Commercial

Medical Policy

Notification

Non-Surgical Spinal Decompression Therapy

Notification Issue Date:

The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.

Title:

Non-Surgical Spinal Decompression Therapy

Policy #:

07.08.01f

Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Although the US Food and Drug Administration (FDA) has approved several devices that are used for nonsurgical spinal decompression therapy, the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. Therefore, nonsurgical spinal decompression therapy is considered experimental/investigational by the Company and is not covered.

BILLING REQUIREMENTS

Nonsurgical spinal decompression therapy must be reported using the Healthcare Common Procedure Coding System (HCPCS) code S9090. Providers must not bill other procedure codes to represent nonsurgical spinal decompression therapy. These services are subject to postpayment review and audit procedures.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, nonsurgical spinal decompression therapy is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for nonsurgical spinal decompression therapy.

Description

Nonsurgical spinal decompression therapy uses a form of mechanical traction as an alternative treatment for neck or back pain associated with degenerated or herniated intervertebral discs. Nonsurgical spinal decompression therapy is designed to apply distraction tension to the individual's lumbar and/or cervical spine to nonsurgically decompress the spine and intervertebral discs.

There are various devices on the market to deliver nonsurgical spinal decompression therapy. These devices include, but are not limited to: VAX-D Genesis G2, SpineMED, Triton DTS Traction System, DRX9000 True Non-Surgical Spinal Decompression System, and DRX9500 Cervical Non-Surgical Decompression Device. The designs of these devices differ in the method in which the individual is secured to the treatment surface and the position in which the individual is placed (e.g., prone vs. supine). The devices use harnesses or other methods to apply a distraction force to the spinal column until the desired tension is reached. The initial application of decompression is followed by a gradual decrease of the tension (i.e., relaxation). The tension levels that are administered are individually calibrated. Theoretically, the cyclic nature of these treatments allows an individual to withstand stronger distraction forces than those provided by static traction techniques.

PEER-REVIEWED LITERATURE

Evidence of the efficacy of nonsurgical spinal decompression therapy on health outcomes is limited. Randomized trials with validated outcome measures are required. The only sham-controlled randomized trial published to date (Schimmel et al., 2009) did not show a benefit compared to the control group. Also, nonsurgical spinal decompression therapy has not been compared to exercise, spinal manipulation, standard medical care, or other less-expensive conservative treatment options, which have an ample body of research demonstrating efficacy.

In 2020, Cheng et al. (2020) completed a systematic review of seven articles and a meta-analysis of literature including 403 participants. The criteria assessed in the randomized control trial included participants with low back pain, with or without sciatica, and those with herniated disc(s) confirmed by magnetic resonance imaging (MRI) or computed tomography (CT). The analysis compared individuals that received any type of traction to the lumbar spine or no traction and pain measurements before and after intervention. The authors concluded that lumbar traction was effective in the short term for reducing low back pain in those with a lumbar herniated disc, but further studies are needed to determine long term effectiveness.

A systematic review with meta-analysis was published in 2021 by Vanti et al. The authors evaluated the efficacy of mechanical traction with or without other conservative treatments on pain and disability in adults with lumbar radiculopathy.Results of the review demonstrated that supine mechanical traction added to physical therapy had significant effects on pain and disability, whereas prone mechanical traction added to physical therapy did not demonstrate these effects.

PRACTICE GUIDELINES

The American College of Physicians published a clinical practice guideline in 2017 on noninvasive treatments for acute, subacute, and chronic low back pain including vertebral axial decompression. The guideline indicated evidence was low quality and showed no clear differences between traction and other active treatments, between traction plus physiotherapy versus physiotherapy alone, or the effectiveness between different types of traction in individuals with low back pain with or without radiculopathy.

The North American Spine Society published coverage guidelines in 2020 on the treatment of chronic low back pain with traction for individuals with subacute or chronic low back pain indicating the evidence is insufficient to recommend traction to provide clinically significant improvements in pain or function.

References

Agency for Healthcare Research and Quality (AHRQ). Decompression therapy for the treatment of lumbosacral pain Technology Assessment Report [AHRQ Web site] 2007. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id47TA.pdf. Accessed February 20, 2024.

