Response to Comments: Facet Joint Interventions for Pain Management

A letter with multiple comments was received from the American Society of Interventional Pain Physicians (ASIPP), American Society of Neuroradiology (ASN), and American Society of Spine Radiology (ASSR) and the state chapters for Arkansas, Colorado, Delaware, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, and Texas Societies of Interventional Pain Physicians.

The commenter writes in strong support of the evidence-based, medically reasonable and necessary criteria for facet joint interventions. The comment explains the ASIPP membership and role and states that within the LCD “multiple other organizations which are prominently quoted in the evidence are not only international, but also interested in interventional pain management only peripherally. Their main goals are totally different being either surgical interventions, neuromodulation, or spinal injections with majority of practice by physicians without fellowship in pain medicine or without certification in pain medicine, either by The American Board of Medical Specialties (ABMS), The American Osteopathic Association (AOA), The American Board of Interventional Pain Physicians (ABIPP), or The American Board of Pain Medicine.”

Thank you for your support for evidence-based medically reasonable and necessary criteria for facet joint interventions. The goal of an LCD is not to represent specific specialties or organizations, but to evaluate the body of literature and evidence on the topic from multiple different specialties and sources. The input from interventional pain providers is critical and we thank you for your input. We also seek to include surgeons, primary care, and the full spectrum of providers involved in the multi-modality care of the Medicare patient. A review of the literature is not limited to United States publications. In the policy we reference the 2020 ASIPP Guidelines which includes international literature. The policy strives to include literature representing the full spectrum of the condition and not preferential to any specific societies, guidelines or journals and focus on a broad representation of the topic and quality of evidence.

Comment was received regarding the section in the LCD, Diagnostic facet joint procedures: (IA or MBB) - The first sentence under this section of the LCD is as follows: The primary indication of a diagnostic facet procedure is to confirm a clinical suspicion of facet syndrome. Intraarticular (IA) facet block(s) are considered reasonable and necessary as a diagnostic test only. If medial branch blocks (MMBs) cannot be performed due to specific documented anatomic restrictions, these restrictions must be clearly documented in the medical record and made available upon request.

It was commented that this will necessitate those individuals undergoing intraarticular injections to undergo medial branch blocks. If a physician desires to treat a patient with therapeutic intraarticular injections, utilization of intraarticular injections is appropriate for diagnostic purposes. Suggested language was provided.

The proposed LCD has been revised to include clarifying language in cases where therapeutic procedures will be utilized, intraarticular injections, rather than medial branch blocks, are appropriate.

Several comments were received regarding the section Diagnostic facet joint procedures: (IA or MBB) The second sentence under this section is as follows:

Diagnostic procedures should be performed with the intent that if successful, a radiofrequency ablation procedure would be considered the primary treatment goal at the diagnosed level(s).

One commenter stated that the decision between therapeutic blocks and radiofrequency ablation should be based on patient choice and medical condition with shared decision making. They state there is extensive evidence supporting therapeutic facet joint nerve blocks, both MBB and IA and therefore are recommending changing the language to allow treatment with either therapeutic blocks or radiofrequency ablation. They explain that based on the evidence, therapeutic facet joint procedures, both intraarticular injections and medial branch blocks are effective. With emerging evidence without overwhelming negative evidence, we believe that it would be inappropriate to issue a noncoverage policy for one or both procedures. This comment also discusses cost of the procedures.

Another commenter supported the use of intraarticular injections as a useful therapeutic tool in carefully selected patients.

A comment received also explained that intraarticular facet joint injections often include both local anesthetic and steroid, thereby making the injection both diagnostic and therapeutic. Some patients will obtain at least 50% relief from a single intraarticular injection of steroid and pain relief can be reinstated every three months with a subsequent injection. Requiring documentation of why radiofrequency neurotomy should not be performed in patients being treated with therapeutic intraarticular facet injections creates unnecessary work for the physician that will not result in improved patient care for certain conditions (e.g., edematous joint/surrounding bone, whiplash injuries).

