House Study Bill 695 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED GOVERNOR BILL) A BILL FOR An Act relating to self-administered hormonal contraceptives. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 5837XL (3) 91 ak/ko
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. For the purposes of this section: 4 a. “Department” means the department of health and human 5 services. 6 b. “Self-administered hormonal contraceptive” means a 7 self-administered hormonal contraceptive that is approved by 8 the United States food and drug administration to prevent 9 pregnancy. “Self-administered hormonal contraceptive” includes 10 an oral hormonal contraceptive, a hormonal vaginal ring, and 11 a hormonal contraceptive patch, but does not include any drug 12 intended to induce an abortion as defined in section 146.1. 13 c. “Standing order” means a preauthorized medication order 14 with specific instructions from the medical director of the 15 department to dispense a medication under clearly defined 16 circumstances. 17 2. a. Notwithstanding any provision of law to the contrary, 18 a pharmacist may dispense a self-administered hormonal 19 contraceptive to a patient who is at least eighteen years of 20 age, pursuant to a standing order established by the medical 21 director of the department in accordance with this section. 22 b. In dispensing a self-administered hormonal contraceptive 23 to a patient under this section, a pharmacist shall comply with 24 all of the following: 25 (1) For an initial dispensing of a self-administered 26 hormonal contraceptive, the pharmacist may dispense only up 27 to a three-month supply at one time of the self-administered 28 hormonal contraceptive. 29 (2) For any subsequent dispensing of the same 30 self-administered hormonal contraceptive, the pharmacist 31 may dispense up to a twelve-month supply at one time of the 32 self-administered hormonal contraceptive. 33 3. A pharmacist who dispenses a self-administered hormonal 34 contraceptive in accordance with this section shall not 35 -1- LSB 5837XL (3) 91 ak/ko 1/ 11
S.F. _____ H.F. _____ require any other prescription drug order authorized by a 1 practitioner prior to dispensing the self-administered hormonal 2 contraceptive to a patient. 3 4. The medical director of the department may establish a 4 standing order authorizing the dispensing of self-administered 5 hormonal contraceptives by a pharmacist who does all of the 6 following: 7 a. Complies with the standing order established pursuant to 8 this section. 9 b. Retains a record of each patient to whom a 10 self-administered hormonal contraceptive is dispensed under 11 this section and submits the record to the department. 12 5. The standing order shall require a pharmacist who 13 dispenses self-administered hormonal contraceptives under this 14 section to do all of the following: 15 a. Complete a standardized training program and continuing 16 education requirements approved by the board in consultation 17 with the board of medicine and the department that are related 18 to prescribing self-administered hormonal contraceptives and 19 include education regarding all contraceptive methods approved 20 by the United States food and drug administration. 21 b. Obtain a completed self-screening risk assessment, 22 approved by the department in collaboration with the board and 23 the board of medicine, from each patient, verify the identity 24 and age of each patient, and perform a blood pressure screening 25 on each patient prior to dispensing the self-administered 26 hormonal contraceptive to the patient. 27 c. Provide the patient with all of the following: 28 (1) Written information regarding all of the following: 29 (a) The importance of completing an appointment with the 30 patient’s primary care or women’s health care practitioner 31 to obtain preventative care, including but not limited to 32 recommended tests and screenings. 33 (b) The effectiveness and availability of long-acting 34 reversible contraceptives as an alternative to 35 -2- LSB 5837XL (3) 91 ak/ko 2/ 11
