be verified by the petitioner.

        ITEM 7.    Amend subrules 99.6(1) and 99.6(2) as follows:    99 99.6 6(1)   Amendments of vital records may be made by the state registrar one year or more after the date of the event upon request from an entitled personor by an order to amend the record by a court of competent jurisdiction. Amendments include the correction of obvious errors, omissions, or transposition of letters in words of common knowledge.    99 99.6 6(2)   For a certificate of live birth, entitled persons include in the following descending order of priority:    a.    The registrant, if the registrant is of legal age, has reached the age of majority or is an emancipated minor;    a.    b.    Either parent as shown on the child’s certificate of live birth;or    b.    The mother, in the case of the death or incapacity of the second parent;    c.    The second parent if listed on the birth certificate, in the case of the death or incapacity of the mother; or    d.    c.    The legal guardian or agency having legal custody of the child.

        ITEM 8.    Amend subrule 99.6(7) as follows:    99.6(7)   The documentary evidence shall have been established at least five years prior to the date of the application or within seven years of the date of the event.    a.    The state registrar shall determine a priority of best evidence and may, at the state registrar’s discretion, require additional documentary evidence to support the requested amendment.    b.    The state registrar shall evaluate the evidence submitted in support of any amendment, and when there is reason to question the validity or adequacy of the evidence, the state registrar may reject the amendment and shall advise the applicant of the reasons for this actionand provide information related to the applicant’s right of appeal to the district court pursuant to Iowa Code section 144.38.    c.    If a request to amend a certificate of birth is rejected under the provisions of Iowa Code section 144.38, a petition may be filed with the district court for an order amending a vital record. The petition shall:    (1)   Be made on a form prescribed and furnished by the state registrar.    (2)   Allege that diligent efforts by the petitioner have failed to obtain the evidence required in accordance with Iowa Code section 144.38.    (3)   Allege that the state registrar has refused to amend the certificate of vital record.    (4)   Include such other allegations as may be required.    (5)   Be accompanied by a statement of the registration official made in accordance with Iowa Code section 144.38 and all documentary evidence which was submitted to the registration official in support of such registration.     (6)   Be verified by the petitioner.

        ITEM 9.    Amend rule 641—99.9(144) as follows:

    641—99.9(144) Other amendments to certificate of live birth.      99.9(1)   The parent’s name or both parents’ names as reported by the parent or parents on the birth worksheet used to establish the certificate of live birth shall not be correctedonly be amended if the amendment is supported by a certified copy of a vital record or amended except by an order from a court of competent jurisdiction.    99.9(2)   Certificates of live birth of deceased persons shall not be amendedonly be amended if the amendment is supported by a certified copy of a vital record or amended by an order from a court of competent jurisdiction.

        ITEM 10.    Amend rule 641—99.11(144) as follows:

    641—99.11(144) Correction or amendment to a certificate of marriage.      99.11(1)   The request to correct a certificate of marriage during the first year may be made by the county registrar that issued the license to marry. The written request shall be submitted to the state registrar with supporting evidence.    99.11(2)   The request to correct or amend a certificate of marriage may be made by either of the parties married. The written request shall be submitted to the state registrar with supporting evidence.    99.11(3)   The correction or amendment process shall not be used to change a legal name after marriageAn order from a court of competent jurisdiction is required to correct or amend a legal name after marriage.        [Filed 3/13/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4399CPublic Health Department[641]Adopted and Filed

    Rule making related to vaporizable forms of medical cannabidiol

        The Public Health Department hereby amends Chapter 154, “Medical Cannabidiol Program,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 124E.11.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 124E.11(2)“c.”Purpose and Summary    The Medical Cannabidiol Board asked the Board of Medicine to reconsider vaporizable forms of medical cannabidiol as allowable forms. The vaporizable forms allow for the administration of medical cannabidiol by a different route that avoids the digestive system and does not require the ability to swallow. The Board of Medicine approved the amendment at its December 14, 2018, meeting. This amendment adds the vaporizable form of inhaled medical cannabidiol to the allowable forms.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 16, 2019, as ARC 4240C. A public hearing was held on February 6, 2019, at 11 a.m. in Room 518, Lucas State Office Building, Des Moines, Iowa. No one attended the public hearing. No public comments were received. No changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the State Board of Health on March 13, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to the Department’s variance and waiver provisions contained in 641—Chapter 178.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making action is adopted:

