Sympathetic Electrical Stimulation Therapy for Chronic Pain Policy Number: 015M0076A Effective Date: April 01, 015 RETIRED 5/11/017 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION COVERAGE RATIONALE/CLINICAL CONSIDERATIONS BACKGROUND REGULATORY STATUS CLINICAL EVIDENCE APPLICABLE CODES REFERENCES POLICY HISTORY/REVISION INFORMATION 3 3 4 4 Spinal Cord Stimulator 014M000B Gastric Electrical Stimulation For Gastroparesis 013M001A Deep Brain Stimulation 01M0005A Pelvic Floor Electrical Stimulation for the Treatment of Urinary Incontinence 013M008A Neuromuscular Electrical Stimulation for Muscle Rehabilitation 015M0074A INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page. 1 of 5
POLICY DESCRIPTION: This policy describes the use of electrical stimulation to the surface of the skin for the purpose of treating chronic pain. Treatment by sympathetic electrical stimulation therapy, also called Sympathetic Therapy System (STS), consists of placing electrodes on the surface of the patient s lower legs and feet or arms and hands and applying mild electrical current. The current treats the entire body. Other machines that use electric currents, such as TENS (transcutaneous electrical nerve stimulation) or interferential electrical stimulation, treat only parts of the body, or localized areas. Treatments typically begin as a series in an outpatient setting followed by treatments in the home. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: Sympathetic electrical stimulation for chronic pain is considered EXPERIMENTAL AND/OR INVESTIGATIONAL due to insufficient clinical evidence of safety and/or efficacy in published, peerreviewed medical literature. Therefore this health service is NOT MEDICALLY NECESSARY. Clinical Considerations: Clinical evidence does not support sympathetic electrical stimulation for treatment of chronic pain. There are no controlled studies that demonstrate the safety and efficacy of this treatment over other treatments for chronic pain. There is an expectation that the advantages, harms and alternatives of the procedure will be explained to the patient. BACKGROUND: Sympathetic electrical stimulation therapy, generally referred to as sympathetic therapy, is a type of electrical stimulation of the peripheral nerves of the sympathetic nervous system in an effort to "normalize" the autonomic nervous system and alleviate chronic pain. Unlike transcutaneous electrical nerve stimulation (TENS) or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain. Sympathetic therapy uses 4 intersecting channels of various frequencies with bilateral electrode placement on the feet, legs, arms, and hands. Electrical current is induced with beat frequencies between 0 and 1000 Hz. Treatment may include daily 1-hour treatments in the physician s office, followed by home treatments. REGULATORY STATUS: Page. of 5
1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): US Food and Drug Administration (FDA) clearance in 001 through a 510(k) process. The FDA-labeled indication is as follows: "Electrical stimulation delivered by the Dynatron STS and Dynatron STS Rx is indicated for providing symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.". CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): CMS Medicare does not have a National Coverage Determination (NCD) for sympathetic electrical stimulation for treatment of chronic pain. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. No Local Coverage Determinations (LCD) for sympathetic electrical stimulation for treatment of chronic pain were identified. 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Use of the Sympathetic Therapy System (e.g. Dynatron STS) is considered investigative for all indications. CLINICAL EVIDENCE: Only one clinical trial was identified in a search of published literature. SUMMARY: There is insufficient evidence from well-designed, randomized clinical trials regarding the impact of sympathetic therapy upon patient management and health outcomes for the treatment of pain or for any other indication. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. Coding information generally will not be entered at the time of policy development. Coding information is provided by Claim Medical Management and added to the policy at a later date. HCPCS Codes E1399 Durable medical equipment, miscellaneous A9900 Miscellaneous DME supply, accessory, and/or service component of another HCPCS code ICD-9 Codes 337.0 Reflex sympathetic dystrophy, unspecified Page. 3 of 5
337.1 Reflex sympathetic dystrophy of the upper limb 337. Reflex sympathetic dystrophy of the lower limb 337.9 Reflex sympathetic dystrophy of other specified site 338.9 Other chronic pain 338.4 Chronic pain syndrome 356.9 Unspecified peripheral neuropathy ICD-10 Codes G60 G71 G89 G98 M60 M79 CPT Codes Hereditary and idiopathic neuropathy Primary disorders of muscles Pain, not elsewhere classified Other disorders of nervous system not elsewhere classified Myositis Other and unspecified soft tissue disorders, not elsewhere classified 64999 Unlisted procedure, nervous system CPT is a registered trademark of the American Medical Association. REFERENCES: 1. BlueShield of Idaho. The Regence Group. Policy No: 83.08. Sympathetic Electrical Stimulation Therapy. Last reviewed June 014. Available at: http://blue.regence.com/trgmedpol/dme/index.html Accessed February, 015.. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. AJPM 00;1:31-34. 3. Sacks SM, Ernst JA. Retrospective study of sympathetic therapy for pain attenuation in 197 patients. Unpublished. Available from the manufacturer, Dynatronics Corp. POLICY HISTORY: DATE ACTION/DESCRIPTION 0-16-015 New Policy number 015M0076A. Reviewed and approved by the Medical Policy Committee. 0/6/015 Reviewed and approved by the Quality Improvement Advisory and Credentialing Committee (QIACC). 03/01/015 Published to ucare.org Page. 4 of 5
07/01/015 Policy Update: Added applicable ICD-10 codes to the Coding Section. The list of codes may not be all-inclusive and does not denote coverage. Page. 5 of 5