House File 691 - Introduced HOUSE FILE 691 BY KONFRST , JAMES , STECKMAN , CAHILL , LEVIN , NIELSEN , KURTH , AMOS JR. , SCHEETZ , MADISON , SRINIVAS , WILSON , BUCK , CROKEN , BAGNIEWSKI , FORBES , BAETH , GAINES , ZABNER , GJERDE , JACOBY , STAED , KRESSIG , EHLERT , ABDUL-SAMAD , B. MEYER , OLSON , BROWN-POWERS , WESSEL-KROESCHELL , SCHOLTEN , WILBURN , MATSON , and COOLING A BILL FOR An Act relating to the prescribing and dispensing of 1 self-administered hormonal contraceptives. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1974YH (5) 90 pf/rh

H.F. 691 Section 1. Section 155A.3, Code 2023, is amended by adding 1 the following new subsections: 2 NEW SUBSECTION . 10A. “Department” means the department of 3 health and human services. 4 NEW SUBSECTION . 45A. “Self-administered hormonal 5 contraceptive” means a self-administered hormonal contraceptive 6 that is approved by the United States food and drug 7 administration to prevent pregnancy. “Self-administered 8 hormonal contraceptive” includes an oral hormonal contraceptive, 9 a hormonal vaginal ring, and a hormonal contraceptive patch, 10 but does not include any drug intended to induce an abortion as 11 defined in section 146.1. 12 NEW SUBSECTION . 45B. “Standing order” means a preauthorized 13 medication order with specific instructions from the medical 14 director of the department to dispense a medication under 15 clearly defined circumstances. 16 Sec. 2. NEW SECTION . 155A.49 Pharmacist dispensing of 17 self-administered hormonal contraceptives —— standing order —— 18 requirements —— limitations of liability. 19 1. a. Notwithstanding any provision of law to the 20 contrary, a pharmacist may dispense a self-administered 21 hormonal contraceptive to a patient pursuant to a standing 22 order established by the medical director of the department in 23 accordance with this section. 24 b. In dispensing a self-administered hormonal contraceptive 25 to a patient under this section, a pharmacist shall comply with 26 all of the following: 27 (1) For an initial dispensing of a self-administered 28 hormonal contraceptive, the pharmacist may dispense up to 29 a twelve-month supply at one time of the self-administered 30 hormonal contraceptive. 31 (2) For any subsequent dispensing of the same 32 self-administered hormonal contraceptive, the pharmacist 33 may dispense up to a twelve-month supply at one time of the 34 self-administered hormonal contraceptive. 35 -1- LSB 1974YH (5) 90 pf/rh 1/ 10

H.F. 691 2. A pharmacist who dispenses a self-administered hormonal 1 contraceptive in accordance with this section shall not 2 require any other prescription drug order authorized by a 3 practitioner prior to dispensing the self-administered hormonal 4 contraceptive to a patient. 5 3. The medical director of the department may establish a 6 standing order authorizing the dispensing of self-administered 7 hormonal contraceptives by a pharmacist who does all of the 8 following: 9 a. Complies with the standing order established pursuant to 10 this section. 11 b. Retains a record of each patient to whom a 12 self-administered hormonal contraceptive is dispensed under 13 this section and submits the record to the department. 14 4. The standing order shall require a pharmacist who 15 dispenses self-administered hormonal contraceptives under this 16 section to do all of the following: 17 a. Complete a standardized training program and continuing 18 education requirements approved by the board in consultation 19 with the board of medicine and the department that are related 20 to prescribing self-administered hormonal contraceptives and 21 include education regarding all contraceptive methods approved 22 by the United States food and drug administration. 23 b. Obtain a completed self-screening risk assessment, 24 approved by the department in collaboration with the board 25 and the board of medicine, from each patient, and verify 26 the identity of each patient prior to dispensing the 27 self-administered hormonal contraceptive to the patient. 28 c. Provide the patient with all of the following: 29 (1) Written information regarding all of the following: 30 (a) The importance of completing an appointment with the 31 patient’s primary care or women’s health care practitioner 32 to obtain preventative care, including but not limited to 33 recommended tests and screenings. 34 (b) The effectiveness and availability of long-acting 35 -2- LSB 1974YH (5) 90 pf/rh 2/ 10

