News Alert

Feds Tell Court They Oppose Health Center’s Effort to Sink 340B Patient Definition

Genesis Health Care, FQHC building and signage
Lawyers for HHS and HRSA told a federal district court yesterday the agencies oppose a health center’s efforts to have the longstanding 340B program definition of patient declared illegal.

Lawyers for federal healthcare officials told a federal district court yesterday that the government opposes a South Carolina health center’s efforts to have the longstanding 340B program definition of patient declared illegal.

In papers filed Sept. 22 in federal district court

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340B Report Exclusive: GAO Is Asking Hospitals if They Share 340B Savings with Low-Income Uninsured Patients at Contract Pharmacies

GAO office building
The Government Accountability Office this month recommended that HHS and Congress take long-proposed actions to better ensure 340B program compliance and Medicare’s financial stability.

A federal watchdog agency wants to know if 340B hospitals give low-income uninsured patients a break on drug prices at their contract and in-house pharmacies as part of the agency’s evaluation of a law that helps some hospitals forced out

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Merck Announces Third Round of 340B Refunds for 2019 Drug Purchases

Merck corporate campus signage
Merck has announced its third round this year of refunds to 340B covered entities for overcharges on select products.

Drug manufacturer Merck has announced its third round this year of refunds to 340B covered entities for overcharges on select products.

The latest round covers 15 NDCs sold during Q3 2019. The previously announced refunds were for sales during Q1

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HRSA Grants 340B Enrollment Flexibility in Puerto Rico Due to Hurricane

Puerto Rico, Hurricane Fiona, Pedro Pierluisi and other officials assess damage
Puerto Rico Gov. Pedro Pierluisi (D) (second from right), FEMA officials, and local residents assessed damage yesterday from Hurricane Fiona.

UPDATE Thursday, Sept. 22, 2022, 1:00 p.m. EDT—This story was updated to include new information from HRSA.


The U.S. Health Resources and Services Administration (HRSA) is letting eligible healthcare providers in Puerto Rico enroll in the 340B

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Feds Tell Judge They Accept that Part B Drug Payment Cuts in 2020-22 Were Unlawful

HHS office sign and building
Federal lawyers told a judge that they do not oppose declaring unlawful Part B drug payments cuts for 340B hospital from 2020-2022.

Federal lawyers last week agreed with national groups that represent 340B hospitals that the U.S. Supreme Court’s June decision to declare illegal Medicare Part B payment cuts in 2018 and 2019 for hospitals’ 340B-purchased drugs “effectively resolves” the groups’ claims

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Judge Issues Stay in Merck’s 340B Contract Pharmacy Lawsuit

Merck wordmark on office building windows
A federal district judge in Washington, D.C., put drug manufacturer Merck’s 340B contract pharmacy lawsuit against the federal government on hold pending a related federal appeals court decision.

A federal district judge in Washington, D.C., put drug manufacturer Merck’s 340B contract pharmacy lawsuit against the federal government on hold until after a federal circuit court in Washington rules in Novartis and United Therapeutics’ 340B contract pharmacy cases.

Lawyers

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Federal Appeals Court Will Hear Arguments in Lilly’s 340B Contract Pharmacy Suit on Oct. 31

Eli Lilly wordmark
A federal appeals court will hear arguments in Lilly's 340B contract pharmacy lawsuit on Oct. 31.

A federal appeals court in Chicago will hear oral arguments in drug manufacturer Eli Lilly’s 340B contract pharmacy lawsuit against the federal government on Oct. 31, the court announced on Tuesday.

The half-hour session will take place one week after

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CMS Gets Conflicting Advice About Unwinding Drug Payment Cuts for 340B Hospitals

outpatient surgery center entrance sign on building facade
Stakeholders offered CMS conflicting advice about how to reverse a nearly 30% cut in Medicare Part B drug reimbursement for hospitals’ 340B-purchased drugs since 2018. | Flickr.com/photos/rxb

Key stakeholders have offered federal healthcare officials conflicting advice about how best to respond to the U.S. Supreme Court’s June decision striking down a nearly 30% cut in Medicare Part B drug reimbursement for hospitals’ 340B-purchased drugs.

Tuesday was the

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Unichem Says 340B Audit Found it Overcharged Just Two Entities and Must Repay Them Just $110.20

Drug manufacturer Unichem wordmark on building
Generic drug manufacturer Unichem says a 340B compliance audit found it overcharged just two entities and the repayment to both totals just $110.20.

Late last month, the U.S. Health Resources and Services Administration (HRSA) said on its website that generic drug manufacturer Unichem Pharmaceuticals USA had to repay 340B covered entities for overcharges found during a 340B program compliance audit.

According to Unichem,

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Judge Dismisses 340B Contract Pharmacy-Related Antitrust Claims Against Insulin Manufacturers

Federal District Court Rochester, N.Y. entrance and building-mounted sign
A federal district judge in Rochester, N.Y., has dismissed two community health centers’ antitrust suit against insulin manufacturers over the companies’ 340B pricing policies.

A federal district judge has dismissed two community health centers’ federal and state antitrust claims against four insulin and diabetes drug manufacturers over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

Chief Judge Elizabeth Wolford of

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