CHAPTER 13
STANDARDS OF PRACTICE AND PRINCIPLES OF MEDICAL ETHICS
[Prior to 5/4/88, see 470—135.251 to 470—135.402]
653—13.1(148,272C) Standards of practice—packaging, labeling and records of prescription drugs dispensed by a physician.
	13.1(1) A physician shall dispense a prescription drug only in a container which meets the requirements of the Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471-1476 (2001), unless otherwise requested by the patient, and of Section 502G of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ss. 301 et seq.	(2001).
	13.1(2) A label shall be affixed to a container in which a prescription drug is dispensed by a physician which shall include:
	1.	The name and address of the physician.
	2.	The name of the patient.
	3.	The date dispensed.
	4.	The directions for administering the prescription drug and any cautionary statement deemed appropriate by the physician.
	5.	The name and strength of the prescription drug in the container.
	13.1(3) The provisions of subrules 13.1(1) and 13.1(2) shall not apply to packaged drug samples.
	13.1(4) A physician shall keep a record of all prescription drugs dispensed by the physician to a patient which shall contain the information required by subrule 13.1(2) to be included on the label. Noting such information on the patient’s chart or record maintained by the physician is sufficient.
This rule is intended to implement Iowa Code sections 147.55, 148.6, 272C.3 and 272C.4.
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 of nonopioid pharmacologic therapy and nonpharmacologic therapy, including but not limited to adjunct therapies such as acupuncture, physical therapy and massage, osteopathic manipulative therapy and occupational therapy in the treatment of acute and chronic pain.
	1.	This rule is intended to encourage appropriate pain management, including the use of opioids 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 is an important part of 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 opioids 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.	 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 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. Nothing in this rule relieves a physician from fully complying with applicable federal and state laws and regulations.
	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 opioids 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 acute and chronic pain. Appropriate assessment of the etiology of the pain is essential to the appropriate treatment of acute and chronic pain.
	a. 	Prescribing opioids for the treatment of acute and chronic pain should be based on clearly diagnosed and documented pain. Appropriate management of acute and 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.  To ensure that chronic pain is properly assessed and treated, a physician who prescribes, dispenses or administers opioids 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 opioids from a single physician and a single pharmacy whenever possible.
	c. 	Informed consent. The physician shall document discussion of the risks and benefits of opioids 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, and 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 opioids 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 opioids. A physician who prescribes opioids to a patient for more than 90 days for the 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 opioids to a patient for more than 90 days for the 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. 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 opioids 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 opioids 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. A 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 prior 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, all prescriptions (controlled and noncontrolled substances) shall be transmitted electronically as electronic prescriptions pursuant to Iowa Code section 124.308. A 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.
	13.2(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 9599B, IAB 7/13/11, effective 8/17/11; ARC 2705C, IAB 9/14/16, effective 10/19/16; ARC 4714C, IAB 10/23/19, effective 11/27/19]
653—13.3(147) Supervision of pharmacists who administer adult immunizations. Rescinded ARC 1033C, IAB 10/2/13, effective 11/6/13.
653—13.4(148) Supervision of pharmacists engaged in collaborative drug therapy management. A supervising physician may only delegate aspects of drug therapy management to an authorized pharmacist pursuant to a written protocol with a pharmacist pursuant to the requirements of this rule. The physician is considered the supervisor and retains the ultimate responsibility for the care of the patient. The authorized pharmacist retains full responsibility for proper execution of pharmacy practice.
	13.4(1) Definitions.
“Authorized pharmacist” means an Iowa-licensed pharmacist who meets the training requirements of the Iowa board of pharmacy (IBP) as specified in the drug therapy management criteria in 657—8.34(155A).
“Board” means the board of medicine of the state of Iowa.
“Collaborative drug therapy management” means participation by a physician and an authorized pharmacist in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.
“Collaborative practice” means that a physician may delegate aspects of drug therapy management for the physician’s patients to an authorized pharmacist through a written community practice protocol. “Collaborative practice” also means that a P&T committee may authorize hospital pharmacists to perform drug therapy management for inpatients and the hospital’s clinic patients through a hospital practice protocol when the clinic and the pharmacist are under the direct authority of the hospital’s P&T committee.
“Community practice protocol” means a written, executed agreement entered into voluntarily between a physician and an authorized pharmacist establishing drug therapy management for one or more of the physician’s patients residing in a community setting. A community practice protocol shall comply with the requirements of subrule 13.4(2).
“Community setting” means a location outside a hospital inpatient, acute care setting or a hospital clinic setting. A community setting may include, but is not limited to, a home, group home, assisted living facility, correctional facility, hospice, or long-term care facility.
“Hospital clinic” means an outpatient care clinic operated and affiliated with a hospital and under the direct authority of the hospital’s P&T committee.
“Hospital pharmacist” means an Iowa-licensed pharmacist who meets the requirements for participating in a hospital practice protocol as determined by the hospital’s P&T committee.
“Hospital practice protocol” means a written plan, policy, procedure, or agreement that authorizes drug therapy management between physicians and hospital pharmacists within a hospital and its clinics as developed and determined by its P&T committee. Such a protocol may apply to all physicians and hospital pharmacists at a hospital or the hospital’s clinics under the direct authority of the hospital’s P&T committee or only to those physicians and pharmacists who are specifically recognized. A hospital practice protocol shall comply with the requirements of subrule 13.4(3).
“IBP” means the Iowa board of pharmacy.
“P&T committee” means a committee of the hospital composed of physicians, pharmacists, and other health professionals that evaluates the clinical use of drugs within the hospital, develops policies for managing drug use and administration in the hospital, and manages the hospital drug formulary system.
“Physician” means a person who is currently licensed in Iowa to practice medicine and surgery or osteopathic medicine and surgery. A physician who executes a written protocol with an authorized pharmacist shall supervise the pharmacist’s activities involved in the overall management of patients receiving medications or disease management services under the protocol. The physician may delegate only drug therapies that are in areas common to the physician’s practice.
“Therapeutic interchange” means an authorized exchange of therapeutic alternate drug products in accordance with a previously established and approved written protocol.
	13.4(2) Community practice protocol.
	a. 	A physician shall engage in collaborative drug therapy management with a pharmacist only under a written protocol that is identified by topic and has been submitted to the IBP or a committee authorized by the IBP. A protocol executed after July 1, 2008, will no longer be required to be submitted to the IBP; however, written protocols executed or renewed after July 1, 2008, shall be made available upon request of the board or the IBP.
	b. 	The community practice protocol shall include:
	(1)	The name, signature, date and contact information for each authorized pharmacist who is a party to the protocol and is eligible to manage the drug therapy of a particular patient. If more than one authorized pharmacist is a party to the agreement, the pharmacists shall work for a single licensed pharmacy and a principal pharmacist shall be designated in the protocol.
	(2)	The name, signature, date and contact information for each physician who may prescribe drugs and is responsible for supervising a patient’s drug therapy management. The physician who initiates a protocol shall be considered the main caregiver for the patient respective to that protocol and shall be noted in the protocol as the principal physician.
	(3)	The name and contact information of the principal physician and the principal authorized pharmacist who are responsible for development, training, administration, and quality assurance of the protocol.
	(4)	A detailed written protocol pursuant to which the authorized pharmacist will base drug therapy management decisions for patients. The protocol shall authorize one or more of the following:
	1.	Prescription drug orders. The protocol may authorize therapeutic interchange or modification of drug dosages based on symptoms or laboratory or physical findings defined in the protocol. The protocol shall include information specific to the dosage, frequency, duration and route of administration of the drug authorized by the patient’s physician. The protocol shall not authorize the pharmacist to change a Schedule II drug or initiate a drug not included in the established protocol.
	2.	Laboratory tests. The protocol may authorize the pharmacist to obtain or conduct specific laboratory tests as long as the tests relate directly to the drug therapy management.
	3.	Physical findings. The protocol may authorize the pharmacist to check certain physical findings, e.g., vital signs, oximetry, or peak flows, that enable the pharmacist to assess and adjust the drug therapy, detect adverse drug reactions or determine if the patient should be referred back to the patient’s physician for follow-up.
	4.	Patient activities. The protocol may authorize the pharmacist to monitor specific patient activities.
	(5)	Procedures for the physician to secure the patient’s written consent. If the physician does not secure the patient’s written consent, the pharmacist shall secure such and notify the patient’s physician within 24 hours.
