Latest Review Date:   January 2024

Category: Surgical                                       

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

DESCRIPTION OF PROCEDURE OF SERVICE:

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 (RF) coblation uses bipolar low-frequency energy in an electrically conductive fluid (e.g., 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 is addressed separately in policy #090- Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty). Peripheral nerve destruction to treat pain associated with musculoskeletal conditions is discussed policy #626- Ablative Procedures of Peripheral Nerves for Treatment of Musculoskeletal Conditions.   

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 (e.g., heavy load resistance training), and nonsteroidal anti-inflammatory medication. For chronic tendinopathies, glucocorticoids should only be used in select cases (e.g., rotator cuff tendinopathy). Surgical consultation following 6 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 1million patient medical visits per year in the U.S. The peak incidence of the condition in the general population occurs between ages40 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 ofosteoporosis. 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 (e.g., 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%.11, Risk factors include smoking, obesity, forceful activity, and repetitive activity for at least 2 hours daily. Lateral epicondylitis is characterized by injury to the extensorcarpi 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 6 months.

KEY POINTS:

This evidence review was created with a literature search of the PubMed database performed through November 3, 2023.

SUMMARY OF EVIDENCE:

For individuals with plantar fasciitis who receive RF coblation tenotomy, the evidence includes nonrandomized, comparative cohort studies, a systematic review of these studies, and case series. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trials reported improved pain and functional scores over 3 to 12 months, with improved outcomes with open versus percutaneous approaches. However, open RF coblation microtenotomy was associated with a higher incidence of postoperative persistent pain (9.1%) compared to endoscopic plantar fasciotomy (0%) in 1 study, with a separate study reporting a complication rate of 33% when both interventions were used in combination. A higher number of postoperative pain recurrences at 6 and 12 months were also reported with open RF coblation microtenotomy compared to endoscopic plantar fasciotomy. The durability of this intervention is unknown as no studies have reported long-term outcomes beyond 12 months. Studies are limited by small sample sizes, heterogeneity in surgical technique (open, percutaneous, endoscopic), missing data and/or inappropriate exclusions, lack of randomization, unclear blinding practices for patient outcome assessments, and poor statistical reporting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with lateral epicondylitis who receive RF coblation tenotomy, the evidence includes small RCTs. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trials compared RF microtenotomy to open or arthroscopic elbow release surgery. Clinically meaningful improvements in pain and functional scores were noted for all treatment arms, with no significant differences between groups through 1 to 7 years of follow-up. For disability assessments in 1 study, open release surgery met the threshold for a clinically meaningful improvement over RF microtenotomy at 1 year, though this mean difference was not statistically significant. Studies were generally underpowered or demonstrated inconsistent delivery and unclear blinding of outcome assessments and inappropriate handling of missing or crossover data. No studies featuring RF coblation tenotomy for the treatment of wrist tendinopathy were identified. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with Achilles tendinopathy who receive RF coblation tenotomy, the evidence includes small, single-blind RCT. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. One trial did not demonstrate an added benefit for RF microdebridement compared to surgical decompression. Pain and functional outcomes improved in both groups but were not statistically different at a 6 month follow-up. The study was limited by a control group that showed significantly less severe symptom scores at baseline that did not fully meet the 2 point threshold for a clinically meaningful difference in pain score reduction. The other small RCT demonstrated potential benefits in pain and quality of life for RF microtenotomy (ArthroCare) compared with physical therapy at 2 years. But, conclusions cannot be drawn based on these findings due to numerous notable study limitations. Larger, adequately controlled studies with longer follow-up durations are lacking. Larger, adequately controlled studies with longer follow-up durations are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with shoulder or rotator cuff tendinopathy who receive RF coblation tenotomy, the evidence includes small RCTs. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. Trials did not demonstrate an added benefit for RF microdebridement compared to arthroscopic subacromial decompression surgery. Pain and functional outcomes improved in both groups but were not statistically different through 1 to 2 years of follow-up. Neither study prespecified a clinically meaningful difference in outcome measures nor were harms assessed throughout their course. The loss to follow-up in 1 study was 18.7%. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with patellar tendinopathy who receive RF coblation tenotomy, the evidence includes 1 small RCT. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The trial did not demonstrate an added benefit for RF microdebridement compared to mechanical debridement in patients with chondral lesions and patellar tendinopathy. The study lacked reporting with validated pain measures over time and reported a higher incidence of crepitus in patients undergoing RF microdebridement. Furthermore, the study only enrolled female participants, limiting the broader applicability of these findings. Larger studies with validated pain and functional outcome measures are required to adequately assess the technology. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American College of Foot and Ankle Surgeons

