Subject:
Mechanical Stretching Devices for Limited Jaw Mobility
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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Limited jaw mobility (mandibular hypomobility) may be related to problems with the jaw joint itself, or surrounding musculature. This condition is also known as "trismus". It may be idiopathic, or due to disease, trauma, or radiological cancer treatment of nearby structures. Loss of range of motion in the temporomandibular joint (TMJ) is one type of temporomandibular dysfunction (TMD). It may result in pain and/or difficulty eating.
Mechanical stretching devices are used to gradually stretch the jaw opening and are intended to increase the range of jaw motion over time or to prevent hypomobility from developing in patients who are at risk of developing mandibular hypomobolity. Examples of these mechanical stretching devices include, but are not limited to, the TheraBite Jaw Motion Rehabilitation System (ATOS Medical AB, Horby, Sweden), the OraStretch Jaw Motion Rehabilitation System (Craniomandibular Rehab, Inc., Denver, CO, USA) , and the Dynasplint Trismus System (Dynasplint Systems, Inc., Severna Park, MD, USA). Theses devices are classified by the U.S. Food and Drug Administration (FDA) as Class I devices and are not required to seek FDA approval either through the Premarket Approval (PMA) or 510(k) process.
The TheraBite Joint Motion Rehabilitation System is a handheld mechanical device used to gradually stretch the jaw opening. It is comprised of padded mouthpieces and a handle with manually-controlled scissor-like mechanisms that open the patient's jaw when the mouthpieces are inserted in the mouth. The OraStretch Jaw Motion Rehabilitation System is a handheld device that uses passive motion to stretch the user's jaw and oral/peri-oral connective tissues to treat trismus. The Dynasplint Trismus System is a handheld spring loaded device that uses low-load, prolonged-duration stretch technology to treat trismus.
[For other mechanical stretching devices, refer to policy on the Treatment of Joint Stiffness and Contracture with Mechanical Stretching Devices (Policy # 027) in the DME Section.]
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
The use of mechanical stretching devices in the treatment of mandibular hypomobility is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for Mechanical Stretching Devices for Limited Jaw Mobility. 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: There is insufficient data published in the peer-reviewed medical literature regarding the effectiveness of mechanical stretching devices in providing rehabilitation for the treatment of mandibular hypomobility, including those secondary to radiation treatment, compared to traditional treatment methods such as stacked tongue depressors or unassisted mandibular exercises. Furthermore, the few clinical studies that have been done involved small number of patients limiting the generalizability of their results.
One clinical trial NCT01649583, which completed in 2014 with 40 participants was located for the Jaw Dynasplint System. Results were published in September 2018 which concluded that compliance in using the device as prescribed was low (25% of the test arm) and "[i]t is unlikely that the prescribed regimen will prove efficacious as a preventative measure due to low compliance". 26 ]
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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:
Mechanical Stretching Devices for Limited Jaw Mobility
Jaw Motion Rehabilitation System
TheraBite Jaw Motion Rehabilitation System
OraStretch Jaw Motion Rehabilitation System
Dynasplint Trismus System
References:
1. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Custom Hotline Response: Mechanical Stretching Device (Therabite and Other Devices) for Limited Jaw Mobility. Updated: 10/01/2009.
2. Oral Health in Cancer Therapy: A Guide for Health Care Professional. 2nd Edition. [This document represents the compilation and distillation of the proceeding s of the 2003 Oral Health in Cancer Therapy Conference.]
3. Oral Complications of Cancer Treatment: What the oral team can do for you. NIH Publication No. 02-4372. Revised June 2002.
4. Oral Complications of Cancer Treatment: What the oncology team can do for you. NIH Publication No. 02-4360. Revised June 2002.
5. Oral Complications of Cancer Therapies: Diagnosis, Prevention, and Treatment. National Institutes of Health Consensus Development Conference Statement April 17-19, 1989.
6. Malone Ge, Mehta N et al. Effect of a passive jaw motion device on pain and range of motion in TMD patients not responding to flat plane intraoral appliances. Cranio. 2002 Jan;20(1):55-66.
7. Buchbinder D, Currivan RB et al. Mobilization regimens for the prevention of jaw hypomobility in the radiated patient: a comparison of three techniques. J Oral Maxillofac Surg. 1993 Aug;51(8):863-7.
