Category: Regulatory

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

The U.S. Centers for Medicare & Medicaid Services (CMS) Tuesday asked the White House to review a hospital payment proposed rule for next year that will either keep, end, or change the nearly 30 percent cut since 2018 in Medicare

The U.S. Health Resources Services Administration (HRSA) has ordered a Michigan-based manufacturer of over-the-counter (OTC) drugs that it audited to repay 340B covered entities because it did not offer its products at the statutory ceiling price.

HRSA posted …

The U.S. Health Resources and Services Administration (HRSA) yesterday asked the White House for permission to rescind the Trump administration’s final rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers

The American Hospital Association (AHA) and ASHP (the American Society of Health-System Pharmacists) want the U.S. Food and Drug Administration (FDA) to “take appropriate action” against white bagging—the health care payer requirement that hospitals obtain specialty drugs for insured patients

News this week that sexually transmitted disease (STD) reported cases in the U.S. reached all-time highs for the sixth straight year shows why STD clinic access to 340B drug discounts is vital, state and local STD program directors say.

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