SSB 1157 (LSB 1164XG (3) 89)

SENATE/HOUSE FILE _____

BY  (PROPOSED GOVERNOR BILL)

A BILL FOR

An Act relating to the prescribing and dispensing of self-administered hormonal contraceptives. 
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  Section 155A.3, Code 2021, is amended by adding the following new subsections:
   NEW SUBSECTION.  10A.  “Department” means the department of public health.
   NEW SUBSECTION.  44A.  “Self-administered hormonal contraceptive” means a self-administered hormonal contraceptive that is approved by the United States food and drug administration to prevent pregnancy. “Self-administered hormonal contraceptive” includes an oral hormonal contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch, but does not include any drug intended to induce an abortion as defined in section 146.1.
   NEW SUBSECTION.  44B.  “Standing order” means a preauthorized medication order with specific instructions from the medical director of the department to dispense a medication under clearly defined circumstances.
    Sec. 2.  NEW SECTION.  155A.47  Pharmacist dispensing of self-administered hormonal contraceptives —— standing order —— requirements —— limitations of liability.
   1.  Notwithstanding any provision of law to the contrary, a pharmacist may dispense, at one time, up to a one-year supply of a self-administered hormonal contraceptive to a patient who is at least eighteen years of age, pursuant to a standing order established by the medical director of the department in accordance with this section.
   2.  A pharmacist who dispenses a self-administered hormonal contraceptive in accordance with this section shall not require any other prescription drug order authorized by a practitioner prior to dispensing the self-administered hormonal contraceptive to a patient.
   3.  The medical director of the department may establish a standing order authorizing the dispensing of self-administered hormonal contraceptives by a pharmacist who does all of the following: 
   a.  Complies with the standing order established pursuant to this section.
   b.  Retains a record of each patient to whom a self-administered hormonal contraceptive is dispensed under this section and submits the record to the department.
   4.  The standing order shall require a pharmacist who dispenses self-administered hormonal contraceptives under this section to do all of the following:
   a.  Complete a standardized training program and continuing education requirements approved by the board in consultation with the department that are related to prescribing self-administered hormonal contraceptives and include education regarding all contraceptive methods approved by the United States food and drug administration.
   b.  Obtain a completed self-screening risk assessment, approved by the department in collaboration with the board and the board of medicine, from each patient prior to dispensing the self-administered hormonal contraceptive to the patient. 
   c.  Provide the patient with all of the following:
   (1)  Written information regarding all of the following: 
   (a)  The importance of completing an appointment with the patient’s primary care or women’s health care practitioner to obtain preventative care, including but not limited to recommended tests and screenings.
   (b)  The effectiveness and availability of long-acting reversible contraceptives as an alternative to self-administered hormonal contraceptives.
   (2)  A copy of the record of the pharmacist’s encounter with the patient that includes all of the following: 
   (a)  The patient’s completed self-screening risk assessment. 
   (b)  A description of the contraceptive dispensed, or the basis for not dispensing a contraceptive.
   (3)  Patient counseling regarding all of the following: 
   (a)  The appropriate administration and storage of the self-administered hormonal contraceptive. 
   (b)  Potential side effects and risks of the self-administered hormonal contraceptive. 
   (c)  The need for backup contraception. 
   (d)  When to seek emergency medical attention.
   (e)  The risk of contracting a sexually transmitted infection or disease, and ways to reduce such a risk. 
   5.  The standing order established pursuant to this section shall prohibit a pharmacist who dispenses a self-administered hormonal contraceptive under this section from doing any of the following: 
   a.  Requiring a patient to schedule an appointment with the pharmacist for the prescribing or dispensing of a self-administered hormonal contraceptive.
   b.  Dispensing self-administered hormonal contraceptives to a patient for more than twenty-four months after the date a self-administered hormonal contraceptive is initially dispensed to the patient without the patient’s attestation that the patient has consulted with a primary care or women’s health care practitioner during the preceding twenty-four months. 
   c.  Dispensing a self-administered hormonal contraceptive to a patient if the results of the self-screening risk assessment completed by a patient pursuant to subsection 4, paragraph “b”, indicate it is unsafe for the pharmacist to dispense the self-administered hormonal contraceptive to the patient, in which case the pharmacist shall refer the patient to a primary care or women’s health care practitioner. 
   6.  A pharmacist who dispenses a self-administered hormonal contraceptive and the medical director of the department who establishes a standing order in compliance with this section shall be immune from criminal and civil liability arising from any damages caused by the dispensing, administering, or use of a self-administered hormonal contraceptive or the establishment of the standing order. The medical director of the department shall be considered to be acting within the scope of the medical director’s office and employment for purposes of chapter 669 in the establishment of a standing order in compliance with this section. 