8. Lemke RR, Van Sickels J. Electromyographic evaluation of continuous passive motion versus manual rehabilitation of the temporomandibular joint. J Oral Maxillofac Surg. 1993 Dec;51(12):1311-4.
9. Cohen EG, Deschler DG, et al. Early use of mechanical stretching device to improve mandibular mobility after composite resection: a pilot study. Arch Phys Med Rehabil. 2005 Jul;86(7):1416-9.
10. McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
11. Dijkstra, PU, Kalk WW, Roodenburg JL. Trismus in head and neck oncology: a systematic review. Oral Oncol. 2004 Oct;40(9):879-89.
12. Dijkstra, PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 apr;35(4):337-42. epub 2005 Nov 8.
13. Dijkstra, PU, Sterken MW, Pater R et al. Exercise therapy for trismus in head and neck cancer. Oral Oncol. 2007 Apr;43(4):389-94. Epub 2006 Sep 18.
14. Sciubba JJ, Goldenberg D. Oral complications of radiotherapy. Lancet Oncol. 2006 Feb;7(2):175-83
15. Jager-Wittenaar H, Dijkstra PU et al. Variation in repeated mouth-opening measurements in head and neck cancer patients with and without trismus. Int J Oral Maxillofac Surg. 2009 Jan;38(1):26-30. Epub 2008 Nov
16. Louise Kent M, Brennan MT, Noll JL et al. Radiation-induced trismus in head and neck cancer patients. Support Care Cancer. 2008 Mar;16(3):305-9. Epub 2007 Oct 27.
17. Teguh DN, Levendag PC, Voet P et al. Trismus in patients with oropharyngeal cancer: relationship with dose in structures of mastication apparatus. Head Neck. 2008 May;30(5):622-30.
18. Manufacturer's information on TheraBite. Available at: http://www.atosmedical.com/Products/Mouth-Jaw/TheraBite.aspx.
19. FDA information on TheraBite (classified as a Class I device). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Listing.cfm?ID=1407 (last accessed 09/11/06).
20. Gibbons AJ, Abulhoul S. Use of a Therabite appliance in the management of bilateral mandibular coronoid hyperplasia. Br J Oral Maxillofac Surg 2007 Sep;45(6):505-6.
21. Fernandez Ferro M, Fernandez Sanroman J et al. Treatment of bilateral hyperplasia of the coronoid process of the mandible. Presentation of a case and review of the literature. Med Oral Patol Oral Cir Bucal. 2008 Sep 1;13(9):E595-8.
22. Loorents V, Rosell J, Karlsson C et al. Prophylactic training for the prevention of radiotherapy-induced trismus - a randomised study.Acta Oncol. 2014 Apr;53(4):530-8.
23. van der Molen L, van Rossum MA, Rasch CR et al. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014 May;271(5):1257-70.
24. UpToDate. Management of late complications of head and neck cancer and its treatment. Literature review current through November 2016. Topic last updated on September 30, 2016.
25. Kraaijenga S, van der Molen L, van Tinteren H, et al. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite) with standard physical therapy exercise. Cranio 2014 Jul;32(3):208-16.
26. Zatarain LA, Smith DK et al. A Randomized Feasibility Trial to Evaluate Use of the Jaw Dynasplint to Prevent Trismus in Patients With Head and Neck Cancer Receiving Primary or Adjuvant Radiation-Based Therapy. Integr Cancer Ther. 2018 Sep;17(3):960-967. doi: 10.1177/1534735418784363. Epub 2018 Jun 28.
27. Galloway T, Amdur RJ. Management of late complications of head and neck cancer and its treatment. In UpToDate, Connor RD (ed), UpToDate, Waltham, MA. (Accessed September 7, 2018).
28. Galloway T, Amdur RJ. Management of late complications of head and neck cancer and its treatment. In UpToDate, Posner MR, Brizel DM, Brockstein BE, Deschler DG, Ganz PA, Shah S (eds), UpToDate, Waltham, MA. (Accessed October 4, 2019).
29. Galloway T, Amdur RJ. Management of late complications of head and neck cancer and its treatment. In UpToDate, Posner MR, Brizel DM, Brockstein BE, Deschler DG, Ganz PA, Shah S (eds), UpToDate, Waltham, MA. (Accessed August 19, 2020).
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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