Iowa-2023-HSB642-Introduced

S.F. _____ H.F. _____ Section 1. NEW SECTION . 155A.49 Pharmacist dispensing of 1 self-administered hormonal contraceptives —— standing order —— 2 requirements —— limitations of liability. 3 1. a. Notwithstanding any provision of law to the contrary, 4 a pharmacist may dispense a self-administered hormonal 5 contraceptive to a patient who is at least eighteen years of 6 age, pursuant to a standing order established by the medical 7 director of the department in accordance with this section. 8 b. In dispensing a self-administered hormonal contraceptive 9 to a patient under this section, a pharmacist shall comply with 10 all of the following: 11 (1) For an initial dispensing of a self-administered 12 hormonal contraceptive, the pharmacist may dispense only up 13 to a three-month supply at one time of the self-administered 14 hormonal contraceptive. 15 (2) For any subsequent dispensing of the same 16 self-administered hormonal contraceptive, the pharmacist 17 may dispense up to a twelve-month supply at one time of the 18 self-administered hormonal contraceptive. 19 2. A pharmacist who dispenses a self-administered hormonal 20 contraceptive in accordance with this section shall not 21 require any other prescription drug order authorized by a 22 practitioner prior to dispensing the self-administered hormonal 23 contraceptive to a patient. 24 3. The medical director of the department may establish a 25 standing order authorizing the dispensing of self-administered 26 hormonal contraceptives by a pharmacist who does all of the 27 following: 28 a. Complies with the standing order established pursuant to 29 this section. 30 b. Retains a record of each patient to whom a 31 self-administered hormonal contraceptive is dispensed under 32 this section and submits the record to the department. 33 4. The standing order shall require a pharmacist who 34 dispenses self-administered hormonal contraceptives under this 35 -1- LSB 5028XL (3) 90 pf/ko 1/ 11

S.F. _____ H.F. _____ section to do all of the following: 1 a. Complete a standardized training program and continuing 2 education requirements approved by the board in consultation 3 with the board of medicine and the department that are related 4 to prescribing self-administered hormonal contraceptives and 5 include education regarding all contraceptive methods approved 6 by the United States food and drug administration. 7 b. Obtain a completed self-screening risk assessment, 8 approved by the department in collaboration with the board and 9 the board of medicine, from each patient, verify the identity 10 and age of each patient, and perform a blood pressure screening 11 on each patient prior to dispensing the self-administered 12 hormonal contraceptive to the patient. 13 c. Provide the patient with all of the following: 14 (1) Written information regarding all of the following: 15 (a) The importance of completing an appointment with the 16 patient’s primary care or women’s health care practitioner 17 to obtain preventative care, including but not limited to 18 recommended tests and screenings. 19 (b) The effectiveness and availability of long-acting 20 reversible contraceptives as an alternative to 21 self-administered hormonal contraceptives. 22 (2) A copy of the record of the pharmacist’s encounter with 23 the patient that includes all of the following: 24 (a) The patient’s completed self-screening risk assessment. 25 (b) A description of the contraceptive dispensed, or the 26 basis for not dispensing a contraceptive. 27 (3) Patient counseling regarding all of the following: 28 (a) The appropriate administration and storage of the 29 self-administered hormonal contraceptive. 30 (b) Potential side effects and risks of the 31 self-administered hormonal contraceptive. 32 (c) The need for backup contraception. 33 (d) When to seek emergency medical attention. 34 (e) The risk of contracting a sexually transmitted 35 -2- LSB 5028XL (3) 90 pf/ko 2/ 11