	(6)	Circumstances that shall cause the pharmacist to initiate communication with the physician, including but not limited to the need for new prescription orders and reports of the patient’s therapeutic response or adverse reaction.
	(7)	A detailed statement identifying the specific drugs, laboratory tests and physical findings upon which the pharmacist shall base drug therapy management decisions.
	(8)	A provision for the collaborative drug therapy protocol to be reviewed, updated and reexecuted or discontinued at least every two years.
	(9)	A description of the method the pharmacist shall use to document the pharmacist’s decisions or recommendations for the physician.
	(10)	A description of the types of reports the physician requires the pharmacist to provide and the schedule by which the pharmacist is to submit these reports. The schedule shall include a time frame in which a pharmacist shall report any adverse reaction to the physician.
	(11)	A statement of the medication categories and the type of initiation and modification of drug therapy that the physician authorizes the pharmacist to perform.
	(12)	A description of the procedures or plan that the pharmacist shall follow if the pharmacist modifies a drug therapy.
	(13)	Procedures for record keeping, record sharing and long-term record storage.
	(14)	Procedures to follow in emergency situations.
	(15)	A statement that prohibits the pharmacist from delegating drug therapy management to anyone other than another authorized pharmacist who has signed the applicable protocol.
	(16)	A statement that prohibits a physician from delegating collaborative drug therapy management to any unlicensed or licensed person other than another physician or authorized pharmacist.
	(17)	A description of the mechanism for the pharmacist and physician to communicate with each other and for documentation by the pharmacist of the implementation of collaborative drug therapy.
	c. 	Collaborative drug therapy management is valid only when initiated by a written protocol executed by at least the patient’s physician and one authorized pharmacist.
	d. 	A collaborative drug therapy management protocol must be filed with the IBP, kept on file in the pharmacy and made available to the board or IBP upon request. A protocol executed after July 1, 2008, will no longer be required to be submitted to the IBP; however, written protocols executed or renewed after July 1, 2008, shall be made available upon request of the board or the IBP.
	e. 	A physician may terminate or amend the collaborative drug therapy management protocol with an authorized pharmacist if the physician notifies, in writing, the pharmacist and the IBP. Notification shall include the name of the authorized pharmacist, the desired change, and the proposed effective date of the change. After July 1, 2008, the physician shall no longer be required to notify the IBP of changes in the protocol.
	f. 	Patient consent for community practice protocols. The physician or pharmacist who initiates a protocol with a patient is responsible for securing a patient’s written consent to participate in drug therapy management and for transmitting a copy of the consent to the other party within 24 hours. The consent shall indicate which protocol is involved. Any variation in the protocol for a specific patient needs to be communicated to the other party at the time of securing the patient’s consent. The patient’s physician shall maintain the patient consent in the patient’s medical record.
	13.4(3) Hospital practice protocol.
	a. 	A hospital’s P&T committee shall determine the scope and extent of collaborative drug therapy management practices that may be conducted by its hospital pharmacists in the hospital and its clinics. Hospital clinics are restricted to outpatient care clinics operated and affiliated with a hospital and under the direct authority of the hospital’s P&T committee.
	b. 	Collaborative drug therapy management within a hospital setting or the hospital’s clinic setting is valid only when approved by the hospital’s P&T committee.
	c. 	The hospital practice protocol shall include:
	(1)	The names or groups of physicians and pharmacists who are authorized by the P&T committee to participate in collaborative drug therapy management.
	(2)	A plan for development, training, administration, and quality assurance of the protocol.
	(3)	A detailed written protocol pursuant to which the hospital pharmacist shall base drug therapy management decisions for patients. The protocol shall authorize one or more of the following:
	1.	Medication orders and prescription drug orders. The protocol may authorize therapeutic interchange or modification of drug dosages based on symptoms or laboratory or physical findings defined in the protocol. The protocol shall include information specific to the dosage, frequency, duration and route of administration of the drug authorized by the physician. The protocol shall not authorize the hospital pharmacist to change a Schedule II drug or initiate a drug not included in the established protocol.
	2.	Laboratory tests. The protocol may authorize the hospital pharmacist to obtain or conduct specific laboratory tests as long as the tests relate directly to the drug therapy management.
	3.	Physical findings. The protocol may authorize the hospital pharmacist to check certain physical findings, e.g., vital signs, oximetry, or peak flows, that enable the pharmacist to assess and adjust the drug therapy, detect adverse drug reactions or determine if the patient should be referred back to the physician for follow-up.
	(4)	Circumstances that shall cause the hospital pharmacist to initiate communication with the patient’s physician, including but not limited to the need for new medication orders and prescription drug orders and reports of a patient’s therapeutic response or adverse reaction.
	(5)	A statement of the medication categories and the type of initiation and modification of drug therapy that the protocol authorizes the hospital pharmacist to perform.
	(6)	A description of the procedures or plan that the hospital pharmacist shall follow if the hospital pharmacist modifies a drug therapy.
	(7)	A description of the mechanism for the hospital pharmacist and the patient’s physician to communicate and for the hospital pharmacist to document implementation of the collaborative drug therapy.
This rule is intended to implement Iowa Code chapter 148.
653—13.5(147,148) Standards of practice—chelation therapy. Chelation therapy or disodium ethylene diamine tetra acetic acid (EDTA) may only be used for the treatment of heavy metal poisoning or in the clinical setting when a licensee experienced in clinical investigations conducts a carefully controlled clinical investigation of its effectiveness in treating other diseases or medical conditions under a research protocol that has been approved by an institutional review board of the University of Iowa or Des Moines University—Osteopathic Medical Center.
This rule is intended to implement Iowa Code chapters 147 and 148.
653—13.6(79GA,HF726) Standards of practice—automated dispensing systems. A physician who dispenses prescription drugs via an automated dispensing system or a dispensing system that employs technology may delegate nonjudgmental dispensing functions to staff assistants in the absence of a pharmacist or physician provided that the physician utilizes an internal quality control assurance plan that ensures that the medication dispensed is the medication that was prescribed. The physician shall be physically present to determine the accuracy and completeness of any medication that is reconstituted prior to dispensing.
	13.6(1) An internal quality control assurance plan shall include the following elements:
	a. 	The name of the physician responsible for the internal quality assurance plan and testing;
	b. 	Methods that the dispensing system employs, e.g., bar coding, to ensure the accuracy of the patient’s name and medication, dosage, directions and amount of medication prescribed;
	c. 	Standards that the physician expects to be met to ensure the accuracy of the dispensing system and the training and qualifications of staff members assigned to dispense via the dispensing system;
	d. 	The procedures utilized to ensure that the physician(s) dispensing via the automated system provide(s) patients counseling regarding the prescription drugs being dispensed;
	e. 	Staff training and qualifications for dispensing via the dispensing system;
	f. 	A list of staff members who meet the qualifications and who are assigned to dispense via the dispensing system;
	g. 	A plan for testing the dispensing system and each staff member assigned to dispense via the dispensing system;
	h. 	The results of testing that show compliance with the standards prior to implementation of the dispensing system and prior to approval of each staff member to dispense via the dispensing system;
	i. 	A plan for interval testing of the accuracy of dispensing, at least annually; and
	j. 	A plan for addressing inaccuracies, including discontinuing dispensing until the accuracy level can be reattained.
	13.6(2) Those dispensing systems already in place shall show evidence of a plan and testing within two months of August 31, 2001.
	13.6(3) The internal quality control assurance plan shall be submitted to the board of medicine upon request.
This rule is intended to implement Iowa Code section 147.107 and 2001 Iowa Acts, House File 726, section 5(10), paragraph “i.”
653—13.7(147,148,272C) Standards of practice—office practices.
	13.7(1) Termination of the physician-patient relationship. A physician may choose whom to serve. Having undertaken the care of a patient, the physician may not neglect the patient. A physician shall provide a patient written notice of the termination of the physician-patient relationship. A physician shall ensure that emergency medical care is available to the patient during the 30-day period following notice of the termination of the physician-patient relationship.
	13.7(2) Patient referrals. A physician shall not pay or receive compensation for patient referrals.
	13.7(3) Confidentiality. A physician shall maintain the confidentiality of all patient information obtained in the practice of medicine. Information shall be divulged by the physician when authorized by law or the patient or when required for patient care.
