Articles by : Tom Mirga, Editor at Large

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Boehringer Ingelheim Extends 340B Contract Pharmacy Conditions to All Covered Entities

June 23, 2023 Tom Mirga, Editor at Large Views

Boehringer Ingelheim today stiffened its conditions on 340B pricing involving deliveries to contract pharmacies and extended them to all types of covered entities.

Drug manufacturer Boehringer Ingelheim announced this morning that, starting Aug. 1, all covered entity types will be subject to its conditions on 340B pricing when entities use contract pharmacies to dispense BI products. Until now, its conditions have applied to

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Health Center Invokes 340B Contract Pharmacy Ruling in Key 340B Patient Definition Federal Lawsuit

June 23, 2023 Tom Mirga, Editor at Large Views

South Carolina health center Genesis Health Care told a federal court that HRSA lacks authority to enforce its 1996 340B patient definition and misinterpreted congressional intent about who is a 340B eligible patient.

Federal health care officials can’t make a South Carolina health center obey their reading of the 340B patient definition for the same reason a federal appeals court said in January that the officials can’t force drug manufacturers to deliver 340B

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State Roundup: Lots of 340B Action as Many Legislatures Conclude Sessions

June 23, 2023 Tom Mirga, Editor at Large Views

Louisiana Gov. John Bel Edwards (D) signed a bill making his state the second to stop drug manufacturer interference with 340B contract pharmacy arrangements.

Louisiana Gov. John Bel Edwards (D) has signed legislation making his state just the second with a law addressing manufacturer conditions on deliveries of 340B-acquired drugs to contract pharmacies.

Arkansas’s Act 1103, passed in August 2021, was the first. A

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U.S. Senate “Group of Six” Elaborates on Why it Wants 340B Stakeholder Input

June 21, 2023 Tom Mirga, Editor at Large Views

"It is critical that the 340B program continues to serve its original purpose of supporting health care providers as they serve the needs of South Dakota patients and communities," Sen. John Thune (R-S.D.) said about his and five fellow senators' request for public input on how to improve 340B.

The six U.S. senators who asked Friday morning for ideas on ways to improve the 340B program elaborated on their reasons why in a news release that afternoon.

Sens. John Thune (R-S.D.), Debbie Stabenow (D-Mich.), Shelley Moore Capito (R-W.Va.), Tammy

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RWC-340B Slams Gilead-funded Study of 340B Grantee Entities

June 21, 2023 Tom Mirga, Editor at Large Views

Shannon Burger, president of RWC-340B,, said the organization “strongly opposes" a new 340B overhaul bill.

Ryan White Clinics for 340B Access yesterday criticized drug manufacturer Gilead Sciences for sponsoring a study that said it is unclear if patients of Ryan White clinics and other 340B grantee covered entities benefit from the drug margin these entities

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340B Registration for Third Quarter of 2023 Will Run from July 1 to July 17

June 21, 2023 Tom Mirga, Editor at Large Views

Q3 2023 covered entity registration for the 340B program runs from July 1 to July 17, HRSA says.

The U.S. Health Resources and Services Administration has added two days to the next quarterly 340B registration period.

A HRSA spokesperson said Friday that Q3 registration for 340B covered entities, their child sites, and their contract pharmacies will begin July

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Six Democratic and Republican U.S. Senators Ask 340B Stakeholders for “Bipartisan Policy Solutions”

June 16, 2023 Tom Mirga, Editor at Large Views

A bipartisan group of six U.S. senators today sought 340B stakeholders' best advice on subjects including 340B contract pharmacy, duplicate discount prevention, accountability, and ensuring that program benefits accrue to covered entities and their patients.

Six Democratic and Republican U.S. senators this morning asked 340B drug pricing program stakeholders for input on “bipartisan policy solutions that would ensure the program has stability and oversight to continue to achieve its original intention of serving eligible patients.”

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Congressional Republicans Want to Know if 340B Plays a Role in Drug Shortages

June 15, 2023 Tom Mirga, Editor at Large Views

The GOP leaders of two congressional committees want public input on whether 340B program growth leads to drug shortages.

U.S. House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Senate Finance Committee ranking Republican Mike Crapo (Idaho) are soliciting public input on what’s driving the increase in drug shortages, including whether or not the 340B drug pricing

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JAMA Study Says, When it Comes to Insulin, Pharma’s Gross-to-Net Problem Is Mostly its Own Doing

June 15, 2023 Tom Mirga, Editor at Large Views

Insulin product manufacturers' take from sales is diminished more by voluntary commercial discounts than by 340B ceiling prices and other mandatory discounts, a new study found.

Drug manufacturers often observe that a growing share of their take from gross sales goes to middlemen and others in the form of rebates and discounts. A term has been coined to describe the phenomenon: the gross-to-net bubble (the difference

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Federal Court Hearing Next Week on California’s Medicaid Drug Benefit Transfer; Bill Introduced in N.J. with 340B Implications

June 13, 2023 Tom Mirga, Editor at Large Views

A federal district judge in Sacramento, Calif., is holding arguments next week in a lawsuit to reverse the state’s transfer of Medicaid managed care benefits to Medicaid fee for service.

A federal district judge in Sacramento, Calif., is holding oral arguments next week in a lawsuit aimed at reversing the state’s January 2022 transfer of Medicaid managed care benefits to Medicaid fee for service.

Meanwhile, a bill was introduced

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