Local Coverage Determination (LCD): Spinal Cord Stimulation (Dorsal Column Stimulation) (L34705)

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1 Local Coverage Determination (LCD): Spinal Cord Stimulation (Dorsal Column Stimulation) (L34705) Contractor Information Contractor Name Novitas Solutions, Inc. LCD Information Document Information LCD ID L34705 LCD Title Spinal Cord Stimulation (Dorsal Column Stimulation) Original Effective Date For services performed on or after 07/24/2014 AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and Revision Effective Date For services performed on or after 07/24/2014 Revision Ending Date Retirement Date Notice Period Start Date 06/05/2014 Notice Period End Date 07/23/2014

2 CDT-2010 are trademarks of the American Dental Association. CMS National Coverage Policy This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Spinal Cord Stimulation (Dorsal Column Stimulation). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Spinal Cord Stimulation (Dorsal Column Stimulation) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies regarding Spinal Cord Stimulation (Dorsal Column Stimulation) are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site: Medicare Benefit Policy Manual Pub Medicare National Coverage Determinations Manual Pub : Chapter 1, Section (specific to the coverage of electrical nerve stimulators). Correct Coding Initiative Medicare Contractor Beneficiary and Provider Communications Manual Pub , Chapter 5. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claims that lacks the necessary information to process the claim. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier. Spinal cord stimulation blocks pain conduction pathways to the brain and may stimulate endorphins. The neurostimulator electrodes used for this purpose are implanted percutaneously in the epidural space through a special needle. Some patients may need an open procedure requiring laminectomy to place the electrodes.

3 After placement of the electrodes, the patient is provided with an external neurostimulator, initially on a trial basis. The trial period may be extended up to four weeks. If during the trial period it is determined that the modality is not effective, or it is not acceptable to the patient, the electrodes may be removed. If the trial has been successful, a spinal neurostimulator and pulse generator are inserted subcutaneously and connected to the implanted electrodes. In some cases, the trial may be conducted using temporary electrodes. Indications Dorsal column stimulators may be covered as therapies for the relief of chronic intractable pain under the following circumstances: To treat chronic pain caused by lumbosacral arachnoiditis that has not responded to medical management including physical therapy. (Presence of arachnoiditis is usually documented by presence of high levels of proteins in the Cerebrospinal Fluid (CSF) and/or by myelography or Magnetic Resonance Imaging (MRI).) To treat intractable pain caused by nerve root injuries, post-surgical or post-traumatic including that of post-laminectomy syndrome (failed back syndrome). To treat intractable pain caused by complex regional pain syndrome I & II. To treat intractable pain caused by phantom limb syndrome that has not responded to medical management. To treat intractable pain caused by end-stage peripheral vascular disease, when the patient cannot undergo revascularization or when revascularization has failed to relieve painful symptoms and the pain has not responded to medical management. To treat intractable pain caused by post-herpetic neuralgia. To treat intractable pain caused by plexopathy. To treat intractable pain caused by intercostal neuralgia that did not respond to medical management and nerve blocks. To treat intractable pain caused by cauda equina injury. To treat intractable pain caused by incomplete spinal cord injury. Limitations No payment may be made for the implantation of dorsal column stimulators or services and supplies related to such implantation, unless all of the following conditions have been met: The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain.

4 Other treatment modalities (pharmacological, surgical, physical or psychological therapies) have been tried and did not prove satisfactory or are judged unsuitable or contraindicated for the given patient. Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation (such screening must include psychological as well as physical evaluation). All facilities, equipment and personnel required for the proper diagnosis, treatment, training and follow-up of the patient must be available. Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation. Generally, electronic analysis services (CPT codes 95970, 95971, 95972, and 95973) are not considered medically necessary when provided at a frequency more often than once every 30 days. More frequent analysis may be necessary in the first month after implantation. Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. As published in CMS IOM , Section , to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: Safe and effective. Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the clinical trials NCD are considered reasonable and necessary). Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: o o o o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient s condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient s medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient s medical needs.

