Medicare Slightly Expands Coverage For Spine Procedure, But Policy Remains Trial-Limited

Vertos Medical asked the US Medicare agency to reconsider its 2014 decision that limits coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis to certain clinical trials. The agency ruled Dec. 7 that it will stick with the trial-limited policy, but expanded it to include longitudinal studies.

The US Centers for Medicare and Medicaid Services is maintaining its coverage-with-evidence-development (CED) approach to percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis, but will expand the coverage policy to include longitudinal studies. CMS issued its National Coverage Analysis decision memo for the PILD procedure Dec. 7.

In 2014, CMS agreed to cover PILD for patients enrolled in an approved clinical trials that meet certain criteria. (Also see "Spine Firms Laud CMS’ Decision To Cover Percutaneous Lumbar Decompression In Trials" - Medtech Insight, 20 January, 2014.) In March, Vertos Medical Inc. requested that CMS consider lifting the evidence-development requirements in the coverage policy in light of the results of data from MiDAS ENCORE, a 302-patient randomized trial comparing epidural steroid injections to PILD with Vertos' mild system. The mild system consists of a set of proprietary instruments for minimally invasive, fluoroscopically-guided PILD in an outpatient procedure

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

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By 

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

More from Medtech Insight

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.