HF 4313

as introduced - 93rd Legislature (2023 - 2024) Posted on 03/25/2024 04:22pm

A bill for an act
relating to health insurance; requiring coverage of over-the-counter contraceptive
drugs, devices, and products by insurers and medical assistance; requiring reports;
amending Minnesota Statutes 2023 Supplement, sections 62Q.522, subdivisions
1, 2, 3; 256B.0625, subdivision 13.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2023 Supplement, section 62Q.522, subdivision 1, is
amended to read:

Subdivision 1.

Definitions.

(a) The definitions in this subdivision apply to this section.

(b) "Closely held for-profit entity" means an entity that:

(1) is not a nonprofit entity;

(2) has more than 50 percent of the value of its ownership interest owned directly or
indirectly by five or fewer owners; and

(3) has no publicly traded ownership interest.

For purposes of this paragraph:

(i) ownership interests owned by a corporation, partnership, limited liability company,
estate, trust, or similar entity are considered owned by that entity's shareholders, partners,
members, or beneficiaries in proportion to their interest held in the corporation, partnership,
limited liability company, estate, trust, or similar entity;

(ii) ownership interests owned by a nonprofit entity are considered owned by a single
owner;

(iii) ownership interests owned by all individuals in a family are considered held by a
single owner. For purposes of this item, "family" means brothers and sisters, including
half-brothers and half-sisters, a spouse, ancestors, and lineal descendants; and

(iv) if an individual or entity holds an option, warrant, or similar right to purchase an
ownership interest, the individual or entity is considered to be the owner of those ownership
interests.

(c) "Contraceptive method" means a drug, device, or other product approved by the Food
and Drug Administration to prevent unintended pregnancy new text begin and includes prescription
contraceptives and over-the-counter contraceptives new text end .

(d) "Contraceptive service" new text begin or "service" new text end means consultation, examination, procedures,
and medical services related to the prevention of unintended pregnancy, excluding
vasectomies. This includes but is not limited to voluntary sterilization procedures, patient
education, counseling on contraceptives, and follow-up services related to contraceptive
methods or services, management of side effects, counseling for continued adherence, and
device insertion or removal.

(e) "Eligible organization" means an organization that opposes providing coverage for
some or all contraceptive methods or services on account of religious objections and that
is:

(1) organized as a nonprofit entity and holds itself out to be religious; or

(2) organized and operates as a closely held for-profit entity, and the organization's
owners or highest governing body has adopted, under the organization's applicable rules of
governance and consistent with state law, a resolution or similar action establishing that the
organization objects to covering some or all contraceptive methods or services on account
of the owners' sincerely held religious beliefs.

(f) "Exempt organization" means an organization that is organized and operates as a
nonprofit entity and meets the requirements of section 6033(a)(3)(A)(i) or (iii) of the Internal
Revenue Code of 1986, as amended.

(g) "Medical necessity" includes but is not limited to considerations such as severity of
side effects, difference in permanence and reversibility of a contraceptive method or service,
and ability to adhere to the appropriate use of the contraceptive method or service, as
determined by the attending provider.

new text begin (h) "Over-the-counter contraceptive" or "OTC contraceptive" means a drug, device, or
other product that does not require a prescription and is approved by the Food and Drug
Administration to prevent unintended pregnancy.
new text end

new text begin (i) "Prescription contraceptive" means a drug, device, or other product that requires a
prescription and is approved by the Food and Drug Administration to prevent unintended
pregnancy.
new text end

deleted text begin (h) deleted text end new text begin (j) new text end "Therapeutic equivalent version" means a drug, device, or product that can be
expected to have the same clinical effect and safety profile when administered to a patient
under the conditions specified in the labeling, and that:

(1) is approved as safe and effective;

(2) is a pharmaceutical equivalent: (i) containing identical amounts of the same active
drug ingredient in the same dosage form and route of administration; and (ii) meeting
compendial or other applicable standards of strength, quality, purity, and identity;

(3) is bioequivalent in that:

(i) the drug, device, or product does not present a known or potential bioequivalence
problem and meets an acceptable in vitro standard; or

(ii) if the drug, device, or product does present a known or potential bioequivalence
problem, it is shown to meet an appropriate bioequivalence standard;

(4) is adequately labeled; and

(5) is manufactured in compliance with current manufacturing practice regulations.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025, and applies to health
plans offered, issued, or renewed on or after that date.
new text end

Sec. 2.

