Latest Review Date: October 2024

Category:  Medical                                                        

POLICY:

Peripheral nerve destruction using cryoablation or thermal, electrical, chemical or radiofrequency ablation to treat pain associated with musculoskeletal conditions is considered investigational for the following conditions, including but not limited to:

• Neuralgia/Neuritis
• Osteoarthritis
• Plantar fasciitis
• Plantar fibromatosis
• Sacroiliitis
• Sprains/Strains
• Trigger point pain

Cryoneurolysis, cryoablation, cryoanalgesia of peripheral nerves to treat pain associated with musculoskeletal conditions is considered investigational for the following conditions, including but not limited to:

• Knee osteoarthritis
• Total knee arthroplasty

DESCRIPTION OF PROCEDURE OR SERVICE:

Ablative procedures including radiofrequency ablation (RFA), cooled radiofrequency, pulsed radiofrequency, cryoneurolysis (cryoablation, cryotherapy, cryoanalgesia) and chemical neurolysis (chemodenervation) have been proposed as a treatment of the peripheral nerves to treat pain related to conditions including but not limited to the following: osteoarthritis, neuralgias/neuritis (intercostal neuralgia, inguinal neuralgia), peripheral neuromas and plantar fasciitis. RFA of nerves is a minimally invasive method that involves use of heat and coagulation necrosis to destroy tissue. A needle electrode is inserted through the skin and then into the tissue to be ablated. A high-frequency electrical current is applied to the target tissue. A small sphere of tissue is coagulated around the needle by the heat generated. It is theorized that the thermal lesioning of the nerve destroys peripheral sensory nerve endings, resulting in the alleviation of pain.

Cooled radiofrequency (RF) treatment is a variation of nerve RFA using a special device that applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue injury away from the nerve. The goal of ablating the nerve is the same.

COOLIEF Cooled RF treatment is a minimally invasive outpatient procedure used in the treatment of hip and knee pain associated with osteoarthritis that uses cooled radiofrequency energy to target the sensory nerves causing pain. COOLIEF circulates water through the device while heating nervous tissue to create a treatment area that is larger than conventional RF treatments. This combination targets the pain causing nerves without excessive heating, leading to pain relief.

Pulsed radiofrequency, which uses short bursts of radiofrequency current, has been proposed as a possibly safer alternative to non-pulsed or continuous RFA in the treatment of variety pain syndromes. It also differs from standard RF procedures in that the temperature will not exceed. While the mechanism of action of pulsed RF treatment is uncertain, it is thought that since the temperatures do not exceed 42°C, the heat is not enough to cause tissue coagulation or permanent damage to the nerve. Pulsed RF may cause less damage than standard RFA.

Table 1. Types of Radiofrequency Ablation

RF: radiofrequency; RFA: radiofrequency ablation (Adapted from Oladeji et al (2019))

Chemical Neurolysis or chemodenervation is the use of a chemical using phenol, alcohol, glycerol or a hypertonic saline to cause destruction of nerves by causing a temporary degeneration of the nerves fibers to interrupt the transmission of nerves signals for pain relief.

Cryoneurolysis is being investigated to alleviate pain in knee osteoarthritis and to manage pain following total knee arthroplasty. Temperatures of -20° to -100°C applied to a nerve cause Wallerian (anterograde axonal) degeneration, with disruption of nerve structure and conduction but maintenance of the perineural and epineural elements of the nerve bundle. Wallerian degeneration allows complete regeneration and recovery of nerve function in about 3 to 5 months. The iovera cryoablation system is a portable handheld device that applies percutaneous and targeted delivery of cold to superficial peripheral nerves.

Plantar Fasciitis

Plantar fasciitis is a common cause of foot pain in adults, characterized by deep pain in the plantar aspect of the heel, particularly on arising from bed. While the pain may subside with activity, in some individuals the pain persists and can impede activities of daily living. On physical examination, firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology of plantar fasciitis is unclear, although repetitive injury is suspected. Heel spurs are a common associated finding, although it has never been proven that heel spurs cause the pain. Asymptomatic heel spurs can be found in up to 10% of the population. Most cases of plantar fasciitis are treated with conservative therapy, including rest or minimization of running and jumping, heel cups, and nonsteroidal anti-inflammatory drugs. Local steroid injection may also be used. Improvement may take up to 1 year in some cases.