5 o At least as beneficial as an existing and available medically appropriate alternative. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 013x Hospital Outpatient 083x Ambulatory Surgery Center 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Publication , Claims Processing Manual, for further guidance. 036X Operating Room Services - General Classification CPT/HCPCS Codes Group 1 Paragraph: Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) codes. Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT

6 book. Group 1 Codes: Implant neuroelectrodes Implant neuroelectrodes Remove spine eltrd perq aray Remove spine eltrd plate Revise spine eltrd perq aray Revise spine eltrd plate Insrt/redo spine n generator Analyze neurostim no prog Analyze neurostim simple Analyze neurostim complex Analyze neurostim complex L8680 Implt neurostim elctr each L8681 Pt prgrm for implt neurostim L8682 Implt neurostim radiofq rec L8683 Radiofq trsmtr for implt neu L8685 Implt nrostm pls gen sng rec L8686 Implt nrostm pls gen sng non L8687 Implt nrostm pls gen dua rec L8688 Implt nrostm pls gen dua non L8689 External recharg sys intern L8695 External recharg sys extern L8699 Prosthetic implant NOS ICD-9 Codes that Support Medical Necessity Group 1 Paragraph: Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims. Note: HCPCS Codes L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8695 and L8699 are used for various other services. Medicare is not establishing limited coverage for these codes at this time. The CPT/HCPCS codes included in this LCD will be subjected to procedure to diagnosis editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Dual diagnosis requirement: Claims submitted for spinal cord stimulation must include both a

7 primary ICD-9-CM diagnosis code indicating the reason for the procedure and a secondary ICD-9-CM diagnosis code indicating the etiology of the chronic pain. Medicare is establishing the following limited coverage for CPT/HCPCS codes 63650, and 63685: Primary Diagnosis Codes Covered for: Group 1 Codes: CHRONIC PAIN DUE TO TRAUMA OTHER CHRONIC POSTOPERATIVE PAIN NEOPLASM RELATED PAIN (ACUTE) (CHRONIC) CHRONIC PAIN SYNDROME Group 2 Paragraph: Secondary Diagnosis Codes Covered for: Group 2 Codes: POSTHERPETIC TRIGEMINAL NEURALGIA HERPES ZOSTER WITH OTHER NERVOUS SYSTEM COMPLICATIONS MENINGITIS UNSPECIFIED REFLEX SYMPATHETIC DYSTROPHY OF THE UPPER LIMB - REFLEX SYMPATHETIC DYSTROPHY OF THE LOWER LIMB REFLEX SYMPATHETIC DYSTROPHY OF OTHER SPECIFIED SITE BRACHIAL PLEXUS LESIONS - LUMBOSACRAL PLEXUS LESIONS PHANTOM LIMB (SYNDROME) OTHER NERVE ROOT AND PLEXUS DISORDERS CAUSALGIA OF UPPER LIMB OTHER MONONEURITIS OF UPPER LIMB - MONONEURITIS OF UPPER LIMB UNSPECIFIED CAUSALGIA OF LOWER LIMB OTHER MONONEURITIS OF LOWER LIMB MONONEURITIS OF LOWER LIMB UNSPECIFIED ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH REST PAIN POSTLAMINECTOMY SYNDROME OF CERVICAL REGION - POSTLAMINECTOMY SYNDROME OF LUMBAR REGION BRACHIAL NEURITIS OR RADICULITIS NOS SCIATICA

