National Medical Policy Subject:

Transanal Endoscopic Microsurgery (TEM) for Rectal Cancer

Policy Number:

NMP433

Effective Date*: August 2008 Updated:

July 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document

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Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)*

Article (Local)* Other None

Reference/Website Link

Category III Codes (L35488): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

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Transanal Endoscopic Microsurgery for Rectal Cancer Jul 16

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Current Policy Statement Health Net, Inc. considers transanal endoscopic microsurgery (TEM) medically necessary for treatment of any of the following: 1.

Benign rectal tumors (adenomas) not amenable to colonoscopic removal;

2.

Low risk TIS tumors (i.e. Tumor confined to mucosa; cancer-in-situ);

3.

Low risk T1 tumors (well-differentiated, 0.05). Recto-anal inhibitory reflex (RAIR) was absent in 1 (2%) patient preoperatively and in 30(60%), 18(36%), 7(14%), 2(4%) at the 1st, 3rd, 6th, 9th months after surgery respectively. ERUS showed similar width and thickness of internal sphincter at 1st and 6th month after surgery compared with preoperative measures (P>0.05). Six months after surgery, the mean FISI score decreased (preoperative vs postoperative: 8.5 vs 5.8, P0.05). The authors concluded TEM has little impact on anorectal anatomic structure. Anal function may be compromised in the short-term, however the vast majority of patients recover completely after 6-9 months. TEM is a safe, effective and minimally invasive surgery. Guerrieri et al (2014) described their experience in treating rectal cancer by TEM, reporting morbidity and mortality and oncological outcome. A total of 425 patients with rectal cancer (120 T1, 185 T2, 120 T3 lesions) were staged by digital rectal examination, rectoscopy, transanal endosonography, magnetic resonance imaging and/or computed tomography. Patients with T1-N0 lesions and favorable histological features underwent TEM immediately. Patients with preoperative stage T2-T3-N0 underwent preoperative high-dose radiotherapy; from 1997 those aged less than 70 years and in good general health also underwent preoperative chemotherapy. Patients with T2-T3-N0 lesions were restaged 30 d after radiotherapy and were then operated on 40-50 d after neoadjuvant therapy. The instrumentation designed by Buess was used for all procedures. There were neither perioperative mortality nor intraoperative complications. Conversion to other surgical procedures was never required. Major complications (urethral lesions, perianal or retroperitoneal phlegmon and rectovaginal fistula) occurred in six (1.4%) patients and minor complications (partial suture line dehiscence, stool incontinence and rectal haemorrhage) in 42 (9.9%). Postoperative pain was minimal. Definitive histological examination of the 425 malignant lesions showed 80 (18.8%) pT0, 153 (36%) pT1, 151 (35.5%) pT2, and 41 (9.6%) pT3 lesions. Eighteen (4.2%) patients (ten pT2 and eight pT3) had a local recurrence and 16 (3.8%) had distant metastasis. Cancer-specific survival rates at the end of follow-up were 100% for pT1 patients (253 mo), 93% for pT2 patients (255 mo) and 89% for pT3 patients (239 mo). The authors concluded TEM is a safe and effective procedure to treat rectal cancer in selected patients without evidence of nodal involvement. T2-T3 lesions require preoperative neoadjuvant therapy.

Scientific Rationale - Update July 2014 Treatment options for localized rectal carcinoid tumors include conventional endoscopic resection (i.e., standard polypectomy or endoscopic mucosal resection [EMR]), advanced endoscopic resection (endoscopic submucosal dissection, transanal endoscopic microsurgery [TEM], cap-assisted endoscopic mucosal resection), transanal surgical resection, or radical resection (low anterior resection [LAR], abdominoperineal resection [APR]). Tumors smaller than 1 cm and confined to the mucosa or submucosa (T1) can generally be treated by endoscopic resection, particularly if they lack other risk factors (i.e., mitotic rate >2 per 10 HPF or LVI). A greater likelihood of negative resection margins may be achievable with more advanced endoscopic techniques including endoscopic submucosal dissection and cap-assisted endoscopic mucosal resection, in which the tumor is suctioned into a cap and then removed with a snare. However it is unclear whether negative margins are necessary given the excellent outcome of patients with low-grade T1 tumors, even with positive or indeterminant margins. Large tumors (>2 cm) or those that invade the muscularis propria (T2) should generally be treated with radical surgical resection (LAR or APR). The management of intermediate-sized tumors (1 to 2 cm confined to mucosa or submucosa) is somewhat controversial. Transanal resection or advanced endoscopic resection techniques (such as TEM) may be appropriate for tumors lacking risk factors, whereas radical resection may be more appropriate for tumors with risk factors such as elevated mitotic rate (or ki-67 index), LVI, or size >1.5 cm. (Goldfinger et al. 2014, UpToDate).

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Scientific Rational Update – July 2013 National Cancer Comprehensive Network (NCCN, 2013) Guidelines for Rectal Cancer note: Criteria For Transanal Excision:          

or =5 cm from the AV (76.1%) vs.