National Medical Policy

National Medical Policy Subject: Policy Number: Spinal Manipulation Under Anesthesia for Chronic Pain NMP125 Effective Date*: March 2004 Updated: August 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 Medicaid Manuals for coverage 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 National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X 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. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Spinal Manipulation Under Anesthesia Aug 15 1

Current Policy Statement Health Net, Inc. does not consider spinal manipulation under anesthesia (SMUA) medically necessary for chronic pain disorders of the spine (cervical, thoracic, lumbar, or sacral) because it has not been established as either safe or effective. Note: Spinal manipulation under anesthesia is appropriate as a closed treatment of vertebral fracture or dislocation. This policy does not address the treatment of vertebral fractures or dislocations, or manipulation of joints under anesthesia. 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 will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 723.0-723.1 Cervicalgia 724.2 Lumbago 724.5 Backache, unspecified ICD-10 Codes M54.12- M54.2 Radiculopathy M54.5 Low back pain M54.6 Pain in thoracic spine M54.8- M54.9 Other dorsalgia CPT Codes 00640 Anesthesia for manipulation of the spine or for closed procedures on the cervical, thoracic, or lumbar spine 22505 Manipulation of spine requiring anesthesia, any region. HCPCS Codes N/A Scientific Rationale Update August 2014 Peterson et al (2014) investigated outcomes of chronic patients unresponsive to previous spinal manipulative therapy subsequently treated with manipulation under anesthesia (MUA). A prospective outcome cohort study was performed on 30 patients who had not improved with previous treatment and who underwent a single MUA by a doctor of chiropractic. The numeric rating scale for pain (NRS) and Spinal Manipulation Under Anesthesia Aug 15 2

Bournemouth Questionnaire (BQ) were collected at 2weeks and 1day before MUA. At 2 and 4weeks after MUA, the Patient's Global Impression of Change, NRS, and BQ were collected. The intraclass correlation coefficient evaluated stability before treatment. Percentage of patients "improved" was calculated at 2 and 4weeks. Wilcoxon test compared pretreatment NRS and BQ scores with posttreatment scores. Mann-Whitney U test compared individual questions on the BQ between improved and not improved patients. Logistic regression compared BQ questions to "improvement." Good stability of NRS and BQ scores before MUA (intraclass correlation coefficient=0.46-0.95) was found. At 2weeks, 52% of the patients reported improvement with 45.5% improved at 4weeks. Significant reductions in NRS scores at 4weeks (P=.01) and BQ scores at 2 (P=.008) and 4weeks (P=.001) were reported. Anxiety/stress levels were significantly different at 2 and 4weeks between improved and not improved patients (P=.007). None of the BQ questions were predictive of improvement. Investigators concluded approximately half of patients previously unresponsive to conservative treatment reported clinically relevant improvement at 2 and 4 weeks post-mua. Controlled clinical trials are needed to determine if SMUA is a potential treatment option for individuals with chronic spine pain. Scientific Rationale - Update February 2008 There continues to be a lack of evidence in the peer review literature to demonstrate that spinal manipulation under anesthesia or sedation is an effective treatment for chronic back pain. Further studies are still needed to determine whether spinal manipulation under anesthesia or sedation provides clinically significant benefits for patients who have chronic back pain. Buchman et al. (2005) compared two different manual treatments, spinal manipulation and postisometric relaxation, for dysfunctional motion segments of the upper cervical spinal column evaluated spinal manipulation under anesthesia in 26 patients. Patients were assigned to an Active Control Group treated with postisometric relaxation (n=8), an Active Treatment Group that underwent spinal manipulation under anesthesia (n=10), or a Placebo Group that underwent placebo spinal manipulation. Patients were examined manually at four testing times: before and after manual treatment, in anesthesia, and within 24 hrs of completing anesthesia. The investigator reported a highly significant effect for both treatments post therapeutically but not for placebo. In anesthesia, the treatment effect of spinal manipulation was further significant when compared with placebo. For postisometric relaxation, however, it was not. A significant difference between spinal manipulation and postisometric relaxation was not found in anesthesia. The treatment effect post narcotically was further significant when compared with placebo only for spinal manipulation. The investigator concluded that both treatments were superior to placebo noting that postisometric relaxation seemed to affect mainly the muscular parts of the treated segments and less so the other parts, while spinal manipulation seemed to influence all other segmental parts more effectively, and the treatment effect persists longer. Although this small randomized controlled trial found that patients had statistically significant improvements in spinal mobility after treatment, this study did not measure pain or disability so it is unclear if patients obtained clinical benefits. Cremata et al. (2005) reported the results of manipulation under anesthesia (MUA) for 4 patients with chronic spinal, sacroiliac, and/or pelvic and low back pain. Patients with chronic pain who had not adequately responded to conservative Spinal Manipulation Under Anesthesia Aug 15 3

