Proposed LCD - Facet Joint Interventions for Pain Management (DL35936)

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Facet Joint Interventions for Pain Management. 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 Facet Joint Interventions for Pain Management 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 may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and BiologicalsCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual, Chapter 1,Part 1, Section 30.3 for AcupuncturePart 2, Section 150.7 for Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing AgentsPart 4, Section 220.1 for Computed Tomography (CT)CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 13,Section 10.1 Billing Part B Radiology Services and Other Diagnostic ProceduresSection 20 Payment Conditions for Radiology ServicesSection 30 Computerized Axial Tomography (CT) ProceduresCMS IOM Publication 100-08,Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References: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 claim that lacks the necessary information to process the claim.Coverage Indications, Limitations, and/or Medical NecessityA. Facet Joint Interventions generally consist of four types of procedures: Intraarticular (IA) Facet Joint Injections, Medial Branch Blocks (MBB), Radiofrequency Ablations (RFA) and Facet cyst rupture/aspiration:Facet Joint Interventions are considered medically reasonable and necessary for the diagnosis and treatment of chronic pain in patients who meetALLthe following criteria:Moderate to severe chronic neck or low back pain, predominantly axial, that causes functional deficit measured on pain or disability scale*Pain present for minimum of 3 months with documented failure to respond to noninvasive conservative management (as tolerated)Absence of untreated radiculopathy or neurogenic claudication (except for radiculopathy caused by facet joint synovial cyst)There is no non-facet pathology per clinical assessment or radiology studies that could explain the source of the patients pain, including but not limited to fracture, tumor, infection, or significant deformity.*Pain assessment must be performed and documented at baseline, after each diagnostic procedure using thesamepain scale for each assessment. A disability scale must also be obtained at baseline to be used for functional assessment (if patient qualifies for treatment).A. Diagnostic Facet Joint Procedures (IA or MBB):The primary indication of a diagnostic facet joint procedure is to diagnose whether the patient has facet syndrome. Intraarticular (IA) facet block(s) are considered reasonable and necessary as a diagnostic test only if medial branch blocks (MMB) cannot be performed due to specific documented anatomic restrictions or there is an indication to proceed with therapeutic intraarticular injections. These restrictions must be clearly documented in the medical record and made available upon request.Diagnostic procedures should be performed with the intent that if successful, radiofrequency ablation (RFA) procedure would be considered the primary treatment goal at the diagnosed level(s).A second diagnostic facet procedure is considered medically necessary to confirm validity of the initial diagnostic facet procedure when administered at the same level. The second diagnostic procedure may only be performed a minimum of 2 weeks after the initial diagnostic procedure. Clinical circumstances that necessitate an exception to the two-week duration may be considered on an individual basis and must be clearly documented in the medical record.For the first diagnostic facet joint procedure:For the first diagnostic facet joint procedure to be considered medically reasonable and necessary, the patient must meet the criteria outlined under indications for facet joint interventions.A second confirmatory diagnostic facet joint procedure is considered medically reasonable and necessary in patients who meetALLthe following criteria:The patient meets the criteria for the first diagnostic procedure;ANDAfter the first diagnostic facet joint procedure, there must be a consistent positive response of at least 80% relief of primary (index) pain (with the duration of relief being consistent with the agent used)Frequency limitation: For each covered spinal region no more than four (4) diagnostic joint sessions will be reimbursed per rolling 12 months, in recognition that the pain generator cannot always be identified with the initial and confirmatory diagnostic procedure.B. Therapeutic Facet Joint Procedures (IA):Therapeutic facet joint injections are considered medically reasonable and necessary for patientswho meetALLthe following criteria:The patient has had two (2) medically reasonable and necessary diagnostic facet joint procedures with each one providing a consistent minimum of 80% relief of primary (index) pain (with the duration of relief being consistent with the agent used);ANDSubsequent therapeutic facet joint procedures at the same anatomic site results in at least consistent 50% pain relief for at least three (3) months from the prior therapeutic procedureorat least 50% consistent improvement in the ability to perform previously painful movements and ADLs as compared to baseline measurement using the same scale;ANDDocumentation of why the patient is not a candidate for radiofrequency ablation (such as established spinal pseudarthrosis, implanted electrical device)Frequency Limitations: For each covered spinal region no more than four (4) therapeutic facet joint (IA) sessions will be reimbursed per rolling 12 months.C. Facet Joint Denervation:The thermal radiofrequency destruction of cervical, thoracic, or lumbar paravertebral facet joint (medial branch) nervesare considered medically reasonable and necessary for patientswho meetALLthe following criteria:Initial