Is disc replacement surgery considered experimental or investigational from an insurance perspective?

Disc Replacement Surgery is Considered Experimental and Investigational from an Insurance Perspective

Disc replacement surgery is considered experimental and investigational from an insurance perspective, particularly for multi-level procedures, due to insufficient evidence of effectiveness and lack of clear clinical indications. 1

Insurance Classification and Evidence Base

• The MCG Disk Arthroplasty guideline explicitly states that "there are currently no clinical indications for this technology" and categorizes it as having "inconclusive or non-supportive evidence" 1
• Aetna Clinical Policy specifically considers lumbar prosthetic intervertebral discs at more than one level to be "experimental, investigational, or unproven" due to insufficient evidence of effectiveness 1
• When a clinical procedure is considered experimental, it typically means insurers will not provide coverage for it as a standard benefit

Evidence Quality and Comparative Effectiveness

• Recent high-quality evidence from a 2021 BMJ umbrella review found that for lumbar spine fusion versus total disc replacement, results were variable in earlier reviews 2
• While some recent reviews showed total disc replacement improved pain and patient satisfaction compared to fusion, the overall quality of evidence remains low 2
• Cochrane reviews have concluded that although statistically significant, the differences between disc replacement and conventional fusion surgery were not beyond clinically important differences for short-term pain relief, disability, and quality of life 3, 4

Complications and Long-Term Concerns

• Complications related to disc replacement surgery are significant:
  • Surgical approach complications: 2.1-18.7%
  • Prosthesis-related complications: 2.0-39.3%
  • Treatment-related complications: 1.9-62.0%
  • General complications: 1.0-14.0% 5
• Reoperation rates at the index level range from 1.0-28.6% 5
• Long-term complications include degeneration at adjacent levels, subsidence of the prosthesis, and facet joint arthrosis 6

Insurance Decision-Making Framework

Insurance companies typically classify procedures as experimental or investigational when:

1. There is insufficient high-quality evidence supporting effectiveness
2. The procedure has not been widely accepted as standard care
3. Long-term outcomes remain uncertain
4. The risk-benefit ratio is not clearly established
5. Alternative established treatments exist

Clinical Implications

• The primary goal of preventing adjacent level disease and facet joint degeneration through disc replacement has not been properly assessed in high-quality studies 4
• The concept of motion preservation through disc replacement remains unproven and needs further review 7
• For patients seeking coverage, insurers will likely require documentation showing failure of conservative management and may only consider single-level procedures in highly selected cases

Caveat for Practitioners

When considering disc replacement surgery, practitioners should be aware that:

• Insurance denials are likely, particularly for multi-level procedures
• Appeals may require substantial clinical documentation
• Patients should be informed about the experimental classification and potential out-of-pocket costs
• The spine surgery community should remain prudent about adopting this technology on a large scale until more long-term data is available 4