	13.7(4) Sexual conduct. It is unprofessional and unethical conduct, and is grounds for disciplinary action, for a physician to engage in conduct which violates the following prohibitions:
	a. 	In the course of providing medical care, a physician shall not engage in contact, touching, or comments of a sexual nature with a patient, or with the patient’s parent or guardian if the patient is a minor.
	b. 	A physician shall not engage in any sexual conduct with a patient when that conduct occurs concurrent with the physician-patient relationship, regardless of whether the patient consents to that conduct.
	c. 	A physician shall not engage in any sexual conduct with a former patient unless the physician-patient relationship was completely terminated before the sexual conduct occurred. In considering whether that relationship was completely terminated, the board will consider the duration of the physician-patient relationship, the nature of the medical services provided, the lapse of time since the physician-patient relationship ended, the degree of dependence in the physician-patient relationship, and the extent to which the physician used or exploited the trust, knowledge, emotions, or influence derived from the physician-patient relationship.
	d. 	A psychiatrist, or a physician who provides mental health counseling to a patient, shall never engage in any sexual conduct with a current or former patient, or with that patient’s parent or guardian if the patient was a minor, regardless of whether the patient consents to that conduct.
	13.7(5) Disruptive behavior. A physician shall not engage in disruptive behavior. Disruptive behavior is defined as a pattern of contentious, threatening, or intractable behavior that interferes with, or has the potential to interfere with, patient care or the effective functioning of health care staff.
	13.7(6) Sexual harassment. A physician shall not engage in sexual harassment. Sexual harassment is defined as verbal or physical conduct of a sexual nature which interferes with another health care worker’s performance or creates an intimidating, hostile or offensive work environment.
	13.7(7) Transfer of medical records. A physician must provide a copy of all medical records generated by the physician in a timely manner to the patient or another physician designated by the patient, upon written request when legally requested to do so by the subject patient or by a legally designated representative of the subject patient, except as otherwise required or permitted by law.
	13.7(8) Retention of medical records. The following paragraphs become effective on January 1, 2004.
	a. 	A physician shall retain all medical records, not appropriately transferred to another physician or entity, for at least seven years from the last date of service for each patient, except as otherwise required by law.
	b. 	A physician must retain all medical records of minor patients, not appropriately transferred to another physician or entity, for a period consistent with that established by Iowa Code section 614.8.
	c. 	Upon a physician’s death or retirement, the sale of a medical practice or a physician’s departure from the physician’s medical practice:
	(1)	The physician or the physician’s representative must ensure that all medical records are transferred to another physician or entity that is held to the same standards of confidentiality and agrees to act as custodian of the records.
	(2)	The physician shall notify all active patients that their records will be transferred to another physician or entity that will retain custody of their records and that, at their written request, the records will be sent to the physician or entity of the patient’s choice.
653—13.8(148,272C) Standards of practice—medical directors at medical spas—delegation and supervision of medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians. This rule establishes standards of practice for a physician or surgeon or osteopathic physician or surgeon who serves as a medical director at a medical spa.
	13.8(1) Definitions. As used in this rule:
“Alter” means to change the cellular structure of living tissue.
“Capable of” means any means, method, device or instrument which, if used as intended or otherwise to its greatest strength, has the potential to alter or damage living tissue below the superficial epidermal cells.
“Damage” means to cause a harmful change in the cellular structure of living tissue.
“Delegate” means to entrust or transfer the performance of a medical aesthetic service to qualified licensed or certified nonphysician persons or qualified laser technicians.
“Medical aesthetic service” means the diagnosis, treatment, or correction of human conditions, ailments, diseases, injuries, or infirmities of the skin, hair, nails and mucous membranes by any means, methods, devices, or instruments including the use of a biological or synthetic material, chemical application, mechanical device, or displaced energy form of any kind if it alters or damages or is capable of altering or damaging living tissue below the superficial epidermal cells, with the exception of hair removal. Medical aesthetic service includes, but is not limited to, the following services: ablative laser therapy; vaporizing laser therapy; nonsuperficial light device therapy; injectables; tissue alteration services; nonsuperficial light-emitting diode therapy; nonsuperficial intense pulse light therapy; nonsuperficial radiofrequency therapy; nonsuperficial ultrasonic therapy; nonsuperficial exfoliation; nonsuperficial microdermabrasion; nonsuperficial dermaplane exfoliation; nonsuperficial lymphatic drainage; collagen induction therapy (microneedling); fat-freezing treatment (cool sculpting); botox injections; collagen injections; and tattoo removal.
“Medical director” means a physician who assumes the role of, or holds oneself out as, medical director at a medical spa. The medical director is responsible for implementing policies and procedures to ensure quality patient care and for the delegation and supervision of medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians at a medical spa. The medical director is ultimately responsible for all medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians at a medical spa.
“Medical spa” means any entity, however organized, which is advertised, announced, established, or maintained for the purpose of providing medical aesthetic services. Medical spa shall not include a dermatology practice which is wholly owned and controlled by one or more Iowa-licensed physicians if at least one of the owners is actively practicing at each location.
“Nonsuperficial” means that the therapy alters or damages or is capable of altering or damaging living tissue below the superficial epidermal cells.
“Qualified laser technician” means any person, licensed or unlicensed, who has successfully completed a minimum of 120 hours of training, including a minimum of 40 hours of didactic study and 80 hours of clinical training, in the safe and effective use of lasers in the performance of medical aesthetic services at an accredited laser training program. For the purposes of this rule, a qualified laser technician may only use lasers in the performance of delegated medical aesthetic services under the supervision of a qualified supervising physician at a medical spa. An unlicensed qualified laser technician may not perform any other medical aesthetic services defined in this rule.
“Qualified licensed or certified nonphysician person” means any person who is not licensed to practice medicine and surgery or osteopathic medicine and surgery but who is licensed or certified by another health- or skin care-related licensing board in Iowa and is qualified to perform delegated medical aesthetic services under the supervision of a qualified supervising physician at a medical spa.
“Supervision” means the oversight of qualified licensed or certified nonphysician persons or qualified laser technicians who perform medical aesthetic services delegated by a medical director.
	13.8(2) Practice of medicine. The performance of medical aesthetic services is the practice of medicine. A medical aesthetic service shall only be performed by qualified licensed or certified nonphysician persons or qualified laser technicians if the service has been delegated by a medical director who is responsible for supervision of the services performed at a medical spa in Iowa.
	13.8(3) Medical director. A physician who serves as medical director at a medical spa shall:
	a. 	Hold an active unrestricted Iowa medical license to supervise each delegated medical aesthetic service;
	b. 	Possess the appropriate education, training, experience and competence to safely supervise each delegated medical aesthetic service;
	c. 	Retain responsibility for the supervision of each medical aesthetic service performed by qualified licensed or certified nonphysician persons or qualified laser technicians;
	d. 	Ensure that advertising activities do not include false, misleading, or deceptive representations; and
	e. 	Be clearly identified as the medical director in all advertising activities, Internet websites and signage related to the medical spa.
	13.8(4) Delegated medical aesthetic service. When a medical director delegates a medical aesthetic service to qualified licensed or certified nonphysician persons or qualified laser technicians, the service shall be:
	a. 	Within the medical director’s scope of practice and medical competence to supervise;
	b. 	Of the type that a reasonable and prudent physician would conclude is within the scope of sound medical judgment to delegate; and
	c. 	A routine and technical service, the performance of which does not require the skill of a licensed physician.
	13.8(5) Supervision. A medical director who delegates performance of a medical aesthetic service to qualified licensed or certified nonphysician persons or qualified laser technicians is responsible for providing appropriate supervision. The medical director shall:
	a. 	Ensure that all licensed or certified nonphysician persons or qualified laser technicians are qualified and competent to safely perform each delegated medical aesthetic service by personally assessing the person’s education, training, experience and ability;
	b. 	Ensure that a qualified licensed or certified nonphysician person does not perform any medical aesthetic services which are beyond the scope of that person’s license or certification unless the person is supervised by a qualified supervising physician;
	c. 	Ensure that all qualified licensed or certified nonphysician persons or qualified laser technicians receive direct, in-person, on-site supervision from the medical director or other qualified licensed physician at least four hours each week and that the regular supervision is documented;
	d. 	Provide on-site review of medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians each week and review at least 10 percent of patient charts for medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians;
	e. 	Be physically located, at all times, within 60 miles of the location where delegated medical aesthetic services are performed;
	f. 	Be available, in person or electronically, at all times, to consult with qualified licensed or certified nonphysician persons or qualified laser technicians who perform delegated medical aesthetic services, particularly in case of injury or an emergency;
	g. 	Assess the legitimacy and safety of all equipment or other technologies being used by qualified licensed or certified nonphysician persons or qualified laser technicians who perform delegated medical aesthetic services;
	h. 	Develop and implement protocols for responding to emergencies or other injuries suffered by persons receiving delegated medical aesthetic services performed by qualified licensed or certified nonphysician persons or qualified laser technicians;
	i. 	Ensure that all qualified licensed or certified nonphysician persons or qualified laser technicians maintain accurate and timely medical records for the delegated medical aesthetic services they perform;
	j. 	Ensure that each patient provides appropriate informed consent for medical aesthetic services performed by the medical director or other qualified licensed physician and all qualified licensed or certified nonphysician persons or qualified laser technicians and that such informed consent is timely documented in the patient’s medical record;
	k. 	Ensure that the identity and licensure and certification of the medical director, other qualified licensed physicians, and all qualified licensed or certified nonphysician persons or qualified laser technicians are visibly displayed at each medical spa where they perform medical aesthetic services and provided in writing to each patient receiving medical aesthetic services at a medical spa; and
	l. 	Ensure that the board receives written verification of the education and training of all qualified licensed or certified nonphysician persons or qualified laser technicians who perform delegated medical aesthetic services at a medical spa, within 14 days of a request by the board.
