Two Drug Makers Providing Refunds for 340B Overcharges

Drug manufacturers Xellia and Chartwell have notified 340B covered entities about possible refunds for overcharges. | Shutterstock

Drug manufacturers Xellia Pharmaceuticals and Chartwell Rx have notified 340B covered entities about possible refunds for overcharges.

Xellia Pharmaceuticals

Xellia notified 340B covered entities about refunds for overcharges on 16 NDCs for its antibiotics vancomycin, daptomycin, and colistimethate.

Xellia posted

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Brooks-LaSure Sworn in as CMS Administrator

HHS Secretary Xavier Becerra (left) administers the oath of office to new CMS Administrator Chiquita Brooks-LaSure as her husband, Allyn Brooks-LaSure looks on.

Chiquita Brooks-LaSure last Thursday was formally sworn in as Administrator of the Centers for Medicare and Medicaid Services (CMS), setting in place another key Biden administration official with influence on the 340B program.

Although CMS does not control federal 340B

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Breaking News

HHS Wants to Audit 340B Providers to See How They Use 340B Net Income

HRSA, headquartered in this suburban Washington office building, would be empowered to audit 340B covered entities to see how they use income from 340B drug purchases, under a Biden administration proposal issued today.

The Biden administration this afternoon proposed amending the 340B statute to let federal health officials audit 340B covered entities “to determine how net income from purchases under [340B] are used by the covered entity.”

The proposed legislation is included in

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HHS Contract Pharmacy Advisory Opinion Author Returns to Private Sector

Former HHS General Counsel Robert Charrow, who wrote the Dec. 30 advisory opinion on 340B contract pharmacy, has rejoined his law firm.

Robert Charrow—the U.S. Health and Human Services (HHS) general counsel who memorably opined that drug companies must offer their products at or below the 340B ceiling price “be it the lunar surface, low-earth orbit, or a neighborhood pharmacy”—has rejoined his

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Ex-HRSA Administrator Wakefield Back at HHS, Hospital Association Exec Joins Too

Former HRSA Administrator Mary Wakefield is back at HHS, serving as counselor to Secretary Xavier Becerra.

Mary Wakefield, who led the U.S. Health Resources and Services Administration (HRSA) from 2009 to 2015, is back at HHS.

HHS announced Tuesday that Wakefield accepted an appointment to serve as counselor to HHS Secretary Xavier Becerra. She served

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Drugmakers Show No Sign So Far of Giving in to HRSA on 340B Contract Pharmacy

So far, drug manufacturers have shown no sign of obeying HRSA's order to resume 340B pricing without regard to how drugs are dispensed. | Shutterstock

Six drug companies have shown no sign so far of acquiescing to the federal government’s order on Monday to immediately resume 340B pricing on their products dispensed by contract pharmacies.

340B covered entities yesterday reported seeing no evidence that Eli

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Year 2 of 340B Contract Pharmacy Fight Starts With a Bang

HRSA's cease and desist letters to six drug manufacturers likely ensures that this will be another explosive year for 340B contract pharmacy. | Shutterstock

Today is the anniversary of Eli Lilly lighting the fuse on the 340B program’s most explosive year ever.

On May 18, 2020, Lilly sent the U.S. Health Resources and Services Administration (HRSA) a letter saying that, unless it heard otherwise

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Drug Makers Defensive, Providers Thrilled About HRSA’s 340B Contract Pharmacy Letters

"Today is the day we’ve been waiting for," RWC-340B President Shannon Stephenson said about HRSA's 340B contract cease and desist letters yesterday to six drug manufacturers.

Drug manufacturers yesterday defended the legality of their restrictions on 340B contract pharmacy, in the wake of cease and desist letters from the U.S. Health Resources and Services Administration (HRSA).

Groups and individuals representing 340B covered entities, meanwhile, praised HRSA

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Breaking News

BREAKING: HRSA to Six Drug Makers—Your 340B Contract Pharmacy Policies Are Illegal, Resume Offering 340B Pricing Immediately

HRSA Acting Administrator Diana Espinosa sent letters this morning to six drug manufacturers telling them their 340B contract pharmacy policies are illegal and must be stopped immediately.

U.S. Health Resources and Services Administration (HRSA) Acting Administrator Diana Espinosa this morning informed six pharmaceutical manufacturers that their restrictions on 340B program pricing to covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in

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HHS Asks U.S. Supreme Court to Reject 340B Hospital Request to Hear Medicare Part B Case

HHS has asked the U.S. Supreme Court to decline taking up 340B hospital suit on Medicare Part B reimbursement.

While 340B hospitals eagerly await to see the Biden administration’s plans for Medicare Part B reimbursement, the U.S. Department of Health and Human Services (HHS) last night asked the U.S. Supreme Court to reject an effort by hospital groups to

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