Medical Policy: 07.01.73 

Original Effective Date: January 2017 

Reviewed: January 2017 

Revised:  

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Radiofrequency ablation (RFA) of the nerves has been proposed as a treatment for several different types of pain. It has been used to treat a number of pain syndromes such as trigeminal neuralgia, cervical and lumbar facet joint pain and headache syndromes. This medical policy evaluates the evidence for radiofrequency ablation in peripheral sites distant from the cranium or spine.

 

Radiofrequency nerve ablation (RFNA) is being proposed in the treatment of chronic knee pain (i.e. chronic osteoarthritis/degenerative joint disease) and plantar fasciitis for individuals that have not been effectively managed by pharmacologic or other alternative therapies.  

 

Radiofrequency Nerve Ablation (RFNA)

         

Radiofrequency nerve ablation (RFNA) is a minimally invasive method that involves the 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 (80 to 85 degrees Celsius). It is theorized that the thermal lesioning of the nerve destroys peripheral sensory nerve endings, resulting in the alleviation of pain. However, the results are typically not permanent as the nerves may regenerate which can cause the pain to return and may require the repetition of the RFNA procedure to alleviate the pain.  

 

Cooled radiofrequency and pulsed radiofrequency are treatment variations that may also be utilized rather than conventional (standard) radiofrequency ablation. Cooled radiofrequency is a variation of conventional (standard) radiofrequency 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 for ablating the nerve is the same. Pulsed radiofrequency treatment uses short bursts of radiofrequency current, rather than continuous current. The mechanism for action of pulsed radiofrequency 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 conventional (standard) RFA.   

 

Knee Osteoarthritis 

  
Knee osteoarthritis is a common cause of joint pain and disability. The treatment of osteoarthritis (OA) is directed towards reduction of symptoms and improve function. However, most treatments do not modify the natural history or progression of OA and are not considered curative. Nonsurgical modalities used include exercise; weight loss; various supportive devices; acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs), nutritional supplements (glucosamine, chondroitin); corticosteroid injections; and intra-articular viscosupplements. Operative treatments for symptomatic OA of the knee include arthroscopic lavage and cartilage debridement, osteotomy, and ultimately a total joint arthroplasty.

 

When an individual exhibits knee pain, the pain signals can be generated from the peripheral nerves innervating the knee including several branches of the genicular nerve. Radiofrequency ablation (RFA) of the genicular nerves may be performed to restore function and alleviate knee pain. 

 

The evidence for radiofrequency ablation of peripheral nerves in individuals who have knee pain consists of 2 case series, 1 non-randomized comparison, and 1 RCT. Treatments given differ slightly across studies and may not be comparable. One study used cooled RFA, another study used pulsed radiofrequency to several nerves in the knee, and another study treated only nerves associated with anteromedial knee pain. The single randomized trial had a small sample size of 38 and assessed outcomes out to 12 weeks. Although the trial showed improvement in pain at 12 weeks, these results are insufficient to draw conclusions about treatment efficacy. Further randomized clinical trials are needed to determine the efficacy of this treatment to include studies with larger sample sizes and longer follow up periods. Also, there are currently no society guidelines that address the use of radiofrequency nerve ablation for the treatment of knee pain. The evidence is insufficient to determine the safety and efficacy of this technology on health outcomes.  

 

Plantar Fasciitis 


Plantar fasciitis is one of the most common causes of foot pain in adults, characterized by pain the plantar region of the foot that is worse when initiating walking. While the pain might subside with activity, in some patients the pain may persist, impairing activities of daily living. On physical examination firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology is unclear, although repetitive injury is suspected. Possible risk factors for the development of plantar fasciitis include obesity, prolonged standing or jumping, flat feet and reduced ankle dorsiflexion. Although heel spurs often coexist with plantar fasciitis, it is unclear whether they have a causal role and may instead represent a secondary response to an inflammatory reaction. Most cases of plantar fasciitis are treated with conservative therapy, including stretching exercises for the plantar fascia and calf muscles; decreasing physical activities that are causative or aggravating ( running, jumping, dancing); avoiding the use of flat shoes or barefoot walking; prefabricated over the counter arch supports/heel cups; molded shoe inserts (orthotics); night splints; nonsteroidal anti-inflammatory drugs (NSAIDs); and injecting tender areas of the plantar region with glucocorticoids and a local anesthetic. Improvement may take up to 1 year in some cases.

