LCD L33930: Facet Joint Interventions for Pain Management

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

The spine is the most common source of chronic pain. Chronic axial spinal pain is one of the major causes of disability and accounts for a substantial U.S. health burden. Chronic spine pain poses a peculiar diagnostic and therapeutic challenge due to multiple pain sources, overlapping clinical features, and nonspecific radiological findings.

The facet joints can cause axial spinal pain and referred pain in the extremities. The pathology of the pain source is due to facet joints being richly innervated by the nerve fibers from the medial branch of the dorsal ramus of spinal nerves. Each facet has a dual nerve supply. One exception is at the C2–C3 zygapophysial joint, which has a singular nerve supply from the third occipital nerve (the superficial medial branch of C3 dorsal ramus). 1

Facet joint interventions may be used in pain management for chronic cervical/thoracic and back pain arising from the paravertebral facet joints. The facet block procedure is an injection of a local anesthetic, with or without a steroid medication, either into the facet joint (intra-articular) or outside the joint space around the nerve supply to the joint (the medial branch nerve) known as medial branch block (MBB). Imaging guidance (fluoroscopy or computed tomography [CT] per code descriptor) is used to assure accurate placement of the needle for the injection. Paravertebral facet joint denervation is a therapeutic intervention used to provide both long-term pain relief and reduce the likelihood of recurrence of chronic cervical/thoracic or back pain confirmed as originating in the facet joint’s medial branch nerve. 1

There are various methods that may be used in performing facet joint denervation. Percutaneous radiofrequency ablation (RFA) is a minimally invasive procedure done with imaging guidance (fluoroscopy or CT per code descriptor) and involves using energy in the radiofrequency range to cause necrosis of specific nerves (medial branches of the dorsal rami), preventing the neural transmission of pain. Conventional radiofrequency ablation (non-pulsed or continuous) applies thermal energy of typically 80 to 85 degrees Celsius. The terms RFA and radiofrequency neurotomy are used interchangeably. Both terms refer to a procedure that destroys the functionality of the nerve using radiofrequency energy. Non-thermal methods of denervation include chemical (chemodenervation), low-grade thermal energy (less than 80 degrees Celsius), pulsed RFA, laser neurolysis, and cryoablation. 1

Throughout this document, societal recommendations with the grading of evidence are referenced. There are multiple systems to grade or rank the quality of medical evidence and develop evidence-based recommendations. Not all grading systems are equivalent, so while there are typically similarities in the grades or recommendations from various grading systems, they must be considered independent of the other. The references in this document refer to the following grading systems.

• GRADE Guidelines used in some systematic reviews, the basis for North American Spine Society (NASS) recommendations align with GRADE.

• A Modified approach to the grading of evidence 2 and development of interventional pain management specific instrument 3 used in American Society of Interventional Pain Physicians (ASIPP) Guidelines and some systematic reviews.

• The U.S. Preventive Services Task Force grading of evidence guidelines used by 2020 Consensus Guidelines by Cohen et al. 4

• Levels of Evidence for Primary Research Question and Grades of Recommendation for Summaries or Review of Studies adopted by NASS. 5

A Multi-MAC Subject Matter Expert (SME) Panel on Facet Joint and Medial Nerve Branch Procedures meeting was held on 5/28/2020.

Covered Indications

Facet Joint Interventions:

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 meet ALL of the following criteria:

• Moderate to severe chronic neck or low back pain, predominantly axial, that causes functional deficit measured on pain or disability scale 6 ; AND*

• Pain that has been present for a minimum of 3 months with documented failure to respond to noninvasive conservative care management (as tolerated) 4,7 , AND

• Absence of untreated radiculopathy or neurogenic claudication (except for radiculopathy caused by facet joint synovial cyst) 4,8 AND

• There is no non-facet pathology per clinical assessment or radiology studies that could explain the source of the patient’s pain, including but not limited to fracture, tumor, infection, or significant deformity. 6

*Pain assessment must be performed and documented at baseline, after each diagnostic procedure using the same pain 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 Injection Procedures (IA or MBB):

The primary indication of a diagnostic facet joint procedure is to diagnose whether the patient has facet syndrome. 1,4,7-9 Intraarticular (IA) facet block(s) are considered medically reasonable and necessary as a diagnostic test only if MBB 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, RFA procedure would be considered the primary treatment goal at the diagnosed level(s). 6

A second diagnostic facet procedure is considered medically reasonable and 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. 8 Clinical circumstances that necessitate an exception to the 2 week duration may be considered on an individual basis and must be clearly documented in the medical record.

