Category: Regulatory

OPA to Hold June 11 Webinar on Final ADR Rule

June 4, 2024 Shannon Young, Associate Editor/Senior Writer Views

The Health Resources and Services Administration announced that the Office of Pharmacy Affairs will hold a June 11 webinar on the ADR final rule.

The federal office tasked with overseeing the 340B program will brief covered entities and manufacturers next week on the administrative [...]

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CMS Drops ‘Stacking’ Proposal Which Could Have Boosted 340B Savings

May 23, 2024 Rich Daly, Editor in Chief Views

CMS said it was no longer considering a "stacking" proposal for Medicaid drug pricing calculations, which could have increased 340B savings.

Federal regulators said they were dropping from consideration a proposal for “stacking” discounts as part of an update to Medicaid [...]

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Novo Nordisk To Provide Refunds on Ozempic and Three Other Drugs to 340B Entities

May 21, 2024 Rich Daly, Editor in Chief Views

Drugmaker Novo Nordisk is providing refunds to 340B covered entities on its blockbuster diabetes/weight loss drug Ozempic and three other products.

Drugmaker Novo Nordisk announced it is providing 340B covered entities 12-months-worth of refunds on four drug products including two of [...]

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2024 Provider Audits Begin with No Adverse Findings

May 14, 2024 Rich Daly, Editor in Chief Views

Federal auditors recently reported no adverse findings in their first fiscal year 2024 340B audit of a pharmaceutical manufacturer.

The first fiscal year 2024 340B provider audit reports included no adverse findings for 19 organizations. The May 8 audit [...]

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IRA Draft Guidance Leaves 340B Details Unclear

May 9, 2024 Rich Daly, Editor in Chief Views

The latest CMS guidance on implementing the Inflation Reduction Act's Medicare price caps left unresolved key 340B pricing details.

Recently released draft guidance for implementing Medicare price caps would allow voluntary provider use of 340B codes on claims, while [...]

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NC Treasurer Report Suggests 340B Hospitals Overcharged State Health Plan, Hospitals Pan the Findings

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

A report from N.C. Treasurer Dale Folwell found some hospitals are using 340B “to enrich themselves rather than to serve vulnerable communities.”

North Carolina hospitals that participate in the 340B program routinely overcharged cancer patients, taxpayers and state employees for oncology drugs, [...]

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340B Hospital Groups Ask MedPAC to Oppose Part B Rate Cut

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

Jonathan Jaffery, chief health care officer for AAMC, said reduced Medicare reimbursement to 340B hospitals would “devastate an already fragile health care safety net.”

Groups representing hospitals that rely on the 340B program recently urged congressional advisers against recommending reduced Medicare reimbursement to 340B [...]

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Eight More Provider Audits Closed with Corrective Action Plans in Latest HRSA Audit Findings

May 7, 2024 Rich Daly, Editor in Chief Views

HRSA's latest update to its ongoing fiscal year 2023 program integrity audits included corrective action plans for eight 340B providers.

Federal auditors closed audits with corrective action plans (CAPs) for eight more 340B providers, which brought the fiscal year 2023 [...]

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Arkansas Enforcing 340B Contract Pharmacy Access Law Against AstraZeneca

May 2, 2024 William Newton, Associate Editor/Senior Writer Views

Arkansas officials are seeking penalties against AstraZeneca in an August hearing for allegedly violating the state's 340B contract pharmacy access law.

Arkansas state officials today scheduled a public hearing to enforce the state’s 340B contract pharmacy access law against AstraZeneca, according [...]

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Cosette Pharmaceuticals Offers 340B Provider Refunds on 38 Drugs

April 30, 2024 Rich Daly, Editor in Chief Views

North Carolina-based drug manufacturer Cosette will refund 340B providers for 38 medications.

Cosette Pharmaceuticals recently announced refunds to 340B covered entities for 38 medications sold over a year and half. The refunds [...]

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