Development May Expedite Ruling on Widely Watched State Law Intended to Require Rx Manufacturers to Provide 340B Discounts

USDC Little Rock courtroom interior
A federal court decision about the legality of an Arkansas law that requires drug makers to honor 340B contract pharmacy arrangements might come sooner than originally thought.

A federal district judge has accepted a plan that might speed up a decision in the drug industry’s lawsuit challenging an Arkansas law that requires drug makers to honor 340B contract pharmacy arrangements.

U.S. Senior District Judge Billy Roy Wilson

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Appeals Court Will Hear Oral Arguments in October in Novartis and United Therapeutics’ 340B Contract Pharmacy Suit

USCA DC courtroom interior
A federal appeals court will hear arguments Oct. 24 about Novartis and United Therapeutics’ conditions on 340B pricing when covered entities use contract pharmacies.

The U.S. government and drug makers Novartis and United Therapeutics’ cross-appeals in their 340B contract pharmacy legal dispute have been set for oral arguments in October, marking the first of the closely watched lawsuits to advance to oral arguments at

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Feds File Briefs in Response to AstraZeneca and Lilly Arguments in Key 340B Cases

AstraZeneca sign and building
The U.S. Justice Department recently responded to AstraZeneca and Lilly's arguments in lawsuits in federal circuit court over the two drug companies' denials of 340B pricing involving the contract pharmacy program.

The federal government during the past week filed responses to arguments that drug manufacturers AstraZeneca and Lilly made in federal appeals courts in their 340B contract pharmacy lawsuits.

“In enacting the 340B program, Congress was clear that drug manufacturers must

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Medicare and Hep C Patients Would Save Over $100 Million if Plan Sponsors Adopted Generic Use, OIG Finds

pill in palm of open hand
The HHS Inspector General says Part D beneficiaries are far less likely than Medicaid beneficiaries to use lower-cost authorized generic versions of HCV drugs Epclusa (pictured above) and Harvoni.

Medicare Part D beneficiaries were much less likely to use lower-cost, authorized generic versions of highly expensive hepatitis C drugs Harvoni and Epclusa in 2019 and 2020 than Medicaid beneficiaries, driving up costs for Part D enrollees and the Medicare

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Federal Data Show 340B Sales Hit $43.9 Billion in 2021, Drug Industry Consultant Reports

screenshot of 2021 drug purchases at 340B discounted prices document
DSH hospitals accounted for 78.1% of all 340B program purchases in 2021, according to federal data obtained by Drug Channels Institute under the Freedom of Information Act.

Total sales in the 340B drug pricing program reached $43.9 billion in 2021, a 15.6% increase over 2020 sales and more than 3.5 times above total sales in 2015 ($12.1 billion), according to federal data obtained by Drug Channels Institute

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At Request of Senior GOP Lawmakers, GAO Studying Law That Gave Relief to Hospitals Forced Out of 340B Due to COVID-19

Government Accountability Office Building building-mounted sign
GAO is studying a new law that enables hospitals to maintain or regain their 340B eligibility despite having fallen below the minimum required Medicare disproportionate share (DSH) adjustment percentage due to COVID 19-related changes in patient mix.

The Government Accountability Office (GAO), Congress’s watchdog agency, is conducting a study of a new law that enables hospitals to maintain or regain their 340B eligibility despite having fallen below the minimum required Medicare disproportionate share (DSH) adjustment percentage due

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Bill Giving Medicare Drug-Price Negotiating Power Set to Become Law

President Joe Biden seated in the Oval Office
President Biden is scheduled to sign historic drug pricing legislation with implications for the 340B program later today.

President Joe Biden this afternoon is scheduled to sign legislation that for the first time will let Medicare negotiate the prices of certain costly prescription drugs and require drug makers to pay Medicare rebates when their prices outpace inflation. 

House

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Let Us Decide How to Remedy Illegal Drug Payment Cut for 340B Hospitals, HHS Asks Judge

Dept. of Health and Human Services sign and building
There were no adverse findings in nearly one quarter of provider audits conducted by HRSA, an agency within HHS.

Federal lawyers asked a judge on Friday to let federal health officials decide how to give 340B hospitals relief for illegal Medicare Part B drug payment cuts since 2018.

In papers filed in U.S. District Court for the District of Columbia

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Senate Panel Wants HRSA to Tell How It Has Responded to Drug Makers’ 340B Pricing Denials

U.S. Senate Appropriations Committee room
The U.S. Senate Appropriations Committee wants a report from HRSA "on actions taken to safeguard covered entities’ lawful access to discounted drugs.”

The U.S. Senate Appropriations Committee wants federal healthcare officials to tell it what they have done about drug manufacturers’ denials of 340B pricing when covered entities use contract pharmacies.

The committee included the directive to the U.S. Health Resources and

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340B Providers Won’t Share in $183 Million Damages Award Against Lilly for Misstating AMP

Lilly corporate center
A federal jury ordered Lilly to pay the federal and state governments millions of dollars for misstating its average manufacturer prices, but 340B providers will not get a share of the award.

A federal jury in Illinois last week ordered drug manufacturer Lilly to pay more than $61 million in damages for misstating its average manufacturer prices (AMP) and underpaying Medicaid drug rebates.  

AMP is a key component used to determine 340B

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