S.F. _____ H.F. _____ self-administered hormonal contraceptives. 1 (2) A copy of the record of the pharmacist’s encounter with 2 the patient that includes all of the following: 3 (a) The patient’s completed self-screening risk assessment. 4 (b) A description of the contraceptive dispensed, or the 5 basis for not dispensing a contraceptive. 6 (3) Patient counseling regarding all of the following: 7 (a) The appropriate administration and storage of the 8 self-administered hormonal contraceptive. 9 (b) Potential side effects and risks of the 10 self-administered hormonal contraceptive. 11 (c) The need for backup contraception. 12 (d) When to seek emergency medical attention. 13 (e) The risk of contracting a sexually transmitted 14 infection or disease, and ways to reduce such a risk. 15 6. The standing order established pursuant to this section 16 shall prohibit a pharmacist who dispenses a self-administered 17 hormonal contraceptive under this section from doing any of the 18 following: 19 a. Requiring a patient to schedule an appointment with the 20 pharmacist for the purpose of prescribing or dispensing of a 21 self-administered hormonal contraceptive. 22 b. Dispensing self-administered hormonal contraceptives 23 to a patient for more than twenty-seven months after the 24 date a self-administered hormonal contraceptive is initially 25 dispensed to the patient, if the patient has not consulted with 26 a primary care or women’s health care practitioner during the 27 preceding twenty-seven months, in which case the pharmacist 28 shall refer the patient to a primary care or women’s health 29 care practitioner. 30 c. Dispensing a self-administered hormonal contraceptive to 31 a patient if the results of the self-screening risk assessment 32 completed by a patient pursuant to subsection 5, paragraph 33 “b” , indicate it is unsafe for the pharmacist to dispense the 34 self-administered hormonal contraceptive to the patient, in 35 -3- LSB 5837XL (3) 91 ak/ko 3/ 11
S.F. _____ H.F. _____ which case the pharmacist shall refer the patient to a primary 1 care or women’s health care practitioner. 2 7. A pharmacist who dispenses a self-administered hormonal 3 contraceptive and the medical director of the department who 4 establishes a standing order in compliance with this section 5 shall be immune from criminal and civil liability arising 6 from any damages caused by the dispensing, administering, 7 or use of a self-administered hormonal contraceptive or the 8 establishment of the standing order. The medical director of 9 the department shall be considered to be acting within the 10 scope of the medical director’s office and employment for 11 purposes of chapter 669 in the establishment of a standing 12 order in compliance with this section. 13 8. The department, in collaboration with the board and 14 the board of medicine, and in consideration of the guidelines 15 established by the American congress of obstetricians and 16 gynecologists, shall adopt rules pursuant to chapter 17A to 17 administer this chapter. 18 Sec. 2. Section 514C.19, Code 2026, is amended to read as 19 follows: 20 514C.19 Prescription contraceptive coverage. 21 1. For the purposes of this section: 22 a. “Self-administered hormonal contraceptive” means the same 23 as defined in section 155A.49. 24 b. “Standing order” means the same as defined in section 25 155A.49. 26 1. 2. Notwithstanding the uniformity of treatment 27 requirements of section 514C.6 , a group policy , or contract , or 28 plan providing for third-party payment or prepayment of health 29 or medical expenses shall not do either of the following comply 30 as follows : 31 a. Exclude Such policy, contract, or plan shall not 32 exclude or restrict benefits for prescription contraceptive 33 drugs or prescription contraceptive devices which prevent 34 conception and which are approved by the United States 35 -4- LSB 5837XL (3) 91 ak/ko 4/ 11
S.F. _____ H.F. _____ food and drug administration, or generic equivalents 1 approved as substitutable by the United States food and 2 drug administration, if such policy , or contract , or plan 3 provides benefits for other outpatient prescription drugs 4 or devices. However, such policy, contract, or plan shall 5 specifically provide for payment of a self-administered 6 hormonal contraceptive, as prescribed by a practitioner as 7 defined in section 155A.3, or as prescribed by standing order 8 and dispensed by a pharmacist pursuant to section 155A.49, 9 including payment for up to an initial three-month supply 10 of a self-administered hormonal contraceptive dispensed at 11 one time and for up to a twelve-month supply of the same 12 self-administered hormonal contraceptive subsequently dispensed 13 at one time. 14 b. Exclude Such policy, contract, or plan shall not exclude 15 or restrict benefits for outpatient contraceptive services 16 which are provided for the purpose of preventing conception if 17 such policy , or contract , or plan provides benefits for other 18 outpatient services provided by a health care professional. 