Regulatory & Reimbursement Newsletter

About This Newsletter

Biocom California’s membership consists of a robust makeup of biopharmaceutical, medical device, diagnostics, research institutions, and provider organizations. We also have a growing food and agriculture membership and newly launched committee. Stay in touch as we increase our policy focuses with our monthly Regulatory & Reimbursement newsletter.

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Recent News

Dr. Califf Nominated to Head FDA

On November 12, President Biden announced his nomination of Robert Califf, MD, to run the FDA. The FDA has been without a permanent leader for the first ten months of the Biden Administration and, if confirmed, this could solidify the President’s health initiatives for his tenure. Robert Califf previously served as FDA Commissioner during the Obama Administration. The White House described him as a “doctor, researcher, leader, and public servant”. His confirmation hearing will likely be in mid-December. Acting commissioner Woodcock will remain in charge of the agency until the permanent candidate takes over.

CMS Officially Withdraws Medicare Coverage for Innovative Technologies

CMS has formally withdrawn Medicare Coverage for Innovative Technologies (MCIT). Dr. Lee Fleisher, CMS Chief Medical Officer and Director for the Center for Clinical Standards and Quality (CCSQ) writes “Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions.” CMS also writes that they “intend to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the health care needs of people with Medicare.” Biocom California strongly supported this proposal in the past.

OSHA Vaccine Mandate

On November 4, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued the COVID-19 Vaccination and Testing; Emergency Temporary Standard (ETS) Interim Final Rule mandating that employers with 100 or more workers require employees to be vaccinated against COVID-19 or undergo weekly testing and wear masks. Several states sued over the rule, and it currently has been temporarily stayed by the US Court of Appeals for the Fifth Circuit. Biocom California is monitoring the ruling and will provide updates as they evolve.