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
House Passage and President Biden’s Signature Expected This Week -
On Sunday, August 7, following an all-night voting session, the Senate approved the Inflation Reduction Act (IRA) by a vote of 51-50. The IRA was...more
8/11/2022
/ Affordable Care Act ,
Biden Administration ,
Carbon Capture and Sequestration ,
Clean Air Act ,
Corporate Taxes ,
Drug Pricing ,
Environmental Justice ,
IRS ,
Local Taxes ,
Prevailing Wages ,
Price Inflation ,
Stock Repurchases ,
Tax Reform
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
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
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
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
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
Another Presidential Administration Attempts to Change Part B Payment for Physician-Administered Drugs -
On October 25, 2018, the Trump Administration released an Advance Notice of Proposed Rulemaking (“ANPRM”) entitled...more
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
State Budget Includes Medicaid Drug Expenditure Cap -
On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more
Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs -
On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more