Regulatory & Reimbursement Newsletter

Biocom California issued a statement in response to CMS’s selection of drugs subject to “negotiation” and submitted comments on a proposed coverage pathway for emerging technologies. The FDA delayed certain Drug Supply Chain Security Act (DSCSA) requirements for another year, released a highly anticipated final guidance on real world evidence, and sent a proposed rule for laboratory developed tests to the White House for review.

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.

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.

Biocom California members met with high-level regulators as part of our Energy and Agriculture Biotech Fly-in.

Biocom California has submitted comments on the Medicare Drug Price Negotiation Program.

Biocom California hosted a roundtable with the FDA’s new director of the Digital Health Center of Excellence and held a recent webinar on the Inflation Reduction Act’s prescription drug pricing reform.

Biocom California unveiled user fee infographics for PDUFA VII, MDUFA V, and BsUFA III. The FDA hosted its annual rare disease day, a prominent FDA director announced his retirement, and the agency recently released a new funding opportunity for pediatric medical devices. CMS held a MEDCAC meeting to review coverage with evidence development requirements, and CMMI plans to test three drug payment models in response to the administration’s executive order on lowering prescription drug costs.

Biocom California has responded to the White House’s recent Request for Information on the biotechnology and biomanufacturing initiative. The FDA has released a report highlighting last year’s novel drug approvals, CDER and CBER are resuming some in-person face-to-face meetings, and a final rule has been published with updates to radiological health regulations. CMS has announced key dates for the first year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act and the agency has engaged stakeholders to provide more feedback on its Discarded Drug Refund Policy.

With its Broad Agency Announcement Day near, the FDA has published initiatives for advancing regulatory science research and development. The agency’s Cybersecurity Modernization Action Plan has been released, and in a recent report the FDA highlighted its successful use of computational modeling and simulation for regulatory decision making.

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.