On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more
The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more
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
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
11/7/2023
/ 21st Century Cures Act ,
ACOs ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Information Blocking Rules ,
Investigations ,
Medicare Shared Savings Program ,
OIG ,
ONC ,
Reporting Requirements ,
Social Security Act
Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the...more
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
The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more
4/6/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Cancer ,
Clinical Laboratory Testing ,
CMP Law ,
Fraud and Abuse ,
Gift-Cards ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Incentives ,
Life Sciences ,
Medicaid ,
Medicare ,
OIG ,
Preventive Health Care
On November 22, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) posted a negative Advisory Opinion regarding a proposed joint venture (JV) for the provision of therapy services...more
On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients...more
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
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
As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more
12/7/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Final Rules ,
Health Care Providers ,
OIG ,
Remuneration ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more
11/3/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Kickbacks ,
Medical Devices ,
Open Payments ,
Sunshine Act
On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback...more
9/16/2020
/ Anti-Kickback Statute ,
Breach of Duty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Patient Referrals ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law
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
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
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Deadlines ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
OIG ,
Relief Measures ,
Stark Law ,
Telehealth ,
Telemedicine ,
Time Extensions ,
Waivers
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
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. The Open Payments reporting requirements,...more
11/18/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Continuing Medical Education ,
Final Rules ,
Health Care Providers ,
Medicaid ,
Medicare ,
Open Payments ,
Physician Fee Schedule ,
Physicians ,
Reporting Requirements ,
Sunshine Act ,
Unique Device Identifiers