mp-626
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Ablation Therapies for the Treatment of Peripheral Nerves and Other Musculoskeletal Conditions

Policy Number: MP-626

 Latest Review Date: October 2019

Category:        Medical                                                          

Policy Grade:  C

 

POLICY:

Effective for dates of service on and after November 1, 2018:

 

Radiofrequency ablation of peripheral nerves to treat pain associated with musculoskeletal conditions is considered not medically necessary and investigational for the following conditions, including but not limited to:

 

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

 

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

  • Knee osteoarthritis
  • Total knee arthroplasty

 

Effective for dates of service May 10, 2016 through October 31, 2018:

Radiofrequency ablation of peripheral nerves to treat pain associated with musculoskeletal conditions is considered not medically necessary and investigational for the following conditions, including but not limited to:

 

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

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Radiofrequency ablation of nerves has been proposed as a treatment for several different types of pain. Radiofrequency ablation can be done in different ways. It can be done using, heat, cold, or pulsed. It has been used to treat a number of clinical pain syndromes by preventing the transmission of pain signals (such as *cervical and lumbar pain or headache syndromes.) This evidence review evaluates the evidence for radiofrequency ablation in peripheral sites distant from the cranium or spine.

 

*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.

 

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 patients 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.

 

Knee Osteoarthritis

Knee osteoarthritis is common, costly, and often the cause of substantial disability. Among U.S. adults, the most common causes of disability are arthritis and rheumatic disorders. 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 patient 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 débridement, 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 patients with focal cartilage defects secondary to injury and are not addressed in this policy.

 

Radiofrequency ablation (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.

 

Nerve RFA is distinguished from pulsed RF treatment, which has been investigated as a treatment for different types of pain. Pulsed RF involves giving short pulses of radiofrequency waves twice a minute. It differs from standard RF procedures in that the needle is not heated above 42 degrees. The mechanism of action of pulsed RF treatment is uncertain, but it is thought not to destroy the nerve. If it does produce some degree of nerve destruction, it is thought to cause less damage than standard RFA. Some studies refer to pulsed RF treatment as ablation.

For the indications assessed in this evidence review, nerve RFA should be distinguished from RF energy applied to areas other than the nerve to cause tissue damage. Some patients have been treated for plantar fasciitis with a fasciotomy procedure using an RF device. This procedure does not ablate a specific nerve.

 

Table 1. Types of Radiofrequency Ablation

Type

Procedure

Tissue Temperature

Key Differences

Standard RFA

Electrode tip provides thermal energy for 90 – 130 seconds

70 – 90 C

Longer lasting but with more adjacent thermal tissue injury and limitation in size and shape of lesion.

Pulsed RFA

Non-ablative - provides 20 ms pulses every 30 seconds

42 C

Limits tissue damage but results in incomplete and transient pain relief

Cooled RFA

Water circulates through RF electrode to cool the tip

60° C

Larger lesion with limited thermal injury to tissue. Less complete and shorter durability than standard RFA

RF: radiofrequency; RFA: radiofrequency ablation

Adapted from Oladeji et al (2019)

 

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.

 

KEY POINTS:

This evidence review was created based on a search of the literature through July 9, 2019.

