Coverage Policy Manual
Policy #: 2018010
Category: Surgery
Initiated: February 2018
Last Review: February 2019
  Ultrasonic Ablation of Soft Tissue, Percutaneous

Description:
The use of percutaneous ultrasonic ablation has been proposed for a variety of soft tissue conditions including:  Achilles tendinosis, lateral or medial elbow tendinosis, patellar tendinosis, recalcitrant plantar fasciitis, and rotator cuff or shoulder tendinosis as well as other chronic or degenerative conditions of the musculoskeletal system involving fascia or tendons of the ankle, foot, elbow, hip, knee, shoulder, or wrist.
 
The TX1 Tissue Removal System and the Tenex Health TX System are ultrasonic surgical aspirators that irrigate, fragment, emulsify and aspirate soft tissue and are proposed for use in the treatment of recalcitrant tendinopathy or plantar fasciopathy. The Tenex Health TX System is identical to the predicate TX1 Tissue Removal System in its mode of operation and FDA-cleared indications for use. Only minor technological differences are noted when comparing the device systems.  
 
In March 2013, the TX1 Tissue Removal System (Tenex Health, Inc., Lake Forest, CA) received U.S. Food and Drug Administration (FDA, 2013) 510(k) clearance (K12364) as "an ultrasonic surgical aspirator" to emulsify and remove soft tissue. In March 2016, the Tenex Health TX® System (K153299) (Tenex Health, Inc., Lake Forest, CA) received 510(k) clearance as substantially equivalent to the predicate device, the TX1 Tissue Removal System. Both systems are intended for use with a TX2 MicroTip in "surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable."
 

Policy/
Coverage:
The use of ultrasonic ablation of soft tissue (percutaneous or by other means) for any condition including but not limited to plantar fasciitis, elbow tendinosis, patellar tendinosis, shoulder/rotator cuff tendinosis, and Achilles tendinosis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, the use of ultrasonic ablation of soft tissue (percutaneous or by other means) for any condition including but not limited to plantar fasciitis, elbow tendinosis, patellar tendinosis, shoulder/rotator cuff tendinosis, and Achilles tendinosis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: If a tenotomy, fasciotomy or fasciectomy code is used to represent percutaneous ultrasonic ablation, the coverage statements in this policy will apply.
 

Rationale:
Patel (2015) reported on a prospective case series study in which patients were allowed either to continue with noninvasive treatment or to undergo focal aspiration and partial fasciotomy with an ultrasonic probe (TX1). Inclusion criteria for the study was plantar fasciitis symptoms lasting 12 months or longer. Twelve patients with refractory plantar fasciitis chose the procedure. All patients had failed conservative care, including physical therapy, casting, shock wave therapy, and invasive procedures such as injections and endoscopic plantar releases. Four of the 12 had undergone an open or endoscopic partial release at a different institution but had experienced no improvement in symptoms. American Orthopaedic Foot and Ankle Society (AOFAS) scores were obtained before and after surgery. Follow-up consisted of clinic visits 2 weeks after surgery and monthly thereafter. The 12 patients had a mean preoperative AOFAS score of 30 (range of 17-46) and a mean postoperative score of 88 (range of 25-92). By the 3 month postoperative visit, symptoms were resolved in 11 patients (no activity restricted by plantar fascia pain). On physical examination, 11 patients had no palpable tenderness at the site of preoperative pain. Pain relief was documented as having occurred between 5 and 13 weeks after treatment. One patient had bilateral procedures. The author concluded that this was the first report of a plantar fascia partial release guided by ultrasonic energy delivered by a percutaneously inserted probe under local anesthesia and that the procedure appears to be a safe, effective, well-tolerated treatment for a condition that is refractory to other options.  The author also acknowledged that more studies are needed to further validate the safety and efficacy of this treatment modality.
 
Sanchez et al (2017) reported on a case series study on the complications associated with percutaneous ultrasonic tenotomy as a treatment for chronic Achilles tendinosis.  The authors reported that percutaneous ultrasonic tenotomy is a relatively new treatment option for many types of tendinopathy and concluded that when considering percutaneous ultrasonic tenotomy, surgeons should be cognizant that it is a surgical procedure with complications similar to those of other Achilles tendon surgeries.
 
Koh et al (2013) reported on a case series study that explored the safety, tolerability, and early efficacy of the TX1 device in the treatment of recalcitrant lateral elbow tendinopathy. Twenty patients (7 male and 13 female aged 33 to 65 years) who failed nonoperative therapy underwent the ultrasonic microresection procedure using the TX1 device through a stab incision under local anesthesia. Outcome parameters included patient satisfaction, visual analog scale (VAS) pain scores, Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1, 3, 6 and 12 months, and ultrasound assessment at 3 and 6 months. A significant improvement in VAS score (from 5.5 to 3.3) occurred by 1 week. Significant improvements in both DASH-Compulsory (from 21.7 to 11.3) and DASH-Work (from 25.0 to 6.3) scores occurred by 1 month. The VAS scores further improved at 3, 6, and 12 months (from 2.0 to 1.0 to 0.50) and the DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6). Both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. Sonographically reduced tendon thickness (n=19), resolved or reduced hypervascularity (n=patients), and reduced hypoechoic area (n=18) occurred by 6 months. Nineteen of the 20 patients (95%) expressed satisfaction (either very or somewhat) with the procedure, with 9 patients being very satisfied with their overall experience at 6 months after the procedure and 1 patient neutral. The authors concluded that ultrasonic microresection of diseased tissue with the TX1 device provides a focally directed, safe, specific, minimally invasive, and well-tolerated treatment for recalcitrant lateral elbow tendinopathy in an office-based or ambulatory surgical setting with good evidence of some level of efficacy in 19 of 20 patients (95%) that is sustained for at least 1 year. The limitations of this study are that it involved a small number of subjects, was uncontrolled and follow-up was short term (12 months).
 
