IRA Draft Guidance Leaves 340B Details Unclear

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Recently released draft guidance for implementing Medicare price caps would allow voluntary provider use of 340B codes on claims, while [...]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

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

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

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

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

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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CBO Recommendation: Restrict 340B Access to Get Hospitals to Join ACOs

The Congressional Budget Office report recommended restricting 340B access to incentivize hospitals to join accountable care organizations.
As part of a report on incentivizing use of accountable care organizations (ACOs), Congress’ primary research arm recently recommended excluding [...]

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Attorneys Expect Many Filings under Newly Reconstituted 340B Dispute Resolution Process

Kyle Vasquez, an attorney for Polsinelli, said he expects a "wave of filings" under HRSA's latest ADR rule because it is more flexible than the prior process.
Attorneys for both covered entities and drug manufacturers say they expect a significant number of filings to the newly re-established [...]

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Maine Issues Draft Rule for 340B Hospital Reporting Requirements with New Data, Enforcement Provisions

After Maine passed one of the nation's first 340B provider reporting laws last year, a state health agency has proposed a rule for implementation.
The state agency tasked with implementing Maine’s state 340B hospital reporting requirement has proposed a rule with additional data and [...]

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Novartis to Refund Covered Entities After Adjusting 340B Ceiling Prices for 100-Plus Products

Drugmaker Novartis filed suit to block Maryland's recently signed 340B contract pharmacy statute.
Thousands of covered entities that purchased more than one hundred Novartis products between late 2019 and early 2023 will be [...]

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