mp-484
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Vertebral Axial Decompression

Policy Number: MP-484

Latest Review Date: April 2021

Category: Therapy                                                                 

Policy Grade: B

POLICY:

Vertebral axial decompression is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Vertebral axial decompression applies traction to the vertebral column to reduce intradiscal pressure and, in doing so, potentially relieves low back pain associated with herniated lumbar discs or degenerative lumbar disc disease.

Vertebral axial decompression (also referred to as mechanized spinal distraction therapy) is used as traction therapy to treat chronic low back pain. Specific devices available are described in the Regulatory Status section. In general, during treatment, the patient wears a pelvic harness and lies prone on a specially equipped table. The table is slowly extended, and a distraction force is applied via the pelvic harness until the desired tension is reached, followed by a gradual decrease of the tension. The cyclic nature of the treatment allows the patient to withstand stronger distraction forces compared to static lumbar traction techniques. An individual session typically includes 15 cycles of tension, and 10 to 15 daily treatments may be administered.

KEY POINTS:

This evidence review has been updated periodically using the MEDLINE database. The most recent literature review was performed through March 1, 2021.

Summary of Evidence

For individuals with chronic lumbar pain who receive vertebral axial decompression, the evidence includes RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Evidence for the efficacy of vertebral axial decompression on health outcomes is limited. Because a placebo effect may be expected with any treatment that has pain relief as the principal outcome, RCT with sham controls and validated outcome measures are required. The only sham-controlled randomized trial published to date did not show a benefit of vertebral axial decompression compared with the control group. The evidence is insufficient to that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

No guidelines or statements were identified.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Vertebral axial decompression, VAX-D, Decompression Reduction Stabilization, System, DRS, Accu-Spina System, DRX-3000, DRX90000, DRX,  SpineMED Decompression Table, Antalgic-Trak, Lordex Traction Unit, Triton DTS, Spina System, PDS, ActivTrac, Tru-Trac, Intervertebral Differential Dynamics Therapy

APPROVED BY GOVERNING BODIES:

Several devices used for vertebral axial decompression have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Devices include the VAX-D®, Decompression Reduction Stabilization (DRS®) System, Accu-SPINA® System, DRX-3000®, DRX9000®, SpineMED Decompression Table®, Antalgic-Trak®, Lordex® Traction Unit, and Triton® DTS. According to labeled indications from FDA, vertebral axial decompression may be used as a treatment modality for patients with incapacitating low back pain and for decompression of the intervertebral discs and facet joints.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: FEP does not consider investigational if FDA approved. Claims may be reviewed for medical necessity.

CURRENT CODING: 

The following CPT code should NOT be used to bill for vertebral axial decompression.

CPT Codes:

97012         

Application of a modality to one or more areas; traction, mechanical

The correct HCPCS code should be used to bill for vertebral axial decompression.

HCPCS Codes:

S9090        

Vertebral axial decompression, per session

REFERENCES:

  1. 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):269-274.
  2. Centers for Medicare & Medicaid Services. National Coverage Decision (NCD) for Vertebral Axial Decompression (VAX-D) (160.16). 1997; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx? NCDId=124&ncdver=1&DocID=160.16&ncd_id=160.16&ncd_version=1&basket=ncd*3a%24160.16 *3a%241*3a%24Vertebral+Axial+Decompression+(VAX-D)&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed February 20, 2020.
  3. Centers for Medicare and Medicaid Services. National Coverage Decision for Vertebral Axial Decompression (VAX-D) (160.16). https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=124&ncdver=1&DocID=160.16&ncd_id=160.16&ncd_version=1&basket=ncd*3a%24160.16*3a%241*3a%24Vertebral+Axial+Decompression+(VAX-D)&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed March 7, 2017.
  4. 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. Spin 20-07; 32(26):E793-800.
  5. 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.
  6. Harte AA, Baster GD, Gracey JH. The effectiveness of motorized lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord 2007; 8:118.
  7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  8. Isner-Horobeti ME, Dufour SP, Schaeffer M, et al. High-force versus low-force lumbar traction in acute lumbar sciatica due to disc herniation: a preliminary randomized trial. J Manipulative Physiol Ther. Nov - Dec 2016; 39(9):645-654.
  9. Macario A, Richmond C, Auster M et al. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract 2008; 8(1):11-17.
  10. Peloza J. Non-Surgical Treatments for Lower Back Pain. Spine-health. https://www.spine-health.com/conditions/lower-back-pain/nonsurgical-treatments-lower-back-pain. Updated April 20, 2017. Accessed February 13, 2020.
  11. Peloza J. Non-Surgical Treatments for Lower Back Pain. Spine-health. https://www.spine-health.com/conditions/lower-back-pain/non-surgical-treatments-lower-back-pain. Updated April 20, 2017. Accessed March 1, 2021.
  12. Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg 1994; 81(3):350-353.
  13. Ramos G. Efficacy of vertebral axial decompression on chronic low back pain:  study of dosage regimen. Neurol Res 2004; 26(3):320-324.
  14. 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.
  15. 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.

POLICY HISTORY:

Medical Policy Panel, October 2011

Medical Policy Group, October 2011 (2): New policy

Medical Policy Administration Committee, October 2011

Available for comment October 19 through December 31, 2011

Medical Policy Panel, October 2012

Medical Policy Group, October 2012 (2): Literature search through August 2012.  Policy unchanged.

Medical Policy Panel, October 2013

Medical Policy Group, December 2013 (2): Literature search through August 2013.  Policy statement unchanged. 

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (3): 2014 Updates to Description & Key Points; no change in policy statement

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (7): 2016 Updates to Description & Key Points; no change in policy statement

Medical Policy Panel, April 2017

Medical Policy Group, April 2017 (7): 2017 Updates to Description, Key Points & References; no change in policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (7): Updates to Key Points; no change in policy statement.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Minor updates to Key Points. No new literature to add. No change in policy statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Updates to Description, Key Points, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.