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The Latest in Regulatory and Reimbursement
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Biocom California hosted Dr. Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research (CBER), at a recent committee meeting and submitted comments on the agency’s decentralized clinical trials draft guidance. FDA recognized a new consensus standard and technical information reports related to medical device sterilization and CBER issued a draft guidance on manufacturing changes for cell and gene therapy products. CMS released new materials related to the Inflation Reduction Act’s (IRA) Part D monthly cap for cost-sharing payments and the agency also issued its Physician Fee Schedule proposed rule for 2024.
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Biocom California Hosts Dr. Peter Marks
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On July 18, members of Biocom California’s Regulatory Affairs Committee (RAC) and Cell and Gene Therapy (CGT) committee gathered in SF, SD, and LA to hear from CBER Director Dr. Peter Marks about the FDA’s CGT initiatives and regulatory policy. |
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Comments on Decentralized Clinical Trials
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FDA Recognizes New Device Sterilization Standard
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New FDA Draft Guidance on CGT Manufacturing Changes
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FDA’s CBER recently released a draft guidance document providing the agency’s current thinking on the management of manufacturing changes for Cell and Gene Therapy products and comparability studies to assess product quality after manufacturing changes. |
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CMS Releases New IRA Materials
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CMS recently released a summary with sample calculations of how monthly costs may be calculated under the IRA requiring Part D sponsors to provide enrollees with the option to pay out-of-pocket prescription drug costs in monthly payments over the course of the plan year, beginning in 2025. |
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CY 2024 Physician Fee Schedule Proposed Rule
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On July 13, CMS issued the CY 2024 Medicare Physician Fee Schedule proposed rule which includes proposed provisions related to the coverage of telehealth services, skin substitutes, refunds for discarded amounts of single-dose container or single-use drugs, and more. |
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Request for Comments
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Biocom California welcomes feedback from members on the following opportunity. Click here to submit comments via email. |
- The pathway uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain Breakthrough Devices.
- TCET is voluntary and includes an evidence development framework that provides manufacturers with opportunities for increased pre-market engagement with CMS and allows for any evidence gaps to be addressed through fit-for-purpose studies.
- The TCET pathway will help coordinate benefit category determination, coding, and payment reviews.
This notice may be of interest to device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Tandem Diabetes on the recent FDA clearance of its Mobi insulin pump, the smallest automated insulin delivery system in the world
Thank you to DLA Piper’s Life Science Policy and Regulatory team for sponsoring a roundtable luncheon last month in San Diego where Biocom California members had the opportunity to learn about key 2023 policy and regulatory issues currently impacting life science companies!
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Biocom California
For over 28 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over {{{dynamic_content_1600}}} companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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