Private equity (PE) investment in the health care industry has grown significantly over the last decade. This past year was no exception. While total deal volume lagged behind 2021 record highs, PE health care deal activity...more
2/9/2024
/ Antitrust Provisions ,
Compliance Manuals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investment ,
Investors ,
OIG ,
Private Equity Funds ,
Qui Tam
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
The Department of Justice and other federal enforcement agencies continued to hotly pursue individuals and entities involved in criminal telefraud schemes in 2022, as evidenced by the national coordinated law enforcement...more
2/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
OIG ,
Public Health Emergency ,
Telemedicine
The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal...more
12/21/2022
/ Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Federal Health Care Programs (FHCP) ,
Healthcare ,
OIG ,
Payment Systems ,
Telehealth ,
TRICARE
This post is the third and final installment of our blog series on the proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). The proposed regulations would repeal the current Part...more
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
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 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
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more
11/24/2020
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Final Rules ,
OIG ,
Safe Harbors ,
Stark Law ,
Value-Based Care
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
Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks....more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Infectious Diseases ,
Natural Disasters ,
OIG ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Relators ,
Whistleblower Protection Policies ,
Whistleblowers
On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory...more
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 reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more
12/19/2019
/ ACOs ,
Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Home Health Care ,
OIG ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care
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 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more
10/22/2019
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Cybersecurity ,
EHR ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
OIG ,
Popular ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
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
Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the...more
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
Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more
2/7/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Civil Monetary Penalty ,
Digital Health ,
Health Care Providers ,
Low-Income Issues ,
Manufacturers ,
Medical Devices ,
New Guidance ,
OIG ,
Patient Assistance Programs ,
Patient Safety ,
Pharmaceutical Industry ,
Smartphones