Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
Report on Research Compliance 18, no. 6 (June 2021) - Nearly four years after noticing spending “irregularities” by a principal investigator (PI), the University of Nevada Las Vegas (UNLV) entered into a settlement...more
As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement...more
On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to...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
If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
On November 2, 2018, the federal Health Resources and Services Administration (HRSA) issued a proposed rule that would advance the implementation date for the oft-postponed 340B Ceiling Price and Civil Monetary Penalties...more
This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more
The 340B Drug Pricing Program (“340B Program”) remains in the regulatory spotlight. Most recently, on March 27, 2018, the Health Resources and Services Administration (“HRSA”) indicated it is poised to delay for the fifth...more
On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more
On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufactures to civil...more
On March 20, 2017, HHS issued an interim final rule further delaying until May 22, 2017, the effective date of a January 5, 2017, final rule for the 340B Drug Pricing Program that addresses the calculation of drug ceiling...more
The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the...more
On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more
A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more
On January 5, 2017, the HHS Health Resources and Services Administration (HRSA) published a final rule updating the price structure that drug manufacturers participating in the 340B Drug Pricing Program may charge to covered...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs - On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more
On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties. ...more
Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more