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 our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and...more
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...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
2/9/2024
/ Anti-Fraud Provisions ,
Biden Administration ,
CARES Act ,
Civil Monetary Penalty ,
Coronavirus/COVID-19 ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Financial Fraud ,
Fraud ,
Health Care Providers ,
HRSA ,
Investigations ,
OIG ,
Popular ,
Qui Tam
On March 9, 2023, the Food and Drug Administration (FDA) published a final rule that updates the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements,...more
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
During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...more
On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee...more
Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus...more
6/23/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FCC ,
Federal Reserve ,
Health Care Providers ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Paycheck Protection Program Flexibility Act of 2020 (PPPFA) ,
Relief Measures ,
SBA ,
Small Business Loans
On Monday, the Chairman of the Federal Communications Commission (FCC), Ajit Pai, circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
FCC ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Interstate Telecommunications Service Providers (ITSP) ,
Medicare ,
OCR ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more
2/3/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
CMP Law ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Travel Expenses
As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more
1/23/2020
/ Bribery ,
Controlled Substances Act ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medical Necessity ,
Medicare Beneficiaries ,
OIG ,
Opioid ,
Physicians ,
Prescription Drugs ,
Telemedicine
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive...more
8/24/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Discovery ,
Dismissals ,
EHR ,
False Claims Act (FCA) ,
Health Care Providers ,
Qui Tam ,
Relators ,
The Granston Memo ,
Two-Midnight Rule
Overview of Qui Tam Activity -
We identified 49 health care-related qui tam cases that were unsealed in September and October 2018.
The government intervened in whole or in part in 10 of those 49 unsealed cases, which...more
2/25/2019
/ Anti-Kickback Statute ,
Dismissals ,
False Claims Act (FCA) ,
Former Employee ,
Fraud ,
Health Care Providers ,
Physician Medicare Reimbursements ,
Qui Tam ,
Relators ,
RICO ,
Sealed Records ,
Voluntary Dismissals ,
Whistleblowers