Radiofrequency Coblation Tenotomy for Musculoskeletal Conditions

POLICY NUMBER

A.7.01.165

DESCRIPTION

Radiofrequency (RF) coblation is being evaluated for the treatment of plantar fasciitis, lateral epicondylitis, and various musculoskeletal tendinopathies. When utilized for tenotomy, bipolar RF energy is directed into the tendon to generate a controlled, low-temperature field of ionizing particles that break organic bonds, ablating or debriding target tissue with the goal of relieving pain and restoring function.

Radiofrequency Coblation

Radiofrequency (RF) coblation uses bipolar low-frequency energy in an electrically conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology and orthopedics. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue. Radiofrequency coblation was also found to exhibit several properties that may make it an attractive option for addressing the underlying pathophysiology of chronic tendinopathies, namely increased angiogenesis, reduction of inflammatory responses, and increased expression of growth factors. Radiofrequency coblation surgical wands are utilized by orthopedic surgeons in minimally invasive arthroscopic procedures to facilitate soft tissue debridement, subacromial decompression, meniscal removal and sculpting, or tendon debridement.

The use of coblation technology for disc nucleoplasty and sacroiliac joint pain is addressed separately in the Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty) medical policy.

Tendinopathy

Tendinopathy is a clinical pain syndrome characterized by tendon thickening due to proliferation and chronic irritation of neovascular repair tissue with a history of repetitive tendon loading. This condition commonly results from overuse and has a high incidence rate in athletes and laborers. Clinical history should clarify predisposing training or activity and assess the level of functioning. Biomechanical abnormalities during activity should be identified and corrected. Standard treatment may, therefore, consist of biomechanical modification, activity modification, physical therapy (eg, heavy load resistance training), and nonsteroidal anti-inflammatory medication. For chronic tendinopathies, glucocorticoids should only be used in select cases (eg, rotator cuff tendinopathy). Surgical consultation following six months of a well-designed physical therapy program with adjunct medical treatments can be considered if there is no improvement in pain or function. Validated and reliable functional assessment scores should be utilized by the clinician to grade symptoms and assess patient function. Examples of suitable scales include the Victoria Institute of Sport Assessment for Achilles tendinopathy. Surgical approaches may involve incisions to the paratendon and removal of adhesions and degenerate tissue. Longitudinal incisions may be made in the tendon to promote a repair response. This latter strategy has also been delivered via minimally invasive arthroscopic approaches. These approaches may also address the debridement of the neovascular supply to the tendon surface. Collectively, a prolonged recovery duration to accommodate tendon healing may be required with these interventions.

Plantar Fasciitis

Plantar fasciitis is a musculoskeletal condition characterized by pain in the plantar region of the foot that worsens upon initiation of walking and with local point tenderness elicited during a clinical examination. Radiographic and ultrasonographic studies are not typically indicated for primary diagnosis but may be useful in ruling out alternative causes and visualizing the thickening of the plantar fascia. Initial standard therapy may consist of stretching exercises, orthotics, activity and lifestyle modification, nonsteroidal anti-inflammatory drugs, splints or casts, and glucocorticoid injections. The vast majority of patients improve without surgery. Surgery is generally considered a last line of therapy and is reserved for individuals who do not respond to at least 6 to 12 months of initial, nonsurgical therapy. Surgical approaches include variations of open or endoscopic, partial or complete, plantar fascia release, which may or may not include calcaneal spur resection, excision of abnormal tissue, and nerve decompression. The use of RF microtenotomy during open or percutaneous surgery has been explored alone or in combination with plantar fasciotomy.

Plantar fasciitis is one of the most common causes of foot and heel pain in adults. It is estimated to be responsible for approximately one million patient medical visits per year in the U. S. The peak incidence of the condition in the general population occurs between ages 40 and 60. There is a higher incidence rate among runners with a younger age of onset. The etiology of plantar fasciitis is poorly understood and may be multifactorial in nature. Contributing risk factors may include obesity, prolonged standing or activity, flat feet, and reduced ankle dorsiflexion. Plantar fasciitis has been reported in association with fluoride use for the treatment of osteoporosis. Differential sources of foot and heel pain may include Achilles tendinopathy, stress fractures due to osteoporosis, rheumatoid arthritis, peripheral neuropathies associated with diabetes, extrinsic factors (eg, inappropriate footwear), aging, and structural disorders.

Lateral Epicondylitis

Lateral epicondylitis, also known as tennis elbow, represents chronic tendinosis of the myotendinous group of the lateral epicondyle characterized by pain and disability. The incidence in the general population may approach 1% to 3%. Risk factors include smoking, obesity, forceful activity, and repetitive activity for at least two hours daily. Lateral epicondylitis is characterized by injury to the extensor carpi radialis brevis or extensor digitorum communis muscles. The condition is diagnosed through findings of localized tenderness and pain with clinical examination. Initial conservative management includes modification of activity and biomechanics, counterforce bracing or splinting, nonsteroidal anti-inflammatory drugs, and physical therapy. Surgical referral is typically reserved for patients with severe symptoms that do not improve despite compliance with an appropriately designed physical therapy program for at least six months.

In 2014, the TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch, an electrosurgical cutting and coagulation device (ArthroCare Corporation, K140521), was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, on the basis of an earlier predicate device (ArthroCare Topaz Wand, K080282, 2008). The surgical wands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, including fasciotomy, synovectomy, tenotomy, and capsulotomy of the foot and tenotomy of the knee, wrist, elbow, ankle, shoulder, and rotator cuff. Food and Drug Administration product code: GEI.

POLICY

Radiofrequency coblation tenotomy is considered investigational as a treatment for musculoskeletal conditions, including but not limited to, the following conditions:

• plantar fasciitis

• lateral epicondylitis

• shoulder or rotator cuff tendinopathy

• Achilles tendinopathy

• patellar tendinopathy

• wrist tendinopathy.

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

07/16/2020: Approved by Medical Policy Advisory Committee.

02/04/2021: Policy reviewed; no changes.

02/07/2022: Policy reviewed; no changes.

01/26/2023: Policy reviewed; no changes.

01/16/2024: Policy reviewed; no changes.

02/17/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.165

CODE REFERENCE

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

Investigational Codes

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