Category: Regulatory

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

February 23, 2024 Rich Daly, Editor in Chief 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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FTC, HHS Seek Comments on Role of GPOs, Wholesalers on Generic Drug Shortages

February 21, 2024 Rich Daly, Editor in Chief 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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Republican Heavyweights Enter Race to Lead House Committee that Oversees 340B

February 15, 2024 William Newton, Associate Editor/Senior Writer Views

Rep. Brett Guthrie (R-Ky.) will run to chair the House E&C Committee next session--and is considered by some lobbyists as the favorite to win--if Republicans maintain control of the House.

If House Republicans maintain control of the chamber after the November elections, several senior members will likely vie to chair [...]

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Connecticut Governor Proposes 340B Provider Reporting Legislation, Faces Pushback from Health Centers

February 13, 2024 William Newton, Associate Editor/Senior Writer Views

New 340B provider reporting requirements were included in recently proposed legislation from a Connecticut state health agency, as part of [...]

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Hospital Groups Urge Supreme Court to Review DSH Payment Case with 340B Implications

February 8, 2024 William Newton, Associate Editor/Senior Writer Views

The Supreme Court of the United States building

Major hospital groups have asked the Supreme Court to review a case that challenges HHS' DSH payment formula.

Major hospital groups last week urged the U.S. Supreme Court to review a federal appeals court decision that upheld how [...]

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GSK Posts 340B Refund Notice on High-Revenue Asthma Treatment

February 6, 2024 Rich Daly, Editor in Chief Views

GlaxoSmithKline and Pfizer announced updates to their 340B contract pharmacy policies to comply with new state laws that will take effect in July.

Drugmaker GlaxoSmithKline has posted another refund notice to 340B providers related to purchases of its high-earning asthma drugs. A Jan. [...]

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Genesis Ruling Creates Legal, Regulatory Uncertainty for 340B, Says Attorney Panel

February 1, 2024 William Newton, Associate Editor/Senior Writer Views

Maureen Testoni, president and CEO of 340B Health, Jason Reddish, a principal at Powers Law, and Ross Margulies, a partner at Foley Hoag, discussed the looming uncertainty in 340B following a key federal district court ruling during the 340B Coalition Winter Conference.

A recent federal district court ruling on the 340B patient definition created a “gray area” for 340B providers and drugmakers, [...]

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Tennessee Bills Introduced to Regulate 340B Funding for Certain STD Clinics

February 1, 2024 William Newton, Associate Editor/Senior Writer Views

Companion bills recently introduced in the Tennessee state house and senate would add regulations for 340B in-kind funding.

Tennessee state lawmakers have introduced companion bills that would require sexually transmitted disease (STD) clinics to enter into a contract [...]

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Former Sen. Cassidy Aide, Trump Administration Executive Criticizes Requiring More Hospital 340B Reporting

January 30, 2024 Rich Daly, Editor in Chief Views

Brenda Destro, a former aide to a Republican senator and HHS official, recently wrote an op-ed that criticized hospital 340B transparency legislation.

A former Trump administration Health and Human Service Department (HHS) executive and adviser to Sen. Bill Cassidy (R-LA) published a [...]

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Genesis Decision Expected to Increase 340B Scripts, Provider-Owned Pharmacies, Says Contractor to Drug Manufacturers and Former Apexus Staffer

January 30, 2024 Rich Daly, Editor in Chief Views

Gavin Magaha, senior director of innovation at Kalderos and a former Apexus executive, said a recent judicial ruling on the 340B patient definition could increase the number of 340B patients and provider-owned pharmacies.

The ruling in a recent, high-profile 340B patient definition case will likely result in providers increasing the number of patients [...]

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