Key Drug Pricing Implications of the Inflation Reduction Act of 2022 -
I. Introduction -
On Sunday, August 7, 2022, the United States Senate passed the most consequential drug and biologics pricing legislation in almost...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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -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
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
11/24/2020
/ Administrative Procedure Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Interim Final Rules (IFR) ,
Medicare ,
Medicare Part D ,
OECD ,
Social Security Act ,
Stark Law ,
Trump Administration
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule -
On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
6/24/2020
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MDRP ,
Medicaid ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements ,
Value-Based Purchasing
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