Dental Policy Bulletins

Number: 023
(Updated)

Subject: TheraBite® Jaw Motion Rehabilitation System

Date: June 5, 2012

Important Note

This Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions based on a review of currently available clinical information including:
  • Clinical outcome studies in the peer-reviewed published medical and dental literature
  • Regulatory status of the technology
  • Evidence-based guidelines of public health and health research agencies
  • Evidence-based guidelines and positions of leading national health professional organizations
  • Views of physicians and dentists practicing in relevant clinical areas
  • Other relevant factors
We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.

Each benefits plan defines which services are covered, excluded and subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply. The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.


Policy

  1. Aetna considers the TheraBite® Jaw Motion Rehabilitation System medically necessary to treat mandibular hypomobility caused by radiation in persons with head and neck cancers.
  2. Aetna considers the Therabite System experimental and investigational for all other indications, including any of the following conditions:
    1. Closed lock treatment
    2. Facial burns
    3. Mandibular coronoid hyperplasia
    4. Non-surgical temporomandibular joint (TMJ) dysfunction
    5. Oral burns
    6. Orofacial pain
    7. Post-surgical TMJ rehabilitation
    8. Rehabilitation following facial trauma
    9. Stroke
    10. Treacher-Collins syndrome
    11. Trismus


Background

Most head and neck cancers are treated with surgery, radiation, or a combination of the two modalities. The choice of treatment depends primarily on the anatomic site, extent and histologic grading of the tumor, and the presence of infection. Modern reconstructive techniques permit cancer patients, especially those with head and neck malignancies, to undergo more immediate reconstruction and thereby achieve better functional outcomes while still progressing through multimodality treatment in a timely manner. However, the more aggressive the cancer therapy, the more it places patients at risk for oral complications related to treatment.

One of the major complications from therapeutic administration of ionizing radiation to the head and neck is mandibular hypomobility -- a reduction in mandibular range of motion caused by radiation-induced scarring and contraction of soft tissues surrounding the jaw. Clinically, the severity of mandibular hypomobility is related to the radiation dose, volume of tissue treated, and age of the patient.

Mandibular hypomobility is treated by stretching the scar tissue. Methods commonly used to stretch the scar tissue and increase mandibular range of motion include:
(i) Oral opening exercises
(ii) Stacking tongue blades between the molars
(iii) Continuous passive motion of the jaw
(iv) Stretching the jaw using custom-made mechanical devices. One such custom-made device is the TheraBite, a threaded screw-type instrument that is placed between the teeth and turned to gradually open the jaw, much like a car jack. Preliminary evidence indicates that the TheraBite is more effective than other modalities in maintaining and/or improving mandibular range of motion in irradiated patients. There are, however, inadequate outcomes data comparing the TheraBite to more conventional methods to support the use of TheraBite for any other condition.

CPT Codes / HCPCS Codes / ICD-9 Codes*
Other CPT codes related to the CPB:
95851 Range-of-motion measurements and report (separate procedure); each extremity, (excluding hand) or each trunk section (spine)
97110 Therapeutic procedure, one or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility
97530 Therapeutic activities, direct (one-on-one) patient contact by the provider (use of dynamic activities to improve functional performance), each 15 minutes
97535 Self care/home management training (for example, activities of daily living [ADL] and compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct one-on-one contact by provider, each 15 minutes
HCPCS codes covered if selection criteria are met:
E1700 Jaw motion rehabilitation system
E1701 Replacement cushions for jaw motion rehabilitation system, package of six
E1702 Replacement measuring scales for jaw motion rehabilitation system, package of 200
ICD-9 codes covered if selection criteria are met:
909.2 Late effect of radiation
990 Effects of radiation, unspecified
ICD-9 codes not covered for indications listed in the CPB: (not all-inclusive):
430 - 438.9 Cerebrovascular disease
524.02 Mandibular hyperplasia [coronoid]
524.60 - 524.69 Temporomandibular joint disorders
781.0 Abnormal involuntary movements
906.5 Late effect of burn of eye, face, head and neck
941.00 - 941.5 Burn of head, face and neck
Other ICD-9 codes related to the CPB:
140.0 -149.9 Malignant neoplasm of lip, oral cavity and pharynx
150.0 - 150.9 Malignant neoplasm of esophagus
160.0 - 162.0 Malignant neoplasm of nasal cavities, middle ear, and accessory sinuses, larynx and trachea
170.0 Malignant neoplasm of bones of skull and face, except mandible
170.1 Malignant neoplasm of mandible
528.9 Other and unspecified diseases of the oral soft tissues
784.0 Headache
784.9 Other symptoms involving head and neck
V15.3 Personal history of irradiation
V10.01 - V10.03 Personal history of malignant neoplasm of tongue, other and unspecified oral cavity and pharynx, or esophagus
V10.12 Personal history of malignant neoplasm of trachea
V10.21 Personal history of malignant neoplasm of larynx
V10.22 Personal history of malignant neoplasm of nasal cavities, middle ear and accessory sinuses
V45.89 Other postprocedural status


