Transanal Endoscopic Microsurgery (TEMS)

Description of Procedure or Service

Transanal endoscopic microsurgery (TEMS) is a minimally invasive surgical approach for local excision 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 fecal incontinence related to stretching of the anal sphincter, and can be performed under general or regional anesthesia.

This procedure has been available 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. For example, most rectal polyps can be removed endoscopically and many rectal cancers need a wide excision and are thus not amenable to local resection. The technique requires specialized equipment including a magnifying rectoscope with ports for insufflation, instrumentation, and irrigation. Local excision 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. Local excision can occur under direct visualization in rectal tumors within 10 cm of the anal verge. TEMS extends local excision ability to the proximal rectosigmoid junction. Adenomas, small carcinoid tumors, and nonmalignant conditions, such as strictures or abscesses, are amenable to local excision by either method.

The use of local excision 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 tumor, node, and metastasis staging system). Presurgical clinical staging, however, may miss up to 15% of regional lymph node spread. During local excision, 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, local excision may be an informed alternative for patients. TEMS permits local excision beyond the reach of direct visualization equipment.

Regulatory Status

As noted, this procedure requires use of specialized equipment. The Transanal Endoscopic Microsurgery (TEMS) Combination System and Instrument Set (Richard Wolf Medical Instruments) received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in 2001. The 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 3 surgical instrucments. The SILS ™ Port (Covidien) subsequently received 510(k) approval in 2011. The SILS ™ Port is a similar instrument that can be used for rectal procedures including TEMS. Another device determined by FDA to be substantially equivalent to these deices is the GelPOINT® Path (Applied Medical Resources).

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

BCBSNC will provide coverage for Transanal Endoscopic Microsurgery when it is determined to be medically necessary because the medical criteria and guidelines shown below are met.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Transanal Endoscopic Microsurgery is covered

Transanal 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:

• Located in the middle or upper part of the rectum,
• Well or moderately differentiated (G1 or G2) by biopsy,
• Without lymphadenopathy, and
• Less than 1/3 the circumference of the rectum

When Transanal Endoscopic Microsurgery is not covered

Transanal endoscopic microsurgery is considered investigational for treatment of rectal tumors that do not meet the criteria noted above.

Policy Guidelines

Transanal endoscopic microsurgery (TEMS) is a minimally invasive surgical approach for local excision of rectal lesions that cannot be directly visualized. It is an alternative to open or laparoscopic excision and has been studied in the treatment of both benign and malignant conditions of the rectum.

For individuals with early rectal adenocarcinoma who receive TEMS, the evidence includes 2 small randomized controlled trials, a few nonrandomized comparative studies, numerous single-arm case series and systematic reviews of these studies. Relevant outcomes are overall survival (OS), functional outcomes, health status measures, quality of life, and treatment-related morbidity. The evidence supports the conclusions that TEMS is associated with fewer postoperative complications but higher local recurrence rates and possibly a higher rate of metastatic disease. One systematic review indicates improved OS with radical surgery compared with TEM; however, the majority of systematic reviews did not demonstrate significant differences in OS. However, due to the low quality of the evidence base, these conclusions cannot be made with certainty. Therefore, the evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with rectal adenomas who receive TEMS, the evidence includes a few nonrandomized comparative studies, and many single-arm case series. Relevant outcomes are overall survival, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The evidence supports the conclusions that removal of polyps by TEMS is associated with low postoperative complication rates and low risk of recurrence. However, due to the low quality of the evidence base, no conclusions can be made on the comparative efficacy of TEMS and alternative procedures. Therefore, the evidence is insufficient to determine the effects of the technology on health outcomes.

The National Comprehensive Cancer Network (v.4.2024) in its updated guidelines on the treatment of rectal cancer states, “When the lesion can be adequately localized to the rectum, local excision of more proximal lesions may be technically feasible using advanced techniques, such as transanal endoscopic microsurgery (TEM) or transanal minimally invasive surgery (TAMIS).” However, under discussion is the statement, “TEM can facilitate excision of small tumors through the anus when lesions can be adequately identified in the rectum. TEM may be technically feasible for more proximal lesions.” 

