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HHS/CMS | RIN: 0938-AV57 | Publication ID: Fall 2024 |
Title: ●Enhancing Coverage of Preventive Services Under the Affordable Care Act (CMS-9887) | |
Abstract:
This rule would amend the regulations implementing the Affordable Care Act’s requirement that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage cover recommended preventive services without cost sharing. Among other actions, the rule would take steps to expand access to certain recommended preventive items and services that are available over-the-counter; require coverage of certain preventive drugs and drug-led devices in a manner that minimizes barriers to accessing the drug or drug-led device of one’s choice; reduce the likelihood that individuals face unexpected out-of-pocket costs when they receive preventive services; and ensure medical management techniques are reasonable and do not unduly prevent individuals from accessing certain preventive services. Together, these actions would make it easier for covered individuals to access certain preventive services and improve health outcomes. |
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Agency: Department of Health and Human Services(HHS) | Priority: Section 3(f)(1) Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: No |
CFR Citation: 45 CFR 147 | |
Legal Authority: Public Health Service Act, Sec. 2713 |
Legal Deadline:
None |
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Statement of Need: Ongoing complaints and reports of noncompliance with section 2713 of the Public Health Service Act (PHS Act) and its implementing regulations indicate that participants, beneficiaries, and enrollees face barriers when attempting to use their coverage to access recommended preventive services without cost sharing. As a result of these concerns and other significant activity related to preventive services, including the Food and Drug Administration’s (FDA) approval in July 2023 of the first daily oral contraceptive available without a prescription and public comments in response to the Departments’ October 2023 Request for Information (RFI) related to coverage of over-the-counter (OTC) recommended preventive services, the Departments are proposing to amend the regulations governing coverage of recommended preventive services to ensure that participants, beneficiaries, and enrollees can access the full range of recommended preventive services to which they are entitled, with particular focus on strengthening coverage requirements with respect to recommended contraceptive items. |
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Summary of the Legal Basis: The HHS regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as amended. |
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Alternatives: In developing this rule, the Departments considered various alternative approaches, including applying the coverage proposals to different subsets of recommended preventive services, requiring plans and issuers to communicate coverage of information in different ways, and different applicability timelines. |
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Anticipated Costs and Benefits: The Departments anticipate that this proposed rule would reduce out-of-pocket costs for certain recommended preventive services, lead to slightly higher premiums, and generate other cost savings for certain individuals. Plans and issuers could incur costs to implement proposed provisions. The Departments expect that this proposed rule would increase Federal spending and tax expenditure on premium tax credits for Exchange plans. The Departments also expect that this proposed rule could lead to a reduction in unintended pregnancies and improved health outcomes for individuals and greater flexibility in utilizing a wider range of recommended preventive services without cost sharing for individuals. |
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Risks: Due to a lack of data and information, there are several areas of uncertainty regarding the potential impacts of this proposed rule, including on utilization of recommended preventive services, compliance costs, premiums, and Federal spending and tax expenditure on premium tax credits for Exchange plans. The Departments request comment on these areas of uncertainty throughout the proposed rule. |
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Timetable:
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Regulatory Flexibility Analysis Required: YES | Government Levels Affected: Federal, Local, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: Yes | |
Related Agencies: Joint: TREAS/IRS, DOL/EBSA; | |
Agency Contact: Lindsey Murtagh Director, Division of Regulations and Policy Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244 Phone:301 492-4106 Email: lindsey.murtagh@cms.hhs.gov |