Contractor Information. Proposed/Draft LCD Information

Transcription

1 PROPOSED/DRAFT Local Coverage Determination (LCD): Facet Joint Injections, Medial Branch Blocks, and Facet Joint Radiofrequency Neurotomy (DL33842) Please note: This is a Proposed/Draft policy. Proposed/Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed/Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Contractor Information Contractor Name Noridian Administrative Services, LLC opens in new window Contract Number Contract Type MAC - Part B Proposed/Draft LCD Information Document Information Source LCD ID Proposed LCD ID DL33842 Proposed LCD Title Facet Joint Injections, Medial Branch Blocks, and Facet Joint Radiofrequency Neurotomy 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 CDT-2010 are trademarks of the American Dental Association. Printed on 1/10/2014. Page 1 of 8 Jurisdiction Alaska

2 CMS National Coverage Policy Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Introduction: The facet joints are potential causes of back pain. Facet joints are paired diarthrodial articulations of the superior and inferior articular processes of adjacent vertebrae. The medial branches (MB) of the dorsal rami of the segmental nerves innervate facet joints. The MB nerves from the two adjacent dorsal rami innervate each joint. [Exceptions to this rule are the C2-3 facet joint, which is innervated by the third occipital nerve; and the L5-S1 facet joint, which is innervated by the L4 MB and the L5 dorsal ramus.] Facet joint injection techniques are used in the diagnosis and/or treatment of chronic neck and back pain. The diagnosis of facet-mediated spinal pain is difficult. History and physical exam may suggest, but cannot confirm, the facet pain as the source of pain. There are no imaging modalities (e.g. MRI, SPECT, CT, plain radiographs) or physiological tests (e.g. ROM testing) that have adequate diagnostic power to confidently distinguish the facet joint as the pain source. The absence of high-grade pain relief immediately following either intra-articular (IA) or MB nerve local anesthetic injections is helpful in excluding the facet joint as a pain source. Conversely, high-grade pain relief following dual medial branch blocks (MBBs) performed at separate sessions is the most reliable and valid method available of establishing a facet joint as the source of pain. Dual MBBs are necessary due to the unacceptably high false positive rate of single MBBs. The efficacy of intraarticular facet joint steroid injection in the treatment of neck and back pain has not been established in the literature. However, emerging literature-based evidence and outcomes documented by provider suggest that intraarticular facet injections may provide limited benefit in carefully selected patients. When dual MBBs provide immediate high-grade pain relief, thermal RF neurotomy has been used to denervate the facet joint in hopes of providing longer-term duration of relief. For purposes of this policy, a zygapophyseal (aka facet) joint level refers to the zygapophyseal joint or the two medial branch (MB) nerves that innervate that zygapophyseal joint. For ease of discussion, the term facet joint will be used to connote the zygapophyseal joint throughout this document. A session is defined as all injections/blocks/rf procedures performed on one day and includes medial branch blocks (MBB), intraarticular injections (IA), facet cyst ruptures, and RF ablations. Indications of Coverage: At least 3 months of moderate to severe pain with functional impairment inadequately responsive to conservative care such as NSAIDs, acetaminophen, physical therapy (if tolerated). Predominant axial pain that is not associated with radiculopathy or neurogenic claudication. Absence of non-facet pathology that could explain the source of the patient s pain, such as fracture, tumor, infection, or significant deformity. Clinical assessment that implicates the facet joint as the putative source of pain. General Procedure Requirements: Facet joint interventions (diagnostic and/or therapeutic) must be performed under fluoroscopic or computed tomographic (CT) guidance. Diagnostic Facet Joint Injections: If, after the first MBB injection, the patient experiences 80% relief of their primary (index) pain, lasting a time period consistent with the local anesthetic used, the patient may undergo a second, confirmatory MBB.Since the technique of MBB relies on the patient s perception of pain relief to establish the diagnosis, the patient must have sufficient pain immediately prior to the injection (generally 3/10 NPRS) to be able to detect significant improvement following the injection. Additionally, provocative maneuvers or positions which normally exacerbate index or typical pain must be determined before the injection. Thermal Medial Branch Radiofrequency Neurotomy: Printed on 1/10/2014. Page 2 of 8