Minnesota Statutes 2023 Supplement, section 62Q.522, subdivision 2, is amended
to read:

Subd. 2.

Required coverage; cost sharing prohibited.

(a) A health plan must provide
coverage for contraceptive methods and services.

(b) A health plan company must not impose cost-sharing requirements, including co-pays,
deductibles, or coinsurance, for contraceptive methods or services.

(c) A health plan company must not impose any referral requirements, restrictions, or
delays for contraceptive methods or services.

(d) A health plan must include at least one of each type of Food and Drug Administration
approved new text begin prescription new text end contraceptive deleted text begin method deleted text end in its formulary. If more than one therapeutic
equivalent version of a new text begin prescription new text end contraceptive deleted text begin method deleted text end is approved, a health plan must
include at least one therapeutic equivalent version in its formulary, but is not required to
include all therapeutic equivalent versions.

(e) For each health plan, a health plan company must list the new text begin prescription new text end contraceptive
deleted text begin methods deleted text end and services that are covered without cost-sharing in a manner that is easily
accessible to enrollees, health care providers, and representatives of health care providers.
The list for each health plan must be promptly updated to reflect changes to the coverage.

(f) If an enrollee's attending provider recommends a particular new text begin prescription new text end contraceptive
deleted text begin method deleted text end or service based on a determination of medical necessity for that enrollee, the health
plan must cover that new text begin prescription new text end contraceptive deleted text begin method deleted text end or service without cost-sharing. The
health plan company issuing the health plan must defer to the attending provider's
determination that the particular new text begin prescription new text end contraceptive deleted text begin method deleted text end or service is medically
necessary for the enrollee.

new text begin (g) A health plan must provide coverage for all types and brands of OTC contraceptives.
new text end

new text begin (h) A health plan must provide coverage for OTC contraceptives at the point-of-sale.
new text end

new text begin (i) A health plan is prohibited from placing limitations on the type, quantity, or purchase
frequency of OTC contraceptives.
new text end

new text begin (j) If the application of this subdivision before an enrollee has met the enrollee's health
plan's deductible would result in: (1) health savings account ineligibility under United States
Code, title 26, section 223; or (2) catastrophic health plan ineligibility under United States
Code, title 42, section 18022(e), then this subdivision applies to contraceptive methods and
services only after the enrollee has met the enrollee's health plan's deductible.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025, and applies to health
plans offered, issued, or renewed on or after that date.
new text end

Sec. 3.

Minnesota Statutes 2023 Supplement, section 62Q.522, subdivision 3, is amended
to read:

Subd. 3.

Exemption.

(a) An exempt organization is not required to cover deleted text begin contraceptives deleted text end new text begin
contraceptive methods new text end or deleted text begin contraceptive deleted text end services if the exempt organization has religious
objections to the coverage. An exempt organization that chooses to not provide coverage
for some or all deleted text begin contraceptives deleted text end new text begin contraceptive methods new text end and deleted text begin contraceptive deleted text end services must notify
employees as part of the hiring process and to all employees at least 30 days before:

(1) an employee enrolls in the health plan; or

(2) the effective date of the health plan, whichever occurs first.

(b) If the exempt organization provides coverage for some contraceptive methods or
services, the notice required under paragraph (a) must provide a list of the contraceptive
methods or services the organization refuses to cover.

Sec. 4.

Minnesota Statutes 2023 Supplement, section 256B.0625, subdivision 13, is
amended to read:

Subd. 13.

Drugs.

(a) Medical assistance covers drugs, except for fertility drugs when
specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed
by a licensed pharmacist, by a physician enrolled in the medical assistance program as a
dispensing physician, or by a physician, a physician assistant, or an advanced practice
registered nurse employed by or under contract with a community health board as defined
in section 145A.02, subdivision 5, for the purposes of communicable disease control.