In 2017, the American College of Foot and Ankle Surgeons published a clinical consensus statement on the diagnosis and treatment of adult acquired infracalcaneal heel pain based upon the best available evidence in the literature. The panel determined that the following statement was uncertain – that is – neither appropriate nor inappropriate:

• “Other surgical techniques (e.g., ultrasonic debridement using a microtip device, cryosurgery, and bipolar radiofrequency ablation) are safe and effective options for chronic, refractory plantar fasciitis.”

American College of Occupational and Environmental Medicine

In 2013, the American College of Occupational and Environmental Medicine updated their treatment guidelines for lateral epicondylitis as a result of a systematic review of the literature. Surgery is recommended for cases inadequately responsive to multiple evidence-based treatments (Level of Evidence: I, insufficient evidence). Microtenotomy is also recommended (Level of Evidence: C, limited evidence base).

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

TOPAZ® EZ Microdebrider Coblation Wand, radiofrequency microtenotomy, fasciotomy, tenotomy, microdebridement, lateral epicondylitis, plantar fasciitis

APPROVED BY GOVERNING BODIES:

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 (FDA) through the510(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. FDA product code: GEI.

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. 

CURRENT CODING:

CPT codes:

There is no specific code for Radiofrequency Coblation Tenotomy or the TOPAZ® EZ Microdebrider Coblation® Wand device. Billing would include coding for the primary procedure.

REFERENCES:

1. Al-Ani Z, Jacobsen EW, Kartus JT, et al. Radiofrequency microtenotomy: a promising method for treatment of rotator cuff tendinopathy. Knee Surg Sports Traumatol Arthrosc. Dec 2019; 27(12): 3856-3863.  
2. Al-Ani Z, Meknas D, Kartus JT, et al. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. Dec 2021; 9(12): 23259671211062555.
3. Chou AC, Ng SY, Su DH, et al. Radiofrequency microtenotomy is as effective as plantar fasciotomy in the treatment of recalcitrant plantar fasciitis. Foot Ankle Surg. Dec 2016; 22(4): 270-273.  
4. Davenport TE, Kulig K, Matharu Y, et al. The EdUReP model for nonsurgical management of tendinopathy. Phys Ther. Oct2005; 85(10): 1093-103.
5. Hamlin K, Munro C, Barker SL, et al. Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial. Shoulder Elbow. Jan 2018; 10(1): 45-51.  
6. Hegmann KT, Hoffman HE, Belcourt RM, et al. ACOEM practice guidelines: elbow disorders. J Occup Environ Med. Nov 2013;55(11): 1365-74.
7. Huang DM, Chou AC, Yeo NE, et al. Radiofrequency Microtenotomy with Concurrent Gastrocnemius Recession Improves Postoperative Vitality Scores in the Treatment of Recalcitrant Plantar Fasciitis. Ann Acad Med Singap. Dec 2018; 47(12): 509-515.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Lee JH, Park I, Hyun HS, et al. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study. Arthroscopy. May 2018; 34(5): 1439-1446.  
10. Lohrer H, David S, Nauck T. Surgical treatment for achilles tendinopathy - a systematic review. BMC Musculoskelet Disord. May10 2016; 17: 207.
11. Lu Y, Zhang Q, Zhu Y, et al. Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study. J Shoulder Elbow Surg. Nov 2013; 22(11): 1488-94.  
12. Martin RL, Chimenti R, Cuddeford T, et al. Achilles Pain, Stiffness, and Muscle Power Deficits: Midportion Achilles Tendinopathy Revision 2018. J Orthop Sports Phys Ther. May 2018; 48(5): A1-A38.  
13. Meknas K, Al Hassoni TN, Odden-Miland A, et al. Medium-Term Results After Treatment of Recalcitrant Lateral Epicondylitis: AProspective, Randomized Study Comparing Open Release and Radiofrequency Microtenotomy. Orthop J Sports Med. Sep2013; 1(4): 2325967113505433.  
14. Morrison RJM, Brock TM, Reed MR, et al. Radiofrequency Microdebridement Versus Surgical Decompression for Achilles Tendinosis: A Randomized Controlled Trial. J Foot Ankle Surg. Jul 2017; 56(4): 708-712.  
15. Nayar SK, Alcock H, Vemulapalli K. Surgical treatment options for plantar fasciitis and their effectiveness: a systematic review andnetwork meta-analysis. Arch Orthop Trauma Surg. Aug 2023; 143(8): 4641-4651.
16. Nirschl RP, Pettrone FA. Tennis elbow. The surgical treatment of lateral epicondylitis. J Bone Joint Surg Am. Sep 1979; 61(6A):832-9.
17. Owens BD, Stickles BJ, Balikian P, et al. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. Feb 2002; 18(2): 151-5.
18. Rano JA, Fallat LM, Savoy-Moore RT. Correlation of heel pain with body mass index and other characteristics of heel pain. J Foot Ankle Surg. Nov-Dec 2001; 40(6): 351-6.  
19. Riddle DL, Pulisic M, Pidcoe P, et al. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. May2003; 85(5): 872-7.  
20. Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. May 2004; 25(5): 303-10.  
21. Riggs BL, Hodgson SF, Hoffman DL, et al. Treatment of primary osteoporosis with fluoride and calcium. Clinical tolerance and fracture occurrence. JAMA. Feb 01 1980; 243(5): 446-9.  
22. Robinson JM, Cook JL, Purdam C, et al. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. Oct 2001; 35(5): 335-41.
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 2018; 57(2): 370-381.
24. Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. FootAnkle Surg. Dec 2010; 16(4): 174-7.  
25. Shibuya N, Thorud JC, Humphers JM, et al. Is percutaneous radiofrequency coblation for treatment of Achilles tendinosis safe and effective?. J Foot Ankle Surg. Nov-Dec 2012; 51(6): 767-71.  
26. Shiri R, Viikari-Juntura E, Varonen H, et al. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. Dec 01 2006; 164(11): 1065-74.  
27. Struijs PA, Kerkhoffs GM, Assendelft WJ, et al. Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both-a randomized clinical trial. Am J Sports Med. Mar 2004; 32(2): 462-9.  
28. Tay KS, Ng YC, Singh IR, et al. Open technique is more effective than percutaneous technique for TOPAZ radiofrequency coblation for plantar fasciitis. Foot Ankle Surg. Dec 2012; 18(4): 287-92.
29. Wang W, Rikhraj IS, Chou ACC, et al. Endoscopic Plantar Fasciotomy vs Open Radiofrequency Microtenotomy for Recalcitrant Plantar Fasciitis. Foot Ankle Int. Jan 2018; 39(1): 11-17.
30. Weil L, Glover JP, Weil LS. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. Feb 2008; 1(1): 13-8.
31. Yeap EJ, Chong KW, Yeo W, et al. Radiofrequency coblation for chronic foot and ankle tendinosis. J Orthop Surg (Hong Kong).Dec 2009; 17(3): 325-30.
32. Yuan Y, Qian Y, Lu H, et al. Comparison of the therapeutic outcomes between open plantar fascia release and percutaneousradiofrequency ablation in the treatment of intractable plantar fasciitis. J Orthop Surg Res. Feb 18 2020; 15(1): 55.

POLICY HISTORY:

Medical Policy Panel, December 2021

Medical Policy Group, January 2022 (7): New policy created to address investigational indications of radiofrequency coblation tenotomy for musculoskeletal conditions which has been previously considered investigational per MP 495 Investigational Criteria. Posted for DRAFT on  February 1, 2022, through March 18, 2022.

Medical Policy Panel, December 2022

Medical Policy Group, January 2023 (7): Update provided to the Key Points and References. No change in Policy Statement.

Medical Policy Panel, December 2023

Medical Policy Group, January 2024 (7): Update to Key Points, Benefit Application, and References. 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.