3 If adequate, but short term, pain relief occurs following MBB facet joint injections (see Diagnostic Facet Joint Injections), RF neurotomy may be a reasonable treatment option and is the only Medicare reimbursable treatment following two successful MBBs as described in this section. Thermocoagulation with radiofrequency energy may achieve long-lasting pain relief via axonotmesis of the sensory afferent medial branch nerve. Dual MBBs are the ideal prognostic test to select patients for thermal RF neurotomy. Only when dual MBBs provide 80% relief of the primary or index pain, consistent with the expected physiological effects of the agents utilized may facet joint denervation with RF medial branch neurotomy be considered. Repeat denervation procedures involving the same joint will only be considered medically necessary if the patient experienced 50% improvement of pain and improvement in patient specific ADLs documented for at least 6 months. Repeat RF neurotomy to treat recurrent facet joint pain in a patient who has failed other conservative measures may be covered without repeating MBB injections if the patient has experienced significant and prolonged ( 6 months) relief of pain in the past following RF ablation. Therapeutic Intraarticular (IA) Facet Injections: Emerging evidence suggests that benefit from palliative care with IA injections may accrue in some patients and is potentially Medicare reimbursable. There is additional limited evidence that facet joint cyst rupture might be effective in a limited number of patients and is potentially Medicare reimbursable. Provider Qualifications: The CMS Manual System, Pub , Program Integrity Manual, Chapter 13, Section 5.1 ( outlines that "reasonable and necessary" services are "ordered and/or furnished by qualified personnel." Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. Patient safety and quality of care mandate that healthcare professionals who perform Epidural Steroid Injections are appropriately trained and/or credentialed by a formal residency/fellowship program and/ or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program. If the practitioner works in a hospital facility at any time an/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure and utilization of the required associated imaging modalities. Limitations of Coverage: Facet joint nerve injections for the treatment of acute, non-recurrent neck or back pain (<3 months duration) are not considered medically necessary. New onset radiculopathy precludes coverage of facet blockade except radicular pain caused by a facet joint synovial cyst in the lumbar spine. Intraarticular facet block will not be reimbursed as a diagnostic test unless medial branch blocks cannot be performed due to anatomic restrictions. A maximum of five (5) facet joint injection sessions inclusive of medial branch blocks, intraarticular injections, or facet cyst rupture and RF ablations may be performed per year in the cervical/thoracic spine and five (5) in the lumbar spine. For each covered spinal region (cervical/thoracic or lumbar), no more than two (2) thermal RF sessions will be reimbursed in any calendar year, involving no more than four (4) joints per session. Repeat neurotomy procedures involving the same joint will only be considered medically necessary when the patient had 50% improvement of pain and documented improvement in patient specific ADLs documented for at least 6 months. Repeat therapeutic facet joint or medial branch injections involving the same joint will only be considered medically necessary when the patient had 50% improvement of pain and improvement in patient specific ADLs for at least 3 months. Neither conscious sedation nor Monitored Anesthesia Care (MAC) is routinely necessary for intraarticular facet joint injections or medial branch blocks and are therefore not reimbursable. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented. Non-thermal RF modalities for facet joint denervation including chemical, low grade thermal energy (<80 degrees Celsius), as well as pulsed RF are not covered. Intraarticular or extraarticular facet joint prolotherapy is not covered. Printed on 1/10/2014. Page 3 of 8