thermal RFA:After the patient has had at least two (2) medically reasonable and necessary diagnostic MBBs, with each one providing a consistent minimum of 80% sustained relief of primary (index) pain (with the duration of relief being consistent with the agentused) ANDRepeat thermal facet joint RFA at the same anatomic site is considered medically reasonable and necessary provided the patient had a minimum of consistent 50% improvement in pain for at least six (6) monthsorat least 50% consistent improvement in the ability to perform previously painful movements and ADLs as compared to baseline measurement using the same scale;Frequency Limitation:For each covered spinal region no more than two (2) radiofrequency sessions will be reimbursed per rolling 12 months.D. Facet Cyst Aspiration/RuptureIntra-articular facet joint injection performed with synovial cyst aspiration is considered medically necessary when both of the following criteria are met:Advanced diagnostic imaging study (e.g. MRI/CT/myelogram) confirm compression or displacement of the corresponding nerve root by a facet joint synovial cyst;ANDClinical and physical symptoms related to synovial facet cyst are documentedFrequency Limitation:Cyst aspiration/rupture may be repeatedonceand only if there is 50% or more consistent improvement in pain for at least three (3) months.LimitationsFacet joint interventions done without CT or fluoroscopic guidance are considered not reasonable and necessary. This includes facet joint interventions done without any guidance, performed under ultrasound guidance, or with magnetic resonance imaging (MRI).Use of Moderate or Deep Sedation, General Anesthesia, and Monitored Anesthesia Care (MAC) is not considered medically reasonable and necessary during facetprocedures of IA, MBB, and facet cyst aspiration/rupture.The use of Moderate Anesthesia for RFA will be considered in individual cases with documentation of medical necessity such as a longstanding well-documented history of inability to cooperate, medical conditions that would prohibit performance of the procedure, or inability to remain motionless. Patient anxiety or preference alone is not sufficient justification. Routine use of Moderate Sedation or Monitored Anesthesia Care (MAC) or use of General Anesthesia or Deep Sedation for RFA is not considered reasonable and necessary.1It is not expected that patients will routinely present with pain in both cervical/thoracic and lumbar spinal regions. Therefore, facet joint interventions (both diagnostic and therapeutic) are limited to one spinal region per session.It is not routinely necessary for multiple blocks (e.g., epidural injections, sympathetic blocks, trigger point injections, etc.) to be provided to a patient on the same day as facet joint procedures. Multiple blocks on the same day could lead to improper or lack of diagnosis. If performed, the medical necessity of each injection (at the same or a different level[s]) must be clearly documented in the medical record. For example, the performance of both paravertebral facet joint procedures(s) and a transforaminal epidural injection (TFESI) at the same or close spinal level at the same encounter would not be expected unless a synovial cyst is compressing the nerve root. In this situation, TFESI may provide relief for the radicular pain, while the facet cyst rupture allows nerve root decompression. Frequent reporting of multiple blocks on the same day may trigger a focused medical review.Facet joint intraarticular injections and medial branch blocks may involve the use of anesthetic, corticosteroids, anti-inflammatories and/or contrast agents, and does not include injections of biologicals or other substances not FDA designated for this use.One to two levels, either unilateral or bilateral, are allowed per session per spine region. Three or four-level procedures are not medically necessary and therefore are non-covered. A session is a time period, which includes all procedures (i.e., medial branch block (MBB), intraarticular injections (IA), facet cyst ruptures, and RFA ablations that are performed during the same day.If there is an extended time, two years or more, since the last RFA or there is a question as to the source of the recurrent pain then diagnostic procedures must be repeated.Therapeutic intraarticular facet injections are not covered unless there is justification in the medical documentation on why RFA cannot be performed. Facet joint procedures in patients for the indication of generalized pain conditions (such as fibromyalgia) or chronic centralized pain syndromes are considered not reasonable and necessary. Individual consideration may be considered under unique circumstances and with sufficient documentation of medical necessity on appeal.In patients with implanted electrical devices, providers must follow manufacturer instructions and extra planning as indicated to ensure safety of procedure.The following are considered not reasonable and necessary and therefore will be denied:Intraarticular and extraarticular facet joint prolotherapyNon-thermal modalities for facet joint denervation including chemical, low-grade thermal energy (less than 80 degrees Celsius), laser neurolysis, and cryoablation.Intra-facet implantsFacet joint procedure performed after anterior lumbar interbody fusion or ALIF.Definitive clinical and/or imaging findings pointing to a specific diagnosis other than facet joint syndromeDiagnostic injections or MMB at the same level as the previously successful RFA procedureNote: The scales used for measurement of pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Notice:Services performed for any given diagnosis must meet all the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.Provider Qualifications:Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.