Radiofrequency Ablation of Peripheral Nerves to Treat Pain

POLICY NUMBER

A.7.01.154

DESCRIPTION

Radiofrequency ablation (RFA) and cryoneurolysis of nerves have been proposed as treatments for several different types of pain. RFA has been used to treat a number of clinical pain syndromes such as trigeminal neuralgia as well as cervical and lumbar pain. This policy evaluates the application of radiofrequency ablation and cryoneurolysis in peripheral sites distant from the spine.

Knee Osteoarthritis

Knee osteoarthritis is common and often the cause of substantial disability. Prevalence increases with age, from about 24% among those 60 to 64 years of age to as high as 40% in those 70 to 74 years of age. Knee osteoarthritis is characterized by pain upon initiation of movement or walking. As osteoarthritis progresses, the pain becomes continuous and joint functionality is severely impaired.

TreatmentTreatment 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 events. If symptom relief is inadequate with conservative measures, invasive treatments may be considered. Total knee arthroplasty is an operative treatment for symptomatic osteoarthritis of the knee.

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.

TreatmentMost 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 one year in some cases.

Occipital Neuralgia

Occipital neuralgia is a specific type of headache that is located on one side of the upper neck, back of the head, and behind the ears, and sometimes extending to the scalp, forehead, and behind the eyes. The pain, which may be piercing, throbbing, or electric-shock-like, follows the course of the greater and lesser occipital nerves. Occipital neuralgia is believed to occur due to pressure or irritation to the occipital nerves, which may result from injury, entrapment by tight muscles, or inflammation.

TreatmentTreatment may include massage and rest, muscle relaxants, nerve blocks, and injection of steroids directly into the affected area.

Cervicogenic Headache

Cervicogenic headache is a headache that is secondary to a disorder of the cervical spine. The pain may be referred from facet joints, intervertebral discs, or soft tissue. The pain is constant rather than throbbing, and may be aggravated by movements of the neck or pressure to certain areas on the neck. The first 3 cervical spinal nerves can refer pain to the head. The C1 suboccipital nerve innervates the atlanto-occipital joint; the C2 spinal nerve and the C3 dorsal ramus have close proximity to and innervate the C2-C3 facet joint. The C2-3 facet joint is the most frequent source of a cervicogenic headache. A diagnosis of a cervicogenic headache may be confirmed by an anesthetic block of the lateral atlanto-axial joint, the C2-3 facet joint, or the C3-4 facet joint.

TreatmentTreatment may include nerve blocks, physical therapy, and exercise.

Nerve Radiofrequency Ablation

Nerve radiofrequency ablation (RFA) 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 into the tissue to be ablated. A high-frequency electrical current is applied to the target tissue and 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 ablation is a variation of nerve RFA using a water-cooled probe that applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue damage away from the nerve (see Table 1). The goal of ablating the nerve is the same.

RFA is also distinguished from pulsed RF treatment, which has been investigated for different types of pain. The mechanism of action of pulsed RF treatment is uncertain, but it is thought not to destroy the nerve. It does produce some degree of nerve destruction, butis thought to cause less damage than standard RFA. Some studies refer to pulsed RF treatment as ablation.

For the indications assessed in this policy, nerve RFA should be distinguished from RF energy applied to areas other than the nerve to cause tissue damage. Some individuals 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

Cryoneurolysis

Cryoneurolysis is being investigated to alleviate pain. 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 ioveraº cryoablation system is a portable handheld device that applies percutaneous and targeted delivery of cold to superficial peripheral nerves.

A number of radiofrequency (RF) generators and probes for the peripheral nervous system 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). One of the indications is specifically 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."

Table 2. Radiofrequency and Cryoneurolysis Devices

POLICY

Radiofrequency ablation of peripheral nerves to treat pain associated with knee osteoarthritis or plantar fasciitis is considered investigational.

Cryoneurolysis of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered investigational.

Radiofrequency ablation or cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational.

Ablation of peripheral nerves to treat pain is considered investigational in all other conditions, with the exception of facet joint pain.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical  necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

03/17/2016: Approved by Medical Policy Advisory Committee.

06/01/2016: Policy number A.7.01.154 added.

10/20/2017: Policy reviewed; no changes.

01/21/2019: Policy description updated to add information regarding occipital neuralgia, cervicogenic headache, cryoneurolysis, and devices. Added investigational policy statements regarding cryoneurolysis for knee osteoarthritis or total knee arthroplasty and for RFA for occipital neuralgia or cervicogenic headache. Added statement that ablation of peripheral nerves to treat pain is investigational in all other conditions, with the exception of facet joint pain.

11/04/2019: Policy description updated regarding devices. Policy statements unchanged.

09/01/2021: Policy description updated regarding types of radiofrequency ablation and devices. Policy section updated to add cryoneurolysis to the policy statement regarding occipital neuralgia or cervicogenic headache. Code Reference section updated to add CPT code 64624.

01/10/2022: Policy description updated regarding devices. Policy statements unchanged.

12/02/2022: Policy description updated regarding knee osteoarthritis and devices. Policy statements unchanged.

10/12/2023: Policy description updated regarding devices. Policy statements unchanged.

11/21/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.154

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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