Latest Review Date: May 2024

Category:  Surgery                                                              

POLICY:

Computer-assisted surgical navigation when used as an adjunct to orthopedic procedures, including but not limited to the pelvis and appendicular skeleton is considered investigational. 

DESCRIPTION OF PROCEDURE OR SERVICE:

Computer-assisted navigation (CAN) in orthopedic procedures describes the use of computer-enabled tracking systems to facilitate alignment in a variety of surgical procedures, including fixation of fractures, ligament reconstruction, osteotomy, preparation of the bone for joint arthroplasty, and verification of the intended implant placement.

Computer-Assisted Navigation

The goal of computer-assisted navigation is to increase surgical accuracy and reduce the chance of malposition. For total knee arthroplasty (TKA), malalignment is commonly defined as variation of greater than three degrees from the targeted position.  Proper implant alignment is believed to be an important factor for minimizing long-term wear, risk of osteolysis, and loosening of the prosthesis. 

In addition to reducing the risk of substantial malalignment, computer navigation may improve soft tissue balance and patellar tracking.  Computer-assisted navigation is also being investigated for operations with limited visibility such as placement of the acetabular cup in total hip arthroplasty (THA), and minimally invasive orthopedic procedures.  Other potential uses of CAN for surgical procedures of the appendicular skeleton include screw placement for fixation of femoral neck fractures, high tibial osteotomy, and tunnel alignment during reconstruction of the anterior cruciate ligament (ACL).

Computer-assisted navigation devices may be image-based or non-image based. Image-based devices use preoperative CT scans and operative fluoroscopy to direct implant positioning. Newer non-image based devices use information obtained in the operating room, typically with infrared probes. For TKA, specific anatomic reference points are made by fixing signaling transducers with pins into the femur and tibia. Signal emitting cameras (e.g., infrared) detect the reflected signals and transmit the data to a dedicated computer. During the surgical procedure, multiple surface points are taken from the distal femoral surfaces, tibial plateaus, and medial and lateral epicondyles. The femoral head center is typically calculated by kinematic methods that involve movement of the thigh through a series of circular arcs, with the computer producing a three-dimensional model that includes the mechanical, transepicondylar, and tibial rotational axes. CAN systems direct the positioning of the cutting blocks and placement of the prosthetic implants based on the digitized surface points and model of the bones in space. The accuracy of each step of the operation (cutting block placement, saw cut accuracy, seating of the implants) can be verified, thereby allowing adjustments to be made during surgery.

Navigation involves three steps described below: data acquisition, registration, and tracking. 

• Data Acquisition
  • Data can be acquired in three different ways: fluoroscopically, CT/MRI-guided, or imageless systems.  This data is then used for registration and tracking. 
• Registration
  • Registration refers to the ability of relating images (i.e., x-rays, CT, MRI, or patients’ 3-D anatomy) to the anatomical position in the surgical field. Registration techniques may require the placement of pins or “fiduciary markers” in the target bone. A surface-matching technique can be used in which the shapes of the bone surface model generated from preoperative images are matched to surface data points collected during surgery.
• Tracking
  • Tracking refers to the sensors and measurement devices that provide feedback during surgery regarding the orientation and relative position of tools to bone anatomy. For example, optical or electromagnetic trackers can be attached to regular surgical tools, which can then provide real time information on the position and orientation of the tools’ alignment with respect to the bony anatomy of interest.

The VERASENSE™ (OrthoSensor™) is a single-use device that replaces the standard plastic tibial trial spacer used in TKA. The device contains microprocessor sensors that quantify load and contact position of the femur on the tibia after resections have been made. The wireless sensors send the data to a graphic user interface that depicts the load. The device is intended to provide quantitative data on the alignment of the implant and on soft tissue balancing in place of intraoperative “feel.”

iAssist™ (Zimmer Biomet) is an accelerometer-based alignment system with the user interface built into disposable electronic pods that attach onto the femoral and tibial alignment and resection guides. For the tibia, the alignment guide is fixed between the tibial spines and a claw on the malleoli. The relationship between the electronic pod of the digitizer and the bone reference is registered by moving the limb into abduction, adduction, and neutral position. Once the information has been registered, the digitizer is removed and the registration data are transferred to the electronic pod on the cutting guide. The cutting guide can be adjusted for varus/valgus alignment and tibial slope. A similar process is used for the femur. The pods use wireless exchange of data and display the alignment information to the surgeon within the surgical field. A computer controller must also be present in the operating room.

