Category: Regulatory

HRSA Urges Federal Court to Reject Health Systems’ Challenge to 340B Child Site Registration Policy Reversal

March 14, 2024 William Newton, Associate Editor/Senior Writer Views

HRSA asked a federal district court to dismiss 44 health systems' challenge to its 340B child site registration policy reversal.

The Health Resources and Services Administration (HRSA) has asked a federal court to dismiss a lawsuit from forty-four health systems [...]

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Biden Budget Request Keeps OPA Funding Flat

March 12, 2024 Rich Daly, Editor in Chief Views

President Joe Biden's fiscal year 2025 budget would increase HRSA funding but not the budget of OPA, the office that oversees the 340B program.

Despite the looming finalization of a major policy change, this week’s fiscal year 2025 budget request would freeze the budget [...]

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Massachusetts to Bar Managed Medicaid Payments for GLP-1 Drugs for 340B Patients

March 7, 2024 Rich Daly, Editor in Chief Views

MassHealth, the Massachusetts Medicaid program, will soon bar managed care plans for paying for certain high-cost obesity drugs using 340B.

Massachusetts will soon change its Medicaid payment policy to bar managed care plans from paying for seven high-cost, anti-obesity medications [...]

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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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