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Transanal endoscopic microsurgery (TEMS) is a minimally invasive surgical approach to local excision (LE) of rectal lesions. It has been used in benign conditions such as large rectal polyps (that cannot be removed through a colonoscope), retrorectal masses, rectal strictures, rectal fistulae, pelvic abscesses, and in malignant conditions such as malignant polyps. Use of TEMS for resection of rectal cancers is more controversial. TEMS can avoid morbidity and mortality associated with major rectal surgery, including the fecal incontinence related to stretching of the anal sphincter, and can be performed under general or regional anesthesia.
The TEMS system has a specialized magnifying rectoscope with ports for insufflation, instrumentation, and irrigation. This procedure has been available for nearly 20 years in Europe but has not been used widely in the United States. Two reasons for this slow diffusion are the steep learning curve for the procedure and the limited indications. As examples, most rectal polyps can be removed endoscopically and many rectal cancers need a wide excision and are thus not amenable to local resection.
The most common treatment for rectal cancer is surgery; the technique chosen will depend on several factors. The size and location of the tumor, evidence of local or distal spread, and patient characteristics and goals are all attributes that will affect this decision. Open, wide resections have the highest cure rate but may also have significant adverse effects. Most patients find the potential adverse effects of lifelong colostomy, bowel; bladder; or sexual dysfunction, acceptable in the face of a terminal illness. Laparoscopic-assisted surgery, with lymph node dissection as indicated, is technically difficult in the pelvic region but is being investigated as a less invasive alternative to open resection.
LE alone does not offer the opportunity for lymph node biopsy and therefore has been reserved for patients in whom the likelihood of cancerous extension is small. LE can occur under direct visualization in rectal tumors within 10 cm of the anal verge. TEMS extends LE ability to the proximal rectosigmoid junction. Adenomas, small carcinoid tumors, and nonmalignant conditions; such as strictures or abscesses; are amenable to LE by either method.
The use of LE in rectal adenocarcinoma is an area of much interest and may be most appropriate in small tumors (<4 cm) confined to the submucosa (T1, as defined by the TNM staging system). Presurgical clinical staging, however, may miss up to 15% of regional lymph node spread. During an LE, the excised specimen should be examined by a pathologist; if adverse features such as high-grade pathology or unclear margins are observed, the procedure can be converted to a wider resection. Despite this increased risk of local recurrence, LE may be an informed alternative for patients. TEMS permits LE beyond the reach of direct visualization equipment.
In March 2001, the Transanal Endoscopic Microsurgery (TEMS) Combination System and Instrument Set (Richard Wolf Medical Instruments Corp., Vernon Hills, IL) was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in inflating the rectal cavity, endoscopically visualizing the surgical site, and accommodating up to three surgical instruments. The Covidien SILS™ Port subsequently received 510(k) approval in 2011. The SILS port is a similar instrument that can be used for rectal procedures including TEMS.
POLICYTransanal endoscopic microsurgery may be considered medically necessary for treatment of rectal adenomas, including recurrent adenomas that cannot be removed using other means of local excision.
Transanal endoscopic microsurgery may be considered medically necessary for treatment of clinical stage T1 rectal adenocarcinomas that cannot be removed using other means of local excision and that meet all of the following criteria:
Transanal endoscopic microsurgery is considered investigational for treatment of rectal tumors that do not meet the criteria noted above.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that FDA-approved technologies may not be considered investigational, and thus the technology may be assessed only on the basis of medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY1/10/2008: Policy added
3/27/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
05/28/2010: Policy statement section revised to include indications that may be considered medically necessary for transanal endoscopic microsurgery; FEP verbiage was added to the Policy Exceptions sections; Code Reference section revised to move CPT Code 0184T from non-covered to covered codes table and added the following ICD-9 Diagnosis codes to covered codes table: 154.1, 209.17, 209.57, 211.4 and 230.4.
12/28/2010: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
11/26/2014: Policy reviewed; description revised. Policy statements unchanged.
08/27/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 48.35 to the Code Reference section.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.112
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.