Category: Regulatory

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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HRSA Sends Previously Audited 340B Hospital a Second Follow-up Compliance Letter

July 27, 2023 Tom Mirga, Editor at Large Views

The Health Resources and Services Administration announced that the Office of Pharmacy Affairs will hold a June 11 webinar on the ADR final rule.

A hospital that the U.S. Health Resources and Services Administration audited for 340B program compliance and then was one of [...]

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CMS’s 340B Hospital Repayment Plan Leaves Medicare Advantage Cuts Untouched

July 27, 2023 Rich Daly, Editor in Chief Views

Attorney Kyle Vasquez says many clients feel they are entitled to a remedy for underpayments from Medicare Advantage plans stemming from CMS' July 7 proposed rule.

The recently proposed Medicare fee-for-service lump sum payments to 340B hospitals to make up for a nearly five-year unlawful rate [...]

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340B Recertification for Hospitals Starts Aug. 14

July 27, 2023 Tom Mirga, Editor at Large Views

HRSA announced this year's 340B eligibility recertification period for hospitals will start Aug. 14 and end Sept. 11.

This year’s 340B eligibility recertification period for hospitals will start Aug. 14 and end Sept. 11, the U.S. Health Resources [...]

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Amgen, Vertex, and AstraZeneca Post 340B Refund and Replenishment Public Notices

July 27, 2023 Tom Mirga, Editor at Large Views

Aranesp is among the drugs listed on HRSA's latest manufacturer's notice posted on behalf of Amgen.

The U.S. Health Resources and Services Administration (HRSA) this week published notices from drug makers Amgen and Vertex about refunds [...]

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