As explained in the LCD, this is an area of great controversy with differing opinions among subject matter experts and conflicting medical evidence. While there is published support for the use of therapeutic injections, most of the evidence and guidelines do not support therapeutic intraarticular injections. This includes multiple studies, systematic reviews and guidelines, including guidelines published by The North American Spine Society (NASS), The National Institute for Health and Care Excellence (NICE), The Agency for Research and Healthcare Quality (AHRQ), The American Association of Neurological Surgeons (AANS), and The Congress of Neurological Surgeons (CNS). In the multidisciplinary 2020 consensus guidelines, developed by representatives from a dozen pain societies including the U.S. Department of Veterans Affairs, multiple different specialties and offered with U.S. and international representation states the use of therapeutic injections received a “D” rating consist with recommendation against the intervention with moderate to high certainty evidence that the service has no net benefit or that the harm outweighs the benefit. This equates to the suggestion for practice to discourage the use of this service. This is in contrast with the guidelines published in the 2020 ASIPP Guidelines which supports the use of therapeutic injection stating level II evidence of support based on three Randomized Control Trials (RCTs). Level II evidence requires at least one relevant high quality RCT or multiple moderate or low quality RCTs per these guidelines. However, the evidence for therapeutic injections is largely based on three RCTs, as compared to Radiofrequency Ablation (RFA) where there is greater than ten RCTs. In addition, there are at least eight RCTs and multiple observational studies that did not demonstrate benefit of therapeutic injections.

The controversy is evident among the subject matter experts. In the Contractor Advisory Committee (CAC) meeting, the experts were divided on this topic. While most experts did not support routine use of therapeutic injections, it was clear the experts felt there is a clinically significant role in select patients. Based upon this feedback, and emerging evidence without overwhelming negative evidence, we ensured access to care by allowing therapeutic injections for this population, allowing the provider to make that judgment if they can provide rationale for their decision.

Regarding the documentation of why a patient is not a candidate for RFA, this is a decision that must be determined by the provider and the patient. There are examples in the LCD, but this is not an all-inclusive or restrictive list. In all cases, we require documentation to explain the rationale for proceeding with therapeutic injections, which would be a standard part of shared decision-making discussions and expected in the medical record documentation.

Comments were received regarding the section in the LCD, Diagnostic facet joint procedures: (IA or MBB) - The second diagnostic procedure may only be performed a minimum of 2 weeks after the initial diagnostic procedure.

Although several commenters agree that a second diagnostic facet procedure is considered medically necessary to confirm the validity of the initial diagnostic procedure when administered at the same level, there are several commenters that are not in agreement with waiting for two weeks between diagnostic blocks and promote various decreased time frames from 48 hours to 2 to 3 days to one week duration between diagnostic procedures. The comment explains that diagnostic injections done with local anesthetic only (i.e., Bupivacaine) can be expected to provide pain relief for the duration of the half-life of the medication used. For a purely diagnostic procedure, it does not benefit the patient to wait two weeks for the second confirmatory injection as waiting for two weeks only prolongs the patient’s pain experience. There is no medical rationale for requiring two weeks between diagnostic injections. The diagnostic protocol simply requires enough time that the effect of the local anesthetic has worn off and that the index pain has returned to baseline. With the duration of the effect of local anesthetics being significantly less than 48 hours, establishing 48 hours as the minimum will facilitate expeditious diagnosis and treatment, and will reduce hardships (e.g., lost wages, travel expenses, childcare) for patients who must travel a distance for treatment. Additionally, many physicians discontinue blood thinners for facet injection and ablation, and many more for any deep injection into the cervical spine. The current recommendations from the American Board of Anesthesiology include discontinuation of blood thinners for neuraxial blockade for 5 half-lives. Consequently, the patient would be off their blood thinners for 4 to 10 days at a time for a period of weeks to accomplish a radiofrequency ablation. There may be potential complications and increased clinical risk to these patients related to discontinuing blood thinners.

