House File 434 - Introduced
HOUSE FILE 434
BY COMMITTEE ON HUMAN
RESOURCES
(SUCCESSOR TO HSB 121)
A BILL FOR
1 An Act relating to the prescribing and dispensing of
2 self-administered hormonal contraceptives.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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1 Section 1. Section 155A.3, Code 2021, is amended by adding
2 the following new subsections:
3 NEW SUBSECTION. 10A. “Department” means the department of
4 public health.
5 NEW SUBSECTION. 44A. “Self-administered hormonal
6 contraceptive” means a self-administered hormonal contraceptive
7 that is approved by the United States food and drug
8 administration to prevent pregnancy. “Self-administered
9 hormonal contraceptive” includes an oral hormonal contraceptive,
10 a hormonal vaginal ring, and a hormonal contraceptive patch,
11 but does not include any drug intended to induce an abortion as
12 defined in section 146.1.
13 NEW SUBSECTION. 44B. “Standing order” means a preauthorized
14 medication order with specific instructions from the medical
15 director of the department to dispense a medication under
16 clearly defined circumstances.
17 Sec. 2. NEW SECTION. 155A.47 Pharmacist dispensing of
18 self-administered hormonal contraceptives —— standing order ——
19 requirements —— limitations of liability.
20 1. a. Notwithstanding any provision of law to the contrary,
21 a pharmacist may dispense a self-administered hormonal
22 contraceptive to a patient who is at least eighteen years of
23 age, pursuant to a standing order established by the medical
24 director of the department in accordance with this section.
25 b. In dispensing a self-administered hormonal contraceptive
26 to a patient under this section, a pharmacist shall comply with
27 all of the following:
28 (1) For an initial dispensing of a self-administered
29 hormonal contraceptive, the pharmacist may dispense only up
30 to a three-month supply at one time of the self-administered
31 hormonal contraceptive.
32 (2) For any subsequent dispensing of the same
33 self-administered hormonal contraceptive, the pharmacist
34 may dispense up to a twelve-month supply at one time of the
35 self-administered hormonal contraceptive.
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1 2. A pharmacist who dispenses a self-administered hormonal
2 contraceptive in accordance with this section shall not
3 require any other prescription drug order authorized by a
4 practitioner prior to dispensing the self-administered hormonal
5 contraceptive to a patient.
6 3. The medical director of the department may establish a
7 standing order authorizing the dispensing of self-administered
8 hormonal contraceptives by a pharmacist who does all of the
9 following:
10 a. Complies with the standing order established pursuant to
11 this section.
12 b. Retains a record of each patient to whom a
13 self-administered hormonal contraceptive is dispensed under
14 this section and submits the record to the department.
15 4. The standing order shall require a pharmacist who
16 dispenses self-administered hormonal contraceptives under this
17 section to do all of the following:
18 a. Complete a standardized training program and continuing
19 education requirements approved by the board in consultation
20 with the board of medicine and the department that are related
21 to prescribing self-administered hormonal contraceptives and
22 include education regarding all contraceptive methods approved
23 by the United States food and drug administration.
24 b. Obtain a completed self-screening risk assessment,
25 approved by the department in collaboration with the board and
26 the board of medicine, from each patient, verify the identity
27 and age of each patient, and perform a blood pressure screening
28 on each patient prior to dispensing the self-administered
29 hormonal contraceptive to the patient.
30 c. Provide the patient with all of the following:
31 (1) Written information regarding all of the following:
32 (a) The importance of completing an appointment with the
33 patient’s primary care or women’s health care practitioner
34 to obtain preventative care, including but not limited to
35 recommended tests and screenings.
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1 (b) The effectiveness and availability of long-acting
2 reversible contraceptives as an alternative to
3 self-administered hormonal contraceptives.
4 (2) A copy of the record of the pharmacist’s encounter with
5 the patient that includes all of the following:
6 (a) The patient’s completed self-screening risk assessment.
7 (b) A description of the contraceptive dispensed, or the
8 basis for not dispensing a contraceptive.
9 (3) Patient counseling regarding all of the following:
10 (a) The appropriate administration and storage of the
11 self-administered hormonal contraceptive.
12 (b) Potential side effects and risks of the
13 self-administered hormonal contraceptive.
14 (c) The need for backup contraception.
15 (d) When to seek emergency medical attention.
16 (e) The risk of contracting a sexually transmitted
17 infection or disease, and ways to reduce such a risk.