	13.8(6) Continuing medical education. All medical directors, qualified licensed or certified nonphysician persons and qualified laser technicians who practice at a medical spa in Iowa shall complete a minimum of 20 hours of continuing medical education in the safe and effective performance of medical aesthetic services each year.
	13.8(7) Exceptions. This rule is not intended to apply to physicians who serve as medical directors of licensed medical facilities, clinics or practices that provide medical aesthetic services as part of or incident to their other medical services.
	13.8(8) Physician assistants. Nothing in this rule shall be interpreted to contradict or supersede the rules established in 645—Chapters 326 and 327.
[ARC 9088B, IAB 9/22/10, effective 10/27/10; ARC 4247C, IAB 1/16/19, effective 2/20/19]
653—13.9(147,148,272C) Standards of practice—interventional chronic pain management. This rule establishes standards of practice for the practice of interventional chronic pain management. The purpose of this rule is to assist physicians who consider interventional techniques to treat patients with chronic pain.
	13.9(1) Definition. As used in this rule:
“Interventional chronic pain management” means the diagnosis and treatment of pain-related disorders with the application of interventional techniques in managing subacute, chronic, persistent, and intractable pain. Interventional techniques include percutaneous (through the skin) needle placement to inject drugs in targeted areas. Interventional techniques also include nerve ablation (excision or amputation) and certain surgical procedures. Interventional techniques often involve injection of steroids, analgesics, and anesthetics and include: lumbar, thoracic, and cervical spine injections, intra-articular injections, intrathecal injections, epidural injections (both regular and transforaminal), facet injections, discography, nerve destruction, occipital nerve blocks, lumbar sympathetic blocks and vertebroplasty, and kyphoplasty. Interventional chronic pain management includes the use of fluoroscopy when it is used to assess the cause of a patient’s chronic pain or when it is used to identify anatomic landmarks during interventional techniques. Specific interventional techniques include: SI joint injections; spinal punctures; epidural blood patches; epidural injections; epidural/spinal injections; lumbar injections; epidural/subarachnoid catheters; occipital nerve blocks; axillary nerve blocks; intercostals nerve blocks; multiple intercostals nerve blocks; ilioinguinal nerve blocks; peripheral nerve blocks; facet joint injections; cervical/thoracic facet joint injections; lumbar facet injections; multiple lumbar facet injections; transforaminal epidural steroid injections; transforaminal cervical steroid injections; sphenopalatine ganglion blocks; paravertebral sympathetic blocks; neurolysis of the lumbar facet nerve; neurolysis of the cervical facet nerve; and destruction of the peripheral nerve.
	13.9(2) Interventional chronic pain management. The practice of interventional chronic pain management shall include the following:
	a. 	Comprehensive assessment of the patient;
	b. 	Diagnosis of the cause of the patient’s pain;
	c. 	Evaluation of alternative treatment options;
	d. 	Selection of appropriate treatment options;
	e. 	Termination of prescribed treatment options when appropriate;
	f. 	Follow-up care; and
	g. 	Collaboration with other health care providers.
	13.9(3) Practice of medicine. Interventional chronic pain management is the practice of medicine.
[ARC 8918B, IAB 6/30/10, effective 8/4/10]
653—13.10(147,148,272C) Standards of practice—physicians who prescribe or administer abortion-inducing drugs.
	13.10(1) Definition. As used in this rule:
“Abortion-inducing drug” means a drug, medicine, mixture, or preparation, when it is prescribed or administered with the intent to terminate the pregnancy of a woman known to be pregnant.
	13.10(2) Physical examination required. A physician shall not induce an abortion by providing an abortion-inducing drug unless the physician has first performed a physical examination of the woman to determine, and document in the woman’s medical record, the gestational age and intrauterine location of the pregnancy.
	13.10(3) Physician’s physical presence required. When inducing an abortion by providing an abortion-inducing drug, a physician must be physically present with the woman at the time the abortion-inducing drug is provided.
	13.10(4) Follow-up appointment required. If an abortion is induced by an abortion-inducing drug, the physician inducing the abortion must schedule a follow-up appointment with the woman at the same facility where the abortion-inducing drug was provided, 12 to 18 days after the woman’s use of an abortion-inducing drug to confirm the termination of the pregnancy and evaluate the woman’s medical condition. The physician shall use all reasonable efforts to ensure that the woman is aware of the follow-up appointment and that she returns for the appointment.
	13.10(5) Parental notification regarding pregnant minors. A physician shall not induce an abortion by providing an abortion-inducing drug to a pregnant minor prior to compliance with the requirements of Iowa Code chapter 135L and rules 641—89.12(135L) and 641—89.21(135L) adopted by the public health department.
[ARC 1034C, IAB 10/2/13, effective 11/6/13]
653—13.11(147,148,272C) Standards of practice—telemedicine. This rule establishes standards of practice for the practice of medicine using telemedicine.
	1.	The board recognizes that technological advances have made it possible for licensees in one location to provide medical care to patients in another location with or without an intervening health care provider.
	2.	Telemedicine is a useful tool that, if applied appropriately, can provide important benefits to patients, including increased access to health care, expanded utilization of specialty expertise, rapid availability of patient records, and potential cost savings.
	3.	The board advises that licensees using telemedicine will be held to the same standards of care and professional ethics as licensees using traditional in-person medical care.
	4.	Failure to conform to the appropriate standards of care or professional ethics while using telemedicine may subject the licensee to potential discipline by the board.
	13.11(1) Definitions. As used in this rule:
“Asynchronous store-and-forward transmission” means the collection of a patient’s relevant health information and the subsequent transmission of the data from an originating site to a health care provider at a distant site without the presence of the patient.
“Board” means the Iowa board of medicine.
“In-person encounter” means that the physician and the patient are in the physical presence of each other and are in the same physical location during the physician-patient encounter.
“Licensee” means a medical physician or osteopathic physician licensed by the board.
“Telemedicine” means the practice of medicine using electronic audio-visual communications and information technologies or other means, including interactive audio with asynchronous store-and-forward transmission, between a licensee in one location and a patient in another location with or without an intervening health care provider. Telemedicine includes asynchronous store-and-forward technologies, remote monitoring, and real-time interactive services, including teleradiology and telepathology. Telemedicine shall not include the provision of medical services only through an audio-only telephone, email messages, facsimile transmissions, or U.S. mail or other parcel service, or any combination thereof.
“Telemedicine technologies” means technologies and devices enabling secure electronic communications and information exchanges between a licensee in one location and a patient in another location with or without an intervening health care provider.
	13.11(2) Practice guidelines. A licensee who uses telemedicine shall utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes. The board acknowledges that some nationally recognized medical specialty organizations have established comprehensive telemedicine practice guidelines that address the clinical and technological aspects of telemedicine for many medical specialties.
	13.11(3) Iowa medical license required. A physician who uses telemedicine in the diagnosis and treatment of a patient located in Iowa shall hold an active Iowa medical license consistent with state and federal laws. Nothing in this rule shall be construed to supersede the exceptions to licensure contained in 653—subrule 9.2(2).
	13.11(4) Standards of care and professional ethics. A licensee who uses telemedicine shall be held to the same standards of care and professional ethics as a licensee using traditional in-person encounters with patients. Failure to conform to the appropriate standards of care or professional ethics while using telemedicine may be a violation of the laws and rules governing the practice of medicine and may subject the licensee to potential discipline by the board.
