Is the Intracept procedure medically necessary for a patient with vertebrogenic low back pain when the criteria states it is not a covered procedure?

Is the Intracept Procedure Medically Necessary for Vertebrogenic Low Back Pain?

No, the Intracept procedure is not medically necessary when your coverage criteria explicitly state it is not a covered procedure, regardless of the clinical evidence supporting its efficacy.

Coverage Policy Takes Precedence

Your coverage policy explicitly states that CPT code 64628 (thermal destruction of intraosseous basivertebral nerve) is not covered for the indications listed in your Clinical Policy Bulletin (CPB) 0016. This administrative determination supersedes clinical evidence when making coverage decisions, as medical necessity is defined within the context of your plan's coverage criteria.

Clinical Evidence Context (For Understanding Only)

While the coverage decision is clear, understanding the clinical evidence helps explain why this remains a coverage issue:

Supporting Clinical Evidence

• The American Society of Pain and Neuroscience gives basivertebral nerve (BVN) ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals with vertebrogenic low back pain 1

• A 2021 prospective trial demonstrated clinical success in 96.5% of patients for both pain and disability reduction, with VAS and ODI scores decreasing significantly at 3- and 12-month follow-up 2

• The procedure targets the basivertebral nerve that innervates vertebral endplates, which has emerged as a recognized source of vertebrogenic chronic low back pain distinct from traditional discogenic models 3, 4

Patient Selection Criteria in Literature

The clinical studies used highly specific inclusion criteria that your patient appears to meet:

• Modic type 1 or 2 endplate changes on MRI (your patient has Modic type I changes) 4, 1
• Failed conservative management including physical therapy, medications, and injections (your patient has tried extensive conservative treatments) 1
• Chronic low back pain duration typically >6 months 4, 1

Evidence Limitations

• Very specific patient populations were studied, leaving many with chronic low back pain ineligible 4
• Most published studies have industry-led funding, raising potential bias concerns 4
• Lack of true control groups due to high crossover rates in published studies 4
• Limited long-term and high-level independent studies available 4

The Coverage Gap

This case illustrates a common scenario where:

1. Clinical evidence supports efficacy in selected patients 1, 2
2. Coverage policies have not yet incorporated this evidence into their criteria
3. The procedure remains investigational or non-covered from a payer perspective

Recommendation for This Case

Deny the prior authorization based on your explicit coverage exclusion. The patient and provider should be informed that:

• The procedure is specifically listed as not covered under CPB 0016
• Clinical evidence, while supportive, does not override coverage policy
• Appeal options may be available if the patient wishes to challenge the coverage determination
• The patient may pursue the procedure as a self-pay option if they choose

The ACR Appropriateness Criteria for low back pain do not specifically address BVN ablation, as this is a newer intervention not yet incorporated into standard imaging and treatment algorithms 5.