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New Guidance › HRSA

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Ogletree, Deakins, Nash, Smoak & Stewart,... on

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...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

Foley & Lardner LLP

COVID-19: Provider Relief Fund General Distribution – Phase 3

Foley & Lardner LLP on

On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga

Foley Hoag LLP - Medicaid and the Law on

We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more

Baker Donelson

Coronavirus: HRSA Issues Guidance Outlining Flexibility to 340B Providers

Baker Donelson on

The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) has created a COVID-19 Resources page on its website providing information for 340B drug pricing program stakeholders. In particular,...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

Foley Hoag LLP - Medicaid and the Law

CMS Issues Guidance to States on 340B Duplicate Discounts

Foley Hoag LLP - Medicaid and the Law on

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...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

Baker Donelson

Guidance, Not Regulations, Expected for 340B Drug Pricing Program

Baker Donelson on

The long-awaited 340B “mega rule,” promised by the Health Resources and Services Administration (HRSA) to be published last summer, has now been officially nixed. HRSA recently announced that it will not release the...more

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