Transanal Endoscopic Microsurgery

POLICY NUMBER

A.7.01.112

DESCRIPTION

Transanal endoscopic microsurgery (TEM) is a minimally invasive 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.

Transanal Endoscopic Microsurgery

Transanal endoscopic microsurgery (TEM) is a minimally invasive approach to 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 (eg, malignant polyps). Use of TEM for resection of rectal cancers is more controversial. TEM can avoid the morbidity and mortality associated with major rectal surgery, including the fecal incontinence related to stretching of the anal sphincter, and can be performed under general or regional anesthesia.

The TEM system has a specialized magnifying rectoscope with ports for insufflation, instrumentation, and irrigation. This procedure has been available in Europe, but has not been used widely in the United States. Two reasons for this slow adoption 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.

Other Treatment Options

The most common treatment for rectal cancer is surgery; the technique chosen will depend on several factors. The size and location of the tumor, evidence of local or distal spread, and an individual's characteristics and goals are all attributes that will affect the treatment approach. Open, wide resections have the highest cure rate, but may also have significant adverse events. Most individuals find the potential adverse events of lifelong colostomy and/or bowel, bladder, or sexual dysfunction acceptable in the face of a terminal illness. Laparoscopic-assisted surgery, with lymph node dissection as indicated, is technically difficult in the pelvic region, but is being investigated as a less invasive alternative to open resection.

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. TEM extends local excision ability to the proximal rectosigmoid junction. Adenomas, small carcinoid tumors, and nonmalignant conditions (eg, strictures, 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. TEM permits local excision beyond the reach of direct visualization equipment.

In 2001, the TEM Combination System and Instrument Set (Richard Wolf Medical Instruments) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. 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 three surgical instruments. In 2011, the SILS™ Port (Covidien) was cleared for marketing by the FDA through the 510(k) process. The SILS Port is a similar instrument that can be used for rectal procedures including TEM. Another device determined by the FDA to be substantially equivalent to these devices is the GelPOINT® Path (Applied Medical Resources).

Transanal Endoscopic Microsurgery Devices Cleared by the U.S. Food and Drug Administration

POLICY

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, AND

• Well or moderately differentiated (G1 or G2) by biopsy, AND

• Without lymphadenopathy, AND

• Less than 1/3 circumference of the rectum.

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

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The clinical staging of rectal cancers is determined from the physical examination, imaging, and biopsy results.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

1/10/2008: 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.

11/26/2014: Policy reviewed; description revised. Policy statements unchanged.

08/27/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 48.35 to the Code Reference section.

11/09/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.7.01.112 added.

12/06/2016: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated regarding determination of rectal cancers.

01/09/2018: Policy description updated. Policy statements unchanged.

01/10/2019: Policy description updated. Policy statements unchanged.

12/12/2019: Policy description updated regarding devices. Policy statements unchanged.

01/18/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to " Mental Health Disorders" and "Medically Necessary" changed to "medical necessity."

02/01/2022: Policy reviewed; no changes.

01/23/2023: Policy description updated with minor wording changes. Policy statements unchanged.

01/05/2024: Policy description updated regarding devices. Policy statements unchanged.

01/31/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 7.01.112

CODE REFERENCE

This 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.

Covered Codes

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