Notification

Denervation of the Spinal Nerves for Chronic Pain


Notification Issue Date: 03/11/2020

This version of the policy will become effective on 06/15/2020, and communicates Company's continuing medical policy position on Denervation of the Spinal Nerves for Chronic Pain.

Description section was updated and the last bullet of medical necessity was reworded for clarity.



Medicare Advantage Policy

Title:Denervation of the Spinal Nerves for Chronic Pain
Policy #:MA11.102h

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Non-pulsed radiofrequency (RF) denervation of the cervical facet joints at or below C2 (i.e., 2nd level vertebra) and lumbar facet joints of the spine are considered medically necessary and, therefore, covered when ALL of the following criteria are met:
  • The individual has a history of severe, disabling neck and/or back pain where other treatable causes of pain (e.g., tumors, infections, spinal stenosis, herniated discs, psychiatric etiology) have been ruled out; and the pain is suggestive of facet joint origin (as evidenced by absence of nerve root compression as documented in the medical record), and is not primarily radicular.
  • The individual has no prior spinal fusion surgery in the vertebral levels being treated with RF.
  • There is documented failure of three months or longer trial of conservative treatments (e.g., physical therapy, home exercise program, acetaminophen, manipulation, and/or non-steroidal anti-inflammatory medications).
  • A successful trial of controlled diagnostic facet joint blocks (i.e. medial branch blocks), consisting of two separate positive blocks conducted on different days with local anesthetic only (no steroids or other drugs) under image guidance resulted in a clinically significant improvement in pain and/or disability when compared to baseline assessment (i.e., 80 percent reduction in pain). No therapeutic intra-articular injections (i.e., steroids, saline, or other substances) should have been administered for at least 4 weeks prior to the diagnostic facet joint block.
  • If there was a prior successful RF denervation (i.e., at least 50 percent reduction in pain), a minimum time of 5 months has elapsed since the prior RF treatment (per side, per anatomical level of the spine): and the individual’s functional status, secondary to the return of pain, seriously impedes their ability to work or to perform their activities of daily living.

For each covered spinal region (cervical or lumbar), non-pulsed radiofrequency (RF) denervation is considered medically necessary and, therefore, covered only when performed at no more than four (4) joints per session (e.g., two [2] bilateral levels or four [4] unilateral levels).

EXPERIMENTAL/INVESTIGATIONAL

All other uses for radiofrequency facet joint denervation of spinal nerves, including, but not limited to, the treatment of chronic thoracic facet or sacroiliac (SI) joint pain, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Pulsed radiofrequency (PRF) denervation of the spinal nerves for treatment of chronic pain is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

All other methods of denervation for the treatment of chronic spinal/back pain, including, but not limited to laser denervation, chemodenervation, (e.g., alcohol, phenol, or high concentration local anesthetics), and cryodenervation, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

Global Perceived Effect (GPE): scales used to provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which an individual feels they have improved or deteriorated over time.

Visual Analogue Scale (VAS): a psychometric response scale, which can be used in questionnaires, to measure subjective characteristics or attitudes. Individuals specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, non-pulsed radiofrequency denervation of cervical and lumbar spinal nerves for chronic pain is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, pulsed radiofrequency (PRF) denervation of the spinal nerves for treatment of chronic pain is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for radiofrequency denervation of spinal nerves for chronic facet pain.

Description

Most back pain resolves with conservative treatment, but a significant number of individuals may develop chronic spinal pain. The causes of chronic back or neck pain are obscure, and imaging techniques are not dependable diagnostic tools. Nerve block studies indicate that nonspecific pain is often attributed to disorders of the facet (zygapophyseal) joint; however, nonspecific pain is a condition with no clear pathological etiology. Although no definitive treatment is available, conventional percutaneous radiofrequency (RF) denervation of the facet joint has been advocated and used with increasing frequency.