4 Proposed/Draft Process Information Associated Information Documentation Requirements: This LCD is subject to provisions in the overarching Pain LCD. Documentation appropriately should reflect what individual care was performed on the day of service. The patient s medical record should contain documentation that fully supports the medical necessity for paravertebral facet joint/nerve injections as they are covered by Medicare (please see Indications and Limitations of Coverage and/or Medical Necessity ). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Medical documentation in the patient s medical record should substantiate the suspected diagnosis. For example, "The patient had primarily axial low back pain without a radicular component, no associated neurologic deficit, and the pain was aggravated by hyperextension of the spine with paravertebral tenderness present at L4-5 and L5-S1." Medical documentation should also demonstrate that the patient s pain has been refractory to conservative medical management. The following lists some specific criteria that should be documented in the medical record: Pre-procedural Documentation: Pre-procedural documentation should include a history and physical. In general pre-procedural documentation should include a complete initial evaluation including history and an appropriate focused musculoskeletal and neurological physical examination. There should be a summary of pertinent diagnostic tests or procedures justifying the possible presence of facet joint pain. Specifically, there should be a detailed clinical pain history which includes suspicion of an organic problem, history of functional impairment, at least 3 months of moderate to severe pain, and impairment and unresponsiveness to conservative treatment. There should be documentation of prior inadequate response to or inability to tolerate or participate in conservative management (e.g. any of the following: pharmacologic therapies, naturopathic remedies, acupuncture, physical therapy, graduated exercise, chiropractic care, flexibility and conditioning regimens, soft tissue manipulation, or massage). There should be documentation that the patient s index pain is primarily axial and is not associated with radiculopathy or claudication. There should be documentation of a focused musculoskeletal and neurological physical examination that should include segmental palpation to determine potential sources of mechanical spine pain. Relevant prior diagnostic tests, including spinal imaging and injections, even if performed at other treatment centers, should be summarized. At a minimum, document the findings of plain films to exclude Red Flag pathology. If advanced imaging is performed, document facet joint pathology if it exists. Before proceeding with any additional therapeutic facet interventions, the physician must establish (through review of the patient s pain diary/log, patient report, or other mechanism) and document significant improvement in both the patient s pain symptomatology and patient-specific ADLs following the initial procedure. Repeat denervation procedures involving the same joint will only be considered medically necessary when the patient had 50% improvement of pain, and improvement in patient-specific ADLs documented for at least 6 months is documented. Additional RF ablation of recurrent pain in a patient who has failed other conservative measures may be covered without repeating MBB injections if the patient has experienced significant and prolonged ( 6 months) relief of pain in the past following RF ablation and this is documented. To establish pain relief, pre- and post-injection pain levels must be assessed and documented in the patient s records. Assessment pre- and post-injection must include an evaluation of pain during performance of pain provoking maneuvers. No evidence of contraindications such as bleeding diathesis or predominantly psychogenic pain should be documented pre-procedure. Procedural Documentation: Facet joint interventions must be performed under fluoroscopic or computed tomographic (CT) guidance. Facet joint interventions performed under ultrasound guidance will not be reimbursed. A hard (plain radiograph with conventional film or specialized paper) or digital copy image or images which adequately document the needle position and contrast medium flow (excluding those cases in which using contrast is contra-indicated, such as patients with documented contrast allergies), must be retained. Medications injected, their doses and volumes and concentrations, the site of the injection, and contrast flow patterns should be documented in the patient's medical record. Printed on 1/10/2014. Page 4 of 8

5 With RF neurotomy, electrode position, cannula size, lesion parameters, and electrical stimulation parameters and findings should be documented. Post-procedural Documentation: To document pain relief, pre- and post-injection pain levels must be assessed and include an evaluation of pain following a diagnostic injection, including pain associated with provocative maneuvers or positions. Postprocedural assessment should be performed at least 20 minutes post-block. To ascertain the duration of pain relief, the patient ideally should complete a post-procedure pain diary for at least 6 hours post-injection, during which time the patient should undertake activities that would normally induce pain. Additional Suggested General Procedural Considerations: In order to maintain target specificity, total IA injection volume must not exceed 1.0 ml per cervical joint or 1.5 ml per lumbar joint, including contrast. Larger volumes may be used only when performing a purposeful facet cyst rupture in the lumbar spine. Total MBB anesthetic volume shall be limited to a maximum of 0.5 ml per MB nerve. For a third occipital nerve block, up to 1.0 ml is allowed. In total, no more than 100 mg of triamcinolone or methylprednisolone or 15 mg of betamethasone or dexamethasone or equivalents shall be injected during any single injection session. Additional Suggested Procedural Considerations: Thermal Radiofrequency Neurotomy: Under multiplanar fluoroscopic imaging, RF cannulae should be placed adjacent and maximally parallel to each of the two medial branch nerves innervating the target joint. This best assures an optimal lesion and subsequent prolonged duration of relief. Properly performed electrical stimulation before both injection of local anesthetic and thermal lesioning may improve safety and specificity. The medical record must be made available to Medicare upon request. When the documentation does not meet the criteria for the service rendered, or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits in addition to guidance in this LCD. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Whichever guidance is more restrictive should be adhered to. When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and literature that supports the request. At a minimum two (2) Phase II studies (human feasibility studies suggesting efficacy, pilots) or one (1) Phase III study (primary evidence of safety and efficacy, pivotal) must be submitted for the Medical Director's review. Sources of Information and Basis for Decision Lumbar Reference Bogduk N, Dreyfuss P, Govind J. A Narrative Review of Lumbar Medial Branch Neurotomy for the Treatment of Back Pain. Pain Med. 2009;10: Lord SM, Barnsley L, Bogduk N. The utility of comparative local anesthetic blocks versus placebo-controlled blocks for the diagnosis of cervical zygapophysial joint pain. Clin J Pain Sep;11(3): MacVicar J, Borowczyk J, MacVicar A, et al. Lumbar medial branch radiofrequency neurotomy in New Zealand. Pain Medicine 2013; 14: Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain. A randomized double-blind trial. Spine 2008;33: Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine 2004;29: Printed on 1/10/2014. Page 5 of 8

