FOR CMS (MEDICARE) MEMBERS ONLY NATIONAL COVERAGE DETERMINATION (NCD) FOR MAGNETIC RESONANCE IMAGING:

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National Imaging Associates, Inc. Clinical guidelines TEMPOROMANDIBULAR JOINT (TMJ) MRI Original Date: May 23, 2003 Page 1 of 5 CPT Code: 70336 Last Review Date: May 2016 NCD 220.2 MRI Last Effective Date: July 2011 Guideline Number: NIA_CG_007 Last Revised Date: September 2015 Responsible Department: Clinical Operations Implementation Date: January 2017 FOR CMS (MEDICARE) MEMBERS ONLY NATIONAL COVERAGE DETERMINATION (NCD) FOR MAGNETIC RESONANCE IMAGING: Item/Service Description A. General 1. Method of Operation Magnetic Resonance Imaging (MRI), formerly called nuclear magnetic resonance (NMR), is a non-invasive method of graphically representing the distribution of water and other hydrogen-rich molecules in the human body. In contrast to conventional radiographs or computed tomography (CT) scans, in which the image is produced by x-ray beam attenuation by an object, MRI is capable of producing images by several techniques. In fact, various combinations of MRI image production methods may be employed to emphasize particular characteristics of the tissue or body part being examined. The basic elements by which MRI produces an image are the density of hydrogen nuclei in the object being examined, their motion, and the relaxation times, and the period of time required for the nuclei to return to their original states in the main, static magnetic field after being subjected to a brief additional magnetic field. These relaxation times reflect the physicalchemical properties of tissue and the molecular environment of its hydrogen nuclei. Only hydrogen atoms are present in human tissues in sufficient concentration for current use in clinical MRI. 2. General Clinical Utility Overall, MRI is a useful diagnostic imaging modality that is capable of demonstrating a wide variety of soft-tissue lesions with contrast resolution equal or superior to CT scanning in various parts of the body. Among the advantages of MRI are the absence of ionizing radiation and the ability to achieve high levels of tissue contrast resolution without injected iodinated radiological contrast agents. Recent advances in technology have resulted in development and Food and Drug Administration (FDA) approval of new paramagnetic contrast agents for MRI which allow even better visualization in some instances. Multi-slice imaging and the ability to image in multiple planes, especially sagittal and coronal, have provided flexibility not easily available with other modalities. Because cortical (outer layer) bone and metallic prostheses do not cause distortion of MR images, it has been possible to visualize certain lesions and 1 NCD/NIA TMJ MRI - 2017 Proprietary

body regions with greater certainty than has been possible with CT. The use of MRI on certain soft tissue structures for the purpose of detecting disruptive, neoplastic, degenerative, or inflammatory lesions has now become established in medical practice. Indications and Limitations of Coverage B. Nationally Covered MRI Indications 1. MRI Although several uses of MRI are still considered investigational and some uses are clearly contraindicated (see subsection C), MRI is considered medically efficacious for a number of uses. Use the following descriptions as general guidelines or examples of what may be considered covered rather than as a restrictive list of specific covered indications. Coverage is limited to MRI units that have received FDA premarket approval, and such units must be operated within the parameters specified by the approval. In addition, the services must be reasonable and necessary for the diagnosis or treatment of the specific patient involved. a) Effective November 22, 1985: a. MRI is useful in examining the head, central nervous system, and spine. b. Multiple sclerosis can be diagnosed with MRI and the contents of the posterior fossa are visible. c. The inherent tissue contrast resolution of MRI makes it an appropriate standard diagnostic modality for general neuroradiology. b) Effective November 22, 1985: a. MRI can assist in the differential diagnosis of mediastinal and retroperitoneal masses, including abnormalities of the large vessels such as aneurysms and dissection. b. When a clinical need exists to visualize the parenchyma of solid organs to detect anatomic disruption or neoplasia, this can be accomplished in the liver, urogenital system, adrenals, and pelvic organs without the use of radiological contrast materials. When MRI is considered reasonable and necessary, the use of paramagnetic contrast materials may be covered as part of the study. c. MRI may also be used to detect and stage pelvic and retroperitoneal neoplasms and d. to evaluate disorders of cancellous bone and soft tissues. e. It may also be used in the detection of pericardial thickening. f. Primary and secondary bone neoplasm and aseptic necrosis can be detected at an early stage and monitored with MRI. g. Patients with metallic prostheses, especially of the hip, can be imaged in order to detect the early stages of infection of the bone to which the prosthesis is attached. c) Effective March 22, 1994: a. MRI may also be covered to diagnose disc disease without regard to whether radiological imaging has been tried first to diagnose the problem. d) Effective March 4, 1991: a. MRI with gating devices and surface coils, and gating devices that eliminate distorted images caused by cardiac and respiratory movement cycles are now considered state of the art techniques and may be covered. Surface and other 2 NCD/NIA TMJ MRI - 2017 Proprietary