S.F. _____ H.F. _____ infection or disease, and ways to reduce such a risk. 1 5. The standing order established pursuant to this section 2 shall prohibit a pharmacist who dispenses a self-administered 3 hormonal contraceptive under this section from doing any of the 4 following: 5 a. Requiring a patient to schedule an appointment with 6 the pharmacist for the prescribing or dispensing of a 7 self-administered hormonal contraceptive. 8 b. Dispensing self-administered hormonal contraceptives 9 to a patient for more than twenty-seven months after the 10 date a self-administered hormonal contraceptive is initially 11 dispensed to the patient, if the patient has not consulted with 12 a primary care or women’s health care practitioner during the 13 preceding twenty-seven months, in which case the pharmacist 14 shall refer the patient to a primary care or women’s health 15 care practitioner. 16 c. Dispensing a self-administered hormonal contraceptive to 17 a patient if the results of the self-screening risk assessment 18 completed by a patient pursuant to subsection 4, paragraph 19 “b” , indicate it is unsafe for the pharmacist to dispense the 20 self-administered hormonal contraceptive to the patient, in 21 which case the pharmacist shall refer the patient to a primary 22 care or women’s health care practitioner. 23 6. A pharmacist who dispenses a self-administered hormonal 24 contraceptive and the medical director of the department who 25 establishes a standing order in compliance with this section 26 shall be immune from criminal and civil liability arising 27 from any damages caused by the dispensing, administering, 28 or use of a self-administered hormonal contraceptive or the 29 establishment of the standing order. The medical director of 30 the department shall be considered to be acting within the 31 scope of the medical director’s office and employment for 32 purposes of chapter 669 in the establishment of a standing 33 order in compliance with this section. 34 7. The department, in collaboration with the board and 35 -3- LSB 5028XL (3) 90 pf/ko 3/ 11

S.F. _____ H.F. _____ the board of medicine, and in consideration of the guidelines 1 established by the American congress of obstetricians and 2 gynecologists, shall adopt rules pursuant to chapter 17A to 3 administer this chapter. 4 8. As used in this section: 5 a. “Department” means the department of health and human 6 services. 7 b. “Self-administered hormonal contraceptive” means a 8 self-administered hormonal contraceptive that is approved by 9 the United States food and drug administration to prevent 10 pregnancy. “Self-administered hormonal contraceptive” includes 11 an oral hormonal contraceptive, a hormonal vaginal ring, and 12 a hormonal contraceptive patch, but does not include any drug 13 intended to induce an abortion as defined in section 146.1. 14 c. “Standing order” means a preauthorized medication order 15 with specific instructions from the medical director of the 16 department to dispense a medication under clearly defined 17 circumstances. 18 Sec. 2. Section 514C.19, Code 2024, is amended to read as 19 follows: 20 514C.19 Prescription contraceptive coverage. 21 1. Notwithstanding the uniformity of treatment requirements 22 of section 514C.6 , a group policy , or contract , or plan 23 providing for third-party payment or prepayment of health or 24 medical expenses shall not do either of the following comply 25 as follows : 26 a. Exclude Such policy, contract, or plan shall not 27 exclude or restrict benefits for prescription contraceptive 28 drugs or prescription contraceptive devices which prevent 29 conception and which are approved by the United States 30 food and drug administration, or generic equivalents 31 approved as substitutable by the United States food and 32 drug administration, if such policy , or contract , or plan 33 provides benefits for other outpatient prescription drugs 34 or devices. However, such policy, contract, or plan shall 35 -4- LSB 5028XL (3) 90 pf/ko 4/ 11

