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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -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
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