H.F. 434 Section 1. Section 155A.3, Code 2021, is amended by adding 1 the following new subsections: 2 NEW SUBSECTION . 10A. “Department” means the department of 3 public health. 4 NEW SUBSECTION . 44A. “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 . 44B. “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.47 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 contrary, 20 a pharmacist may dispense a self-administered hormonal 21 contraceptive to a patient who is at least eighteen years of 22 age, pursuant to a standing order established by the medical 23 director of the department in 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 only up 29 to a three-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 1164HV (4) 89 pf/rh 1/ 11

H.F. 434 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 and 25 the board of medicine, from each patient, verify the identity 26 and age of each patient, and perform a blood pressure screening 27 on each patient prior to dispensing the self-administered 28 hormonal contraceptive to the patient. 29 c. Provide the patient with all of the following: 30 (1) Written information regarding all of the following: 31 (a) The importance of completing an appointment with the 32 patient’s primary care or women’s health care practitioner 33 to obtain preventative care, including but not limited to 34 recommended tests and screenings. 35 -2- LSB 1164HV (4) 89 pf/rh 2/ 11

H.F. 434 (b) The effectiveness and availability of long-acting 1 reversible contraceptives as an alternative to 2 self-administered hormonal contraceptives. 3 (2) A copy of the record of the pharmacist’s encounter with 4 the patient that includes all of the following: 5 (a) The patient’s completed self-screening risk assessment. 6 (b) A description of the contraceptive dispensed, or the 7 basis for not dispensing a contraceptive. 8 (3) Patient counseling regarding all of the following: 9 (a) The appropriate administration and storage of the 10 self-administered hormonal contraceptive. 11 (b) Potential side effects and risks of the 12 self-administered hormonal contraceptive. 13 (c) The need for backup contraception. 14 (d) When to seek emergency medical attention. 15 (e) The risk of contracting a sexually transmitted 16 infection or disease, and ways to reduce such a risk. 17 5. The standing order established pursuant to this section 18 shall prohibit a pharmacist who dispenses a self-administered 19 hormonal contraceptive under this section from doing any of the 20 following: 21 a. Requiring a patient to schedule an appointment with 22 the pharmacist for the prescribing or dispensing of a 23 self-administered hormonal contraceptive. 24 b. Dispensing self-administered hormonal contraceptives 25 to a patient for more than twenty-seven months after the 26 date a self-administered hormonal contraceptive is initially 27 dispensed to the patient, if the patient has not consulted with 28 a primary care or women’s health care practitioner during the 29 preceding twenty-seven months, in which case the pharmacist 30 shall refer the patient to a primary care or women’s health 31 care practitioner. 32 c. Dispensing a self-administered hormonal contraceptive to 33 a patient if the results of the self-screening risk assessment 34 completed by a patient pursuant to subsection 4, paragraph 35 -3- LSB 1164HV (4) 89 pf/rh 3/ 11

H.F. 434 “b” , indicate it is unsafe for the pharmacist to dispense the 1 self-administered hormonal contraceptive to the patient, in 2 which case the pharmacist shall refer the patient to a primary 3 care or women’s health care practitioner. 4 6. A pharmacist who dispenses a self-administered hormonal 5 contraceptive and the medical director of the department who 6 establishes a standing order in compliance with this section 7 shall be immune from criminal and civil liability arising 8 from any damages caused by the dispensing, administering, 9 or use of a self-administered hormonal contraceptive or the 10 establishment of the standing order. The medical director of 11 the department shall be considered to be acting within the 12 scope of the medical director’s office and employment for 13 purposes of chapter 669 in the establishment of a standing 14 order in compliance with this section. 15 7. The department, in collaboration with the board and 16 the board of medicine, and in consideration of the guidelines 17 established by the American congress of obstetricians and 18 gynecologists, shall adopt rules pursuant to chapter 17A to 19 administer this chapter. 20 Sec. 3. Section 514C.19, Code 2021, is amended to read as 21 follows: 22 514C.19 Prescription contraceptive coverage. 23 1. Notwithstanding the uniformity of treatment requirements 24 of section 514C.6 , a group policy , or contract , or plan 25 providing for third-party payment or prepayment of health or 26 medical expenses shall not do either of the following comply 27 as follows : 28 a. Exclude Such policy, contract, or plan shall not 29 exclude or restrict benefits for prescription contraceptive 30 drugs or prescription contraceptive devices which prevent 31 conception and which are approved by the United States 32 food and drug administration, or generic equivalents 33 approved as substitutable by the United States food and 34 drug administration, if such policy , or contract , or plan 35 -4- LSB 1164HV (4) 89 pf/rh 4/ 11

H.F. 434 provides benefits for other outpatient prescription drugs 1 or devices. However, such policy, contract, or plan shall 2 specifically provide for payment of a self-administered 3 hormonal contraceptive, as prescribed by a practitioner as 4 defined in section 155A.3, or as prescribed by standing order 5 and dispensed by a pharmacist pursuant to section 155A.47, 6 including payment for up to an initial three-month supply 7 of a self-administered hormonal contraceptive dispensed at 8 one time and for up to a twelve-month supply of the same 9 self-administered hormonal contraceptive subsequently dispensed 10 at one time. 11 b. Exclude Such policy, contract, or plan shall not exclude 12 or restrict benefits for outpatient contraceptive services 13 which are provided for the purpose of preventing conception if 14 such policy , or contract , or plan provides benefits for other 15 outpatient services provided by a health care professional. 16 2. A person who provides a group policy , or contract , or 17 plan providing for third-party payment or prepayment of health 18 or medical expenses which is subject to subsection 1 shall not 19 do any of the following: 20 a. Deny to an individual eligibility, or continued 21 eligibility, to enroll in or to renew coverage under the terms 22 of the policy , or contract , or plan because of the individual’s 23 use or potential use of such prescription contraceptive drugs 24 or devices, or use or potential use of outpatient contraceptive 25 services. 26 b. Provide a monetary payment or rebate to a covered 27 individual to encourage such individual to accept less than the 28 minimum benefits provided for under subsection 1 . 29 c. Penalize or otherwise reduce or limit the reimbursement 30 of a health care professional because such professional 31 prescribes contraceptive drugs or devices, or provides 32 contraceptive services. 33 d. Provide incentives, monetary or otherwise, to a health 34 care professional to induce such professional to withhold 35 -5- LSB 1164HV (4) 89 pf/rh 5/ 11

H.F. 434 from a covered individual contraceptive drugs or devices, or 1 contraceptive services. 2 3. This section shall not be construed to prevent a 3 third-party payor from including deductibles, coinsurance, or 4 copayments under the policy , or contract, or plan as follows: 5 a. A deductible, coinsurance, or copayment for benefits 6 for prescription contraceptive drugs shall not be greater than 7 such deductible, coinsurance, or copayment for any outpatient 8 prescription drug for which coverage under the policy , or 9 contract , or plan is provided. 10 b. A deductible, coinsurance, or copayment for benefits for 11 prescription contraceptive devices shall not be greater than 12 such deductible, coinsurance, or copayment for any outpatient 13 prescription device for which coverage under the policy , or 14 contract , or plan is provided. 15 c. A deductible, coinsurance, or copayment for benefits for 16 outpatient contraceptive services shall not be greater than 17 such deductible, coinsurance, or copayment for any outpatient 18 health care services for which coverage under the policy , or 19 contract , or plan is provided. 20 4. This section shall not be construed to require a 21 third-party payor under a policy , or contract , or plan 22 to provide benefits for experimental or investigational 23 contraceptive drugs or devices, or experimental or 24 investigational contraceptive services, except to the extent 25 that such policy , or contract , or plan provides coverage for 26 other experimental or investigational outpatient prescription 27 drugs or devices, or experimental or investigational outpatient 28 health care services. 29 5. This section shall not be construed to limit or otherwise 30 discourage the use of generic equivalent drugs approved by the 31 United States food and drug administration, whenever available 32 and appropriate. This section , when a brand name drug is 33 requested by a covered individual and a suitable generic 34 equivalent is available and appropriate, shall not be construed 35 -6- LSB 1164HV (4) 89 pf/rh 6/ 11

