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

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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HRSA Lacks Authority to Reverse 340B Child Site Registration Policy, Hospital Group Tells Court

U.S. District Court of the District of Columbia
A hospital association asked the U.S. District Court of the District of Columbia to side with more than 40 health systems that sued federal regulators over a hospital registration policy change.
A 340B hospital association this week asked a federal court to bar, without a full trial, federal regulators from reversing [...]

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

HRSA provider audits
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

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

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

Ned Lamont speaking at Connecticut state Capitol
A Connecticut state health agency under Gov. Ned Lamont (D) proposed legislation to implement certain 340B provider reporting requirements.
New 340B provider reporting requirements were included in recently proposed legislation from a Connecticut state health agency, as part of [...]

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

GlaxoSmithKline wordmark and GSK logo on a building
Drugmaker GSK owes refunds to certain 340B providers for its asthma product Nucala, a notice posted to a government site said.
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

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

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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