18 5. The standing order established pursuant to this section
19 shall prohibit a pharmacist who dispenses a self-administered
20 hormonal contraceptive under this section from doing any of the
21 following:
22 a. Requiring a patient to schedule an appointment with
23 the pharmacist for the prescribing or dispensing of a
24 self-administered hormonal contraceptive.
25 b. Dispensing self-administered hormonal contraceptives
26 to a patient for more than twenty-seven months after the
27 date a self-administered hormonal contraceptive is initially
28 dispensed to the patient, if the patient has not consulted with
29 a primary care or women’s health care practitioner during the
30 preceding twenty-seven months, in which case the pharmacist
31 shall refer the patient to a primary care or women’s health
32 care practitioner.
33 c. Dispensing a self-administered hormonal contraceptive to
34 a patient if the results of the self-screening risk assessment
35 completed by a patient pursuant to subsection 4, paragraph
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1 “b”, indicate it is unsafe for the pharmacist to dispense the
2 self-administered hormonal contraceptive to the patient, in
3 which case the pharmacist shall refer the patient to a primary
4 care or women’s health care practitioner.
5 6. A pharmacist who dispenses a self-administered hormonal
6 contraceptive and the medical director of the department who
7 establishes a standing order in compliance with this section
8 shall be immune from criminal and civil liability arising
9 from any damages caused by the dispensing, administering,
10 or use of a self-administered hormonal contraceptive or the
11 establishment of the standing order. The medical director of
12 the department shall be considered to be acting within the
13 scope of the medical director’s office and employment for
14 purposes of chapter 669 in the establishment of a standing
15 order in compliance with this section.
16 7. The department, in collaboration with the board and
17 the board of medicine, and in consideration of the guidelines
18 established by the American congress of obstetricians and
19 gynecologists, shall adopt rules pursuant to chapter 17A to
20 administer this chapter.
21 Sec. 3. Section 514C.19, Code 2021, is amended to read as
22 follows:
23 514C.19 Prescription contraceptive coverage.
24 1. Notwithstanding the uniformity of treatment requirements
25 of section 514C.6, a group policy, or contract, or plan
26 providing for third-party payment or prepayment of health or
27 medical expenses shall not do either of the following comply
28 as follows:
29 a. Exclude Such policy, contract, or plan shall not
30 exclude or restrict benefits for prescription contraceptive
31 drugs or prescription contraceptive devices which prevent
32 conception and which are approved by the United States
33 food and drug administration, or generic equivalents
34 approved as substitutable by the United States food and
35 drug administration, if such policy, or contract, or plan
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1 provides benefits for other outpatient prescription drugs
2 or devices. However, such policy, contract, or plan shall
3 specifically provide for payment of a self-administered
4 hormonal contraceptive, as prescribed by a practitioner as
5 defined in section 155A.3, or as prescribed by standing order
6 and dispensed by a pharmacist pursuant to section 155A.47,
7 including payment for up to an initial three-month supply
8 of a self-administered hormonal contraceptive dispensed at
9 one time and for up to a twelve-month supply of the same
10 self-administered hormonal contraceptive subsequently dispensed
11 at one time.
12 b. Exclude Such policy, contract, or plan shall not exclude
13 or restrict benefits for outpatient contraceptive services
14 which are provided for the purpose of preventing conception if
15 such policy, or contract, or plan provides benefits for other
16 outpatient services provided by a health care professional.
17 2. A person who provides a group policy, or contract, or
18 plan providing for third-party payment or prepayment of health
19 or medical expenses which is subject to subsection 1 shall not
20 do any of the following:
21 a. Deny to an individual eligibility, or continued
22 eligibility, to enroll in or to renew coverage under the terms
23 of the policy, or contract, or plan because of the individual’s
24 use or potential use of such prescription contraceptive drugs
25 or devices, or use or potential use of outpatient contraceptive
26 services.
27 b. Provide a monetary payment or rebate to a covered
28 individual to encourage such individual to accept less than the
29 minimum benefits provided for under subsection 1.
30 c. Penalize or otherwise reduce or limit the reimbursement
31 of a health care professional because such professional
32 prescribes contraceptive drugs or devices, or provides
33 contraceptive services.
34 d. Provide incentives, monetary or otherwise, to a health
35 care professional to induce such professional to withhold
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1 from a covered individual contraceptive drugs or devices, or
2 contraceptive services.
3 3. This section shall not be construed to prevent a
4 third-party payor from including deductibles, coinsurance, or
5 copayments under the policy, or contract, or plan as follows:
6 a. A deductible, coinsurance, or copayment for benefits
7 for prescription contraceptive drugs shall not be greater than
8 such deductible, coinsurance, or copayment for any outpatient
9 prescription drug for which coverage under the policy, or
10 contract, or plan is provided.
