Category: Regulatory

Hospitals in Texas and Other States Sue HHS Over DSH Calculation Changes That Impact 340B Eligibility

July 2, 2024 Shannon Young, Associate Editor/Senior Writer Views

Dozens of hospitals in Texas and other states have filed suit against HHS to block a rule that they say lowers their disproportionate share hospital adjustment percentage and could result in a loss of 340B discounts.

Dozens of hospitals in Texas and other states have filed suits against Department of Health and Human Services (HHS) Secretary [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

New York Times Sues HRSA To Release 340B Data, Communications Between Office of Pharmacy Affairs and Apexus Leaders; Information Could Be Released Soon

June 27, 2024 Shannon Young, Associate Editor/Senior Writer Views

A federal court sided with a group of Texas hospitals’ efforts to block an HHS rule.

The New York Times has sued the federal agency tasked with overseeing the 340B program to force the release of [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

IRA Could ‘Crush the 340B Margin,’ Force Transparency into Program, Says Adam Fein of Drug Channels

June 25, 2024 William Newton, Associate Editor/Senior Writer Views

Adam Fein, Ph.D., president of Drug Channels Institute, hosted a June 21 webinar that discussed the IRA's interaction with the 340B program.

The Inflation Reduction Act (IRA) may reduce 340B margins for certain high-cost drugs and drive more transparency into the program, an influential pharmaceutical supply chain analyst who has been a frequent 340B critic told an audience of stakeholders late last

…

Lilly Adds Significant New Restrictions on 340B Contract Pharmacy Access; Alleges Lack of Oversight by HRSA, Pharmacies and TPAs

June 21, 2024 Bella Czajkowski, National Correspondent & Ted Slafsky, Publisher & CEO Views

Pharmaceutical giant Eli Lilly has significantly escalated its restrictions on access to 340B pricing in the contract pharmacy setting, the company announced June 19 on the drug industry vendor site 340B ESP.

Pharmaceutical giant Eli Lilly has significantly escalated its restrictions on access to 340B pricing in the contract pharmacy setting, the [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Lilly Posts 340B Refund Notice for Insulin Product Humulin

June 21, 2024 Bella Czajkowski, National Correspondent Views

Eli Lilly and Amgen announced refunds for 340B covered entities that purchased certain drugs in 2021.

Drug manufacturer Eli Lilly announced a new round of refunds for Humulin, a brand-name insulin, following a 340B ceiling price [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

It’s Official: Long-Awaited Final 340B ADR Rule Takes Effect, But Findings Still Distant

June 21, 2024 William Newton, Associate Editor/Senior Writer Views

The U.S. Department of Health and Human Services' final 340B Administrative Dispute Resolution rule formally took effect on June 18.

Fourteen years after the Congressional deadline, the long-anticipated revision to the 340B Administrative Dispute Resolution (ADR) process officially took effect [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

GAO Reissues Recommendations to Improve 340B Compliance, Medicare Financial Stability

June 21, 2024 Shannon Young, Associate Editor/Senior Writer Views

The Government Accountability Office this month recommended that HHS and Congress take long-proposed actions to better ensure 340B program compliance and Medicare’s financial stability.

HHS and Congress should each take long-proposed actions—including a contentious action to curb certain Part B prescribing incentives—to better ensure [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Sanofi Sues HHS, HRSA for Contract Details Between Covered Entities, Pharmacies

June 13, 2024 Rich Daly, Editor in Chief Views

Drug manufacturer Sanofi has sued the federal government for information about contracts between covered entities and contract pharmacies.

French drugmaker Sanofi recently filed suit against federal agencies seeking details from contracts between 340B covered entities and outside pharmacies. [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Supreme Court to Review Case that Could Result in More Hospitals Qualifying for 340B Program

June 13, 2024 Shannon Young, Associate Editor/Senior Writer Views

Supreme Court Justices announced in a June 10 order that they’d review the U.S. Court of Appeals for the D.C. Circuit’s September 2023 decision in Advocate Christ Medical Center v. Becerra.

The U.S. Supreme Court this week agreed to take on a case that potentially could expand the number of hospitals [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Five Manufacturers Announce Refunds to 340B Providers

June 11, 2024 Rich Daly, Editor in Chief Views

Apotex Corp. announced in a July 2 notice to 340B providers that it will issue refunds to 340B covered entities that purchased any of nearly 400 products.

Five drugmakers have issued recent refund notices to 340B covered entities for drug overcharges. In letters posted on the website [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Site Footer Live