1. Medtech Insight
  2. >>Policy & Regulation

Industry Groups Push CMS To Pay For Algorithms In Multi-Analyte Tests

The agency’s proposal not to separately pay for the algorithmic analysis that forms the basis of many multi-analyte molecular diagnostic tests misconstrues the nature of the tests, industry groups argue. They call for a final determination by CMS that more truly reflects the value of these assays.

CMS’ proposal not to establish payments for newly created codes for multi-analyte assays that rely on algorithmic analysis is attracting a strong rebuke from diagnostic industry and lab stakeholders.

AdvaMedDx, the American Clinical Laboratory Association (ACLA) and Biotechnology Industry Organization (BIO) each pressed CMS in recent comments to withdraw...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

More from Medtech Insight

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Execs On The Move: 2-6 June 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.