Category: Regulatory

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Lilly to Conduct HRSA-Approved Audit That Includes First-Time Look for Medicaid MCO Duplicate Discounts

December 19, 2023 Rich Daly Editor in Chief Views

Eli Lilly is conducting government approved 340B provider audits that for the first time look for certain Medicaid health plan duplicate discounts.

Federal regulators have approved a first-time 340B provider audit by a drug manufacturer to examine processes to prevent duplicate discounts [...]

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CMS Defers Decision on Adding 340B Modifiers for Part D Drugs

December 19, 2023 Rich Daly Editor in Chief Views

In response to the ongoing Change Healthcare cyberattack, CMS will direct contractors to provide some accelerated payments to hospitals.

Federal regulators recently deferred a decision on whether to add identifiers to 340B drugs purchased under Medicare Part D. The [...]

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HRSA Unveils Web Page with Patient Definition Compliance Resources, Guidance

December 14, 2023 Rich Daly Editor in Chief Views

HRSA released a new web page with resources on the agency's 340B program patient definition and compliance guidelines.

In the wake of a high-profile federal court ruling casting doubt on the definition of eligible “patient” in the 340B [...]

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340B Dispute Resolution Coming This Month, White House Says

December 14, 2023 Tom Mirga Editor at Large Views

The White House plans to release a revised administrative dispute resolution process for the 340B program this month.

The federal 340B program remains on track to publish a final rule this month revising its administrative dispute resolution (ADR) [...]

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Minnesota Issues Draft Guidance Implementing 340B Provider Reporting Requirements

December 14, 2023 William Newton Washington Correspondent Views

The Minnesota Department of Health finalized guidance for the state's new annual 340B covered entity reporting requirements.

Stakeholder comments are due Tuesday on Minnesota’s recently published guidance to implement one of the nation’s first state laws requiring [...]

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Michigan to Increase Medicaid Payment for 340B Hospitals, Adds Reporting Requirements

December 14, 2023 William Newton Washington Correspondent Views

The Michigan Department of Health and Human Services released a new 340B hospital billing and reporting rule.

At the start of 2024, Michigan 340B hospitals can bill the state at higher payment rates for outpatient drugs; later [...]

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Novo Nordisk to Provide 340B Refunds on Hemophilia Drugs

December 14, 2023 Rich Daly Editor in Chief Views

Novo Nordisk will issue 340B provider refunds for formulations of two hemophilia drugs, according to a HRSA manufacturer notice.

Novo Nordisk will issue its fifth round of refunds this year on prices charged to 340B providers. The latest are [...]

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Federal 340B Leader Moves On After 21 Months

December 7, 2023 Rich Daly Editor in Chief Views

U.S. Public Health Service Lieutenant Commander Emeka Egwim left his position as director of OPA at HRSA 21 months after he started.

U.S. Public Health Service Lieutenant Commander Emeka Egwim left his position as director of the federal office overseeing the 340B [...]

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Amid Record Drugmaker Refunds, No Adverse Audit Findings for Teva

December 7, 2023 Rich Daly Editor in Chief Views

The final HRSA manufacturer 340B program audit conducted in fiscal year 2023 had no adverse findings for Teva Pharmaceuticals.

The fifth and final fiscal year 2023 manufacturer audit by federal officials recently concluded with no adverse findings. Meanwhile, the [...]

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New Part B Drug Claims Modifier Requirement for 340B Entities Starts Jan. 1

December 7, 2023 Tom Mirga Editor at Large Views

In response to the ongoing Change Healthcare cyberattack, CMS will direct contractors to provide some accelerated payments to hospitals.

Critical access hospitals (CAHs) and Ryan White HIV/AIDS clinics do not expect problems implementing a new requirement starting Jan. 1, [...]

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