6 Tekin I, Mirzai H, Ok G, Erbuyun K, Vatansever D. A comparison of convetnional and pulsed radiofrequency denervation in the treatment ofchronic facet joint pain. Clin J Pain 2007;23: Van Kleef M, Barendse GA, Kessels A, et al. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine 1999; 24: Cervical References: Govind J, King W, Bailey B, et al. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiat 2003;74: Husted DS, Orton D, Schofferman J, et al. Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain. J Spinal Disord Tech 2008;21: MacVicar J, Borowczyk J, MacVicar A, et al. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Medicine 2012; 13: Carrier Advisory Committee (CAC) Meetings Meeting Meeting Information Date Advisory Committee Meeting Notes This medical policy will be presented at the Medicare Part B Open Public Meeting September 10, It will again be discussed at the following Carrier Advisory Committee meetings on the following dates: 09/10/2013 Alaska 09/12/2013 Arizona 09/17/2013 Idaho 09/18/2013 Montana 09/12/2013 North Dakota 09/10/2013 Oregon 09/21/2013 South Dakota 09/12/2013 Utah 09/19/2013 Washington 09/10/2013 Wyoming 09/12/2013 Comment Period Start Date 09/10/2013 Comment Period End Date 11/06/2013 Released to Final LCD Date 01/03/2014 Reason for Proposed LCD Provider Education/Guidance Proposed Contact Noridian Healthcare Solutions, LLC JF Part B Contractor Medical Director(s) Policy Development - Medicare Part B - Drafts nd Street S., PO Box 6704 Fargo, ND policyb.drafts@noridian.com Coding Information Printed on 1/10/2014. Page 6 of 8

7 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. 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. CPT/HCPCS Codes Group 1 Paragraph: Group 1 Codes: (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; SINGLE LEVEL (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; SECOND LEVEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; THIRD AND ANY ADDITIONAL LEVEL(S) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; SINGLE LEVEL (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; SECOND LEVEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; THIRD AND ANY ADDITIONAL LEVEL(S) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); CERVICAL OR THORACIC, SINGLE FACET JOINT DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); CERVICAL OR THORACIC, EACH ADDITIONAL FACET JOINT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); LUMBAR OR SACRAL, SINGLE FACET JOINT DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); LUMBAR OR SACRAL, EACH ADDITIONAL FACET JOINT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) ICD-9 Codes that Support Medical Necessity Printed on 1/10/2014. Page 7 of 8

8 Group 1 Paragraph: Group 1 Codes: CERVICAL SPONDYLOSIS WITHOUT MYELOPATHY THORACIC SPONDYLOSIS WITHOUT MYELOPATHY LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY 724.8* OTHER SYMPTOMS REFERABLE TO BACK * NONUNION OF FRACTURE Group 1 Medical Necessity ICD-9 Codes Asterisk Explanation: *724.8* Use for FACET SYNDROME ONLY * Use for PSEUDOARTHROSIS ONLY ICD-9 Codes that DO NOT Support Medical Necessity Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Keywords Read the LCD Disclaimer opens in new window Printed on 1/10/2014. Page 8 of 8