	13.11(5) Scope of practice. A licensee who uses telemedicine shall ensure that the services provided are consistent with the licensee’s scope of practice, including the licensee’s education, training, experience, ability, licensure, and certification.
	13.11(6) Identification of patient and physician. A licensee who uses telemedicine shall verify the identity of the patient and ensure that the patient has the ability to verify the identity, licensure status, certification, and credentials of all health care providers who provide telemedicine services prior to the provision of care.
	13.11(7) Physician-patient relationship.
	a. 	A licensee who uses telemedicine shall establish a valid physician-patient relationship with the person who receives telemedicine services. The physician-patient relationship begins when:
	(1)	The person with a health-related matter seeks assistance from a licensee;
	(2)	The licensee agrees to undertake diagnosis and treatment of the person; and
	(3)	The person agrees to be treated by the licensee whether or not there has been an in-person encounter between the physician and the person.
	b. 	A valid physician-patient relationship may be established by:
	(1)	In-person encounter. Through an in-person medical interview and physical examination where the standard of care would require an in-person encounter;
	(2)	Consultation with another licensee. Through consultation with another licensee (or other health care provider) who has an established relationship with the patient and who agrees to participate in, or supervise, the patient’s care; or
	(3)	Telemedicine encounter. Through telemedicine, if the standard of care does not require an in-person encounter, and in accordance with evidence-based standards of practice and telemedicine practice guidelines that address the clinical and technological aspects of telemedicine.
	13.11(8) Medical history and physical examination. Generally, a licensee shall perform an in-person medical interview and physical examination for each patient. However, the medical interview and physical examination may not be in-person if the technology utilized in a telemedicine encounter is sufficient to establish an informed diagnosis as though the medical interview and physical examination had been performed in-person. Prior to providing treatment, including issuing prescriptions, electronically or otherwise, a licensee who uses telemedicine shall interview the patient to collect the relevant medical history and perform a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient. An Internet questionnaire that is a static set of questions provided to the patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview, does not constitute an acceptable medical interview and physical examination for the provision of treatment, including issuance of prescriptions, electronically or otherwise, by a licensee.
	13.11(9) Nonphysician health care providers. If a licensee who uses telemedicine relies upon or delegates the provision of telemedicine services to a nonphysician health care provider, the licensee shall:
	a. 	Ensure that systems are in place to ensure that the nonphysician health care provider is qualified and trained to provide that service within the scope of the nonphysician health care provider’s practice;
	b. 	Ensure that the licensee is available in person or electronically to consult with the nonphysician health care provider, particularly in the case of injury or an emergency.
	13.11(10) Informed consent. A licensee who uses telemedicine shall ensure that the patient provides appropriate informed consent for the medical services provided, including consent for the use of telemedicine to diagnose and treat the patient, and that such informed consent is timely documented in the patient’s medical record.
	13.11(11) Coordination of care. A licensee who uses telemedicine shall, when medically appropriate, identify the medical home or treating physician(s) for the patient, when available, where in-person services can be delivered in coordination with the telemedicine services. The licensee shall provide a copy of the medical record to the patient’s medical home or treating physician(s).
	13.11(12) Follow-up care. A licensee who uses telemedicine shall have access to, or adequate knowledge of, the nature and availability of local medical resources to provide appropriate follow-up care to the patient following a telemedicine encounter.
	13.11(13) Emergency services. A licensee who uses telemedicine shall refer a patient to an acute care facility or an emergency department when referral is necessary for the safety of the patient or in the case of an emergency.
	13.11(14) Medical records. A licensee who uses telemedicine shall ensure that complete, accurate and timely medical records are maintained for the patient when appropriate, including all patient-related electronic communications, records of past care, physician-patient communications, laboratory and test results, evaluations and consultations, prescriptions, and instructions obtained or produced in connection with the use of telemedicine technologies. The licensee shall note in the patient’s record when telemedicine is used to provide diagnosis and treatment. The licensee shall ensure that the patient or another licensee designated by the patient has timely access to all information obtained during the telemedicine encounter. The licensee shall ensure that the patient receives, upon request, a summary of each telemedicine encounter in a timely manner.
	13.11(15) Privacy and security. A licensee who uses telemedicine shall ensure that all telemedicine encounters comply with the privacy and security measures of the Health Insurance Portability and Accountability Act to ensure that all patient communications and records are secure and remain confidential.
	a. 	Written protocols shall be established that address the following:
	(1)	Privacy;
	(2)	Health care personnel who will process messages;
	(3)	Hours of operation;
	(4)	Types of transactions that will be permitted electronically;
	(5)	Required patient information to be included in the communication, including patient name, identification number and type of transaction;
	(6)	Archiving and retrieval; and
	(7)	Quality oversight mechanisms.
	b. 	The written protocols should be periodically evaluated for currency and should be maintained in an accessible and readily available manner for review. The written protocols shall include sufficient privacy and security measures to ensure the confidentiality and integrity of patient-identifiable information, including password protection, encryption or other reliable authentication techniques.
	13.11(16) Technology and equipment. The board recognizes that three broad categories of telemedicine technologies currently exist, including asynchronous store-and-forward technologies, remote monitoring, and real-time interactive services. While some telemedicine programs are multispecialty in nature, others are tailored to specific diseases and medical specialties. The technology and equipment utilized for telemedicine shall comply with the following requirements:
	a. 	The technology and equipment utilized in the provision of telemedicine services must comply with all relevant safety laws, rules, regulations, and codes for technology and technical safety for devices that interact with patients or are integral to diagnostic capabilities;
	b. 	The technology and equipment utilized in the provision of telemedicine services must be of sufficient quality, size, resolution and clarity such that the licensee can safely and effectively provide the telemedicine services; and
	c. 	The technology and equipment utilized in the provision of telemedicine services must be compliant with the Health Insurance Portability and Accountability Act.
	13.11(17) Disclosure and functionality of telemedicine services. A licensee who uses telemedicine shall ensure that the following information is clearly disclosed to the patient:
	a. 	Types of services provided;
	b. 	Contact information for the licensee;
	c. 	Identity, licensure, certification, credentials, and qualifications of all health care providers who are providing the telemedicine services;
	d. 	Limitations in the drugs and services that can be provided via telemedicine;
	e. 	Fees for services, cost-sharing responsibilities, and how payment is to be made, if these differ from an in-person encounter;
	f. 	Financial interests, other than fees charged, in any information, products, or services provided by the licensee(s);
	g. 	Appropriate uses and limitations of the technologies, including in emergency situations;
	h. 	Uses of and response times for emails, electronic messages and other communications transmitted via telemedicine technologies;
	i. 	To whom patient health information may be disclosed and for what purpose;
	j. 	Rights of patients with respect to patient health information; and
	k. 	Information collected and passive tracking mechanisms utilized.
	13.11(18) Patient access and feedback. A licensee who uses telemedicine shall ensure that the patient has easy access to a mechanism for the following purposes:
	a. 	To access, supplement and amend patient-provided personal health information;
	b. 	To provide feedback regarding the quality of the telemedicine services provided; and
	c. 	To register complaints. The mechanism shall include information regarding the filing of complaints with the board.
	13.11(19) Financial interests. Advertising or promotion of goods or products from which the licensee(s) receives direct remuneration, benefit or incentives (other than the fees for the medical services) is prohibited to the extent that such activities are prohibited by state or federal law. Notwithstanding such prohibition, Internet services may provide links to general health information sites to enhance education; however, the licensee(s) should not benefit financially from providing such links or from the services or products marketed by such links. When providing links to other sites, licensees should be aware of the implied endorsement of the information, services or products offered from such sites. The maintenance of a preferred relationship with any pharmacy is prohibited. Licensees shall not transmit prescriptions to a specific pharmacy, or recommend a pharmacy, in exchange for any type of consideration or benefit from the pharmacy.