• For the first diagnostic facet joint injection 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 injection is considered medically reasonable and necessary in patients who meet ALL the following criteria:

• The patient meets the criteria for the first diagnostic injection; AND

• After the first diagnostic facet joint injection, 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). 6

Frequency limitation : For each covered spinal region no more than 4 diagnostic joint sessions will be considered medically reasonable and necessary 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 Injection Procedures (IA or MBB):

Therapeutic facet joint injections are considered medically reasonable and necessary for patients who meet ALL the following criteria:

• The patient has had 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); AND

• Subsequent therapeutic facet joint procedures at the same anatomic site results in at least consistent 50% pain relief for at least 3 months from the prior therapeutic procedure or at least 50% consistent improvement in the ability to perform previously painful movements and activities of daily living (ADLs) as compared to baseline measurement using the same scale 6 ; AND

• Documentation of why the patient is not a candidate for radiofrequency ablation (such as established spinal pseudarthrosis, implanted electrical device). 5, 10-12

Frequency limitation : For each covered spinal region no more than 4 therapeutic facet joint injection 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) nerves is considered medically reasonable and necessary for patients who meet the following criteria:

• Initial RFA: After the patient has had at least 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 agent used).

• Repeat 6 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 6 months and at 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 2 radiofrequency sessions will be reimbursed per rolling 12 months.

D. Facet Cyst Aspiration/Rupture

Intra-articular facet joint injection performed with synovial cyst aspiration is considered medically reasonable and necessary when BOTH of the following criteria are met:

• Advanced diagnostic imaging study (e.g., magnetic resonance imaging [MRI]/ computed tomography [CT]/myelogram) confirm compression or displacement of the corresponding nerve root by a facet joint synovial cyst; AND

• Clinical and physical symptoms related to synovial facet cyst are documented in the medical record.

Frequency limitation : Cyst aspiration/rupture may be repeated once per individual cyst and only if there is 50% or more consistent improvement in pain for at least 3 months. 6

Limitations

• Facet joint interventions done without CT or fluoroscopic guidance are considered not medically reasonable and necessary. This includes facet joint interventions done without any guidance, performed under ultrasound guidance, 4, 6 or with Magnetic Resonance Imaging (MRI). 4

• The use of Moderate or Deep Sedation, General Anesthesia, and Monitored Anesthesia Care (MAC) is not considered medically reasonable and necessary during facet injections. 13

• The use of Moderate Sedation for RFA or cyst rupture/aspiration 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. 13

• It 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 1 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 procedure(s) and a transforaminal epidural steroid 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 anesthetics, corticosteroids, anti-inflammatories and/or contrast agents and does not include injections of biologicals or other substances not U.S. Food and Drug Administration (FDA) designated for this use.

• One to 2 levels, either unilateral or bilateral, are allowed per session per spine region. Three or 4 level procedures are not medically necessary and therefore are non-covered. A session is a time period, which includes all procedures (i.e., MBB, IA, facet cyst ruptures, and RFA ablations) that are performed during the same day.

• If there is a question as to the source of the recurrent pain then diagnostic procedures must be repeated.

• Therapeutic facet injections are not covered unless there is justification in the medical documentation on why RFA cannot be performed. 5, 10-12

• Facet joint procedures in patients for the indication of generalized pain conditions (such as fibromyalgia) or chronic centralized pain syndromes are considered not medically reasonable and necessary. Individual consideration may be considered under unique circumstances and with sufficient documentation of medical necessity. 14

• 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 medically reasonable and necessary:

• Intraarticular and extraarticular facet joint prolotherapy 5, 10-12

• Non-thermal modalities for facet joint denervation including chemical, low-grade thermal energy (less than 80 degrees Celsius), laser neurolysis, and cryoablation

• Intra-facet implants 15

• Facet 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 syndrome

Note: 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 Patient Reported Outcomes Measurement Information System (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

The Medicare Program Integrity Manual states 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 facet injections/procedures 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 and/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.

In addition to the above requirements, non-physician providers, such as certified nurse anesthetist, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22;58,18543, April 7, 2000). Each practitioner must provide only those services within the scope of practice for each state.

Definitions

Acute Pain: The temporal definition of pain persisting for up to 4 weeks after the onset of the pain.

Axial: Relating to or situated in the central part of the body, in the head and trunk as distinguished from the limbs, e.g., axial skeleton.

Biopsychosocial Model: Interdisciplinary model that looks at the interconnection between biology, pathology and socioenvironmental factors.

Central Neuropathic Pain: Pain, which is causally related to a lesion or disease of the central somatosensory nerves.

Centralized Pain: A neurological chronic pain syndrome of the central nervous system (brain, brainstem, and spinal cord) which commonly presents with widespread generalized allodynia which is causally related to the increased responsiveness of nociceptive nerves in the central nervous system to the normal threshold or subthreshold simulation from the afferent nerves. The condition has also been called “central sensitization,” “central amplification,” and “central pain syndrome.” Fibromyalgia is considered one of the most common centralized pain syndromes.

Cervical Facet Pain: Pain located in the cervical spine, which may be characterized by chronic headaches, restricted motion, and axial neck pain, which may radiate sub-occipitally to the shoulders or mid-back.

Chronic Pain: The temporal definition of pain persisting for greater than or equal to 12 weeks after the onset of the pain.

