Category: Regulatory

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

December 5, 2023 Rich Daly, Editor in Chief Views

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

November 30, 2023 Tom Mirga, Editor at Large Views

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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340B Provides Benefits, Needs Reform, Says Literature Review

November 28, 2023 Tom Mirga, Editor at Large Views

A JAMA Health Network literature review found that the 340B program provides a range of benefits but needs reforms.

The 340B program has provided a range of benefits but also needs reforms, according to a recent review of published [...]

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Two Drugmakers Offer Refunds for 340B Overcharges

November 28, 2023 Tom Mirga, Editor at Large Views

Two drugmakers, Mallinckrodt's subsidiary SpecGx and Novo Nordisk, owe refunds to 340B providers for certain overcharges.

Two drugmakers will offer refunds to 340B providers for overcharges in recent years. Drug manufacturer Mallinckrodt’s SpecGx generic pharmaceutical subsidiary [...]

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Apexus Asks Appeals Court to Affirm Dismissal of Contract Breach Lawsuit

November 17, 2023 Tom Mirga, Editor at Large Views

AHF has asked a federal appeals court to reverse an earlier court's decision to dismiss a case against Apexus over its provision of 340B sub-ceiling price discounts on drugs.

Apexus, the 340B prime vendor, asked a federal appeals court to affirm a lower court’s dismissal of claims that it [...]

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Jazz Pharmaceuticals Posts Refund Notice on HRSA Website

November 17, 2023 Rich Daly, Editor in Chief Views

Jazz Pharmaceuticals owes refunds to 340B providers, according to a notice posted on HRSA's website.

Jazz Pharmaceuticals owes refunds to 340B providers, according to a notice posted on the Health Resources and Services Administration’s Office [...]

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