Category: Regulatory

White House Completes Review of Final Rule for 340B Dispute Process, Release Expected Soon

April 11, 2024 Rich Daly, Editor in Chief Views

The Department of Health and Human Services is expected to soon release its final 340B administrative dispute resolution rule after the White House completed its final review this week.

After missing its self-imposed deadline of the end of 2023, the White House this week completed its review to implement [...]

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HRSA Names Britton As New Leader of Office Overseeing 340B Program

April 9, 2024 Shannon Young, Associate Editor/Senior Writer Views

The Health Resources and Services Administration (HRSA) on Monday announced Chantelle Britton as its next Office of Pharmacy Affairs (OPA) [...]

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Manufacturer Refunds to 340B Providers Have Steadily Increased Since 2019, Says Analysis

April 9, 2024 Rich Daly, Editor in Chief Views

An analysis from the law firm Spencer Fane found that 340B refunds have been concentrated among certain manufacturers and drugs.

A recent analysis of the increasing annual total number of drug manufacturer refunds to 340B covered entities notes they are [...]

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Hospitals Say HRSA Violated Federal Rulemaking in 340B Child Site Waiver Reversal

April 4, 2024 Rich Daly, Editor in Chief Views

More than 40 health systems told a federal district court that a HRSA hospital offsite clinic registration policy reversal violated federal rulemaking requirements.

The dozens of health systems suing the federal government over the reversal of a pandemic-era 340B child site registration waiver [...]

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Amgen, J&J to Issue Refunds on High-Selling Drugs to 340B Providers

April 2, 2024 Rich Daly, Editor in Chief Views

Drugmakers Amgen and Johnson & Johnson have announced they will provide refunds to 340B providers on past purchases of multiple [...]

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Three 340B Terminations, Seven Paybacks to Manufacturers in Latest Provider Audit Findings

March 28, 2024 Rich Daly, Editor in Chief Views

Federal regulators released a March 20 update to ongoing 340B program integrity audits for fiscal year 2023.

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

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Senate, House Appropriators Agree on Budget for Office of Pharmacy Affairs but Have Different Priorities

March 21, 2024 Rich Daly, Editor in Chief Views

Senate and House appropriators have agreed on funding for HHS and the office within it that oversees 340B, but they appear to have different regulatory priorities.

While it appears that Senate and House appropriators have agreed on a funding level for the office that oversees the [...]

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Hawaii Lawmakers Urge State Health Department to Protect 340B

March 21, 2024 William Newton, Associate Editor/Senior Writer Views

Hawaii legislators in the house and senate introduced resolutions that urged the state health department to act to protect the 340B program.

Influential Hawaiian state legislators have introduced resolutions that call on the state health department to “ensure continued access to affordable [...]

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Two More Drug Companies Restore 340B Contract Pharmacy Access in Arkansas After Court Decision; Enforcement Action Imminent Against Others

March 19, 2024 William Newton, Associate Editor/Senior Writer Views

As AID prepares to initiate enforcement of Arkansas' 340B contract pharmacy law, two more drugmakers announced they would exempt state providers from their contract pharmacy policies.

Months after nine drug manufacturers restored 340B contract pharmacy access in Arkansas, two more companies have announced they will exempt [...]

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Imminent Enforcement of Arkansas 340B Contract Pharmacy Law to Follow Court Decision Upholding It

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

Arkansas Insurance Department office sign

The Arkansas Insurance Department will imminently enforce a state 340B contract pharmacy law following a key federal appeals court decision.

After a federal appeals court recently upheld Arkansas’ 340B contract pharmacy law, the state will initiate enforcement against 14 drugmakers [...]

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