Summary of Evidence

For individuals who have knee OA who receive RFA of peripheral nerves, the evidence includes 2 RCTs with a total of 211 patients with a 6-month follow-up and observational studies with 12 months of follow-up. The relevant outcomes include symptoms, functional outcomes, and 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. To date, the evidence on RFA for knee pain includes 2 RCTs with a total of 211 patients with a 6-month follow-up and prospective observational studies with 12 months of follow-up. The larger of the RCTs compared C-RFA to active control of steroid injection and utilized genicular nerve blocks to select patients for the study. At 1 month after treatment, pain scores on an 11-point NRS differed by less than 1 point, a finding that was statistically significant but of marginal clinical significance. By three months after treatment pain scores had increased in the steroid group, consistent with the known durability of the treatment. Pain scores in the RFA group remained low in patients who remained in the study. Durability of this treatment approach to 1 year has been evaluated in a follow-up to the RCT, a retrospective study, and a small (n=25) independent prospective study. In both of the industry-sponsored publications, 65% of the patients treated with C-RFA reported a greater than 50% reduction in pain scores at 12 months. In an independent and prospective observational study, about one-third continued to show a response at one year after RFA of the genicular nerves. The second RCT used stimulation to identify the genicular nerves, rather than genicular nerve blocks with an anesthetic. None of the studies were blinded, which may have biased the subjective outcome measures. It should be noted that the anatomy of the genicular nerves is variable, and the best method for their identification has not been determined. Study in a larger number of patients, preferably in blinded studies with active control and follow-up longer than 12 months, is needed to determine the benefits and potential harms of this treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have knee osteoarthritis or total knee arthroplasty who receive cryoneurolysis of peripheral nerves, the evidence includes an RCT with 180 patients and a retrospective comparative study. Relevant outcomes include symptoms, functional outcomes, and quality of life. Cryoneurolysis in patients 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. Perioperative cryoneurolysis was shown in a retrospective comparison to reduce the length of stay and opioid use in patients undergoing total knee arthroplasty. These results need to be confirmed in an RCT. 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. Relevant outcomes include symptoms, functional outcomes, and quality of life. One of the randomized trials only evaluated 17 patients, and assessment of randomized outcomes was limited to 4 weeks posttreatment. A second RCT evaluated 36 patients 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.

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

The American College of Foot and Ankle Surgeons

The American College of Foot and Ankle Surgeons (2018) issued consensus guidelines on the diagnosis and treatment of acquired infracalcaneal heel pain. The safety and efficacy of bipolar radiofrequency was listed as uncertain (neither appropriate nor inappropriate).

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

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. In 2005, the SInergy® (Kimberly Clark/Baylis), a water-cooled single-use probe, was cleared by FDA, listing the Baylis Pain Management Probe as a predicate device. The intended use is with a RF generator to create RF lesions in nervous tissue.

 

In September 2011, NeuroTherm® NT 2000 (NeuroTherm) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in lesioning neural tissue. Existing predicate devices included the NeuroTherm NT 1000, Stryker Multi-Gen, and Cosman G4 RF Generator.

 

In 2013, the Cryo-Touch IV (iovera°; Myoscience) was cleared for marketing by FDA through the 510(k) process (K123516). Predicate devices were the Cryo-Touch II (K102021) and Cryo-Touch III (K120415).

 

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."

 

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.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

 

CURRENT CODING: 

CPT Codes:    

64624

Destruction by neurolytic agent; genicular nerve branches including imaging guidance, when performed (Effective 01/01/20) 

64630

Destruction by neurolytic agent; pudendal nerve

64632

Destruction by neurolytic agent; plantar common digital nerve

64640

Destruction by neurolytic agent; other peripheral nerve or branch

64999

Unlisted procedure, nervous system

 

REFERENCES:

