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
- CMS Issues CY 2026 MA & Part D Rate Announcement, Final Rule on CY 2026 Policy and Technical Changes to Programs, While Seeking Input on Burdensome Medicare Regulations for Rescission
- Pushback of Deadline for SNFs to Submit Significantly More Detailed Ownership and Control Information in New “SNF Attachment” to CMS Form 855A
- Podcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care
- Non-Competes in Health Care: 2025 Update
- Seventh Circuit Ruling Paves the Way for More Flexible Healthcare Marketing Services