1.1 A bill for an act 1.2 relating to health insurance; establishing supply requirements for prescription 1.3 contraceptives; requiring health plans to cover contraceptive methods, sterilization, 1.4 and related medical services, patient education, and counseling; establishing 1.5 accommodations for eligible organizations; amending Minnesota Statutes 2022, 1.6 section 256B.0625, subdivision 13; proposing coding for new law in Minnesota 1.7 Statutes, chapter 62Q. 1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 1.9 Section 1. [62Q.522] COVERAGE OF CONTRACEPTIVE METHODS AND 1.10SERVICES. 1.11 Subdivision 1.Definitions.(a) The definitions in this subdivision apply to this section. 1.12 (b) "Closely held for-profit entity" means an entity that: 1.13 (1) is not a nonprofit entity; 1.14 (2) has more than 50 percent of the value of its ownership interest owned directly or 1.15indirectly by five or fewer owners; and 1.16 (3) has no publicly traded ownership interest. 1.17For purposes of this paragraph: 1.18 (i) ownership interests owned by a corporation, partnership, limited liability company, 1.19estate, trust, or similar entity are considered owned by that entity's shareholders, partners, 1.20members, or beneficiaries in proportion to their interest held in the corporation, partnership, 1.21limited liability company, estate, trust, or similar entity; 1Section 1. S0287-1 1st EngrossmentSF287 REVISOR SGS SENATE STATE OF MINNESOTA S.F. No. 287NINETY-THIRD SESSION (SENATE AUTHORS: MURPHY, Pappas, Port and Boldon) OFFICIAL STATUSD-PGDATE Introduction and first reading19201/17/2023 Referred to Health and Human Services Author added Boldon35201/23/2023 Comm report: To pass and re-referred to Commerce and Consumer Protection82602/16/2023 Comm report: To pass as amended and re-refer to Health and Human Services03/08/2023 2.1 (ii) ownership interests owned by a nonprofit entity are considered owned by a single 2.2owner; 2.3 (iii) ownership interests owned by all individuals in a family are considered held by a 2.4single owner. For purposes of this item, "family" means brothers and sisters, including 2.5half-brothers and half-sisters, a spouse, ancestors, and lineal descendants; and 2.6 (iv) if an individual or entity holds an option, warrant, or similar right to purchase an 2.7ownership interest, the individual or entity is considered to be the owner of those ownership 2.8interests. 2.9 (c) "Contraceptive method" means a drug, device, or other product approved by the Food 2.10and Drug Administration to prevent unintended pregnancy. 2.11 (d) "Contraceptive service" means consultation, examination, procedures, and medical 2.12services related to the prevention of unintended pregnancy, excluding vasectomies. This 2.13includes but is not limited to voluntary sterilization procedures, patient education, counseling 2.14on contraceptives, and follow-up services related to contraceptive methods or services, 2.15management of side effects, counseling for continued adherence, and device insertion or 2.16removal. 2.17 (e) "Eligible organization" means an organization that opposes providing coverage for 2.18some or all contraceptive methods or services on account of religious objections and that 2.19is: 2.20 (1) organized as a nonprofit entity and holds itself out to be religious; or 2.21 (2) organized and operates as a closely held for-profit entity, and the organization's 2.22owners or highest governing body has adopted, under the organization's applicable rules of 2.23governance and consistent with state law, a resolution or similar action establishing that the 2.24organization objects to covering some or all contraceptive methods or services on account 2.25of the owners' sincerely held religious beliefs. 2.26 (f) "Exempt organization" means an organization that is organized and operates as a 2.27nonprofit entity and meets the requirements of section 6033(a)(3)(A)(i) or (iii) of the Internal 2.28Revenue Code of 1986, as amended. 2.29 (g) "Medical necessity" includes but is not limited to considerations such as severity of 2.30side effects, difference in permanence and reversability of a contraceptive method or service, 2.31and ability to adhere to the appropriate use of the contraceptive method or service, as 2.32determined by the attending provider. 2Section 1. S0287-1 1st EngrossmentSF287 REVISOR SGS 3.1 (h) "Therapeutic equivalent version" means a drug, device, or product that can be expected 3.2to have the same clinical effect and safety profile when administered to a patient under the 3.3conditions specified in the labeling, and that: 3.4 (1) is approved as safe and effective; 3.5 (2) is a pharmaceutical equivalent, (i) containing identical amounts of the same active 3.6drug ingredient in the same dosage form and route of administration, and (ii) meeting 3.7compendial or other applicable standards of strength, quality, purity, and identity; 3.8 (3) is bioequivalent in that: 3.9 (i) the drug, device, or product does not present a known or potential bioequivalence 3.10problem and meets an acceptable in vitro standard; or 3.11 (ii) if the drug, device, or product does present a known or potential bioequivalence 3.12problem, it is shown to meet an appropriate bioequivalence standard; 3.13 (4) is adequately labeled; and 3.14 (5) is manufactured in compliance with current manufacturing practice regulations. 3.15 Subd. 2.Required coverage; cost sharing prohibited.(a) A health plan must provide 3.16coverage for contraceptive methods and services. 3.17 (b) A health plan company must not impose cost-sharing requirements, including co-pays, 3.18deductibles, or co-insurance, for contraceptive methods or services. 3.19 (c) A health plan company must not impose any referral requirements, restrictions, or 3.20delays for contraceptive methods or services. 