Radiofrequency (RF) lesioning (also known as RF ablation, RF facet denervation, RF rhizotomy, facet rhizotomy, and percutaneous RF neurotomy) for disorders of the facet joint is performed in an outpatient setting. RF denervation is used to treat back and neck pain originating in the facet joints with degenerative changes. Diagnosis of facet joint pain is confirmed by a positive response from nerve blocks. The goal of RF facet denervation is for long-term pain relief of the facet joint pressure.

The facet joints, also known as apophyseal or zygapophyseal joints, are formed by the superior and inferior articular processes of sequential vertebrae. On the dorsolateral surface of each superior articular facet is a prominence known as the mammillary body or process. The nerves that communicate with these joints sometimes become inflamed or impinged, which leads to pain.

There are two types of radiofrequency facet joint denervation used to treat chronic spinal pain. They are:
  • Pulsed radiofrequency (PRF), which consists of short bursts of electrical current of a high voltage, but without heating the tissue enough to cause coagulation.
  • Percutaneous or non-pulsed RF, which is performed for a predetermined amount of time with no interruption in the RF flow until the full dosing time is achieved.

PULSED RADIOFREQUENCY (RF)

Pulsed RF, a nonablative alternative to RF, uses short bursts of radiofrequency current, rather than a continuous current. The heat from pulsed RF is not enough to cause the tissue to coagulate. Pulsed radiofrequency denervation causes the transmission across small unmyelinated nerve fibers to be disrupted, but not permanently damaged. This is because the temperatures will not exceed 42 degrees Celsius, versus the 60 degrees Celsius reached in (thermal) percutaneous RF.

One small RCT was identified using pulsed RF. Van Zundert et al. (2007) conducted a randomized sham-controlled trial investigating the treatment of pulsed RF for the indication of chronic cervical radicular pain. The study included 23 participants who reported neck pain that radiated over the posterior shoulder to the arm and lasted more than 6 months; these participants had failed conservative therapy. The participants were assessed 3 months following the treatment. Success was defined as at least a 50% pain improvement of the global perceived effect (GPE), at least a 20% reduction in pain on the visual analog scale (VAS), and a reduction in pain medication consumption. Nine out of 11 participants in the treatment arm, and 4 out of 12 in the sham group, had at least a 50% pain improvement. Nine out of 11 in the treatment group, and 3 of the 12 in the sham group, achieved at least a 20% reduction in pain on VAS (P=0.2). At 6-month follow-up, there was an increase in participants in the treatment group who reduced their use of pain medication, but the difference was not significant. The authors concluded that pulsed RF may provide cervical pain relief for a limited number of select individuals, but larger studies are needed to validate this conclusion.

Although pulsed RF seemed to provide limited relief in select individuals, most studies revealed that those who received percutaneous RF experienced greater improvement over time than those treated with pulsed RF.

Most studies published on pulsed RF are composed of small case series and reports with limited follow-up. Additional larger RCTs on pulsed RF are needed to establish safety and effectiveness for use in treating chronic facet pain.

NON-PULSED (PERCUTANEOUS) RADIOFREQUENCY

Prior to having an RF denervation procedure, a diagnostic paravertebral facet joint nerve block is commonly performed to assess the relative contribution of sympathetic and somatosensory nerves in relation to the pain syndrome. A diagnostic nerve block localizes the nerve(s) responsible for the pain or neuromuscular dysfunction, particularly when multiple sources of pain are potentially present. This procedure is performed under fluoroscopic guidance to ensure accurate placement of the needle in the facet joint or at the medial nerve branch of the facet joint.

Upon needle placement, a long-acting local anesthetic is injected to temporarily numb the facet joint. The individual is then asked to engage in the activities that had previously precipitated pain, and to evaluate the effect of the procedure at 4 to 8 hours post-injection. A temporary or prolonged absence of spinal pain strongly suggests that the facet joint is the source of the symptoms. A repeat injection may be needed to establish consistency of results, particularly if diagnostic nerve blocks are followed by neurolysis.