S.F. _____ H.F. _____ specifically provide for payment of a self-administered 1 hormonal contraceptive, as prescribed by a practitioner as 2 defined in section 155A.3, or as prescribed by standing order 3 and dispensed by a pharmacist pursuant to section 155A.49, 4 including payment for up to an initial three-month supply 5 of a self-administered hormonal contraceptive dispensed at 6 one time and for up to a twelve-month supply of the same 7 self-administered hormonal contraceptive subsequently dispensed 8 at one time. 9 b. Exclude Such policy, contract, or plan shall not exclude 10 or restrict benefits for outpatient contraceptive services 11 which are provided for the purpose of preventing conception if 12 such policy , or contract , or plan provides benefits for other 13 outpatient services provided by a health care professional. 14 2. A person who provides a group policy , or contract , or 15 plan providing for third-party payment or prepayment of health 16 or medical expenses which is subject to subsection 1 shall not 17 do any of the following: 18 a. Deny to an individual eligibility, or continued 19 eligibility, to enroll in or to renew coverage under the terms 20 of the policy , or contract , or plan because of the individual’s 21 use or potential use of such prescription contraceptive drugs 22 or devices, or use or potential use of outpatient contraceptive 23 services. 24 b. Provide a monetary payment or rebate to a covered 25 individual to encourage such individual to accept less than the 26 minimum benefits provided for under subsection 1 . 27 c. Penalize or otherwise reduce or limit the reimbursement 28 of a health care professional because such professional 29 prescribes contraceptive drugs or devices, or provides 30 contraceptive services. 31 d. Provide incentives, monetary or otherwise, to a health 32 care professional to induce such professional to withhold 33 from a covered individual contraceptive drugs or devices, or 34 contraceptive services. 35 -5- LSB 5028XL (3) 90 pf/ko 5/ 11

S.F. _____ H.F. _____ 3. This section shall not be construed to prevent a 1 third-party payor from including deductibles, coinsurance, or 2 copayments under the policy , or contract, or plan as follows: 3 a. A deductible, coinsurance, or copayment for benefits 4 for prescription contraceptive drugs shall not be greater than 5 such deductible, coinsurance, or copayment for any outpatient 6 prescription drug for which coverage under the policy , or 7 contract , or plan is provided. 8 b. A deductible, coinsurance, or copayment for benefits for 9 prescription contraceptive devices shall not be greater than 10 such deductible, coinsurance, or copayment for any outpatient 11 prescription device for which coverage under the policy , or 12 contract , or plan is provided. 13 c. A deductible, coinsurance, or copayment for benefits for 14 outpatient contraceptive services shall not be greater than 15 such deductible, coinsurance, or copayment for any outpatient 16 health care services for which coverage under the policy , or 17 contract , or plan is provided. 18 4. This section shall not be construed to require a 19 third-party payor under a policy , or contract , or plan 20 to provide benefits for experimental or investigational 21 contraceptive drugs or devices, or experimental or 22 investigational contraceptive services, except to the extent 23 that such policy , or contract , or plan provides coverage for 24 other experimental or investigational outpatient prescription 25 drugs or devices, or experimental or investigational outpatient 26 health care services. 27 5. This section shall not be construed to limit or otherwise 28 discourage the use of generic equivalent drugs approved by the 29 United States food and drug administration, whenever available 30 and appropriate. This section , when a brand name drug is 31 requested by a covered individual and a suitable generic 32 equivalent is available and appropriate, shall not be construed 33 to prohibit a third-party payor from requiring the covered 34 individual to pay a deductible, coinsurance, or copayment 35 -6- LSB 5028XL (3) 90 pf/ko 6/ 11

S.F. _____ H.F. _____ consistent with subsection 3 , in addition to the difference of 1 the cost of the brand name drug less the maximum covered amount 2 for a generic equivalent. 3 6. A person who provides an individual policy , or contract , 4 or plan providing for third-party payment or prepayment of 5 health or medical expenses shall make available a coverage 6 provision that satisfies the requirements in subsections 7 1 through 5 in the same manner as such requirements are 8 applicable to a group policy , or contract , or plan under those 9 subsections. The policy , or contract , or plan shall provide 10 that the individual policyholder may reject the coverage 11 provision at the option of the policyholder. 12 7. a. This section applies to the following classes of 13 third-party payment provider contracts , or policies , or plans 14 delivered, issued for delivery, continued, or renewed in this 15 state on or after July 1, 2000 January 1, 2025 : 16 (1) Individual or group accident and sickness insurance 17 providing coverage on an expense-incurred basis. 18 (2) An individual or group hospital or medical service 19 contract issued pursuant to chapter 509 , 514 , or 514A . 20 (3) An individual or group health maintenance organization 21 contract regulated under chapter 514B . 22 (4) Any other entity engaged in the business of insurance, 23 risk transfer, or risk retention, which is subject to the 24 jurisdiction of the commissioner. 25 (5) A plan established pursuant to chapter 509A for public 26 employees. 27 b. This section shall not apply to accident-only, 28 specified disease, short-term hospital or medical, hospital 29 confinement indemnity, credit, dental, vision, Medicare 30 supplement, long-term care, basic hospital and medical-surgical 31 expense coverage as defined by the commissioner, disability 32 income insurance coverage, coverage issued as a supplement 33 to liability insurance, workers’ compensation or similar 34 insurance, or automobile medical payment insurance. 35 -7- LSB 5028XL (3) 90 pf/ko 7/ 11

