Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Transanal endoscopic microsurgery (TEMS) involves the use of specialized equipment including an operating proctoscope, insufflation, and magnified stereoscopic views for resection of rectal tumors.  This technique is covered for patients meeting specific criteria.

Transanal endoscopic microsurgery (TEMS) is covered for the following conditions:

1. Rectal adenomas, including recurrent adenomas, that cannot be removed using other means of local excision, or
2. T1 rectal adenocarcinomas that cannot be removed using other means of local excision and also meet all of the following criteria:

• Located in the middle or upper part of the rectum
• Well or moderately differentiated (G1 or G2)
• Without lymphadenopathy or microscopic angiolymphatic invasion
• Less than 1/3 the circumference of the rectum.

Codes Used In This BI:

0184T, Excision of rectal tumor, transanal endoscopic microsurgical approach

TEMS is considered experimental for all other indications.

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 US Food and Drug Administration in 2001.

Lezoche and colleagues randomized 70 patients with T (2) N (0), G (1-2) rectal cancer to TEMS or laparoscopic resection (LR) via total mesorectal excision. All patients received chemoradiation prior to surgery. (Lezoche, 2008) Median follow-up was 84 months (range, 72-96 months). Two local recurrences (5.7%) were observed after TEMS and 1 (2.8%) after LR. Distant metastases occurred in one patient in each group. The probability of survival for rectal cancer was 94% for TEMS and 94% for LR. Moore et al. report on a retrospective review of patients who underwent transanal excision for rectal neoplasms and compared results for traditional transanal resection and TEMS. (Moore, 2008) Of 296 patients identified, 76 were excluded because surgery was for abscess, fistulas, inflammatory bowel disease, or multiple lesions. Forty-nine patients were excluded because of incomplete or missing charts. Records of 171 patients were analyzed; 82 patients who underwent TEMS and 89 who had transanal resection (TA) were analyzed. For patients who received TEMS, those with T1 lesions without adverse histologic features (poor differentiation or lymphovascular invasion) received local excision alone. Patients with T1 lesions with adverse features or T2 lesions received postoperative chemoradiation. Local excision was performed for T3 lesions only in high-risk patients or those who refused radical resection. In the TEMS group there were 40 polyps, 5 carcinoma in situ, 21 T1, 7 T2, 8 T3, 0 indeterminate, and 1 carcinoid, and in the TA group: 38 polyps, 4 carcinoma in situ, 20 T1, 19 T2, 6 T3, 1 indeterminate, and 1 carcinoid. All patients treated before December 2001 received TA (7 surgeons), TEMS was performed by one surgeon. Since the introduction of TEMS, 20 TAs were performed. There were 12 (15%) postoperative complications (4 major) in the TEMS group and 15 (17%) complications in the TA group (6 major). In the TEMS group, 90% had negative tumor margins and none had indeterminate margins versus 71% negative and 15% indeterminate in the TA patients. There were 4 recurrences in the TEMS group and 24 in the TA group. Local recurrence was less frequent after TEMS (4 vs 24%, P=0.004). The difference between groups in distant recurrence was not significant. Three TEMS patients with malignant lesions underwent radical resection and were excluded from recurrence analyses. The recurrence rate among cancer patients was not statistically different between groups. For patients with adenomas, the overall recurrence rate after TEMS was 3% versus 32% for TA. In patients with polyps, clear margins were achieved more frequently after TEMS (83%) than after TA (61%).

Doornebosch and colleagues, in a systematic review, discuss weaknesses in the available evidence and still unanswered questions about the role of TEMS. (Doornebosch, 2009) They pose 3 questions: “First, is there enough evidence to propagate local excision (LE) as a curative option in selected (T1) rectal carcinomas? Second, if LE is justified, which technique should be the method of choice? Third, can we adequately identify, pre-and postoperatively, tumors suitable for LE?” They note that selection bias in studies complicates answering the first question; and a significant portion of tumors recurred in all studies using various techniques for local excision (including TEMS), although it seemed not to influence survival rates. The authors note that the published case series reporting outcomes after TEMS for T1 rectal carcinomas utilized inclusion criteria that are not always clear and use of salvage procedures may introduce bias. TEMS was demonstrated to be a safe procedure in all series; complications rates vary between 5% and 26%, and complications were generally minor. Local recurrence rates for TEMS varied between 4% and 33% in the studies reviewed. Regarding the third question, the authors wonder if high recurrence rates can be improved by better tumor selection. The author’s note that based largely on retrospective case series, TEMS has been incorporated into the surgical armamentarium. They also note that despite the lack of level I evidence, its use seems justified in well-selected T1 rectal cancers. Some might view TEMS as an alternative for those with T1 lesions who are currently undergoing other methods of local excision such as local excision according to Parks, instead of radical surgery, for their T1 lesions.

The National Comprehensive Cancer Network (NCCN) guideline on treatment of rectal cancer states that, when criteria for transanal resection are met, transanal endoscopic microsurgery can be used when the tumor can be adequately identified in the rectum. (NCCN) The guideline is based on level 2A evidence for T1 tumors and level 2B evidence for T2 tumors, further stating that “Data are limited on long-term patient outcomes, including risk of local recurrence, for patients undergoing local excision for T2 tumors.”

Cataldo PA. (2006) Transanal microscopic microsurgery. Surg Clin North Am, 2006; 86:915-25.

Doornebosch PG, Tollenaar RA, De Graaf EJ. (2009) is the increasing role of transanal endoscopic microsurgery in curation for T1 rectal cancer justified? A systematic review. Acta Oncol 2009; 48:343-353.

Lezoche E, Guerrieri M, et al. (2005) Transanal endoscopic versus total mesorectal laparoscopic resections of T2-N0 low rectal cancers after neoadjuvant treatment: a prospective randomized trial with a 3-years minimum follow-up period. Surg Endosc, 2005; 19:751-6.

Lezoche G, Baldarelli M, et al. (2007) A prospective randomized study with a 5-year minimum follow-up evaluation of transanal endoscopic microsurgery versus laparoscopic total mesorectal excision after neoadjuvant therapy. Surg Endosc, 2007; [epub ahead of print].

Lezoche G, Baldarelli M, Guerrieri M et al.(2008) A prospective randomized study with a 5-year minimum follow-up evaluation of transanal endoscopic microsurgery versus laparoscopic total mesorectal excision after neoadjuvant therapy. Surg Endosc 2008; 22:352-358.

Maslekar S, Pillinger SH, Monson JR. (2007) Transanal endoscopic microsurgery for carcinoma of the rectum. Surg Endosc, 2007; 21:97-102.

Middleton PF, Sutherland LM, Maddern GJ. (2005) Transanal endoscopic microsurgery: a systematic review. Dis Colon Rectum, 2005; 48:270-84.

Moore JS, Cataldo PA, Osler T et al. (2008) Transanal endoscopic microsurgery is more effective than traditional transanal excision for resection of rectal masses. Dis Colon Rectum 2008; 5:1026-1030.

NCCN (National Comprehensive Cancer Network). 2009. Practice Guidelines in Oncology. Rectal Cancer. Accessible at http://www.nccn.org/professionals/physician_gls/PDF/rectal.pdf, accessed 15 Oct 2009.

Transanal Endoscopic Microsurgery for rectal cancer. Hayes Directory, Dec 31, 2007.