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 individuals, or has an ownership structure that is substantially 1.16similar; and 1.17 (3) has no publicly traded ownership interest, having any class of common equity 1.18securities required to be registered under United States Code, title 15, section 781. 1.19For purposes of this paragraph: 1.20 (i) ownership interests owned by a corporation, partnership, estate, or trust are considered 1.21owned proportionately by that entity's shareholders, partners, or beneficiaries; 1Section 1. 23-01099 as introduced01/17/23 REVISOR SGS/LN SENATE STATE OF MINNESOTA S.F. No. 831NINETY-THIRD SESSION (SENATE AUTHORS: PAPPAS) OFFICIAL STATUSD-PGDATE Introduction and first reading01/26/2023 Referred to Health and Human Services 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 an individual are considered owned, directly or 2.4indirectly, by or for the individual's family. For purposes of this item, "family" means 2.5brothers and sisters, including half-brothers and half-sisters, a spouse, ancestors, and lineal 2.6descendants; and 2.7 (iv) if an individual or entity holds an option to purchase an ownership interest, the 2.8individual or entity is considered to be the owner of those ownership interests. 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. This includes but is not limited 2.13to voluntary sterilization procedures, patient education, counseling on contraceptives, and 2.14follow-up services related to contraceptive methods or services, management of side effects, 2.15counseling for continued adherence, and device insertion or removal. 2.16 (e) "Eligible organization" means an organization that opposes providing coverage for 2.17some or all contraceptive methods or services on account of religious objections and that 2.18is: 2.19 (1) organized as a nonprofit entity and holds itself as a religious organization; or 2.20 (2) organized and operates as a closely held for-profit entity, and the organization's 2.21highest governing body has adopted, under the organization's applicable rules of governance 2.22and consistent with state law, a resolution or similar action establishing that it objects to 2.23covering some or all contraceptive methods or services on account of the owners' sincerely 2.24held religious beliefs. 2.25 (f) "Medical necessity" includes but is not limited to considerations such as severity of 2.26side effects, difference in permanence and reversability of a contraceptive method or service, 2.27and ability to adhere to the appropriate use of the contraceptive method or service, as 2.28determined by the attending provider. 2.29 (g) "Religious organization" means an organization that is organized and operates as a 2.30nonprofit entity and meets the requirements of section 6033(a)(3)(A)(i) or (iii) of the Internal 2.31Revenue Code of 1986, as amended. 2Section 1. 23-01099 as introduced01/17/23 REVISOR SGS/LN 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) Notwithstanding paragraph (b), a health plan that is a high-deductible health plan in 3.20conjunction with a health savings account must include cost-sharing for contraceptive 3.21methods and services at the minimum level necessary to preserve the enrollee's ability to 3.22make tax exempt contributions and withdrawals from the health savings account, as provided 3.23by section 223 of the Internal Revenue Code of 1986, as amended. 3.24 (d) A health plan company must not impose any referral requirements, restrictions, or 3.25delays for contraceptive methods or services. 3.26 (e) A health plan must include at least one of each type of Food and Drug Administration 3.27approved contraceptive method in its formulary. If more than one therapeutic equivalent 3.28version of a contraceptive method is approved, a health plan must include at least one 3.29therapeutic equivalent version in its formulary, but is not required to include all therapeutic 3.30equivalent versions. 3.31 (f) For each health plan, a health plan company must list the contraceptive methods and 3.32services that are covered without cost-sharing in a manner that is easily accessible to 3Section 1. 23-01099 as introduced01/17/23 REVISOR SGS/LN 4.1enrollees, health care providers, and representatives of health care providers. The list for 4.2each health plan must be promptly updated to reflect changes to the coverage. 4.3 (g) If an enrollee's attending provider recommends a particular contraceptive method or 4.4service based on a determination of medical necessity for that enrollee, the health plan must 4.5cover that contraceptive method or service without cost-sharing. The health plan company 4.6issuing the health plan must defer to the attending provider's determination that the particular 4.7contraceptive method or service is medically necessary for the enrollee. 4.8 Subd. 3.Religious employers; exempt(a) A religious employer is not required to cover 4.9contraceptive methods or services if the employer has religious objections to the coverage. 4.10A religious employer that chooses to not provide coverage for contraceptive methods and 4.11services must notify employees as part of the hiring process and to all employees at least 4.1230 days before: 4.13 (1) an employee enrolls in the health plan; or 4.14 (2) the effective date of the health plan, whichever occurs first. 4.15 (b) If the religious employer provides coverage for some contraceptive methods or 4.16services, the notice must provide a list of the contraceptive methods or services the employer 4.17refuses to cover. 4.18 Subd. 4.Accommodation for eligible organizations.(a) A health plan established or 4.19maintained by an eligible organization complies with the requirements of subdivision 2 to 4.20provide coverage of contraceptive methods and services if the eligible organization provides 4.21notice to any health plan company the eligible organization contracts with that it is an eligible 4.22organization and that the eligible organization has a religious objection to coverage for all 4.23or a subset of contraceptive methods or services. 4.24 (b) The notice from an eligible organization to a health plan company under paragraph 4.25(a) must include (1) the name of the eligible organization, (2) a statement that it objects to 4.26coverage for some or all of contraceptive methods or services, including a list of the 4.27contraceptive methods or services the eligible organization objects to, if applicable, and (3) 4.28the health plan name. The notice must be executed by a person authorized to provide notice 4.29on behalf of the eligible organization. 4.30 (c) An eligible organization must provide a copy of the notice under paragraph (b) to 4.31prospective employees as part of the hiring process and to all employees at least 30 days 4.32before: 4.33 (1) an employee enrolls in the health plan; or 4Section 1. 23-01099 as introduced01/17/23 REVISOR SGS/LN 5.1 (2) the effective date of the health plan, whichever occurs first. 5.2 (d) A health plan company that receives a copy of the notice under paragraph (a) with 5.3respect to a health plan established or maintained by an eligible organization must: 5.4 (1) expressly exclude coverage for some or all contraceptive methods or services from 5.5the health plan; and 5.6 (2) provide separate payments for any contraceptive methods or services required to be 5.7covered under subdivision 2 for enrollees as long as the enrollee remains enrolled in the 5.8health plan. 5.9 (e) The health plan company must not impose any cost-sharing requirements, including 5.10co-pays, deductibles, or co-insurance, or directly or indirectly impose any premium, fee, or 5.11other charge for contraceptive services or methods on the eligible organization, health plan, 5.12or enrollee. 5.13 (f) On January 1, 2025, and every year thereafter a health plan company must notify the 5.14commissioner, in a manner to be determined by the commissioner, regarding the number 5.15of eligible organizations granted an accommodation under this subdivision. 5.16 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage 5.17offered, sold, issued, or renewed on or after that date. 5.18 Sec. 2. [62Q.523] COVERAGE FOR PRESCRIPTION CONTRACEPTIVES; 5.19SUPPLY REQUIREMENTS. 5.20 Subdivision 1.Scope of coverage.Except as otherwise provided in section 62Q.522, 5.21subdivision 3, all health plans that provide prescription coverage must comply with the 5.22requirements of this section. 5.23 Subd. 2.Definition.For purposes of this section, "prescription contraceptive" means 5.24any drug or device that requires a prescription and is approved by the Food and Drug 5.25Administration to prevent pregnancy. Prescription contraceptive does not include an 5.26emergency contraceptive drug that prevents pregnancy when administered after sexual 5.27contact. 5.28 Subd. 3.Required coverage.(a) Health plan coverage for a prescription contraceptive 5.29must provide a 12-month supply for any prescription contraceptive, regardless of whether 5.30the enrollee was covered by the health plan at the time of the first dispensing. 5.31 (b) The prescribing health care provider must determine the appropriate number of 5.32months to prescribe the prescription contraceptives for, up to 12 months. 5Sec. 2. 23-01099 as introduced01/17/23 REVISOR SGS/LN 6.1 EFFECTIVE DATE.This section is effective January 1, 2024, and applies to coverage 6.2offered, sold, issued, or renewed on or after that date. 6.3 Sec. 3. Minnesota Statutes 2022, section 256B.0625, subdivision 13, is amended to read: 6.4 Subd. 13.Drugs.(a) Medical assistance covers drugs, except for fertility drugs when 6.5specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed 6.6by a licensed pharmacist, by a physician enrolled in the medical assistance program as a 6.7dispensing physician, or by a physician, a physician assistant, or an advanced practice 6.8registered nurse employed by or under contract with a community health board as defined 6.9in section 145A.02, subdivision 5, for the purposes of communicable disease control. 