S.F. _____ H.F. _____ 8. This section shall not be construed to require a 1 third-party payor under a policy, contract, or plan to 2 provide payment to a practitioner for the dispensing of 3 a self-administered hormonal contraceptive to replace a 4 self-administered hormonal contraceptive that has been 5 dispensed to a covered person and that has been misplaced, 6 stolen, or destroyed. This section shall not be construed to 7 require a third-party payor under a policy, contract, or plan 8 to replace covered prescriptions that are misplaced, stolen, 9 or destroyed. 10 9. For the purposes of this section, “self-administered 11 hormonal contraceptive” and “standing order” mean the same as 12 defined in section 155A.49. 13 Sec. 3. INFORMATION PROGRAM FOR DRUG PRESCRIBING AND 14 DISPENSING —— SELF-ADMINISTERED HORMONAL CONTRACEPTIVES. The 15 board of pharmacy in collaboration with the board of medicine 16 and the department of health and human services shall expand 17 the information program for drug prescribing and dispensing 18 established pursuant to section 124.551, to collect from 19 pharmacists information relating to the dispensing of 20 self-administered hormonal contraceptives as provided pursuant 21 to section 155A.49. The board of pharmacy shall adopt 22 rules pursuant to chapter 17A related to registration of 23 participating pharmacists, the information to be reported by a 24 pharmacist to the information program, access to information 25 from the program, and other rules necessary to carry out the 26 purposes and to enforce the provisions of this section. 27 Sec. 4. APPLICATION TO MEDICAID PROGRAM. This Act shall 28 apply to the Medicaid program including a managed care 29 organization acting pursuant to a contract with the department 30 of health and human services to administer the Medicaid program 31 under chapter 249A. However, if it is determined that any 32 provision of this Act would cause denial of federal funds under 33 Tit. XVIII or XIX of the federal Social Security Act, or would 34 otherwise be inconsistent or conflict with the requirements of 35 -8- LSB 5028XL (3) 90 pf/ko 8/ 11

S.F. _____ H.F. _____ federal law or regulation, such provision shall be suspended, 1 but only to the extent necessary to prevent denial of such 2 funds or to eliminate the inconsistency or conflict with the 3 requirements of federal law or regulation. 4 EXPLANATION 5 The inclusion of this explanation does not constitute agreement with 6 the explanation’s substance by the members of the general assembly. 7 This bill relates to the dispensing of self-administered 8 hormonal contraceptives by a pharmacist. The bill 9 defines “self-administered hormonal contraceptive” as a 10 self-administered hormonal contraceptive that is approved by 11 the United States food and drug administration to prevent 12 pregnancy, including an oral hormonal contraceptive, a hormonal 13 vaginal ring, and a hormonal contraceptive patch, but not 14 including any drug intended to induce an abortion. 15 The bill provides that notwithstanding any provision of law 16 to the contrary, a pharmacist may dispense a self-administered 17 hormonal contraceptive to a patient who is at least 18 18 years of age pursuant to a standing order established by the 19 medical director (medical director) of the department of 20 health and human services (HHS). For an initial dispensing, 21 a pharmacist may dispense only up to a three-month supply at 22 one time of the self-administered hormonal contraceptive, and 23 for any subsequent dispensing of the same self-administered 24 hormonal contraceptive, a 12-month supply at one time. 25 Additionally, the bill prohibits a pharmacist who dispenses 26 a self-administered hormonal contraceptive in accordance 27 with the bill from requiring any other prescription drug 28 order authorized by a practitioner prior to dispensing the 29 self-administered hormonal contraceptive. 30 The bill authorizes the medical director to establish a 31 standing order authorizing the dispensing of self-administered 32 hormonal contraceptives by any pharmacist who complies with the 33 standing order and retains and submits the patient’s record to 34 HHS. 35 -9- LSB 5028XL (3) 90 pf/ko 9/ 11