Published literature by Manchikanti et al. describes the acute pain model vs. chronic pain models. In the acute model, pain relief is limited to the duration of pharmacological action of local anesthetic. In the chronic pain model, relief may last beyond pharmacological duration of action which challenges the concept that the pain relief achieved from local anesthetic alone is limited to the half-life of the anesthetic. The authors reported pain relief at ≥80% for 6 days for lidocaine alone and 11.86 days for bupivacaine alone. Authors also reported long term relief in many patients, serving as the basis for their support for therapeutic injections. However, relief is variable with duration of effect ranging from several hours to months in the literature. Due to the potential of continued pain relief, especially during the first 2 weeks after diagnostic injection, the duration between injections will remain at 2 weeks in order to provide the most accurate diagnosis.

We recognize the concerns of extenuating circumstances, such as the need to reverse anticoagulation to perform the procedure, to increase the patient's clinical risk by waiting the two-week duration. Therefore, we will consider exceptions to the two-week duration under these extenuating circumstances.

Comments regarding the percentage of pain relief and improvement required to define success are discussed in Comment Response #5.

Comments were received regarding the section in the LCD, Therapeutic Facet Joint Procedures (IA or MBB) – Patients with two (2) medically reasonable and necessary diagnostic facet joint procedures with each one providing a consistent minimum of 80% relief of primary (index) pain. Although a number of commenters were not opposed to the criteria for patients to have two (2) medically reasonable and necessary diagnostic facet joint procedures, and in agreement that a second diagnostic facet procedure is considered medically necessary to confirm validity of the initial diagnostic facet procedure when administered at the same level; some commenters were not in agreement with the criteria of each one providing a consistent minimum of 80% relief of primary (index) pain. Some commenters stated that while the evidence may support 80% relief and agree with this criteria, to avoid false positives, there are others who are recommending that the criteria be changed to 50% relief of primary index pain relief to allow as a target to move forward with radiofrequency ablation. Commenters in support of the criteria of a consistent minimum of 80% relief of primary index pain are suggesting that the language be changed to conform to proposed language, as well as maintain the present language with avoidance of confusion by stating "After 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) or at least 50% consistent objective improvement in the ability to perform previously painful movements or provocative maneuvers."

There is significant controversy on the percentage of improvement to be a candidate for a diagnostic block to be considered successful. This is exemplified by the comments received. While there is emerging data on the use of fewer diagnostic blocks and lower percentage for cut off, most studies on facet interventions utilize the 80% cut-off (at least 10 studies as reviewed in the 2020 ASIPP Guidelines). In the reviewed published literature by Cohen et.al. and Manchikanti et.al., most societal guidance supports the 80% cut off and two diagnostic block criteria. In the literature to support a lower cut-off, the authors acknowledge that the existing evidence does not adequately address the 50-80% group. The existing evidence is clear there is a high risk of false positives with a single block and 50% cut off and that a dual block and higher cut-off (50-80%) improves diagnostic accuracy. The evidence also supports that improved diagnostic accuracy predicts greater improvement with RFA treatments. While there is high quality evidence that demonstrates patients with dual blocks using ≥80% relief are more likely to show a positive response to RFA and is consistent with several societal guidelines, this must be balanced against excluding some patients for treatment who may potentially benefit. Given the lack of supporting literature to define this population, current evidence supports dual blocks at 75-80% improvement is more strongly supported than the alternative less stringent approach. If additional literature can further define this population and provide support for a lower cut-off, that can be considered through the reconsideration process.

Several comments were received regarding the section in the LCD, Diagnostic facet joint procedures: (IA or MBB) - at least 50% consistent objective improvement in the ability to perform activities of daily living (ADLs) support the medical necessity criteria of 50% improvement in activities of daily living (ADLs) for facet neurotomy procedures. However, additional clarity is required to establish a consistent standard for 50% ADL improvement.

Representatives of several societies for spine radiology, rehabilitation, neuroradiology and interventional radiology state there is insufficient evidence to support the new, alternate criteria proposed “…at least 50% consistent objective improvement in the ability to perform previously painful movements and activities of daily living (ADLs)”; encouraging MACs to further consider how this improvement in function will be accurately quantified, measured, and reported and provide alternative language recommending to change from “ADLs” to “previously painful movements or provocative maneuvers”.

