Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
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
On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more
In its August 15, 2023, Enforcement listserv notice, the U. S. Department of Health and Human Services Office of Inspector General (“OIG”) published its Work Plan Updates for August. This article will highlight three of the...more
Hospitals and other providers should brace for recoupment of possibly hundreds of millions of dollars they were reportedly overpaid for services provided under the COVID-19 uninsured program (UIP) in the wake of new audit...more
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration...more
The Health Resources and Services Administration (HRSA) reminded providers through a program update on Monday, June 5, 2023, that the Provider Relief Fund (PRF) and COVID-19 Uninsured Program (UIP) Terms and Conditions...more
The “epidemic” of COVID-19 related fraud continued unabated in 2022, and we expect to see the same in 2023. The Department of Justice (DOJ) appears poised to continue to aggressively investigate and prosecute COVID-19-related...more
By now, if you are a provider who received Provider Relief Funds, you are familiar with the related reporting requirements on the use of the Funds. But do you also have an obligation to conduct a mandatory Single Audit? ...more
On September 19, 2020, the Health Resources and Services Administration (“HRSA”) of the Department of Health and Human Services (“HHS”) issued guidance (“September Guidance”) regarding the post-payment reporting requirements...more
On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
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
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
On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more