RF facet joint denervation employs a percutaneously introduced electrode that applies heat from radio waves to selectively destroy sensory afferent nerve fibers, thereby interrupting pain signals from a specific site. A minimum of two levels must be addressed to denervate a single joint; RF lesioning is directed at each of the levels to be lesioned. Destruction of the nerve may be permanent or temporary. In some cases, the treated nerve repairs itself and becomes less irritable, thus resulting in continued resolution of the pain. In cases where the pain returns, the procedure can be repeated in the same joint, following an elapsed time of at least 6 months and a previous positive result from RF denervation, as measured by significant improvement in functional status and reduced facet mediated pain.

PEER-REVIEWED LITERATURE
Lumbar Facet Joint Pain

A 2015 systematic review by Manchikanti et al identified 9 randomized controlled trials (RCTs) or comparative studies on RF denervation of lumbar facet joints. The sample sizes ranged from 31 to 100 subjects. All studies but one showed short- or long-term benefit of facet joint denervation, and the overall body of evidence was rated as level II.

The largest study included in Manchikanti’s systematic review compared facet joint injection and facet joint denervation in 100 subjects. There were no sham controls, limiting interpretation of the results. In a 2013 double-blind RCT by Lakemeier et al, RF facet joint denervation was compared with intra-articular steroid injections in 56 subjects. Subjects were selected first on magnetic resonance imaging findings of hypertrophy of the facet joints followed by a positive response to an intra-articular infiltration of the facet joints with anesthetics. A diagnostic double-block of the facet joint was not performed. At 6 months, there was no significant difference between the 2 groups.

Nath and associates performed an RCT involving 40 individuals, following a screening of 376 individuals, to evaluate short- and intermediate-term effects of RF for lumbar facet pain study data. Individuals who were included in the study complained of pain involving one or more lumbar zygapophysial joints, paravertebral tenderness, and had obtained at least an 80% reduction of pain following controlled medial branch blocks. The 40 participants were randomly assigned to an RF or sham group and were followed for 6 months. Multiple lesions were treated in each participant in the RF group. The GPE and VAS measurements were used to assess outcomes following treatment in both groups. While back pain was reduced in both groups, the RF participants were significantly more improved on secondary measures of back and hip movement, quality-of-life variables, paravertebral tenderness, and reduction in use of analgesics.

In 2005, van Wijk et al. performed a multicenter randomized controlled study. Inclusion criteria was continuous low back pain with or without radiating pain to the upper leg greater than 6 months, as well as tenderness over the facet joints. A total of 226 participants were screened for the study. Of those screened, 81 were randomly assigned to either an RF group (40) or a sham treatment group (41). The primary outcome was determined by defined outcome measures using a visual analog scale (VAS), (a psychometric response scale that can be used to measure subjective characteristics or attitudes), daily physical activities, and individual use of analgesics. Success was defined as 50% reduction of the median VAS-back score without reduction in daily activities and/or increase in analgesic use or reduction of at least 25% in a participant's analgesic use. Participants kept weekly diaries and were followed up at 3 months. Failures at 3 months in the sham group were unblinded and offered RF. Follow-up then continued at 6, 9, and 12 months. At 3 months there was no difference between the two groups. Although some participants were lost to follow-up between 3 months and 12 months, the authors' overall conclusion was that significantly more participants in the RF group than the sham group achieved greater than 50% pain relief on the Global Perceived Effect (GPE) measure, which used a 4-point Lickert scale.

The available peer-reviewed data, including the aforementioned studies, suggest that RFA has improved outcomes related to pain and functional status when used for the treatment of lumbar facet pain in selected individuals.

Cervical Facet Joint Pain

An RCT published in 1995 by Lord et al. utilized RFA to treat chronic cervical pain of the facet joints. (Individuals with C2-C3 zygapophyseal joint pain were excluded due to the technical difficulty in treating this level of pain.) Of the 54 screened individuals, 24 participants met the inclusion criteria and were randomly assigned to an RFA or sham group. The individuals' perception of pain was confirmed using placebo-controlled blocks. In the RFA group, two or three thermal lesions using RFA were made at each cervical location being treated. Participants were followed for the first few days, then weeks, and then again at 3 months using a VAS measurement and the McGill pain questionnaire, indicating whether activities of daily living had been restored. Those from either group who had no relief of pain or an early return of pain were offered RFA. Those who had pain relief at 3 months were asked to follow up when their pain returned to 50% or more of their pretreatment level. The results were an average return to greater than 50% of pretreatment pain at 263 days in the RFA group versus 8 days in the placebo group.

