An official from the Department of Justice (“DOJ”) recently announced the DOJ’s plans to “substantially” add to its current roster of 75 prosecutors specializing in healthcare fraud. On November 7, John “Fritz” Scanlon,...more
On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more
6/5/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...more
The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants. In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice...more
12/5/2019
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Mortgage Fraud ,
Pharmaceutical Industry ,
Qui Tam ,
Relators ,
Shell Corporations ,
The Granston Memo
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
I. Introduction -
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more
1/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Kickbacks ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
Medicare Advantage and Part D Preclusion List -
The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more
11/2/2018
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Fee-for-Service ,
Final Rules ,
Health Care Providers ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Beneficiaries ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Rules