In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead.
Hear from a dynamic group of...more
In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
1/17/2025
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Hospitals ,
Medicaid ,
Medical Bills ,
Medicare ,
Physicians ,
Stark Law
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
The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law...more
2/13/2024
/ Anti-Kickback Statute ,
Compensation ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Liability ,
Medicaid ,
Medicare ,
Physicians ,
Stark Law
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more
2/3/2022
/ Anti-Kickback Statute ,
Appeals ,
CARES Act ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Opioid ,
Paycheck Protection Program (PPP) ,
Purdue Pharma ,
Settlement ,
TRICARE ,
Whistleblowers
On June 3, 2019, the U.S. Supreme Court issued a decision in Azar v. Allina Health Services. The case involved a challenge by hospitals over whether the Department of Health and Human Services (“HHS”) was required to proceed...more
6/5/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more
2/5/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS
On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more
1/16/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS
In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by...more
The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending –...more
Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more
Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial...more
As has been widely discussed, the Centers for Medicare & Medicaid Services (‘‘CMS’’) Feb. 12 published the long-awaited final rule governing the return of Medicare Part A and Part B overpayments within 60 days (the...more
On March 19, 2015, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) issued their annual Health Care Fraud and Abuse Control (HCFAC) Program report highlighting that the HCFAC Program obtained...more
The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations...more
The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”). Shelby Regional had received...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more