Category: Regulatory

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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340B Report Publisher and CEO to Providers: New 340B Reporting Requirements are Inevitable

July 27, 2023 Tom Mirga, Editor at Large Views

Minnesota became the first state to impose 340B reporting requirements after Gov. Tim Walz (D) signed legislation in late May.

Health care providers almost certainly will have to accept new 340B reporting requirements in order to get unfettered access to [...]

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Generic Drugmaker Amring Providing Refunds for 340B Overcharges

July 20, 2023 Tom Mirga, Editor at Large Views

Generic drug manufacturer Amring Pharmaceuticals is giving 340B covered entities refunds for overcharges on 14 products between the first quarter [...]

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NY FQHCs Receive $135 Million to Offset State’s 340B Medicaid Shift, While Other Providers Wait

July 20, 2023 Rich Daly, Editor in Chief Views

New York health centers are getting $135 million this week to partially replace revenue providers lost when the state implemented an April 1 shift of its Medicaid managed care drug benefits to Medicaid FFS, called NYRx.

Federally qualified health centers in New York received $135 million lump sum payments this week to partially offset expected 340B [...]

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Medicare Part B Keeping Default Pay Rate for 340B Drugs, Says OPPS Proposed Rule

July 18, 2023 Rich Daly, Editor in Chief Views

Medicare Part B plans to continue paying average sales price plus 6% for for 340B acquired drugs and biologicals in 2024, the U.S. Centers for Medicare & Medicaid Services said July 13.

Medicare Part B plans to continue paying the statutory default rate—generally average sales price plus 6%—for 340B acquired drugs and [...]

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In What Could be a First, Drug Maker Gives Providers Deadline to Request 340B Overcharge Refunds

July 13, 2023 Tom Mirga, Editor at Large Views

Drug manufacturer VistaPharm says requests for refunds for 340B overcharges must be received before Aug. 31. No manufacturer is believed to have set such a deadline before, and it's unclear if VistaPharm is the first to say refunds are available upon request.

Generic and over-the-counter drug manufacturer VistaPharm said in a public notice this week that it has identified 340B covered entities [...]

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Some 340B Hospitals Might Get Less Than Expected Under Fix for Illegal Medicare Drug Payment Cuts

July 13, 2023 Rich Daly, Editor in Chief Views

CMS's projections of what it owes 340B hospitals for unlawful Medicare Part B drug payment cuts might not align with what health systems and hospitals expect to get.

A $9 billion Medicare proposal to repay 340B hospitals for unlawful Part B drug payment cuts includes a spreadsheet showing [...]

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