Category: Regulatory

Drug manufacturer Lilly said this morning it looks forward to reviewing the Biden administration’s proposed new 340B administrative dispute resolution (ADR) regulation when it becomes available “and hope[s] that it addresses the serious shortcomings of the current rule.”

“As Lilly

The Biden administration plans to replace its 340B administrative dispute resolution (ADR) regulation with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”

The administration

Precision Dose, a maker of liquid generic drugs in unit-dose syringes and cups, and Tagi Pharma, a wholly owned subsidiary that makes generic oral and injectable drugs, will have to repay 340B covered entities for overcharges following an 340B program

The U.S. Health Resources and Services Administration (HRSA) said this morning it “respectfully disagrees with” and “continues to evaluate its options” about a federal district judge’s Nov. 5 finding that drug manufacturers Novartis and United Therapeutic’s 340B contract pharmacy policies

After a 10-month delay, it looks like we may be getting close to the appointment of a permanent leader of the U.S. Health Resources and Services Administration (HRSA), the federal agency that runs the 340B drug pricing program.

News organization

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