3.21 (d) A health plan must include at least one of each type of Food and Drug Administration 3.22approved contraceptive method in its formulary. If more than one therapeutic equivalent 3.23version of a contraceptive method is approved, a health plan must include at least one 3.24therapeutic equivalent version in its formulary, but is not required to include all therapeutic 3.25equivalent versions. 3.26 (e) For each health plan, a health plan company must list the contraceptive methods and 3.27services that are covered without cost-sharing in a manner that is easily accessible to 3.28enrollees, health care providers, and representatives of health care providers. The list for 3.29each health plan must be promptly updated to reflect changes to the coverage. 3.30 (f) If an enrollee's attending provider recommends a particular contraceptive method or 3.31service based on a determination of medical necessity for that enrollee, the health plan must 3.32cover that contraceptive method or service without cost-sharing. The health plan company 3Section 1. S0287-1 1st EngrossmentSF287 REVISOR SGS 4.1issuing the health plan must defer to the attending provider's determination that the particular 4.2contraceptive method or service is medically necessary for the enrollee. 4.3 Subd. 3. Exemption.(a) An exempt organization is not required to cover contraceptives 4.4or contraceptive services if the exempt organization has religious objections to the coverage. 4.5An exempt organization that chooses to not provide coverage for some or all contraceptives 4.6and contraceptive services must notify employees as part of the hiring process and to all 4.7employees at least 30 days before: 4.8 (1) an employee enrolls in the health plan; or 4.9 (2) the effective date of the health plan, whichever occurs first. 4.10 (b) If the exempt organization provides coverage for some contraceptive methods or 4.11services, the notice required under paragraph (a) must provide a list of the contraceptive 4.12methods or services the organization refuses to cover. 4.13 Subd. 4.Accommodation for eligible organizations.(a) A health plan established or 4.14maintained by an eligible organization complies with the requirements of subdivision 2 to 4.15provide coverage of contraceptive methods and services, with respect to the contraceptive 4.16methods or services identified in the notice under this paragraph, if the eligible organization 4.17provides notice to any health plan company the eligible organization contracts with that it 4.18is an eligible organization and that the eligible organization has a religious objection to 4.19coverage for all or a subset of contraceptive methods or services. 4.20 (b) The notice from an eligible organization to a health plan company under paragraph 4.21(a) must include (1) the name of the eligible organization, (2) a statement that it objects to 4.22coverage for some or all of contraceptive methods or services, including a list of the 4.23contraceptive methods or services the eligible organization objects to, if applicable, and (3) 4.24the health plan name. The notice must be executed by a person authorized to provide notice 4.25on behalf of the eligible organization. 4.26 (c) An eligible organization must provide a copy of the notice under paragraph (a) to 4.27prospective employees as part of the hiring process and to all employees at least 30 days 4.28before: 4.29 (1) an employee enrolls in the health plan; or 4.30 (2) the effective date of the health plan, whichever occurs first. 4.31 (d) A health plan company that receives a copy of the notice under paragraph (a) with 4.32respect to a health plan established or maintained by an eligible organization must, for all 4.33future enrollments in the health plan: 4Section 1. S0287-1 1st EngrossmentSF287 REVISOR SGS 5.1 (1) expressly exclude coverage for those contraceptive methods or services identified 5.2in the notice under paragraph (a) from the health plan; and 5.3 (2) provide separate payments for any contraceptive methods or services required to be 5.4covered under subdivision 2 for enrollees as long as the enrollee remains enrolled in the 5.5health plan. 5.6 (e) The health plan company must not impose any cost-sharing requirements, including 5.7co-pays, deductibles, or co-insurance, or directly or indirectly impose any premium, fee, or 5.8other charge for contraceptive services or methods on the eligible organization, health plan, 5.9or enrollee. 5.10 (f) On January 1, 2024, and every year thereafter a health plan company must notify the 5.11commissioner, in a manner to be determined by the commissioner, of the number of eligible 5.12organizations granted an accommodation under this subdivision. 5.13 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage 5.14offered, sold, issued, or renewed on or after that date. 5.15 Sec. 2. [62Q.523] COVERAGE FOR PRESCRIPTION CONTRACEPTIVES; 5.16SUPPLY REQUIREMENTS. 5.17 Subdivision 1.Scope of coverage.Except as otherwise provided in section 62Q.522, 5.18subdivisions 3 and 4, all health plans that provide prescription coverage must comply with 5.19the requirements of this section. 5.20 Subd. 2.Definition.For purposes of this section, "prescription contraceptive" means 5.21any drug or device that requires a prescription and is approved by the Food and Drug 5.22Administration to prevent pregnancy. Prescription contraceptive does not include an 5.23emergency contraceptive drug that prevents pregnancy when administered after sexual 5.24contact. 5.25 Subd. 3.Required coverage.Health plan coverage for a prescription contraceptive must 5.26provide a 12-month supply for any prescription contraceptive if a 12-month supply is 5.27prescribed by the prescribing health care provider. The prescribing health care provider 5.28must determine the appropriate duration to prescribe the prescription contraceptives for, up 5.29to 12 months. 