Three Terminations, 10 Paybacks to Manufacturers in HRSA’s 2023 Pending Provider Audits

HRSA provider audits
HRSA audits found terminations were required for a 340B provider site and a contract pharmacy and that another provider owed repayments to drugmakers.
Three provider organizations may have contract pharmacies terminated from the 340B program and 10 providers would owe repayments to drug [...]

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HHS Asks Court to Deny Injunction Against Medicare Drug Price Negotiations

Dayton v. Becerra
HHS asked the U.S. District Court in Dayton, Ohio to deny a preliminary injunction that would prevent Medicare drug price negotiations.
The U.S. Department of Health and Human Services (HHS) asked a federal court to deny a preliminary injunction sought by [...]

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HRSA Allows Immediate 340B Enrollment in Hawaii Due to Wildfires

Hawaii wildfires
HRSA is allowing eligible covered entities in Hawaii to enroll in the 340B program immediately rather than having to wait for the next quarterly registration period.
Eligible covered entities in Hawaii may enroll in the 340B program immediately rather than having to wait for the next [...]

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Enforceability of State Contract Pharmacy Laws Uncertain Amid Legal Challenges

Louisiana capitol
PhRMA has asked a federal district judge to block Louisiana's 340B contract pharmacy law, Act 358, which took effect Aug. 1.
While two drug manufacturers have recently relaxed or suspended their 340B contract pharmacy restrictions as a result of state laws [...]

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AHA Warns of “Legal Consequences” from Proposed Cuts to Fund 340B Lump Sum Payments

American Hospital Association logo
The American Hospital Association opposed parts of draft legislation from the House E&C Committee concerning the 340B program.
The lead plaintiff in the legal battle that resulted in Medicare proposing an unusual lump sum payback for hospitals’ lost [...]

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Medicare DSH Changes Will Cut 340B Access, Draw Legal Challenge, Say Attorneys

CMS headquarters
CMS issued the final rule to implement a $9 billion lump sum payment to 340B hospitals for previous illegal cuts between 2018 and 2021.
Changes in the ways Medicare calculates hospitals’ shares of low-income patients that were finalized in a recent payment rule will [...]

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Government Watchdog Reissues Controversial Finding on Adverse Incentives in 340B Program

GAO 340B
GAO restated its controversial 2015 finding that 340B covered entities prescribe more drugs or more expensive drugs than necessary.
The U.S. Government Accountability Office late last month restated its controversial recommendation that Congress take actions to reduce incentives for [...]

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House E&C GOP Leaders’ Draft Bill Would Exempt Sterile Generic Injectables from 340B Pricing Requirements

House Energy & Commerce Committee's draft bill.
GOP leaders on the House Energy & Commerce Committee released a draft bill to address drug shortages that includes a provision that would exempt certain drug products from 340B pricing requirements.
Republican leaders of the U.S. House Energy and Commerce (E&C) Committee released a draft bill late last week that would [...]

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HRSA Tells Federal Court it Still Stands by its 340B Patient Definition in Closely Watched Case

Genesis
HRSA says it stands by its patient definition in Genesis' federal lawsuit seeking a far broader definition.
The U.S. Health Resources and Services Administration (HRSA) still stands by its 340B program patient definition, the agency said in [...]

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Do 340B Lump Sum Payments Underscore Need for More Transparency or Are They Unrelated?

Peter Pitts
Peter Pitts, president of the Center for Medicine in the Public Interest, says the recently released 340B Medicare lump sum payments underscore the need for more 340B program transparency.
A recently proposed list of planned Medicare payments for individual 340B hospitals is seen as ammunition to some 340B critics. [...]

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