Category: Federal

Lifestar, Chartwell Announce Refunds for Q4 2022 340B Overcharges

In Federal, Pharma Industry, RegulatoryMay 9, 2023295 Views

HRSA recently posted notices on its website of refunds for 340B overcharges from two generic drug manufacturers.

Generic drug manufacturers Lifestar Pharma and Chartwell Pharmaceuticals may owe refunds to 340B covered entities for overcharges on drugs purchased from the companies in the fourth quarter of 2022, according to recent notices posted on the U.S. Health

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HRSA Says COVID Flexibility About Dispensing 340B Drugs in Unregistered Hospital Offsite Locations Will End Thursday

In Exclusive, Federal, RegulatoryMay 8, 20232363 Views

Tom Mirga

HRSA has reversed course and will end a 340B COVID-19 flexibility that it previously said was permanent that lets hospitals under certain conditions start using 340B drugs at offsite outpatient locations sooner than HRSA would normally allow.

The U.S. Health Resources and Services Administration said late Friday that when the COVID-19 public health emergency ends on Thursday, so too will a nearly three-year-old policy clarification that lets hospitals under certain conditions dispense 340B drugs at

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In Shift, 340B Health and AHA Now Say They Back Congressional Action on 340B Contract Pharmacy

In Federal, Legislative, ProvidersMay 4, 20231613 Views

Tom Mirga

340B Health and the AHA say they support 340B contract pharmacy legislation that Rep. Doris Matsui (D-Calif.) is working on.

Hospital group 340B Health and the American Hospital Association both have decided to support federal legislation to prohibit drug manufacturer restrictions on 340B covered entities’ use of contract pharmacies. A senior AHA official was quoted in a news

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Ex-GOP Congressman Burton Slams Current GOP Rep. Rosendale’s 340B Bill

In Federal, LegislativeMay 4, 2023200 Views

Laura Gilcrest

Retired U.S. Rep. Dan Burton (R-Ind.) lauded the 340B program and criticized a current GOP congressman's 340B bill in a newspaper op-ed this week.

Former Republican Congressman Dan Burton (Ind.) called the 340B program “a win for all parties involved” in a Kokomo, Indiana newspaper op-ed this week and said a current House Republican’s 340B bill could deny vulnerable Hoosiers access to

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340B-Related Amendment Might Be Offered to PBM Reform Bill That Senate Panel Is Trying to Mark Up Today

In Federal, LegislativeMay 2, 2023940 Views

Tom Mirga

Sen. Mike Braun (R-Ind.) is expected offer an amendment in committee today to PBM reform legislation to require 340B hospitals to be more transparent about how they use 340B program savings.

A U.S. Senate committee is attempting to mark up bipartisan legislation today to reform the pharmacy benefit management industry. The draft bill itself does not address the 340B program. Republican Sen. Mike Braun (Ind.), however, has filed an

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Judge Denies Health Center’s Request for More Government Files in 340B Patient Definition Case

In Federal, JudicialMay 2, 2023603 Views

Tom Mirga

A federal district judge declined to order HRSA to give Genesis Health Care any more documents linked to the center’s brief expulsion from and subsequent reinstatement to the 340B program in 2018.

A federal district judge last week declined to make federal health officials give a South Carolina health center any more documents linked to the center’s brief expulsion from and subsequent reinstatement to the 340B program in 2018.

U.S.

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340B COVID-19 Flexibilities Will End May 11 as Public Health Emergency Expires

In Federal, RegulatoryMay 2, 2023489 Views

Ted Slafsky

340B program flexibilities allowed under the COVID-19 public health emergency will expire May 11, HRSA said Monday.

Certain flexibilities to the 340B program allowed under the COVID-19 public health emergency will expire May 11 alongside the PHE, the U.S. Health Resources and Services Administration announced Monday.

The update, which HRSA posted prominently on the Office

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Astellas Notifies 340B Entities for Second Time in 2023 About a Change in Drug’s NDC

In Federal, Pharma Industry, RegulatoryMay 2, 2023171 Views

Laura Gilcrest

Astellas says for 340B replenishment, the new and old NDCs of Cresemba’s 372mg intravenous formulation are interchangable.

Drug maker Astellas will let 340B covered entities count accumulations of an injectable form of its antifungal drug Cresemba under its old National Drug Code toward replenishment of equal quantities under the product’s corresponding new NDC, provided the

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AHA Tells House Panel It Opposes New 340B Hospital Reporting Requirements

In Federal, LegislativeApril 27, 2023792 Views

Tom Mirga

“I'm just not sure additional [340B hospital] reporting requirements are needed at this time,” AHA Senior Vice President Ashley Thompson told a U.S. House subcommittee yesterday.

An American Hospital Association senior executive told a U.S. House subcommittee yesterday her group opposes creating “significant new reporting requirements for 340B hospitals that do not reflect the true value or intent of the 340B program.”

But when

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340B Abuse Claims Raised During House Hearing on Nonprofit Hospitals’ Tax Status

In Federal, LegislativeApril 27, 2023691 Views

Laura Gilcrest

“Right now, there’s no transparency regarding the 340B program,” Johns Hopkins University professor Ge Bai said yesterday at a U.S. House Ways and Means oversight subcommittee hearing.

The 340B program has evolved into a “buy low, sell high” drug pricing system abused by some hospitals that have profits as their main goal, a health policy researcher told lawmakers Wednesday at a U.S. House subcommittee hearing.

The House

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