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Category: Federal

House E&C Full Committee May Vote on 340B Transparency Bill as Soon as Next Week

In Federal, Legislative496 Views Tom Mirga
Pallone
House E&C full committee ranking Democrat Frank Pallone said yesterday that 340B hospital reporting legislation the E&C health subcommittee passed yesterday "may be used to draw an inaccurate narrative about the value of the program.”

The full House Energy & Commerce Committee as of late this morning had not yet said when it will markup 340B hospital reporting legislation that split its health subcommittee in two along party lines yesterday. The committee’s Republican

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Amgen and GSK Announce Refunds for 340B Overcharges

In Federal, Pharma Industry, Regulatory362 Views Tom Mirga
Nucala
GlaxoSmithKline is providing refunds for overcharges during Q2 2021 on sales of two NDCs of its severe asthma medicine Nucala.

Drug manufacturers Amgen and GlaxoSmithKline have notified 340B covered entities about refunds for overcharges, Amgen for sales in 2020 and GSK for sales in 2021.

The U.S. Health Resources and Services Administration posted both companies’ notices on its

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Breaking News

House Subcommittee Votes on Party Lines to Impose Reporting Requirements on 340B DSH Hospitals & Potentially Other Covered Entities

In Breaking, Federal, Legislative1486 Views Tom Mirga
Bucshon
A U.S. House subcommittee voted 16-12 along party lines to pass Rep. Larry Bucshon's (R-Ind.) bill to impose significant reporting requirements on 340B DSH hospitals. The HHS Secretary would have the discretion to impose the requirements on "any other covered entity."

In a significant development, a GOP-led U.S. House health subcommittee this afternoon voted 16 to 12 along party lines to pass and send to the full committee legislation to impose significant new reporting requirements on 340B disproportionate share

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House Subcommittee Says it Will Markup 340B Transparency Bill Tomorrow

In Federal, Legislative823 Views Tom Mirga
Energy and Commerce
The U.S. House Energy & Commerce health subcommittee is due tomorrow to markup 17 health care bills including one that would impose significant reporting requirements on 340B DSH hospitals and, potentially, other covered entity types.

The U.S. House Energy & Commerce health subcommittee tomorrow will markup a bill by Vice Chair Larry Bucshon (R-Ind.) to impose significant annual reporting requirements on 340B disproportionate share hospitals “and any other covered entity” that the U.S.

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New Evidence that HRSA in 2020 Declared Permanent a 340B Policy it Abruptly Ended Last Week

In Federal, Regulatory1064 Views Tom Mirga
Correspondence
In a May 18, 2020, email exchange, a 340B prime vendor executive (bottom excerpt) confirmed to a lawyer representing a 340B hospital (top excerpt) that HRSA's policy about using 340B drugs in hospital sites not on the hospital's most recently filed cost report was "applicable regardless of COVID-19."

Correspondence in April and May 2020 between the 340B prime vendor and a law firm sheds more light on the start of a policy that the federal government ended abruptly last week that let hospitals start using 340B

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Breaking News

HRSA and Prime Vendor Yank FAQs About 340B Use in Hospital Child Sites, and GAO Issues a New 340B Study

In Breaking, Federal, Regulatory, Research/Reports1844 Views Tom Mirga
FAQ excerpt
Excerpts from 340B FAQs that HRSA (top) and the 340B prime vendor Apexus (bottom) have removed from their websites.

The U.S. Health Resources and Services Administration midday yesterday and the 340B prime vendor Apexus this morning, in connection with the end of the COVID-19 public health emergency late last night, withdrew mostly identical 340B program FAQs about

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340B Did Not Arise in Senate Committee Today, But Might in House Subcommittee Next Week

In Federal, Legislative378 Views Tom Mirga
Braun
Sen. Mike Braun (R-Ind.) did not offer a 340B covered entity transparency amendment to a PBM oversight bill during a Senate HELP hearing today. There was speculation that he might.

U.S. Sen. Mike Braun (R-Ind.) did not seek to amend a PBM oversight bill that is being marked up today to require 340B hospitals and possibly other covered entities to be more transparent about how they use money

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Janssen to Pay Refunds for 340B Overcharges in Q2 2020

In Federal, Pharma Industry, Regulatory217 Views Laura Gilcrest
Janssen
Janssen Pharmaceuticals is paying refunds for overcharges on 340B drugs purchased in the second quarter of 2020, including top-selling psoriasis drug Stelara.

Drug manufacturer Janssen Pharmaceuticals said last week it would pay refunds for overcharges on 340B drugs purchased in the second quarter of 2020, including top-selling psoriasis drug Stelara.

Janssen, part of Johnson & Johnson, said it owes or

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“This Is Bananas”: Hospitals Irate About HRSA’s Snap Decision to End 340B Patient Eligibility Clarification

In Federal, Regulatory2403 Views Tom Mirga
Hospital outpatient location
340B hospitals expressed shock at HRSA's decision to cease a policy that has let patients receive 340B drugs at offsite outpatient locations that are sill going through the 340B registration process.

Editor’s note: New information from HRSA and Apexus obtained as we were going to press appears at the end of this article.

Hospital representatives said they were floored to learn yesterday that a June 2020 federal 340B patient

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U.S. House Panel Not Expected to Markup 340B Legislation at Hearing Next Week

In Federal, Legislative486 Views Tom Mirga
House Energy & Commerce Committee
The U.S. House Energy & Commerce health subcommittee is not expected to move any 340B legislation in May, sources say.

A U.S. House Energy & Commerce subcommittee plans next week to markup bills on transparency and competition in health care and send them to the full committee for votes before Memorial Day. Although its Republican vice chair’s draft

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