On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more
8/9/2023
/ Biosimilars ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Orphan Drugs ,
Prescription Drugs
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more
7/25/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Excise Tax ,
Fifth Amendment ,
First Amendment ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Unconstitutional Condition
The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part...more
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
7/16/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Most-Favored Nations ,
OMB ,
Pharmaceutical Industry ,
Transparency