	13.11(20) Circumstances where the standard of care may not require a licensee to personally interview or examine a patient. Under the following circumstances, whether or not such circumstances involve the use of telemedicine, a licensee may treat a patient who has not been personally interviewed, examined and diagnosed by the licensee:
	a. 	Situations in which the licensee prescribes medications on a short-term basis for a new patient and has scheduled or is in the process of scheduling an appointment to personally examine the patient;
	b. 	For institutional settings, including writing initial admission orders for a newly hospitalized patient;
	c. 	Call situations in which a licensee is taking call for another licensee who has an established physician-patient relationship with the patient;
	d. 	Cross-coverage situations in which a licensee is taking call for another licensee who has an established physician-patient relationship with the patient;
	e. 	Situations in which the patient has been examined in person by an advanced registered nurse practitioner or a physician assistant or other licensed practitioner with whom the licensee has a supervisory or collaborative relationship;
	f. 	Emergency situations in which the life or health of the patient is in imminent danger;
	g. 	Emergency situations that constitute an immediate threat to the public health including, but not limited to, empiric treatment or prophylaxis to prevent or control an infectious disease outbreak;
	h. 	Situations in which the licensee has diagnosed a sexually transmitted disease in a patient and the licensee prescribes or dispenses antibiotics to the patient’s named sexual partner(s) for the treatment of the sexually transmitted disease as recommended by the U.S. Centers for Disease Control and Prevention; and
	i. 	For licensed or certified nursing facilities, residential care facilities, intermediate care facilities, assisted living facilities and hospice settings.
	13.11(21) Prescribing based solely on an Internet request, Internet questionnaire or a telephonic evaluation—prohibited. Prescribing to a patient based solely on an Internet request or Internet questionnaire (i.e., a static questionnaire provided to a patient, to which the patient responds with a static set of answers, in contrast to an adaptive, interactive and responsive online interview) is prohibited. Absent a valid physician-patient relationship, a licensee’s prescribing to a patient based solely on a telephonic evaluation is prohibited, with the exception of the circumstances described in subrule 13.11(20).
	13.11(22) Medical abortion. Nothing in this rule shall be interpreted to contradict or supersede the requirements established in rule 653—13.10(147,148,272C).
This rule is intended to implement Iowa Code chapters 147, 148 and 272C.
[ARC 1983C, IAB 4/29/15, effective 6/3/15]
653—13.12(135,147,148,272C,280) Standards of practice—prescribing epinephrine auto-injectors in the name of an authorized facility.
	13.12(1) Definitions. For purposes of this rule:
“Authorized facility” means any nonpublic school which is accredited pursuant to Iowa Code section 256.11, any school directly supported in whole or in part by taxation, a food establishment as defined in Iowa Code section 137F.1, a carnival as defined in Iowa Code section 88A.1, a recreational camp, a youth sports facility, or a sports area.
“Epinephrine auto-injector” means a device for immediate self-administration or administration by another trained person of a measured dose of epinephrine to a person at risk of anaphylaxis.
“Physician” means a person licensed pursuant to Iowa Code chapter 148 to practice medicine and surgery or osteopathic medicine and surgery.
	13.12(2) Notwithstanding any other provision of law to the contrary, a physician may prescribe epinephrine auto-injectors in the name of an authorized facility to be maintained for use pursuant to Iowa Code sections 135.185, 280.16 and 280.16A.
	13.12(3) A physician who prescribes epinephrine auto-injectors in the name of an authorized facility to be maintained for use pursuant to Iowa Code sections 135.185, 280.16 and 280.16A, provided the physician has acted reasonably and in good faith, shall not be liable for any injury arising from the provision, administration, or assistance in the administration of an epinephrine auto-injector.
[ARC 2387C, IAB 2/3/16, effective 3/9/16]
653—13.13(144E,147,148,272C) Standards of practice—experimental treatments for patients with a terminal illness.
	13.13(1) Exemption from discipline. To the extent consistent with state law, the board shall not revoke, fail to renew, suspend, or take any action against a physician’s license based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device.
	13.13(2) Eligible patient. A physician shall ensure that a patient meets all of the following conditions prior to the use of an investigational drug, biological product, or device pursuant to this rule:
	a. 	The patient has a terminal illness, attested to by the patient’s treating physician.
	b. 	The patient has considered and rejected or has tried and failed to respond to all other treatment options approved by the U.S. Food and Drug Administration (FDA).
	c. 	The patient has received a recommendation from the patient’s physician for an investigational drug, biological product, or device.
	d. 	The patient has given written informed consent for the use of the investigational drug, biological product, or device.
	e. 	The patient has documentation from the patient’s physician that the patient meets the requirements of this rule.
	13.13(3) Investigational drug, biological product, or device. A physician may recommend access to or treatment with an investigational drug, biological product, or device that has successfully completed phase 1 of an FDA-approved clinical trial but has not yet been approved for general use by the FDA and remains under investigation in an FDA-approved clinical trial.
	13.13(4) Terminal illness. A physician shall ensure that a patient has a terminal illness prior to the use of an investigational drug, biological product, or device pursuant to this rule. A terminal illness is a progressive disease or medical or surgical condition that entails significant functional impairment and that is not considered by a treating physician to be reversible even with administration of treatments approved by the FDA and that, without life-sustaining procedures, will result in death.
	13.13(5) Written informed consent. A physician shall obtain written informed consent prior to the use of an investigational drug, biological product, or device pursuant to this rule. Written informed consent is a written document that is signed by a patient, a parent of a minor patient, or a legal guardian or other legal representative of the patient and attested to by the patient’s treating physician and a witness and that includes all of the following:
	a. 	An explanation of the products and treatments approved by the FDA for the disease or condition from which the patient suffers.
	b. 	An attestation that the patient concurs with the patient’s treating physician in believing that all products and treatments approved by the FDA are unlikely to prolong the patient’s life.
	c. 	Clear identification of the specific proposed investigational drug, biological product, or device that the patient is seeking to use.
	d. 	A description of the best and worst potential outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by use of the proposed investigational drug, biological product, or device. The description shall be based on the treating physician’s knowledge of the proposed investigational drug, biological product, or device in conjunction with an awareness of the patient’s condition.
	e. 	A statement that the patient’s health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device, unless the patient’s health plan or third-party administrator and provider are specifically required to do so by law or contract.
	f. 	A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if treatment ends and the patient meets hospice eligibility requirements.
	g. 	A statement that the patient understands that the patient is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that this liability extends to the patient’s estate unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.
	13.13(6) Assisting suicide. This rule shall not be construed to allow a patient’s treating physician to assist the patient in committing or attempting to commit suicide as prohibited in Iowa Code section 707A.2.
	13.13(7) Grounds for discipline. A physician may be subject to disciplinary action for violation of rule 653—13.13(144E,147,148,272C) or 653—Chapter 23. Grounds for discipline include, but are not limited to, the following:
	a. 	The physician recommends access to or treatment with an investigational drug, biological product, or device to an individual who is not an eligible patient pursuant to this rule.
	b. 	The physician fails to obtain appropriate written informed consent prior to recommending access to or treatment with an investigational drug, biological product, or device pursuant to this rule.
	c. 	The physician assists the patient in committing or attempting to commit suicide as prohibited in Iowa Code section 707A.2.
This rule is intended to implement Iowa Code chapters 144E, 147, 148 and 272C.
[ARC 3588C, IAB 1/17/18, effective 2/21/18]
653—13.14(147,148,272C) Standards of practice—tick-borne disease diagnosis and treatment.
	13.14(1) Exemption from discipline. A person licensed by the board under Iowa Code chapter 148 shall not be subject to discipline under this chapter or the board’s enabling statute based solely on the physician’s recommendation or provision of a treatment method for Lyme disease or other tick-borne disease if the recommendation or provision of such treatment meets all the following criteria:
	a. 	The treatment is provided after an examination is performed and informed consent is received from the patient.
	b. 	The physician identifies a medical reason for recommending or providing the treatment.
	c. 	The treatment is provided after the physician informs the patient about other recognized treatment options and describes to the patient the physician’s education, experience, and credentials regarding the treatment of Lyme disease or other tick-borne disease.
	d. 	The physician uses the physician’s own medical judgment based on a thorough review of all available clinical information and Lyme disease or other tick-borne disease literature to determine the best course of treatment for the individual patient.
	e. 	The treatment will not, in the opinion of the physician, result in the direct and proximate death of or serious bodily injury to the patient.
	13.14(2) Lyme disease. According to the Centers for Disease Control and Prevention (CDC), Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans through the bite of infected blacklegged ticks, commonly known as deer ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed based on symptoms, physical findings (e.g., a rash), and the possibility of exposure to infected ticks. Laboratory testing is helpful if used correctly and performed with validated methods. Steps to prevent Lyme disease include using insect repellent, removing ticks promptly, applying pesticides, and reducing tick habitat. The ticks that transmit Lyme disease can occasionally transmit other tick-borne diseases as well.