The data suggest certain selected individuals would benefit from RFA in treating cervical facet joint pain.

Thoracic Facet Joint Pain

There is a current paucity of high-quality data evaluating the safety and effectiveness of treatment with RF denervation in the thoracic facet joints for chronic pain.

Sacroiliac Joint Pain

The literature on radiofrequency denervation of the sacroiliac joint is limited. Two small RCTs using a cooled radiofrequency probe were identified. A third RCT used palisade sacroiliac joint radiofrequency neurotomy.

In 2010, Aydin et al. published a meta-analysis of radiofrequency ablation (RFA) for sacroiliac pain. Nine studies were reviewed that reported the primary outcome measure of a reduction of pain of 50% or greater, assessed using VAS. This included a randomized placebo controlled study, three prospective observational studies, and five retrospective studies. All of the studies used injection of local anesthetic to determine if RFA was indicated for the individual. Seven studies reported follow-up treatment to 3 months, and 6 studies reported follow-up to 6 months. Meta-analysis indicated that at least half of the individuals who received RFA at the sacroiliac joint showed a reduction in their pain of 50% or more at 3 and 6 months. The conclusion determined by the meta-analysis review of this literature is limited by the low quality of the studies and lack of RCTs. In addition, the authors concluded, no standards have been established for the specific nerves to ablate or type of technique.

The single RCT included in the meta-analysis by Aydin et al. examined the effect of lateral branch radiofrequency denervation in 28 patients with injection-diagnosed sacroiliac joint pain. Two (14%) of 14 patients in the placebo-control group reported pain relief at 1-month follow-up. None reported benefit at 3-month follow-up. Of 14 patients treated with radiofrequency denervation, 11 (79%) reported pain relief at 1 month, 9 (64%) at 3 months, and 8 (57%) at 6 months.

In 2012, Patel et al. published results from a double-blind placebo controlled trial designed to compare the efficacy of lateral branch neurotomy using cooled radiofrequency to a sham intervention for the treatment of sacroiliac joint pain. The authors randomized N=51 individuals with had a positive response to 2 lateral branch blocks to lateral branch radiofrequency or sham treatment at a 2:1 ratio. The primary outcomes were pain, physical function, disability, quality of life and treatment success. Significant improvements in pain (-2.4 vs -0.8), physical function (14 vs 3), disability (-11 vs 2), and quality of life (0.09 vs 0.02) were observed for radiofrequency treatment compared with controls at the 3-month follow-up point. Treatment success was defined as a 50% or greater reduction in the numeric rating scale (NRS). Using this definition, 47% of radiofrequency-treated patients and 12% of sham patients achieved treatment success.

In a subsequent publication the Patel et al. workgroup reported that the treatment response was maintained out to 12 months in among the 25 of 34 patients who completed all follow-up visits. Of the 9 patients who terminated study participation, 4 were considered treatment failures (12% of 34).

In 2014, Zheng et al reported a RCT of palisade sacroiliac RFA in 155 subjects with ankylosing
spondylitis. Palisade RFA uses a row of radiofrequency cannulae perpendicular to the dorsal sacrum. Study participants were randomized to either palisade RFA or celecoxib. Blinded evaluation found that RFA resulted in lower global VAS scores compared with celecoxib (2.8 vs 5.0, respectively, p<0.001), as well improved scores for secondary outcome measures. This study is limited by the lack of a sham control.

Additional, larger, well-designed trials are needed for comparing specific procedures in defined populations to for use in sacroiliac pain.

Repeat Procedures

Two retrospective small series studies (Schofferman J, Kine G, 2004; Husted DS et al, 2008) were found (20 and 24 participants, respectively) involving the use of repeat RF procedures. In both studies, over 80% of participants had greater than 50% relief from repeat RF treatment. The duration of pain relief following the repeat RF was comparable to the duration of relief from the initial RF treatment. Since then, similar outcomes using repeat RF have been observed.

A 2012 systematic review of 16 studies of repeated medial branch neurotomy for facet joint pain found that repeated RF denervation was successful 33% to 85% of the time when the first procedure was successful. The average duration of pain relief was estimated to be 7 to 9 months after the first treatment and 11.6 months after a repeated lumbar procedure.

Alternate Methods of Denervation

Other methods with denervation include laser denervation, cryodenervation, and chemodenervation.

Laser denervation involves the use of a laser to denervate or destroy the nerves for facet joint pain. Iwatsuki et al., in 2007, reported laser denervation to the dorsal surface of the facet capsule in 21 participants who had a positive response to a diagnostic medical branch block. One year following laser denervation, 17, or 81%, of the participants had greater than 70% pain reduction. In four participants (19%) who previously had spinal surgery, the response to laser denervation was not successful. Additional controlled trials are needed to evaluate this technique.

Cryodenervation involves inserting a slim, luminated, double-walled cryodenervation probe under local anesthesia. The cryodenervation probe has been cooled to -70 degrees Celsius by carbon dioxide, thereby freezing the pain-causing nerves.

Chemodenervation involves injections with diluted phenol solution, a chemical ablating agent that is injected into the facet joint nerve.

There is a paucity of literature on laser denervation, cryodenervation, and chemodenervation. Long-term controlled studies are lacking. Additional literature is needed to establish safety and long-term efficacy to support the use of these methods in the treatment of facet joint pain.

PROFESSIONAL SOCIETIES

Updated guidelines on interventional techniques in the management of chronic spinal pain from the American Society of Interventional Pain Physicians (ASIPP) were published in 2013. For the treatment of facet joint pain, evidence was considered good for conventional RF and limited for pulsed RF. Based on the evidence review, ASIPP recommends treatment with conventional RF neurotomy.

In 2014, the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) published updated guidelines on the treatment of degenerative disease of the lumbar spine. AANS/CNS indicated that lumbar medial nerve ablation is suggested for the short-term (3- to 6-month) relief of facet-mediated pain in patients who have chronic lower back pain without radiculopathy from degenerative disease of the lumbar spine (Grade B).

The American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine published guidelines for chronic pain management in 2010. The guidelines stated that conventional (e.g., 80°C) or thermal (e.g., 67°C) radiofrequency ablation of the medial branch nerves to the facet joint should be performed for low back (medial branch) pain when previous diagnostic or therapeutic injections of the joint or medial branch nerve have provided temporary relief.

SUMMARY

Percutaneous radiofrequency (RF) facet denervation is used to treat neck and back pain originating in facet joints with degenerative changes. Diagnosis of facet joint pain is confirmed by response to nerve blocks. The goal of facet denervation is long-term pain relief. However, the nerves regenerate and, therefore, repeat procedures may be required.

For individuals who have suspected facet joint pain who receive diagnostic medial branch blocks, the evidence includes a systematic review of 17 diagnostic accuracy studies, a small randomized trial, and several large case series. Relevant outcomes are other test performance measures, symptoms, and functional outcomes. There is considerable controversy about the role of these blocks, the number of positive blocks required, and the extent of pain relief obtained. Studies have reported the use of single or double blocks and at least 50% or 80% improvement in pain and function. This evidence has suggested that there are relatively few patients who exhibit pain relief following 2 nerve blocks, but that these select patients may have pain relief for several months following RF denervation. Other large series have reported the prevalence and false-positive rates following controlled diagnostic blocks, although there are issues with the reference standards used in these studies because there is no criterion standard for the diagnosis of facet joint pain. There is level I evidence for the use of medial branch blocks for diagnosing chronic lumbar facet joint pain and level II evidence for diagnosing cervical and thoracic facet joint pain. The evidence available supports a threshold of at least 75% to 80% pain relief to reduce the false-positive rate. 

