Read today’s Kaiser Health News
In other news:
Trump's health team takes shape as FDA, NIH picks confirmed: The US Senate on Thursday confirmed Marty Makary as Commissioner of the FDA and Jay Bhattacharya as director of the National Institutes of Health (NIH), completing key appointments to President Donald Trump's health leadership team.
About health insurance/insurers
CMS to end 4 Medicare payment programs early : The CMS Innovation Center will terminate four Medicare payment models early in a move that aims to save nearly $750 million and shift focus to more viable approaches to value-based care.
The models set to end by Dec. 31, 2025, include:
Maryland Total Cost of Care (originally scheduled to run through 2026)
Primary Care First (2021-2026)
End-Stage Renal Disease Treatment Choices (2021-2027; will require rulemaking for termination)
Making Care Primary (2024-2034)
CMS said the decision reflects ongoing evaluations of financial impact, quality outcomes and operational feasibility and ensures that resources are allocated to programs with the highest potential for success.
About pharma
Trends In FDA FY 2024 Inspection-Based Warning Letters:The U.S. FDA issued a total of 190 warning letters to drug and biologics manufacturers in Fiscal Year 2024 (FY24). Of those, 113 were based on an FDA inspection, including 12 letters issued to clinical investigators or sponsors following inspections conducted as part of the FDA’s Bioresearch Monitoring (BIMO) Program. For the purposes of this article, we have chosen to analyze 111 of those letters, removing two due to their focus on new animal drugs and medical devices, respectively.1
The FY24 warning letter total is higher than the 94 letters issued in FY23 and the 74 letters issued in FY22. While the FDA’s top observations remained generally consistent, the FY24 breakdown for both country of origin and facility type varies greatly from previous years.
Mallinckrodt, Endo set for $6.7B merger: Confirming rumours that surfaced yesterday, Mallinckrodt and Endo announced Thursday that the companies will combine in a cash and stock transaction valued at $6.7 billion. The deal comes as both firms look to recover from financial and legal challenges related to the US opioid epidemic, which saw both declare bankruptcy.
Under terms of the agreement, Endo shareholders will receive a total of $80 million in cash and will own 49.9% of the combined company, with Mallinckrodt shareholders owning the remaining 50.1%. The transaction, which has been approved by both boards, is expected to close in the second half.
About the public’s health
The toll of chronic conditions: Where each state stands: West Virginia has the highest proportion of adults with at least one chronic condition of any state, according to new analysis from KFF.
The report is based on 2023 survey data from the CDC's Behavioral Risk Factor Surveillance System. Figures represent the percentage of adults ages 18 to 64 who reported at least one of the following health conditions: hypertension, diabetes, cancer, arthritis, asthma, chronic obstructive pulmonary disease, depression or kidney disease.