Apfel CC, Cakmakkaya OS, Martin W, et al. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010;11:155.

Beattie PF, Nelson RM, Michener LA, et al. Outcomes after a prone lumbar traction protocol for patients with activity-limiting low back pain: a prospective case series study. Arch Phys Med Rehabil. 2008;89(2):264-274.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 160.16: Vertebral axial decompression (VAX-D). [CMS Web site]. 04/15/97. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=124&ncdver=1&bc=AgAAgAAAAAAA&. Accessed February 20, 2024.

Cheng Y-H, Hsu C-Y, Lin Y-N. The effect of mechanical traction on low back pain in patients with herniated intervertebral disks: a systemic review and meta-analysis. Clin Rehabil. 2020;34(1):13-22.

Daniel DM. Non-surgical spinal decompression therapy: does the scientific literature support efficacy claims made in the advertising media? Chiropr Osteopat. 2007;15:7.

Deen HG Jr, Rizzo TD, Fenton DS. Sudden progression of lumbar disk protrusion during vertebral axial decompression traction therapy. Mayo Clin Proc. 2003;78(12):1554-1556.

Fritz JM, Lindsay W, Matheson JW, et al. Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis. Spine. 2007;32(26):E793-800.

Gay RE, Brault JS. Evidence-informed management of chronic low back pain with traction therapy. Spine J. 2008;8(1):234-242.

Gose EE, Naguszewski WK, Naguszewski RK. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurol Res.1998;20(3):186-190.

Harte AA, Baxter GD, Gracey JH. The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord. 2007;(8):118.

Issac Z, Atlas SJ, Law K. Management of non-radicular neck pain in adults. Revised: 01/12/2024. Available at: http://www.uptodate.com/contents/treatment-of-neck-pain?source=search_result&search=cervical+non-surgical+spinal+decompression&selectedTitle=8~150 [via subscription only]. Accessed February 20, 2024.

Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006;6(3):171-178.

Macario A, Richmond C, Auster M, Pergolizzi JV. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract. 2008;8(1):11-17.

North American Spine Society. Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis & treatment of low back pain. 2020. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf. Accessed February 20, 2024.

Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514-530.

Ramos G. Efficacy of vertebral axial decompression on chronic back pain: study of dosage regimen. Neurol Res. 2004;26(3):320-324.

Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg.1994;81(3):350-353.

Schimmel JJ, de Kleuver M, Horsting PP, et al. No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy. Eur Spine J. 2009;18(12):1843-1850.

Sherry E, Kitchener P, Smart R. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurol Res. 2001;23(7):780-784.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. DRX9000 True Non-Surgical Spinal Decompression System. 510(k) summary. [FDA Web site]. 05/26/2006. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060735.pdf . Accessed February 20, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. SpineMed. 510(k) summary. [FDA Web site]. 04/27/2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051013.pdf. Accessed February 20, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. VAX-D Genesis G2. 510(k) summary. [FDA Web site]. 10/05/2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071347.pdf. Accessed February 20, 2024.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Triton/Tru-Trac/TX/Triton DTS Traction System. 510(k) summary. [FDA Web site]. 05/24/2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053223.pdf. Accessed February 20, 2024.

Vanti C, Turone L, Panizzolo A, et al. Vertical traction for lumbar radiculopathy: a systematic review. Arch Physiother. 2021;11(1):7.

Coding

CPT Procedure Code Number(s)

DO NOT USE THE FOLLOWING CODES TO REPRESENT NON-SURGICAL SPINAL DECOMPRESSION THERAPY:

97012, 97039, 97799

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.

HCPCS Level II Code Number(s)

S9090 Vertebral axial decompression, per session

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.08.01f:

03/06/2024	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.
02/22/2023	This policy has been reissued in accordance with the Company's annual review process.
05/18/2022	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.
05/19/2021	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.
06/17/2020	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.
09/25/2019	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.
04/25/2018	The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

3/28/2016

Version Issued Date:

3/28/2016

Version Reissued Date:

3/6/2024