H.F. 691 reversible contraceptives as an alternative to 1 self-administered hormonal contraceptives. 2 (2) A copy of the record of the pharmacist’s encounter with 3 the patient that includes all of the following: 4 (a) The patient’s completed self-screening risk assessment. 5 (b) A description of the contraceptive dispensed, or the 6 basis for not dispensing a contraceptive. 7 (3) Patient counseling regarding all of the following: 8 (a) The appropriate administration and storage of the 9 self-administered hormonal contraceptive. 10 (b) Potential side effects and risks of the 11 self-administered hormonal contraceptive. 12 (c) The need for backup contraception. 13 (d) When to seek emergency medical attention. 14 (e) The risk of contracting a sexually transmitted 15 infection or disease, and ways to reduce such a risk. 16 5. The standing order established pursuant to this section 17 shall prohibit a pharmacist who dispenses a self-administered 18 hormonal contraceptive under this section from doing any of the 19 following: 20 a. Requiring a patient to schedule an appointment with 21 the pharmacist for the prescribing or dispensing of a 22 self-administered hormonal contraceptive. 23 b. Dispensing a self-administered hormonal contraceptive to 24 a patient if the results of the self-screening risk assessment 25 completed by a patient pursuant to subsection 4, paragraph 26 “b” , indicate it is unsafe for the pharmacist to dispense the 27 self-administered hormonal contraceptive to the patient, in 28 which case the pharmacist shall refer the patient to a primary 29 care or women’s health care practitioner. 30 6. A pharmacist who dispenses a self-administered hormonal 31 contraceptive and the medical director of the department who 32 establishes a standing order in compliance with this section 33 shall be immune from criminal and civil liability arising from 34 any damages caused by the dispensing, administering, or use of 35 -3- LSB 1974YH (5) 90 pf/rh 3/ 10

H.F. 691 a self-administered hormonal contraceptive or the establishment 1 of the standing order provided that the pharmacist acts 2 reasonably and in good faith. The medical director of the 3 department shall be considered to be acting within the scope 4 of the medical director’s office and employment for purposes 5 of chapter 669 in the establishment of a standing order in 6 compliance with this section. 7 7. The department, in collaboration with the board and 8 the board of medicine, and in consideration of the guidelines 9 established by the American congress of obstetricians and 10 gynecologists, shall adopt rules pursuant to chapter 17A to 11 administer this chapter. 12 Sec. 3. Section 514C.19, Code 2023, is amended to read as 13 follows: 14 514C.19 Prescription contraceptive coverage. 15 1. Notwithstanding the uniformity of treatment requirements 16 of section 514C.6 , a group policy , or contract , or plan 17 providing for third-party payment or prepayment of health or 18 medical expenses shall not do either of the following comply 19 as follows : 20 a. Exclude Such policy, contract, or plan shall not 21 exclude or restrict benefits for prescription contraceptive 22 drugs or prescription contraceptive devices which prevent 23 conception and which are approved by the United States 24 food and drug administration, or generic equivalents 25 approved as substitutable by the United States food and drug 26 administration, if such policy , or contract , or plan provides 27 benefits for other outpatient prescription drugs or devices. 28 However, such policy, contract, or plan shall specifically 29 provide for payment including reimbursement for pharmacist 30 consultations, for a self-administered hormonal contraceptive, 31 as prescribed by a practitioner as defined in section 32 155A.3, or as prescribed by standing order and dispensed by a 33 pharmacist pursuant to section 155A.49, including payment for 34 up to an initial twelve-month supply of a self-administered 35 -4- LSB 1974YH (5) 90 pf/rh 4/ 10

H.F. 691 hormonal contraceptive dispensed at one time and for up to a 1 twelve-month supply of the same self-administered hormonal 2 contraceptive subsequently dispensed at one time. 3 b. Exclude Such policy, contract, or plan shall not exclude 4 or restrict benefits for outpatient contraceptive services 5 which are provided for the purpose of preventing conception if 6 such policy , or contract , or plan provides benefits for other 7 outpatient services provided by a health care professional. 8 2. A person who provides a group policy , or contract , or 9 plan providing for third-party payment or prepayment of health 10 or medical expenses which is subject to subsection 1 shall not 11 do any of the following: 12 a. Deny to an individual eligibility, or continued 13 eligibility, to enroll in or to renew coverage under the terms 14 of the policy , or contract , or plan because of the individual’s 15 use or potential use of such prescription contraceptive drugs 16 or devices, or use or potential use of outpatient contraceptive 17 services. 18 b. Provide a monetary payment or rebate to a covered 19 individual to encourage such individual to accept less than the 20 minimum benefits provided for under subsection 1 . 21 c. Penalize or otherwise reduce or limit the reimbursement 22 of a health care professional because such professional 23 prescribes contraceptive drugs or devices, or provides 24 contraceptive services. 25 d. Provide incentives, monetary or otherwise, to a health 26 care professional to induce such professional to withhold 27 from a covered individual contraceptive drugs or devices, or 28 contraceptive services. 29 3. This section shall not be construed to prevent a 30 third-party payor from including deductibles, coinsurance, or 31 copayments under the policy , or contract, or plan as follows: 32 a. A deductible, coinsurance, or copayment for benefits 33 for prescription contraceptive drugs shall not be greater than 34 such deductible, coinsurance, or copayment for any outpatient 35 -5- LSB 1974YH (5) 90 pf/rh 5/ 10

