Category: Regulatory

Drug Maker Owes 340B Providers Repayment, HRSA Pending Audit Finds

August 22, 2023 Views

A HRSA fiscal year 2023 audit tentatively found that drug maker Nephron Pharmaceuticals owes 340B repayments to providers.

The first posted fiscal year 2023 audit of a drug maker tentatively found the company owes repayments to providers. The [...]

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340B Drugs Among Those at Tornado-Hit Facility Requiring Direct Purchase

August 22, 2023 Views

Pfizer has limited multiple 340B-eligible drugs to direct purchase after a tornado damaged one of the drug maker's manufacturing facilities.

Federal officials confirmed that 340B-eligible drugs are among the 12 medications pharmaceutical manufacturer Pfizer has limited to direct purchase after [...]

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

August 17, 2023 Views

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

August 17, 2023 Views

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

August 17, 2023 Views

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

August 10, 2023 Views

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

August 10, 2023 Views

The American Hospital Association (AHA), 340B Health, Maryland Hospital Association and Mid-Atlantic Association of Community Health Centers urged a federal judge to reject Novartis’ attempt to block Maryland’s new 340B contract pharmacy access law.

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

August 8, 2023 Views

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

August 8, 2023 Views

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

August 1, 2023 Views

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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