Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Non-Surgical Spinal Decompression Therapy
Policy #:MA11.021a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

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.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, non-surgical spinal decompression therapy is not eligible for payment under the medical benefits of the Company’s Medicare Advantage plans because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are excluded from the Company's Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

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

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 (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.

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.
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 April 30, 2020.

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. 09/21/2017. 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 April 03, 2018.

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 April 30, 2020.

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 April 30, 2020.

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 April 30, 2020.

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 April 30, 2020.



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)

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

97012, 97039, 97799


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

Coding and Billing Requirements

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

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.





Policy History

Revisions from MA11.021a:

06/17/2020The policy has been reviewed and reissued to communicate the Company's continuing position on Non-Surgical Spinal Decompression Therapy.

09/25/2019This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track.
04/25/2018This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track.
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
03/28/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Non-Surgical Spinal Decompression Therapy.

The following CPT codes have been added to this policy: 97012, 97039, 97799.

Revisions from MA11.021:
01/07/2015This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track.
01/01/2015This is a new policy




Version Effective Date: 03/28/2016
Version Issued Date: 03/28/2016
Version Reissued Date: 06/17/2020