The above policy is based on the following references:

  1. Kouyoumdjian JH, Chalian VA, Hutton C. An intraoral positive-pressure device for treatment of trismus. Oral Surg. 1986;61(5):456-458.
  2. Buchbinder D, Currivan RB, Kaplan AJ, et al. Mobilization regimens for the prevention of jaw hypomobility in the radiated patient: A comparison of three techniques. J Oral Maxillofac Surg. 1993;51(8):863-867.
  3. Friedman MH. Closed lock. A survey of 400 cases. Oral Surg Oral Med Oral Pathol. 1993;75(4):422-427.
  4. King GE, Toth BB, Fleming TJ. Oral dental care of the cancer patient. Tex Dent J. 1988;105:10-11.
  5. No authors listed. National Institutes of Health Consensus Development Conference Statement: Oral complications of cancer therapies: Diagnosis, prevention, and treatment. J Am Dent Assoc. 1989;119(1):179-183.
  6. Toth BB, Martin JW, Fleming TJ. Oral and dental care associated with cancer therapy. Cancer Bull. 1991;43:397-402.
  7. Toth BB, Frame RT. Dental oncology: The management of disease and treatment-related oral/dental complications associated with chemotherapy. Curr Probl Cancer. 1983;7:7-35.
  8. Toth BB, Martin JW, Fleming TJ. Oral complications associated with cancer therapy: An M.D. Anderson Cancer Center experience. J Clin Periodontol. 1990;17:508-515.
  9. Schweiger JW. Oral complications following radiation therapy: A five-year retrospective report. J Prosthet Dent. 1987;58:78-82.
  10. Fleming TJ. Oral tissue changes of radiation-oncology and their management. Dent Clin North Am. 1990;34:233-237.
  11. Barrett VJ, Martin JW, Jacob RF, et al. Physical therapy techniques in the treatment of the head and neck patient. J Prosthet Dent. 1988;59:343-346.
  12. Rocabardo M, Johnston BE, Blakney MG. Physical therapy and dentistry: An overview. J Craniomand Pract. 1983;1:46-49.
  13. Therabite Corporation. TheraBite Jaw Motion Rehabilitation System. West Chester, PA: TheraBite; 2002.  Available at: http://www.therabite.com. Accessed December 9, 2002.
  14. Gaziano JE. Evaluation and management of oropharyngeal dysphagia in head and neck cancer. Cancer Control. 2002;9(5):400-409.
  15. Maloney GE, Mehta N, Forgione AG, 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; 20(1):55-66.
  16. Nicalaou N. Prevention and management of radiation toxicity. In: Cancer Management: A Multidisciplinary Approach. 7th ed. R Pazdur, LR Coia, WJ Hoskins, LD Wagman, eds. Melville, NY: PRR; 2003; Ch. 46: 909-939.
  17. Dijkstra PU, Kalk WW, Roodenburg JL. Trismus in head and neck oncology: A systematic review. Oral Oncol. 2004;40(9):879-889.
  18. Gibbons AJ, Abulhoul S. Use of a TheraBite appliance in the management of bilateral mandibular coronoid hyperplasia. Br J Oral Maxillofac Surg. 2007;45(6):505-506.
  19. Wenghoefer M, Martini M, Anwander T, et al. Hyperplasia of the coronoid process: Diagnosis and treatment. Mund Kiefer Gesichtschir. 2006;10(6):409-414.
  20. Fernández Ferro M, Fernández Sanromán J, Sandoval Gutierrez 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;13(9):E595-E598.
  21. Melchers LJ, Van Weert E, Beurskens CH, et al. Exercise adherence in patients with trismus due to head and neck oncology: a qualitative study into the use of the TheraBite((R)). Int J Oral Maxillofac Surg. 2009 May Available at: http://www.ijoms.com/article/S0901-5027(09)00860-1/abstract.  Accessed May 25, 2011.

Revision Dates

Original policy: November 4, 2004
Updated: September 25, 2006; June 5, 2012
Revised: January 20, 2011
Medical Bulletin #0412: August 24, 2011



Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. .

*Current Procedural Terminology(CPT<®) 2010 copyright
2010 American Medical Association. All Rights Reserved.

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