On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
11/17/2023
/ Chief Compliance Officers ,
Compliance ,
Corporate Integrity Agreement ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Policies and Procedures ,
Risk Assessment
On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more
3/29/2022
/ AdvaMed ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Ethics ,
Final Rules ,
Health Care Providers ,
Healthcare Workers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Technology Sector ,
Value-Based Care
The Revised PhRMA Code Takes Effect January 1, 2022 -
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released highly anticipated revisions to its Code on Interactions with Health Care...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing -
Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
2/4/2021
/ Anti-Kickback Statute ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Qualified Health Plans ,
Rebates ,
Safe Harbors
Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -
INTRODUCTION -
On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more
11/30/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Manufacturers ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors ,
Social Security Act
Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs -
A Special Fraud Alert issued by the U.S....more
11/25/2020
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud ,
Healthcare Workers ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers -
In today’s Federal Register, the...more
10/17/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Rules ,
Safe Harbors ,
Value-Based Care
President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more
4/22/2019
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Life Sciences ,
Manufacturers ,
MDRP ,
Medicaid ,
OIG ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
12/14/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Deductibles ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Life Sciences ,
OIG ,
Pharmacies ,
Remuneration ,
Safe Harbors