H.F. 691 prescription drug for which coverage under the policy , or 1 contract , or plan is provided. 2 b. A deductible, coinsurance, or copayment for benefits for 3 prescription contraceptive devices shall not be greater than 4 such deductible, coinsurance, or copayment for any outpatient 5 prescription device for which coverage under the policy , or 6 contract , or plan is provided. 7 c. A deductible, coinsurance, or copayment for benefits for 8 outpatient contraceptive services shall not be greater than 9 such deductible, coinsurance, or copayment for any outpatient 10 health care services for which coverage under the policy , or 11 contract , or plan is provided. 12 4. This section shall not be construed to require a 13 third-party payor under a policy , or contract , or plan 14 to provide benefits for experimental or investigational 15 contraceptive drugs or devices, or experimental or 16 investigational contraceptive services, except to the extent 17 that such policy , or contract , or plan provides coverage for 18 other experimental or investigational outpatient prescription 19 drugs or devices, or experimental or investigational outpatient 20 health care services. 21 5. This section shall not be construed to limit or otherwise 22 discourage the use of generic equivalent drugs approved by the 23 United States food and drug administration, whenever available 24 and appropriate. This section , when a brand name drug is 25 requested by a covered individual and a suitable generic 26 equivalent is available and appropriate, shall not be construed 27 to prohibit a third-party payor from requiring the covered 28 individual to pay a deductible, coinsurance, or copayment 29 consistent with subsection 3 , in addition to the difference of 30 the cost of the brand name drug less the maximum covered amount 31 for a generic equivalent. 32 6. A person who provides an individual policy , or contract , 33 or plan providing for third-party payment or prepayment of 34 health or medical expenses shall make available a coverage 35 -6- LSB 1974YH (5) 90 pf/rh 6/ 10

H.F. 691 provision that satisfies the requirements in subsections 1 1 through 5 in the same manner as such requirements are 2 applicable to a group policy , or contract , or plan under those 3 subsections. The policy , or contract , or plan shall provide 4 that the individual policyholder may reject the coverage 5 provision at the option of the policyholder. 6 7. a. This section applies to the following classes of 7 third-party payment provider contracts , or policies , or plans 8 delivered, issued for delivery, continued, or renewed in this 9 state on or after July 1, 2000 January 1, 2024 : 10 (1) Individual or group accident and sickness insurance 11 providing coverage on an expense-incurred basis. 12 (2) An individual or group hospital or medical service 13 contract issued pursuant to chapter 509 , 514 , or 514A . 14 (3) An individual or group health maintenance organization 15 contract regulated under chapter 514B . 16 (4) Any other entity engaged in the business of insurance, 17 risk transfer, or risk retention, which is subject to the 18 jurisdiction of the commissioner. 19 (5) A plan established pursuant to chapter 509A for public 20 employees. 21 b. This section shall not apply to accident-only, 22 specified disease, short-term hospital or medical, hospital 23 confinement indemnity, credit, dental, vision, Medicare 24 supplement, long-term care, basic hospital and medical-surgical 25 expense coverage as defined by the commissioner, disability 26 income insurance coverage, coverage issued as a supplement 27 to liability insurance, workers’ compensation or similar 28 insurance, or automobile medical payment insurance. 29 8. For the purposes of this section: 30 a. “Self-administered hormonal contraceptive” means a 31 self-administered hormonal contraceptive that is approved 32 by the United Sates food and drug administration to prevent 33 pregnancy. “Self-administered hormonal contraceptive” includes 34 an oral hormonal contraceptive, a hormonal vaginal ring, and 35 -7- LSB 1974YH (5) 90 pf/rh 7/ 10

