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Medical Policy

Policy Num:     04.001.019
Policy Name:    Robotic Surgery in Gynecology
Policy ID:          [04.001.019]  [Ac / L / M+ / P+]  [0.00.00]

Last Review:     October 26, 2023
Next Review:     October 20, 2024
 

Related Policies: None

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Robotic Surgery in Gynecology

Summary

In the decade of the ‘80s, the idea of having a military ambulance in the battlefield; equipped with a robot so that a surgeon in a hospital "Mobile Army Surgical Hospital" (MASH), located many miles away could operate a wounded soldier. In this way, saves his life by preventing blood loss and other physiological damages, avoiding disasters.

The National Aeronautics and Space Administration (NASA) had a similar vision, displaying a robot operating an astronaut with acute appendicitis in a space station. By 1990’s, with the advent of laparoscopic surgery, the idea that this kind of surgery could be performed using a robot was conceived. But there were severe limitations. Many anastomosis, particularly of microscopic range, could not be performed well.

These instruments are rigid tools, which can only move in two planes, in, out or turning in favor or against clockwise. However, they could not duplicate the movement of the hand and wrist of the surgeon; that is, tilt or move the instruments at different angles.

In 1999 it was introduced the da Vinci Surgical System, the only commercial system for gynecological surgery. In 2005, FDA gave approval for this use. The current system consists of four components:

1. A console where the surgeon sits watches a screen and controls the instruments through digital potholders and pedals.

2. The cart with three or four arms that grip interactive ranging trocars the patient.

3. A vision system in three dimensions.

4. A computerized system algorithms that converts the movement of the fingers and hands of the surgeon to the trocars within the patient's abdomen.

The potential advantages of this system are: improved depth perception in three dimensions, elimination of tremor, tele potential use in surgery, shorter hospital stays and less blood loss. The disadvantages are: high cost (more than one million dollars) in the initial acquisition of equipment, increased operating time, loss of tactile sensitivity surgeon, inability to reposition the patient, space occupied by the robot, difficult to maneuver the wizard and difficulty to train residents.

Applications of robotic surgery are developing rapidly, but experience with this technology is very limited at present.

Objective

The objective of this review is to determine if robotic surgery improved the outcomes of gynecological laparoscopic surgery.

Policy Statements

The robot-assisted gynecologic surgery (robotic surgery) is considered a modality of conventional laparoscopic gynecological surgery currently paid. It is not considered additional payment to those established for standard procedure.

Policy Guidelines

Robotic gynecological surgery is considered a modality of standard gynecological laparoscopic surgery and no additional compensation will be offer.

Benefit Application

BlueCard/National Account Issues - N/A

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

A surgical robot is a computer-controlled device that can be programmed to aid the positioning and manipulation of surgical instruments. Surgical robotics is typically used in laparoscopy rather than open surgical approaches. Since the 1980s, surgical robots have been developed to address the limitations of laparoscopy, including twodimensional visualization, incomplete articulation of instruments, and ergonomic limitations. The goal of robotassisted laparoscopic surgery is to help surgeons improve patient care by converting procedures that would have otherwise been performed by laparotomy into minimally invasive procedures. Robot-assisted laparoscopic surgery has all of the advantages of minimally invasive surgery include less postoperative pain, smaller and possibly more cosmetically appealing incisions, shorter hospital stay, shorter recovery time, and faster return to work.

Barriers to the adoption of robotics in surgery include the expense, training requirements for physicians and nurses, and lack of high quality data.

Both ACOG (American College of Obstetricians and Gynecologists) and SGS (General Society of Surveillance) recommend that general robot-assisted training requirements for gynecologic surgery for obstetrician–gynecologists who have completed an accredited residency training and who are using robot-assisted surgery in their practices include the following components:

The obstetrician–gynecologist must have completed a didactic educational program focused on robot-assisted surgery, such as approved online training modules. These programs may have been a part of residency or fellowship training and may be offered and accredited by organizations such as ACOG, SGS, AAGL, the Society of Gynecologic Oncology, and the American Urogynecologic Society.

Individuals should have hands-on training using the new technology, including docking, bedside assisting, and sitting at the console. This experience may include inanimate, animate, cadaver laboratory setting, and virtual reality simulation . Standardized and validated assessment tools such as Global Evaluative Assessment of Robotic Skills (or GEARS) https://www.csats.com/gears and Objective Structured Assessment of Technical Skills (or OSATS) may be used for evaluation in both simulation and intraoperative settings

Regulatory Status

N/A

Rationale

Similar to conventional laparoscopy, robot-assisted laparoscopy has been widely adopted prior to emergence of data supporting efficacy and safety. For benign gynecologic disease, there is no high quality evidence that robot-assisted laparoscopy is superior to laparotomy or conventional laparoscopy. The American Association of Gynecologic Laparoscopists (AAGL) states that robot-assisted laparoscopy should not replace conventional laparoscopic or vaginal procedures for benign gynecologic disease.