19 2. 3. A person who provides a group policy , or contract , or 20 plan providing for third-party payment or prepayment of health 21 or medical expenses which is subject to subsection 1 2 shall 22 not do any of the following: 23 a. Deny to an individual eligibility, or continued 24 eligibility, to enroll in or to renew coverage under the terms 25 of the policy , or contract , or plan because of the individual’s 26 use or potential use of such prescription contraceptive drugs 27 or devices, or use or potential use of outpatient contraceptive 28 services. 29 b. Provide a monetary payment or rebate to a covered 30 individual to encourage such individual to accept less than the 31 minimum benefits provided for under subsection 1 2 . 32 c. Penalize or otherwise reduce or limit the reimbursement 33 of a health care professional because such professional 34 prescribes contraceptive drugs or devices, or provides 35 -5- LSB 5837XL (3) 91 ak/ko 5/ 11
S.F. _____ H.F. _____ contraceptive services. 1 d. Provide incentives, monetary or otherwise, to a health 2 care professional to induce such professional to withhold 3 from a covered individual contraceptive drugs or devices, or 4 contraceptive services. 5 3. 4. This section shall not be construed to prevent a 6 third-party payor from including deductibles, coinsurance, or 7 copayments under the policy , or contract, or plan as follows: 8 a. A deductible, coinsurance, or copayment for benefits 9 for prescription contraceptive drugs shall not be greater than 10 such deductible, coinsurance, or copayment for any outpatient 11 prescription drug for which coverage under the policy , or 12 contract , or plan is provided. 13 b. A deductible, coinsurance, or copayment for benefits for 14 prescription contraceptive devices shall not be greater than 15 such deductible, coinsurance, or copayment for any outpatient 16 prescription device for which coverage under the policy , or 17 contract , or plan is provided. 18 c. A deductible, coinsurance, or copayment for benefits for 19 outpatient contraceptive services shall not be greater than 20 such deductible, coinsurance, or copayment for any outpatient 21 health care services for which coverage under the policy , or 22 contract , or plan is provided. 23 4. 5. This section shall not be construed to require 24 a third-party payor under a policy , or contract , or plan 25 to provide benefits for experimental or investigational 26 contraceptive drugs or devices, or experimental or 27 investigational contraceptive services, except to the extent 28 that such policy , or contract , or plan provides coverage for 29 other experimental or investigational outpatient prescription 30 drugs or devices, or experimental or investigational outpatient 31 health care services. 32 5. 6. This section shall not be construed to limit or 33 otherwise discourage the use of generic equivalent drugs 34 approved by the United States food and drug administration, 35 -6- LSB 5837XL (3) 91 ak/ko 6/ 11
S.F. _____ H.F. _____ whenever available and appropriate. This section , when a brand 1 name drug is requested by a covered individual and a suitable 2 generic equivalent is available and appropriate, shall not 3 be construed to prohibit a third-party payor from requiring 4 the covered individual to pay a deductible, coinsurance, or 5 copayment consistent with subsection 3 4 , in addition to the 6 difference of the cost of the brand name drug less the maximum 7 covered amount for a generic equivalent. 8 6. 7. A person who provides an individual policy , or 9 contract , or plan providing for third-party payment or 10 prepayment of health or medical expenses shall make available 11 a coverage provision that satisfies the requirements in 12 subsections 1 2 through 5 6 in the same manner as such 13 requirements are applicable to a group policy , or contract , or 14 plan under those subsections. The policy , or contract , or plan 15 shall provide that the individual policyholder may reject the 16 coverage provision at the option of the policyholder. 17 7. 8. a. This section applies to the following classes of 18 third-party payment provider contracts , or policies , or plans 19 delivered, issued for delivery, continued, or renewed in this 20 state on or after July 1, 2000 January 1, 2027 : 21 (1) Individual or group accident and sickness insurance 22 providing coverage on an expense-incurred basis. 