During the Contractor Advisory Committee (CAC) meeting there was extensive discussion about the use of functional measurement as part of the evaluation of success with facet joint procedures. The panel agreed that measurement of function can provide valuable clinical input into improvement such as the ability to stand, walk and do activities of daily living (ADLs). There are multiple tools to measure function. However, these comments raise notable concerns that the clinical literature utilizes a percent improvement on Visual Analog Scale (VAS) to measure response to diagnostic injections and to measure success of Radiofrequency Ablation (RFA). There are not standardized cut-off values for measurement of function in the published literature. We agree with the comments that we need a clear standard for measurement. Based on the current evidence, functional measurement is appropriate for evaluation of long-term success with the procedure, but not for the initial diagnostic evaluation to determine if the patient is an appropriate candidate for an RFA procedure. Therefore, the functional assessment will be removed from the diagnostic section.

The criteria of functional measure were already included in evaluation of success for therapeutic facet joint procedures and denervation procedures and will remain. As commenters suggested the language was revised from “ADLs” to “provocative maneuvers” to provide clarity. However, since the existing pain measurement tools do not include provocative maneuvers and measure many aspects of ADLs, and we are no longer including this under diagnostics we will retain ADLs. Also, the LCD requires pain and function to be measured and documented at baseline, and at each follow-up using the same pain or disability scale for each assessment. Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OLBDQ), Quebec Back Pain Disability Score (QBPDS), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the Patient Reported Outcomes Measurement Information System (PROMIS) profile domains are several functional scales that can be used to assess function to measure if the required 50% improvement from baseline is achieved.

Comment received regarding the Facet Joint Denervation – In the Limitations Section of the LCD requesting clarification of the number of spinal levels that can be treated with RFA per session.

A facet level is defined in the LCD definition section. Facet Level- refers to the zygapophyseal joint or the two medial branch (MB) nerves that innervate that zygapophyseal joint. Each facet level in the spinal region has a pair of facet joints, one on the right side and one on the left side of the spine.

A session is a time period, which includes all procedures (i.e., medial branch blocks [MBBs], intraarticular injections [IAs], facet cyst ruptures, and radiofrequency ablations [RFAs]) performed during one day.

Region- The segments of the back involved will be defined in this policy as two regions: Cervical/Thoracic region= C1-C7/T1-T12 and Lumbar/Sacral region= L1-L5/S1-S5.

This means in one session (same day) a provider can inject a maximum of two levels bilaterally within one region. Facet joint interventions (both diagnostic and therapeutic) are limited to one spinal region per session. Limitations #3 in the LCD states “It is not expected that patients will routinely present with pain in both cervical/thoracic and lumbar spinal regions.” Therefore, we are referring to one region per session.

This means a maximum of one injection on the right and one on the left in two separate joints for a total of four injections in one region (cervical/thoracic or lumbar-sacral) per session (same day). For unilateral injections, this means a maximum of two injections on the right or two on the left in two separate joints within one region for a total of two injections.

Despite the support from the pain management community demonstrated above to allow three or more levels routinely, this practice is not supported in the medical literature. No supporting literature was provided with the above comments that support the concept that the facet pain may extend routinely beyond 1-2 levels. During the CAC meeting, prevalence data was shared demonstrating L4/L5 followed by L5/S1 levels comprise around 80% of the overall prevalence for lumbar spinal pain. In the cervical spine C2/C3 represents 50% followed by C5/C6 and C6/C7. This was correlated with Medicare national data, which demonstrates that most facet procedures involve 1-2 levels, with more than two levels being in the minority of procedures performed. If additional literature is published in peer-reviewed journals that provide evidence of medical necessity for treating three or more levels in the same session, this can be considered on reconsideration.

Comment was received regarding repeat or additional diagnostic MBB or intraarticular injections after 24 months at the same site previously treated with facet joint injections stating that they are not in agreement that patients who received 24 months of relief from a RF neurotomy should be required to receive additional MBBs. Since the RFA treatment was effective and durable, additional diagnostic blocks should not be required to continue treatment. If patients experienced more than 24 months of relief from the procedure, a repeat neurotomy should be permitted at the same level to reinstate relief. Number 6 under the not reasonable and necessary and therefore denied section, should be amended to instead state, “diagnostic injections or MBB at the same level as the previously successful RFA procedure unless it has been an extended period of time (greater than three years) since the last RFA and/or there is a question as to the source of the recurrent pain”.

