This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe to Manatt on Health, please reach out to Barret Jefferds.
On June 27, the House Ways and Means Committee (W&M) held a markup to consider legislation to promote medical innovation, remove barriers to treatment, and increase access to innovative screenings and tests for Medicare enrollees. The committee advanced the following bills:
- Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691). This legislation would expand coverage for medical devices approved under the Food and Drug Administration’s Breakthrough Devices Program and establish a four-year transitional coverage period for these devices. At the end of the four years, the Centers for Medicare & Medicaid Services (CMS) would be required to make a permanent coverage determination for the device.
- Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407). This legislation would expand Medicare coverage and provide for Medicare payment for FDA-approved multi-cancer early detection screening tests beginning in 2028.
- American Medical Innovation and Investment Act of 2024 (H.R. 8816). Introduced by the W&M Subcommittee on Health Chairman Vern Buchanan (R-FL), this legislation proposes several Medicare policy changes, including:
- Limiting the duration of Medicare coverage determinations to ten years, unless agreed upon by the applicant;
- Providing for Medicare coverage of self-administered home infusion pumps; and
- Establishing a new “cognitive impairment detection benefit” under Medicare and requiring the Medicare annual wellness visit to include a cognitive impairment test.
- Treat and Reduce Obesity Act of 2023 (TROA, H.R. 4818). As introduced, TROA proposed expanding Medicare coverage of intensive behavioral therapy for obesity beyond primary care providers and covering FDA-approved obesity medications that complement this form of therapy. The substitute amendment (TROA 2024) that the committee advanced narrowed this new exception to the Part D weight loss exclusion by permitting coverage of FDA-approved obesity medications for certain eligible individuals.
While the Congressional Budget Office (CBO) has not released a public score of the substitute amendments, W&M staff said during the markup that TROA 2024 is likely to cost $1.7 billion over the ten year budget window. For all of the marked up bills, the substitute amendments are likely to reduce the cost below that of the introduced versions. The House Energy and Commerce Committee (E&C) is slated to take up the bills next.
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