 

Radiofrequency ablation of peripheral nerves may be performed for the treatment of chronic heel pain associated with plantar fasciitis and the literature on the use of this is limited. The evidence for radiofrequency ablation of peripheral nerves in individuals who have plantar fasciitis includes case series studies and 1 randomized controlled trial (RCT). The case series generally have small sample sizes, and many have methodologic deficiencies such as retrospective assessment of pain. The single RCT evaluated only 17 patients, and randomized outcomes could only be assessed out to 4 weeks post-treatment. Although the studies report that radiofrequency ablation reduces heel pain, the quality of the evidence is poor. Because of the variable natural history of plantar fasciitis and the subjective nature of the outcome measures, randomized clinical trials (RCTs) are needed to determine whether outcomes are improved with interventions for pain. Trials should include homogenous population of patients with defined clinical condition, use standardized outcome measures to include longer follow up periods and define clinically relevant outcome measures for pain treatments which includes measures of pain severity and functional limitations. The evidence is insufficient to determine the effects of this technology on health outcomes.     

 

Practice Guidelines and Position Statements 


In 2010, the American College of Foot and Ankle Surgeons issued a guideline on the treatment of heel pain. Bipolar radiofrequency is listed as a third tier option for patients who have failed other treatments. It was given a grade C recommendation, meaning that this treatment option is supported either conflicting or level IV expert opinion evidence. 

 

Regulatory Status 


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.

 

Prior Approval:

 

Prior approval is required

 

Policy:

  • See also Medical Policy 07.01.66 Ablative Treatments of Occipital Neuralgia, Chronic Headaches and Atypical Facial Pain

  • See also Medical Policy 07.01.41 Pulsed Radiofrequency

  • See also Medical Policy 07.01.58 Facet Joint Denervation

Radiofrequency ablation (RFA) of peripheral nerves to treat pain associated with plantar fasciitis or chronic knee pain including but not limited to the following: knee osteoarthritis/degenerative joint disease as a treatment prior to knee replacement; as a treatment following knee replacement; as a treatment for individuals who are not candidates for knee replacement surgery is considered investigational.

 

Based on the peer review medical literature the evidence limited and insufficient to determine the safety and efficacy of radiofrequency ablation of the peripheral nerves to treat pain associated with plantar fasciitis or for knee pain. Further randomized clinical trials (RCTs) are needed to determine the efficacy of this treatment to include studies with larger sample sizes and longer follow periods. The evidence is insufficient to determine the effects of this technology on net health outcomes and therefore is considered investigational.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 64640 Destruction of neurolytic agent; other peripheral nerve or branch (radiofrequency is considered neurolytic agent by CPT so the following code would be reported for RFA of peripheral nerve)

 

Selected References:

  • 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. PMID 24165571
  • 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. PMID 19232965
  • 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. PMID 23328847
  • 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. PMID 20817845
  • 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. PMID 19857819
  • 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. PMID 21055873
  • 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. PMID 21463469
  • Bellini M, Barbieri M. Cooled radiofrequency system relieves chronic knee osteoarthritis pain: the first caseseries. Anaesthesiol Intensive Ther. 2015;47(1):30-33. PMID 25751290
  • 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. PMID 25415774
  • 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. PMID 20439021
  • Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014; 6(4):373-376. PMID 24373908
  • ECRI. Hotline Response. Radiofrequency Ablation for Treatment Knee Osteoarthritis. Published April 2016.
  • UpToDate. Treatment of Osteoarthritis Resistant to Initial Pharmacologic Therapy. Kenneth C. Kalunian M.D. Topic last updated November 21, 2016.
  • UpToDate. Nonpharmacologic Therapy for Osteoarthritis. Kenneth C Kalunian M.D. Topic last updated July 22, 2016.
  • UpToDate. Total Knee Arthroplasty. Gregory M Martin M.D., Thomas S. Thornhill M.D., Jeffrey N Katz M.D., MSc. Topic last updated August 4, 2015.
  • UpToDate. Plantar Fasciitis. Rachelle Buchbinder MBBS, PhD, FRACP. Topic last updated October 14, 2016.

 

Policy History:

January 2017 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.