News & Analysis as of

Life Sciences Centers for Medicare & Medicaid Services (CMS) Final Rules

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

Jones Day on

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

McGuireWoods Consulting

Washington Healthcare Update - October 2021 #4

McGuireWoods Consulting on

Upcoming Hearings/Markups - October 26 - House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods:...more

Robinson+Cole Health Law Diagnosis

CMS Final Rule on Drug Pricing Transparency in Consumer Television Ads

On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more

6 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide