Humana Dysphagia Imaging Evaluation - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Internet- Only §80.4 - Coverage of Portable X-Ray Services Not Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Dysphagia Imaging Evaluation Page: 2 of 7 Manuals (IOMs) Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services Under the Direct Supervision of a Physician §80.4.4 – Exclusions from Coverage as Portable X-Ray Services §230.3 - Practice of Speech- Language Pathology LCD LCA LCD LCA Swallowing Studies for Dysphagia L33449 A56621 Swallowing Studies for Dysphagia L33449 A56621 JJ - Palmetto GBA (Part A/B MAC) AL, GA, TN JM - Palmetto GBA (Part A/B MAC) NC, SC, VA, WV Description Dysphagia is a swallowing disorder that may be caused by a wide variety of structural and functional abnormalities of the oral cavity, pharynx, esophagus, and gastric cardia. The term “dysphagia” is also used to describe the symptom of “the perception of obstruction during swallowing”. Barium Contrast Esophagram (Barium Swallow): An imaging test that uses barium and x-rays (fluoroscopy) to create images of the esophagus. Esophagogastroduodenoscopy (EGD): An examination using a lighted camera on the end of a tube, which is passed down the throat to visualize the esophagus, stomach, and duodenum. Esophageal manometry: A test used to measure the muscle contractions of the esophagus during swallowing. Computed Tomography (CT) Scan: An imaging study using x-ray s and computer processing which creates cross - sectional views of a body area. Magnetic Resonance Imaging (MRI): An imaging study using magnetic fields and radiowaves to create detailed images of organs and tissues. Modified Barium Swallow (MBS): A video fluoroscopic, radiographic test that differs from the traditional barium swallow procedure in both procedure and purpose. During the procedure, the patient is seated in an upright or semi-reclining position and given various quantities and textures of food and/or liquids mixed with a contrast material. The procedure includes observation of containment of the food/liquid in the oral cavity, mastication, tongue mobility during oral bolus transport, elevation and retraction of the velum, tongue base retraction, upward and forward movement of the hyoid bone and larynx, laryngeal closure, pharyngeal contraction, and extent and duration of pharyngoesophageal segment opening. The presence, timing and Dysphagia Imaging Evaluation Page: 3 of 7 cause of penetration or aspiration into the upper airways are observed. Observations of esophageal clearance in the upright position, sensation, and muscle strength may be measured directly or inferred. The video fluoroscopic swallowing study is a collaborative study that can be performed by a speech-language pathologist and a radiologist3. Among the important clinical syndromes that contribute to the presentation of dysphagia and where instrumental assessment of swallowing may be helpful include, but are not limited to3: • Patients with stroke or other Central Nervous System (CNS) disorder with associated impairment of speech and swallowing • Patients with surgical ablation or radiation due to head and neck cancer with documented difficulty in swallowing • Patients without obvious CNS disorder, but with documented difficulty in swallowing • Patients with generalized debilitation and with difficulty swallowing food • Patients with neuromuscular diseases and rheumatologic diseases known to cause dysphagia • Patients with a clinical history of aspiration or a history of aspiration pneumonia • Patients with head or neck (throat) injury, including peripheral nerve injury from any cause Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Radiologic evaluation of dysphagia will be considered medically reasonable and necessary when the following requirements are met3: • after clinical examination identifies an issue that cannot be resolved without further assessment; AND • for the evaluation of a patient with dysphagia who has a pharyngeal dysfunction; OR for a patient who is at risk for aspiration; AND • Barium Swallow (including Modified Barium Swallow) is performed as the initial test in the evaluation of dysphagia; AND • Additional secondary testing (eg, EGD, esophageal manometry, CT scan, and MRI) are performed to assess for structural abnormalities; AND • when performed in the following places of service: o Office (11) o Off Campus-Outpatient Hospital (19) Dysphagia Imaging Evaluation Page: 4 of 7 o Inpatient Hospital (21) o On Campus-Outpatient Hospital (22) o Emergency Room Hospital (23) o Comprehensive Inpatient Rehabilitation Facility (61) o Comprehensive Outpatient Rehabilitation Facility (62); AND • There is physician presence during procedures that are performed in a mobile setting (in a Skilled Nursing Facility (SNF), nursing home, or home environment) due to expressed concerns that the use of such services in a mobile setting lacks evidence of medical effectiveness and questions of patient safety that have yet to be resolved for these types of procedures to be performed in such settings5. The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Diagnostic x-ray services furnished by a portable x-ray supplier are covered under Part B when furnished in a place or residence used as the patient’s home and in nonparticipating institutions. These services must be performed under the general supervision of a physician, the supplier must meet FDA certification requirements, and certain conditions relating to health and safety (as prescribed by the Secretary) must be met4. Procedures and examinations which are not covered under the portable x-ray provision include the following4: • Procedures involving fluoroscopy; • Procedures involving the use of contrast media; • Procedures requiring the administration of a substance to the patient or injection of a substance into the patient and/or special manipulation of the patient; • Procedures which require special medical skill or knowledge possessed by a doctor of medicine or doctor of osteopathy or which require that medical judgment be exercised; • Procedures requiring special technical competency and/or special equipment or materials; • Routine screening procedures; and • Procedures which are not of a diagnostic nature. These treatments and services fall within the Medicare program’s statutory exclusion that prohibits payment for items and services that have not been demonstrated to be reasonable and necessary for the diagnosis and treatment of illness or injury (§1862(a)(1) of the Act). The following services will not be considered medically reasonable and necessary: • Multiple x-ray services for the evaluation of dysphagia including, but not limited to the following Dysphagia Imaging Evaluation Page: 5 of 7 anatomical regions: o Spine o Mandible o Teeth o Neck (cervical) o Chest Published evidence strongly supports the use of CT scan as an additional imaging study to look for further structural abnormalities.6, 8, 9 The use of additional x-ray services in a mobile setting (ie x-rays of mandible and teeth) lack published evidence of medical effectiveness.