   7.  The department, in collaboration with the board and the board of medicine, and in consideration of the guidelines established by the American congress of obstetricians and gynecologists, shall adopt rules pursuant to chapter 17A to administer this chapter. 
    Sec. 3.  Section 514C.19, Code 2021, is amended to read as follows:
   514C.19  Prescription contraceptive coverage.
   1.  Notwithstanding the uniformity of treatment requirements of section 514C.6, a group policy, or contract, or plan providing for third-party payment or prepayment of health or medical expenses shall not do either of the following comply as follows:
   a.  Exclude Such policy, contract, or plan shall not exclude or restrict benefits for prescription contraceptive drugs or prescription contraceptive devices which prevent conception and which are approved by the United States food and drug administration, or generic equivalents approved as substitutable by the United States food and drug administration, if such policy, or contract, or plan provides benefits for other outpatient prescription drugs or devices.  However, such policy, contract, or plan shall specifically provide for payment of a one-year supply of self-administered hormonal contraceptives, as prescribed by a practitioner as defined in section 155A.3, or as prescribed by standing order and dispensed by a pharmacist pursuant to section 155A.47, including self-administered hormonal contraceptives dispensed at one time.
   b.  Exclude Such policy, contract, or plan shall not exclude or restrict benefits for outpatient contraceptive services which are provided for the purpose of preventing conception if such policy, or contract, or plan provides benefits for other outpatient services provided by a health care professional.
   2.  A person who provides a group policy, or contract, or plan providing for third-party payment or prepayment of health or medical expenses which is subject to subsection 1 shall not do any of the following:
   a.  Deny to an individual eligibility, or continued eligibility, to enroll in or to renew coverage under the terms of the policy, or contract, or plan because of the individual’s use or potential use of such prescription contraceptive drugs or devices, or use or potential use of outpatient contraceptive services.
   b.  Provide a monetary payment or rebate to a covered individual to encourage such individual to accept less than the minimum benefits provided for under subsection 1.
   c.  Penalize or otherwise reduce or limit the reimbursement of a health care professional because such professional prescribes contraceptive drugs or devices, or provides contraceptive services.
   d.  Provide incentives, monetary or otherwise, to a health care professional to induce such professional to withhold from a covered individual contraceptive drugs or devices, or contraceptive services.
   3.  This section shall not be construed to prevent a third-party payor from including deductibles, coinsurance, or copayments under the policy, or contract, or plan as follows:
   a.  A deductible, coinsurance, or copayment for benefits for prescription contraceptive drugs shall not be greater than such deductible, coinsurance, or copayment for any outpatient prescription drug for which coverage under the policy, or contract, or plan is provided.
   b.  A deductible, coinsurance, or copayment for benefits for prescription contraceptive devices shall not be greater than such deductible, coinsurance, or copayment for any outpatient prescription device for which coverage under the policy, or contract, or plan is provided.
   c.  A deductible, coinsurance, or copayment for benefits for outpatient contraceptive services shall not be greater than such deductible, coinsurance, or copayment for any outpatient health care services for which coverage under the policy, or contract, or plan is provided.
   4.  This section shall not be construed to require a third-party payor under a policy, or contract, or plan to provide benefits for experimental or investigational contraceptive drugs or devices, or experimental or investigational contraceptive services, except to the extent that such policy, or contract, or plan provides coverage for other experimental or investigational outpatient prescription drugs or devices, or experimental or investigational outpatient health care services.
   5.  This section shall not be construed to limit or otherwise discourage the use of generic equivalent drugs approved by the United States food and drug administration, whenever available and appropriate. This section, when a brand name drug is requested by a covered individual and a suitable generic equivalent is available and appropriate, shall not be construed to prohibit a third-party payor from requiring the covered individual to pay a deductible, coinsurance, or copayment consistent with subsection 3, in addition to the difference of the cost of the brand name drug less the maximum covered amount for a generic equivalent.
   6.  A person who provides an individual policy, or contract, or plan providing for third-party payment or prepayment of health or medical expenses shall make available a coverage provision that satisfies the requirements in subsections 1 through 5 in the same manner as such requirements are applicable to a group policy, or contract, or plan under those subsections. The policy, or contract, or plan shall provide that the individual policyholder may reject the coverage provision at the option of the policyholder.
   7.  a.  This section applies to the following classes of third-party payment provider contracts, or policies, or plans delivered, issued for delivery, continued, or renewed in this state on or after July 1, 2000 January 1, 2022:
   (1)  Individual or group accident and sickness insurance providing coverage on an expense-incurred basis.
   (2)  An individual or group hospital or medical service contract issued pursuant to chapter 509, 514, or 514A.
   (3)  An individual or group health maintenance organization contract regulated under chapter 514B.
   (4)  Any other entity engaged in the business of insurance, risk transfer, or risk retention, which is subject to the jurisdiction of the commissioner.
