Category: Regulatory

HHS and HRSA Urge Judge to Reject Health Center’s Take on 340B Patient Definition

October 13, 2023 Tom Mirga, Editor at Large Views

Genesis Health Care building and signage

Genesis Health Care's proposed 340B patient definition would remove all limits on dispensing 340B drugs, HHS and HRSA told a federal district judge.

Federal healthcare agencies recently told a federal district judge that backing a South Carolina health center’s interpretation of the 340B [...]

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HRSA Audit Finds Fourth Drugmaker Owes Refunds

October 13, 2023 Rich Daly, Editor in Chief Views

Drugmaker RedHill Biopharma owes repayments to 340B covered entities, a finalized HRSA audit found.

A fourth drugmaker owes repayment to 340B covered entities, according to final audits posted this week by federal officials. RedHill [...]

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Hospital Fighting 340B Expulsion Gets Temporary Reprieve

October 11, 2023 Tom Mirga, Editor at Large Views

Insight Hospital and Medical Center Chicago has an additional 31 days to fight its expulsion from the 340B program, a federal district judge ordered.

A federal district judge has granted a Chicago hospital an additional 31 days to fight its expulsion from the 340B [...]

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Hospital Advocates Meet with Regulators on Lump Sum Rule

October 11, 2023 Rich Daly, Editor in Chief Views

Boris Bershteyn, an attorney representing AHA, will advocate for for changes in the 340B lump sum re-payment rule before federal regulators.

Two hospital advocacy groups are meeting with federal healthcare regulators to press their case for changes in the 340B lump [...]

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Drugmaker Overcharge Fines for 340B Drugs Reach Nearly $7,000

October 11, 2023 Rich Daly, Editor in Chief Views

Drugmaker overcharge fines, which the Department of Health and Human Services assesses, recently increased to nearly $7,000.

The federal fine for each instance of drugmaker overcharges for 340B covered entities recently increased to nearly $7,000. The fine [...]

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Hospital Sues to Stop 340B Expulsion Over Alleged Failure to Recertify

October 5, 2023 Tom Mirga, Editor at Large Views

The hospital Insight Chicago and federal regulators have agreed to dismiss a case before a federal district court over the hospital's 340B eligibility.

A federal district judge is temporarily keeping an inner-city Chicago hospital in the 340B program as it fights to prevent [...]

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Novartis Offering 340B Refunds on Two Diagnostic Radiopharmaceuticals

October 5, 2023 Tom Mirga, Editor at Large Views

Drugmaker Novartis is offering refunds to 340B covered entities on certain purchases of two radiopharmaceuticals.

Drug manufacturer Novartis is offering 340B covered entities refunds on purchases of two imaging agents, partly contingent on whether an [...]

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Speaker Vacancy Paralyzes House, Stalls 340B Legislation

October 5, 2023 William Newton, Associate Editor/Senior Writer Views

The U.S. House is unlikely to vote on any legislation—including multiple bills with 340B provisions—until a new speaker is elected.

The U.S. House’s vote to remove Rep. Kevin McCarthy (R-Calif.) from the speakership has paused action on multiple bills with [...]

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Major Drugmakers Agree to Negotiate Drug Prices with Medicare

October 5, 2023 William Newton, Associate Editor/Senior Writer Views

Judge Michael Newman of the U.S. District Court for the Southern District of Ohio denied a business group's request to pause Medicare negotiations while legal challenges to the IRA play out.

Medicare drug price negotiations will move ahead as planned after major drugmakers agreed to participate and a federal district judge [...]

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Hospitals Defend 340B Compliance Amid Influential Senator’s Investigation

October 3, 2023 William Newton, Associate Editor/Senior Writer Views

Sen. Bill Cassidy (R-La.) expanded his ongoing inquiry into 340B revenue with letters to two major contract pharmacies.

The two hospital systems subject to a senator’s investigation into 340B program revenue have said they are fully compliant with [...]

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