National Medical Policy

National Medical Policy Subject: Policy Number: Vertebral Axial Decompression (VAX-D) NMP42 Effective Date*: October 2003 Updated: November 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Vertebral Axial Decompression (VAX-D)(16.16): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Vertebral Axial Decompression (VAX-D) Nov 15 1

If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net Inc. considers Vertebral axial decompression not medically necessary because it has not been proven to be more or less beneficial than other forms of traction. There lacks large randomized clinical trials compare Vertebral axial decompression with other types of traction, surgery or any other treatment, nor have there been studies on length of treatment. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes 722.10 Lumbar intervertebral disc without myelopathy 722.2 Displacement of intervertebral disc, site unspecified, without myelopathy 722.52 Lumbar or lumbosacral intervertebral disc 722.6 Degeneration of intervertbral disc, site unspecified 722.73 Intervertebral disc disorder with myelopathy 724.2 Backache, unspecified ICD-10 Codes M51.Ø6 Intervertebral disc disorders with myelopathy, lumbar region M51.Ø7 Intervertebral disc disorders with myelopathy, lumbosacral region M51.26 Other intervertebral disc displacement, lumbar region M51.27 Other intervertebral disc displacement, lumbosacral region M51.36 Other intervertebral disc degeneration, lumbar region M51.37 Other intervertebral disc degeneration, lumbosacral region M54.5 Low back pain CPT Codes 97799 Unlisted physical medicine/rehabilitation service or procedure HCPCS Codes S9090 Vertebral axial decompression, per session Scientific Rationale Update February 2011 There continues to be a paucity of well designed controlled clinical trials available to support improved clinical outcomes that have determined that vertebral axial decompression is an effective adjunct to conservative therapy for back pain. There is insufficient evidence in the published, peer-reviewed scientific literature to demonstrate that vertebral axial decompression (VAX-D), used for the treatment of back pain is as effective or more effective than standard established methods of treatment. Vertebral Axial Decompression (VAX-D) Nov 15 2

Scientific Rationale Update November 2008 Several devices used for vertebral axial decompression have received 510 (k) premarket approval from the U. S. Food and Drug Administration (FDA). These include, but are not limited to: VAX-D Therapeutic Table, Decompression Reduction Stabilization [DRS] System, Bass Antalgic-Trak, DRX9000, Healthstar Elite, SpineMED Decompression Table and Accu-Spina System IDD Therapy. Intervertebral Differential Dynamics (IDD) Therapy is marketed as a noninvasive spinal rehabilitation treatment for the treatment of lower back pain due to herniated or bulging discs, degenerative disc disease, posterior facet syndrome, sciatica and acute or chronic back pain. IDD Therapy consists of a physician prescribed treatment period on a device called the Accu-Spina system (North American Medical Corporation) and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. A typical course of treatment consisting of 20 sessions of 25 to 30 minutes, spread over a six-week period. Proponents of IDD therapy claim that this device allows for the controlled distraction of targeted vertebrae to mobilize the joint and to create a negative pressure inside the intervertebral disc. They state that this negative pressure leads to the diffusion of fluid and nutrients into the disc to stimulate its metabolism and promote hydration and healing. The Washington Department of Labor and Industries has published two technology assessments of powered traction devices used for intervertebral decompression. Both reports concluded that published literature had not demonstrated that such devices are more effective than other forms of traction, other conservative treatments, or surgery. The Agency for Healthcare Research and Quality's technology assessment on decompression therapy for the treatment of lumbosacral pain (2007) reported: At this time, there is insufficient, convincing evidence in the peer-reviewed medical literature, in terms of clinical effectiveness and safety to support the use of any method of mechanized spinal distraction therapy for the treatment of low back pain. Of the studies examined for assessment of efficacy, neither included patients over 65 years of age. Adverse event reporting for decompression therapy is infrequent. There was one case report of an enlargement of an existing disc protrusion, and other studies reported worsening of pain in some patients." Daniel et al (2007) reported that only one small randomized controlled trial and several lower level efficacy studies have been performed on spinal decompression therapy. He notes that in general the quality of these studies is questionable. Many of the studies were performed using the VAX-D unit which places the patient in a prone position, however, often companies utilize this research for their marketing although their units place the patient in the supine position. There currently is an ongoing randomized phase IV clinical trial, "Comparison of IDD Therapy and Non-Surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease." This study is looking at a machine (Accu-Spina) that administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program. Vertebral Axial Decompression (VAX-D) Nov 15 3