        ITEM 1.    Amend rule 641—154.14(124E) as follows:

    641—154.14(124E) Form and quantity of medical cannabidiol.   The form and quantity of medical cannabidiol authorized in this rule may be modified pursuant to recommendations by the medical cannabidiol board, subsequent approval of the recommendations by the board of medicine and adoption of the recommendations by the department by rule.    154.14(1) Quantity.  A 90-day supply is the maximum amount of each product that shall be dispensed by a dispensary at one time.    154.14(2) Form.      a.    A manufacturer may only manufacture medical cannabidiol in the following forms:    (1)   Oral forms, including but not limited to:
    1. Tablet.
    2. Capsule.
    3. Liquid.
    4. Tincture.
    5. Sublingual.
        (2)   Topical forms, including but not limited to:
    1. Gel.
    2. Ointment, cream or lotion.
    3. Transdermal patch.
        (3)   Nebulizable inhaled forms.Inhaled forms, limited to:    1.   Nebulizable.    2.   Vaporizable.    (4)   Rectal/vaginal forms, including but not limited to suppository.        b.    A manufacturer may not produce medical cannabidiol in any form that may be smoked.    c.    A manufacturer may not produce medical cannabidiol in an edible form as defined in rule 641—154.1(124E).        [Filed 3/13/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4400CTransportation Department[761]Adopted and Filed

    Rule making related to reference manual for bridge evaluation

        The Department of Transportation hereby amends Chapter 181, “Statewide Standard for Permitting Certain Implements of Husbandry,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code section 307.12.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code section 321.463(4).Purpose and Summary    This amendment updates subrule 181.1(2) to reference the 2018 edition of the American Association of State Highway and Transportation Officials Manual for Bridge Evaluation.  This manual is used by local authorities to evaluate bridges when issuing special permits for certain implements of husbandry with a weight in excess of the weights allowed under Iowa Code chapter 321. The amendment, which updates the edition of the manual, will allow engineers to use the most current information for the evaluation of bridges. The dynamic load allowance sections of the manual, sections 6A.4.4.3 and 6A.4.5.5, referenced in Chapter 181 remain unchanged between manual editions. Other changes in section 6 of the manual are nonsubstantive.Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 30, 2019, as ARC 4257C. No public comments were received. No changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Department on March 12, 2019.Fiscal Impact     This rule making has no fiscal impact to the State of Iowa. Jobs Impact    After analysis and review of this rule making, no impact on jobs has been found.Waivers    Any person who believes that the person’s circumstances meet the statutory criteria for a waiver may petition the Department for a waiver under 761—Chapter 11.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making action is adopted:

        ITEM 1.    Amend subrule 181.1(2) as follows:    181.1(2)   A local authority shall evaluate a bridge according to section 6 of the American Association of State Highway and Transportation Officials (AASHTO) Manual for Bridge Evaluation (MBE), Second Edition (2010), as revised by the 2014 Interim RevisionsThird Edition (2018). The operating level shall be used for the evaluation of the bridge with only one fence-line feeder, grain cart, tank wagon or tracked implement of husbandry on the bridge at a time. The live load to be used in the analysis for permit decisions should be the actual vehicle crossing the bridge, together with a dynamic load allowance in accordance with section 6A.4.4.3 or 6A.4.5.5 of the AASHTO MBE Second Edition (2010) and 2014 Interim Revisions, Third Edition (2018).    [Filed 3/18/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.    ARC 4401CTransportation Department[761]Adopted and Filed

    Rule making related to federal motor carrier safety and hazardous materials regulations

        The Department of Transportation hereby amends Chapter 520, “Regulations Applicable to Carriers,” Chapter 529, “For-Hire Interstate Motor Carrier Authority,” and Chapter 607, “Commercial Driver Licensing,” Iowa Administrative Code.Legal Authority for Rule Making    This rule making is adopted under the authority provided in Iowa Code sections 307.12, 321.188, 321.449 and 321.450.State or Federal Law Implemented    This rule making implements, in whole or in part, Iowa Code sections 321.188, 321.449 and 321.450.Purpose and Summary    These amendments are part of the regular, annual update by the Department to adopt the most recent updates to the federal regulations published by the Federal Motor Carrier Safety Administration (FMCSA) and the Pipeline and Hazardous Materials Safety Administration.    Iowa Code section 321.188 requires the Department to adopt rules to administer commercial driver’s licenses in compliance with certain portions of 49 Code of Federal Regulations (CFR) Part 383.    Iowa Code section 321.449 requires the Department to adopt rules consistent with the Federal Motor Carrier Safety Regulations (FMCSR) promulgated under United States Code, Title 49, and found in 49 CFR Parts 385 and 390 to 399.     Iowa Code section 321.450 requires the Department to adopt rules consistent with the Federal Hazardous Materials Regulations (HMR) promulgated under United States Code, Title 49, and found in 49 CFR Parts 107, 171 to 173, 177, 178 and 180.    Commercial vehicles transporting goods in interstate commerce are subject to the FMCSR on the effective dates specified in the Federal Register (FR). Commercial vehicles transporting hazardous materials in interstate commerce or transporting certain hazardous materials intrastate are subject to the HMR on the effective dates specified in the FR. The adoption of the federal regulations by the Department will extend the enforcement of the regulations to commercial vehicles operated intrastate unless exempted by statute.    The amendments to Chapter 520 adopt the current CFR dated October 1, 2018, for 49 CFR Parts 107, 171 to 173, 177, 178, 180, 385 and 390 to 399.    The amendment to Chapter 529 adopts the current CFR dated October 1, 2018, for 49 CFR Parts 365 to 368 and 370 to 379.     The amendment to Chapter 607 adopts the current CFR dated October 1, 2018, for certain portions of 49 CFR Part 383.    Proposed federal regulations are published in the FR to allow a period for public comment, and after adoption, the final regulations are published in the FR.    To ensure the consistency required by statute, the Department adopts the specified parts of 49 CFR as adopted by the United States Department of Transportation.    The following paragraphs provide a specific description of the amendments to the FMCSR and the HMR that have become final and effective since the 2018 edition of the CFR and that affect Chapters 520, 529 and 607:    Amendments to the FMCSR and Federal HMR    Part 367 (FR Vol. 83, No. 4, Pages 605-613, 01-05-18)    This final rule establishes reductions in the annual registration fees collected from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies for the Unified Carrier Registration Plan and Agreement for the registration years 2018 and 2019 and subsequent years. For the 2018 registration year, the fees will be reduced below the current level by approximately 9.10 percent to ensure that fee revenues do not exceed the statutory maximum and to account for the excess funds held in the depository. For the 2019 registration year and subsequent years, the fees will be reduced below the current level by approximately 4.55 percent to ensure the fee revenues in 2019 and future years do not exceed the statutory maximum. Effective date: January 5, 2018.    Parts 370, 371, 373, 375, 376, 378-380, 382, 387, 390, 391, 395, 396, and 398 (FR Vol. 83, No. 73, Pages 16210-16228, 04-16-18)    This final rule amends the FMCSR to allow the use of electronic records and signatures to satisfy FMCSA’s regulatory requirements. The amendments permit the use of electronic methods to generate, certify, sign, maintain, or exchange records so long as the documents accurately reflect the required information and can be used for their intended purpose. This rule applies only to those documents that FMCSA’s regulations obligate entities or individuals to retain; it does not apply to forms or other documents that must be submitted directly to FMCSA unless there are already procedures in place in the regulations for electronic submission to FMCSA. This rule partially implements the Government Paperwork Elimination Act and the Electronic Signatures in Global and National Commerce Act. Effective date: June 15, 2018.    Parts 350, 360, 365, 373, 380, 382-385, 387, 390, 393, and 395-398 (FR Vol. 83, No. 96, Pages 22865-22882, 05-17-18)    This final rule amends FMCSR by making technical corrections. FMCSA makes minor changes to correct inadvertent errors and omissions, remove or update obsolete references, ensure conformity with Office of the Federal Register style guidelines, and improve the clarity and consistency of certain regulatory provisions. Effective date: June 18, 2018.    Parts 370, 371, 373, 375, 376, 378, 379, 380, 382, 387, 390, 391, 395, 396, and 398 (FR Vol. 83, No. 102, Page 24228, 05-25-18)    This final rule corrects the electronic documents and signatures final rule published on April 16, 2018, that amended FMCSR to allow the use of electronic records and signatures to satisfy FMCSA’s regulatory requirements. This document corrects an amendatory instruction, removes two extra commas at the end of two phrases, and adds “of this section” to a cross reference in a paragraph. Finally, FMCSA rescinds its January 4, 2011, interpretations and regulatory guidance. Effective date: June 15, 2018.    Part 373 (FR Vol. 83, No. 110, Page 26374, 06-07-18)    This final rule corrects the technical corrections final rule published on May 17, 2018, that amended FMCSR to make minor changes to correct inadvertent errors and omissions, remove or update obsolete references, ensure conformity with Office of the Federal Register style guidelines, and improve the clarity and consistency of certain regulatory provisions. This document corrects an amendatory instruction. Effective date: June 18, 2018.    Parts 390 and 391 (FR Vol. 83, No. 112, Pages 26846-26864, 06-11-18)    This final rule amends FMCSR to establish an alternative process for qualified advanced practice nurses, doctors of chiropractic, doctors of medicine, doctors of osteopathy, physician assistants, and other medical professionals who are employed in the U.S. Department of Veterans Affairs (VA) and are licensed, certified, or registered in a state to perform physical examinations (qualified VA examiners) to be listed on FMCSA’s National Registry of Certified Medical Examiners (National Registry), as required by the Fixing America’s Surface Transportation (FAST) Act and the Jobs for Our Heroes Act. After successful completion of online training and testing developed by FMCSA, these qualified VA examiners will become certified VA medical examiners who can perform medical examinations of, and issue medical examiner’s certificates to, commercial motor vehicle operators who are military veterans enrolled in the VA health care system. This rule will reduce the costs for qualified VA examiners to be listed on the National Registry. Effective date: August 10, 2018.    Parts 172, 173, and 180 (FR Vol. 83, No. 117, Pages 28162-28168, 06-18-18)    This final rule is in response to appeals submitted to a previously published final rule. On June 2, 2016, the Pipeline and Hazardous Materials Safety Administration published a final rule that made miscellaneous amendments to the HMR. This final rule specifically responds to appeals to extend the effective date of certain nitric acid packaging and emergency response telephone number amendments as previously adopted. This final rule also clarifies amendments associated with the trigger date of the ten-year test period for certain motor carrier 331 cargo tanks in dedicated propane service and corrects editorial errors. Effective date: July 18, 2018.    Parts 383, 384, and 391 (FR Vol. 83, No. 120, Pages 28774-28783, 06-21-18)    This interim final rule amends FMCSR to delay the compliance date from June 22, 2018, to June 22, 2021, for several provisions of FMCSA’s April 23, 2015, Medical Examiner’s Certification Integration final rule. This action is being taken to provide FMCSA additional time to complete certain information technology system development tasks for its National Registry and provide state driver’s licensing agencies sufficient time to make the necessary information technology programming changes after upgrades to the National Registry. Effective date: June 21, 2018.    Part 391 (FR Vol. 83, No. 182, Pages 47486-47521, 09-19-18)    This final rule revises FMCSR to permit individuals with a stable insulin regimen and properly controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. Previously, individuals with ITDM were prohibited from driving CMVs in interstate commerce unless the individuals obtained an exemption from FMCSA. This rule enables a certified medical examiner to grant an individual with ITDM a Medical Examiner’s Certificate, MCSA-5876, for up to a maximum of 12 months. To do so, the treating clinician (the health care professional who manages and prescribes insulin for the treatment of the individual’s diabetes) provides the Insulin-Treated Diabetes Mellitus Assessment Form MCSA-5870 to the certified medical examiner indicating that the individual maintains a stable insulin regimen and proper control of the individual’s diabetes. The certified medical examiner then determines that the individual meets FMCSA’s physical qualifications standards and can operate CMVs in interstate commerce. Effective date: November 19, 2018.    Parts 360, 380, 382, 385, 390, 391, and 395-397 (FR Vol. 83, No. 188, Pages 48721-48726, 09-27-18)    This final rule makes technical corrections throughout the FMCSR. FMCSA makes minor changes to correct inadvertent errors and omissions, remove or update obsolete references, and improve the clarity and consistency of certain regulatory provisions. Effective date: September 27, 2018.    Parts 383 and 384 (FR Vol. 83, No. 189, Pages 48964-48976, 09-28-18)    This final rule allows, but does not require, state driver’s licensing agencies to waive the requirement of the commercial learner’s permit knowledge test for certain individuals who are, or were, regularly employed within the last year in a military position that requires, or required, the operation of a CMV. This rule includes the option for a state driver’s licensing agency to waive the tests required for a passenger carrier (P) endorsement, tank vehicle (N) endorsement, or hazardous material (H) endorsement, with proof of training and experience. Effective date: November 27, 2018. Public Comment and Changes to Rule Making    Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on January 30, 2019, as ARC 4256C. No public comments were received. No changes from the Notice have been made.Adoption of Rule Making    This rule making was adopted by the Department on March 12, 2019.Fiscal Impact     The fiscal impact cannot be determined. The federal regulations to be adopted by this rule making were subject to fiscal impact review by either the Federal Motor Carrier Safety Administration or the Pipeline and Hazardous Materials Safety Administration when the regulations were enacted and were determined not to be cost-prohibitive. Jobs Impact    The amendments may have a slight impact on motor carrier operations. However, the amendments should not negatively impact jobs or employment opportunities because the amendments align the rules to federal regulations and bring uniformity and consistency to the industry, which should have a positive impact on employment. Waivers    Various portions of the federal regulations and Iowa statutes allow some exceptions when the exceptions will not adversely impact the safe transportation of commodities on the nation’s highways. Granting additional exceptions for drivers and the motor carrier industry in Iowa would adversely impact the safety of the traveling public in Iowa.Review by Administrative Rules Review Committee    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).Effective Date    This rule making will become effective on May 15, 2019.    The following rule-making actions are adopted:

        ITEM 1.    Amend paragraph 520.1(1)"a" as follows:    a.    Motor carrier safety regulations.The Iowa department of transportation adopts the Federal Motor Carrier Safety Regulations, 49 CFR Parts 385 and 390-399 (October 1, 20172018).

        ITEM 2.    Amend paragraph 520.1(1)"b" as follows:    b.    Hazardous materials regulations.The Iowa department of transportation adopts the Federal Hazardous Materials Regulations, 49 CFR Parts 107, 171-173, 177, 178, and 180 (October 1, 20172018).

        ITEM 3.    Amend rule 761—529.1(327B) as follows:

    761—529.1(327B) Motor carrier regulations.  The Iowa department of transportation adopts the Code of Federal Regulations, 49 CFR Parts 365-368 and 370-379, dated October 1, 20172018, for regulating interstate for-hire carriers.Copies of this publication are available from the state law library or through the Internet at www.fmcsa.dot.gov.

        ITEM 4.    Amend paragraph 607.10(1)"c" as follows:    c.    The following portions of 49 CFR Part 383 (October 1, 20172018):    (1)   Section 383.51, Disqualification of drivers.    (2)   Subpart E—Testing and Licensing Procedures.    (3)   Subpart G—Required Knowledge and Skills.    (4)   Subpart H—Tests.    [Filed 3/18/19, effective 5/15/19][Published 4/10/19]Editor’s Note: For replacement pages for IAC, see IAC Supplement 4/10/19.
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