CLINICAL POLICY IMPLANTED ELECTRICAL STIMULATOR FOR SPINAL CORD Policy Number: PAIN 022.3 T2 Effective Date: July 1, 2014 Table of Contents Page CONDITIONS OF COVERAGE................................... COVERAGE RATIONALE……………………………….. U.S. FOOD AND DRUG ADMINISTRATION............... APPLICABLE CODES................................................. REFERENCES............................................................ POLICY HISTORY/REVISION INFORMATION............ 1 1 2 2 3 3 Policy History Revision Information Related Policies: • Bariatric Surgery • Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation • Gastrointestinal Motility Disorders • Occipital Neuralgia and Cervicogenic, Cluster and Migraine Headache The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Member’s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern. CONDITIONS OF COVERAGE Applicable Lines of Business/Products Benefit Type Referral Required This policy applies to Oxford Commercial plan membership General Benefits Package No (Does not apply to non-gatekeeper products) Yes Authorization Required (Precertification always required for inpatient admission) Precertification with Medical Director Review Required Applicable Site(s) of Service No Inpatient, Outpatient (If site of service is not listed, Medical Director review is required) COVERAGE RATIONALE For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 18th edition, 2014, MCG: Implanted Electrical Stimulator, Spinal Cord ACG: A-0243 (AC). Implanted Electrical Stimulator for Spinal Cord: Clinical Policy (Effective 07/01/2014) ©1996-2014, Oxford Health Plans, LLC 1 U.S. FOOD AND DRUG ADMINISTRATION (FDA) Spinal Cord Stimulators (SCS) devices are approved for use “as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain” (FDA, 2004). They are not specifically approved for the treatment of chronic stable angina. Totally implantable SCS systems are regulated by the FDA as Class III premarket-approval (PMA) devices. Examples of these devices include the PRECISION™ Plus SCS (Spinal Cord Stimulator) System (Boston Scientific, MA) and the Genesis™ IPG System (St. Jude Medical, Inc. previously Advanced Neuromodulation Systems, Inc.; Plano, TX). Systems with external transmitters (e.g., X-trel® Neurostimulation Systems [Medtronic, Inc., Minneapolis MN]) are regulated by the FDA as Class II 510(k) Additional information (product code LGW) is available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed March 18, 2014. APPLICABLE CODES The 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. Coverage is determined by the Member’s plan of benefits or Certificate of Coverage. This list of codes may not be all inclusive. CPT®/HCPCS Code 0282T 0283T 0284T 0285T 63650 63655 63685 L8680 L8681 L8682 L8685 L8686 L8687 L8688 Description Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; for trial, including removal at the conclusion of trial period Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; permanent, with implantation of a pulse generator Revision or removal of pulse generator or electrodes, including imaging guidance, when performed, including addition of new electrodes, when performed Electronic analysis of implanted peripheral subcutaneous field stimulation pulse generator, with reprogramming when performed Percutaneous implantation of neurostimulator electrode array, epidural Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling Implantable neurostimulator electrode, each Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Implantable neurostimulator radiofrequency receiver Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension ® CPT is a registered trademark of the American Medical Association. Implanted Electrical Stimulator for Spinal Cord: Clinical Policy (Effective 07/01/2014) ©1996-2014, Oxford Health Plans, LLC 2 REFERENCES The foregoing Oxford policy has been adapted from an existing UnitedHealthcare national policy that was researched, developed and approved by UnitedHealthcare Medical Technology Assessment Committee. [2014T0567C] POLICY HISTORY/REVISION INFORMATION Date • 07/01/2014 • Action/Description Updated list of applicable CPT/HCPCS codes; added 0282T, 0283T, 0284T, 0285T, L8680, L8681, L8682, L8685, L8686, L8687 and L8688 Archived previous policy version PAIN 022.2 T2 Implanted Electrical Stimulator for Spinal Cord: Clinical Policy (Effective 07/01/2014) ©1996-2014, Oxford Health Plans, LLC 3
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