Insights: Healthcare

Nutrition Policy

HHS Secretary Kennedy has directed the FDA to consider rulemaking to eliminate the self-affirmed “Generally Recognized as Safe” (GRAS) pathway, which currently allows companies to determine the safety of food ingredients without notifying the agency or the public.

HHS Rulemaking Process

Late last week, the Department of Health & Human Services (HHS) rescinded a 1970’s memo, referred to as the “Richardson Waiver,” under which the agency agreed to (1) follow the notice-and-comment rulemaking process for rules related to “agency management or personnel or to public property, loans, grants, benefits, or contracts” and (2) sparingly...

Medicare Extenders

Republican Congressional and committee leaders are working to develop a “continuing resolution” (CR) to extend FY25 funding/appropriations beyond the current 3/14 deadline. Lawmakers are jockeying to have their preferred “riders” (provisions extraneous to ordinary annual government funding) added to that measure and in recent days, Rep. Murphy...

Late last week, the FDA issued a Declaratory Order determining that the semaglutide drug shortage has been resolved and announcing that the drug (the active ingredient in Ozempic, Rybelsus, and Wegovy) would be removed from the agency’s 506e shortage list. Just days later, the Outsourcing Facilities Association (OFA) – which represents the...

Pharmacy Benefit Managers (PBMs)

Earlier this week, the House Energy & Commerce (E&C) Health Subcommittee held a hearing to discuss the practices of PBMs and set the table for possible legislative reforms this year.

Medicare Advantage (MA)

Improper upcoding by MA plans is gaining some visibility amongst regulators and policymakers. Last week, it was reported that the DOJ had initiated a civil fraud investigation into UnitedHealth’s MA billing practices, focusing on whether the company recorded questionable diagnoses to secure higher payments for its MA plans. And following the...