Category: Regulatory

HRSA Allows Immediate 340B Enrollment in Hawaii Due to Wildfires

August 17, 2023 Tom Mirga, Editor at Large 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 William Newton, Associate Editor/Senior Writer 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 Rich Daly, Editor in Chief Views

AHA officials penned a Medical Economics op-ed on “the truth behind growth of the 340B prescription drug 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

August 8, 2023 Rich Daly, Editor in Chief 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 William Newton, Associate Editor/Senior Writer 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 William Newton, Associate Editor/Senior Writer 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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HRSA Tells Federal Court it Still Stands by its 340B Patient Definition in Closely Watched Case

August 1, 2023 Tom Mirga, Editor at Large Views

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?

August 1, 2023 Rich Daly, Editor in Chief Views

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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Amid Historic Financial Challenges, 340B Proposed Payments Will ‘Make a Difference’ for Some Hospitals’ Budgets, Says Rating Official

August 1, 2023 Rich Daly, Editor in Chief Views

A Fitch Ratings webinar on the not-for-profit hospital sector discussed the financial implications of the proposed $9 billion lump sum Medicare payment to make up for five years of illegal 340B cuts.

As the not-for-profit hospital sector slowly emerges from its worst financial year in recent history, some of those organizations’ bottom [...]

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Broad Support Emerges for Adding Duplicate Discount Modifiers to Medicaid Cards

August 1, 2023 Rich Daly, Editor in Chief Views

340B stakeholders broadly support adding identifiers to Medicaid drug beneficiaries’ cards to held avoid duplicate 340B discounts, comments on a CMS proposed rule show.

A federal proposal to require the addition of new identifiers to Medicaid drug beneficiaries’ cards to avoid duplicate 340B discounts [...]

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