For individuals who have facet joint pain who receive radiofrequency ablation, the evidence includes a systematic review of randomized controlled trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. While evidence is limited to a few randomized controlled trials with small sample sizes, RF facet denervation appears to provide at least 50% pain relief in carefully selected patients. Diagnosis of facet joint pain is difficult. However, response to controlled medial branch blocks and the presence of tenderness over the facet joint appears to be reliable predictors of success. When RF facet denervation is successful, repeat treatments appear to have similar success rates and duration of pain relief. Thus, the data indicate that, in carefully selected individuals with lumbar or cervical facet joint pain, RF treatments can improve outcomes. 

There is clinical supported the use of RF denervation for facet joint pain, and this support extends to use of 2 diagnostic blocks achieving a 50% reduction in pain.

For individuals who have facet joint pain who receive therapeutic medial nerve branch blocks or alternative methods of facet joint denervation, the evidence includes uncontrolled case series and randomized trials without a sham control. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Pulsed RF does not appear to be as effective as conventional RF denervation, and there is insufficient evidence to evaluate the efficacy of other methods of denervation (e.g., alcohol, laser, cryodenervation) for facet joint pain or the effect of therapeutic medial branch blocks on facet joint pain.

For individuals who have sacroiliac joint (SIJ) pain who receive radiofrequency ablation (RFA), the evidence includes 4 small RCTs using different radiofrequency applications and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. For RFA with a cooled probe, the 2 small RCTs reported short-term benefits, but these are insufficient to determine the overall effect on health outcomes. The RCT on palisade RFA of the SIJ did not include a sham control. Another sham-controlled randomized trial showed no benefit of RFA. Further high-quality controlled trials are needed to compare this procedure in defined populations with sham control and alternative treatments. 


References

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Kim WM, Lee HG, Jeong CW, et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med. 2010;16(12):1285-90.

Klessinger S. Radiofrequency neurotomy for the treatment of therapy-resistant neck pain after ventral cervical operations. Pain Medicine. 2010;11(10):1504-1510.

Kline MT, Yin W. Radiofrequency techniques in clinical practice. In: Waldman SD, ed. Interventional Pain Management. Philadelphia, PA: WB Saunders Co.; 2001: 249-250; 475.

Kornick C, Kramarich SS, Lamer TJ, Todd Sitzmann B. Complications of lumbar facet radiofrequency denervation. Spine. 2004;29(12):1352-1354.

Kroll HR, Kim D, Danic MJ, et al. A randomized, double-blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndrome. J Clin Anesth. 2008;20(7):534-537.

Lakemeier S, Lind M, Schultz W, et al. A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double-blind trial. Anesth Analg. 2013;117(1):228-235.

Lindner R, Sluijter ME, Schleinzer W. Pulsed radiofrequency treatment of the lumbar medial branch for facet pain: a retrospective analysis. Pain Med. 2006;7(5):435-9.

Lord SM, Barnsley L, Wallis BJ, et al. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996;335(23):1721-1726.

Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013;16(2 Suppl):S49-283.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING CODES ARE USED TO REPRESENT NON-PULSED RADIOFREQUENCY (RF) DENERVATION: 64633, 64634, 64635, 64636

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT RADIOFREQUENCY DENERVATION OF THE SACROILIAC JOINT: 64625



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A


Misc Code

N/A:



Coding and Billing Requirements






Policy History

Revisions from MA11.102h:
06/15/2020This version of the policy will become effective on 06/15/2020, and communicates Company's continuing medical policy position on Denervation of the Spinal Nerves for Chronic Pain.

Description section was updated and the last bullet of medical necessity was reworded for clarity.

Revisions from MA11.102g:
01/01/2020This version of the policy will become effective on 01/01/2020 due to a coding update.

The following code is being added to the policy:

64625

Revisions from MA11.102f:
01/14/2019This version of the policy will become effective on 01/14/2019.

