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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on the CMS FY 2024 Inpatient Prospective Payment System (IPPS) proposed rule and the EPA’s proposed changes to the regulation of ethylene oxide. CMS released revised guidance on its Medicare Drug Price Negotiation Program and a proposed notice on a new Medicare coverage pathway for Breakthrough Devices. FDA launched a new oncology drug pilot program, and CDER released its annual report from the Office of Translational Sciences.
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Biocom California Comments on Proposed EtO Regulation
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Biocom California submitted comment letters on the EPA’s proposed changes to the regulation of Ethylene Oxide (EtO) under the National Emission Standards for Hazardous Air Pollutants and Federal Insecticide, Fungicide, and Rodenticide Act. |
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Biocom California Opposes Proposed NTAP Changes
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Biocom California’s comment letter on the CMS FY 2024 Inpatient Prospective Payment System (IPPS) proposed rule opposes changes to the timeline and eligibility criteria of the new technology add-on payment (NTAP) program. |
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CMS Releases Final Drug Price Negotiation Guidance
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On June 30, CMS released revised guidance implementing the IRA’s Medicare Drug Price Negotiation Program. Biocom California previously submitted comments on the agency’s initial guidance. |
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TCET Proposed Notice and NCD Guidance Released
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FDA Launches Oncology Drug Pilot Program
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FDA’s Oncology Center of Excellence recently launched the Oncology Dx Pilot, a new voluntary program focused on the use of certain laboratory-developed tests with oncology products to identify cancer biomarkers. |
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FDA OTS Annual Report Released
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CDER’s Office of Translational Sciences (OTS) 2022 annual report highlights its efforts in drug regulatory reviews, regulatory science research, and collaborations between CDER and stakeholders to advance regulatory decision making. |
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Request for Comments
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Biocom California welcomes feedback from members on the following opportunities. Click here to submit comments via email. |
- DCT design, the use of digital health technologies and software, and remote clinical trial visits.
- Sponsor and investigator roles and responsibilities.
- Informed consent and IRB oversight of DCTs.
- The use of investigational products in a DCT and their packaging and shipping.
This draft guidance may be of interest to 1) sponsors and investigators of drugs, biological products, and devices, 2) clinical research organizations, 3) clinical management and regulatory teams.
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- 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 draft guidance may be of interest to device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Foundation Medicine received FDA approval for FoundationOne®LiquidCDx as a companion diagnostic for Pfizer’s BRAFTOVI® in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer.
The FDA recently approved Biomarin’s adeno-associated virus vector-based gene therapy, Roctavian, as the first gene therapy for adults with severe Hemophilia A.
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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 1,700 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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