In this issue, we provide an overview of 62 recently unsealed qui tam cases and take an in-depth look at four of those cases. Two of the featured cases concern alleged schemes to provide unnecessary therapy to residents of...more
11/9/2018
/ Anti-Kickback Statute ,
False Claims Act (FCA) ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Part D ,
Physicians ,
Qui Tam ,
Relators ,
Settlement Agreements ,
TRICARE
State Medicaid Agencies have historically engaged in an epic balancing act. Federal law requires State Medicaid Agencies to ensure beneficiaries have access to medically necessary services. Federal law also requires State...more
On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more
8/23/2017
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Generic Drugs ,
Medicaid ,
Medical Devices ,
Mylan Pharmaceuticals ,
OIG ,
Prescription Drug Coverage ,
Prescription Drugs ,
Qui Tam ,
Rebates ,
Section 340B ,
Settlement
The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more
6/7/2017
/ Brand Name Prescription Drugs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Generic Drugs ,
Medicaid ,
Medical Devices ,
Mylan Pharmaceuticals ,
OIG ,
Prescription Drug Coverage ,
Rebates
On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more
5/29/2017
/ American Bar Association (ABA) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Exemptions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Materiality ,
Medicare Part D ,
OIG ,
Opioid ,
Universal Health Services Inc v United States ex rel Escobar ,
Yates Memorandum
In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified...more
4/17/2017
/ Attorney General ,
Business Associates ,
Enforcement Actions ,
False Claims Act (FCA) ,
HIPAA Privacy Rule ,
Kickbacks ,
Patient Privacy Rights ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Settlement
Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more
Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more
12/12/2016
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Co-payments ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Generic Drugs ,
Hospitals ,
Inducements ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors
In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more
New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. The case,...more
Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA). In his opinion, Judge...more
Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more
In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more
Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over...more
The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). ...more
Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 claims submitted by Life Care Centers of America, Inc. (a nursing...more
With its March 31, 2014 denial of certiorari in U.S. ex rel. Nathan v. Takeda, the U.S. Supreme Court declined to wade into the ongoing debate over the degree of particularity with which a false claims relator must plead a...more
On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more
In August, I wrote about the unusual decision by the U.S. Department of Justice (DOJ) to appeal a district court’s dismissal of a declined qui tam brought under the federal and state false claims acts (FCAs). In appealing...more
Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care...more
Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where – using the theory of implied certification - the alleged falsity is not apparent on the face of...more
The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more
This week the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an...more
On April 1st, the Sixth Circuit reversed an $11.1 million dollar summary judgment finding entered against MedQuest Associates, a diagnostic testing company. In its opinion, the Sixth Circuit found that violation of two...more