H.F. 434 to prohibit a third-party payor from requiring the covered 1 individual to pay a deductible, coinsurance, or copayment 2 consistent with subsection 3 , in addition to the difference of 3 the cost of the brand name drug less the maximum covered amount 4 for a generic equivalent. 5 6. A person who provides an individual policy , or contract , 6 or plan providing for third-party payment or prepayment of 7 health or medical expenses shall make available a coverage 8 provision that satisfies the requirements in subsections 9 1 through 5 in the same manner as such requirements are 10 applicable to a group policy , or contract , or plan under those 11 subsections. The policy , or contract , or plan shall provide 12 that the individual policyholder may reject the coverage 13 provision at the option of the policyholder. 14 7. a. This section applies to the following classes of 15 third-party payment provider contracts , or policies , or plans 16 delivered, issued for delivery, continued, or renewed in this 17 state on or after July 1, 2000 January 1, 2022 : 18 (1) Individual or group accident and sickness insurance 19 providing coverage on an expense-incurred basis. 20 (2) An individual or group hospital or medical service 21 contract issued pursuant to chapter 509 , 514 , or 514A . 22 (3) An individual or group health maintenance organization 23 contract regulated under chapter 514B . 24 (4) Any other entity engaged in the business of insurance, 25 risk transfer, or risk retention, which is subject to the 26 jurisdiction of the commissioner. 27 (5) A plan established pursuant to chapter 509A for public 28 employees. 29 b. This section shall not apply to accident-only, 30 specified disease, short-term hospital or medical, hospital 31 confinement indemnity, credit, dental, vision, Medicare 32 supplement, long-term care, basic hospital and medical-surgical 33 expense coverage as defined by the commissioner, disability 34 income insurance coverage, coverage issued as a supplement 35 -7- LSB 1164HV (4) 89 pf/rh 7/ 11

H.F. 434 to liability insurance, workers’ compensation or similar 1 insurance, or automobile medical payment insurance. 2 8. This section shall not be construed to require a 3 third-party payor to provide payment to a practitioner for the 4 dispensing of a self-administered hormonal contraceptive to 5 replace a self-administered hormonal contraceptive that has 6 been dispensed to a covered person and that has been misplaced, 7 stolen, or destroyed. This section shall not be construed to 8 require a third-party payor to replace covered prescriptions 9 that are misplaced, stolen, or destroyed. 10 9. For the purposes of this section: 11 a. “Self-administered hormonal contraceptive” means a 12 self-administered hormonal contraceptive that is approved 13 by the United Sates food and drug administration to prevent 14 pregnancy. “Self-administered hormonal contraceptive” includes 15 an oral hormonal contraceptive, a hormonal vaginal ring, and 16 a hormonal contraceptive patch, but does not include any drug 17 intended to induce an abortion as defined in section 146.1. 18 b. “Standing order” means a preauthorized medication order 19 with specific instructions from the medical director of the 20 department of public health to dispense a medication under 21 clearly defined circumstances. 22 Sec. 4. INFORMATION PROGRAM FOR DRUG PRESCRIBING AND 23 DISPENSING —— SELF-ADMINISTERED HORMONAL CONTRACEPTIVES. The 24 board of pharmacy in collaboration with the board of 25 medicine and the department of public health shall expand 26 the information program for drug prescribing and dispensing 27 established pursuant to section 124.551, to collect from 28 pharmacists information relating to the dispensing of 29 self-administered hormonal contraceptives as provided pursuant 30 to section 155A.47. The board of pharmacy shall adopt 31 rules pursuant to chapter 17A related to registration of 32 participating pharmacists, the information to be reported by a 33 pharmacist to the information program, access to information 34 from the program, and other rules necessary to carry out the 35 -8- LSB 1164HV (4) 89 pf/rh 8/ 11

