Senate File 348 - Introduced SENATE FILE 348 BY MILLER-MEEKS 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 2637XS (1) 88 pf/rh
S.F. 348 Section 1. Section 155A.3, Code 2019, 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. Notwithstanding any provision of law to the contrary, a 20 pharmacist may dispense, at one time, up to a one-year supply 21 of a self-administered hormonal contraceptive to a patient 22 who is at least eighteen years of age, pursuant to a standing 23 order established by the medical director of the department in 24 accordance with this section. 25 2. A pharmacist who dispenses a self-administered hormonal 26 contraceptive in accordance with this section shall not 27 require any other prescription drug order authorized by a 28 practitioner prior to dispensing the self-administered hormonal 29 contraceptive to a patient. 30 3. The medical director of the department may establish a 31 standing order authorizing the dispensing of self-administered 32 hormonal contraceptives by a pharmacist who does all of the 33 following: 34 a. Complies with the standing order established pursuant to 35 -1- LSB 2637XS (1) 88 pf/rh 1/ 10
S.F. 348 this section. 1 b. Retains a record of each patient to whom a 2 self-administered hormonal contraceptive is dispensed under 3 this section and submits the record to the department. 4 4. The standing order shall require a pharmacist who 5 dispenses self-administered hormonal contraceptives under this 6 section to do all of the following: 7 a. Complete a standardized training program and continuing 8 education requirements approved by the board in consultation 9 with the department that are related to prescribing 10 self-administered hormonal contraceptives and include education 11 regarding all contraceptive methods approved by the United 12 States food and drug administration. 13 b. Obtain a completed self-screening risk assessment, 14 approved by the department in collaboration with the board and 15 the board of medicine, from each patient prior to dispensing 16 the self-administered hormonal contraceptive to the patient. 17 c. Provide the patient with all of the following: 18 (1) Written information regarding all of the following: 19 (a) The importance of completing an appointment with the 20 patient’s primary care or women’s health care practitioner 21 to obtain preventative care, including but not limited to 22 recommended tests and screenings. 23 (b) The effectiveness and availability of long-acting 24 reversible contraceptives as an alternative to 25 self-administered hormonal contraceptives. 26 (2) A copy of the record of the pharmacist’s encounter with 27 the patient that includes all of the following: 28 (a) The patient’s completed self-screening risk assessment. 29 (b) A description of the contraceptive dispensed, or the 30 basis for not dispensing a contraceptive. 31 (3) Patient counseling regarding all of the following: 32 (a) The appropriate administration and storage of the 33 self-administered hormonal contraceptive. 34 (b) Potential side effects and risks of the 35 -2- LSB 2637XS (1) 88 pf/rh 2/ 10
S.F. 348 self-administered hormonal contraceptive. 1 (c) The need for backup contraception. 2 (d) When to seek emergency medical attention. 3 (e) The risk of contracting a sexually transmitted 4 infection or disease, and ways to reduce such a risk. 5 5. The standing order established pursuant to this section 6 shall prohibit a pharmacist who dispenses a self-administered 7 hormonal contraceptive under this section from doing any of the 8 following: 9 a. Requiring a patient to schedule an appointment with 10 the pharmacist for the prescribing or dispensing of a 11 self-administered hormonal contraceptive. 12 b. Dispensing self-administered hormonal contraceptives to 13 a patient for more than twenty-four months after the date a 14 self-administered hormonal contraceptive is initially dispensed 15 to the patient without the patient’s attestation that the 16 patient has consulted with a primary care or women’s health 17 care practitioner during the preceding twenty-four months. 18 c. Dispensing a self-administered hormonal contraceptive to 19 a patient if the results of the self-screening risk assessment 20 completed by a patient pursuant to subsection 4, paragraph 21 “b” , indicate it is unsafe for the pharmacist to dispense the 22 self-administered hormonal contraceptive to the patient, in 23 which case the pharmacist shall refer the patient to a primary 24 care or women’s health care practitioner. 25 6. A pharmacist who dispenses a self-administered hormonal 26 contraceptive and the medical director of the department who 27 establishes a standing order in compliance with this section 28 shall be immune from criminal and civil liability arising 29 from any damages caused by the dispensing, administering, 30 or use of a self-administered hormonal contraceptive or the 31 establishment of the standing order. The medical director of 32 the department shall be considered to be acting within the 33 scope of the medical director’s office and employment for 34 purposes of chapter 669 in the establishment of a standing 35 -3- LSB 2637XS (1) 88 pf/rh 3/ 10
