Category: Regulatory

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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Providers Celebrate 340B Medicare Drug Payment Fix, Object to How It’s Funded

July 11, 2023 Rich Daly, Editor in Chief Views

CMS today formally published in the Federal Register its proposed remedy for illegal Medicare Part B drug payments cuts for many 340B hospitals from 2018 through 2022.

Provider groups widely celebrated the Medicare proposal to provide a $9 billion lump sum payment to reimburse 340B hospitals for [...]

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CMS Proposes $9 Billion in Lump Sum Payments to Reimburse Hospitals for Past 340B Part B Drug Payment Cuts

July 7, 2023 Rich Daly, Editor in Chief Views

CMS late this afternoon proposed how it will repay 340B hospitals for $10.5 billion in illegal Medicare Part B drug payment cuts.

The U.S. Centers for Medicare & Medicaid Services plans to provide lump sum Medicare Part B drug payments to 340B [...]

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White House Clears CMS to Issue Proposed Fix for 340B Hospital Part B Drug Payment Cuts

July 7, 2023 Rich Daly, Editor in Chief Views

OMB clearance of CMS Part B remedy proposal

The White House Office of Management and Budget yesterday cleared CMS to issue its proposed remedy for five year's worth of Medicare Part B drug payment cuts for 340B hospitals.

The White House yesterday gave the U.S. Centers for Medicare & Medicaid Services the go-ahead to publish its proposed remedy [...]

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340B Issues Remain Unresolved in Latest CMS Medicare Drug Price Negotiation Guidance

July 7, 2023 Rich Daly, Editor in Chief Views

CMS said in its latest Medicare Drug Price Negotiation Program guidance it still working on a process to allow manufacturers to avoid providing a 340B price and a negotiated fair price for the same drug.

The latest guidance to implement first-time drug price negotiation under Medicare said federal officials still are looking for a process [...]

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