S.F. _____ H.F. _____ The standing order includes requiring a pharmacist who 1 dispenses a self-administered hormonal contraceptive under 2 the bill to: complete a standardized training program and 3 continuing education requirements related to prescribing the 4 hormonal contraceptives; obtain a completed self-screening risk 5 assessment from each patient, verify the identity and age of 6 each patient, and perform a blood pressure screening on each 7 patient before dispensing the hormonal contraceptives; provide 8 the patient with certain written information; provide the 9 patient with a copy of the record of the pharmacist’s encounter 10 with the patient; and provide patient counseling. 11 The standing order would prohibit a pharmacist who dispenses 12 hormonal contraceptives under the bill from requiring a 13 patient to schedule an appointment with the pharmacist for 14 the prescribing or dispensing of the hormonal contraceptives; 15 dispensing the hormonal contraceptives to a patient for more 16 than 27 months after the date initially dispensed without the 17 patient’s attestation that the patient has consulted with a 18 practitioner during the preceding 27 months; and dispensing 19 the hormonal contraceptives to a patient if the results of the 20 patient’s self-screening risk assessment indicate it is unsafe 21 for the pharmacist to dispense the hormonal contraceptives 22 to the patient, in which case the pharmacist shall refer the 23 patient to a practitioner. 24 The bill provides immunity for a pharmacist who dispenses a 25 self-administered hormonal contraceptive and for the medical 26 director who establishes a standing order in compliance with 27 the bill from criminal and civil liability arising from any 28 damages caused by the dispensing, administering, or use of a 29 self-administered hormonal contraceptive or the establishment 30 of the standing order. Additionally, the medical director 31 shall be considered to be acting within the scope of the 32 medical director’s office and employment for purposes of Code 33 chapter 669 (Iowa tort claims Act) in the establishment of a 34 standing order in compliance with the bill. 35 -10- LSB 5028XL (3) 90 pf/ko 10/ 11

S.F. _____ H.F. _____ The bill requires HHS, in collaboration with the boards of 1 pharmacy and medicine, and in consideration of the guidelines 2 established by the American congress of obstetricians and 3 gynecologists, to adopt administrative rules to administer the 4 provisions of the bill. 5 The bill amends prescription contraceptive coverage 6 provisions in the Code to require that a group policy, 7 contract, or plan delivered, issued for delivery, continued, 8 or renewed in the state on or after January 1, 2025, 9 providing for third-party payment or prepayment of health or 10 medical expenses, shall specifically provide for payment of 11 self-administered hormonal contraceptives, prescribed and 12 dispensed as specified in the bill, including those dispensed 13 at one time. The bill provides, however, that the provisions 14 relating to coverage are not to be construed to require a 15 third-party payor under a policy, contract, or plan to provide 16 payment to a practitioner for dispensing a self-administered 17 hormonal contraceptive to replace a self-administered 18 hormonal contraceptive that has been dispensed to a covered 19 person and that has been misplaced, stolen, or destroyed. 20 These provisions are also not to be construed to require a 21 third-party payor under a policy, contract, or plan to replace 22 covered prescriptions that are misplaced, stolen, or destroyed. 23 The bill also requires the board of pharmacy in 24 collaboration with the board of medicine and HHS to expand 25 the information program for drug prescribing to collect 26 from pharmacists information relating to the dispensing of 27 self-administered hormonal contraceptives as provided in the 28 bill. 29 The bill applies to the Medicaid program as specified in the 30 bill. 31 -11- LSB 5028XL (3) 90 pf/ko 11/ 11