Category: Federal

340B Could Come Up During Congressional Hearings Thursday

In Federal, LegislativeApril 13, 2021

The U.S. Senate Finance Committee is scheduled to hold a hearing Thursday morning on President Biden’s nominations of Chiquita Brooks-LaSure to run the U.S. Centers for Medicare & Medicaid Services, and Andrea Palm to be U.S. Health and Human Services …

MACPAC Backs Medicaid Change That Could Lower Some 340B Prices

In Federal, LegislativeApril 13, 2021

Tom Mirga

Congressional Medicaid policy advisers voted Friday to recommend raising the Medicaid rebate percentage and inflation penalty on drugs that are quickly and conditionally approved to treat serious conditions that fill an unmet need. If Congress follows the advice, 340B covered …

340B Entities Won’t Share in BMS’s $75 Million Medicaid Drug Pricing Settlement

In Federal, JudicialApril 8, 2021

Tom Mirga

340B covered entities were not included in Bristol-Myers Squibb’s $75 million settlement last week of a whistleblower’s claims that BMS “falsely reported improperly reduced average manufacturer prices” (AMPs) on multiple drugs from October 2007 through March 2016.

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AHA Warns MedPAC its Recommendations Would Harm 340B Hospitals

In Federal, Legislative, RegulatoryApril 6, 2021

Tom Mirga

Congressional Medicare policy advisers on Friday unanimously endorsed Medicare Part B drug reimbursement changes that hospitals say would amplify the effect of Part B drug payment cuts for 340B hospitals in place since 2018.

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Panelists Share Insights on Using 340B in Prisons and Jails

In Federal, RegulatoryApril 1, 2021

Ron Shinkman

Prisons struggling with the high cost of treating inmates with viral illnesses such as hepatitis C and HIV can turn to the 340B program for relief, but participation is often tricky.

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HHS’s Latest Regulatory Agenda Is Silent on 340B, but Program Rulemaking Is Possible

In Federal, RegulatoryApril 1, 2021

Tom Mirga

The U.S. Health and Human Services Department (HHS) yesterday released the spring edition of its twice-annual public inventory of forthcoming regulatory actions. Although it was silent about the 340B program, 340B stakeholders shouldn’t breathe a sigh of relief yet. …

AHA Asks Becerra to Waive a 340B Hospital Eligibility Requirement During COVID-19 Emergency

In Federal, RegulatoryApril 1, 2021

Tom Mirga

The American Hospital Association (AHA) yesterday asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra to temporarily waive 340B program eligibility criteria for hospitals at risk of losing their 340B eligibility due to changes in payer mix caused by …

For-Profit Hospitals Back Medicare’s 340B Hospital Cuts in Legal Brief, Study, and Blog

In Federal, JudicialApril 1, 2021

Tom Mirga

The association for U.S. for-profit hospitals yesterday made its strongest pitch yet to preserve the nearly 30 percent cut in what Medicare pays many public and private nonprofit hospitals for physician-administered, 340B-purchased drugs.

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For-Profit Hospitals Make Major Pitch for Keeping Medicare’s 340B Hospital Cuts

In Breaking, Federal, Judicial, RegulatoryMarch 31, 2021

Tom Mirga

The association for U.S. for-profit hospitals submitted a brief to the U.S. Supreme Court and released a study today arguing against reversing the nearly 30 percent cut in what Medicare pays many public and private nonprofit hospitals for physician-administered, 340B-purchased …

Feds Oppose Hospitals’ Intervention in Three More Pharma 340B Lawsuits

In Federal, JudicialMarch 30, 2021

Tom Mirga

The federal government has asked federal district judges in Indianapolis, Delaware, and New Jersey to deny hospital groups’ requests for active roles in drug manufacturers’ Eli Lilly’s, AstraZeneca’s, and Sanofi’s lawsuits against the government over its 340B contract pharmacy requirements. …