S.F. 348 order in compliance with this section. 1 7. The department, in collaboration with the board and 2 the board of medicine, and in consideration of the guidelines 3 established by the American congress of obstetricians and 4 gynecologists, shall adopt rules pursuant to chapter 17A to 5 administer this chapter. 6 Sec. 3. Section 514C.19, Code 2019, is amended to read as 7 follows: 8 514C.19 Prescription contraceptive coverage. 9 1. Notwithstanding the uniformity of treatment requirements 10 of section 514C.6 , a group policy , or contract , or plan 11 providing for third-party payment or prepayment of health or 12 medical expenses shall not do either of the following comply 13 as follows : 14 a. Exclude Such policy, contract, or plan shall not 15 exclude or restrict benefits for prescription contraceptive 16 drugs or prescription contraceptive devices which prevent 17 conception and which are approved by the United States 18 food and drug administration, or generic equivalents 19 approved as substitutable by the United States food and drug 20 administration, if such policy , or contract , or plan provides 21 benefits for other outpatient prescription drugs or devices. 22 However, such policy, contract, or plan shall specifically 23 provide for payment of a one-year supply of self-administered 24 hormonal contraceptives, as prescribed by a practitioner as 25 defined in section 155A.3, or as prescribed by standing order 26 and dispensed by a pharmacist pursuant to section 155A.47, 27 including self-administered hormonal contraceptives dispensed 28 at one time. 29 b. Exclude Such policy, contract, or plan shall not exclude 30 or restrict benefits for outpatient contraceptive services 31 which are provided for the purpose of preventing conception if 32 such policy , or contract , or plan provides benefits for other 33 outpatient services provided by a health care professional. 34 2. A person who provides a group policy , or contract , or 35 -4- LSB 2637XS (1) 88 pf/rh 4/ 10
S.F. 348 plan providing for third-party payment or prepayment of health 1 or medical expenses which is subject to subsection 1 shall not 2 do any of the following: 3 a. Deny to an individual eligibility, or continued 4 eligibility, to enroll in or to renew coverage under the terms 5 of the policy , or contract , or plan because of the individual’s 6 use or potential use of such prescription contraceptive drugs 7 or devices, or use or potential use of outpatient contraceptive 8 services. 9 b. Provide a monetary payment or rebate to a covered 10 individual to encourage such individual to accept less than the 11 minimum benefits provided for under subsection 1 . 12 c. Penalize or otherwise reduce or limit the reimbursement 13 of a health care professional because such professional 14 prescribes contraceptive drugs or devices, or provides 15 contraceptive services. 16 d. Provide incentives, monetary or otherwise, to a health 17 care professional to induce such professional to withhold 18 from a covered individual contraceptive drugs or devices, or 19 contraceptive services. 20 3. This section shall not be construed to prevent a 21 third-party payor from including deductibles, coinsurance, or 22 copayments under the policy , or contract, or plan as follows: 23 a. A deductible, coinsurance, or copayment for benefits 24 for prescription contraceptive drugs shall not be greater than 25 such deductible, coinsurance, or copayment for any outpatient 26 prescription drug for which coverage under the policy , or 27 contract , or plan is provided. 28 b. A deductible, coinsurance, or copayment for benefits for 29 prescription contraceptive devices shall not be greater than 30 such deductible, coinsurance, or copayment for any outpatient 31 prescription device for which coverage under the policy , or 32 contract , or plan is provided. 33 c. A deductible, coinsurance, or copayment for benefits for 34 outpatient contraceptive services shall not be greater than 35 -5- LSB 2637XS (1) 88 pf/rh 5/ 10
