Spinal Stabilization Devices and Interspinous Spacers
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Medicare medical policy governing coverage and medical necessity determinations for dynamic spinal stabilization devices and interspinous spacers for Providence Health Plan Medicare members; applies when Medicare coverage criteria are not fully established. Affects providers submitting claims or prior authorization requests for these devices/procedures.
No material clinical or coverage changes in this revision.
Coverage determinations
Not medically necessary
Covered status conclusion
Systematic reviews note paucity of long-term, high-quality trials and guideline support is lacking or limited.
Any implanted spinal stabilization device that has not received FDA approval (or IRB approval where applicable) will be considered not medically necessary for Medicare members. The policy clarifies that FDA clearance alone (e.g., 510(k)) does not establish medical necessity for Medicare coverage, and lack of FDA or IRB approval precludes consideration for coverage under this policy.
All unlisted procedure codes submitted for services addressed by this policy are reviewed at the claim level for medical necessity, correct coding, and pricing. If an unlisted code is submitted for a service that is not covered by this policy, the claim will be denied as not covered. For unlisted codes that may represent potentially covered services, the Company recommends obtaining prior authorization to avoid post-service denial.
After an evidence review the Company concluded that the body of evidence does not support the safety and efficacy of dynamic stabilization devices and interspinous spacers. All systematic reviews cited note a paucity of long-term, high-quality trials and the literature is largely composed of small, uncontrolled studies with short follow-up and methodological limitations. Consequently, these services are considered not medically necessary for Medicare plan members under this policy.
Billing and coding guidance
| 22867 | Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level |
| 22867 (add-on) | Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level (List separately in addition to code for primary procedure) |
| 22899 | Unlisted procedure, spine |
| 64999 | Unlisted procedure, nervous system |
| C1821 | Interspinous process distraction device (implantable) |
| L8699 | Prosthetic implant, not otherwise specified |
| 22533 | CPT listed as not applicable |
| 22534 | CPT listed as not applicable |
| 22558 | CPT listed as not applicable |
| 22585 | CPT listed as not applicable |
| 22586 | CPT listed as not applicable |
| 22612 | CPT listed as not applicable |
| 22614 | CPT listed as not applicable |
| 22630 | CPT listed as not applicable |
| 22632 | CPT listed as not applicable |
| 22633 | CPT listed as not applicable |
| 22867 | Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level |
| 22899 | Unlisted procedure, spine |
| 64999 | Unlisted procedure, nervous system |
| C1821 | Interspinous process distraction device (implantable) |
| L8699 | Prosthetic implant, not otherwise specified |
Provider requirements and recommendations
Prior authorization recommended for unlisted or potentially covered device procedures
Prior authorization is recommended for unlisted procedure codes and for potentially covered interspinous process device procedures (examples in the policy include CPT 22867, unlisted spine/nervous system codes 22899 and 64999, and HCPCS C1821/L8699).
Prior authorization recommended to avoid post-service denial
When submitting an unlisted procedure code for a service that could be potentially covered under this policy, prior authorization is recommended to avoid post-service denial.
- The policy explicitly states prior authorization is recommended when an unlisted code is submitted for potentially covered services to avoid post-service denial.
No step therapy pathway — devices considered not medically necessary
The Company determined that evidence does not support the safety and efficacy of dynamic stabilization devices and interspinous spacers; therefore there is no step therapy pathway because these services are considered not medically necessary.
- Company conclusion: devices considered not medically necessary for Medicare members based on evidence review.
Provider actions — summary guidance for coding, review, and authorization
All provider actions below reflect requirements in the policy: do not bill inapplicable CPTs, submit unlisted codes only when appropriate, expect unlisted-code review at claim level, and seek prior authorization for potentially covered unlisted services to avoid denials.
- Do not use CPT codes listed as not applicable for minimally invasive dynamic stabilization procedures.
- Submit unlisted procedure codes (e.g., 22899, 64999) only when no specific code applies and provide documentation to support medical necessity.
- Request prior authorization for unlisted codes for potentially covered services to avoid post-service denial.
- All unlisted codes will be reviewed at claim level for medical necessity, correct coding, and pricing.
Unlisted codes: review for medical necessity, correct coding, and pricing
All unlisted procedure codes submitted for services related to this policy are reviewed at the claim level for medical necessity, correct coding, and pricing; prior authorization is recommended when such codes are submitted for potentially covered services.
Unlisted codes reviewed at claim level for medical necessity and pricing
Unlisted codes will be evaluated at claim adjudication for medical necessity and appropriate pricing; documentation and accurate coding are required to support payment decisions.
- All unlisted codes are subject to review for medical necessity, correct coding, and pricing at the claim level.
Denial risk for unlisted codes submitted for non-covered services
Unlisted codes submitted for services that this policy identifies as non‑covered will be denied as not covered; unlisted codes for potentially covered services should have prior authorization to reduce risk of post-service denial.
- If an unlisted code is submitted for non-covered services addressed in this policy it will be denied as not covered.
- Prior authorization is recommended for unlisted codes submitted for potentially covered services to avoid post-service denial.
Inapplicable CPT codes — do not bill (billing misuse)
Do not use the CPT codes listed in the policy (e.g., 22533, 22534, 22558, 22585, 22586, 22612, 22614, 22630, 22632–22634, 22800–22804, 22808–22812, 22840–22847, 22853–22854, 22859) to bill for minimally invasive dynamic stabilization procedures; these codes do not apply and using them would be billing misuse.
- Policy statement: 'The following codes do not apply to minimally invasive dynamic stabilization procedures of the spine and should not be used to bill for these services:' followed by the listed CPT codes.
Unlisted code submissions for non-covered services will be denied
Submission of an unlisted code for services that the policy designates as non‑covered will be denied as not covered; providers should not expect payment for non‑covered services coded with unlisted procedure codes.
- Explicit policy language: 'If an unlisted code is submitted for non-covered services addressed in this policy then it will be denied as not covered.'
Clinical background
Dynamic stabilization devices are implantable systems designed to provide spinal segment stabilization while preserving some degree of motion as an alternative or adjunct to fusion. Examples include flexible constructs anchored to vertebrae (for example, cord-based or pedicle screw–based systems such as Dynesys®, Aspen, DSS, and Isobar) that aim to limit pathologic motion without achieving rigid fusion.
Interspinous spacers are small implants placed between adjacent spinous processes to distract and stabilize posterior elements and reduce lumbar extension; they are intended to relieve symptoms of lumbar spinal stenosis and neurogenic claudication by limiting extension and increasing foraminal dimensions. Examples include Coflex®, Vertiflex™ Superion, and DIAM™.
The policy notes that clinical rationale for these devices is to provide dynamic stabilization or distraction of lumbar segments as an alternative to interbody fusion and/or decompression. However, evidence limitations — including heterogeneous populations, nonrandomized designs, small sample sizes, short follow-up, and risk of bias — undermine confidence in long-term safety and effectiveness, which informed the Company’s determination that these devices are not medically necessary for Medicare members.
Key definitions
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