Morton neuroma is a common and painful compression neuropathy of the common digital nerve of the foot that may also be referred to as interdigital neuroma, interdigital neuritis, or Morton metatarsalgia. It is histologically characterized by perineural fibrosis, endoneurial edema, axonal degeneration, and local vascular proliferation. Thus, some investigators do not consider Morton neuroma to be a true neuroma; instead, they consider it to be an entrapment neuropathy occurring secondary to compression of the common digital nerve under the overlying transverse metatarsal ligament. The incidence and prevalence of Morton neuroma are not clear, but it appears 10-fold more often in women than in men, with an average age at presentation of around 50 years. Morton neuroma is usually treated with conservative measures, surgery, or minimally invasive procedures. Alcohol injection is a minimally invasive alternative to open surgery to treat Morton neuroma. Alcohol causes chemical neurolysis through dehydration, necrosis, and precipitation of the treated area, ultimately destroying the lesion after multiple injections.

Knee Osteoarthritis

Knee osteoarthritis is common, costly, and often the cause of substantial disability. Treatment for osteoarthritis of the knee aims to alleviate pain and improve function. However, most treatments do not modify the natural history or progression of osteoarthritis and are not considered curative. Nonsurgical modalities used include exercise; weight loss; various supportive devices; acetaminophen or nonsteroidal anti-inflammatory drugs, such as ibuprofen; nutritional supplements (glucosamine, chondroitin); and intra-articular viscosupplements. Corticosteroid injection may be considered when relief from nonsteroidal anti-inflammatory drugs is insufficient, or the individual is at risk of gastrointestinal adverse effects. If symptom relief is inadequate with conservative measures, invasive treatments may be considered. Operative treatments for symptomatic osteoarthritis of the knee include arthroscopic lavage and cartilage debridement, osteotomy, and, ultimately, total joint arthroplasty. Surgical procedures intended to repair or restore articular cartilage in the knee (e.g., abrasion arthroplasty, microfracture techniques, autologous chondrocyte implantation) are appropriate only for younger individuals with focal cartilage defects secondary to injury and are not addressed in this policy.

*For additional information on headache syndromes, see medical policy # 314 Treatment of Cervicogenic Headache and Occipital Neuralgia.

*For additional information on cervical and lumbar pain, see medical policy # 141 Facet Joint Denervation.

*For additional information on sacroiliac joint pain, see medical policy # 558 Diagnosis and Treatment of Sacroiliac Joint Pain.

KEY POINTS:

This evidence review was created based on a search of the literature through July 23, 2024.

Summary of Evidence

For individuals who have knee osteoarthritis (OA) who receive radiofrequency ablation (RFA) of peripheral nerves, the evidence includes systematic reviews of randomized controlled trials (RCTs), RCTs with 24 to 200 individuals and non-randomized comparative studies with up to 12 months of follow-up. Relevant outcomes include symptoms, functional outcomes, and quality of life (QOL). Knee OA is a common disorder in older adults. RFA of the genicular nerves has the potential to alleviate pain and improve function in this population, and might also delay or eliminate the need for TKA. At this time, there is high heterogeneity in methods and comparators. The systematic reviews generally found that RFA had a benefit on pain, function, and composite scores compared to the control treatments at 3 and 6-month follow-up; however, most estimates were determined to have moderate to high heterogeneity. The network meta-analysis compared multiple RFA modalities and found that cooled RFA had significantly improved efficacy for pain and function through 6 months follow-up compared with traditional or pulsed RFA. The 2 multicenter trials conducted in the U.S. used anesthetic nerve block under fluoroscopic guidance and compared efficacy of cooled RFA to either steroid injection or hyaluronic acid injection. Both studies reported a responder rate of approximately 70% at 6 months, which was significantly greater than the control conditions. A small, double-blind RCT of bipolar RFA with genicular nerve block compared to genicular nerve block and sham RFA found no differences between groups for visual analog score (VAS) pain or the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores through 12 months follow-up. Given that OA of the knee is a common condition; adequately powered studies, preferably blinded with active and sham controls and follow-up of at least 12 months, is needed to determine the benefits and potential harms of this treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have knee osteoarthritis or total knee arthroplasty who receive cryoneurolysis of peripheral nerves, the evidence includes 2 RCTs with a total of 304 participants, a comparative, retrospective cohort study of 57 participants, and a registry study of 140 individuals. Relevant outcomes include symptoms, functional outcomes, and quality of life. In one RCT, cryoneurolysis in individuals with knee osteoarthritis resulted in a greater decrease in WOMAC pain score, WOMAC total score, and visual analog scale score at 30 days compared with sham-treated controls. However, subsequent measurements showed no significant benefit of cryoneurolysis on WOMAC score at 60 days or visual analog scale scores at 60 or 90 days. Another RCT investigated cryoneurolysis compared to standard of care for patients with knee OA who were planning to undergo TKA. Cryoneurolysis resulted in a lower rate of opioid consumption, a reduction in numeric rating scale (NRS) pain scores, and Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) functional performance at 12 weeks post discharge. The retrospective cohort study reported superiority of cryoneruolysis on the KOOS JR and Short Form-12 item (SF-12) mental score at 1 year follow-up; no significant differences were observed on the SF-12 physical score at 1 year follow-up or for any outcome at earlier 3-month assessment. A registry study found improved pain and lowered opioid use with cryoneurolysis prior to TKA; however, functional outcomes through 6 months were similar. Several technical issues including the optimal number of applications for each nerve, the duration of treatment, and the duration of thawing before moving the cannula have not been resolved. The most effective method for determining probe insertion location (e.g., ultrasound-guided or based on anatomic landmarks) also need to be established. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have plantar fasciitis who receive RFA of peripheral nerves, the evidence includes 2 RCTs and a meta-analysis. Relevant outcomes include symptoms, functional outcomes, and quality of life. The meta-analysis pooled evidence from 2 RCTs and did not demonstrate a significant improvement in pain outcomes compared to the control group.

The analysis revealed significant heterogeneity, and the overall quality of evidence was graded as low. One of the randomized trials only evaluated 17 individuals, and assessment of randomized outcomes was limited to 4 weeks post treatment. A second RCT evaluated 36 individuals out to 12 weeks. The case series generally had small sample sizes, and many had methodologic deficiencies such as retrospective assessment of pain. To be more confident in the efficacy of this treatment, controlled trials with larger samples and longer follow-up would be necessary. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have Morton neuroma who receive RFA or intralesional alcohol injection(s), the evidence includes retrospective cases series. Relevant outcomes are symptoms, resource utilization, and treatment-related morbidity. The body of evidence is limited, consisting of case series reporting on the treatment response of individuals with refractory Morton neuroma. The available series have generally reported that some individuals experience pain relief and express satisfaction with the procedure. Some evidence has suggested that surgery after failed cases of alcohol injections is more complex and challenging than in untreated individuals due to the presence of fibrosis. There is a lack of controlled trials comparing alcohol injections with alternative therapies, and there are no controlled studies comparing outcomes for alcohol injections with those for surgery in surgical candidates. Four case series identified reported outcomes for RFA to treat Morton neuroma. The body of evidence is highly heterogeneous regarding RFA protocols, descriptions of prior conservative management, individual characteristics, follow-up durations, outcome measures, and reporting of outcomes. Variable proportions of individuals require surgery after RFA, making the benefit of RFA for avoiding more invasive treatment uncertain. Only 2 retrospective case series on the use of cryoablation to treat peripheral nerve pain were identified in a literature review. The case series were heterogeneous regarding cryoablation protocols and length of follow-up. Outcome measures did not provide information on functional end points. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The evidence for radiofrequency ablation for myofascial trigger points includes a small number of case-studies, and one case-series.  Limitations across published literature on RF and PRF in trigger-point therapy include small sample sizes, lack of a control group and the mechanism of therapeutic effect remains unknown. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons et al

In 2021, the American Academy of Orthopaedic Surgeons published a clinical practice guideline, endorsed by the American Association of Hip and Knee Surgeons and the American Physical Therapy Association, on management of osteoarthritis (OA) of the knee. The guideline did not specifically address RFA or cryoneurolysis, but did include a guideline statement on denervation therapy that included various ablation techniques (e.g., RFA, cryoneurolysis, thermal ablation and chemical ablation). The guideline stated, "denervation therapy may reduce pain and improve function in patients with symptomatic osteoarthritis of the knee" (strength of recommendation: limited).

