Articles by : Rich Daly, Editor in Chief

100 Days and Counting: ADR Final Rule Still Under White House Review

February 29, 2024 Views

Stephen Kuperberg, principal at the Law Offices of Stephen Kuperberg, said the Supreme Court underscored the importance of having a well-functioning ADR process.

After missing its self-imposed deadline of publishing the 340B administrative dispute resolution final rule by the end of 2023, the [...]

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Takeda Adds Drug to 340B Contract Pharmacy Restrictions

February 29, 2024 Views

Japanese drugmaker Takeda announced its cancer medication Ninlaro will be subject to its 340B contract pharmacy policy.

After implementing its first contract pharmacy restrictions in January, Japanese pharmaceutical giant Takeda recently subjected another drug to conditions on [...]

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Amgen Extends Contract Pharmacy Restrictions to Grantees, Receives Early Pushback

February 27, 2024 Views

Drugmaker Amgen last week extended its existing 340B contract pharmacy restrictions to federal grantees.

Biopharmaceutical manufacturer Amgen recently expanded its conditions on 340B pricing at contract pharmacies to include grantees. The Thousand Oaks, California-based [...]

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Cybersecurity Disruption of Major Claims Processor Continues to Affect 340B Providers

February 27, 2024 Views

Change Healthcare, a major pharmacy claims processor, disconnected pharmacy services following a recent cyberattack.

Change Healthcare’s systems are down for a seventh straight day after it disconnected pharmacy services following a Feb. 21 cyberattack. [...]

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DSH Hospitals Are Using 340B in ‘Margin-Motivated Ways,’ Says Research Review

February 27, 2024 Views

A recent Milbank Quarterly research review suggested DSH hospitals participate in 340B in "margin-motivated ways."

The highest-quality evidence from published 340B research indicates nonprofit, disproportionate share hospitals may be using the 340B program in margin-motivated [...]

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340B ESP New Data Request Raises Concerns About Overreach

February 23, 2024 Views

Courtney McFarland, partner at AAFCPAs, said 340B ESP was asking for types of data that she had not seen the vendor previously request.

The drugmaker vendor 340B ESP’s recent requests for additional claims data from some 340B hospitals has raised concerns from 340B [...]

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Two 340B Site Terminations, One Payback to Manufacturers in Latest Provider Audit Findings

February 23, 2024 Views

HRSA audits found terminations were required for a 340B provider site and a contract pharmacy and that another provider owed repayments to drugmakers.

Federal auditors determined terminations from the 340B program were required for either a covered entity site or a contract pharmacy [...]

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Health System, Drugmakers Battle Over Dismissal Request in 340B Penny Pricing Fraud Suit

February 21, 2024 Views

Calif-based Adventist Health System/West and four drugmakers are clashing in federal district court over allegations of 340B overcharges.

A California health system and four drugmakers have filed dueling arguments over the pharmaceutical companies’ effort to dismiss a fraud [...]

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FTC, HHS Seek Comments on Role of GPOs, Wholesalers on Generic Drug Shortages

February 21, 2024 Views

Federal Trade Commission sign over entrance.

The FTC and HHS asked for stakeholder feedback on generic drug shortages, which could have implications for the 340B program.

The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are requesting comments on how group [...]

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PhRMA Washington Post Advertorial Highlights Data Critical of 340B Program

February 21, 2024 Views

A pharmaceutical industry advertorial in the Washington Post questioned whether the 340B program benefited hospital patients.

The leading advocacy group for pharmaceutical manufacturers recently published an advertorial in the Washington Post that highlights a range of [...]

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