S.F. 348 such deductible, coinsurance, or copayment for any outpatient 1 health care services for which coverage under the policy , or 2 contract , or plan is provided. 3 4. This section shall not be construed to require a 4 third-party payor under a policy , or contract , or plan 5 to provide benefits for experimental or investigational 6 contraceptive drugs or devices, or experimental or 7 investigational contraceptive services, except to the extent 8 that such policy , or contract , or plan provides coverage for 9 other experimental or investigational outpatient prescription 10 drugs or devices, or experimental or investigational outpatient 11 health care services. 12 5. This section shall not be construed to limit or otherwise 13 discourage the use of generic equivalent drugs approved by the 14 United States food and drug administration, whenever available 15 and appropriate. This section , when a brand name drug is 16 requested by a covered individual and a suitable generic 17 equivalent is available and appropriate, shall not be construed 18 to prohibit a third-party payor from requiring the covered 19 individual to pay a deductible, coinsurance, or copayment 20 consistent with subsection 3 , in addition to the difference of 21 the cost of the brand name drug less the maximum covered amount 22 for a generic equivalent. 23 6. A person who provides an individual policy , or contract , 24 or plan providing for third-party payment or prepayment of 25 health or medical expenses shall make available a coverage 26 provision that satisfies the requirements in subsections 27 1 through 5 in the same manner as such requirements are 28 applicable to a group policy , or contract , or plan under those 29 subsections. The policy , or contract , or plan shall provide 30 that the individual policyholder may reject the coverage 31 provision at the option of the policyholder. 32 7. a. This section applies to the following classes of 33 third-party payment provider contracts , or policies , or plan 34 delivered, issued for delivery, continued, or renewed in this 35 -6- LSB 2637XS (1) 88 pf/rh 6/ 10
S.F. 348 state on or after July 1, 2000 January 1, 2020 : 1 (1) Individual or group accident and sickness insurance 2 providing coverage on an expense-incurred basis. 3 (2) An individual or group hospital or medical service 4 contract issued pursuant to chapter 509 , 514 , or 514A . 5 (3) An individual or group health maintenance organization 6 contract regulated under chapter 514B . 7 (4) Any other entity engaged in the business of insurance, 8 risk transfer, or risk retention, which is subject to the 9 jurisdiction of the commissioner. 10 (5) A plan established pursuant to chapter 509A for public 11 employees. 12 b. This section shall not apply to accident-only, 13 specified disease, short-term hospital or medical, hospital 14 confinement indemnity, credit, dental, vision, Medicare 15 supplement, long-term care, basic hospital and medical-surgical 16 expense coverage as defined by the commissioner, disability 17 income insurance coverage, coverage issued as a supplement 18 to liability insurance, workers’ compensation or similar 19 insurance, or automobile medical payment insurance. 20 8. This section shall not be construed to require a 21 third-party payor to provide payment to a practitioner for the 22 dispensing of a self-administered hormonal contraceptive to 23 replace a self-administered hormonal contraceptive that has 24 been dispensed to a covered person and that has been misplaced, 25 stolen, or destroyed. This section shall not be construed to 26 require a third-party payor to replace covered prescriptions 27 that are misplaced, stolen, or destroyed. 28 9. For the purposes of this section: 29 a. “Self-administered hormonal contraceptive” means a 30 self-administered hormonal contraceptive that is approved 31 by the United Sates food and drug administration to prevent 32 pregnancy. “Self-administered hormonal contraceptive” includes 33 an oral hormonal contraceptive, a hormonal vaginal ring, and 34 a hormonal contraceptive patch, but does not include any drug 35 -7- LSB 2637XS (1) 88 pf/rh 7/ 10
