Category: Regulatory

The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to delay implementing a portion of a regulation encouraging value-based purchasing for drugs in the Medicaid program that may lead to drugs having multiple best prices.

Finalized during the

Drug manufacturer Sanofi yesterday sent the U.S. Health Resources and Services Administration (HRSA) a 30-page defense of its requirement that 340B covered entities must submit their contract pharmacy claims data to a vendor to continue to be able to access

Chiquita Brooks-LaSure last Thursday was formally sworn in as Administrator of the Centers for Medicare and Medicaid Services (CMS), setting in place another key Biden administration official with influence on the 340B program.

Although CMS does not control federal 340B

Robert Charrow—the U.S. Health and Human Services (HHS) general counsel who memorably opined that drug companies must offer their products at or below the 340B ceiling price “be it the lunar surface, low-earth orbit, or a neighborhood pharmacy”—has rejoined his

Mary Wakefield, who led the U.S. Health Resources and Services Administration (HRSA) from 2009 to 2015, is back at HHS.

HHS announced Tuesday that Wakefield accepted an appointment to serve as counselor to HHS Secretary Xavier Becerra. She served

Today is the anniversary of Eli Lilly lighting the fuse on the 340B program’s most explosive year ever.

On May 18, 2020, Lilly sent the U.S. Health Resources and Services Administration (HRSA) a letter saying that, unless it heard otherwise

Drug manufacturers yesterday defended the legality of their restrictions on 340B contract pharmacy, in the wake of cease and desist letters from the U.S. Health Resources and Services Administration (HRSA).

Groups and individuals representing 340B covered entities, meanwhile, praised HRSA