Blue Cross Blue Shield - Iowa investigational policy

Coverage Determinations and Evidence Summary

inv-01: Percutaneous annuloplasty — investigational

Coverage stance summarized

Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, intradiscal biacuplasty) is considered investigational.

Evidence is insufficient to determine that the technology results in an improvement in the net health outcome; randomized trials have reported conflicting results or lack of efficacy compared with sham (see evidence summaries).

inv-02: Basivertebral nerve ablation — investigational

Coverage stance summarized

Intraosseous basivertebral nerve ablation: Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept system) is considered investigational.

Two randomized trials (SMART, INTRACEPT) provide limited or conflicting evidence and have notable limitations including high crossover rates and limited long-term comparative data; evidence is insufficient to establish net health benefit.

inv-03: Intradiscal electrothermal annuloplasty — evidence

Evidence summary for intradiscal electrothermal annuloplasty:

RCT evidence summary: Two randomized controlled trials with conflicting results: Pauza et al (2004) reported statistically significant greater reductions in pain and disability versus sham; Freeman et al (2005) reported no treatment successes and no difference versus sham.

Both trials are small, single‑center or industry‑sponsored, and the most recent RCT identified was from 2005; no more recent literature identified.

inv-04: Percutaneous intradiscal radiofrequency thermocoagulation — evidence

Evidence summary for percutaneous intradiscal radiofrequency thermocoagulation/annuloplasty:

RCT evidence summary: Two sham‑controlled randomized trials found no benefit over placebo: one trial reported 1 of 14 treatment successes and the other was terminated early for lack of effect.

Available RCT evidence does not demonstrate efficacy versus sham for percutaneous intradiscal radiofrequency thermocoagulation.

inv-05: Trial-based eligibility elements for BVN ablation

Evidence‑based trial entry criteria commonly used for BVN ablation in RCTs (informational for coverage criteria)

BVN ablation trial eligibility (elements reported in RCTs): Patients had chronic isolated lumbar pain unresponsive to ≥6 months of nonoperative management; minimum Oswestry Disability Index (ODI) ≥30; minimum visual analog scale (VAS) ≥4; Modic type 1 or 2 changes at the vertebral endplates of targeted levels; treatment limited to specified vertebral levels (SMART: 2–3 consecutive levels L3–S1; INTRACEPT: up to 4 nonconsecutive levels L3–S1).as above

These elements were used for enrolment in the SMART and INTRACEPT randomized trials and represent the trial‑based eligibility framework.

inv-06: Trial-based elements for intradiscal biacuplasty

Elements reported in biacuplasty RCTs (informational)

Biacuplasty trial features: Trials enrolled patients with discogenic low back pain; some trials used provocation discography to confirm discogenic pain (Desai 2016); strict inclusion/exclusion criteria led to high screen‑fail rates (Kapural 2013).

Evidence limited to small, industry‑sponsored randomized trials, some without sham control and with post hoc definitions of success.

inv-07: Evidence summary and limitations

Evidence and guideline-based considerations

RCT evidence summary: Two RCTs for BVN ablation exist: the SMART trial (sham‑controlled) found no ITT difference at 3 months with high crossover limiting long‑term comparative data; the INTRACEPT trial (open‑label vs standard care) found short‑term benefit but lacked sham control and allowed early crossover, limiting long‑term comparative conclusions.

High crossover rates and limited long‑term comparative data reduce the certainty of benefit; guideline panels (e.g., ISASS) have provided conditional recommendations when strict imaging and conservative‑therapy criteria are met.

This evidence review does not address disc nucleoplasty or laser discectomy. Those procedures are conceptually distinct — disc nucleoplasty (coblation) and laser discectomy involve tissue removal or ablation for decompression — and are evaluated under a separate policy, 07.01.88.

There is little recent literature for intradiscal electrothermal annuloplasty (IDET); the two RCTs identified reported conflicting results and the most recent randomized trial was published in 2005. No newer randomized evidence was identified in this review.

The available trials for percutaneous intradiscal thermal procedures frequently lacked adequate sham control or enrolled narrowly selected populations. The document explicitly notes that additional sham‑controlled trials in broader patient populations are needed to determine treatment effects with greater certainty.

The National Institute for Health and Care Excellence (NICE) has concluded that evidence for percutaneous intradiscal radiofrequency thermocoagulation and for electrothermal annuloplasty is limited or inconsistent and recommended these procedures be used only with special arrangements (clinical governance, consent, audit, or research).

Policy conclusion: because randomized trial evidence is limited, inconsistent, or has important methodological limitations, intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty/thermocoagulation, intradiscal biacuplasty, and intraosseous basivertebral nerve ablation are considered investigational and therefore not medically necessary under this policy.

Randomized data for percutaneous intradiscal radiofrequency thermocoagulation do not show benefit over sham: two sham‑controlled trials found no evidence of efficacy (one trial reporting only 1 of 14 treatment successes; another terminated early for lack of effect).

Evidence for biacuplasty is limited to small, industry‑sponsored RCTs with methodological concerns: strict enrollment criteria and high screen‑fail rates, lack of sham control in at least one trial, post‑hoc definitions of success in another, and uncertain study power limit confidence in generalized benefit.

Overall evidence landscape: trial results are inconsistent or methodologically limited across intradiscal thermal procedures and BVN ablation. Systematic reviews and guideline bodies have rated evidence as limited-to-fair or inconsistent and have highlighted potential complications. These assessments are concordant with the policy’s investigational stance and with NICE’s recommendation for restricted use under special arrangements.