American College Of Rheumatology And Arthritis Foundation

The 2019 Guidelines from the American College of Rheumatology and the Arthritis Foundation gave a conditional recommendation for radiofrequency ablation for the treatment of knee OA.  The recommendation was based on evidence of a potential analgesic benefit, but the studies used heterogeneous techniques and there was a lack of long-term safety data.

The American College of Foot and Ankle Surgeons

In 2018, the American College of Foot and Ankle Surgeons issued a clinical consensus statement on the diagnosis and treatment of adult acquired infracalcaneal heel pain. The panel determined that the following statement were uncertain – neither appropriate nor inappropriate.

 American Society of Pain and Neuroscience

The American Society of Pain and Neuroscience (2021) issued consensus guidelines using U.S. Preventive Services Task Force (USPSTF) grading criteria on the use of RFA to treat various pain conditions. The guidelines stated that genicular RFA may be used for the treatment of osteoarthritis-related and post-surgical knee joint pain (Grade B), and may be selectively offered for the treatment of occipital neuralgia pain when greater or lesser nerves have been identified as the etiology of pain via diagnostic blocks (Grade C).

Association of Extremity Nerve Surgeons

The Association of Extremity Nerve Surgeons issued practice guidelines (2020) which drew the following conclusions:

• We do not recommend ablation in the primary treatment of Intermetatarsal Nerve Entrapment (“Morton’s Neuroma”).
  • Alcohol injections: The literature regarding alcohol injections is equivocal. There may be some short-term positive effect, but long-term effect is poor for this therapy. Some of the literature recommends using 30% alcohol solution to get effective results. However, new research has shown the use of 30% ethanol alcohol does not create any measurable change in the histology of nerve tissue. There is also moderate risk of necrosis of surrounding tissues. As a general rule, we do not advocate the use of alcohol injections.
  • Radiofrequency ablation: Radiofrequency ablation has use in the lower extremity, but must be done with caution as this procedure has the potential for thermal necrosis of the adjacent tissues. Judicious use of fluoroscopy and other visualization techniques is advised while utilizing radiofrequency ablation...further research in this technique is needed.
  • Cryoablation: Cryoablation (cryotherapy) should be used with extreme caution, as the amount of literature in the lower extremity is limited.If cryotherapy is used, it should ideally be performed with opentechnique rather than percutaneously for optimal results.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Radiofrequency ablation, genicular neurotomy, Coblation, osteoarthritis, plantar fasciitis, SInergy®, NeuroTherm® NT 2000, cooled radiofrequency, pulsed radiofrequency, microtenotomy RF, Topaz procedure, trigger point, myofascial pain syndrome, iovera° cryoablation system, Cryo-Touch, RFA, COOLIEF, cryoneurolysis, chemodenervation, peripheral nerve, genicular nerve, Morton’s neuroma, RFA, chemical neurolysis

APPROVED BY GOVERNING BODIES:

A number of radiofrequency (RF) generators and probes have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Some examples are listed in Table 2.

In 2017, the COOLIEF Cooled Radiofrequency Probe (Avanos, previously known as Halyard Health) was cleared for marketing by the FDA through the 510(k) process to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue (K163461). "The device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥ 50% reduction in pain) to a diagnostic genicular nerve block."

In 2013, the iovera system (Myoscience, Inc) received 510K clearance from the U.S. Food and Drug Administration (FDA). It is cleared to be used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by application of cold to selected site for blocking of pain. The iovera device is not indicated for the treatment of central nervous system tissue.

Table 2. Radiofrequency and Cryoneurolysis Devices

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:    

