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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Surgery
Policy Number:149
Effective Date: 05/30/2015
Original Policy Date:04/28/2015
Last Review Date:03/10/2020
Date Published to Web: 04/28/2015
Subject:
TX1 Device for Percutaneous Ultrasonic Tenotomy or Fasciotomy for the Treatment of Chronic Pain

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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The TX1 device, also referred to as the Tenex Health TX System, is used in the performance of percutaneous ultrasonic tenotomy or fasciotomy. It is being investigated as a surgical treatment option for chronic pain caused by various tendinopathies/tendinitis or fasciitis. The procedure is also referred to as Focused Aspiration of Soft Tissue (FAST).

Background

According to information provided by Tenex Health, Inc., the TX1 device is used to treat chronic pain caused by diseased tendon or fascia such as in swimmer’s shoulder (shoulder pain), tennis/golfers elbow, jumper’s/runner’s knee (knee), Achilles tendon (ankle) and plantar fasciitis (foot).

The TX1 device uses ultrasound imaging to guide a proprietary needle-like device (TX MicroTip) into the targeted tendon or fascia to remove diseased tissue. Ultrasonic energy rapidly oscillates the hollow18-gauge tip of the TX1 device to emulsify tissue, which is subsequently removed by an inflow-outflow liquid circuit. (2) The TX1 technique is performed percutaneously under local anesthesia. The TX1 technology is based on the widely used process of phaco-emulsification that is used to treat cataracts. (2)

Regulatory Status

On March 20, 2013, the TX1 Tissue Removal System (Tenex Health, Lake Forest, CA) received marketing clearance from the U.S. FDA via the 510(k) approval process (K123640) for use as an ultrasonic surgical aspirator of soft tissue. It "is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery." Product Code GEI. (1)


Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

Use of the TX1 device in the performance of percutaneous ultrasonic tenotomy or fasciotomy for the treatment of chronic pain due to various tendinopathies/tendinitis or fasciitis is considered investigational.


Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE-SNP Coverage:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.



[RATIONALE:
A literature search on the use of the TX1 device using the MEDLINE database for the treatment of chronic pain due to various tendinopathies/tendinitis of fasciitis was performed through February 2019.

No randomized controlled trials (RCTs) or controlled trials were identified.

Three case series studies on the use of the TX1 device for the treatment of elbow tendinopathy and plantar fasciitis were identified.

Elbow Tendinopathy

In a 2013 case series study, Koh and colleagues explored the safety, tolerability, and early efficacy of the TX1 device in the treatment of recalcitrant lateral elbow tendinopathy. (3)Twenty patients 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; P < .001) occurred by 1 week, and significant improvements in both DASH-Compulsory (from 21.7 to 11.3; P = .001) and DASH-Work (from 25.0 to 6.3; P = .012) 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; P = .003 and .023). The DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6; P = .003), and both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. Sonographically reduced tendon thickness (19 patients), resolved or reduced hypervascularity (17 patients), and reduced hypoechoic area (18 patients) occurred by 6 months. Nineteen of the 20 patients (95%) expressed satisfaction with the procedure, with 9 patients being very satisfied with their overall experience at 6 months after the procedure, 10 patients somewhat satisfied, 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).

In 2015, Barnes and colleagues prospectively studied 19 patients with medial (7) or lateral (12) elbow tendinopathy who had failed conservative management. (2)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 11-item version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed by an independent observer before treatment and at 6 weeks, 3 months, 6 months, and 12 months after treatment. Average VAS scores were significantly improved from 6.4 to 2.6 at 6 weeks and were 0.7 at 12 months (P <.0001). Similar improvement occurred with the Quick DASH (pretreatment, 44.1; 12 months, 8.6, P < .0001) and MEPS (pretreatment, 59.1; 12 months, 83.4; P < .0001).

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, does not provide insight regarding the therapeutic mechanism of the TX1 treatment, and that future prospective comparative investigations are warranted. Two of the authors (Barnes DE and Smith J) also disclosed a financial relationship with Tenex Health which is related to the subject of the study.