Required Nonoperative Management Before Consideration

inv-46: Conservative care trial prior to considering invasive procedures

Conservative care trial prior to considering invasive procedures

Conservative care trial: Conservative therapy (e.g., physical therapy, medication management) should be attempted prior to considering percutaneous intradiscal or intraosseous procedures.>= 6 months for Intracept intended use

The Intracept device labeling and trial protocols specify chronic low back pain of at least 6 months duration not responsive to at least 6 months of conservative care.

inv-47: Documented failure of conservative management is implied for study populations

Documented failure of conservative management is implied for study populations

Implied requirement from trials: Clinical trials enrolling patients for intradiscal and intraosseous procedures generally required failure of conservative management prior to enrollment, implying that documented failure of nonoperative care was a precondition in study populations.

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization for listed CPT codes

Prior authorization is required for the listed CPT codes for basivertebral nerve ablation and intradiscal annuloplasty procedures. Providers should verify prior authorization policies with the payer before scheduling procedures and include required clinical documentation in the request.

Affected CPT codes include 22526, 22527, 22899 (unlisted spine procedure), 64628, and 64629.
Place of service: outpatient or inpatient; Type of Service: Surgery.

Denial Risk

Investigational procedures — risk of denial if criteria not met

Procedures described in this policy (percutaneous intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, intradiscal biacuplasty, and intraosseous basivertebral nerve ablation) are considered investigational or have limited evidence in some contexts and may be denied as not medically necessary when criteria are not met.

Procedure and Reference Codes

Referenced Codes tablemixed

See Codes table

Policy references a Codes table for procedure and billing codes; specific codes not listed in this excerpt

Procedure CPT CodesCPT

22526	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level.
22527	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more additional levels (List separately in addition to code for primary procedure).
22899	Unlisted procedure code, spine (used for the Intercept procedure).
64628	Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral.
64629	Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure).

inv-18: Conservative care duration (Intracept intended use)

Conservative care durationAt least 6 months of conservative (nonsurgical) management prior to considering Intracept (Intracept intended use specifies chronic low back pain of at least 6 months duration not responsive to ≥6 months of conservative care)

Documented treatmentsConservative care may include medications, physical therapy, and injections as described in trial eligibility and device labeling

Outcome follow-upClinical trials and reviews recommend follow-up of at least 6–12 months to assess pain, function, and adverse events

Radiologic Findings Needed to Support Eligibility

Documentation Required

Imaging requirement: radiologic confirmation referenced for BVN/discogenic pain

Radiologic confirmation (MRI) is referenced for evaluation of vertebrogenic or discogenic pain and is required by trial enrollment criteria for BVN ablation.

MRI demonstrating degenerative disc disease or Modic changes is part of diagnostic evaluation.
Include MRI reports in documentation for BVN ablation consideration.

Documentation Required

Imaging for IDET/annuloplasty: MRI evidence of degenerative disc disease per Freeman trial

In the Freeman intradiscal electrothermal annuloplasty trial, MRI evidence of degenerative disc disease was required for enrollment and should be documented when applicable.

Key Terms and Interventions

inv-38: Discogenic low back pain definition

DefinitionDiscogenic low back pain: low back pain without radicular symptom findings with radiologically confirmed degenerative disc disease

Typical featuresChronic axial low back pain localized to the lumbar spine without radicular neurologic signs

Imaging requirementRadiologic confirmation (e.g., MRI) of degenerative disc disease is referenced in trial inclusion and clinical context

inv-39: Vertebrogenic pain definition (BVN-related)

DefinitionVertebrogenic pain: pain transmitted via the basivertebral nerve associated with vertebral endplate damage or degeneration (Modic changes)

Anatomic targetBasivertebral nerve enters posterior vertebral body and supplies superior and inferior endplates

Treatment Frequency and Level Limits

inv-51: Not applicable — procedures are investigational per policy

Policy stancePercutaneous intradiscal annuloplasty procedures and intraosseous basivertebral nerve ablation are considered investigational under this policy

Coverage implicationBecause these procedures are investigational, they are designated not medically necessary and will be denied under this policy

ExamplesIncludes intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, intradiscal biacuplasty, and BVN ablation

inv-52: Not specified in this document portion

Not specifiedSpecific frequency limits or repeat procedure intervals are not specified in this document portion for many procedures

Policy context

Clinical Background and Rationale

Discogenic low back pain refers to persistent low back pain without radicular symptoms and with radiologic evidence of degenerative intervertebral disc disease. Annuloplasty techniques apply thermal energy intradiscally to thermocoagulate nociceptive fibers and/or modify annular tissue; biacuplasty uses paired cooled radiofrequency probes to expand the ablation zone. Basivertebral nerve ablation targets intraosseous nerves supplying vertebral endplates and is directed at vertebrogenic pain associated with Modic changes.

Procedures Not Covered

Not covered under this policy: percutaneous intradiscal electrothermal annuloplasty (IDET), percutaneous intradiscal radiofrequency annuloplasty/thermocoagulation, intradiscal radiofrequency biacuplasty, and intraosseous basivertebral nerve ablation. The policy designates these procedures as investigational because current evidence is insufficient to establish benefit over comparators or sham.

OpenPayer

Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, Biacuplasty and Intraosseous Basivertebral Nerve Ablation