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65. Rajput K, Reddy S, Shankar H. Painful neuromas. Clin J Pain. Sep 2012; 28(7): 639-45.
66. Ray D, Goswami S, Dasgupta SR, Ray S, Basu S. Intra-articular hyaluronic acid injection versus RF ablation of genicular nerve for knee osteoarthritis pain: A randomized open-label, clinical study. Indian J Pain. 2018; 32:36-9.
67. Santana Pineda MM, Vanlinthout LE, Moreno Martin A, et al. Analgesic effect and functional improvement caused by radiofrequency treatment of genicular nerves in patients with advanced osteoarthritis of the knee until 1 year following treatment. Reg Anesth Pain Med. Jan/Feb 2017;42(1):62-68.
68. Sari S, Aydin ON, Turan Y, et al. Which one is more effective for the clinical treatment of chronic pain in knee osteoarthritis: radiofrequency neurotomy of the genicular nerves or intra-articular injection?. Int J Rheum Dis. Oct 2018; 21(10): 1772-1778.
69. Schneider HP, Baca JM, Carpenter BB, et al. American College of Foot and Ankle Surgeons clinical consensus statement: diagnosis and treatment of adult acquired infracalcaneal heel pain. J Foot Ankle Surg. Mar-Apr 2018;57(2):370-381.
70. Shen WS, Xu XQ, Zhai NN, et al. Radiofrequency Thermocoagulation in Relieving Refractory Pain of Knee Osteoarthritis. Am J Ther.Nov/Dec 2017; 24(6): e693-e700.
71. Tamimi MA, McCeney MH, Krutsch J. A case series of pulsed radiofrequency treatment of myofascial trigger points and scar neuromas. Pain Med. 2009; 10(6):1140-1143.
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75. Walega, DD, McCormick, ZZ, Manning, DD. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect on postoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med, 2019 Apr 27.
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78. Wu L, Li Y, Si H, et al. Radiofrequency Ablation in Cooled Monopolar or Conventional Bipolar Modality Yields More Beneficial Short-Term Clinical Outcomes Versus Other Treatments for Knee Osteoarthritis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Arthroscopy. Jul 2022; 38(7): 2287-2302.
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POLICY HISTORY:

Medical Policy Panel, January 2016

Medical Policy Group, March 2016 (2): New policy created.

Medical Policy Administration Committee, April 2016

Available for comment March 18 through May 9, 2016

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): 2017 Updates to Description and Key Points. No change in Policy Statement.

Medical Policy Panel, September 2018

Medical Policy Group, November 2018 (7): Updates to Title, Description, Key Points, Approved by Governing Bodies and References. Policy Statement updated to include an investigational listing for cryoneurolysis. Added Key Words: “iovera° cryoablation system, Cryo-Touch and RFA”. Policy Statement updated to add investigational statement regarding cryoneurolysis of peripheral nerves to treat pain.

Medical Policy Panel, September 2019

Medical Policy Group, October 2019 (7): Updates Key Points and References. No change in Policy Statement. Added Key Word: COOLIEF.

Medical Policy Panel, September 2020

Medical Policy Group, October 2020 (7): Updates Description, Key Points and References. No change in Policy Statement. Added Key Word: COOLIEF.

Medical Policy Group, December 2019: 2020 Annual Coding Update.  Added CPT codes 64624 to the Current coding section. No change in Policy Statement.

Medical Policy Panel, September 2020

Medical Policy Group, February 2021 (7): Updates to Title, Key Points and References. Policy Statement updated to clarify peripheral nerve destruction to treat pain associated with musculoskeletal conditions is considered investigational.

Medical Policy Panel, June 2021

Medical Policy Group, July 2021 (7): Updates to Description, Key Points, Approved by Governing Bodies and References. Added Key Words: “cryoneurolysis, chemodenervation, peripheral nerve, genicular nerve, Morton’s neuroma, RFA, chemical neurolysis.” Removed “not medically necessary” verbiage from Policy Statement. No change in intent.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (7): Minor update to Key Points related to Morton’s neuroma and associated references. Removed previous Policy Statement prior to October 2018. No change in intent.

Medical Policy Panel, September 2022

Medical Policy Group, October 2022 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, September 2023

Medical Policy Group, October 2023 (7): Updates to Key Points, Benefit Application, and References. No change in Policy Statement.

Medical Policy Group, June 2024 (7): Added CPT codes- 0440T, 0441T, 0442T. No change to Policy Statement.

Medical Policy Panel, September 2024

Medical Policy Group, October 2024 (7): Updates to Key Points and References. No change in Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1.  The technology must have final approval from the appropriate government regulatory bodies;
2.  The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3.  The technology must improve the net health outcome;
4.  The technology must be as beneficial as any established alternatives;
5.  The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1.  In accordance with generally accepted standards of medical practice; and
2.  Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3.  Not primarily for the convenience of the patient, physician or other health care provider; and
4.  Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.