Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
8/15/2023
/ Advisory Opinions ,
Algorithms ,
Anti-Kickback Statute ,
Federal Health Care Programs (FHCP) ,
Fees ,
Fraud and Abuse ,
Health Care Providers ,
Health Technology ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG
The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more
6/13/2023
/ Anti-Kickback Statute ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Hospitals ,
Medicare ,
Mental Health ,
Physicians ,
Safe Harbors ,
Stark Law ,
Wellness Programs
In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more
9/30/2022
/ Anti-Kickback Statute ,
Debt Restructuring ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Federal Health Care Programs (FHCP) ,
HRSA ,
Liens ,
Master Service Agreement ,
Medicaid ,
Medicare ,
OIG ,
Patient Referrals ,
Quality of Care Standards ,
Regulatory Oversight ,
Safe Harbors
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
8/1/2022
/ Anti-Kickback Statute ,
Bribery ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
OIG ,
Telehealth ,
Telemedicine
Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more