RWC-340B Assessing Dispute Resolution Proposed Rule’s Impact on Its Lawsuit and Current Dispute Resolution Petition

Ryan White Clinics-340B wordmark
RWC-340B is assessing how HRSA's proposed new 340B dispute resolution process would affect the group's ongoing dispute with AstraZeneca and ongoing lawsuit against HRSA and HHS.

Ryan White Clinics for 340B Access told a federal district judge last week it needs time to assess how proposed new 340B administrative dispute resolution regulations, if finalized, could affect the 340B overcharging claims it brought against AstraZeneca under the

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340B Dispute Resolution Proposed Rule Would Eject CMS Staff and HHS Lawyers from Process and Put OPA in Charge

graphic image of people in business attire with one announced as the winner
The Biden administration wants major changes to the 340B program administrative dispute resolution process, including giving OPA the only votes on ADR panels.

As we were the first to report on Tuesday morning, the Biden administration has proposed major changes to the 340B program administrative dispute resolution process, including stripping the Centers for Medicare & Medicaid Services and the Department of Health and

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Provider Groups Cite Inaction on 340B Pricing Denials in Their Reactions to Dispute Resolution Proposal

Screenshot of HRSA ADR notice
HRSA posted a notice about its proposed rule to revamp the 340B administrative dispute resolution process on the Office of Pharmacy Affairs homepage.

Groups that represent 340B covered entities said they looked forward to studying the federal government’s proposal Tuesday to revamp the 340B administrative dispute process. But they expressed concern that drug manufacturers still are not being punished for denying 340B pricing

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Local Community Group Continues Late Congressman’s Push for 340B Hospital Oversight

Rep. A. Donald McEachin (D-VA) headshot
U.S. Rep. A. Donald McEachin (D-Va.), who began an inquiry into alleged 340B program misuse involving a hospital in his district, died from complications of colorectal cancer Monday.

A Richmond, Va., citizen’s group is continuing the fight against a health system accused of 340B program misuse at a hospital in a low-income, majority Black neighborhood in the wake of the death of U.S. Rep. A. Donald McEachin (D-Va.),

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HHS Enlists Health Centers in Six-Week COVID Vaccine Drive, GOP Leaders Question Funding and Priorities

Elderly patient receives a Covid vaccination
HHS is giving health centers $350 million in unused COVID-19 provider relief funds to increase vaccinations in underserved communities.

The U.S. Department of Health and Human Services (HHS) said last week it would apply $350 million in unused monies from the COVID-19 Provider Relief Fund to launch a new initiative aimed at increasing COVID-19 vaccinations in underserved communities. 

HHS

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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 final rule,” the

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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 the

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HRSA Sanctions Manufacturer for Not Issuing Refund for 340B Overcharges

KVK Tech office building
HRSA has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

The U.S. Health Resources and Services Administration has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

HRSA posted its audit findings Nov. 15. “KVK-Tech failed to refund covered entities for

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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 website Nov.

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340B Law Should Be Amended to Include Emergency-Use COVID-19 Drugs, Health Affairs Opinion Article Says

screenshot of Bebtelovimab product page
A screen shot from an HHS video about the monoclonal antibody betelovimab used to treat COVID-19 infection.

The 340B statute should be amended to extend discounts to emergency-use drugs to treat COVID-19 as a first step in rebuilding the COVID-19 safety net, an opinion piece published yesterday in the medical journal Health Affairs says.

The Nov.

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