8 724.4 THORACIC OR LUMBOSACRAL NEURITIS OR RADICULITIS UNSPECIFIED C1-C4 LEVEL SPINAL CORD INJURY UNSPECIFIED - C5-C7 LEVEL WITH OTHER SPECIFIED SPINAL CORD INJURY T1-T6 LEVEL SPINAL CORD INJURY UNSPECIFIED - T7-T12 LEVEL WITH OTHER SPECIFIED SPINAL CORD INJURY LUMBAR SPINAL CORD INJURY WITHOUT SPINAL BONE INJURY CAUDA EQUINA SPINAL CORD INJURY WITHOUT SPINAL BONE INJURY MULTIPLE SITES OF SPINAL CORD INJURY WITHOUT SPINAL BONE INJURY - UNSPECIFIED SITE OF SPINAL CORD INJURY WITHOUT SPINAL BONE INJURY INJURY TO CERVICAL NERVE ROOT - INJURY TO LUMBOSACRAL PLEXUS INJURY TO MULTIPLE SITES OF NERVE ROOTS AND SPINAL PLEXUS - INJURY TO UNSPECIFIED SITE OF NERVE ROOTS AND SPINAL PLEXUS ICD-9 Codes that DO NOT Support Medical Necessity Paragraph: Codes: BIPOLAR I DISORDER, SINGLE MANIC EPISODE, UNSPECIFIED - BIPOLAR I DISORDER, SINGLE MANIC EPISODE, IN FULL REMISSION MANIC AFFECTIVE DISORDER RECURRENT EPISODE UNSPECIFIED DEGREE - MANIC AFFECTIVE DISORDER RECURRENT EPISODE IN FULL REMISSION MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE UNSPECIFIED DEGREE - MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE IN FULL REMISSION MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE UNSPECIFIED DEGREE - MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE IN FULL REMISSION BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, UNSPECIFIED - BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, IN FULL REMISSION BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, UNSPECIFIED - BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, IN FULL REMISSION BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, UNSPECIFIED - BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, IN FULL REMISSION BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) UNSPECIFIED BIPOLAR DISORDER, UNSPECIFIED - ATYPICAL DEPRESSIVE DISORDER OTHER AND UNSPECIFIED BIPOLAR DISORDERS, OTHER

9 UNSPECIFIED EPISODIC MOOD DISORDER OTHER SPECIFIED EPISODIC MOOD DISORDER DEPRESSIVE TYPE PSYCHOSIS DYSTHYMIC DISORDER ADJUSTMENT DISORDER WITH DEPRESSED MOOD ADJUSTMENT REACTION WITH PROLONGED DEPRESSIVE REACTION 311 DEPRESSIVE DISORDER NOT ELSEWHERE CLASSIFIED General Information Associated Information Documentation Requirements 1. Documentation supporting medical necessity should be legible, maintained in the patient s medical record and made available to Medicare upon request. 2. For CPT codes (revise spine eltrd perq array) and (revise spine eltrd plate), documentation must include the date the initial insertion was performed. Utilization Guidelines In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice. Generally, the physician should be able to determine whether the patient is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of four weeks. In a few cases, this determination may take longer to make. Documentation of the medical necessity for such diagnostic services furnished beyond four weeks must be provided upon request for redetermination. Generally, electronic analysis services (CPT codes 95970, 95971, 95972, and 95973) are not considered medically necessary when provided at a frequency more often than once every 30 days. More frequent analysis may be necessary in the first month after implantation. Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the

10 number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. Sources of Information and Basis for Decision L32753, Spinal Cord Stimulation (Dorsal Column Stimulation), Novitas Solutions Jurisdiction H Local Coverage Determination Other Contractor Policies Contractor Medical Directors Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date 07/24/2014 R1 Revision History Number Revision History Explanation LCD posted for notice on 06/05/2014 to become effective 07/24/2014. Please note that through the creation of a uniform LCD across Novitas MAC jurisdictions, this LCD has been assigned a new LCD number. Spinal Cord Stimulation (Dorsal Column Stimulation) LCDs currently in effect will be retired when this LCD becomes effective. 01/16/2014 Draft LCD posted for comment. Reason(s) for Change Creation of Uniform LCDs With Other MAC Jurisdiction Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Version(s) Updated on 05/28/2014 with effective dates 07/24/ Updated on 05/28/2014 with effective dates 07/24/2014 -

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