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The Latest in Regulatory and Reimbursement
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Biocom submitted feedback to CMS urging against the codification of the Medicare Drug Price Negotiation Program. The White House tapped the next FDA Commissioner, and the Senate confirmed a new CDC Director. FDA released the Prescription Drug User Fee Act (PDUFA) VIII draft commitment letter and published a new discussion paper focused on the regulation of generative artificial intelligence-enabled medical devices. CMS has also proposed a new coverage pathway for breakthrough devices.
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Biocom Comments on Drug Pricing Proposed Rule
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Biocom submitted feedback to the Centers for Medicare & Medicaid Services on its proposed rule and urged against the codification of the Medicare Drug Price Negotiation Program. |
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FDA Releases Proposed PDUFA VIII Commitments
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Next FDA Leader Announced
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President Trump nominated current White House domestic policy aide, Dr. Heidi Overton, to succeed Dr. Marty Makary as the new FDA Commissioner. |
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New CDC Director Confirmed
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New FDA AI Discussion Paper Released
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FDA is seeking feedback on a new discussion paper focused on the regulation of generative AI-enabled medical devices, including a risk assessment framework, premarket evaluation and postmarket monitoring.
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CMS Publishes RAPID Procedural Notice
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CMS released details of the new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to coordinate FDA approval and Medicare coverage for certain breakthrough devices. |
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Request for Comments
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Biocom welcomes feedback from members on the following FDA draft guidance. Click here to submit comments via email. |
► Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway
- New Medicare coverage pathway for eligible Class II FDA-designated Breakthrough Devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and eligible Class III Breakthrough Devices.
- Leverages FDA’s existing process to assess clinical outcomes in proposed Investigational Device Exemption (IDE) studies to facilitate Medicare coverage after FDA market authorization.
- CMS will join early and frequent engagement opportunities between FDA and device manufacturers to understand what clinical outcomes are most relevant for Medicare beneficiaries.
- For devices completing the RAPID coverage pathway, a proposed National Coverage Determination will be issued the same day as FDA market authorization.
This notice would be of interest to device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Member
Congratulations to Biocom member, Takeda Pharmaceuticals, on the FDA approval of Orzeyful, the first medicine approved to treat narcolepsy type 1 as a complete disorder.
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Biocom Policy & Advocacy
Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.
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