   (5)  A plan established pursuant to chapter 509A for public employees.
   b.  This section shall not apply to accident-only, specified disease, short-term hospital or medical, hospital confinement indemnity, credit, dental, vision, Medicare supplement, long-term care, basic hospital and medical-surgical expense coverage as defined by the commissioner, disability income insurance coverage, coverage issued as a supplement to liability insurance, workers’ compensation or similar insurance, or automobile medical payment insurance.
   8.  This section shall not be construed to require a third-party payor to provide payment to a practitioner for the dispensing of a self-administered hormonal contraceptive to replace a self-administered hormonal contraceptive that has been dispensed to a covered person and that has been misplaced, stolen, or destroyed. This section shall not be construed to require a third-party payor to replace covered prescriptions that are misplaced, stolen, or destroyed. 
   9.  For the purposes of this section:
   a.  “Self-administered hormonal contraceptive” means a self-administered hormonal contraceptive that is approved by the United Sates food and drug administration to prevent pregnancy. “Self-administered hormonal contraceptive” includes an oral hormonal contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch, but does not include any drug intended to induce an abortion as defined in section 146.1. 
   b.  “Standing order” means a preauthorized medication order with specific instructions from the medical director of the department of public health to dispense a medication under clearly defined circumstances.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to the dispensing of self-administered hormonal contraceptives by a pharmacist. The bill defines “self-administered hormonal contraceptive” as a self-administered hormonal contraceptive that is approved by the United States food and drug administration to prevent pregnancy, including an oral hormonal contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch, but not including any drug intended to induce an abortion.
   The bill provides that notwithstanding any provision of law to the contrary, a pharmacist may dispense at one time, up to a one-year supply of a self-administered hormonal contraceptive to a patient who is at least 18 years of age pursuant to a standing order established by the medical director of the department of public health (medical director). Additionally, the bill prohibits a pharmacist who dispenses a self-administered hormonal contraceptive in accordance with the bill from requiring any other prescription drug order authorized by a practitioner prior to dispensing the self-administered hormonal contraceptive.
   The bill authorizes the medical director to establish a standing order authorizing the dispensing of self-administered hormonal contraceptives by any pharmacist who complies with the standing order and retains and submits the patient’s record to the department of public health (DPH). 
   The standing order includes requiring a pharmacist who dispenses a self-administered hormonal contraceptive under the bill to: complete a standardized training program and continuing education requirements related to prescribing the hormonal contraceptives; obtain a completed self-screening risk assessment from each patient before dispensing the hormonal contraceptives; provide the patient with certain written information; provide the patient with a copy of the record of the pharmacist’s encounter with the patient; and provide patient counseling. 
   The standing order would prohibit a pharmacist who dispenses hormonal contraceptives under the bill from requiring a patient to schedule an appointment with the pharmacist for the prescribing or dispensing of the hormonal contraceptives; dispensing the hormonal contraceptives to a patient for more than 24 months after the date initially dispensed without the patient’s attestation that the patient has consulted with a practitioner during the preceding 24 months; and dispensing the hormonal contraceptives to a patient if the results of the patient’s self-screening risk assessment indicate it is unsafe for the pharmacist to dispense the hormonal contraceptives to the patient, in which case the pharmacist shall refer the patient to a practitioner. 
   The bill provides immunity for a pharmacist who dispenses a self-administered hormonal contraceptive and for the medical director who establishes a standing order in compliance with the bill from criminal and civil liability arising from any damages caused by the dispensing, administering, or use of a self-administered hormonal contraceptive or the establishment of the standing order. Additionally, the medical director shall be considered to be acting within the scope of the medical director’s office and employment for purposes of Code chapter 669 (Iowa tort claims Act) in the establishment of a standing order in compliance with the bill.
   The bill requires DPH, in collaboration with the boards of pharmacy and medicine, and in consideration of the guidelines established by the American congress of obstetricians and gynecologists, to adopt administrative rules to administer the bill. 
   The bill amends prescription contraceptive coverage provisions to require that a group policy, contract, or plan delivered, issued for delivery, continued, or renewed in the state on or after January 1, 2022, providing for third-party payment or prepayment of health or medical expenses, shall specifically provide for payment of a one-year supply of self-administered hormonal contraceptives, as prescribed and dispensed as specified in the bill, including those dispensed at one time. The bill provides, however, that the provisions of the bill relating to coverage are not to be construed to require a third-party payor to provide payment to a practitioner for dispensing a self-administered hormonal contraceptive to replace a self-administered hormonal contraceptive that has been dispensed to a covered person and that has been misplaced, stolen, or destroyed. These provisions are also not to be construed to require a third-party payor to replace covered prescriptions that are misplaced, stolen, or destroyed.