Medical Coverage Policy Effective Date ............................................. 7/15/2021 Next Review Date ......................................11/15/2021 Coverage Policy Number .................................. 0504 Omnibus Codes Table of Contents Related Coverage Resources Overview .............................................................. 1 Category III Current Procedural Terminology (CPT®) Coverage Policy ................................................... 1 codes General Background ............................................ 7 Deep Brain and Motor Cortex and Responsive Services without Food and Drug Cortical Stimulation Administration (FDA) Approval ....................... 7 Electrodiagnostic Testing (EMG/NCV) Cardiovascular ................................................ 7 Serological Testing for Inflammatory Bowel Disease Gastroenterology .......................................... 36 Neurology ...................................................... 61 Obstetrics/Gynecology .................................. 67 Urology .......................................................... 69 Ophthalmology .............................................. 72 Oncology ....................................................... 80 Otolaryngology .............................................. 86 Other ............................................................. 89 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This Coverage Policy addresses multiple services and procedures. Coverage Policy Currently, the evidence does not support any definitive benefit for one type of oxygen delivery system over another. As the operational costs of liquid oxygen systems may be significantly higher than other oxygen systems (e.g., portable or stationary oxygen concentrators), coverage of liquid oxygen systems may depend on the applicable health benefit plan definition of medical necessity. Where that definition limits coverage to the most cost-effective equivalent treatment, the use of liquid oxygen system is not Page 1 of 95 Medical Coverage Policy: 0504 considered medically necessary. In addition when another type of oxygen system (e.g., concentrators) is available in network, a network adequacy exception for liquid oxygen will not be made. Transanal Endoscopic Microsurgery (TEMS) Approach for Excision of Rectal Tumor (CPT Code 0184T) Transanal endoscopic microsurgery (TEMS) is considered as medically necessary for EITHER of the following indications: • Benign adenoma • T1N0 rectal cancer when ALL of the following criteria are met: • tumor has a diameter of < 3cm • tumor is located within 8 cm of the anal verge • tumor is well to moderately differentiated • tumor is limited to < 30% of the rectal circumference • lesion is adequately identified in the rectum • no signs of systemic or metastatic disease TEMS for any other indication is considered experimental, investigational and unproven. Tumor Treatment Fields (TTF) Therapy (HCPCS Codes A4555, E0766, 64999) TTF therapy (i.e., Optune™) is considered medically necessary for individual 22 years of age or older with presence of histologically-confirmed glioblastoma multiforme (GBM) when EITHER of the following criteria are met: • with confirmed recurrence after receiving chemotherapy and the device is being used as a monotherapy • for adjuvant therapy with temozolomide TTF (i.e., Optune™) for any other indication is considered experimental, investigational or unproven. The use of treatment planning software (i.e., NovoTAL) (CPT code 64999) for use with tumor treatment fields for any indication, is considered experimental, investigational or unproven. Insertion of Ocular Telescope Prosthesis Including Crystalline Lens (CPT Code 0308T, HCPCS Code C1840) Intraocular telescope (Implantable Miniature Telescope [IMT]) is considered medically necessary for an individual 65 years of age or older when ALL of the following criteria are met: • with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration (AMD) • has retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography • has evidence of visually significant cataract (≥ grade 2) • agrees to undergo pre-surgery training and assessment (two to four visits) with low vision specialists (e.g., optometrist or occupational therapist) in the use of an external telescope • achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart with an external telescope on the eye scheduled for surgery • have adequate peripheral vision in the eye not scheduled for surgery • agree to participate in postoperative visual training with a low vision specialist Calprotectin, fecal (CPT Code 83993) Fecal calprotectin is considered medically necessary when ALL of the following criteria are met: Page 2 of 95 Medical Coverage Policy: 0504 • for the evaluation of chronic diarrhea (>4 weeks) • for purpose of distinguishing irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) Fecal calprotectin for any other indication, including but not limited to management of IBD, is considered experimental, investigational or unproven. EXPERIMENTAL, INVESTIGATIONAL OR UNPROVEN SERVICES Each of the following services for any indication is considered experimental, investigational or unproven: CPT®* Description Comment Codes 33289 Transcatheter implantation of wireless pulmonary artery pressure sensor for long- term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed 34717 Endovascular repair of iliac artery at the time of aorto-iliac artery endograft placement by deployment of an iliac branched endograft including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for rupture or other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer, traumatic disruption), unilateral (List separately in addition to code for primary procedure) 34718 Endovascular repair of iliac artery, not associated with placement of an aorto-iliac artery endograft at the same session, by deployment of an iliac branched endograft, including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer), unilateral Page 3 of 95 Medical Coverage Policy: 0504 CPT®* Description Comment Codes 46999 Unlisted procedure, anus Considered Experimental/Investigational/Unproven when used to report transanal radiofrequency therapy for fecal Incontinence (e.g., SECCA procedure) 53860 Transurethral radiofrequency micro- remodeling of the female bladder neck and