KEY POINTS:

The policy has been updated regularly using the MEDLINE database. The most recent literature update was performed through February 13, 2024.

Summary of Evidence

For individuals who are undergoing orthopedic surgery for trauma or fracture and receive computer-assisted navigation, the evidence includes two retrospective studies, reviews, and in vitro studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. Functional outcomes were not included in the first clinical trial, although it did note fewer complications with computer-assisted navigation versus conventional methods. The second trial found no differences between groups in rates of fracture reduction or screw positions.  The evidence is insufficient to determine the effects of the technology on net health outcomes.

For individuals who are undergoing ligament reconstruction and receive computer-assisted navigation, the evidence includes a systematic review of 5 randomized controlled trials (RCTs) of computer-assisted navigation versus conventional surgery for anterior and posterior cruciate ligament. Relevant outcomes are symptoms, morbid events, and functional outcomes. Trial results showed no consistent improvement of tunnel placement with computer-assisted navigation, and no trials looked at functional outcomes or need for revision surgery with computer-assisted navigation. The evidence is insufficient to determine the effects of the technology on net health outcomes.

For individuals who are undergoing hip arthroplasty and periacetabular osteotomy and receive computer-assisted navigation, the evidence includes systematic reviews of older RCTs and comparison studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. Evidence on the relative benefits of computer-assisted navigation with conventional or minimally invasive total hip arthroscopy is inconsistent, and more recent RCTs are lacking. The evidence is insufficient to determine the effects of the technology on net health outcomes.

For individuals who are undergoing total knee arthroscopy (TKA)  and receive computer-assisted navigation, the evidence includes RCTs, systematic reviews of RCTs, and comparative studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. The main difference found between total knee arthroscopy with computer-assisted navigation and TKA without computer-assisted navigation is increased surgical time with computer-assisted navigation. Few differences in clinical and functional outcomes were seen at up to 12 years postprocedure. The evidence is insufficient to determine the effects of the technology on net health outcomes.

For individuals who are undergoing spine surgery and receive computer-assisted navigation, the evidence includes RCTs, comparative observational studies, and systematic reviews of those observational studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. Computer-assisted navigation for pedicle screw insertion was consistently associated with lower rates of screw perforation relative to other screw insertion methods, but evidence on clinical outcomes such as revision rate is inconsistent or lacking, including long-term outcome follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Academy of Orthopedic Surgeons

The American Academy of Orthopedic Surgeons updated guidelines in 2022 on surgical management of osteoarthritis of the knee. Related to computer-assisted surgical navigation, the guidelines state there is no difference in outcomes, function, or pain between computer-navigation and conventional techniques for total knee arthroplasty (strength of evidence: strong; strength of recommendation: moderate), and make no specific recommendation related to its use. The guidelines note that the advantages of surgical navigation remain unclear.

U.S. PREVENTATIVE SERVICE TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Computer-assisted navigation (CAN), total hip arthroplasty (THA), total knee arthroplasty (TKA), anterior cruciate ligament (ACL), computer-assisted minimally invasive total knee arthroplasty, periacetabular osteotomy, surgical-navigation system, VERASENSE™ Knee System, iASSIST™ Knee, NuVasive Pulse System, NuVasive Next Generation NVM5 System, JointPoint, Exactech GPS, Verasense Knee System, IAssist Knee System, CTC TCAT®-TPLAN® Surgical System, Digimatch orthodoc Robodoc Encore Surgical System.

APPROVED BY GOVERNING BODIES:

Because computer-assisted navigation is a surgical navigation system in which the surgeon is only acting on the information that is provided by the navigation system, surgical navigation systems generally are subject only to 510(k) clearance from FDA. As such, the FDA does not require data documenting the intermediate or final health outcomes associated with computer-assisted surgery.  (In contrast, robotic procedures, in which the actual surgery is robotically performed, are subject to the more rigorous requirement of the PMA process.)

A variety of surgical navigation procedures have been cleared for marketing by FDA through the 510(k) process with broad labeled indications. For example, The OEC FluoroTrak 9800 plus is marketed for locating anatomic structures anywhere on the human body.

Several navigation systems have received FDA clearance specifically for total knee arthroplasty. These include the PiGalileo™ Computer-Assisted Orthopedic Surgery System, PLUS Orthopedics; OrthoPilot® Navigation System, Braun; Navitrack® Navigation System, and ORTHO soft. FDA-cleared indications for the PiGalileo™ system are representative. This system “is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc). Examples of some surgical procedures include but are not limited to:

• Total knee replacement supporting both bone referencing and ligament balancing techniques
• Minimally invasive total knee replacement”

In 2013, the VERASENSE™ Knee System from OrthoSensor™ and the iAssist™ Knee from Zimmer Biomet received 510(k) clearance from FDA.

