Enhancing Coverage of Preventive Services Under the Affordable Care Act

DEPARTMENT OF THE TREASURY <SUBAGY>Internal Revenue Service</SUBAGY> <CFR>26 CFR Part 54</CFR> <DEPDOC>[REG-110878-24]</DEPDOC> <RIN>RIN 1545-BR35</RIN> DEPARTMENT OF LABOR <SUBAGY>Employee Benefits Security Administration</SUBAGY> <CFR>29 CFR Part 2590</CFR> <RIN>RIN 1210-AC25</RIN> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>45 CFR Part 147</CFR> <DEPDOC>[CMS 9887-P]</DEPDOC> <RIN>RIN 0938-AV57</RIN> <SUBJECT>Enhancing Coverage of Preventive Services Under the Affordable Care Act</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document sets forth proposed rules that would amend the regulations regarding coverage of certain preventive services under the Public Health Service Act. Specifically, this document proposes rules that would provide that medical management techniques used by non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage with respect to such preventive services would not be considered reasonable unless the plan or issuer provides an easily accessible, transparent, and sufficiently expedient exceptions process that would allow an individual to receive coverage without cost sharing for the preventive service that is medically necessary with respect to the individual, as determined by the individual's attending provider, even if such service is not generally covered under the plan or coverage. These proposed rules also contain separate requirements that would apply to coverage of contraceptive items that are preventive services under the Public Health Service Act. Specifically, these proposed rules would require plans and issuers to cover certain recommended over-the-counter contraceptive items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost-sharing requirements, unless a therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. Finally, this document proposes to require a disclosure pertaining to coverage and cost-sharing requirements for over-the-counter contraceptive items in plans' and issuers' Transparency in Coverage internet-based self-service tools or, if requested by the individual, on paper. These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below by December 27, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Written comments may be submitted to the address specified below. Any comment that is submitted will be shared with the Department of the Treasury, Internal Revenue Service, and the Department of Health and Human Services (HHS). Commenters should not submit duplicates. Comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are posted on the internet exactly as received and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records. Comments may be submitted anonymously. In commenting, please refer to file code 1210-AC25. Comments must be submitted in one of the following two ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">https://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. <E T="03">By mail.</E> You may mail written comments to the following address ONLY: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, Washington, DC 20210, Attention: 1210-AC25. Always allow sufficient time for mailed comments to be received before the close of the comment period. Because of staff and resource limitations, the Departments cannot accept comments by facsimile (FAX) transmission. <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. The comments are posted on the following website as soon as possible after they have been received: <E T="03">https://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a summary of these proposed rules of not more than 100 words in length, in plain language, may be found at <E T="03">https://www.regulations.gov/.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Regan Rusher, Internal Revenue Service, Department of the Treasury, at (202) 317-5500. Matthew Meidell, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335. Rebecca Miller, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335. Geraldine Doetzer, Centers for Medicare & Medicaid Services, Department of Health and Human Services at (667) 290-8855. Kendra May, Centers for Medicare & Medicaid Services, Department of Health and Human Services at (301) 448-3996. <E T="03">Customer Service Information:</E> Individuals interested in obtaining information from the Department of Labor (DOL) concerning employment-based health coverage laws may call the Employee Benefits Security Administration (EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the DOL's website ( <E T="03">www.dol.gov/ebsa</E> ). In addition, information from HHS on private health insurance coverage and on non-Federal governmental plans can be found on the Centers for Medicare & Medicaid Services (CMS) website ( <E T="03">www.cms.gov/cciio</E> ), and information on health care reform can be found at <E T="03">www.HealthCare.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> <HD SOURCE="HD2">A. Coverage of Preventive Services Under the Affordable Care Act and Implementing Regulations</HD> The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30, 2010. These statutes are collectively known as the Affordable Care Act (ACA). The ACA reorganized, amended, and added to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The ACA added section 715(a)(1) to the Employee Retirement Income Security Act of 1974 (ERISA)  <SU>1</SU> <FTREF/> and section 9815(a)(1) to the Internal Revenue Code (Code)  <SU>2</SU> <FTREF/> to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans. <FTNT> <SU>1</SU>  29 U.S.C. 1185d. </FTNT> <FTNT> <SU>2</SU>  26 U.S.C. 9815. </FTNT> Section 2713 of the PHS Act, <SU>3</SU> <FTREF/> as added by section 1001 of the ACA and incorporated into ERISA and the Code, and its implementing regulations require that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage (plans and issuers) provide coverage without imposing any cost-sharing requirements for the following items and services:  <SU>4</SU> <FTREF/> <FTNT> <SU>3</SU>  42 U.S.C. 300gg-13. </FTNT> <FTNT> <SU>4</SU>  The items and services described in these recommendations and guidelines are referred to in this preamble as “recommended preventive services.” </FTNT> • Evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved, except for the recommendations of the USPSTF regarding breast cancer screening, mammography, and prevention issued in or around November 2009;  <E T="51">5 6</E> <FTREF/> <FTNT> <SU>5</SU>  The USPSTF published updated breast cancer screening recommendations in April 2024. However, section 223 of title II of Division D of the Further Consolidated Appropriations Act, 2024 (Pub. L. 118-47) requires that for purposes of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued before 2009 remain in effect until January 1, 2026. <SU>6</SU>  On September 19, 2024, the Departments filed a petition for a writ of certiorari requesting U.S. Supreme Court review of the decision of the U.S. Court of Appeals for the Fifth Circuit in <E T="03">Braidwood Management</E> v. <E T="03">Becerra,</E> which found in part that the actions taken by the Departments under section 2713(a) of the PHS Act to require coverage of certain preventive services recommended by the USPSTF are unconstitutional and unenforceable by the Departments as to the named plaintiffs. <E T= ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 370k characters. 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