With Just a Month to Go, HRSA Releases First FY 2022 Manufacturer 340B Audit Result

Unichem building mounted sign
Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during an FY 2022 340B program compliance audit.

Generic drug manufacturer Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during a 340B program compliance audit, the U.S. Health Resources and Services Administration (HRSA) said yesterday.

HRSA has been auditing five drug manufacturers per

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Sixth Group of 340B Hospitals Sues HHS Over Medicare Drug Payment Cuts

Oschner Medical Center hospital complex
New Orleans-based Ochsner Medical Center and six other 340B hospitals have sued in federal court to force HHS to immediately remedy illegal Medicare Part B drug payment cuts in place since 2018.

Correction, Friday, Aug. 26, 2022, 3:00 p.m. EDT—The original version of this article mistakenly said the hospital plaintiffs’ complaint stated that HHS improperly based 2020 and 2021 Medicare Part B drug payment cuts for 340B hospitals on a survey

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GSK Announces Third Round of Refunds This Year for 340B Overcharges

GlaxoSmithKline wordmark building-mounted sign
GSK for the third time this year has announced refunds for overcharging 340B covered entities, this time for purchases during Q3 2020.

Drug manufacturer GlaxoSmithKline for the third time this year has announced refunds for overcharging 340B covered entities, this time for purchases of 16 NDCs during Q3 2020.

The U.S. Health Resources and Services Administration (HRSA) posted GSK’s notice to

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HHS Has ‘No Real Plan to Stop Underpaying’ 340B Hospitals’ Part B Claims, Groups Tell Court

Department of Health and Human Services building mounted sign
Hospital groups asked a federal district court to deny HHS's request to be allowed to craft its own plan to remedy unlawful Medicare Part B drug payments cuts to 340B hospitals since 2018.

Federal health officials should not be allowed to craft their own plan to remedy unlawful Medicare Part B drug payments cuts for 340B hospitals since 2018, as the government has not shown how it would stop future illegal payment

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Development May Expedite Ruling on Widely Watched State Law Intended to Require Rx Manufacturers to Provide 340B Discounts

USDC Little Rock courtroom interior
A federal court decision about the legality of an Arkansas law that requires drug makers to honor 340B contract pharmacy arrangements might come sooner than originally thought.

A federal district judge has accepted a plan that might speed up a decision in the drug industry’s lawsuit challenging an Arkansas law that requires drug makers to honor 340B contract pharmacy arrangements.

U.S. Senior District Judge Billy

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Appeals Court Will Hear Oral Arguments in October in Novartis and United Therapeutics’ 340B Contract Pharmacy Suit

USCA DC courtroom interior
A federal appeals court will hear arguments Oct. 24 about Novartis and United Therapeutics’ conditions on 340B pricing when covered entities use contract pharmacies.

The U.S. government and drug makers Novartis and United Therapeutics’ cross-appeals in their 340B contract pharmacy legal dispute have been set for oral arguments in October, marking the first of the closely watched lawsuits to advance to oral arguments

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Federal Data Show 340B Sales Hit $43.9 Billion in 2021, Drug Industry Consultant Reports

screenshot of 2021 drug purchases at 340B discounted prices document
DSH hospitals accounted for 78.1% of all 340B program purchases in 2021, according to federal data obtained by Drug Channels Institute under the Freedom of Information Act.

Total sales in the 340B drug pricing program reached $43.9 billion in 2021, a 15.6% increase over 2020 sales and more than 3.5 times above total sales in 2015 ($12.1 billion), according to federal data obtained by Drug Channels

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At Request of Senior GOP Lawmakers, GAO Studying Law That Gave Relief to Hospitals Forced Out of 340B Due to COVID-19

Government Accountability Office Building building-mounted sign
GAO is studying a new law that enables hospitals to maintain or regain their 340B eligibility despite having fallen below the minimum required Medicare disproportionate share (DSH) adjustment percentage due to COVID 19-related changes in patient mix.

The Government Accountability Office (GAO), Congress’s watchdog agency, is conducting a study of a new law that enables hospitals to maintain or regain their 340B eligibility despite having fallen below the minimum required Medicare disproportionate share (DSH) adjustment percentage

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Health Centers Criticize Kaiser Health News Story About Profit Margins

Tony Megna outside a Genesis Health Care facility

Community health center advocates have strongly criticized a new Kaiser Health News (KHN) investigative report that found that some health centers have large profit margins.

The article found that nine of the nation’s nearly 1,400 health centers reported

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Bill Giving Medicare Drug-Price Negotiating Power Set to Become Law

President Joe Biden seated in the Oval Office
President Biden is scheduled to sign historic drug pricing legislation with implications for the 340B program later today.

President Joe Biden this afternoon is scheduled to sign legislation that for the first time will let Medicare negotiate the prices of certain costly prescription drugs and require drug makers to pay Medicare rebates when their prices outpace inflation. 

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