At this time, the available evidence is limited in quality and quantity to allow for the formulation of evidence-based conclusions regarding the efficacy of vertebral axial decompression therapy as a therapy for chronic back pain. Scientific Rationale Update December 2005 VAX-D continues to be a treatment modality that has not been established as more or less beneficial than other forms of traction. A search of the recent literature continues to reveal that there continue to be no controlled studies that compare VAX-D with other types of traction, surgery or any other treatment, nor have there been studies on length of treatment. Scientific Rationale - Initial Vertebral axial decompression (VAX-D) is a type of lumbar traction that has been investigated as a technique to reduce intravesical pressure and relieve low back pain associated with herniated lumbar discs or degenerative lumbar disc disease. A pelvic harness is worn by the patient. The specially equipped table on which the patient lies is slowly extended, and a distraction force is applied via the pelvic harness until the desired tension is reached. This is followed by a gradual decrease of the tension, and the cycle is repeated. The cyclic nature of the treatment allows the patient to withstand stronger distraction forces compared to static lumbar traction techniques. The level of tension is individually calibrated and recorded. An individual session typically includes 15 cycles of tension, lasting approximately 30 minutes, and 10 to 15 daily treatments may be administered. According to the U.S. Food and Drug Administration (FDA) labeled indications, 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. A search of the MEDLINE database did not identify any published studies that validated the patient outcomes associated with vertebral axial decompression. A 1994 study of five patients reported that intradiscal pressure decreased during the treatment period. In 1998, researchers reported on an uncontrolled case series of 778 patients. Although this study reported improvements in pain, mobility and activity in the majority of patients, the study did not detail methods of patient identification or collection of data and did not indicate the duration of treatment success. Finally, the study was uncontrolled. One more recent study involving 40 patients compared VAX-D to TENS in the treatment of chronic low back pain. Although the authors concluded that a statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D, it is not possible to draw conclusions from this study, as detailed statistics concerning the outcomes for each cohort were not included in the analysis. In addition, the patients were not blinded to the treatment received, so there may have been a negative placebo effect in the TENS cohort. Review History October 16, 2003 December 2005 December 2006 March 2007 January 2008 Medical Advisory Council, initial approval Coding Updates Update - no revisions Vertebral Axial Decompression (VAX-D) Nov 15 4

November 2008 February 2011 November 2011 November 2012 November 2013 November 2014 November 2015 Update. Policy statement unchanged. Scientific rationale updated to include other devices in this category that are also considered investigational and therefore not medically necessary. Update. Added Medicare Table with link to LCD and Article. Added unlisted code. No revisions.. Codes updated.. Codes updated. This policy is based on the following evidence-based guidelines: 1. Washington State Department of Labor and Industries. Vertebral Axial Decompression. (VAX-D) Technology Assessment. 2. Wang G. Powered traction devices for intervertebral decompression: Health technology assessment update. Washington Department of Labor and Industries, June 14, 2004. Available at: http://www.chirobase.org/06dd/vaxd/wa2004.html 3. Martin CW. Vertebral axial decompression for low back pain. Australian Evidence-Based Practice Group, Feb 2005. 4. Jurecki-Tiller M, Bruening W, Tregear S, et al. Decompression therapy for the treatment of lumbosacral pain. Prepared by the ECRI Institute Evidence-Based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) (Contract No. 290-02-0019). Rockville, MD: AHRQ; April 26, 2007. References Update November 2015 1. Clinicaltrials.gov. Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain (Pold-LBP). ClinicalTrials.gov Identifier:NCT01591824. October 18, 2015. References Update November 2014 1. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidencebased guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283 2. Park WM, Kim K, Kim YH. Biomechanical analysis of two-step traction therapy in the lumbar spine. Man Ther. 2014 May 22. References Update November 2012 1. Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic). Encinitas, CA: Work Loss Data Institute; 2011 References Update November 2011 1. Holtzman G, Harris-Hayes M, Hoffman SL, et al. Clinical Examination Procedures to Determine the Effect of Axial Decompression on Low Back Pain Symptoms in People With Chronic Low Back Pain. Orthop Sports Phys Ther. 2011 Oct 25 References Update February 2011 1. Wheeler AH. Pathophysiology of low back pain. emedicine specialties. Last updated May 11, 2010. 2. CMS. Centers for Medicare & Medicaid Services. Local Coverage Article for VAX-D and MEDX - Not Proven Effective (A27882). Vertebral Axial Decompression (VAX-D) Nov 15 5

3. CMS. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD) for Physical Medicine and Rehabilitation Policy (L28290). References Update November 2008 2. Daniel DM. Non-surgical spinal decompression therapy: does the scientific literature support efficacy claims made in the advertising media? Chiropr Osteopat. 2007 May 18; 15:7. 3. Clinical trials. gov. Comparison of IDD Therapy and Non-Surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease. Available at: http://clinicaltrials.gov/ct2/show/nct00165893 4. U.S FDA 510 (K) premarket approval. Spina System. 5. U.S. FDA 510 (k) Summary of Safety and Effectiveness. SpineMED. References Update January 2008 1. Kinkade S. Evaluation and Treatment of Acute Low Back Pain. American Academy of Family Physicians (AAFP). 2007 Apr;75(8):1181-8. 2. Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006 Sep; 6(3): 171-8. References Update - December 2005 1. Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. 2004 Apr;26(3):320-4. References Initial 1. Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994 Sep;81(3):350-3. 2. 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 Oct;23(7):780-4. 3. Tekeoglu I, Adak B, Bozkurt M, Gurbuzoglu N. Distraction of lumbar vertebrae in gravitational traction. Spine. 1998 May 1;23(9):1061-3; discussion 1064. 4. 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 Apr;20(3):186-90. 5. Naguszewski WK, Naguszewski RK, Gose EE. Dermatomal somatosensory evoked potential demonstration of nerve root decompression after VAX-D therapy. Neurol Res. 2001 Oct;23(7):706-14. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and Vertebral Axial Decompression (VAX-D) Nov 15 6

otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Vertebral Axial Decompression (VAX-D) Nov 15 7

Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Vertebral Axial Decompression (VAX-D) Nov 15 8