News

Traditional Medicare has been an important proving ground for U.S. healthcare for decades, and Medicare reimbursement has been used to support rural healthcare and medical education. In an opinion piece published by JAMA, Gretchen Jacobson and David Blumenthal of The Commonwealth Fund discuss some of the pitfalls of shrinking enrollment in traditional Medicare as the proportion of beneficiaries in Medicare Advantage plans grows.

Kirsten Axelsen, Richard Frank and Rachel Sachs agreed that the rapid development of the COVID-19 vaccines was a government-business success story. There was less to celebrate as the Kaiser Family Foundation panelists also unpacked the legal issues and economic consequences of drug rebates, international reference pricing, high deductible health coverage and compulsory licensing.

In COVID-19 news, FDA expanded EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years and cleared first at-home combo COVID-19, RSV and flu test, but declined an EUA for the antidepressant fluvoxamine to treat COVID-19. Regulators also approved Lilly’s novel diabetes drug and Dupixent eosinophilic esophagitis, modified Dsuvia REMS program and issued a CRL for bimekizumab for psoriasis.

A recent HHS Office of Inspector General's report found that Medicare Advantage (MA) plans inappropriately deny prior authorization requests. With MA enrollment growing, scrutiny of MA plans and their utilization management strategies is also likely to grow, according to Alina Czekai, M.P.H., of Cohere Health. Czekai argues that artificial intelligence and machine learning can improve utilization management and prevent inappropriate denials.

In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.

Research and discussion about the high cancer rates among Black Americans used to be dominated by genetics and the search for biological differences. Now attention has shifted to the social determinants of health.