Dual Diagnostic Blocks: The diagnostic technique of injecting the same spinal nerve on 2 separate occasions to be used as an efficacy comparison to increase diagnostic accuracy.

Epidural Steroid Injection: The administration via injection of steroid medicine into the potential epidural space in the spinal column to deliver steroids to the spinal nerves.

Facet Joint Intraarticular Injections, Diagnostic: The placement of local anesthetic and possibly a corticosteroid into the facet joint to diagnose facet joint pain.

Facet Joint Intraarticular Injections, Therapeutic: The placement of local anesthetic and possibly a corticosteroid into the facet joint to produce the beneficial effect of pain reduction.

Facet Joint: A diarthrodial joint in the spinal column (also called the zygapophysial joint or z-joint), producing the articulation of the posterior elements of 1 vertebra with its neighboring vertebra. There are bilateral superior and inferior articular surfaces at each spinal level. The terminology or nomenclature of the facet joint is classified by the specific vertebrae level that forms it (e.g., C4-5 or L2-3). There are 2 facet joints, right and left, at each spinal level.

Facet Injection: (also called facet block) - A general term used to describe the injection of local anesthetic and possibly a corticosteroid in the facet joint capsule or along the medial branch nerves supplying the facet joints.

Facet Joint Denervation or Radiofrequency Ablation (RFA): A general term used to describe the minimally invasive procedure that uses thermal energy generated by the radiofrequency current to deprive the facet joint of its nerve supply. The procedure is also known as a Medial Branch Radiofrequency Neurotomy (Ablation) because it is used to thermally remove the medial branch nerve by using electrical current to create thermal energy to coagulate the adjacent tissues around the targeted medial branch nerve.

Facet Joint Syndrome: A set of concurrent signs or symptoms to describe facet joint pain as the pain generator. The typical clinical signs or symptoms of a facet syndrome may include local paraspinal tenderness; pain that is brought about or increased on hyperextension, rotation, and lateral bending; low back stiffness; absence of neurologic deficit; absence of root tension signs (non-radiating below the knee, absence of paresthesia). Cervical facet pain is often characterized by chronic headaches, restricted motion, and axial neck pain, which may radiate sub-occipitally to the shoulders or mid-back.

Facet Level: Refers to the zygapophyseal joint or the 2 medial branch (MB) nerves that innervate that zygapophyseal joint. Each level has a pair of facet joints: one on the right side and one on the left side of the spine.

Intra-Articular Injection (IA): The injection of local anesthetic and possibly a corticosteroid into the facet joint capsule.

Medial Branch: The dorsal ramus is the dorsal branch of a spinal nerve that forms from the dorsal root of the nerve after it emerges from the spinal cord.

Medial Branch Block (MBB): The placement of local anesthetic and possibly a corticosteroid near the medial branch nerve which supplies the sensory innervation to a specific facet joint.

Diagnostic Facet Joint Injections

Due to the lack of reliable history, physical exam, or imaging to predict response, providers must rely on facet interventions diagnostic injections given for diagnostic purposes to determine if the facet joint is the source of suspected spinal pain. There is controversy over optimal patient selection for diagnostic injections, which measures successful response and type and number of diagnostic injections performed.

Numerous investigations have been undertaken to correlate symptoms and physical exam findings with facet pathology and have concluded conventional clinical findings are unreliable in identifying facet joint success. 4,8,16 A 2020 summary of the literature by Cohen et al “Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group” included 21 studies evaluating the association of physical exam findings with facet block results, and concluded there was no historical or physical exam findings that could reliably predict response to facet joint blocks, grade C evidence, low level of certainty. 4 This is consistent with ASIPP 2020 Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines (2020 ASIPP Guidelines) which rated accurate diagnosis of facet joint pain with physical examination and symptoms level IV with a weak strength of recommendation. 8 2020 NASS Guidelines reported insufficient evidence to make a recommendation for or against patient reported reproduction of pain during a facet joint injection as a predictor of response to dual diagnostic blocks with a grade 1 recommendation. 5, 8 A careful medical history and exam remain an important component to the evaluation of other etiologies of low back pain and raise suspicion of facet source. 8 Physical findings can help identify levels for blocks and maneuvers can aid in the detection of radicular symptoms. 4

Imaging studies have been investigated as a marker of painful lumbar facet joints. While degenerative changes can be found in imaging, they have not been correlated as a reliable predictor of success with facet interventions. 4, 8 Nonetheless, imaging studies often play an important role in the exclusion of other etiologies of back and cervical/thoracic pain. Single-photon emission computed tomography (SPECT), a nuclear medicine imaging technique, can identify active inflammatory markers as seen in facet disease but have not shown consistent results in the prediction of facet joint intervention success. 2020 Consensus Guidelines reported on 12 studies and concluded moderate evidence for SPECT (grade C, moderate certainty) and weak evidence for scintigraphy, MRI, and CT with no to weak supporting evidence. 4 2020 ASIPP Guidelines reported level III evidence for SPECT with weak strength of recommendation and level V evidence for other imaging modalities, weak recommendation. 8