News Alert

HRSA Unveils Web Page with Patient Definition Compliance Resources, Guidance

HRSA patient definition web page
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

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Minnesota Issues Draft Guidance Implementing 340B Provider Reporting Requirements

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

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

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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Exclusive

Federal 340B Leader Moves On After 21 Months

Lt. Cmdr. Emeka Egwim headshot
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

Teva
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

CMS
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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Four 340B Terminations, Eight Paybacks to Manufacturers in Latest Provider Audit Findings

HRSA provider audits
Federal auditors determined terminations from the 340B program were required for either covered entity sites or a contract pharmacy of two more 340B providers.
Federal auditors determined terminations from the 340B program were required for either covered entity sites or contract pharmacies of four [...]

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N.Y. State, Health Centers Seek Brief Pause in Medicaid Drug Benefit Lawsuit

The parties involved in a legal challenge over certain Medicaid managed care drug benefits have jointly asked for a pause in proceedings.
Both sides in a lawsuit over New York state’s transfer of Medicaid managed care drug benefits to Medicaid fee for [...]

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