This was not intended to repeat diagnostics for patients who were successfully treated with facet joint interventions. The intent of this limitation was for circumstances in which patients have not had any treatments in over two years and thereby, to be re-revaluated to ensure correct diagnosis before treatment. The LCD has been revised to clarify this.

Several commenters were not in agreement with the limitation for facet joint procedure performed at a fused posterior spinal motion segment and suggest removing this limitation. “Facet joint pain is not based on instability, rather it is an inflammatory mechanism, which may be somewhat related to the instability or fusion.” One commenter stated that not addressed, is a fused anterior segment Anterior Lumbar Interbody Fusion (ALIF) that does allow for movement and subsequent pain generated from the posterior segment. Our concern is with the heating of the fused metal within the pedicle. This is not a major consideration in the ALIF, but it is a fused lumbar segment.

There is a paucity of literature to address use of RFA in this region. We will remove this restriction for fused posterior segments and add the restriction for anterior lumbar interbody fusion where there is concern.

A comment was received expressing agreement that facet interventions represent an important conservative therapeutic tool for chronic pain patients, and it is critical that all Medicare Administrative Contractors (MACs) ensure proper coverage guidelines for this treatment modality. Alternative therapies may include the use of chronic opioids or other more expensive procedures that provide a marginal expectation of success.

Thank you for your comment.

A comment was received expressing support that facet joint interventions are reasonable and necessary for the diagnosis and treatment of chronic pain in patients who meet the inclusion criteria as outlined in the LCD.

Another commenter agrees with the criteria which calls for pain to be present for a minimum of three months with documented failure to respond to non-invasive conservative treatment (as tolerated) noting that this makes sense for patients with chronic pain that is slow in onset. However, this should not apply to patients with traumatic induced facet joint pain which can occur from a fall, accident, lifting or other strenuous situation. In these circumstances, patients should be allowed to receive treatment as early as within one month of conservative treatment.

Also, regarding indication 3-Absence of untreated radiculopathy or neurogenic claudication, many patients have multiple sources for their pain. Optimal results often require that more than one structure is treated. Patients with acute herniation and predominately lower extremity pain may need only an epidural steroid injection, but patients with degenerative facet disease that causes central or foraminal stenosis frequently have both radicular and facet related pain simultaneously. Proper treatment requires that both sources of pain be treated to maximize a patient’s pain relief and functional improvement.

Literature to support the requested coverage for facet joint procedures in the acute phase for traumatic facet joint pain and for untreated radiculopathy or neurogenic claudication can be submitted and reviewed on reconsideration.

In regards to the Provider Qualification section of the LCD, a comment was received stating that while it is appreciated that all healthcare professionals have a very important role to play in team-based care within our medical system, training provided to non-physicians does not provide necessary background and experience in accurately selecting patients; safely performing technically demanding procedures; and immediately recognizing, evaluating, and addressing potentially serious, life-altering complications. In addition to the noted requirements, the following language was recommended: "non-physician providers, such as a certified nurse anesthetist, with certain exceptions, may certify order and establish the plan of care as authorized by State law."

There was also a comment with a request to include a grandfathering provision in the Provider Qualifications section of the proposed LCD.

The scope of practice for non-physician providers (NPPs) and Certified Nurse Anesthetists (CRNAs) are established by State laws and is not within the scope of this LCD. However, we understand that facet joint injections carry risk and appropriate training is necessary. In order to ensure the safety of the Medicare beneficiaries, we will require all providers to have documentation of training as outlined in the LCD.

There were a number of societies with comment regarding the removal of medial branch blocks from the Therapeutic Facet Joint Procedures section of the proposed LCD, stating that Medial branch blocks are performed outside the joint, where the medial branch nerves are predictably located, and identify whether the source of pain is within the distribution of the medial branch nerves. These injections are purely diagnostic using only local anesthetic. They are not therapeutic procedures and do not provide extended pain relief. Therefore, medial branch blocks should be removed from the Therapeutic Facet Joint Procedures section.