S.F. 348 intended to induce an abortion as defined in section 146.1. 1 b. “Standing order” means a preauthorized medication order 2 with specific instructions from the medical director of the 3 department of public health to dispense a medication under 4 clearly defined circumstances. 5 EXPLANATION 6 The inclusion of this explanation does not constitute agreement with 7 the explanation’s substance by the members of the general assembly. 8 This bill relates to the dispensing of self-administered 9 hormonal contraceptives by a pharmacist. The bill 10 defines “self-administered hormonal contraceptive” as a 11 self-administered hormonal contraceptive that is approved by 12 the United States food and drug administration to prevent 13 pregnancy, including an oral hormonal contraceptive, a hormonal 14 vaginal ring, and a hormonal contraceptive patch, but not 15 including any drug intended to induce an abortion. 16 The bill provides that notwithstanding any provision of 17 law to the contrary, a pharmacist may dispense at one time, 18 up to a one-year supply of a self-administered hormonal 19 contraceptive to a patient who is at least 18 years of age 20 pursuant to a standing order established by the medical 21 director of the department of public health (medical director). 22 Additionally, the bill prohibits a pharmacist who dispenses 23 a self-administered hormonal contraceptive in accordance 24 with the bill from requiring any other prescription drug 25 order authorized by a practitioner prior to dispensing the 26 self-administered hormonal 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 -8- LSB 2637XS (1) 88 pf/rh 8/ 10
S.F. 348 continuing education requirements related to prescribing the 1 hormonal contraceptives; obtain a completed self-screening risk 2 assessment from each patient before dispensing the hormonal 3 contraceptives; provide the patient with certain written 4 information; provide the patient with a copy of the record 5 of the pharmacist’s encounter with the patient; and provide 6 patient counseling. 7 The standing order is to prohibit a pharmacist who dispenses 8 hormonal contraceptives under the bill from requiring a 9 patient to schedule an appointment with the pharmacist for 10 the prescribing or dispensing of the hormonal contraceptives; 11 dispensing the hormonal contraceptives to a patient for more 12 than 24 months after the date initially dispensed without the 13 patient’s attestation that the patient has consulted with a 14 practitioner during the preceding 24 months; or dispensing the 15 hormonal contraceptives to a patient if the results of the 16 patient’s self-screening risk assessment indicate it is unsafe 17 for the pharmacist to dispense the hormonal contraceptives 18 to the patient, in which case the pharmacist shall refer the 19 patient to a practitioner. 20 The bill provides immunity, for a pharmacist who dispenses a 21 self-administered hormonal contraceptive and for the medical 22 director who establishes a standing order in compliance with 23 the bill, from criminal and civil liability arising from any 24 damages caused by the dispensing, administering, or use of a 25 self-administered hormonal contraceptive or the establishment 26 of the standing order. Additionally, the medical director 27 shall be considered to be acting within the scope of the 28 medical director’s office and employment for purposes of Code 29 chapter 669 (Iowa tort claims Act) in the establishment of a 30 standing order in compliance with the bill. 31 The bill requires DPH, in collaboration with the boards of 32 pharmacy and medicine, and in consideration of the guidelines 33 established by the American congress of obstetricians and 34 gynecologists, to adopt administrative rules to administer the 35 -9- LSB 2637XS (1) 88 pf/rh 9/ 10
S.F. 348 bill. 1 The bill amends prescription contraceptive coverage 2 provisions to require that a group policy, contract, or plan 3 delivered, issued for delivery, continued, or renewed in the 4 state on or after January 1, 2020, providing for third-party 5 payment or prepayment of health or medical expenses, shall 6 specifically provide for payment of a one-year supply of 7 self-administered hormonal contraceptives, as prescribed 8 and dispensed as specified in the bill, including those 9 dispensed at one time. The bill provides, however, that 10 the provisions of the bill relating to coverage are not 11 to be construed to require a third-party payor to provide 12 payment to a practitioner for dispensing a self-administered 13 hormonal contraceptive to replace a self-administered 14 hormonal contraceptive that has been dispensed to a covered 15 person and that has been misplaced, stolen, or destroyed. 16 These provisions are also not to be construed to require a 17 third-party payor to replace covered prescriptions that are 18 misplaced, stolen, or destroyed. 19 -10- LSB 2637XS (1) 88 pf/rh 10/ 10