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HHS Sends Enforcement Letters to Drug Manufacturers Regarding 340B Contract Pharmacies While Litigation Against HHS Continues

On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers notifying them that their actions placing restrictions on access to 340B-discounted drug prices by health care...more

HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more

Lawmakers Call on HHS to Stop Drug Companies from Denying 340B Drug Pricing

Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more

Medicare Proposes Deeper Drug Payment Cuts to 340B Hospitals

On August 4, 2020, CMS issued a proposed rule to further reduce outpatient drug payment rates under Medicare to certain hospitals participating in the 340B drug pricing program. As part of the 2021 OPPS Proposed Rule, CMS...more

Oversight Interest in the 340B Program Continues

Conversations also continue regarding the 340B drug pricing program, which requires drug manufacturers to sell outpatient drugs at discounted prices to safety net providers, including certain public and private non-profit...more

Addressing High Drug Prices Remains Key Area of Bipartisan Interest

Both Congress and the White House continue to push for bipartisan action to address high drug prices, with hopes of enacting legislation as part of a spending package that must pass by May 22, 2020....more

Oral Arguments Scheduled in Challenge to 340B Payment Cuts While HHS Solicits Comments on Potential Remedy for 340B Hospitals

The D.C. Circuit Court of Appeals has scheduled oral arguments for November 8, 2019 in the ongoing lawsuit challenging Medicare payment cuts to hospitals in the 340B drug pricing program. The court is considering an appeal by...more

Bipartisan Interest in Tackling High Drug Prices with Competing Solutions Being Considered

Both the House and Senate are expected to consider legislation to address high drug prices when Congress returns. Meanwhile, the Administration has faced roadblocks to several of its high-profile proposals to address drug...more

GAO Recommends Improvements to 340B Contract Pharmacy Oversight

The Government Accountability Office (GAO) issued a report on June 28, 2018 regarding federal oversight of compliance at 340B program contract pharmacies. The 340B drug pricing program requires drug manufacturers to sell...more

President Trump Releases Drug Pricing Blueprint

On Friday, May 11, President Donald Trump and Department of Health and Human Services (HHS) Secretary Alex Azar presented the Administration's long-awaited plan to address drug pricing. The proposed framework, entitled,...more

HHS Solicits Comments on Possible 340B Program Changes to Reduce Drug Prices

The Department of Health and Human Services (HHS) is soliciting comments from the public on the Administration's proposals to reduce drug prices and is targeting the 340B drug pricing program as an area of focus. ...more

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