BREAKING: HRSA Proposes Streamlined, Less Trial-like 340B Dispute Resolution Process

Screenshot of HRSA, HHS 340B ADR document
HRSA this morning released its proposed replacement for its December 2020 340B administrative dispute resolution final rule.

The U.S. Health Resources and Services Administration this morning proposed a replacement for its two-year-old 340B administrative dispute resolution process. Comments are due Jan. 30.

“HRSA has encountered policy and operational challenges with implementation of the

2020

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340B Hospitals Use Biosimilars Less Than Others, PhRMA-Commissioned Study Finds

graphic image of biosimilar pills depicted equal on a scale
340B hospitals use biosimilar drugs less than other hospitals, a PhRMA-funded study found.

340B hospitals use biosimilar drugs less than other hospitals, which may expose patients to higher out-of-pocket costs, a drug industry funded study concludes.

Pharmaceutical Research and Manufacturers of America released the study last week. Healthcare consulting firm Milliman did the

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340B Prime Vendor Sued for Allegedly Not Negotiating Sub-Ceiling Pricing on HIV/AIDS Drugs

Screenshot of complaint AHF v. Apexus
AIDS Healthcare Foundation says in a lawsuit that Apexus, the 340B prime vendor, fails and refuses to negotiate sub-ceiling 340B discounts on HIV/AIDS medicines.

AIDS Healthcare Foundation sued Apexus, the federally contracted 340B prime vendor, on Friday for allegedly failing and refusing to negotiate sub-ceiling 340B discounts on HIV/AIDS prescription drugs pursuant to its agreement with the government.

An Apexus spokesperson yesterday

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Arkansas Health System Asks State to Enforce its 340B Contract Pharmacy Law Against Novo Nordisk

Arkansas Insurance Department office sign
An Arkansas health system has asked state insurance officials to enforce the state's 340B contract pharmacy anti-discrimination law against Novo Nordisk.

An Arkansas health system is urging state officials to enforce the state’s novel 340B contract pharmacy anti-discrimination law against drug maker Novo Nordisk to end the company’s restrictions on 340B-priced drugs dispensed at multiple contract pharmacies. The lawsuit marks

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White House Gives HRSA Green Light to Publish Proposed New 340B Dispute Resolution Regulations

Screenshot of reginfo.gov 340B program ADR record
The White House yesterday authorized HRSA to publish a proposed rule to replace the 340B administrative dispute resolution final rule HRSA promulgated in late December 2020.

The White House yesterday unexpectedly gave the U.S. Health Resources and Services Administration permission to publish a proposed replacement for HRSA’s December 2020 340B administrative dispute resolution final rule.

The Office of Management and Budget announced on its

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A Closer Look at Tuesday’s Arguments in Federal Appeals Court Over the Legality of the 340B Contract Pharmacy Program

Third Circuit Court building entrance
Today 340B Report takes a closer look at Tuesday's oral arguments in federal circuit court in Philadelphia in three 340B contract pharmacy lawsuits.

On Tuesday we reported about oral arguments before a federal appeals court in Philadelphia in AstraZeneca, Novo Nordisk, and Sanofi’s lawsuits challenging federal agency findings that the companies’ conditions on 340B covered entities’ use of contract pharmacies violate the 340B

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Breaking News

Two of Three Appeals Court Judges Question Government’s Stance That Drug Companies May Not Impose Conditions on 340B Sales

U.S. Third Circuit Court of Appeals court room
Two judges on a three-judge federal appeals court panel in Philadelphia today questioned whether the 340B statute forbids drug manufacturers from imposing distribution conditions on offers of 340B pricing.

Two judges on a three-judge federal appeals court panel this morning challenged a federal government lawyer’s stance that federal law forbids drug manufacturers from limiting how their drugs may be distributed when they offer to sell the drugs at

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With Democrats Retaining Control of U.S. Senate, Expect New Leadership in Key Committee

Citizen holding I Voted election sticker
Missouri’s 340B contract pharmacy access law has become a hot topic in the state's primary races.

Democrats will still control the U.S. Senate for the next two years, it became clear over the weekend, but control of the House has not yet been decided one week after the Nov. 8 midterm elections.

As of

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Fake Lilly Twitter Account Tweets “Insulin Is Free Now,” Temporarily Wiping Billions From Company’s Stock Value

screenshot of counterfeit Eli Lilly insulin tweet
On Friday, a counterfeit Eli Lilly account bearing a checkmark that caused many to believe the account was authentic tweeted, “We are excited to announce insulin is free now," causing havoc.

The havoc caused by Twitter’s new policy on user identity verification struck drug manufacturer Eli Lilly last week when a counterfeit account bearing one of Twitter’s new $8 checkmarks tweeted, “We are excited to announce insulin is free now.”

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MedPAC Is Expected to Make a Policy Recommendation That Could Prompt a Look at 340B Hospital Program Eligibility Criteria

MedPAC wordmark
MedPAC is on track to make a recommendation to Congress that could prompt debate or even action on the 340B program’s use of the Medicare disproportionate share (DSH) patient percentage to determine hospital eligibility.

Congressional Medicare advisers are moving toward recommending what they say is a better way to give extra Medicare funding to safety-net hospitals that disproportionately serve low-income and/or uninsured beneficiaries.

If Congress and the executive branch adopt the proposal,

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