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 0184T

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 12/3/2007

Specialty Matched Consultant Advisory Panel - 4/2008

National Comprehensive Cancer Network. Practice Guidelines in Oncology: Rectal Cancer (V.3.2009). Available online at http://www.nccn.org/professionals/physician_gls/PDF/rectal.pdf

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 10/06/09

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/10/11

Specialty Matched Consultant Advisory Panel – 10/2012

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/8/12

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 9/12/13

Specialty Matched Consultant Advisory Panel – 10/2013

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 9/11/14

Specialty Matched Consultant Advisory Panel – 11/2014

Senior Medical Director review—12/2014

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 9/10/2015

Specialty Matched Consultant Advisory Panel 11/2015

Senior Medical Director review 11/2015

Specialty Matched Consultant Advisory Panel 11/2016

Medical Director review 11/2016

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/2016

Specialty Matched Consultant Advisory Panel 11/2017

Medical Director review 11/2017

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/2017

Specialty Matched Consultant Advisory Panel 11/2018

Medical Director review 11/2018

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/2018

Specialty Matched Consultant Advisory Panel 11/2019

Medical Director review 11/2019

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 11/2019

Specialty Matched Consultant Advisory Panel 11/2020

Medical Director review 11/2020

BCBSA Medical Policy Manual [Electronic Version] - 7.01.112, 12/2020

Specialty Matched Consultant Advisory Panel 11/2021

Medical Director review 11/2021

Specialty Matched Consultant Advisory Panel 11/2022

Medical Director review 11/2022

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Rectal Cancer. Version 5.2023. https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf.

Specialty Matched Consultant Advisory Panel 11/2023

Medical Director review 11/2023

Specialty Matched Consultant Advisory Panel 11/2024

Medical Director review 11/2024

Policy Implementation/Update Information

6/16/08 New policy adopted from BCBSA. Specialty Matched Consultant Advisory Panel review 4/30/ 2008. Transanal endoscopic microsurgery is considered investigational for the treatment of rectal conditions including rectal cancers and rectal polyps. (btw)

6/22/10 Policy Number(s) removed (amw)

11/23/10 Description section revised. Policy statement changed from Investigational to Medically Necessary when criteria are met. Transanal 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 than cannot be removed using other means of local excision and that meet all of the following criteria: Located in the middle or upper part of the rectum, Well or moderately differentiated (G1 or G2) by biopsy, Without lymphadenopathy, and Less than 1/3 the circumference of the rectum. Transanal endoscopic microsurgery is considered investigational for treatment of rectal tumors that do not meet the criteria noted above. Policy Guidelines revised. References updated. Specialty Matched Consultant Advisory Panel review meeting 10/28/10. Policy accepted as written. (adn)

10/30/12 Specialty Matched Consultant Advisory Panel review 10/17/12. Policy Guidelines updated. No change to policy intent. (sk)

1/15/13 Reference added. No change to policy statement. (sk)

11/12/13 Reference added. Specialty Matched Consultant Advisory Panel review 10/16/13. No change to policy intent. (sk)

1/13/15 References updated. Specialty Matched Consultant Advisory Panel review 11/2014. Senior Medical Director review 12/2014. No change to policy intent. (td)

12/30/15 Policy Guidelines section updated. References updated. Specialty Matched Consultant Advisory Panel review 11/18/2015. Senior Medical Director review 11/2015. (td)

12/30/16 Description section and references updated. Specialty Matched Consultant Advisory Panel 11/2016. Medical Director review 11/2016. (jd)

12/15/17 References updated. Specialty Matched Consultant Advisory Panel 11/2017. Medical Director review 11/2017. (jd)

12/14/18 Minor update to regulatory status. Revision to policy guidelines for consistency. References updated. Specialty Matched Consultant Advisory Panel 11/2018. Medical Director review 11/2018. (jd)

12/31/19 References updated. Specialty Matched Consultant Advisory Panel 11/2019. Medical Director review 11/2019. (jd)

12/8/20 References updated. Specialty Matched Consultant Advisory Panel 11/2020. Medical Director review 11/2020. (jd)

11/30/21 Specialty Matched Consultant Advisory Panel 11/2021. Medical Director review 11/2021. (jd)

11/29/22 References updated. Minor edits to Policy Guidelines section for clarity, no change to policy statement. Specialty Matched Consultant Advisory Panel 11/2022. Medical Director review 11/2022. (tm)

12/29/23 Description, Policy Guidelines and References updated. Specialty Matched Consultant Advisory Panel 11/2023. Medical Director review 11/2023. (tm)

12/17/24 Policy Guidelines and References updated. Specialty Matched Consultant Advisory Panel 11/2024. Medical Director review 11/2024. (tm)