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
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
8/29/2023
/ Advertising ,
Artificial Intelligence ,
Automotive Industry ,
Biometric Information ,
Clean Energy ,
Clinical Trials ,
Confidentiality Policies ,
Cybersecurity ,
Data Protection ,
Data Security ,
Diagnostic Imaging Services ,
Disclosure Requirements ,
Distribution Rules ,
Driverless Cars ,
Energy Sector ,
Enforcement ,
Environmental Social & Governance (ESG) ,
Equal Employment Opportunity Commission (EEOC) ,
Ethics ,
Family Offices ,
Fantasy Sports ,
Fashion Industry ,
Fraud and Abuse ,
Greenwashing ,
Healthcare ,
Hospitality Industry ,
Intellectual Property Protection ,
Labor Regulations ,
Life Sciences ,
Logistics ,
Long-Term Care ,
Machine Learning ,
Medical Devices ,
Medical Research ,
Nonprofits ,
Open Source Software ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Privacy Laws ,
Privately Held Corporations ,
Regulatory Agenda ,
Renewable Energy ,
Retailers ,
Software ,
Sports ,
Sports Betting ,
Technology Sector ,
Vehicle Navigation Systems
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
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
2/17/2021
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Digital Health ,
DMEPOS ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Stark Law ,
Technology ,
Value-Based Care
The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more
8/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Hospitals ,
Medical Devices ,
Medical Records ,
Medicare ,
Open Payments ,
Opioid ,
Pharmaceutical Industry ,
Physician Assistants ,
Physician Fee Schedule ,
Physicians ,
Sunshine Act ,
Telehealth ,
Telemedicine