Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks. It has an extensive history of violations and settlements....more
Healthcare fraud is an ever-growing constant in our economy. It is a battle that presents new and exponential challenges. The U.S. Department of Justice, the HHS-Office of Inspector general and State Attorneys’ General all...more
On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
Healthcare enforcement is never quiet. There’s always something, or many things, going on, and compliance teams need to stay on top of the trends to ensure that their programs are staying ahead of the risks. To find out...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS). False Claims Act relator Adam Hart alleged that...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
The False Claims Act (FCA) is seeing quite a bit of action at the Supreme Court this term, with multiple cases under consideration. In this third installment in PilieroMazza’s blog series on “The FCA at the Supreme Court,” we...more
Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
Several days ago, Biogen Inc. announced that it had reached a settlement to resolve a whistleblower lawsuit under the False Claims Act (FCA). Relator’s claims were based on allegations that Biogen’s speaker and consultant...more
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
I. Introduction - Use and acceptance of telehealth technologies have grown very substantially since the start of the COVID-19 pandemic. This growth has been substantially facilitated by waivers and relaxations of existing...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
The Seventh Circuit’s novel statutory interpretation of the government’s dismissal authority under 31 USC § 3730(c)(2)(A) may have unintended consequences. ...more
The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic. The federal government is increasing spending and support of drug and device companies in...more