Category: Regulatory

The U.S. Health Resources and Services Administration (HRSA) yesterday asked the White House to review and approve a 340B administrative dispute resolution (ADR) proposed regulation for publication in the Federal Register.

The proposed rule’s purpose is unknown. HRSA published a

The U.S. Health Resources and Services Administration (HRSA) has reconfirmed that it is auditing 340B covered entities for program compliance both remotely and in-person this fiscal year.

HRSA told 340B Report in mid-September that in October it would resume

The Biden administration said yesterday it is delaying by six months the effective date of a Trump administration final rule to let drug manufacturers report multiple best prices on their products if states opt to participate in value-based purchasing (VBP)

The federal fine for overcharging a 340B covered entity just went up from $5,883.00 to $5,953.00 per each instance of overcharging.

The U.S. Health and Human Services Department (HHS) Office of Inspector General (OIG) posted its annual inflation adjustments to

In a major organizational change, the U.S. Health Resources and Services Administration (HRSA) has redefined the job of Director of the Office of Pharmacy Affairs (OPA), the HRSA unit that runs the 340B program.

For the first time in 340B

In a big disappointment for 340B hospital organizations, the U.S. Centers for Medicare & Medicaid Services (CMS) announced late this afternoon that it will continue a nearly 30% reduction in place since 2018 in Medicare Part B reimbursement for hospitals’

The U.S. Centers for Medicare & Medicaid Services (CMS) could disclose as soon as today whether it will continue, end, or modify the nearly 30% cut in certain hospitals’ Medicare Part B reimbursement for 340B-purchased drugs.

The White House Office

The Biden administration last Friday, as widely expected, proposed withdrawing or repealing a Trump administration final rule that will automatically extinguish all U.S. Health and Human Services (HHS) regulations if HHS does not renew each regulation within a certain timeframe.