H.F. 691 a hormonal contraceptive patch, but does not include any drug 1 intended to induce an abortion as defined in section 146.1. 2 b. “Standing order” means a preauthorized medication 3 order with specific instructions from the medical director 4 of the department of health and human services to dispense a 5 medication under clearly defined circumstances. 6 Sec. 4. MEDICAID COVERAGE —— SELF-ADMINISTERED HORMONAL 7 CONTRACEPTIVES. Notwithstanding section 514B.32, subsection 8 5, and any other provision of law to the contrary, the 9 department of health and human services shall, contractually 10 and by administrative rules adopted pursuant to chapter 11 17A, require under Medicaid fee-for-service and Medicaid 12 managed care administration, coverage for a self-administered 13 hormonal contraceptive as prescribed by a practitioner as 14 defined in section 155A.3, or as prescribed by standing order 15 and dispensed by a pharmacist pursuant to section 155A.49, 16 including payment for up to an initial twelve-month supply 17 of the self-administered hormonal contraceptive dispensed 18 at one time and for up to a twelve-month supply of the same 19 self-administered hormonal contraceptive subsequently dispensed 20 at one time. 21 EXPLANATION 22 The inclusion of this explanation does not constitute agreement with 23 the explanation’s substance by the members of the general assembly. 24 This bill relates to the dispensing of self-administered 25 hormonal contraceptives by a pharmacist. The bill 26 defines “self-administered hormonal contraceptive” as a 27 self-administered hormonal contraceptive that is approved by 28 the United States food and drug administration to prevent 29 pregnancy, including an oral hormonal contraceptive, a hormonal 30 vaginal ring, and a hormonal contraceptive patch, but not 31 including any drug intended to induce an abortion. 32 The bill provides that notwithstanding any provision of law 33 to the contrary, a pharmacist may dispense a self-administered 34 hormonal contraceptive to a patient pursuant to a standing 35 -8- LSB 1974YH (5) 90 pf/rh 8/ 10

H.F. 691 order established by the medical director of the department of 1 health and human services (medical director). For an initial 2 dispensing, a pharmacist may dispense up to a 12-month supply 3 at one time of the self-administered hormonal contraceptive, 4 and for any subsequent dispensing of the same self-administered 5 hormonal contraceptive, a 12-month supply at one time. 6 Additionally, the bill prohibits a pharmacist who dispenses 7 a self-administered hormonal contraceptive in accordance 8 with the bill from requiring any other prescription drug 9 order authorized by a practitioner prior to dispensing the 10 self-administered hormonal contraceptive. 11 The bill authorizes the medical director to establish a 12 standing order authorizing the dispensing of self-administered 13 hormonal contraceptives by any pharmacist who complies with the 14 standing order and retains and submits the patient’s record to 15 the department of health and human services (HHS). 16 The standing order includes requiring a pharmacist who 17 dispenses a self-administered hormonal contraceptive under 18 the bill to: complete a standardized training program and 19 continuing education requirements related to prescribing the 20 hormonal contraceptives; obtain a completed self-screening risk 21 assessment from each patient and verify the identity of each 22 patient before dispensing the hormonal contraceptives; provide 23 the patient with certain written information; provide the 24 patient with a copy of the record of the pharmacist’s encounter 25 with the patient; and provide patient counseling. 26 The standing order would prohibit a pharmacist who dispenses 27 hormonal contraceptives under the bill from requiring a 28 patient to schedule an appointment with the pharmacist for 29 the prescribing or dispensing of the hormonal contraceptive; 30 and dispensing the hormonal contraceptives to a patient if 31 the results of the patient’s self-screening risk assessment 32 indicate it is unsafe for the pharmacist to dispense the 33 hormonal contraceptives to the patient, in which case the 34 pharmacist shall refer the patient to a practitioner. 35 -9- LSB 1974YH (5) 90 pf/rh 9/ 10

H.F. 691 The bill provides immunity for a pharmacist who dispenses a 1 self-administered hormonal contraceptive and for the medical 2 director who establishes a standing order in compliance with 3 the bill from criminal and civil liability arising from any 4 damages caused by the dispensing, administering, or use of a 5 self-administered hormonal contraceptive or the establishment 6 of the standing order provided the pharmacist acts reasonably 7 and in good faith. Additionally, the medical director shall 8 be considered to be acting within the scope of the medical 9 director’s office and employment for purposes of Code chapter 10 669 (Iowa tort claims Act) in the establishment of a standing 11 order in compliance with the bill. 12 The bill requires HHS, in collaboration with the boards of 13 pharmacy and medicine, and in consideration of the guidelines 14 established by the American congress of obstetricians and 15 gynecologists, to adopt administrative rules to administer the 16 bill. 17 The bill amends prescription contraceptive coverage 18 provisions to require that a group policy, contract, or plan 19 delivered, issued for delivery, continued, or renewed in the 20 state on or after January 1, 2024, providing for third-party 21 payment or prepayment of health or medical expenses, shall 22 specifically provide for payment of self-administered hormonal 23 contraceptives, prescribed and dispensed as specified in the 24 bill, including those dispensed at one time. 25 The bill also requires HHS to provide prescription 26 contraceptive coverage under the Medicaid program consistent 27 with the coverage under private insurance as provided under the 28 bill. 29 -10- LSB 1974YH (5) 90 pf/rh 10/ 10