CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work

“Why are insurers so reluctant to get enthusiastic and really embrace molecular diagnostics?” asked the director of CMS’ coverage and analysis group at a recent cancer diagnostics symposium. “Because half the time we have no idea what on earth we’re paying for.”

CMS Coverage and Analysis Group director Louis Jacques tried to temper the widespread enthusiasm for scientific advances in cancer diagnosis in his concluding speech at an Oct. 29 Washington, D.C. symposium on cancer diagnostics and personalized medicine.

He reminded the diagnostics industry that molecular diagnostics for the disease remain a largely unproven technology. “Why are insurers so...

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

More from Policy & Regulation

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

Device User Fees Up About 7% For FY2026

 
• By 

The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 

There is still no clarity on how life sciences will be treated in the final agreement.

More from Medtech Insight

Edwards Lifesciences Lowers Tariff Impact Forecast, Keeps Gross Margin Guidance Intact

 
• By 

The company reaffirmed its guidance for adjusted gross profit margin for the full year 2025 to remain within the original range of 78% to 79%. Chief financial officer Scott Ullem attributed this to currency and tariff dynamics.

Olympus, Revival Co-Found Swan In $458M Deal, Face Tech and Regulatory Hurdles

 
• By 

Olympus and Revival Healthcare Capital have launched Swan Endosurgical in a $458m milestone-based joint venture to develop a robotic platform for endoluminal surgery. The deal combines Olympus’ GI expertise with Revival’s start-up model, but will face technical and regulatory hurdles.

Alternative Funding Sources Emerge Amid Biotech Industry Challenges

 
• By 

The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.