6.10 (b) The dispensed quantity of a prescription drug must not exceed a 34-day supply, 6.11unless authorized by the commissioner or the drug appears on the 90-day supply list published 6.12by the commissioner. The 90-day supply list shall be published by the commissioner on the 6.13department's website. The commissioner may add to, delete from, and otherwise modify 6.14the 90-day supply list after providing public notice and the opportunity for a 15-day public 6.15comment period. The 90-day supply list may include cost-effective generic drugs and shall 6.16not include controlled substances as provided in paragraph (h). 6.17 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical 6.18ingredient" is defined as a substance that is represented for use in a drug and when used in 6.19the manufacturing, processing, or packaging of a drug becomes an active ingredient of the 6.20drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle 6.21for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and 6.22excipients which are included in the medical assistance formulary. Medical assistance covers 6.23selected active pharmaceutical ingredients and excipients used in compounded prescriptions 6.24when the compounded combination is specifically approved by the commissioner or when 6.25a commercially available product: 6.26 (1) is not a therapeutic option for the patient; 6.27 (2) does not exist in the same combination of active ingredients in the same strengths 6.28as the compounded prescription; and 6.29 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded 6.30prescription. 6.31 (d) Medical assistance covers the following over-the-counter drugs when prescribed by 6.32a licensed practitioner or by a licensed pharmacist who meets standards established by the 6.33commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family 6Sec. 3. 23-01099 as introduced01/17/23 REVISOR SGS/LN 7.1planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults 7.2with documented vitamin deficiencies, vitamins for children under the age of seven and 7.3pregnant or nursing women, and any other over-the-counter drug identified by the 7.4commissioner, in consultation with the Formulary Committee, as necessary, appropriate, 7.5and cost-effective for the treatment of certain specified chronic diseases, conditions, or 7.6disorders, and this determination shall not be subject to the requirements of chapter 14. A 7.7pharmacist may prescribe over-the-counter medications as provided under this paragraph 7.8for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter 7.9drugs under this paragraph, licensed pharmacists must consult with the recipient to determine 7.10necessity, provide drug counseling, review drug therapy for potential adverse interactions, 7.11and make referrals as needed to other health care professionals. 7.12 (e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable 7.13under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and 7.14Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible 7.15for drug coverage as defined in the Medicare Prescription Drug, Improvement, and 7.16Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these 7.17individuals, medical assistance may cover drugs from the drug classes listed in United States 7.18Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to 7.1913g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall 7.20not be covered. 7.21 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing 7.22Program and dispensed by 340B covered entities and ambulatory pharmacies under common 7.23ownership of the 340B covered entity. Medical assistance does not cover drugs acquired 7.24through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies. 7.25 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal 7.26contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section 7.27151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a 7.28licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists 7.29used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed 7.30pharmacist in accordance with section 151.37, subdivision 16. 7.31 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month 7.32supply for any prescription contraceptive, regardless of whether the enrollee was covered 7.33by medical assistance or the health plan at the time of the first dispensing. The prescribing 7.34health care provider must determine the appropriate number of months to prescribe the 7.35prescription contraceptives for, up to 12 months. 7Sec. 3. 23-01099 as introduced01/17/23 REVISOR SGS/LN 8.1For purposes of this paragraph, "prescription contraceptive" means any drug or device that 8.2requires a prescription and is approved by the Food and Drug Administration to prevent 8.3pregnancy. Prescription contraceptive does not include an emergency contraceptive drug 8.4approved to prevent pregnancy when administered after sexual contact. For purposes of this 8.5paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3. 8.6 EFFECTIVE DATE.This section applies to medical assistance and MinnesotaCare 8.7coverage effective January 1, 2024. 8Sec. 3. 23-01099 as introduced01/17/23 REVISOR SGS/LN