Thank you for your comment. After review and consideration, the LCD language has been clarified as appropriate.

Several commenters disagree with the limiting language in the proposed LCD that states that it is not expected that patients will routinely present with pain in both cervical/thoracic and lumbar spinal regions. Therefore, the routine performance of facet joint interventions (both diagnostic and therapeutic) to both spinal regions may trigger a focused medical review.

The process of an aging spine leads to cervicothoracic kyphotic deformity and thoracic kyphosis. This process overloads the facet joints as the center of gravity moves forward. It is not uncommon for a Medicare patient to have both cervical and thoracic pain and or cervical and lumbar pain. In fact, it is not uncommon for the elderly to have deterioration in the entire spine especially the lumbar and cervical regions. Patients with degenerative spondylosis in one area are very likely to have it in other areas of their spine if it is degenerative in nature. If they have trauma, then it would depend whether both areas were injured by that trauma or just one. Traumatically injured facets would be confined to the area(s) of injury, but patients can sustain injuries in more than one area as well and there is recommendation that this statement be removed.

While we understand a single patient may have multiple sources of pain, if the pain source is not diagnosed correctly it is not possible to target appropriate treatment. This may put the patient at risk for repetitive and potentially unindicated procedures. Since facet joints require diagnostic injections to determine if facet syndrome is present and identify the level, other procedures performed simultaneously may make it difficult to perform accurate diagnostics. Therefore, we affirm 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.

A comment was received stating that the entire proposed LCD addresses the Cervical/Thoracic, and Lumbar spine. Thoracic spine is not included in this statement. Entry level policy staff may read this and not recognize that thoracic pain is covered in this LCD. Recommended language was provided.

Thank you, we have made this correction throughout the LCD where appropriate.

Comment was received regarding language in the History, Background and/or General Information section of the proposed LCD. Our organizations recommend revision of the last paragraph in the History/Background and/or General Information section that refers to utilization growth for facet joint interventions. We recommend this section be deleted or amended to appropriately account for the increase in training for interventional pain physicians in the past twenty years and thus, the wider availability for patients to access evidenced-based pain treatments like facet joint injections. The section makes no mention of the increased quality of life for patients as a result of the dissemination of the technology nor does it recognize the reduced demand for spine surgery that is the result of increased use of facet joint injection procedures. This reduction in need for surgery is better for patients (i.e., avoiding multiple risks and possible complications, the need for further surgery such as occurs with ‘adjacent level disease’ and reducing costs for payers, such as Medicare and Medicaid). We recommend the document acknowledge these benefits and trends when addressing utilization growth rather than imply that most of the utilization growth is not medically appropriate or necessary.

Also recommended, that the grading include and be driven by the 2020 Multi-Society Facet Guidelines by Cohen, et al. as this guideline was produced by a coalition of pain and interventional societies who determined the grading and recommendations. The document is referenced but we believe that document to be the most comprehensive and evidenced-based review of literature in this space as opposed to surgical driven evaluation and grading tools.

Your concerns regarding utilization are recognized and this section has been removed. In terms of specific guidelines, we recognize and appreciate the important work in the 2020 Multi-Society Facet Guidelines. Please see response to comment #1 for the scope of the LCD.

Commenter requests to add diagnosis codes M54.2 Cervicalgia and M54.5 Low back pain to support the first two criteria: Moderate to severe chronic neck or low back pain, predominantly axial, that causes functional deficit measured on pain or disability scale* and Pain present for minimum of 3 months with documented failure to respond to noninvasive conservative management (as tolerated).

Low back pain and neck pain can be related to conditions unrelated to the spine for which facet blocks would not be appropriate. Prior to the performance of a facet interventional procedure the provider's differential diagnosis should be narrowed to a high suspicion of facet joint syndrome and other paraspinal process excluded. Therefore, these less specific diagnosis codes will not be added.

Several commenters disagree with parenthetical listed in Limitation 9, that states, “(such as fibromyalgia)” recommending this reference be deleted. Patients with fibromyalgia (FM) can have other pathology that may be amenable to treatment. This unfairly discriminates against patients with FM. We also know that many patients are misdiagnosed with FM when they have other potentially more treatable conditions.