The following change is made to the policy:
  • Consideration may be given for repeat radiofrequency (RF) treatment at least 5 months following a prior successful RF denervation when there is at least 50% reduction in pain, AND other medical necessity criteria detailed in this policy bulletin are met (i.e. following a prior successful RF denervation, if the individual’s functional status, secondary to the return of pain, seriously impedes their ability to work or to care for their activities of daily living (i.e., at least 50% reduction in pain)).

02/20/2019: In the lead-in sentence to the above criterion, "If there was a prior successful RF denervation, a minimum time of 5 months has elapsed since the prior RF treatment (per side, per anatomical level of the spine"; minium time was fixed from inadvertently typed 6 months to 5 months.


Revisions from MA11.102e
03/01/2018This version of the policy will become effective on 03/01/2018.

The following major changes are made to the medical necessity criteria in this medical policy:
  • Clarified the levels for cervical facet joints: at or above C2 (i.e., 2nd level vertebra)
  • A successful trial of controlled diagnostic facet joint blocks (e.g., intraarticular facet joint or medial branch block) should result in 80 percent reduction in pain.


On 02/27/2018 the following clarifications were made to the policy in Notification:
  • Non-pulsed radiofrequency (RF) denervation of the cervical facet joints at or above below C2 (i.e., 2nd level vertebra)...
  • A successful trial of controlled diagnostic facet joint blocks (e.g., intraarticular facet joint or i.e. medial branch blocks), consisting of two separate positive blocks conducted on different days with local anesthetic only (no steroids or other drugs) or a placebo-controlled series of facet joint blocks under image guidance... 
  • The following statement added to the POLICY section: "For each covered spinal region (cervical or lumbar), non-pulsed radiofrequency (RF) denervation is considered medically necessary and, therefore, covered only when performed at no more than four (4) joints per session (e.g., two [2] bilateral levels or four [4] unilateral levels)."


MA11.02d
02/15/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Denervation of the Spinal Nerves for Chronic Pain.
01/06/2017The intent of this policy remains unchanged.
Chemodenervation added as an example of denervation that is considered experimental/investigational.

The following CPT code has been added to this policy:
64640

The following CPT code has been removed from this policy:
64999

The following ICD-10 CM code has been removed from this policy:
M25.50 Pain in unspecified joint

The following ICD-10 CM codes have been added to this policy:
M45.7, M45.8, M45.9, M46.1, M47.15, M47.25, M47.27, M47.28, M47.815, M47.817, M47.818, M47.895, M47.897, M47.898, M48.07, M48.08, M48.8X9, M51.37, M53.2X8, M53.3, M53.86, M53.87, M53.88, M54.18, M54.30, M54.31, M54.32, M54.40, M54.41, M54.42, M54.5, S33.2, S33.6XXA, S33.6XXD, S33.6XXS


MA11.02c
10/01/2016The following ICD-10 CM code has been deleted from this policy:

M50.32

ICD-10 CM codes have been added to this policy:

M50.320: Other cervical disc degeneration, mid-cervical region, unspecified level
M50.321: Other cervical disc degeneration at C4-C5 level
M50.322: Other cervical disc degeneration at C5-C6 level
M50.323: Other cervical disc degeneration at C6-C7 level


MA11.02b
12/02/2015This version of the policy will become effective 12/02/2015.

The policy has been reissued to communicate the Company’s continuing position on denervation of the spinal nerves for chronic pain. There are no changes to the coverage position or the criteria.


MA11.102a
10/01/2015This policy has been identified for the ICD-10 CM code update, effective 10/01/2015.
The following ICD-10 CM code has been termed from this policy: M47.17
The following ICD-10 narrative has been revised in this policy: M08.88

ICD-9 codes have been removed from this policy, since ICD-10 codes are effective 10/01/15.


MA11.102
01/01/2015This is a new policy.






Version Effective Date: 06/15/2020
Version Issued Date: 06/15/2020
Version Reissued Date: N/A