HRSA Posts Four Manufacturer Notices to 340B Entities

Humalog
Lilly is providing refunds for 340B overcharges during Q1 2020 on Humalog and Trulicity.

The U.S. Health Resources and Services Administration yesterday posted notices of refunds for 340B overcharges from drug manufacturers Lilly, Novo Nordisk, and Neurocrine and a notice from Amneal about product NDC changes.

Lilly

Lilly’s May 30 notice covers purchases

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HRSA Allows Immediate 340B Enrollment in Guam Due to Typhoon

Guam typhoon Mawar
Destruction in Tamuning, Guam, caused by super typhoon Mawar, which made landfall on May 24 as a Category 4-equivalent storm.

Health care providers in Guam eligible to participate in the 340B program may do so immediately, rather than having to wait for the next normal quarterly registration period July 1-15, the U.S. Health Resources and Services Administration said yesterday.

Secretary

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Merck to Pay Refunds for 340B Overcharges in Q1 and Q2 2020

Cubicin
Merck is providing refunds for 340B overcharges on NDCs of its antibiotic Cubicin and other drugs during the first two quarters of 2020.

Drug manufacturer Merck is paying refunds for overcharges on 340B drugs purchased during the first two quarters of 2020.

Merck recently asked the U.S. Health Resources and Services Administration to post notices about its 340B ceiling price recalculations on the

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CMS Is a Step Closer to Saying How It Will Fix Medicare Drug Payment Cuts for 340B Hospitals

OMB
CMS sent its proposed remedy for illegal Medicare Part B drug payment cuts for 340B hospitals to the White House for clearance to be released.

The U.S. Centers for Medicare & Medicaid Services has sent its proposed remedy for almost five years of illegal Medicare Part B drug payments cuts for 340B hospitals to the White House for clearance to be published in the Federal

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CMS Proposes Rules That Addresses 340B Duplicate Discounts in Medicaid Managed Care

CMS
CMS proposes adding information to Medicaid managed care beneficiaries' insurance cards to facilitate 340B duplicate discount prevention.

The U.S. Centers for Medicare & Medicaid Services wants to make Medicaid managed care organizations use Medicaid-specific codes and group numbers on beneficiary insurance cards to help states, MCOs, and 340B covered entities avoid invoicing manufacturers for prohibited duplicate 340B

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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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Amgen and GSK Announce Refunds for 340B Overcharges – May 23

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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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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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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