News & Analysis as of

Section 340B Medicare New Guidance

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Foley Hoag LLP

Medicare Drug Price Negotiation Program Initial Guidance

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On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more

Holland & Knight LLP

Holland & Knight Health Dose: February 7, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...more

Baker Donelson

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

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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

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

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On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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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

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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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