Plantar Fasciitis

In 2015, Patel 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). (4) Study inclusion criteria were plantar fasciitis symptoms lasting 12 months or longer. Twelve patients with refractory plantar fasciitis lasting a mean of 19 months chose the procedure. They all 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 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 , 17-46) and a mean postoperative score of 88 (range, 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. One foot was treated, pain resolved by the 3-month postoperative visit, and the patient asked for the other foot to be treated. Three months after the procedure, patient had minimal non-activity-restricting pain.

The author concluded that this is the first report of a plantar fascia partial release guided by ultrasonic energy delivered by a percutaneously inserted probe under local anesthesia, that the procedure appears to be a safe, effective, well-tolerated treatment for a condition that is refractory to other options but that more studies are needed to further validate the safety and efficacy of this innovative treatment modality. The author also reported that he is a member of the medical advisory board of Tenex Health, which developed the tissue removal system used in the study.

Summary of Evidence
The currently available published evidence on the safety and efficacy of the TX1 device in the treatment of pain caused by various tendinopathies/tendinitis and fasciitis is limited to case series studies with small number of subjects and short term follow-up periods. There is insufficient evidence to conclude that the use of the TX1 device results in improved health outcomes and therefore, its use is considered investigational. Randomized controlled studies with larger number of subjects and longer term follow up are needed.
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
TX1 Device for Percutaneous Ultrasonic Tenotomy or Fasciotomy for the Treatment of Chronic Pain
Percutaneous Ultrasonic Tenotomy
Percutaneous Tenotomy
Percutaneous Ultrasonic Fasciotomy
Percutaneous Fasciotomy
TX1 Tissue Removal System
TX1 Device
Tenex Health TX System
Focused Aspiration of Soft Tissue
FAST

References:
1. U.S. FDA 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

2. Barnes De, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015 Jan;24(1):67-73. Epub 2014 Oct 8. Available at: http://www.jshoulderelbow.org/article/S1058-2746(14)00428-5/pdf

3. Koh JS, Mohan PC, Howe TS et al. 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.

4. Patel MM. A novel treatment for refractory plantar fasciitis. Am J Orthop (Belle Meed NJ). 2015 Mar;44(3):107-10.

5. Tenex Health TX™ Quick Reference.

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

6. UpToDate. Overview of the management of overuse (chronic) tendinopathy. Literature review current through February 2016.

7. UpToDate. Plantar fasciitis. Literature review current through February 2016.

8. UpToDate. Epicondylitis (tennis and golf elbow). Literature review current through February 2016.

9. Khan K, Scott A. Overview of the management of overuse (chronic) tendinopathy. In: UpToDate, Fields KB, Grayzel J, (Eds), UpToDate, Waltham, MA (Accessed March 3, 2017.)

10. Buchbinder R. Plantar fasciitis. In: UpToDate, Isaac Z, Curtis MR (Eds), UpToDate, Waltham, MA (Accessed March 3, 2017.)

11. Jayanthi N. Epicondylitis (tennis and golf elbow). In: UpToDate, Fields KB, Grayzel J (Eds), UpToDate, Waltham, MA (Accessed March 3, 2017.)

12. Khan K, Scott A. Overview of the management of overuse (chronic) tendinopathy. In: UpToDate, Fields KB, Grayzel J, (Eds), UpToDate, Waltham, MA (Accessed March 1, 2018.)

13. Buchbinder R. Plantar fasciitis. In: UpToDate, Isaac Z, Curtis MR (Eds), UpToDate, Waltham, MA (Accessed March 1, 2018.)

14. Jayanthi N. Epicondylitis (tennis and golf elbow). In: UpToDate, Fields KB, Grayzel J (Eds), UpToDate, Waltham, MA (Accessed March 1, 2018.)

15. Jayanthi N. Epicondylitis (tennis and golf elbow). In: UpToDate, Fields KB, Grayzel J (Eds), UpToDate, Waltham, MA (Accessed March 11, 2019.)

16. Niedermeier SRCrouser NSpeeckaert AGoyal KS. A Survey of Fellowship-Trained Upper Extremity Surgeons on Treatment of Lateral Epicondylitis. Hand (N Y). 2018 Apr 1:1558944718770212. doi: 10.1177/1558944718770212. [Epub ahead of print] .

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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