Effective Date: 12/01/2011
Title: Transanal Enoscopic Microsurgery (TEMS)
Revision Date: 10/01/2015
CPT Code(s): 0184T
will apply to all services performed on or after the above revision date which
will become the new effective date.
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
adenomas, including recurrent adenomas, that cannot be removed using other
means of local excision, or
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:
Excision of rectal tumor, transanal endoscopic microsurgical approach
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;
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,
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.