Category: Regulatory

News Alert

CMS Directs Contractors to Provide Accelerated Payments as Part of Change Healthcare Cyber Attack Response

March 5, 2024 Rich Daly, Editor in Chief Views

In response to the ongoing Change Healthcare cyberattack, CMS will direct contractors to provide some accelerated payments to hospitals.

The Centers for Medicare & Medicaid Services (CMS) will direct Medicare administrative contractors (MACs) to provide some accelerated payments to [...]

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Minnesota Finalizes 340B Provider Reporting Rules, Data Submission to Start April 1

March 5, 2024 William Newton, Associate Editor/Senior Writer Views

The Minnesota Department of Health finalized guidance for the state's new annual 340B covered entity reporting requirements.

The Minnesota Department of Health (MDH) last Friday released its final guidance on one of the first state 340B provider [...]

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

February 29, 2024 Rich Daly, Editor in Chief 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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HRSA Lacks Authority to Reverse 340B Child Site Registration Policy, Hospital Group Tells Court

February 29, 2024 William Newton, Associate Editor/Senior Writer Views

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

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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