Category: Federal

Drug Industry Takes Issue with IRA’s Drug Negotiation Guidance

July 11, 2024 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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340B Providers Take Issue with CMS Draft Guidance on IRA Implementation Calling It “Problematic, Unworkable and Inconsistent”

July 9, 2024 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340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.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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Hospitals in Texas and Other States Sue HHS Over DSH Calculation Changes That Impact 340B Eligibility

July 2, 2024 Views

Dozens of hospitals in Texas and other states have filed suit against HHS to block a rule that they say lowers their disproportionate share hospital adjustment percentage and could result in a loss of 340B discounts.

Dozens of hospitals in Texas and other states have filed suits against Department of Health and Human Services (HHS) Secretary [...]

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New York Times Sues HRSA To Release 340B Data, Communications Between Office of Pharmacy Affairs and Apexus Leaders; Information Could Be Released Soon

June 27, 2024 Views

The New York Times has filed suit in the U.S. District Court for the Southern District of New York against the Health Resources and Services Administration to obtain an order requiring the production of 340B-related records requested in November 2023 under the Freedom of Information Act.

The New York Times has sued the federal agency tasked with overseeing the 340B program to force the release of [...]

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California Hospital Association Pans ASAP 340B-Endorsed Bill, Encourages Congress to Support 340B PATIENTS Act

June 27, 2024 Views

The California Hospital Association argued in a June 20 letter to the state’s congressional delegation that “core provisions” of the 340B Affording Care for Communities and Ensuring a Strong Safety-Net (340B ACCESS) Act “will reduce access to care for vulnerable populations.”

The California Hospital Association (CHA) is the latest organization to raise concerns about the 340B ACCESS Act, a bill recently [...]

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It’s Official: Long-Awaited Final 340B ADR Rule Takes Effect, But Findings Still Distant

June 21, 2024 Views

The U.S. Department of Health and Human Services' final 340B Administrative Dispute Resolution rule formally took effect on June 18.

Fourteen years after the Congressional deadline, the long-anticipated revision to the 340B Administrative Dispute Resolution (ADR) process officially took effect [...]

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Senate Companion Bill Introduced to Expand 340B Eligibility to Certain Rural, Outpatient Hospitals

June 21, 2024 Views

Sen. Gary Peters (D-Mich.) introduced companion legislation to a House bill that would extend 340B eligibility to certain rural, emergency hospitals.

A U.S. senator introduced a bill to extend 340B eligibility to certain outpatient rural hospitals with emergency services, mirroring a [...]

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CBO Analysts Say Drug Spending Through 340B Grew 19% Annually From 2010 to 2021, 340B Champion Points Finger at Drug Industry

June 21, 2024 Views

Spending on pharmaceuticals in the 340B drug discount program went from nearly $7 billion in 2010 to $44 billion by 2021—a 19% annual increase—according to preliminary Congressional Budget Office estimates released this week.

Spending on pharmaceuticals in the 340B drug discount program went from nearly $7 billion in 2010 to $44 billion by [...]

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GAO Reissues Recommendations to Improve 340B Compliance, Medicare Financial Stability

June 21, 2024 Views

The Government Accountability Office this month recommended that HHS and Congress take long-proposed actions to better ensure 340B program compliance and Medicare’s financial stability.

HHS and Congress should each take long-proposed actions—including a contentious action to curb certain Part B prescribing incentives—to better ensure [...]

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COLUMN: After 340B Hearing and New Bills Emerging; The Likely Path Forward

June 21, 2024 Views

The latest column from Ted Slafsky, publisher and CEO of 340B Report, addresses the likeliest path forward for 340B federal legislation.

Despite its importance, the 340B drug discount program rarely ever goes under the Congressional spotlight. In fact, until the June [...]

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