On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
9/19/2024
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Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Group Health Plans ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Shared Savings Program
On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
6/28/2024
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Anti-Kickback Statute ,
Fraud and Abuse ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs
The recent Request for Information by the Federal Trade Commission (FTC), Department of Justice (DOJ) and Department of Health and Human Services (HHS) seeking input on the effects of private equity (PE) investment in the...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
2/27/2024
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Settlement ,
Stark Law ,
Telemedicine
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
2/1/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Information Blocking Rules ,
Litigation Strategies ,
New Guidance ,
OIG ,
Regulatory Agenda ,
Telehealth
On January 11, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Final Rule that seeks to provide clarity regarding OCR’s enforcement authority and processes relating to federal...more
On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more
On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of the...more
10/19/2023
/ Advisory Opinions ,
Ambulatory Surgery Centers ,
Department of Health and Human Services (HHS) ,
Employer Liability Issues ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Profits ,
Proposed Regulation ,
Safe Harbors
On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud...more
4/11/2023
/ Advisory Opinions ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Request For Information ,
Self-Disclosure Requirements ,
Telemedicine ,
Wellness Programs
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more
On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...more
On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more
1/6/2023
/ Acute Facilities ,
Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Nurse Practitioners ,
OIG ,
Physicians ,
Remuneration ,
Stark Law
On October 5, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion No. 22-19, finding that a proposal by an entity funded entirely by manufacturers of oncology...more
10/12/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Appeals ,
C-Corporation ,
Cost-Sharing ,
Federal Poverty Line ,
Fraud and Abuse ,
Generic Drugs ,
Inflation Reduction Act (IRA) ,
Medicare Part D ,
OIG ,
Patient Assistance Programs
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently released a template that parties may use when preparing advisory opinion requests. The voluntary template provides a simple...more
On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more
7/29/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Appeals ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
New York ,
OIG ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Summary Judgment
On June 29, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-14, approving in part, and denying in part, a request from an ophthalmology practice...more
On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more
6/28/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiaries ,
Customers ,
Department of Health and Human Services (HHS) ,
Financial Institutions ,
Health Care Providers ,
Lenders ,
Manufacturers ,
Medical Supplies ,
OIG ,
Patients
On April 25, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-07, approving an arrangement whereby physicians hold ownership interests in a medical...more
On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more
On January 3 and January 6, respectively, the Department of Health and Human Services Office of Inspector General (OIG) issued a final rule amending the regulations that govern the agency’s advisory opinion process and a...more
On November 16, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published Advisory Opinion 21-16, approving an arrangement under which a pharmaceutical manufacturer provides free...more
One of the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) key compliance priorities is modernizing the agency’s program integrity and compliance information.
OIG has explained that its...more