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The Latest in Regulatory and Reimbursement
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The FDA has started implementing its PDUFA, MDUFA, and BsUFA commitments. HHS has announced efforts to create a new National Biodefense Strategy and the Biden administration wants to take additional action to lower prescription drug costs. CMS has finalized its CY 2023 Physician Fee Schedule and has shared the principles that will be used to develop an accelerated coverage pathway for medical devices.
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PDUFA VII FDA Commitments Underway
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CMS Finalizes CY 2023 Physician Fee Schedule
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On November 1st, CMS issued the Physician Fee Schedule final rule, effective January 1, 2023. Of note, the proposed skin substitute provisions were struck down as requested by Biocom California in our comment letter.
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BsUFA III Regulatory Science Pilot Program Launched
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Under BsUFA III, the FDA has announced the launch of its regulatory science pilot program to advance the development of interchangeable products and improve biosimilar development.
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HHS Announces Actions to Support National Biodefense Strategy
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To support implementation of the National Biodefense Strategy, HHS announced that it intends to strengthen early warning and awareness of pandemics and biological threats, enhance diagnostic, vaccine, and therapeutic capabilities, and much more.
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Biden Signs Executive Order to Lower Drug Pricing Costs
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President Biden signed an Executive Order directing HHS to explore additional actions to lower prescription drug costs via the CMS Innovation Center.
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CMS Shares Plans for an Accelerated Coverage Pathway for Emerging Technologies
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CMS published a Viewpoint article in the Journal of the American Medical Association describing the principles that will be used to develop a future CMS proposed rule for an accelerated coverage pathway for medical devices.
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Request for Comments
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Biocom California welcomes feedback from members on the following pilot program. Click here to submit comments via email or to receive more information regarding the program.
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As part of the MDUFA V commitments, the FDA has announced the launch of its voluntary Total Product Life Cycle Advisory Program (TAP) Pilot. The TAP Pilot is intended to improve FDA’s early interactions with participants and interactions between participants and other stakeholders, such as patients, providers, and payers. The Federal Register notice outlines the pilot program’s enrollment criteria and procedures, expansion schedule, and performance metrics.
The FDA is requesting feedback on the TAP pilot and the following questions:
- What additional Offices of Health Technology should be included in the TAP Pilot?
- What additional questions or topics could patients, providers, and/or payers address that could help inform sponsors’ strategic decision-making?
- Are there specific patient, provider, or payer organizations whose members may be well-suited and willing to provide insights regarding evidence generation strategies to sponsors who wish to obtain such input?
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Upcoming Regulatory and Reimbursement Events:
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Biocom California
For over 27 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 1,600 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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