Barnes et al (2015) prospectively studied 19 patients (aged 38 to 67) with medial (n=7) or lateral (n=12) elbow tendinopathy who had failed conservative management. All patients were treated with percutaneous ultrasonic tenotomy of the elbow using the TX1 device by a single operator. Visual analog scale (VAS) for pain, the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed before treatment and after treatment (6 weeks, 3 months, 6 months, and 12 months). Average VAS scores were significantly improved from 6.4 to 2.6 at 6 weeks and were 0.7 at 12 months. Similar improvement occurred with the Quick DASH (pretreatment, 44.1; 12 months, 8.6) and MEPS (pretreatment, 59.1; 12 months, 83.4). The authors concluded that sonographically guided percutaneous ultrasonic tenotomy and debridement using the TX1 device appears to be a safe treatment option for patients presenting with chronic, refractory lateral or medial elbow tendinopathy and provides significant and sustainable improvements in pain and function during a 1-year follow-up period. However, the authors acknowledged several study limitations including a small number of subjects, no control group, and lack of insight regarding the therapeutic mechanism of the TX1 treatment. The authors also acknowledged that future prospective comparative studies are needed.  
 
Elattrache and Morrey (2013) published an article on percutaneous ultrasonic tenotomy as a treatment for chronic patellar tendinopathy which is commonly called Jumper’s knee.  Based on early two-year results, the authors concluded that the procedure appears to be a safe and effective treatment with rapid recovery for Jumper’s knee.
 
Summary of Evidence
There is currently a lack of evidence in the peer-reviewed medical literature in the form of randomized, double-blind controlled trials demonstrating the efficacy and safety of percutaneous ultrasonic ablation of soft tissue using minimally invasive devices for the treatment of any condition, including, but not limited to chronic conditions of the musculoskeletal system (for example, fasciopathy or tendinopathy).  While short-term results from a limited number of small case series report early positive outcomes in reduction of pain and improvement in physical function, further investigation is needed to determine if percutaneous ultrasonic ablation with devices such as the TX1 Tissue Removal System or Tenex Health TX System can sustain functional improvement and eliminate or reduce pain in individuals with chronic or recalcitrant conditions of the soft tissue. Well-designed prospective, randomized controlled trials comparing percutaneous ultrasonic ablation to standard treatments are needed to determine if spontaneous improvement without the procedure can be excluded and if a durable treatment effect can be established over placebo.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
 
 

CPT/HCPCS:
17999Unlisted procedure, skin, mucous membrane and subcutaneous tissue
20999Unlisted procedure, musculoskeletal system, general
28899Unlisted procedure, foot or toes

References: Barnes DE, Beckley JM, Smith J.(2015) Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. Journal of shoulder and elbow surgery. Jan 2015;24(1):67-73.

Battista CT, Dorweiler MA, Fisher ML, Morrey BF, Noyes MP.(2017) Ultrasonic Percutaneous Tenotomy of Common Extensor Tendons for Recalcitrant Lateral Epicondylitis. Tech Hand Up Extrem Surg. Nov 16 2017.

Elattrache NS, Morrey BF.(2013) Percutaneous Ultrasonic Tenotomy as a Treatment for Chronic Patellar Tendinopathy-Jumper's Knee. Operative Techniques in Orthopaedics. June 2013 2013;23(2).

Koh JS, Mohan PC, Howe TS et al.(2013) Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med. 2013 Mar;41(3):634-44. Epub 2013 Jan 9.

Langer PR.(2015) Two emerging technologies for Achilles tendinopathy and plantar fasciopathy. Clin Podiatr Med Surg. 2015 Apr;32(2):183-93.

Patel MM(2015) A novel treatment for refractory plantar fasciitis. American journal of orthopedics (Belle Mead, NJ). Mar 2015;44(3):107-110.

Sanchez PJ, Grady JF, Saxena A(2017) Percutaneous Ultrasonic Tenotomy for Achilles Tendinopathy Is a Surgical Procedure With Similar Complications. J Foot Ankle Surg. Sep - Oct 2017;56(5):982-984.

Seng C, Mohan PC, Koh SB, et al.(2016) Ultrasonic Percutaneous Tenotomy for Recalcitrant Lateral Elbow Tendinopathy: Sustainability and Sonographic Progression at 3 Years. The American journal of sports medicine. Feb 2016;44(2):504-510.

Stuhlman MD et al(2016) Current Concepts and the Role of Surgery in the Treatment of Jumper's Knee. Healio Orthopedics. Aug. 3, 2016.

Tenex Health TX™(2018) Tenex Health TX System. ™. Available at: https://www.tenexhealth.com/ Accessed January 25, 2018.

U.S. FDA(2013) 510(k) approval for the TX1 Tissue Removal System (K123640). March 20, 2013. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K123640.pdf

Williams RC, Pourcho AM.(2017) Percutaneous Ultrasonic Tenotomy for Refractory Common Extensor Tendinopathy After Failed Open Surgical Release: A Report of Two Cases. PM R : the journal of injury, function, and rehabilitation. 2017 Aug 5.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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