Is the Intracept Procedure (64628) medically indicated and necessary for the treatment of vertebrogenic low back pain with diagnosis code M54.51?

Medical Necessity Assessment for Intracept Procedure (CPT 64628) for Vertebrogenic Low Back Pain (M54.51)

The Intracept Procedure (basivertebral nerve ablation) is medically indicated and necessary for appropriately selected patients with vertebrogenic chronic low back pain when specific diagnostic criteria are met, conservative treatments have failed for at least 6 months, and imaging demonstrates characteristic vertebral endplate changes (Modic changes). 1

Diagnostic Requirements for Medical Necessity

The American Society of Pain and Neuroscience provides Level A grade evidence (high certainty of substantial net benefit) for basivertebral nerve (BVN) ablation in appropriately selected individuals with vertebrogenic low back pain 1. However, proper patient selection requires meeting specific criteria:

Essential Diagnostic Criteria

• Chronic low back pain duration of at least 6 months that has failed conservative management including physical therapy, medications, and other non-invasive treatments 1, 2

• MRI evidence of vertebral endplate degeneration with Modic changes (Types 1 or 2), which represent cortical bone damage and subchondral bone inflammatory reaction that characterize vertebrogenic pain 2, 1

• Pain localized to the lumbar spine without significant radicular symptoms - the procedure targets axial back pain, not leg pain from nerve root compression 3, 1

• Exclusion of other pain generators through comprehensive imaging to rule out discogenic pain, facet-mediated pain, or radiculopathy as the primary source 4, 1

Critical Distinction: Vertebrogenic vs. Radicular Pain

A critical pitfall is confusing vertebrogenic pain (M54.51) with radiculopathy. The traditional guidelines from the American College of Physicians and American Pain Society focus on radiculopathy and disc herniation, recommending MRI only for patients who are candidates for surgery or epidural steroid injection for radicular symptoms 4. These guidelines do not address vertebrogenic pain, which is a distinct entity involving the basivertebral nerve innervation of vertebral endplates rather than nerve root compression 3, 1.

Evidence Supporting Medical Necessity

Clinical Efficacy Data

• Randomized controlled trials demonstrate superiority over both sham and standard care with improvements in pain (VAS), disability (ODI), and quality of life measures maintained through 5-year follow-up 5, 1

• Independent community practice data shows statistically significant improvements with ODI declining 21.1 points at 6 months (exceeding minimal clinically important difference), VAS improvements, and SF-36 Pain Component Summary improvements (all p<0.05) 6

• Clinical success rates of 96.5% for both pain and disability reduction at 3- and 12-month follow-up when patients are properly selected using multidisciplinary imaging assessment 2

Safety Profile

• The procedure demonstrates excellent safety with no immediate or delayed complications reported in prospective trials, mean operative time of 32 minutes, and successful CT-assisted targeting in 100% of patients 2

• Cost-effectiveness analysis shows an ICER of $11,376 per QALY at 5 years, with >99% probability of cost-effectiveness at willingness-to-pay thresholds of $100,000-$150,000 5

Medical Necessity Determination Algorithm

The procedure is medically necessary when ALL of the following are met:

1. Duration criterion: Chronic low back pain present for ≥6 months 1

2. Conservative treatment failure: Documented trial of physical therapy, medications, and activity modification without adequate relief 1, 6

3. Imaging confirmation: MRI demonstrates Modic Type 1 or 2 changes at vertebral endplates corresponding to pain location 2, 1

4. Pain pattern: Predominantly axial low back pain without significant radicular leg pain 3, 1

5. Exclusion of alternative diagnoses: No evidence that disc herniation, facet arthropathy, or spinal stenosis is the primary pain generator 4, 1

6. Functional impairment: Documented disability affecting activities of daily living (typically ODI >30) 6, 2

The procedure is NOT medically necessary when:

• Primary complaint is radicular leg pain rather than axial back pain - these patients require evaluation for disc herniation or spinal stenosis per traditional guidelines 4, 7

• Imaging shows no Modic changes at vertebral endplates 1

• Conservative treatment duration <6 months unless red flag symptoms are present 1

• Alternative pain generators are identified as the primary source (e.g., large disc herniation with nerve root compression) 4

Important Caveats

The American College of Physicians guidelines from 2007 do not address vertebrogenic pain or BVN ablation because this diagnostic entity and treatment were not yet established 4. These older guidelines focus on discogenic models of back pain and radiculopathy management 4. The more recent evidence from the American Society of Pain and Neuroscience (2022) specifically addresses vertebrogenic pain as a distinct clinical entity requiring different diagnostic and treatment approaches 1.

Diagnosis code M54.51 (low back pain) is non-specific and does not automatically qualify a patient for the Intracept Procedure. The medical necessity determination requires documentation of the specific diagnostic criteria outlined above, particularly MRI evidence of Modic changes and exclusion of other pain sources 1, 2.