HRSA Posts Two Drug Manufacturer Notices to 340B Entities

Vtama pharmaceutical product tube
Dermavant Sciences is giving refunds to health care providers that paid above the 340B ceiling price for Vtama, a treatment for plaque psoriasis.

Biopharmaceutical company Dermavant Sciences is giving refunds to health care providers that paid above the 340B ceiling price for Vtama, a non-steroidal cream to treat plaque psoriasis.

The U.S. Health Resources and Services Administration posted Dermavant’s notice to 340B covered

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340B Registration for Second Quarter of 2023 Begins April 1, with COVID Public Health Emergency Set to Expire in May

Q2 340B registration
Q2 2023 registration for the 340B program starts April 1 and is expected to end April 17.

The second quarterly period this year for 340B registration of new covered entities, outpatient facilities, and contract pharmacies will begin Saturday, April 1, and is expected to end on Monday, April 17.

Normally, a quarterly 340B registration period runs from

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CMS Announces First Drugs Subject to Medicare Inflation Rebates, Issues Guidance Addressing 340B and Medicare Negotiated Drug Prices

CMS building
CMS said planned Medicare Part B premium increases are partly the result of the proposed lump sum payment for previous illegal 340B hospital cuts.

The U.S. Centers for Medicare & Medicaid Services Tuesday announced the first 27 prescription drugs that will be subject to Medicare Part B inflation rebates, a list that includes AbbVie’s blockbuster arthritis drug Humira, which generated $5.6 billion in global

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Amneal Offering 340B Refunds on Long List of Drugs for Sales Between Q3 2019 and Q3 2022

Amneal wordmark on building
Amneal Pharmaceuticals is offering refunds for 340B overcharges on an 18-page-long list of products for purchases between Q3 2019 and Q3 2022.

Generic and specialty drug manufacturer Amneal Pharmaceuticals is offering refunds for 340B overcharges on an 18-page-long list of products for purchases between Q3 2019 and Q3 2022.

The U.S. Health Resources and Services Administration posted New Jersey-based Amneal’s notice to

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Bottom Line, not Altruism, Could be the Main Driver of Lilly’s Insulin Price Cut, Drug Pricing Expert Says

Humalog vial
Lilly's decision to cut the price of its fast-acting insulin Humalog might have been driven by a desire to avoid exposure to Medicaid rebates, drug pricing expert Sean Dickson says.

Drug manufacturer Lilly’s announcement last week that it is slashing the price of Humalog, its most commonly prescribed insulin, may have been less about altruism and more about avoiding exposure to bigger Medicaid rebates, a prominent drug pricing expert says.

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Zydus Pharmaceuticals USA Announces Refunds for 340B Overcharges During 2022

Zydus wordmark
Zydus Pharmaceuticals is providing refunds for 340B overcharges during 2022 on 83 NDCs.

Generic drug manufacturer Zydus Pharmaceuticals USA said in a recent public notice it will pay refunds for 340B overcharges that occurred mostly in the first two quarters of 2022. The products include Zydus’ equivalents of the widely prescribed antibiotic Zithromax,

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Exclusive: HRSA Asking Hospitals About 340B Patient Definition, 340B Savings, and Using 340B at Child Sites

Dept. of Health and Human Services building and signage
Hospital advocates said HRSA's recent decision to end a 340B program waiver for hospitals could draw legal challenges.

UPDATED Thursday March 2, 2023, 12:30 p.m. EDT to include comment from HRSA.

The U.S. Health Resources and Services Administration has asked multiple hospitals to explain how they determine patient eligibility for 340B drugs, how they define, track, and use

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Study Raises Questions About Using 340B Claim Modifiers to Implement Medicare Drug Price Negotiation and Inflation Rebate Provisions

IQVIA white paper title page
IQVIA questions whether 340B claims identifiers can be used successfully to implement the Inflation Reduction Act's Medicare drug price negotiation and drug inflation rebate provisions.

New research by drug industry contractor IQVIA questions whether claims identifiers can be used successfully to exclude 340B-purchased drugs from new Medicare drug inflation rebates or to protect manufacturers from paying both a new negotiated Medicare price and a 340B

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America’s Essential Hospitals Asks HHS to Swiftly Repay 340B Hospitals for Unlawful Medicare Drug Payment Cuts

America's Essential Hospitals wordmark and tagline
America’s Essential Hospitals wants HHS “to swiftly remedy five years of unlawful drug reimbursement cuts to 340B hospitals under Medicare Part B.”

America’s Essential Hospitals asked U.S. Health and Human Services Secretary Xavier Becerra late last week “to swiftly remedy five years of unlawful drug reimbursement cuts to 340B
hospitals under Medicare Part B.”

“These cuts, and a delay in recompensing hospitals for

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CMS Seeks Input on Excluding 340B Drugs from New Medicare Part D Inflation Rebates

Part D inflation rebate press release
CMS is seeking comment on how best to exclude 340B drugs from new Part D inflation rebate invoices.

The U.S. Centers for Medicare & Medicaid Services is seeking comments by March 11 on “the most reliable way to identify” 340B-purchased drugs dispensed to Medicare Part D beneficiaries so they can be excluded from new Part D inflation rebate

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