Population Reference No. 1

Individuals undergoing gynecologic surgery

Population Reference No. 2

Gynecologic malignancies

Supplemental Information

N/A

Practice Guidelines and Position Statements

ACOG (American College of Obstetricians and Gynecologists): Robot-assisted surgical devices are tools for a minimally invasive approach. Appropriate training on robotic devices is necessary to ensure patient safety and appropriate use of technology. Robot-assisted cases should be selected based on the likelihood of improved outcomes compared with other surgical approaches due to the complexity of the case or patient factors, with appropriate consideration to costs. As with any procedure, informed consent should be obtained from patients before surgery with discussion of the surgeon’s experience with robot-assisted surgery, indications for surgery, and potential risks and benefits associated with the robot-assisted technique compared with alternative surgical approaches and other therapeutic options. Ongoing quality assurance is essential to ensure appropriate use of the technology and, most importantly, patient safety. Well-designed studies are needed to determine which patients are most likely to benefit from robot-assisted surgery over other minimally invasive approaches.

ASRM : (American Society of Reproductive Medicine )The quest for improved patient outcomes has been a driving force for adoption of novel surgical innovations across surgical subspecialties. Gynecologic oncology is one such surgical discipline in which minimally invasive surgery has had a robust and evolving role in defining standards of care. Robotic-assisted surgery has developed during the past two decades as a more technologically advanced form of minimally invasive surgery in an effort to mitigate the limitations of conventional laparoscopy and improved patient outcomes. Robotically assisted technology offers potential advantages that include improved three-dimensional stereoscopic vision, wristed instruments that improve surgeon dexterity, and tremor canceling software that improves surgical precision. These technological advances may allow the gynecologic oncology surgeon to perform increasingly radical oncologic surgeries in complex patients. However, the platform is not without limitations, including high cost, lack of haptic feedback, and the requirement for additional training to achieve competence. This review describes the role of robotic-assisted surgery in the management of endometrial, cervical, and ovarian cancer, with an emphasis on comparison with laparotomy and conventional laparoscopy. The literature on novel robotic innovations, special patient populations, cost effectiveness, and fellowship training is also appraised critically in this regard.

The rapid adoption of robotic technology for gynecologic surgery is not supported by high-quality patient outcomes, safety, or cost data. A wide array of literature exists, but most studies are retrospective, observational, and noncomparative. Four RCTs compared robot-assisted surgery for benign gynecologic disease with laparoscopy, and none showed any benefit from using the robotic approach.

Medicare National Coverage

N/A

References

1. Statement on Robotic Surgery by ACOG President James T. Breeden, MD.

2. Robot-assisted surgery. ACOG Technology Assesment in Obstetrics and Gynecology No. 6. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009; 114: 1153-5

3. Falcone T. Goldberg JM. Robotics in gynecology. Surg Clin North Am 2003; 83:1483-9, xii.

4. Visco AG, Advincula AP. Robotic gynecologic surgery. Obstet Gynecol 2008; 112:1369-84.

5. Young Tae Kim, Sang Wun Kim, and Yong Wook Jung, Yonsei Med J. 2008 December 31; 49(6): 886-890. Published online 2008 December 31. doi: 10.3349/ymj.2008.49.6886

6. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: Robotic-assisted laparoscopic surgery in benign gynecology. J Minim Invasive Gynecol 2013; 20:2.

7. Jin LX, Ibrahim AM, Newman NA, Makarov DV, Pronovost PJ, Makary MA. Robotic surgery claims on United States hospital websites. J Healthc Qual 2011;33:48–52. [PubMed] [Full Text] ⇦

8. Visco AG, Advincula AP. Robotic gynecologic surgery. Obstet Gynecol 2008;112:1369–84. [PubMed] [Obstetrics & Gynecology] ⇦

9. Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol 2012;120:604–11. [PubMed] [Obstetrics & Gynecology] ⇦

10. Paraiso MF, Jelovsek JE, Frick A, Chen CC, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol 2011;118:1005–13. [PubMed] [Obstetrics & Gynecology] ⇦

11. Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, et al. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol 2013;208:368.e1–368.e7. [PubMed] [Full Text] ⇦

12. Anger JT, Mueller ER, Tarnay C, Smith B, Stroupe K, Rosenman A, et al. Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled  trial [published erratum appears in Obstet Gynecol 2014;124:165]. Obstet Gynecol 2014;123:5–12. [PubMed] [Obstetrics & Gynecology

13. Robotic Surgery in Gynecology, Committee on Gynecologic Practice Society of Gynecologic Surgeons, Comittee Opinion no. 628, March 2015 (Reafirmed 2017), The American College of Obstrtricians an Gynecologists. Obstet Gynecol:

14. Robot-Assisted Surgery for Noncancerous Gynecologic Conditions; ACOG Committee Opinion CO: Number 810;September 2020 11

15. Robotic-assisted surgery in gynecologic oncology Abdulrahman K. Sinno, M.D. Amanda N. Fader, M.D. DOI:https://doi.org/10.1016/j.fertnstert.2014.08.020 ASRM American Society of Reproductive Medicine https://doi.org/10.1016/j.fertnstert.2014.08.020

Codes

Appplicable Modifiers

N/A

Policy History