On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals