Q3 340B Entity Registration Starts Tomorrow

Screenshot of HRSA Office of Pharmacy Affairs 340B registration page
The Q3 2022 registration period for healthcare providers, outpatient facilities, and contract pharmacies to participate in 340B begins July 1 and ends July 15.

The third quarterly period this year for 340B registration of new covered entities, outpatient facilities, and contract pharmacies will begin tomorrow, July 1, and end on Friday, July 15.

Eligible hospitals, health centers, clinics, and their child sites and contract

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HRSA Tells UCB its 340B Contract Pharmacy Policy Is Illegal

UCB exterior sign and building
HRSA told drug manufacturer UCB yesterday its conditions on 340B pricing when hospitals use contract pharmacies are illegal and must stop or the company could face civil monetary penalties.

Federal healthcare officials told drug manufacturer UCB yesterday its restrictions on 340B pricing when covered entities use contract pharmacies are illegal and must stop or the company could face civil monetary penalties of up to $6,323.00 for each instance of

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Feds Ask Appeals Court to Partially Reverse Ruling on Lilly’s 340B Contract Pharmacy Policy

Lilly corporate center exterior sign
The federal government asked an appeals court to affirm one part and vacate another of a lower court's opinion about the legality of Lilly's 340B contract pharmacy restrictions.

A federal district judge was right to decide that drug manufacturer Lilly cannot tie strings to 340B pricing on its drugs, the U.S. Justice Department told a federal appeals court in Chicago on Friday. But, DOJ said, the judge was

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Clinics Pay Gilead $33 Million to Settle Fraud Claims Involving 340B-Related PrEP Transactions

Truvada open pill bottle and pills
A group of Florida healthcare providers will pay $33 million to settle Gilead's claims the group made fraudulent 340B-related transactions involving the company’s HIV pre-exposure prophylaxis drugs.

One of two groups of Florida health care providers that drug maker Gilead accused of making fraudulent 340B-related transactions involving the company’s HIV pre-exposure prophylaxis drugs agreed last week to settle Gilead’s claims against it for $33 million.

A mediation

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Supreme Court DSH Calculation Ruling Leaves 340B Status Quo in Place, Experts Say

U.S. Supreme Court building
A U.S. Supreme Court decision about the Medicare DSH adjustment percentage calculation is expected to have little effect on hospitals currently in the 340B drug pricing program.

A U.S. Supreme Court decision last week about the Medicare disproportionate share adjustment percentage calculation will have little effect on hospitals currently in the 340B drug pricing program, experts say. It could mean, though, that some on the cusp of

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340B Report Publisher and CEO: Takeaways from Supreme Court’s Part B Cuts Decision

screenshot of Supreme Court decision
The U.S. Supreme Court opinion striking down huge cuts in 340B hospitals’ Medicare Part B drug reimbursement “is a clear and much welcome victory" for the hospitals, 340B Report Publisher and CEO Ted Slafsky says.

The U.S. Supreme Court’s unanimous June 15 ruling that huge cuts in 340B hospitals’ Medicare Part B drug reimbursement were unlawful “is a clear and much welcome victory for 340B hospitals,” 340B Report Publisher and CEO Ted Slafsky says in

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White House Now Says This Is Target Month for New 340B ADR Rule, but Publication Date Remains a Mystery

screenshot of HRSA 340B Administrative Dispute Resolution page
The White House says this is the target month to release a long delayed proposed rule to replace the existing 340B ADR final rule. But it is unclear whether it will be delayed again.

The White House office that oversees issuance of federal healthcare regulations now says that this is the target month for releasing a long delayed proposed rule to replace 340B program dispute resolution regulations. But the administration has not given a

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Gilead Adds 45-Day Lookback Clause to its 340B Contract Pharmacy Policy

Image of Harvoni pill bottle and pill
Gilead had added 45-day time limits for replenishment orders and claims submissions under its 340B contract pharmacy restrictions on Harvoni and its other branded hepatitis C medicines.

Drug manufacturer Gilead on Wednesday added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

Ten manufacturers require covered entities to provide claims data to industry contractor 340B

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Exclusive: 340B Entities Report Unannounced and Unexplained Claims Reversals Involving CVS and Blue Cross Blue Shield

Blue Cross Blue Shield wordmarks
Providers say claims have been reversed without notice or explanation for 340B-purchased drugs that CVS Specialty dispensed to BCBS FEP participants.

UPDATE Wednesday, June 22, 2022, 2:50 p.m. EDT—CVS Health issued this statement: “We do not comment on specific PBM client contract terms. Our clients are sophisticated purchasers, and we work closely with them to customize a benefit design meeting their

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Feds Urge Appeals Court to Overrule Lower Court in AstraZeneca’s 340B Contract Pharmacy Lawsuit

AstraZeneca wordmark building-mounted sign
The federal government wants an appeals court to rule that drug manufacturer AstraZeneca may not unilaterally dictate how many contract pharmacies a 340B covered entity may use to dispense 340B drugs.

The federal government told a federal appeals court in Philadelphia yesterday it should use “the familiar tools of statutory interpretation” to hold that drug manufacturer AstraZeneca may not unilaterally dictate how many contract pharmacies a 340B covered entity may use

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