Another commenter disagrees with the limitation that facet joint procedures in patients with generalized pain conditions (such as poorly controlled fibromyalgia) or chronic centralized pain syndromes are considered not reasonable and necessary. There are some instances where such individuals have legitimate facet joint pain that is separate from their central pain condition. And while it is appreciated that the proposed LCD allows for potential exceptions to the broad prohibition against the use of facet joint procedures in patients with generalized pain conditions, there is concern that this broad limitation will result in an overall negative effect on treatment of patients with FM or other generalized pain conditions, particularly given that the opportunity for coverage would only be made available upon appeal. The proposed language would create significant burden and uncertainty for those physicians willing to follow their judgement to furnish facet joint interventions to patients with FM, with such care virtually guaranteed to be denied at first pass. We therefore do not believe a blanket statement excluding these individuals from effective treatment except through appeal is appropriate, and we urge the Medicare contractors to eliminate the statement in the final LCDs.

We agree that there are some instances where individuals with centralized pain syndrome have legitimate facet joint pain that is separate from their central pain condition. This limitation is not intended to not allow access to patients with centralized pain syndromes, such as fibromyalgia, who meet the full diagnostic criteria for facet syndrome, but require they meet the full diagnostic criteria per the LCD for facet joint syndrome and achieve appropriate improvement with intervention. The limitation is that facet joint procedures are not used to treat centralized pain syndrome which is not considered reasonable and necessary. The language in the LCD was modified for clarity.

Commenter states that for implanted electrical devices, the document should include a requirement to follow manufacturer instructions and highlight that implanted electrical stimulated devices are not a contraindication to radiofrequency denervation (RFD) but require extra planning. And state that “Thousands of patients with a SCS implant or a cardiac implantable device have been treated safely with RFD.”

We appreciate your comment and clarifying language has been added to the LCD.

One commenter was not in agreement with the criteria for 50% pain relief for 6 months after the RFA procedure. Stating that the literature reveals, the growth of nerve is different in different patients. Personal experience showed that patients were noted to experience pain relief somewhere between 4 months to 2 years with the RFA done the same way, with same technique, by the same doctor, with the same length active tip and the same temperature. This goes with the literature. The patients who have quicker generating nerve and having pain back in 4 months would not qualify for the subsequent RFA procedure. This is unfair for those patients.

The current evidence supports the reasonable and necessary repeat thermal facet joint Radiofrequency Ablation (RFA) at the same anatomic site provided the patient had a minimum of consistent 50% improvement in pain for at least six (6) months or at least 50% consistent improvement in the ability to perform previously painful movements and ADLs as compared to baseline measurement using the same scale. Individual consideration may be given on redetermination (appeal) for payment in unique circumstances with clear documentation of medical necessity in the medical record.

While a decision to proceed with RF lesioning should be made thoughtfully, this decision should precede, not follow, the performance of a diagnostic block. While the patient can withdraw their consent at any time, RF lesioning has an extraordinary safety profile in well-trained hands and mandating an additional delay is neither reasonable, necessary nor compassionate and recommends the adoption of a single diagnostic block standard.

Thank you for your comment. The current evidence supports the use of a second diagnostic block at the same level(s) in order to provide the most accurate diagnosis. Please see response to comment #5.

In any region of the spine (cervical/thoracic and/or lumbar), if the need for bilateral joint treatment is medically necessary, a physician may perform each side separately, limiting to 2 radiofrequency sessions per year per side if performed separately. Many physicians perform bilateral procedures on two separate dates of service for multiple reasons (patient tolerance, concerns for local anesthetic toxicity, operating room scheduling). This reasonable and medically appropriate practice needs to be protected by this LCD.

There was no supporting literature provided to support the necessity of performance of the procedures in separate sessions per side. It makes clinical sense to perform both sides in the same session to optimize onset of pain relief (avoiding having to wait longer for the other side), less visits for the patient, ability to perform assessments on both sides in single visit, reduce radiation exposure and time in the procedure room or Operating Room. In cases where there is medical necessity to perform procedures separately the reason should be clearly documented in the patient’s medical record and may be considered on appeal.