medical and/or a reasonable trial (4 months minimum) of chiropractic adjustments, and had no contraindications to anesthesia or adjustments, were included in the study. The 4 patients went through 3 consecutive days of MUA followed by an 8- week protocol of the same procedures plus physiotherapy in-office without anesthesia. Data included pre- and post-mua passive ranges of motion, changes in the visual analog scale, and neurologic and orthopedic examination findings. The patients had follow-up varying from 9 to 18 months. The author reported that an increases in passive ranges of motion, decreases in the visual analog scale rating, and diminishment of subsequent visit frequency were seen in each of the patients. They concluded that manipulation under anesthesia was an effective approach to restoring articular and myofascial movements for these 4 patients who did not adequately respond to either medical and/or in-office conservative chiropractic adjustments and adjunctive techniques. Scientific Rationale - Update February 2006 An updated Medline search failed to identify any additional published studies that would alter the conclusions reached above. Scientific Rationale - Initial Spinal manipulation under anesthesia is a noninvasive procedure using a combination of specific short lever manipulations, passive stretches and specific articular and postural kinesthetic maneuvers to break up fibrous adhesions and scar tissue around the spine and surrounding tissue. It has been used to treat pain arising from the cervical, thoracic and lumbar spine as well as the sacroiliac and pelvic regions for chronic patients who have not adequately responded to a reasonable trial of conservative management that has included spinal manipulation. Contraindications include various conditions such as malignancy with metastasis to bone, tuberculosis of the bone or other infectious disease, recent fractures, arthritis, gout, select disc disorders or spinal stenosis. In the absence of vertebral fracture or dislocation, SMUA is intended to overcome the conscious patient's protective reflex mechanism, which may limit the success of prior attempts of spinal manipulation or adjustment in the conscious patient thereby increasing joint function and reducing pain. Chiropractors and Osteopaths, with the assistance of anesthesiologists, are the specialists that most utilize this procedure. Chiropractor must be appropriately trained by qualified chiropractic and medical instructors in a MUA certification training course with a minimum of 15 supervised MUA treatments prior to receiving course certification. SMUA is usually performed utilizing conscious sedation usually using Pentothal or Diprivan (Propofol), and Versed as the anesthesia. The patient is taken through passive cervical/thoracic and lumbar ranges of motion in flexion, rotation and then stretching of the paraspinal and surrounding supportive musculature. Manipulation usually takes 7 to 10 minutes It is recommended that the patient return to the facility for 2 4 consecutive days for repeat procedures. Each time the procedure is performed, the movements are increased incrementally as it is thought to be more effective than attempting to accomplish the desired effect in a single procedure. Following this procedure, a post- SMUA rehabilitation regimen entailing one week of daily manipulation is implemented to maintain joint mobility and avoid re-adhesion of fibrotic tissue. Spinal Manipulation Under Anesthesia Aug 15 4

Both general anesthesia and conscious sedation carry some risk of anaphylaxis or malignant hyperpyrexia. Complications following lumbar spinal manipulation are uncommon but massive cauda equina compression or vertebral pedicle fracture have been reported. Basivertebral and/or verterbral artery injury can occur with manipulation of the cervical spine. A search of the recently published medical literature did not identify any randomized, controlled clinical trials though several case series were identified, which included patients with cervical, thoracic and lumbar back pain. West et al reported on an uncontrolled study that included 177 patients with back pain. After failing conservative therapy, spinal manipulation under anesthesia was performed in three consecutive sessions. Chiropractic spinal manipulation was then performed for 4 to 6 weeks. Sixty percent improvement was reported at 6 months follow-up. Critiques of the study state that it cannot isolate the contribution of the manipulation under anesthesia compared to the placebo effect, the effect of continued chiropractic therapy, or the natural history of the condition. The authors state there is a need for large-scale studies on MUA. Review History March 16, 2004 February 2006 February 2007 February 2008 February 2010 October 2011 September 2012 September 2013 August 2014 August 2015 Medical Advisory Council, initial approval Update - no revisions Update no revisions Update no revisions Update no revisions to policy statement. Changed name to Spinal Manipulation under anesthesia for chronic pain. Update no revisions Update - no revisions Update no revisions. Codes updated. Update no revisions Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. Hayes. Medical Technology Directory. Hayes Alert. Meta-Analysis Questions Benefit of Spinal Manipulation. Volume VI, Number 6-June 2003. 2. Hayes. Health Technology Brief. Spinal Manipulation Under Anesthesia for the Treatment of Pain. December 30, 2007, Updated December 14, 2009. Archived Jan 2011 References Update August 2015 1. Gordon R, Cremata E, Hawk C. Guidelines for the practice and performance of manipulation under anesthesia. Chiropr Man Therap. 2014;22(1):7. References Update September 2014 1. Digiorgi D. Spinal manipulation under anesthesia: a narrative review of the literature and commentary. Chiropr Man Therap. 2013 May 14;21(1):14. 2. Peterson CK, Humphreys BK, Vollenweider R, et al. Outcomes for Chronic Neck and Low Back Pain Patients After Manipulation Under Anesthesia: A Prospective Cohort Study. J Manipulative Physiol Ther. 2014 Jul 3. References Update September 2013 1. Rosenquist EWK. Overview of the treatment of chronic pain. UpToDate. October 31, 2012. Spinal Manipulation Under Anesthesia Aug 15 5

