Category: Regulatory

HRSA Agrees to Send New York Times FOIA-Requested Documents

July 30, 2024 Shannon Young, Associate Editor/Senior Writer Views

Dept. of Health and Human Services exterior sign and building

HRSA will review and release some of the 340B-related records the New York Times is seeking through FOIA requests.

The federal agency tasked with overseeing the 340B program will review and release some of the 340B-related records the New [...]

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Two Hospitals Sue HRSA to Block ‘Unlawfully Authorized’ Drugmaker 340B Program Audits

July 26, 2024 William Newton, Associate Editor/Senior Writer Views

Oregon Health & Science University Hospital is one of two 340B hospitals to sue HRSA over approving a drugmaker audit. (Photo by M.O. Stevens)

Two 340B hospitals urged a federal district court to block drugmaker Johnson & Johnson (J&J) from conducting “unlawfully authorized” audits [...]

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SK Life Science Posts Refund Notice; Dr. Reddy’s and Pfizer Issue NDC Changes

July 18, 2024 Bella Czajkowski, National Correspondent Views

Amgen announced a change to the national drug code for its osteoporosis drug, Prolia.

SK Life Science issued a refund notice for an epilepsy drug following a 340B price ceiling recalculation. Multiple drug manufacturers [...]

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HRSA Allows for Immediate 340B Enrollment in Texas Due to Hurricane; Hawaii Remains Eligible

July 18, 2024 William Newton, Associate Editor/Senior Writer Views

Due to Hurricane Beryl, certain Texas providers can immediately enroll in the 340B program without waiting for the normal registration period.

Eligible providers in Texas can now immediately enroll in the 340B program without waiting for the normal quarterly registration period [...]

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GOP-Led House Appropriations Committee Votes to Cut HRSA Funding, Flat Funds OPA in Party Line Vote

July 16, 2024 Shannon Young, Associate Editor/Senior Writer Views

The House Appropriations Committee approved the Labor, Health and Human Services, Education and Related Agencies Appropriations Act on July 10.

The House panel responsible for federal appropriations legislation passed a bill last week that would cut funding for the Health [...]

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CMS Proposes Rule to Exclude 340B Claims from Inflation Rebates; Reflects ‘Stronger Understanding’ of 340B than IRA Negotiation Guidance, Says Attorney

July 16, 2024 William Newton, Associate Editor/Senior Writer Views

CMS recently proposed a rule to fulfill its statutory obligation to exclude 340B claims from Medicare inflationary rebates.

The Centers for Medicare & Medicaid Services (CMS) has outlined how it plans to identify 340B claims to remove when [...]

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Drug Industry Takes Issue with IRA’s Drug Negotiation Guidance

July 11, 2024 Shannon Young, Associate Editor/Senior Writer Views

PhRMA recently urged CMS to establish a neutral clearinghouse and require accurate use of 340B claim modifiers to address nonduplication in its final guidance for Medicare drug price negotiations under the IRA.

Editor’s Note: In Tuesday’s issue, we looked at comments from 340B provider stakeholders, today we look more closely at the [...]

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Apotex to Issue Refunds to 340B Covered Entities

July 11, 2024 Shannon Young, Associate Editor/Senior Writer Views

Apotex Corp. announced in a July 2 notice to 340B providers that it will issue refunds to 340B covered entities that purchased any of nearly 400 products.

A Canadian drug manufacturer recently announced that it will refund covered entities for hundreds of different products purchased between 2021 [...]

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340B Providers Take Issue with CMS Draft Guidance on IRA Implementation Calling It “Problematic, Unworkable and Inconsistent”

July 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.

Editor’s Note: In today’s issue, we look at the 340B provider community’s comments to CMS. In a future issue, we [...]

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Astellas Suspends its Contract Pharmacy Restrictions in More States; BMS and Sanofi Also Announce State Exemptions

July 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

Astellas Pharma announced the suspension of its contract pharmacy policy in Maryland and Mississippi.

A Japanese drug manufacturer has ended its 340B contract pharmacy restrictions in Maryland and Mississippi in conjunction with new contract [...]

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