23 (2) An individual or group hospital or medical service 24 contract issued pursuant to chapter 509 , 514 , or 514A . 25 (3) An individual or group health maintenance organization 26 contract regulated under chapter 514B . 27 (4) Any other entity engaged in the business of insurance, 28 risk transfer, or risk retention, which is subject to the 29 jurisdiction of the commissioner. 30 (5) A plan established pursuant to chapter 509A for public 31 employees. 32 b. This section shall not apply to accident-only, 33 specified disease, short-term hospital or medical, hospital 34 confinement indemnity, credit, dental, vision, Medicare 35 -7- LSB 5837XL (3) 91 ak/ko 7/ 11
S.F. _____ H.F. _____ supplement, long-term care, basic hospital and medical-surgical 1 expense coverage as defined by the commissioner, disability 2 income insurance coverage, coverage issued as a supplement 3 to liability insurance, workers’ compensation or similar 4 insurance, or automobile medical payment insurance. 5 9. This section shall not be construed to require a 6 third-party payor under a policy, contract, or plan to 7 provide payment to a practitioner for the dispensing of 8 a self-administered hormonal contraceptive to replace a 9 self-administered hormonal contraceptive that has been 10 dispensed to a covered person and that has been misplaced, 11 stolen, or destroyed. This section shall not be construed to 12 require a third-party payor under a policy, contract, or plan 13 to replace covered prescriptions that are misplaced, stolen, 14 or destroyed. 15 Sec. 3. INFORMATION PROGRAM FOR DRUG PRESCRIBING AND 16 DISPENSING —— SELF-ADMINISTERED HORMONAL CONTRACEPTIVES. The 17 board of pharmacy in collaboration with the board of medicine 18 and the department of health and human services shall expand 19 the information program for drug prescribing and dispensing 20 established pursuant to section 124.551, to collect from 21 pharmacists information relating to the dispensing of 22 self-administered hormonal contraceptives pursuant to section 23 155A.49. The board of pharmacy shall adopt rules pursuant 24 to chapter 17A related to registration of participating 25 pharmacists, the information to be reported by a pharmacist 26 to the information program, access to information from the 27 program, and other rules necessary to carry out the purposes 28 and to enforce the provisions of this section. 29 Sec. 4. APPLICATION TO MEDICAID PROGRAM. This Act shall 30 apply to the Medicaid program under chapter 249A, including a 31 managed care organization acting pursuant to a contract with 32 the department of health and human services to administer 33 the Medicaid program. However, if it is determined that any 34 provision of this Act would cause denial of federal funds under 35 -8- LSB 5837XL (3) 91 ak/ko 8/ 11
S.F. _____ H.F. _____ Tit. XVIII or XIX of the federal Social Security Act, or would 1 otherwise be inconsistent or conflict with the requirements of 2 a federal law or regulation, such provision shall be suspended 3 to the extent necessary to prevent denial of such funds or to 4 eliminate the inconsistency or conflict with the requirements 5 of the federal law or regulation. 6 EXPLANATION 7 The inclusion of this explanation does not constitute agreement with 8 the explanation’s substance by the members of the general assembly. 9 This bill relates to the dispensing of self-administered 10 hormonal contraceptives by a pharmacist. The bill 11 defines “self-administered hormonal contraceptive” as a 12 self-administered hormonal contraceptive that is approved by 13 the United States food and drug administration to prevent 14 pregnancy, including an oral hormonal contraceptive, a hormonal 15 vaginal ring, and a hormonal contraceptive patch, but not 16 including any drug intended to induce an abortion. 17 The bill provides that notwithstanding any provision of law 18 to the contrary, a pharmacist may dispense a self-administered 19 hormonal contraceptive to a patient who is at least 18 20 years of age pursuant to a standing order established by the 21 medical director (medical director) of the department of 22 health and human services (HHS). For an initial dispensing, 23 a pharmacist may dispense only up to a three-month supply at 24 one time of the self-administered hormonal contraceptive, and 25 for any subsequent dispensing of the same self-administered 26 hormonal contraceptive, a 12-month supply at one time. 27 Additionally, the bill prohibits a pharmacist who dispenses 28 a self-administered hormonal contraceptive in accordance 29 with the bill from requiring any other prescription drug 30 order authorized by a practitioner prior to dispensing the 31 self-administered hormonal contraceptive. 32 The bill authorizes the medical director to establish a 33 standing order authorizing the dispensing of self-administered 34 hormonal contraceptives by any pharmacist who complies with the 35 -9- LSB 5837XL (3) 91 ak/ko 9/ 11
