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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Comments Due Today on How Feds Should Rectify Drug Payment Cuts for 340B Hospitals

image of a calendar showing September 2022
Today is the deadline for public comments on Medicare’s proposed rule for how it will pay for hospital outpatient services and clinician-administered drugs in 2023.

Today is the deadline for public comments on Medicare’s proposed rule for how it will pay for hospital outpatient services and clinician-administered drugs in 2023.

340B stakeholders will be paying close attention to comments on how Medicare Part B should

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Restoring 340B Hospitals’ Part B Drug Payments Would Cut Net Outpatient Payments for 80% of Hospitals, Private Cancer Doctor-Funded Study Finds

Outpatient exterior sign on hospital
80% of hospitals in Medicare’s outpatient prospective payment system would see their net payments decline next year if CMS ends a nearly 30% cut in 340B hospitals’ drug payments, according to a private oncologist group funded study.

Eighty percent of all hospitals in Medicare’s outpatient prospective payment system—including 52% of all 340B hospitals—would see their net OPPS payments decline next year if Medicare ends a nearly 30% cut in 340B hospitals’ drug payments that began in 2018,

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Judge Continues Stay in 340B Dispute Resolution Lawsuit

screenshot of HRSA 340B, Administrative dispute resolution web page
A federal district judge continued the stay in community health centers’ lawsuit over the 340B administrative dispute resolution process.

A federal district judge on Wednesday continued the stay in community health centers’ lawsuit against federal health officials over the administrative dispute resolution process for the 340B program after accepting the explanation for a missed deadline to file a report

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