(b) The dispensed quantity of a prescription drug must not exceed a 34-day supply unless
authorized by the commissioner or as provided in paragraph (h) or the drug appears on the
90-day supply list published by the commissioner. The 90-day supply list shall be published
by the commissioner on the department's website. The commissioner may add to, delete
from, and otherwise modify the 90-day supply list after providing public notice and the
opportunity for a 15-day public comment period. The 90-day supply list may include
cost-effective generic drugs and shall not include controlled substances.

(c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical
ingredient" is defined as a substance that is represented for use in a drug and when used in
the manufacturing, processing, or packaging of a drug becomes an active ingredient of the
drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle
for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and
excipients which are included in the medical assistance formulary. Medical assistance covers
selected active pharmaceutical ingredients and excipients used in compounded prescriptions
when the compounded combination is specifically approved by the commissioner or when
a commercially available product:

(1) is not a therapeutic option for the patient;

(2) does not exist in the same combination of active ingredients in the same strengths
as the compounded prescription; and

(3) cannot be used in place of the active pharmaceutical ingredient in the compounded
prescription.

(d) Medical assistance covers the following over-the-counter drugs when prescribed by
a licensed practitioner or by a licensed pharmacist who meets standards established by the
commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family
planning products new text begin including coverage for all types and brands of over-the-counter
contraceptives in compliance with section 62Q.522 new text end , aspirin, insulin, products for the treatment
of lice, vitamins for adults with documented vitamin deficiencies, vitamins for children
under the age of seven and pregnant or nursing women, and any other over-the-counter drug
identified by the commissioner, in consultation with the Formulary Committee, as necessary,
appropriate, and cost-effective for the treatment of certain specified chronic diseases,
conditions, or disorders, and this determination shall not be subject to the requirements of
chapter 14. A pharmacist may prescribe over-the-counter medications as provided under
this paragraph for purposes of receiving reimbursement under Medicaid. When prescribing
over-the-counter drugs under this paragraph, licensed pharmacists must consult with the
recipient to determine necessity, provide drug counseling, review drug therapy for potential
adverse interactions, and make referrals as needed to other health care professionals.

(e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable
under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible
for drug coverage as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these
individuals, medical assistance may cover drugs from the drug classes listed in United States
Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to
13g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall
not be covered.

(f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing
Program and dispensed by 340B covered entities and ambulatory pharmacies under common
ownership of the 340B covered entity. Medical assistance does not cover drugs acquired
through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.

(g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal
contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section
151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a
licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists
used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed
pharmacist in accordance with section 151.37, subdivision 16.

(h) Medical assistance coverage for a prescription contraceptive must provide a 12-month
supply for any prescription contraceptive if a 12-month supply is prescribed by the
prescribing health care provider. The prescribing health care provider must determine the
appropriate duration for which to prescribe the prescription contraceptives, up to 12 months.
For purposes of this paragraph, "prescription contraceptive" means any drug or device that
requires a prescription and is approved by the Food and Drug Administration to prevent
pregnancy. Prescription contraceptive does not include an emergency contraceptive drug
approved to prevent pregnancy when administered after sexual contact. For purposes of this
paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2025.
new text end

Sec. 5. new text begin OUTREACH AND REPORTS.
new text end

new text begin (a) The Department of Commerce must work in conjunction with the Departments of
Health and Human Services to provide outreach and information to parties affected by
sections 1 and 2. Affected parties include but are not limited to health plan companies,
health plan company enrollees, and enrollees of medical assistance and MinnesotaCare.
new text end

new text begin (b) The Department of Commerce must work in conjunction with the Departments of
Health and Human Services to provide a report by March 31, 2026, and annually thereafter,
to the legislative committees with oversight of issues relating to commerce, health, and
human services. The report must include information and data regarding the use of coverage
and related costs to health plans and the state to provide OTC contraceptives.
new text end