CurrentBlue Cross Blue Shield - IowaPolicy N/A

Image-Guided Minimally Invasive Decompression for Spinal Stenosis

Defines Wellmark/Blue Cross Blue Shield - Iowa policy position on image-guided minimally invasive spinal decompression (MILD) for lumbar, cervical, and thoracic spinal stenosis, including evidence review, regulatory status, and coding reference. Part 1 of 2; contains description, evidence summary, policy determination, and supporting background.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyImage-Guided Minimally Invasive Decompression for Spinal Stenosis

Policy CodePolicy N/A

Change TypeRevised; Annual Review/Renewed

Effective DateJan 1, 2010

Next Review Date

Key ActionDo not submit prior approval; claims may be denied because the procedure is considered investigational with insufficient evidence to demonstrate net health benefit.

POLICY UPDATE CHANGES

Policy revised July 2023; review date July 2025.

Policy underwent Annual Review and Renewal in July 2025.

Content moved from retired policy 'Miscellaneous Surgical Treatments of Back Pain' in July 2023.

2RCTs cited

478Total RCT participants

insufficientEvidence conclusion

4Codes listed

Coverage Summary & Determination

Scope: This policy (Wellmark/Blue Cross Blue Shield - Iowa) addresses image-guided minimally invasive spinal decompression (mild®) for spinal stenosis, summarizing evidence, regulatory status, and coding references. Overview: Image-guided minimally invasive decompression (mild®) is intended for central lumbar stenosis; the procedure and associated device (mild® kit) have FDA 510(k) clearance (product code HRX). The policy determination is that the procedure is considered investigational and the evidence is insufficient to conclude an improvement in net health outcome.

Policy Determination

Coverage determination for image-guided minimally invasive spinal decompression:

Determination: Image-guided minimally invasive spinal decompression is considered investigational.
Evidence Conclusion: The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Indication-specific evidence statements

Evidence-based conclusions by anatomic site:

Lumbar: For lumbar spinal stenosis, randomized trials (MiDAS ENCORE, MOTION), systematic reviews, and cohort studies exist but have limitations (unblinded designs, variable comparators, limited follow-up); the evidence is insufficient to determine efficacy versus placebo, open decompression, or conservative treatment.

Cervical or Thoracic: For cervical or thoracic spinal stenosis, no evidence was identified; the evidence is insufficient to determine improvement in net health outcome.

Policy dates and status

Effective dateJanuary 2010

Last reviewJuly 2025

Next reviewNot specified

Policy statusCURRENT

SubjectImage-guided minimally invasive spinal decompression (MILD) for spinal stenosis

Medical Necessity / Evidence Summary

Evidence summary: For lumbar spinal stenosis, the evidence includes randomized controlled trials (MiDAS ENCORE, MOTION), systematic reviews, and observational studies; however, trials were unblinded, had variable comparators and follow-up, and other design limitations. Overall quality of evidence is assessed as insufficient to determine efficacy versus placebo, open decompression, or conservative treatment, and therefore insufficient to demonstrate an improvement in the net health outcome.

Indication-specific conclusions (by anatomic site)

Indication-by-indication evidence conclusion:

Lumbar: Randomized trials (MiDAS ENCORE N=302; MOTION N=138), systematic reviews, and observational studies report symptom and function improvements but have important limitations (lack of blinding, variable comparators, differential dropout, and limited long-term comparative data); overall evidence is insufficient to conclude net health benefit compared with placebo, open decompression, or conservative care.

Cervical or Thoracic: No studies were identified assessing image-guided minimally invasive decompression for cervical or thoracic stenosis; evidence is insufficient to determine net health outcome improvement.

Coding References

Coding table mentionmixed

No codes listed

CPT codes referencedCPT

0274T	Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (e.g., fluoroscopic, CT), single or multiple levels, unilateral or bilateral;, cervical or thoracic.
62330	Decompression, percutaneous, with partial removal of the ligamentum flavum, including laminotomy for access, epidurography, and imaging guidance (i.e., CT or fluoroscopy), bilateral; one interspace, lumbar.
62331	Decompression, percutaneous, with partial removal of the ligamentum flavum, including laminotomy for access, epidurography, and imaging guidance (i.e., CT or fluoroscopy), bilateral; additional interspace(s), lumbar (List separately in addition to code for primary procedure).

HCPCS codes referencedHCPCS

G0276

Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial.

Place/Type of Service / Revenuemixed

Surgery	Type of Service
Inpatient	Place of Service

Actions — Prior Authorization, Documentation & Billing

Documentation Required

Prior approval

Prior Approval: Not applicable

Denial Risk

Investigational determination

Claims may be denied or considered not medically necessary because image-guided minimally invasive spinal decompression is categorized as investigational; the evidence is insufficient to determine improvement in net health outcome.

Background & Definitions

Background: Image-guided minimally invasive decompression (mild®) is a percutaneous, fluoroscopically guided procedure that uses a specialized cannula and single-use tools to resect hypertrophied ligamentum flavum and small pieces of lamina to decompress the central spinal canal for treatment of central lumbar stenosis. The devices and procedure are performed under fluoroscopic guidance only, are not intended for disc procedures or for decompression of lateral neural elements, and the mild® tool kit received FDA 510(k) clearance (product code HRX) for marketing.

Term	Definition
Image-guided minimally invasive decompression (MILD)	A percutaneous fluoroscopically guided decompression procedure using a specialized cannula and single‑use tools (mild®) to resect hypertrophied ligamentum flavum and small bone from the lamina for central canal decompression.
Net health outcome	Balance of benefits and harms including length of life, quality of life, and ability to function.

Medicare Determinations

Name	Type	Number	Effective date
MiDAS ENCORE protocol approval	NCD

Revision History

January 2010Original Effective Date

Original Effective Date January 2010; document header indicates policy was created in January 2010.

July 2023Policy revised

Policy revised July 2023; content moved from retired policy 'Miscellaneous Surgical Treatments of Back Pain'. Detailed note: Document header lists Revised July 2023 and July 2023 action noted as Policy Revised - content moved from retired policy.

July 2023Policy revised

Policy revised July 2023; review date recorded as July 2025 per document header.

Study	Key point
MiDAS ENCORE (MIDAS ENCORE)	302 randomized patients; compared MILD vs epidural steroid injections; primary endpoints favored MILD but trial was unblinded, had differential withdrawals and follow-up (high risk of bias); 2-year follow-up reported for MILD group only; limitations include comorbidities not addressed by the technique.
MOTION RCT	138 randomized patients; MILD + conventional medical management (CMM) vs CMM alone; 1-year ODI improvement greater with MILD (+16.1 vs +2.0, p<.001); limitations: wide variation in CMM, lack of blinding, 12‑month follow-up, crossover after 1 year limiting comparative 2‑year analysis.
Systematic review	Included small RCTs and cohorts (one RCT N=38 and 12 cohorts/series); overall low-quality evidence with mean final ODI often >30; reported short-term and 1-year improvements but body of evidence judged low quality.
Key recent trials / reviews	Multiple recent publications including MOTION (1‑ and 2‑year reports) and systematic reviews through 2025; recent trials/reviews support reported improvements but continue to note limitations (unblinded designs, variable comparators, limited follow-up) and overall insufficient evidence to determine efficacy versus placebo or open decompression.