References Update September 2012 1. Reid RJ, Desimone R, Eubank B. Manipulation Under Anesthesia for Pain. Spine- Health. 2012. References Update October 2011 1. Kawchuk GN, Haugen R, Fritz J. A true blind for subjects who receive spinal manipulation therapy. Arch Phys Med Rehabil. 2009 Feb;90(2):366-8. References - Update February 2008 1. Cremata E, Collins S, Clauson W, et al. Manipulation under anesthesia: a report of four cases. J Manipulative Physiol Ther. 2005 Sep; 28(7): 526-33. 2. Buchmann J, Wende K, Kundt G, et al. Manual treatment effects to the upper cervical apophysial joints before, during, and after endotracheal anesthesia: a placebo-controlled comparison. Am J Phys Med Rehabil. 2005 Apr; 84(4): 251-7. References - Update February 2006 1. American Chiropractic Association. Spinal manipulation policy statement. Updated 2003. Accessed January 2006. Available at: http://www.acatoday.com/pdf/spinal_manipulation_policy.pdf 2. Assendelft, WJ, Morton, SC, Yu, EI, et al. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med 2003; 138:871. 3. Cherkin, DC, Sherman, KJ, Deyo, RA, Shekelle, PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med 2003; 138:898. 4. Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, et al. Spinal manipulative therapy in the management of cervicogenic headache. Headache. 2005 Oct;45(9):1260-3. 5. Kohlbeck FJ, Haldeman S, Hurwitz EL, et al. Supplemental care with medicationassisted manipulation versus spinal manipulation therapy alone for patients with chronic low back pain. J Manipulative Physiol Ther. 2005 May;28(4):245-52. 6. Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med. 2002 May;112:566-71. References - Initial 1. Guidelines for Chiropractic Quality Assurance and Practice Parameters: Proceedings of the Mercy Center Consensus Conference, Burlingame, CA, January 25-30, 1992, S Haldeman et al (eds.), Gaithersburg, MD: Aspen Publishers, Inc. 1993. 2. Dreyfuss P, et al. MUJA: Manipulation under joint anesthesia/analgesia: A treatment approach for recalcitrant low back pain of synovial joint origin. J Manipulative Physiol Ther. 1995;18:537-546. 3. Ben-David B, Raboy M. Manipulation under anesthesia combined with epidural steroid injection. J Manipulative Physiol Ther 1994;17:605-9 4. Davis CG. Chronic cervical spine pain treated with manipulation under anesthesia. J Neuromusculoskeletal Syst. 1996;4:102-115. 5. Francis R. Spinal manipulation under general anesthesia: A chiropractic approach in a hospital setting. ACA J Chiro. 1989;12:39-41. Spinal Manipulation Under Anesthesia Aug 15 6

6. West DT, Mathews RS, Miller MR et al. Effective management of spinal pain in one hundred seventy-seven patients evaluated for manipulation under anesthesia. J Manipulative Physiol Ther 1999;22(5):299-308 7. Alexander GK. Manipulation under anesthesia of lumbar post-laminectomy syndrome patients with epidural fibrosis and recurrent HNP. ACA J Chiro. 1993;June:79-81. 8. Dan NG, Saccasan PA. Serious complications of lumbar spinal manipulation. Med J Aust. 1983;2(12):672-673. 9. Hughes BL. Management of cervical disk syndrome utilizing manipulation under anesthesia. J Manipulative Physiol Ther. 1993;16:174-181. 10. Aspegren DD, et al. Manipulation under epidural anesthesia with corticosteroid injection: Two case reports. J Manipulative Physiol Ther. 1997;20(9):618-621. 11. Kohlbeck FJ, Haldeman S. Technical assessment: Medication assisted spinal manipulation. Spine J. 2002;2(4). 12. Palmieri NF, Smoyak S. Chronic low back pain: A study of the effects of manipulation under anesthesia. J Manipulative Physiol Ther. 2002;25(8):E8-E17. 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 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. Spinal Manipulation Under Anesthesia Aug 15 7

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. 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. Spinal Manipulation Under Anesthesia Aug 15 8