States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more
California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in...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
Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more
10/4/2023
/ Advisory Opinions ,
Billing ,
Carve Out Provisions ,
Clinical Laboratories ,
Competition ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more
Record Settlement in a Declined Case -
While defendants typically breathe a sigh of relief when the Department of Justice (DOJ) declines to intervene in a qui tam False Claims Act (FCA) case, a more favorable outcome is by...more
2/13/2023
/ Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Long-Term Care ,
Private Equity Firms ,
Qui Tam ,
Settlement
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
For many health care systems, patient leakage – when patients leave a health care system’s network in favor of out-of-network providers – is a rampant problem that results in substantial lost revenue. While sometimes patient...more
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
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i)...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more
On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark...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
The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded...more
6/12/2020
/ Bribery ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Public Health Emergency ,
Securities Fraud
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, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care...more
As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician...more
11/22/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Health Care Providers ,
Healthcare Reform ,
Physician Compensation Arrangements ,
Physicians ,
Safe Harbors ,
Stark Law
This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the...more
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more
10/23/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare Reform ,
OIG ,
Personal Services ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care ,
Warranties
On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in...more
9/13/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicare
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
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more
2/22/2019
/ Department of Justice (DOJ) ,
Failure to Comply ,
False Claims Act (FCA) ,
Health Care Providers ,
Local Coverage Determination (LCD) ,
Medical Necessity ,
Medicare ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators
Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more
2/14/2019
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
Health Care Providers ,
Meaningful Use ,
Medicaid ,
Medicare ,
OIG ,
Settlement Agreements ,
Software ,
Third-Party Service Provider