Table 1. Computer-Assisted Navigation Devices Cleared by the U.S. Food and Drug Administration

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 benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT codes:     

PREVIOUS CODING:

REFERENCES:

1. American Academy of Orthopaedic Surgeons. Surgical management of osteoarthritis of the knee. 2022. https://www.orthoguidelines.org/topic?id=1041.
2. Antonios JK, Kang HP, Robertson D, et al. Population-based Survivorship of Computer-navigated Versus Conventional TotalKnee Arthroplasty. J Am Acad Orthop Surg. Oct 15 2020; 28(20): 857-864.
3. Arand M, Hartwig E, Kinzl L, et al. Spinal navigation in tumor surgery of the thoracic spine: first clinical results. Clin Orthop Relat Res. Jun 2002; (399): 211-8.
4. Beyer F, Pape A, Lutzner C, et al. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. Aug 18 2021; 22(1): 707.
5. Blakeney WG, Khan RJ, Palmer JL. Functional outcomes following total knee arthroplasty: a randomised trial comparing computer-assisted surgery with conventional techniques. Knee 2014; 21(2):364-368.
6. Cip J, Obwegeser F, Benesch T, et al. Twelve-Year Follow-Up of Navigated Computer-Assisted Versus Conventional Total Knee Arthroplasty: A Prospective Randomized Comparative Trial. J Arthroplasty. 2018 May;33(5):1404-1411.
7. Cip J, Widemschek M, Luegmair M, et al. Conventional versus computer-assisted technique for total knee arthroplasty: a minimum of 5-year follow-up of 200 patients in a prospective randomized comparative trial. J Arthroplasty. Sep 2014; 29(9):1795-1802.
8. Dyrhovden GS, Fenstad AM, Furnes O, et al. Survivorship and relative risk of revision in computer-navigated versus conventional total knee replacement at 8-year follow-up. Acta Orthop. Dec 2016l 87(6):592-599.
9. Eggerding V, Reijman M, Scholten RJ, et al. Computer-assisted surgery for knee ligament reconstruction. Cochrane Database Syst Rev. 2014; 8:CD007601.
10. Farhan-Alanie OM, Altell T, O'Donnell S, et al. No advantage with navigated versus conventional mechanically aligned total knee arthroplasty-10 year results of a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. Mar 2023; 31(3): 751-759.
11. Gelalis ID, Paschos NK, Pakos EE, et al. Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques. Eur Spine J. Feb 2012; 21(2): 247-55.
12. Hart R, Krejzla J, Svab P et al. Outcomes after conventional versus computer-navigated anterior cruciate ligament reconstruction. Arthroscopy 2008; 24(5):569-578.
13. Hoffart HE, Langenstein E, Vasak N. A prospective study comparing the functional outcome of computer-assisted and conventional total knee replacement. J Bone Joint Surg Br 2012; 94(2):194-199.
14. Hofstetter R, et al. Computer-assisted fluoroscopy-based reduction of femoral fractures and antetorsion. Computer Aided Surgery, January 2000; 5(5): 311-325.
15. Hoppe S, Mainzer JD, Frauchiger L et al. More accurate component alignment in navigated total knee arthroplasty has no clinical benefit at 5-year follow-up. Acta Orthop 2012; 83(6):629-633.
16. Hsieh PH, et al. Image-guided periacetabular osteotomy: computer-assisted navigation compared with the conventional technique: A randomized study of 36 patients followed for 2 years. Acta Orthopedics, August 2006; 77(4): 591-597.
17. Hsu RW, Hsu WH, Shen WJ, et al. Comparison of computer-assisted navigation and conventional instrumentation for bilateraltotal knee arthroplasty: The outcomes at mid-term follow-up. Medicine (Baltimore). Nov 2019; 98(47): e18083.
18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
19. Kim YH, Park JW, Kim JS. Computer-navigated versus conventional total knee arthroplasty a prospective randomized trial. J Bone Joint Surg Am 2012; 94(22):2017-2024.
20. Kunze KN, Bovonratwet P, Polce EM, et al. Comparison of Surgical Time, Short-term Adverse Events, and Implant Placement Accuracy Between Manual, Robotic-assisted, and Computer-navigated Total Hip Arthroplasty: A Network Meta-analysis of Randomized Controlled Trials. J Am Acad Orthop Surg Glob Res Rev. Apr 01 2022; 6(4).
