The Latest in Regulatory and Reimbursement

Biocom California submitted comments on CMS’s Medicare Drug Price Negotiation Program and the agency released its final guidance detailing a new “patient smoothing” payment option. A prominent FDA director announced his retirement, CDRH plans to expand its TAP Pilot, CBER will begin interactive site tours of cell and gene therapy manufacturing facilities and FDA launches a new Rare Disease Innovation Hub.

Comments on Drug Price “Negotiation” Program

Biocom California submitted comments responding to the Medicare Drug Price Negotiation Program draft guidance and held a webinar where attendees learned about the proposed policy changes for the next round of drug price “negotiations.”

Longtime FDA CDRH Director Announces Retirement

Dr. Jeff Shuren announced his retirement from the FDA after 15 years as director of the Center for Devices and Radiological Health (CDRH). Thank you, Dr. Shuren, for your many years of commitment and service to the medical device industry.

Upcoming FDA TAP Pilot Expansion

CDRH’s Total Product Life Cycle Advisory Program (TAP) will expand to include radiological health and ophthalmic devices this fall, followed by orthopedic devices in 2025. Launched in 2023, the TAP pilot aims to help spur faster development of innovative medical devices.

CBER Initiates Interactive Site Tours Program

The Cellular and Gene Therapies Interactive Site Tours Program will provide CBER project managers and reviewers the opportunity to tour cell and gene therapy manufacturing facilities. Companies interested in participating may send proposed agendas to the FDA by August 14.

New FDA Rare Disease Innovation Hub Announced

The FDA Rare Disease Innovation Hub will focus on products intended for smaller populations or for diseases where the natural history is not well understood. The hub will leverage the activities of the CDER Accelerating Rare disease Cures (ARC) program and CBER Rare Disease Program.

CMS Releases Final Guidance on Patient Smoothing

CMS released its Medicare Prescription Payment Plan part two final guidance, detailing the “patient smoothing” payment option which will allow Medicare beneficiaries to spread their prescription drug costs over the year rather than paying in full at the pharmacy each time.

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