Latest Review Date: May 2024

Category: Surgery                                                                

POLICY:

Natural orifice transluminal endoscopic surgery (NOTES) procedures are considered investigational.

Endoscopic suturing devices (e.g. Overstich, Over the Scope clips [OTSC]) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Natural orifice transluminal endoscopic surgery (NOTES) is an emerging area of surgery in which the surgeon accesses the peritoneal cavity via a hollow viscus and performs diagnostic and therapeutic procedures.  The surgeon passes a flexible scope through a natural orifice (oral, vaginal, urethral, nasal or rectal) and transects through that lumen into the open peritoneum where the actual surgery is performed.  The NOTES procedure may have the potential to be the “ideal scar-free” surgery and have a shorter postoperative recovery if the technological and practical issues are achieved.

The key technical elements in a NOTES procedure are access via a hollow viscus, performance of the desired maneuver once in the target cavity, and closure of the port upon exit.

The specific surgical or diagnostic procedure will dictate which orifice should be used.  For example, rectal entry provides easy access to the gall bladder and upper abdominal structures and is simpler than a gastric entry.  However, it requires colon cleansing and has an increased infection risk and the concept is unpleasant to patients.  An appendectomy, cholecystectomy, or sleeve gastrectomy can be performed via the vagina.  The problem with vaginal access is that it requires a blind insertion into the peritoneum.  Access through the bladder is sterile, but limits the size of instruments that can be used.  One aspect of bladder entry is for transvesicular assistance for transoral procedures, or the use of two orifices for one procedure, where one orifice is used for viewing while the other is used for operating.

There are several limitations to these procedures.  There will be some degree of bacterial contamination in the peritoneal cavity, with a risk of peritonitis and abscess formation.  There may be effects on the immune system.  It may be difficult to deal with major complications such as major bleeding, laceration, or perforation of other organs.  Another concern with NOTES is the possibility of over-insufflation of the peritoneal cavity and subsequent decreased venous return to the heart.

KEY POINTS:

This policy’s most recent literature review was performed through May 2, 2024.

Summary of Evidence

The evidence regarding the NOTES procedure and endoscopic suturing devices is still evolving.  There are many studies still being conducted in animals.  The literature available states pain and hospital stays are reduced after having the NOTES procedure vs laparoscopic procedures. There was no difference in morbidity, but cosmetic satisfaction was better for the NOTES group. However, there is no long term evidence for these procedures.  Larger trials with long term follow up is needed to determine the efficacy of these procedures.  The evidence is insufficient to determine the net health outcome of this procedure.

Practice Guidelines and Position Statements

National Orifice Surgery Consortium for Assessment and Research (NOSCAR)

In 2005, the American Society of Gastrointestinal Endoscopy (ASGE) and the Society of Gastrointestinal Endoscopic Surgeons (SAGES) came together in a consortium, the National Orifice Surgery Consortium for Assessment and Research, or NOSCAR, to provide consensus and guidelines for this procedure.  Currently, NOSCAR requires that all NOTES procedures must be performed under an investigational research board protocol, and the laboratory rehearsal using NOTES procedures and techniques is first practiced on cadavers.  The literature states that at present, NOTES should be considered experimental and should be performed only in a research setting.

In 2009, NOSCAR announced that they would be conducting a multicenter human trial on transoral and transvaginal cholecystectomies using NOTES, and enrolling patients to take part in this study.  The study will compare NOTES cholecystectomy versus conventional laparoscopic cholecystectomy.

In 2012, NOSCAR stated that “while NOTES procedures are still considered experimental and require IRB approval, data regarding instrumentation are now sufficiently robust to make new recommendations.”  They conclude that the flexible endoscope should not be considered experimental when used to “traverse the wall of the GI tract or vagina”; however, the procedure itself is considered experimental.

KEY WORDS:

Natural orifice, transluminal endoscopic surgery, hollow viscus, target cavity, NOTES, endoscopic suturing device, endoscopic closure device, overstitch, OTSC

APPROVED BY GOVERNING BODIES:

Not applicable.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefits consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

There is no specific code for natural orifice transluminal endoscopic surgery.

There is no specific code for endoscopic suturing devices.  It would likely be submitted using the unlisted procedure, stomach code, 43999.

