Lexology November 13, 2025
The Centers for Medicare & Medicaid Services (“CMS”) recently finalized a Medicare payment rule with significant implications for life sciences companies, particularly biotech and pharmaceutical manufacturers.
The Medicare final rule (the “Final Rule”), which governs payment under the physician fee schedule (“PFS”) for calendar year (“CY”) 2026, adopts most of CMS’s proposed policies with targeted modifications to key payment reforms. (For background on the proposed rule (the “Proposed Rule”), see our prior Alert here.) The finalized changes will affect several areas of interest to life sciences companies, including:
- Drug price reporting and reimbursement
- Cell and gene therapy
- Digital mental health treatment devices used to support behavioral health services
Unless otherwise noted, these policies take effect January 1, 2026.
...Today's Sponsors
Today's Sponsor