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Healthcare HRSA New Guidance

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program (Updated)

As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Ballard Spahr LLP

FAQs Provide Guidance on Preventive Care

Ballard Spahr LLP on

Summary - The Departments of Labor, the Treasury, and Health and Human Services have jointly issued FAQs that address the requirement to cover the full cost of certain preventive care services in view of the recent ruling...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

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