Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Non-Surgical Spinal Decompression Therapy

Policy #:07.08.01e

The below medical or claim payment policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products for dates of service on or after 1/01/2015 are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Intent

The intent of this policy is to communicate that non-surgical spinal decompression therapy is considered experimental/investigational.

This policy does not address standard traction devices that may be used in a home setting. For information on policies related to this topic, refer to the Cross References section in this policy.
Description

Non-surgical 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. Non-surgical spinal decompression therapy is designed to apply distraction tension to the individual's lumbar and/or cervical spine to non-surgically decompress the spine and intervertebral discs.

There are various devices on the market to deliver non-surgical 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 (eg, 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 (ie, 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.

Evidence of the efficacy of non-surgical 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 JJ, de Kleuver M, Horsting PP, et al. 2009) did not show a benefit compared to the control group. Also, non-surgical 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.
Policy

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

BILLING REQUIREMENTS

Non-surgical 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 non-surgical spinal decompression therapy. These services are subject to post-payment review and audit procedures.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, non-surgical 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.

MEDICARE

This policy is consistent with Medicare's coverage determination.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for non-surgical spinal decompression therapy.

References

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, Cammarata J, Donley J. 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 4, 2013.

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. The Spine Journal. 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.

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):11-7.

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):1843-50.

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.

Up-to-Date. Treatment of neck pain. 01/17/12. Available at: http://www.uptodate.com/contents/treatment-of-neck-pain?source=search_result&search=cervical+non-surgical+spinal+decompression&selectedTitle=8%7E150 [via subscription only]. Accessed February 4, 2013.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. SpineMed. 510(k) summary. [FDA Web site]. 04/27/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051013.pdf. Accessed February 4, 2013.

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]. 05/26/06. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060735.pdf. Accessed February 4, 2013.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. VAX-D Genesis G2. 510(k) summary. [FDA Web site]. 10/05/07. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071347.pdf. Accessed February 4, 2013.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A

ICD - 9 Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

ICD-10-PCS codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.



ICD - 9 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses.

ICD -10 Diagnosis Code Number(s)

ICD-10-CM codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.



HCPCS Level II Code Number(s)

S9090: Vertebral axial decompression, per session

Revenue Code Number(s)

N/A


Cross References



Version Effective Date: 03/27/2013



2014 AmeriHealth.