11 b. A deductible, coinsurance, or copayment for benefits for
12 prescription contraceptive devices shall not be greater than
13 such deductible, coinsurance, or copayment for any outpatient
14 prescription device for which coverage under the policy, or
15 contract, or plan is provided.
16 c. A deductible, coinsurance, or copayment for benefits for
17 outpatient contraceptive services shall not be greater than
18 such deductible, coinsurance, or copayment for any outpatient
19 health care services for which coverage under the policy, or
20 contract, or plan is provided.
21 4. This section shall not be construed to require a
22 third-party payor under a policy, or contract, or plan
23 to provide benefits for experimental or investigational
24 contraceptive drugs or devices, or experimental or
25 investigational contraceptive services, except to the extent
26 that such policy, or contract, or plan provides coverage for
27 other experimental or investigational outpatient prescription
28 drugs or devices, or experimental or investigational outpatient
29 health care services.
30 5. This section shall not be construed to limit or otherwise
31 discourage the use of generic equivalent drugs approved by the
32 United States food and drug administration, whenever available
33 and appropriate. This section, when a brand name drug is
34 requested by a covered individual and a suitable generic
35 equivalent is available and appropriate, shall not be construed
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1 to prohibit a third-party payor from requiring the covered
2 individual to pay a deductible, coinsurance, or copayment
3 consistent with subsection 3, in addition to the difference of
4 the cost of the brand name drug less the maximum covered amount
5 for a generic equivalent.
6 6. A person who provides an individual policy, or contract,
7 or plan providing for third-party payment or prepayment of
8 health or medical expenses shall make available a coverage
9 provision that satisfies the requirements in subsections
10 1 through 5 in the same manner as such requirements are
11 applicable to a group policy, or contract, or plan under those
12 subsections. The policy, or contract, or plan shall provide
13 that the individual policyholder may reject the coverage
14 provision at the option of the policyholder.
15 7. a. This section applies to the following classes of
16 third-party payment provider contracts, or policies, or plans
17 delivered, issued for delivery, continued, or renewed in this
18 state on or after July 1, 2000 January 1, 2022:
19 (1) Individual or group accident and sickness insurance
20 providing coverage on an expense-incurred basis.
21 (2) An individual or group hospital or medical service
22 contract issued pursuant to chapter 509, 514, or 514A.
23 (3) An individual or group health maintenance organization
24 contract regulated under chapter 514B.
25 (4) Any other entity engaged in the business of insurance,
26 risk transfer, or risk retention, which is subject to the
27 jurisdiction of the commissioner.
28 (5) A plan established pursuant to chapter 509A for public
29 employees.
30 b. This section shall not apply to accident-only,
31 specified disease, short-term hospital or medical, hospital
32 confinement indemnity, credit, dental, vision, Medicare
33 supplement, long-term care, basic hospital and medical-surgical
34 expense coverage as defined by the commissioner, disability
35 income insurance coverage, coverage issued as a supplement
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1 to liability insurance, workers’ compensation or similar
2 insurance, or automobile medical payment insurance.
3 8. This section shall not be construed to require a
4 third-party payor to provide payment to a practitioner for the
5 dispensing of a self-administered hormonal contraceptive to
6 replace a self-administered hormonal contraceptive that has
7 been dispensed to a covered person and that has been misplaced,
8 stolen, or destroyed. This section shall not be construed to
9 require a third-party payor to replace covered prescriptions
10 that are misplaced, stolen, or destroyed.
11 9. For the purposes of this section:
12 a. “Self-administered hormonal contraceptive” means a
13 self-administered hormonal contraceptive that is approved
14 by the United Sates food and drug administration to prevent
15 pregnancy. “Self-administered hormonal contraceptive” includes
16 an oral hormonal contraceptive, a hormonal vaginal ring, and
17 a hormonal contraceptive patch, but does not include any drug
18 intended to induce an abortion as defined in section 146.1.
19 b. “Standing order” means a preauthorized medication order
20 with specific instructions from the medical director of the
21 department of public health to dispense a medication under
22 clearly defined circumstances.
23 Sec. 4. INFORMATION PROGRAM FOR DRUG PRESCRIBING AND
24 DISPENSING —— SELF-ADMINISTERED HORMONAL CONTRACEPTIVES. The
25 board of pharmacy in collaboration with the board of
26 medicine and the department of public health shall expand
27 the information program for drug prescribing and dispensing
28 established pursuant to section 124.551, to collect from
29 pharmacists information relating to the dispensing of
30 s