In “Nasty Surprise,” House Subcommittee Votes to Require Billing Medicaid MCOs at Cost Plus Dispensing Fee for Drugs, Including 340B

Energy & Commerce Health
The U.S. House E&C health subcommittee yesterday unexpectedly passed a bill 27-0 with language that would make it impossible nationally for 340B entities to earn revenue from billing state Medicaid managed care plans above what they pay for 340B-acquired drugs.

340B covered entity representatives are scrambling to respond to a U.S. House subcommittee’s unanimous approval yesterday of a bill that includes language that would make it impossible nationally for entities to earn revenue from billing state Medicaid managed care contractors

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

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 majority reportedly

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Amgen and GSK Announce Refunds for 340B Overcharges

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 website yesterday.

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Breaking News

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

Bucshon
Rep. Larry Bucshon (R-Ind.), who has led high-profile 340B-related legislation, will retire at the end of this Congress.

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 hospitals.

The

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House Subcommittee Says it Will Markup 340B Transparency Bill Tomorrow

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. Secretary of

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

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 drugs at

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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

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 use of

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

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 saved or

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Janssen to Pay Refunds for 340B Overcharges in Q2 2020

Janssen
Janssen Biotech is paying refunds for overcharges on certain 340B drugs purchased in the third quarter of 2020.

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 may owe

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

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 eligibility policy

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