S.F. _____ H.F. _____ standing order and retains and submits the patient’s record to 1 HHS. 2 The standing order includes requiring a pharmacist who 3 dispenses a self-administered hormonal contraceptive under 4 the bill to: complete a standardized training program and 5 continuing education requirements related to prescribing the 6 hormonal contraceptives; obtain a completed self-screening risk 7 assessment from each patient, verify the identity and age of 8 each patient, and perform a blood pressure screening on each 9 patient before dispensing the hormonal contraceptives; provide 10 the patient with certain written information; provide the 11 patient with a copy of the record of the pharmacist’s encounter 12 with the patient; and provide patient counseling. 13 The standing order would prohibit a pharmacist who dispenses 14 hormonal contraceptives under the bill from requiring a 15 patient to schedule an appointment with the pharmacist for 16 the prescribing or dispensing of the hormonal contraceptives; 17 dispensing the hormonal contraceptives to a patient for more 18 than 27 months after the date initially dispensed without the 19 patient’s attestation that the patient has consulted with a 20 practitioner during the preceding 27 months; and dispensing 21 the hormonal contraceptives to a patient if the results of the 22 patient’s self-screening risk assessment indicate it is unsafe 23 for the pharmacist to dispense the hormonal contraceptives 24 to the patient, in which case the pharmacist shall refer the 25 patient to a practitioner. 26 The bill provides immunity for a pharmacist who dispenses a 27 self-administered hormonal contraceptive and for the medical 28 director who establishes a standing order in compliance with 29 the bill from criminal and civil liability arising from any 30 damages caused by the dispensing, administering, or use of a 31 self-administered hormonal contraceptive or the establishment 32 of the standing order. Additionally, the medical director 33 shall be considered to be acting within the scope of the 34 medical director’s office and employment for purposes of Code 35 -10- LSB 5837XL (3) 91 ak/ko 10/ 11
S.F. _____ H.F. _____ chapter 669 (Iowa tort claims Act) in the establishment of a 1 standing order in compliance with the bill. 2 The bill requires HHS, in collaboration with the boards of 3 pharmacy and medicine, and in consideration of the guidelines 4 established by the American congress of obstetricians and 5 gynecologists, to adopt administrative rules to administer the 6 bill. 7 The bill amends prescription contraceptive coverage 8 provisions in the Code to require that a group policy, 9 contract, or plan delivered, issued for delivery, continued, 10 or renewed in the state on or after January 1, 2027, 11 providing for third-party payment or prepayment of health 12 or medical expenses, shall specifically provide for payment 13 of self-administered hormonal contraceptives, prescribed 14 and dispensed as specified in the bill. The bill provides, 15 however, that the provisions relating to coverage are not to 16 be construed to require a third-party payor under a policy, 17 contract, or plan to provide payment to a practitioner for 18 dispensing a self-administered hormonal contraceptive to 19 replace a self-administered hormonal contraceptive that has 20 been dispensed to a covered person and that has been misplaced, 21 stolen, or destroyed. These provisions are also not to be 22 construed to require a third-party payor under a policy, 23 contract, or plan to replace covered prescriptions that are 24 misplaced, stolen, or destroyed. 25 The bill also requires the board of pharmacy in 26 collaboration with the board of medicine and HHS to expand 27 the information program for drug prescribing to collect 28 from pharmacists information relating to the dispensing of 29 self-administered hormonal contraceptives as provided in the 30 bill. 31 The bill applies to the Medicaid program as specified in the 32 bill. 33 -11- LSB 5837XL (3) 91 ak/ko 11/ 11