CMS Proposes Noncoverage For Percutaneous Image-guided Lumbar Decompression

The procedure, aimed at treating lumbar spinal stenosis, is not reasonable and necessary, the Medicare agency says. A final decision is due Jan. 15.

An Oct. 17 proposed

decision by CMS states that percutaneous image-guided lumbar decompression for lumbar spinal stenosis is not reasonable and necessary and should be nationally noncovered by Medicare.

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

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

More from Medtech Insight

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By 

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

ConcertAI Launches Generative AI-Powered Precision Suite

 

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.