	13.14(3) Lyme disease treatment. Most cases of Lyme disease can be treated successfully with a few weeks of antibiotics. Over the past several years, the International Lyme and Associated Diseases Society (ILADS) has supported longer courses of antibiotics for some patients, versus the prescribed treatment durations identified by the Infectious Diseases Society of America (IDSA) and referenced by the CDC. While IDSA has expressed concern about overtreatment, ILADS points out that treatment decisions should be based on a risk-benefit analysis. Both groups have published evidence-based guidelines.
	13.14(4) Tick-borne diseases. According to the CDC, tick-borne diseases include:
	a. 	Anaplasmosis is transmitted to humans by tick bites primarily from the blacklegged tick (Ixodes scapularis) in the northeastern and upper midwestern regions of the United States (U.S.) and the western blacklegged tick (Ixodes pacificus) along the Pacific coast.
	b. 	Babesiosis is caused by microscopic parasites that infect red blood cells. Most human cases of babesiosis in the U.S. are caused by Babesia microti. Babesia microti is transmitted by the blacklegged tick (Ixodes scapularis) and is found primarily in the northeastern and upper midwestern regions of the U.S.
	c. 	Borrelia mayonii infection has recently been described as a cause of illness in the upper midwestern region of the U.S. This infection has been found in blacklegged ticks (Ixodes scapularis) in Minnesota and Wisconsin. Borrelia mayonii is a new species and is the only species besides B. burgdorferi known to cause Lyme disease in North America.
	d. 	Borrelia miyamotoi infection has recently been described as a cause of illness in the U.S. This infection is transmitted by the blacklegged tick (Ixodes scapularis) and has a geographic range similar to that of Lyme disease.
	e. 	Bourbon virus infection has been identified in a limited number of patients in the midwestern and southern regions of the U.S. At this time, it is not known if the virus might be found in other areas of the U.S.
	f. 	Colorado tick fever is caused by a virus transmitted by the Rocky Mountain wood tick (Dermacentor andersoni). Colorado tick fever occurs in the Rocky Mountain states at elevations of 4,000 to 10,500 feet.
	g. 	Ehrlichiosis is transmitted to humans by the lone star tick (Amblyomma americanum), found primarily in the south central and eastern regions of the U.S.
	h. 	Heartland virus cases have been identified in the midwestern and southern regions of the U.S. Studies suggest that lone star ticks (Amblyomma americanum) can transmit the virus. It is unknown if the virus may be found in other areas of the U.S.
	i. 	Lyme disease is transmitted by the blacklegged tick (Ixodes scapularis) in the northeastern and upper midwestern regions of the U.S. and by the western blacklegged tick (Ixodes pacificus) along the Pacific coast.
	j. 	Powassan disease is transmitted by the blacklegged tick (Ixodes scapularis) and the groundhog tick (Ixodes cookei). Cases have been reported primarily from northeastern states and the Great Lakes region.
	k. 	Rickettsia parkeri rickettsiosis is transmitted to humans by the Gulf Coast tick (Amblyomma maculatum).
	l. 	Rocky Mountain spotted fever is transmitted by the American dog tick (Dermacentor variabilis), Rocky Mountain wood tick (Dermacentor andersoni), and the brown dog tick (Rhipicephalus sanguineus) in the U.S. The brown dog tick and other tick species are associated with Rocky Mountain spotted fever in Central America and South America.
	m. 	Southern tick-associated rash illness is transmitted via bites from the lone star tick (Amblyomma americanum) found in the southeastern and eastern regions of the U.S.
	n. 	Tick-borne relapsing fever is transmitted to humans through the bite of infected soft ticks. Tick-borne relapsing fever has been reported in 15 states: Arizona, California, Colorado, Idaho, Kansas, Montana, Nevada, New Mexico, Ohio, Oklahoma, Oregon, Texas, Utah, Washington, and Wyoming and is associated with sleeping in rustic cabins and vacation homes.
	o. 	Tularemia is transmitted to humans by the dog tick (Dermacentor variabilis), the wood tick (Dermacentor andersoni), and the lone star tick (Amblyomma americanum). Tularemia occurs throughout the U.S.
	p. 	364D rickettsiosis (Rickettsia phillipi) is transmitted to humans by the Pacific Coast tick (Dermacentor occidentalis). This is a new disease that has been found in California.
	13.14(5) Grounds for discipline. A physician may be subject to disciplinary action for violation of these rules or the rules found in 653—Chapter 23. Grounds for discipline include, but are not limited to, the following:
	a. 	The physician fails to perform and document an appropriate examination or fails to obtain and document appropriate informed consent from the patient.
	b. 	The physician fails to identify and document a medical reason for recommending or providing the treatment.
	c. 	The physician fails to inform the patient about other recognized treatment options or fails to describe to the patient the physician’s education, experience, and credentials regarding the treatment of Lyme disease or other tick-borne diseases.
	d. 	The physician fails to use the physician’s own medical judgment based on a thorough review of all available clinical information and Lyme disease or other tick-borne disease literature to determine the best course of treatment for the individual patient.
	e. 	The treatment provided, in the opinion of the physician, will likely result in the direct and proximate death of or serious bodily injury to the patient.
This rule is intended to implement Iowa Code chapters 147, 148 and 272C.
[ARC 3589C, IAB 1/17/18, effective 2/21/18]
653—13.15(124E,147,148,272C) Standards of practice—medical cannabidiol.
	13.15(1) Definitions. For purposes of this rule:
“Board of medicine” means the board established pursuant to Iowa Code chapters 147 and 148.
“Bordering state” means the same as defined in Iowa Code section 331.910.
“Debilitating medical condition” means any of the following:
	1.	Cancer, if the underlying condition or treatment produces one or more of the following:
	●	Severe or chronic pain.
	●	Nausea or severe vomiting.
	●	Cachexia or severe wasting.
	2.	Multiple sclerosis with severe and persistent muscle spasms.
	3.	Seizures, including those characteristic of epilepsy.
	4.	AIDS or HIV as defined in Iowa Code section 141A.1.
	5.	Crohn’s disease.
	6.	Amyotrophic lateral sclerosis.
	7.	Any terminal illness, with a probable life expectancy of under one year, if the illness or its treatment produces one or more of the following:
	●	Severe or chronic pain.
	●	Nausea or severe vomiting.
	●	Cachexia or severe wasting.
	8.	Parkinson’s disease.
	9.	Untreatable pain.
	10.	Ulcerative colitis.
	11.	Severe, intractable pediatric autism with self-injurious or aggressive behaviors.
	12.	Corticobasal degeneration.
“Department” means the Iowa department of public health.
“Form and quantity” means the types and amounts of medical cannabidiol allowed to be dispensed to a patient or primary caregiver as approved by the department subject to recommendation by the medical cannabidiol board and approval by the board of medicine.
“Medical cannabidiol”  means any pharmaceutical grade cannabinoid found in the plant Cannabis sativa L. or Cannabis indica or any other preparation thereof that has a tetrahydrocannabinol level of no more than 3 percent and that is delivered in a form recommended by the medical cannabidiol board, approved by the board of medicine, and adopted by the department pursuant to rule.
“Medical cannabidiol board” means the board established pursuant to Iowa Code section 124E.5.
“Primary caregiver” means a person who is a resident of this state or a bordering state, including but not limited to a parent or legal guardian, at least 18 years of age, who has been designated by a patient’s health care practitioner as a necessary caretaker taking responsibility for managing the well-being of the patient with respect to the use of medical cannabidiol pursuant to the provisions of this chapter.
“Untreatable pain” means any pain whose cause cannot be removed and, according to generally accepted medical practice, the full range of pain management modalities appropriate for the patient has been used without adequate result or with intolerable side effects.
“Written certification” means a document signed by a physician licensed pursuant to Iowa Code chapter 148 with whom the patient has established a patient-physician relationship and who is the patient’s primary care provider which states that the patient has a debilitating medical condition and identifies that condition and provides any other relevant information.
	13.15(2) Written certification. A physician who is a patient’s primary care provider may provide the patient a written certification of diagnosis if, after examining and treating the patient, the physician determines, in the physician’s medical judgment, that the patient suffers from a debilitating medical condition that qualifies for the use of medical cannabidiol pursuant to Iowa Code chapter 124E.
	a. 	The physician shall provide explanatory information as provided by the department to the patient about the therapeutic use of medical cannabidiol and the possible risks, benefits, and side effects of the proposed treatment.
	b. 	Subsequently, the physician shall do the following:
	(1)	Determine, on an annual basis, if the patient continues to suffer from a debilitating medical condition and, if so, may issue the patient a new written certification of that diagnosis.
	(2)	Otherwise comply with all requirements established by the department pursuant to rule.
	c. 	A physician may provide, but has no duty to provide, a written certification pursuant to this rule.
	13.15(3) Adding or removing debilitating medical conditions and amending form and quantity of medical cannabidiol. Recommendations made by the medical cannabidiol board pursuant to Iowa Code section 124E.5 relating to the addition or removal of allowable debilitating medical conditions for which the medical use of cannabidiol would be medically beneficial or to the amendment of the form and quantity of allowable medical uses of cannabidiol shall be made to the board of medicine for consideration. The medical cannabidiol board shall submit a written recommendation, a copy of the petition and all other information received during consideration of the petition. The board of medicine shall consider the information received from the medical cannabidiol board and may seek information from other sources if it is deemed relevant by the board of medicine. The decision regarding a recommendation by the medical cannabidiol board is at the sole discretion of the board of medicine. The board of medicine shall make its decision within 180 days of receipt of the recommendation from the medical cannabidiol board. If the recommendation is approved by the board of medicine, it shall be adopted by rule.
	13.15(4) Financial interests. A physician shall not share office space with, accept referrals from, or have any financial relationship with a medical cannabidiol manufacturer or dispensary.
	13.15(5) Criminal prosecution. A physician, including any authorized agent or employee thereof, shall not be subject to prosecution for the unlawful certification, possession, or administration of marijuana under the laws of this state for activities arising directly out of or directly related to the certification or use of medical cannabidiol in the treatment of a patient diagnosed with a debilitating medical condition as authorized by Iowa Code chapter 124E.
	13.15(6) Civil or disciplinary penalties. A physician, including any authorized agent or employee thereof, shall not be subject to any civil or disciplinary penalties by the board of medicine or any business, occupational, or professional licensing board or entity, solely for activities conducted relating to a patient’s possession or use of medical cannabidiol as authorized by Iowa Code chapter 124E. Nothing in this rule prevents the board of medicine from taking action in response to violations of any other sections of law or rule.
	13.15(7) Grounds for discipline. A physician may be subject to disciplinary action for violation of these rules or the rules found in 653—Chapter 23. Grounds for discipline include, but are not limited to, the following:
	a. 	The physician provides an individual a written certification without establishing a patient-physician relationship, including examining and treating the individual, or without being the individual’s primary care provider.
	b. 	The physician provides a patient a written certification without determining, in the physician’s medical judgment, that the patient suffers from a debilitating medical condition that qualifies for the use of medical cannabidiol pursuant to Iowa Code chapter 124E.
	c. 	The physician provides a patient a written certification without providing explanatory information as provided by the department to the patient about the therapeutic use of medical cannabidiol and the possible risks, benefits, and side effects of the proposed treatment.
	d. 	The physician provides an individual a new written certification without determining, on an annual basis, that the patient continues to suffer from a debilitating medical condition.
	e. 	The physician shares office space with, accepts referrals from, or has a financial relationship with a medical cannabidiol manufacturer or dispensary.
This rule is intended to implement Iowa Code chapters 124E, 147, 148 and 272C.
[ARC 3830C, IAB 6/6/18, effective 7/11/18; ARC 4248C, IAB 1/16/19, effective 2/20/19; ARC 4377C, IAB 3/27/19, effective 5/1/19; ARC 4658C, IAB 9/11/19, effective 10/16/19]
653—13.16 to 13.19  Reserved.
653—13.20(147,148) Principles of medical ethics. The Code of Medical Ethics (2002-2003) prepared and approved by the American Medical Association and the Code of Ethics (2002-2003) prepared and approved by the American Osteopathic Association shall be utilized by the board as guiding principles in the practice of medicine and surgery and osteopathic medicine and surgery in this state.
	13.20(1) Conflict of interest. A physician should not provide medical services under terms or conditions which tend to interfere with or impair the free and complete exercise of the physician’s medical judgment and skill or tend to cause a deterioration of the quality of medical care.
	13.20(2) Fees. Any fee charged by a physician shall be reasonable.
653—13.21(17A,147,148,272C) Waiver or variance prohibited. Rules in this chapter are not subject to waiver or variance pursuant to 653—Chapter 3 or any other provision of law.
[Filed 2/5/79, Notice 11/29/78—published 2/21/79, effective 3/29/79]
[Filed 3/13/81, Notice 1/7/81—published 4/1/81, effective 5/6/81]
[Filed emergency 4/15/88—published 5/4/88, effective 4/15/88]
[Filed 5/11/90, Notice 3/7/90—published 5/30/90, effective 6/6/90]
[Filed 3/22/96, Notice 9/27/95—published 4/10/96, effective 6/15/96]1
[Filed 11/22/96, Notice 8/28/96—published 12/18/96, effective 1/22/97]
[Filed 5/2/97, Notice 3/26/97—published 5/21/97, effective 6/25/97]
[Filed 11/7/00, Notice 4/19/00—published 11/29/00, effective 1/3/01]
[Filed 12/1/00, Notice 10/18/00—published 12/27/00, effective 1/31/01]
[Filed 2/16/01, Notice 12/27/00—published 3/7/01, effective 4/11/01]
[Filed emergency 8/31/01 after Notice 7/25/01—published 9/19/01, effective 8/31/01]
[Filed 2/14/02, Notice 1/9/02—published 3/6/02, effective 4/10/02]
[Filed 6/6/02, Notice 5/1/02—published 6/26/02, effective 7/31/02]
[Filed 1/3/03, Notice 11/27/02—published 1/22/03, effective 2/26/03]
[Filed 12/4/03, Notice 8/20/03—published 12/24/03, effective 1/28/04]
[Filed 5/20/04, Notice 4/14/04—published 6/9/04, effective 7/14/04]
[Filed 5/3/06, Notice 2/15/06—published 5/24/06, effective 10/1/06]
[Filed 6/28/07, Notice 5/9/07—published 8/1/07, effective 9/5/07]
[Filed 4/3/08, Notice 2/13/08—published 4/23/08, effective 5/28/08]
[Filed 9/18/08, Notice 8/13/08—published 10/8/08, effective 11/12/08]
[Filed ARC 8918B (Notice ARC 8579B, IAB 3/10/10), IAB 6/30/10, effective 8/4/10]
[Filed ARC 9088B (Notice ARC 8925B, IAB 6/30/10), IAB 9/22/10, effective 10/27/10]
[Filed ARC 9599B (Notice ARC 9414B, IAB 3/9/11), IAB 7/13/11, effective 8/17/11]
[Filed ARC 1033C (Notice ARC 0890C, IAB 7/24/13), IAB 10/2/13, effective 11/6/13]
[Filed ARC 1034C (Notice ARC 0891C, IAB 7/24/13), IAB 10/2/13, effective 11/6/13]
[Filed ARC 1983C (Notice ARC 1769C, IAB 12/10/14), IAB 4/29/15, effective 6/3/15]
[Filed ARC 2387C (Notice ARC 2249C, IAB 11/25/15), IAB 2/3/16, effective 3/9/16]
[Filed ARC 2705C (Notice ARC 2535C, IAB 5/11/16), IAB 9/14/16, effective 10/19/16]
[Filed ARC 3588C (Notice ARC 3360C, IAB 10/11/17), IAB 1/17/18, effective 2/21/18]
[Filed ARC 3589C (Notice ARC 3361C, IAB 10/11/17), IAB 1/17/18, effective 2/21/18]
[Filed ARC 3830C (Notice ARC 3675C, IAB 3/14/18), IAB 6/6/18, effective 7/11/18]
[Filed ARC 4247C (Notice ARC 4093C, IAB 10/24/18), IAB 1/16/19, effective 2/20/19]
[Filed ARC 4248C (Notice ARC 4082C, IAB 10/24/18), IAB 1/16/19, effective 2/20/19]
[Filed ARC 4377C (Notice ARC 4241C, IAB 1/16/19), IAB 3/27/19, effective 5/1/19]
[Filed ARC 4658C (Notice ARC 4445C, IAB 5/22/19), IAB 9/11/19, effective 10/16/19]
[Filed ARC 4714C (Notice ARC 4382C, IAB 4/10/19), IAB 10/23/19, effective 11/27/19]
1	Effective date of 13.2(148,272C) delayed 70 days by the Administrative Rules Review Committee at its meeting held May 14, 1996.