5.30 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage 5.31offered, sold, issued, or renewed on or after that date. 5Sec. 2. S0287-1 1st EngrossmentSF287 REVISOR SGS 6.1 Sec. 3. Minnesota Statutes 2022, section 256B.0625, subdivision 13, is amended to read: 6.2 Subd. 13.Drugs.(a) Medical assistance covers drugs, except for fertility drugs when 6.3specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed 6.4by a licensed pharmacist, by a physician enrolled in the medical assistance program as a 6.5dispensing physician, or by a physician, a physician assistant, or an advanced practice 6.6registered nurse employed by or under contract with a community health board as defined 6.7in section 145A.02, subdivision 5, for the purposes of communicable disease control. 6.8 (b) The dispensed quantity of a prescription drug must not exceed a 34-day supply, 6.9unless authorized by the commissioner or as provided in paragraph (h) or the drug appears 6.10on the 90-day supply list published by the commissioner. The 90-day supply list shall be 6.11published by the commissioner on the department's website. The commissioner may add 6.12to, delete from, and otherwise modify the 90-day supply list after providing public notice 6.13and the opportunity for a 15-day public comment period. The 90-day supply list may include 6.14cost-effective generic drugs and shall not include controlled substances. 6.15 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical 6.16ingredient" is defined as a substance that is represented for use in a drug and when used in 6.17the manufacturing, processing, or packaging of a drug becomes an active ingredient of the 6.18drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle 6.19for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and 6.20excipients which are included in the medical assistance formulary. Medical assistance covers 6.21selected active pharmaceutical ingredients and excipients used in compounded prescriptions 6.22when the compounded combination is specifically approved by the commissioner or when 6.23a commercially available product: 6.24 (1) is not a therapeutic option for the patient; 6.25 (2) does not exist in the same combination of active ingredients in the same strengths 6.26as the compounded prescription; and 6.27 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded 6.28prescription. 6.29 (d) Medical assistance covers the following over-the-counter drugs when prescribed by 6.30a licensed practitioner or by a licensed pharmacist who meets standards established by the 6.31commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family 6.32planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults 6.33with documented vitamin deficiencies, vitamins for children under the age of seven and 6.34pregnant or nursing women, and any other over-the-counter drug identified by the 6Sec. 3. S0287-1 1st EngrossmentSF287 REVISOR SGS 7.1commissioner, in consultation with the Formulary Committee, as necessary, appropriate, 7.2and cost-effective for the treatment of certain specified chronic diseases, conditions, or 7.3disorders, and this determination shall not be subject to the requirements of chapter 14. A 7.4pharmacist may prescribe over-the-counter medications as provided under this paragraph 7.5for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter 7.6drugs under this paragraph, licensed pharmacists must consult with the recipient to determine 7.7necessity, provide drug counseling, review drug therapy for potential adverse interactions, 7.8and make referrals as needed to other health care professionals. 7.9 (e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable 7.10under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and 7.11Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible 7.12for drug coverage as defined in the Medicare Prescription Drug, Improvement, and 7.13Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these 7.14individuals, medical assistance may cover drugs from the drug classes listed in United States 7.15Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to 7.1613g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall 7.17not be covered. 7.18 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing 7.19Program and dispensed by 340B covered entities and ambulatory pharmacies under common 7.20ownership of the 340B covered entity. Medical assistance does not cover drugs acquired 7.21through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies. 7.22 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal 7.23contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section 7.24151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a 7.25licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists 7.26used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed 7.27pharmacist in accordance with section 151.37, subdivision 16. 7.28 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month 7.29supply for any prescription contraceptive if a 12-month supply is prescribed by the 7.30prescribing health care provider. The prescribing health care provider must determine the 7.31appropriate duration to prescribe the prescription contraceptives for, up to 12 months. 7.32For purposes of this paragraph, "prescription contraceptive" means any drug or device that 7.33requires a prescription and is approved by the Food and Drug Administration to prevent 7.34pregnancy. Prescription contraceptive does not include an emergency contraceptive drug 7Sec. 3. S0287-1 1st EngrossmentSF287 REVISOR SGS 8.1approved to prevent pregnancy when administered after sexual contact. For purposes of this 8.2paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3. 8.3 EFFECTIVE DATE.This section applies to medical assistance and MinnesotaCare 8.4coverage effective January 1, 2024. 8Sec. 3. S0287-1 1st EngrossmentSF287 REVISOR SGS