340B Stakeholders Seek Clarity on HRSA Flexibilities as COVID-19 Public Health Emergency Winds Down

screenshot of HRSA COVID-19 resources web page
340B covered entities are wondering if 340B program COVID-19 flexibilities might become permanent 340B program features.

The U.S. Center for Medicare & Medicaid Services encouraged health care providers on its blog last month “to prepare for the end” of its COVID-19 waivers and flexibilities “as soon as possible and to begin moving forward to reestablishing previous

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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 year for

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Advocates Urge Feds to Allow Distressed Rural Hospitals to Remain 340B Eligible

Save Our Hospital lawn sign
Financially distressed critical access hospitals should be allowed to keep their 340B drug discounts if they opt under a new federal law to downgrade into emergency hospitals to remain solvent, rural health advocates told CMS in comments on proposed rules to implement the law.

Congress and the White House should let financially distressed critical access hospitals keep their 340B drug discounts if they opt under a new law to downgrade into emergency hospitals to remain solvent, rural health advocates told federal health officials in

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Exclusive: HRSA Hasn’t Posted a Limited Distribution Plan Notice to 340B Entities in Almost a Year. No One Outside of the Agency Knows Why.

chart depicts limited distribution plan notices by HRSA in years from 2015 to 2022
HRSA has published no drug manufacturer limited distribution plan notices to 340B covered entities since mid-September 2021.

Last September, the U.S. Health Resources and Services Administration (HRSA) published a drug manufacturers’ notice to 340B covered entities that it was limiting distribution of a medicine that alleviates a side effect of HIV/AIDS treatment.

It was the fifth limited

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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 entities yesterday

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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 Institute

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HRSA Grants 340B Enrollment Flexibility in Kentucky Due to Floods

American Red Cross disaster relief worker standing in debris
Due to severe flooding in eastern Kentucky, HRSA is letting eligible providers in the state enroll in 340B on an expedited basis.

The U.S. Health Resources and Services Administration (HRSA) is letting eligible healthcare providers in flood-devastated Kentucky enroll in the 340B program immediately instead of making them wait until the next quarterly enrollment period in October.

U.S. Health and Human Services

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Purdue Pharma Is Providing 340B Refunds Spanning 16 Years of Overcharges

A bottle of Betasept antiseptic scrub
Purdue Pharma announced refunds for 340B overcharges on Betasept antiseptic surgical scrub for purchases spanning 16 years—more than half of the 340B program's existence.

Purdue Pharma’s Avrio Health subsidiary is giving 340B covered entities refunds for overcharges on Betasept antiseptic surgical scrub for purchases spanning 16 years—from Q2 2005 through Q2 2021. That period covers more than half of the 340B program’s existence.

During

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HRSA Unveils New 340B Contract Pharmacy Services Webpage That Is Silent on Manufacturer Obligations

screenshot of HRSA contract pharmacy services
HRSA has posted a new 340B Contract Pharmacy Services webpage that addresses requirements for covered entities but not for pharmaceutical manufacturers.

The U.S. Health Resources and Services Administration overnight unveiled a new Contract Pharmacy Services page on the 340B program website that addresses requirements for covered entities but not for pharmaceutical manufacturers.

The webpage links to HRSA’s 2010 contract pharmacy final

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Part 2: “There Have Been Challenges Up and Down the Supply Chain”: The View from the Field and Responses from Stakeholders

Beth Peery headshot
Beth Peery is the 340B Coordinator at Memorial Health Systems in Seward, Nebraska, a town of 6,000 in the southeastern part of the state.

A Special Report From 340B Report:
A two-part series on the growing frustrations safety net providers face in restoring access to 340B pricing in the contract pharmacy setting. Part 1 provides important background on the challenges that covered entities face

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