Policy & Medicine - Legal, Regulatory, and Compliance Issues

On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute…

The Centers for Medicare and Medicaid Services announced that it will finalize its proposal for Medicare to cover Aduhelm and…

The US Food and Drug Administration is recommending sponsors include a plan to increase diversity when proposing clinical trial…

On May 24, 2022, a bipartisan duo of Senators introduced legislation to crack down on certain pharmacy benefit manager (PBM)…

Beginning June 1, 2022, the Massachusetts Board of Registration in Medicine (BORIM) will require that both applicants for initial…

The Transparency and Aggregate Spend Virtual Summit is scheduled for June 27th and 28th, 2022. The conference chair is Kelly Tope,…

Earlier this year, Eargo Inc. agreed to a $34.37 settlement with the United States Department of Justice (DOJ) over allegations…

In mid-April 2022, the United States Department of Justice (DOJ) announced a $22,690,458 settlement with Providence Health &…

On April 11, 2022, New York Governor Kathy Hochul signed the state budget into law, which includes reforms surrounding services…

On March 31, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an…