DEPARTMENT OF HEALTH AND HUMAN SERVICES
For the reasons stated in the preamble, the Department of Health and Human Services proposes to amend 45 CFR part 147 as set forth below:
PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS
1.	The authority citation for part 147 continues to read as follows:
Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, 300gg-92, and 300gg-111 through 300gg-139, as amended, and section 3203, Pub. L. 116-136, 134 Stat. 281.
1.	Section 147.130 is amended by revising paragraph (a)(4), adding paragraph (a)(6), and revising paragraph (d) to read as follows:
•	[ 147.130|#sectno-citation-147.130]
Coverage of preventive health services.
(a) * * *
(4) Reasonable medical management. (i) Nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service described in paragraph (a)(1) of this section to the extent not specified in the relevant recommendation or guideline. To the extent not specified in a recommendation or guideline described in paragraph (a)(1) of this section, a plan or issuer may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service.
(ii) For a medical management technique to be considered reasonable under paragraph (a)(4)(i) of this section, a plan or issuer must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on a participant, beneficiary, enrollee, or attending provider (or other person acting as the individual's authorized representative) that ensures the individual can receive coverage, without cost-sharing requirements, for the item or service specified in a recommendation or guideline described in paragraph (a)(1) of this section, according to the frequency, method, treatment, or setting, that is medically necessary with respect to the individual, as determined by the individual's attending provider.
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(6) Contraceptive items —(i) Definitions. For purposes of this paragraph (a)(6)—
(A) Drug-led combination product means a combination product, as defined under 21 CFR 3.2(e), that comprises a drug and a device, and for which the drug component provides the primary mode of action.
(B) Therapeutic equivalent has the meaning given the term therapeutic equivalents in 21 CFR 314.3(b).
(ii) Over-the-counter contraception. Subject to §§ 147.131, 147.132, and 147.133, a plan or issuer is not considered to comply with paragraph (a)(1) of this section with respect to a contraceptive item that can be lawfully obtained by a participant, beneficiary, or enrollee without a prescription and for which the applicable recommendation or guideline does not require a prescription, unless the plan or issuer provides coverage for the contraceptive item without requiring a prescription and without imposing any cost-sharing requirements in accordance with paragraph (a)(1) of this section.
(iii) Therapeutic equivalents. For purposes of paragraph (a)(4) of this section, a plan's or issuer's medical management techniques are not considered to be reasonable unless the plan or issuer provides coverage, without imposing any cost-sharing requirements, for all contraceptive items recommended under paragraph (a)(1) of this section that are drugs or drug-led combination products, other than those items for which there is at least one therapeutic equivalent drug or drug-led combination product, as applicable, for which the plan or issuer provides coverage without imposing any cost-sharing requirements.
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(d) Applicability date. The provisions of this section apply for plan years (in the individual market, for policy years) beginning on or after September 23, 2010. Notwithstanding the previous sentence, the provisions of paragraph (a)(4)(ii) of this section apply beginning on [EFFECTIVE DATE OF FINAL RULE] and the provisions of paragraph (a)(6) of this section apply for plan years (in the individual market, for policy years), beginning on or after January 1, 2026. See § 147.140 of this part for determining the application of this section to grandfathered health plans (providing that these rules regarding coverage of preventive health services do not apply to grandfathered health plans).
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1.	Section 147.211 is amended by—
2.	Redesignating paragraphs (b)(1)(vi) and (vii) as paragraphs (b)(1)(vii) and (viii);
3.	Adding new paragraph (b)(1)(vi); and
4.	Revising paragraph (c)(1).
The addition and revision read as follows:
•	[ 147.211|#sectno-citation-147.211]
Transparency in coverage—required disclosures to participants, beneficiaries, or enrollees.
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(b) * * *
(1) * * *
(vi) If a participant, beneficiary, or enrollee requests cost-sharing information for any covered contraceptive item or service, a statement explaining that over-the-counter contraceptive items are covered without a prescription and without cost sharing in accordance with § 147.130(a)(6), along with a phone number and internet link to where a participant, beneficiary, or enrollee can learn more information about the plan or policy's contraception coverage.
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(c) * * *
(1) The provisions of this section apply for plan years (in the individual market, for policy years) beginning on or after January 1, 2023, with respect to the 500 items and services to be posted on a publicly available website, and with respect to all covered items and services, for plan years (in the individual market, for policy years) beginning on or after January 1, 2024. Notwithstanding the previous sentence, the provisions of paragraph (b)(1)(vi) of this section apply for plan years (in the individual market, for policy years) beginning on or after January 1, 2026.