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Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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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

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

Bass, Berry & Sims PLC

Specialty Pharmacy Compliance During COVID-19 Pandemic

Bass, Berry & Sims PLC on

The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more

Foley Hoag LLP - Medicaid and the Law

CMS Releases Block Grant Guidance: Answers to your FAQs

Foley Hoag LLP - Medicaid and the Law on

On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its long awaited and highly anticipated State Medicaid Director Letter (SMD Letter) announcing the “Healthy Adult Opportunity” (HAO) initiative...more

Brownstein Hyatt Farber Schreck

CMS Releases Long-Awaited Block Grant Guidance

Brownstein Hyatt Farber Schreck on

On Thursday, Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released the Healthy Adult Opportunity initiative, long-awaited guidance that would enable states to convert Medicaid funding into a block grant for...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

K&L Gates LLP

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

K&L Gates LLP on

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

Foley Hoag LLP - Medicaid and the Law

Ten Things to Watch for in the Forthcoming Block Grant Guidance (Updated)

Foley Hoag LLP - Medicaid and the Law on

UPDATED: It’s out! The much anticipated guidance, entitled the “Healthy Adult Opportunity” (HAO), from CMS introducing ways to revamp Medicaid financing has been out for nearly a week and we have had some time to review the...more

Holland & Knight LLP

FDA Guidance on HCEI and Communications to Payors of Unapproved Products and Uses

Holland & Knight LLP on

On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers"...more

Buchalter

OIG Finalizes New and Expanded Anti-Kickback Safe Harbors, Issues Guidance Regarding Nominal Gifts

Buchalter on

In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...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

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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