REFERENCES:

1. Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Morlion B, Weyers S, Mol B, Bosteels J. Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial). BJOG. 2021 Oct;128(11):1782-1791.
2. Daher R, Chouillard E, Panis Y. New trends in colorectal surgery: Single port and natural orifice techniques. World Journal of Gastroenterology. 2014 December 28; 20(48): 18104-18120.
3. Eid GM, McCloskey CA, Eagleton JK, et al. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en Y gastric bypass patients: a randomized clinical trial. JAMA Surg. Apr 2014; 149(4):372-379.
4. Garud SS, Willingham FF. Natural orifice transluminal endoscopic surgery. Gastrointest Endosc. 2012 Sep;76(3):491-5. doi: 10.1016/j.gie.2012.06.025.
5. Gonzalez-Panizo-Tamargo F, Rojoas-Sanchez A, Miranda-Garcia P et al. Endoscopic management of common pathologies with a new suturing system. Rev Esp Enferm Dig. 2014 Jun; 106(6): 413-7.
6. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
7. Khashab MA, Kalloo AN. NOTES: current status and new horizons. Gastroenterology. 2012 Apr;142(4):704-710.e1. doi: 10.1053/j.gastro.2012.02.022. Epub 2012 Feb 17.
8. Lehmann KS, Ritz JP, et al. The German Registry for Natural Orifice Translumenal Endoscopic Surgery: report of the first 551 patients. Ann Surg. 2010;252: 263-270.
9. Liu L, Chiu PW, Reddy N, et al.; APNOTES Working Group. Natural orifice transluminal endoscopic surgery (NOTES) for clinical management of intra-abdominal diseases. Dig Endosc. 2013 Nov;25(6):565-77. doi: 10.1111/den.12154. Epub 2013 Aug 23.
10. Magdeburg R, Kaehler G. Natural orifice transluminal endoscopic surgery in humans: feasibility and safety of transgastric closure using the OTSC system. Surg Endosc, 24 March 2015.
11. Pasricha PJ.  NOTES: a gastroenterologist's perspective. Gastrointest Endosc Clin N Am. 2007 Jul;17(3):611-6.
12. Puisungnoen N, Yantapant A, Yanaranop M. Natural Orifice Transluminal Endoscopic Surgery-assisted Vaginal Hysterectomy versus Total Laparoscopic Hysterectomy: A Single-center Retrospective Study Using Propensity Score Analysis. Gynecol Minim Invasive Ther. 2020 Oct 15;9(4):227-230.
13. Schwaitzberg SD, Dorozhkin D, Sankaranarayanan G, et al. Natural orifice translumenal endoscopic surgery (NOTES): emerging trends and specifications for a virtual simulator. Surg Endosc. 2016 Jan;30(1):190-8. doi: 10.1007/s00464-015-4182-1. Epub 2015 Apr 4.
14. Sodergren MH, et al.  Natural orifice transluminal endoscopic surgery: Critical appraisal of applications in clinical practice.  Surgical Endoscopy, January 2009.
15. Swain PA.  A justification for NOTES-natural orifice transluminal endosurgery.  Gastrointestinal Endoscopy 2007; 65: 514.
16. Xu B, Liu Y, Ying X, et al. Transvaginal endoscopic surgery for tubal ectopic pregnancy. JSLS. 2014 Jan-Mar; 18(1): 76-82.
17. Yagci MA and Kayaalp C. Transvaginal appendectomy: A systematic review. Minim Invasive Surg. 2014; Dec.
18. Zorron R, et al.  NOTES transvaginal for cancer diagnostic staging: Preliminary clinical application.  Surgical Innovations 2008. Sep;15(3):161-5.

POLICY HISTORY:

Medical Policy Group, January 2009

Medical Policy Administration Committee, February 2009

Available for comment February 6-March 23, 2009

Medical Policy Group, April 2015 (4):  Update to Description, Key Points, and References.  No policy statement change.

Medical Policy Group, February 2018 (4): Updates to Description, Key Points, Current Coding, Key Words, and References.  Update to Policy section by adding endoscopic closure devices investigational. These devices were previously considered investigational.  Added 43999 to Current Coding.

Medical Policy Group, October 2019 (5): Updates to Key Points and References. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2021 (5): Reviewed by consensus. Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2022 (5): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2023 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2024 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.