On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1] CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.
The new proposed rule reflects a significant policy change. Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.
Blog Editors
Recent Updates
- Georgia & North Dakota: More State Judges Question the Constitutionality of Abortion Bans
- OCR Withdraws Appeal of District Court Order Declaring Unlawful and Vacating the “Proscribed Combination” Portion of Its HIPAA Online Tracking Technologies Guidance
- As the Window for Comments Closes on ONC/ASTP’s HTI-2 Proposed Rule: What’s in HTI-2 and What Does It Mean for You?
- Unpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 522
- Video: New State Legislation Increases Oversight of Health Care Transactions – Thought Leaders in Health Law