Category: Regulatory

UPDATED Thursday March 2, 2023, 12:30 p.m. EDT to include comment from HRSA.

The U.S. Health Resources and Services Administration has asked multiple hospitals to explain how they determine patient eligibility for 340B drugs, how they define, track, and use

America’s Essential Hospitals asked U.S. Health and Human Services Secretary Xavier Becerra late last week “to swiftly remedy five years of unlawful drug reimbursement cuts to 340B
hospitals under Medicare Part B.”

“These cuts, and a delay in recompensing hospitals for

The U.S. Centers for Medicare & Medicaid Services is seeking comments by March 11 on “the most reliable way to identify” 340B-purchased drugs dispensed to Medicare Part D beneficiaries so they can be excluded from new Part D inflation rebate

The U.S. Department of Health and Human Services Office of the Inspector General says the Centers for Medicare and Medicaid Services should monitor non-hospital 340B covered entities’ use of modifiers to identify 340B-priced drugs in Part B claims, as these

The fight over 340B contract pharmacy loomed large in stakeholders’ comments last week on a proposed federal regulation to revamp the 340B program’s administrative dispute resolution system.

Health care provider groups, citing manufacturers’ contract pharmacy policies, said they want the

The Biden administration said on Monday that it plans to end the nationwide COVID-19 public health emergency on May 11. When the PHE ends, COVID-related 340B program flexibilities announced in March 2020 could end too.

The U.S. Health Resources and