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.

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, but is 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.

02/23/2026: Policy reviewed; no changes.

09/23/2026: Policy description revised regarding devices and to remove sections on knee osteoarthritis, plantar fasciitis, occipital neuralgia, and cervicogenic headache. Policy statements unchanged.

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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