  1. Bellini M, Barbieri M. Cooled radiofrequency system relieves chronic knee osteoarthritis pain: the first case-series. Anaesthesiol Intensive Ther. 2015; 47(1):30-33.
  2. Choi WJ, Hwang SJ, Song JG, et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. Mar 2011; 152(3):481-487.
  3. Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). Apr 2011; 153(4):763-771.
  4. Cione JA, Cozzarelli J, Mullin CJ. A retrospective study of radiofrequency thermal lesioning for the treatment of neuritis of the medial calcaneal nerve and its terminal branches in chronic heel pain. J Foot Ankle Surg. Mar-Apr 2009; 48(2):142-147.
  5. Cozzarelli J, Sollitto RJ, Thapar J, et al. A 12-year long-term retrospective analysis of the use of radiofrequency nerve ablation for the treatment of neurogenic heel pain. Foot Ankle Spec. Dec 2010; 3(6):338-346.
  6. Dasa V, Lensing G, Parsons M, et al. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. Jun 2016;23(3):523-528.
  7. Davis T, Loudermilk E, DePalma M, et al. Prospective, multicenter, randomized, crossover clinical trial comparing the safety and effectiveness of cooled radiofrequency ablation with corticosteroid injection in the management of knee pain from osteoarthritis. Reg Anesth Pain Med. Jan 2018;43(1):84-91.
  8. El-Hakeim EH, Elawamy A, Kamel EZ, et al. Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic KneeOsteoarthritis: A Single-Blind Randomized Controlled Trial. Pain Physician, 2018 Mar 23;21(2).
  9. Erken HY, Ayanoglu S, Akmaz I, et al. Prospective study of percutaneous radiofrequency nerve ablation for chronic plantar fasciitis. Foot Ankle Int. Feb 2014; 35(2):95-103.
  10. Gabriel RA, Ilfeld BM. Novel methodologies in regional anesthesia for knee arthroplasty. Anesthesiol Clin. Sep 2018;36(3):387-401.
  11. House, LL, Korn, MM, Garg, AA. Severity of Knee Osteoarthritis and Pain Relief After Cooled Radiofrequency Ablation of the GenicularNerves. Pain Med, 2019 May 3.
  12. Ikeuchi M, Ushida T, Izumi M, et al. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. Apr 2011; 12(4):546-551.
  13. Jamison DE, Cohen SP. Radiofrequency techniques to treat chronic knee pain: a comprehensive review of anatomy, effectiveness, treatmentparameters, and patient selection. J Pain Res, 2018 Oct 3;11:1879-1888.
  14. Kapural, L. Long-term retrospective assessment of clinical efficacy of radiofrequency ablation of the knee using a cooled RF system. Pain Physician. Sep2019;22(5):489-494.
  15. Kumaran, BB, Watson, TT. Treatment using 448kHz capacitive resistive monopolar radiofrequency improves pain and function in patientswith osteoarthritis of the knee joint: a randomised controlled trial.. Physiotherapy, 2018 Oct 3;105(1).
  16. Landsman AS, Catanese DJ, Wiener SN, et al. A prospective, randomized, double-blinded study with crossover to determine the efficacy of radio-frequency nerve ablation for the treatment of heel pain. J Am Podiatr Med Assoc. Jan-Feb 2013; 103(1):8-15.
  17. Liden B, Simmons M, Landsman AS. A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis. J Foot Ankle Surg. Nov-Dec 2009; 48(6):642-647.
  18. McCormick, ZZ, Reddy, RR, Korn, MM. A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the PredictiveValue for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. Pain Med, 2018 Jan 5;19(8).
  19. Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, andOutcomes. J Knee Surg, 2018 Nov 6;32(1).
  20. Park C, Lee Y, Kim Y, et al. Treatment experience of pulsed radiofrequency under ultrasound guided to the trapezius muscle at myofascial pain syndrome. Korean J Pain. 2012; 25(1):52-54.
  21. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. Aug 2017;25(8):1247-1256.
  22. 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.
  23. 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.
  24. 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.
  25. Thomas JL, Christensen JC, Kravitz SR, et al. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. May-Jun 2010; 49(3 Suppl):S1-19.
  26. Vas L, Pai R, Khandagale N, et al. Pulsed radiofrequency of the composite nerve supply to the knee joint as a new technique for relieving osteoarthritic pain: a preliminary report. Pain Physician. Nov-Dec 2014; 17(6):493-506.
  27. Walega, DD, McCormick, ZZ, Manning, DD. Radiofrequency ablation of genicular nerves prior to total knee replacement has no effect onpostoperative pain outcomes: a prospective randomized sham-controlled trial with 6-month follow-up. Reg Anesth Pain Med, 2019 Apr
  28. Wu YT, Chang CY, Chou YC, et al. Ultrasound-guided pulsed radiofrequency stimulation of posterior tibial nerve: a potential novel intervention for recalcitrant plantar fasciitis. Arch Phys Med Rehabil. May 2017;98(5):964-970.
  29. Xiao, LL, Shu, FF, Xu, CC. Highly selective peripheral nerve radio frequency ablation for the treatment of severe knee osteoarthritis. ExpTher Med, 2018 Oct 23;16(5).

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 Group, December 2019: 2020 Annual Coding Update.  Added CPT codes 64624 to the Current coding section. 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.