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DESCRIPTIONTransanal endoscopic microsurgery (TEMS) involves the use of specialized equipment including an operating proctoscope, insufflation, and magnified stereoscopic views for resection of rectal tumors. Use of this equipment deals with limitations on local resection due to the anal sphincter and boney confines of the pelvis. Lesions which could not be removed through the anus under usual circumstances become accessible with the use of TEMS. Use of this technique should not change the type of rectal lesion that is or is not removed by a localized resection; this only changes the surgical approach.
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.
TEMS has potential use when traditional transanal approaches are not possible. TEMS 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, T1 –T2 rectal cancer, and palliative excision of T3 rectal cancers. When these lesions cannot be removed through the anus, an anterior abdominal approach or abdominoperineal resection would often be used. TEMS is viewed as an alternative in these cases.
As noted above, this procedure requires use of specialized equipment. The Transanal Endoscopic Microsurgery (TEM) Combination System and Instrument Set (Richard Wolf Medical Instruments Corp) received 510(k) marketing clearance from the U.S. Food and Drug Administration in 2001.
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.
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.