specialty coils may also be covered, as they are used routinely for high resolution imaging where small limited regions of the body are studied. They produce high signal-to-noise ratios resulting in images of enhanced anatomic detail. C. Contraindications and Nationally Non-Covered Indications 1. Contraindications The MRI is not covered when the following patient-specific contraindications are present: MRI is not covered for patients with cardiac pacemakers or with metallic clips on vascular aneurysms unless the Medicare beneficiary meets the provisions of the following exceptions: Effective July 7, 2011, the contraindications will not apply to pacemakers when used according to the FDA-approved labeling in an MRI environment 2. Nationally Non-Covered Indications CMS has determined that MRI of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications, are not considered reasonable and necessary indications within the meaning of section 1862(a)(1)(A) of the Act, and are therefore noncovered. D. Other Effective June 3, 2010, all other uses of MRI or MRA for which CMS has not specifically indicated coverage or non-coverage continue to be eligible for coverage through individual local MAC discretion. 3 NCD/NIA TMJ MRI - 2017 Proprietary

NIA CLINICAL GUIDELINE FOR TEMPOROMANDIBULAR JOINT (TMJ) MRI: INTRODUCTION: Temporomandibular joint (TMJ) dysfunction causes pain and dysfunction in the jaw joint and muscles controlling jaw movement. Symptoms may include: jaw pain, jaw muscle stiffness, limited movement or locking of the jaw, clicking or popping in jaw joint when opening or closing the mouth, and a change in how the upper and lower teeth fit together. The cause of the condition is not always clear but may include trauma to the jaw or temporomandibular joint, e.g., grinding of teeth, clenching of jaw, or impact in an accident. Osteoarthritis or rheumatoid arthritic may also contribute to the condition. The modality of choice for the evaluation of temporomandibular joint dysfunction is magnetic resonance imaging (MRI) which provides tissue contrast for visualizing the soft tissue and periarticular structures of the TMJ. Initial Clinical Reviewers (ICRs) and Physician Clinical Reviewers (PCRs) must be able to apply criteria based on individual needs and based on an assessment of the local delivery system. INDICATIONS FOR TEMPOROMANDIBULAR JOINT (TMJ) MRI: For evaluation of dysfunctional temporomandibular joint after unsuccessful conservative therapy for at least four (4) weeks with bite block or splint and antiinflammatory medicine. For pre-operative evaluation of dysfunctional temporomandibular joint in candidates for orthognathic surgery. For evaluation of locked or frozen jaw. For persistent temporomandibular joint dysfunction after surgical repair. ADDITIONAL INFORMATION RELATED TO TEMPOROMANDIBULAR JOINT (TMJ) MRI: Request for a follow-up study - A follow-up study may be needed to help evaluate a patient s progress after treatment, procedure, intervention or surgery. Documentation requires a medical reason that clearly indicates why additional imaging is needed for the type and area(s) requested. MRI imaging Metal devices or foreign body fragments within the body, such as indwelling pacemakers and intracranial aneurysm surgical clips that are not compatible with the use of MRI, may be contraindicated. Other implanted metal devices in the patient as well as external devices such as portable O2 tanks may also be contraindicated. MRI Imaging of Temporomandibular Joint Imaging of the temporomandibular joint has been difficult as the mandibular condyle is small and located close to dense and complex anatomic structures. MRI produces cross-sectional multiplanar images that document both soft and osseous tissue abnormalities of the joint and the surrounding structures and may help in determining the pathology around the joint. 4 NCD/NIA TMJ MRI - 2017 Proprietary

REFERENCES American Society of Temporomandibular Joint Surgeons. (2001). Guidelines for diagnosis and management of disorders involving the temporomandibular joint and related musculoskeletal structures. American Society of Temporomandibular Joint Surgeon, Retrieved from http://astmjs.org/final%20guidelines-04-27-2005.pdf. Arvidsson, L.Z., Smith, H.J., Flato, B., & Larheim, T.A. (2010, July). Temporomandibular joint findings in adults with long-standing juvenile idiopathic arthritis: CT and MR imaging assessment. Radiology, 256(1), 191-200. doi: 10.1148/radiol.10091810. Larheim, T.A. (2005). Role of magnetic resonance imaging in the clinical diagnosis of the temporomandibular joint. Cells, Tissues, Organs, 180(1), 6-21. doi: 10.1159/000086194 Ohnuki, T., Fukuda, M., Iino, M., Takahashi, T. (2003) Magnetic resonance evaluation of the disk before and after arthroscopic surgery for temporomandibular joint disorders. Oral Surgery, Oral medicine, Oral Pathology, Oral Radiology and Endocrinology, Volume 96, issue 2, August 2003, pp 141-148. http://www.ncbi.nlm.nih.gov/pubmed/12931085 Shaefer, J.R., Riley, C.J., Caruso, P. & Keith, D. (2012). Analysis of Criteria for MRI Diagnosis of TMJ Disc Displacement and Arthralgia. Int J Dent. 283163. doi: 10.1155/2012/283163. Wadhwa, S., & Kapila, S. (2008). TMJ disorders: Future innovations in diagnostics and therapeutics. Journal of Dental Education, 72(8), 930-947. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2547984/pdf/nihms66136.pdf. 5 NCD/NIA TMJ MRI - 2017 Proprietary