Articles by : Tom Mirga, Editor at Large

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.

August 25, 2022 Tom Mirga, Editor at Large Views

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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Judge Orders HHS to Respond to Ruling Letting Health Center Challenge 340B Patient Definition

August 25, 2022 Tom Mirga, Editor at Large Views

Genesis health care pharmacy workers wearing face masks

A federal appeals court gave South Carolina-based Genesis Health Care another chance to challenge the legality of the 340B drug pricing program's patient definition.

A federal district judge on Tuesday gave federal health officials a Sept. 22 deadline to respond to a higher court’s ruling last month that a South Carolina health center has the right to challenge the legality of the government’s 340B

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House GOP Lawmaker Reintroduces Bill to Collect and Report 340B Hospital Data

August 25, 2022 Tom Mirga, Editor at Large Views

U.S. Rep. Bruce Westerman (R-Ark.) has reintroduced a bill that would create new reporting requirements for 340B disproportionate share (DSH), children’s, and free-standing cancer hospitals and their child sites.

U.S. Rep. Bruce Westerman (R-Ark.) has reintroduced a comprehensive health care bill he sponsored during the last session of Congress that would create new reporting requirements for 340B disproportionate share (DSH), children’s, and free-standing cancer hospitals and their child sites.

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

August 23, 2022 Tom Mirga, Editor at Large Views

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

August 18, 2022 Tom Mirga, Editor at Large Views

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 Roy Wilson

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Feds File Briefs in Response to AstraZeneca and Lilly Arguments in Key 340B Cases

August 18, 2022 Tom Mirga, Editor at Large Views

The U.S. Justice Department recently responded to AstraZeneca and Lilly's arguments in lawsuits in federal circuit court over the two drug companies' denials of 340B pricing involving the contract pharmacy program.

The federal government during the past week filed responses to arguments that drug manufacturers AstraZeneca and Lilly made in federal appeals courts in their 340B contract pharmacy lawsuits.

“In enacting the 340B program, Congress was clear that drug manufacturers must

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

August 16, 2022 Tom Mirga, Editor at Large Views

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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Health Centers Criticize Kaiser Health News Story About Profit Margins

August 16, 2022 Tom Mirga, Editor at Large Views

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 profit margins

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Let Us Decide How to Remedy Illegal Drug Payment Cut for 340B Hospitals, HHS Asks Judge

August 16, 2022 Tom Mirga, Editor at Large Views

Dept. of Health and Human Services sign and building

There were no adverse findings in nearly one quarter of provider audits conducted by HRSA, an agency within HHS.

Federal lawyers asked a judge on Friday to let federal health officials decide how to give 340B hospitals relief for illegal Medicare Part B drug payment cuts since 2018.

In papers filed in U.S. District Court for the District of Columbia

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Senate Panel Wants HRSA to Tell How It Has Responded to Drug Makers’ 340B Pricing Denials

August 11, 2022 Tom Mirga, Editor at Large Views

U.S. Senate Appropriations Committee room

The U.S. Senate Appropriations Committee wants a report from HRSA "on actions taken to safeguard covered entities’ lawful access to discounted drugs.”

The U.S. Senate Appropriations Committee wants federal healthcare officials to tell it what they have done about drug manufacturers’ denials of 340B pricing when covered entities use contract pharmacies.

The committee included the directive to the U.S. Health Resources and

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