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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -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
The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements -
On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more
5/14/2019
/ Administrative Authority ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
Drug Pricing ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency
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
The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more
2/4/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Manufacturers ,
Medicaid ,
Medicare Part D ,
Point of Sale Terminals ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
On Friday, May 11, the Trump Administration released a 39-page “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (“Blueprint”). The Blueprint raises in very broad strokes potential Administration strategies to...more
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