H.F. 434 purposes and to enforce the provisions of this section. 1 EXPLANATION 2 The inclusion of this explanation does not constitute agreement with 3 the explanation’s substance by the members of the general assembly. 4 This bill relates to the dispensing of self-administered 5 hormonal contraceptives by a pharmacist. The bill 6 defines “self-administered hormonal contraceptive” as a 7 self-administered hormonal contraceptive that is approved by 8 the United States food and drug administration to prevent 9 pregnancy, including an oral hormonal contraceptive, a hormonal 10 vaginal ring, and a hormonal contraceptive patch, but not 11 including any drug intended to induce an abortion. 12 The bill provides that notwithstanding any provision of law 13 to the contrary, a pharmacist may dispense a self-administered 14 hormonal contraceptive to a patient who is at least 18 years 15 of age pursuant to a standing order established by the medical 16 director of the department of public health (medical director). 17 For an initial dispensing, a pharmacist may dispense only up 18 to a three-month supply at one time of the self-administered 19 hormonal contraceptive, and for any subsequent dispensing 20 of the same self-administered hormonal contraceptive, a 21 twelve-month supply at one time. Additionally, the bill 22 prohibits a pharmacist who dispenses a self-administered 23 hormonal contraceptive in accordance with the bill from 24 requiring any other prescription drug order authorized by a 25 practitioner prior to dispensing the self-administered hormonal 26 contraceptive. 27 The bill authorizes the medical director to establish a 28 standing order authorizing the dispensing of self-administered 29 hormonal contraceptives by any pharmacist who complies with the 30 standing order and retains and submits the patient’s record to 31 the department of public health (DPH). 32 The standing order includes requiring a pharmacist who 33 dispenses a self-administered hormonal contraceptive under 34 the bill to: complete a standardized training program and 35 -9- LSB 1164HV (4) 89 pf/rh 9/ 11

H.F. 434 continuing education requirements related to prescribing the 1 hormonal contraceptives; obtain a completed self-screening risk 2 assessment from each patient, verify the identity and age of 3 each patient, and perform a blood pressure screening on each 4 patient before dispensing the hormonal contraceptives; provide 5 the patient with certain written information; provide the 6 patient with a copy of the record of the pharmacist’s encounter 7 with the patient; and provide patient counseling. 8 The standing order would prohibit a pharmacist who dispenses 9 hormonal contraceptives under the bill from requiring a 10 patient to schedule an appointment with the pharmacist for 11 the prescribing or dispensing of the hormonal contraceptive; 12 dispensing the hormonal contraceptives to a patient for more 13 than 27 months after the date initially dispensed without the 14 patient’s attestation that the patient has consulted with a 15 practitioner during the preceding 27 months; and dispensing 16 the hormonal contraceptives to a patient if the results of the 17 patient’s self-screening risk assessment indicate it is unsafe 18 for the pharmacist to dispense the hormonal contraceptives 19 to the patient, in which case the pharmacist shall refer the 20 patient to a practitioner. 21 The bill provides immunity for a pharmacist who dispenses a 22 self-administered hormonal contraceptive and for the medical 23 director who establishes a standing order in compliance with 24 the bill from criminal and civil liability arising from any 25 damages caused by the dispensing, administering, or use of a 26 self-administered hormonal contraceptive or the establishment 27 of the standing order. Additionally, the medical director 28 shall be considered to be acting within the scope of the 29 medical director’s office and employment for purposes of Code 30 chapter 669 (Iowa tort claims Act) in the establishment of a 31 standing order in compliance with the bill. 32 The bill requires DPH, in collaboration with the boards of 33 pharmacy and medicine, and in consideration of the guidelines 34 established by the American congress of obstetricians and 35 -10- LSB 1164HV (4) 89 pf/rh 10/ 11

H.F. 434 gynecologists, to adopt administrative rules to administer the 1 bill. 2 The bill amends prescription contraceptive coverage 3 provisions to require that a group policy, contract, or plan 4 delivered, issued for delivery, continued, or renewed in the 5 state on or after January 1, 2022, providing for third-party 6 payment or prepayment of health or medical expenses, shall 7 specifically provide for payment of self-administered hormonal 8 contraceptives, prescribed and dispensed as specified in 9 the bill, including those dispensed at one time. The bill 10 provides, however, that the provisions of the bill relating 11 to coverage are not to be construed to require a third-party 12 payor to provide payment to a practitioner for dispensing 13 a self-administered hormonal contraceptive to replace a 14 self-administered hormonal contraceptive that has been 15 dispensed to a covered person and that has been misplaced, 16 stolen, or destroyed. These provisions are also not to be 17 construed to require a third-party payor to replace covered 18 prescriptions that are misplaced, stolen, or destroyed. 19 The bill also requires the board of pharmacy in 20 collaboration with the board of medicine and DPH to expand 21 the information program for drug prescribing to collect 22 from pharmacists information relating to the dispensing of 23 self-administered hormonal contraceptives as provided in the 24 bill. 25 -11- LSB 1164HV (4) 89 pf/rh 11/ 11