News & Analysis as of

Section 340B Compliance Department of Health and Human Services (HHS)

McDermott Will & Emery

This Week in 340B: January 14 – 20, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 45. News Briefs: December 2020 #2

Report on Medicare Compliance 29, no. 45 (December 21, 2020) - CMS said Dec. 18 it will audit a sample of hospitals for compliance with price transparency requirements, which take effect Jan. 1, according to MLN Connects....more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

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