Providers Added Immediately to 340B Under COVID-19 Flexibility Are Not Losing their Eligibility, HRSA Confirms

HRSA OPA homepage
HRSA confirmed that providers granted immediate 340B enrollment under a COVID-19 flexibility are not losing their 340B eligibility and will not need to re-enroll. HRSA recently posted a notice about those enrollments on the OPA homepage.

Federal 340B program officials confirmed last week that providers granted immediate 340B enrollment under a COVID-19 public health emergency flexibility are not losing their 340B eligibility and will not need to re-enroll now that the PHE is over.

The U.S.

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Bills Filed in New York to Help 340B Providers Hurt by Medicaid Drug Benefit Transfer

Gustavo Rivera
New York State Sen. Gustavo Rivera (D) introduced bills to help 340B providers hurt by the state’s transfer of Medicaid managed care drug benefits to Medicaid fee for service on April 1.

A New York state lawmaker and strong 340B program supporter last week introduced bills to help 340B providers hurt by the state’s transfer of Medicaid managed care drug benefits to Medicaid fee for service on April 1.

Under Medicaid managed

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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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Expert Tip From Alinea Group

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TIP: When it comes to duplicate discount prevention, don’t assume that all 340B drugs are billed to Medicaid using the same NPI. Routine

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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
Rep. Cathy McMorris Rogers (R-Washington) chair of the Energy & Commerce Committee, and Rep. Morgan Griffith (R-Virginia), chair of the Oversight and Investigations Subcommittee, announced a June 4 hearing on 340B.

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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Sanofi Late Yesterday Tightened Restrictions on 340B Pricing

Sanofi
Sanofi was the second drug manufacturer yesterday to tighten its conditions on 340B pricing.

Drug manufacturer Sanofi late yesterday afternoon toughened its policy on 340B pricing involving the use of contract pharmacies. Its announcement came about two hours after Merck made a similar move.

Sanofi’s original policy applied to disproportionate share hospitals, rural

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