21. Laine T, Lund T, Ylikoski M, et al. Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients. Eur Spine J. Jun 2000; 9(3): 235-40.
22. Liebergall M, et al. Computerized navigation for the internal fixation of femoral neck fractures. American Journal Bone Joint Surgery. August 2006; 88(8): 1748-1754.
23. Lutzner J, Dexel J, Kirschner S. No difference between computer-assisted and conventional total knee arthroplasty: five-year results of a prospective randomised study. Knee Surg Sports Traumatol Arthrosc 2013; 21(10):2241-2247.
24. Manzotti A, Cerveri P, De Momi E et al. Does computer-assisted surgery benefit leg length restoration in total hip replacement? Navigation versus conventional freehand. Int Orthop 2011; 35(1):19-24.
25. Mauch F, Apic G, Becker U and Bauer G. Differences in the placement of the tibial tunnel during reconstruction of the anterior cruciate ligament with and without computer-assisted navigation. Am J Sports Med, November 2007; 35(11): 1824-1832.
26. Meuffels DE, Reijman M, Verhaar JA. Computer-assisted surgery is not more accurate or precise than conventional arthroscopic ACL reconstruction: a prospective randomized clinical trial. J Bone Joint Surg Am 2012; 94(17):1538-1545.
27. Plaweski S, et al. Anterior cruciate ligament reconstruction using navigation: A comparative study on 60 patients.  American Journal Sports Medicine, April 2006; 34(4): 542-552.
28. Rajasekaran S, Vidyadhara S, Ramesh P, et al. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). Jan 15 2007; 32(2): E56-64.
29. Rebal BA, Babatunde OM, Lee JH et al. Imageless computer navigation in total knee arthroplasty provides superior short term functional outcomes: a meta-analysis. J Arthroplasty 2014; 29(5):938-944.
30. Reininga IH, Stevens M, Wagenmakers R et al. Comparison of gait in patients following a computer-navigated minimally invasive anterior approach and a conventional posterolateral approach for total hip arthroplasty: a randomized controlled trial. J Orthop Res 2013; 31(2):288-294.
31. Schep NW, et al. Computer-assisted orthopedic and trauma surgery. State of the art and future perspectives. Injury, May 2003; 34(4): 299-306.
32. Shin BJ, James AR, Njoku IU, et al. Pedicle screw navigation: a systematic review and meta-analysis of perforation risk for computer-navigated versus freehand insertion. J Neurosurg Spine. Aug 2012; 17(2): 113-22.
33. Slomczykowski, MA, et al. Novel computer-assisted fluoroscopy system for intraoperative guidance: Feasibility study for distal locking of femoral nails. Journal of Orthopaedic Trauma, February 2001; 15(2): 122-131.
34. Smitherman SM, Tatsui CE, Rao G, et al. Image-guided multilevel vertebral osteotomies for en bloc resection of giant cell tumor of the thoracic spine: case report and description of operative technique. Eur Spine J. Jun 2010; 19(6): 1021-8.
35. Song EK, Agrawal PR, Kim SK, et al. A randomized controlled clinical and radiological trial about outcomes of navigation-assisted TKA compared to conventional TKA: long-term follow-up. Knee Surg Sports Traumatol Arthrosc. Nov 2016; 24(11):3381-3386.
36. Staartjes VE, Klukowska AM, Schroder ML. Pedicle Screw Revision in Robot-Guided, Navigated, and Freehand Thoracolumbar Instrumentation: A Systematic Review and Meta-Analysis. World Neurosurg. Aug 2018; 116: 433-443.e8.
37. Stiehler M, Goronzy J, Hartmann A et al. The First SICOT Oral Presentation Award 2011: imageless computer-assisted femoral component positioning in hip resurfacing: a prospective randomised trial. Int Orthop 2013; 37(4):569-581.
38. Swartman B, Pelzer J, Beisemann N, et al. Fracture reduction and screw position after 3D-navigated and conventional fluoroscopy-assisted percutaneous management of acetabular fractures: a retrospective comparative study. Arch Orthop Trauma Surg. Apr 2021; 141(4): 593-602.
39. Ulrich SD, Bonutti PM, Seyler TM, et al. Outcomes-based evaluations supporting computer-assisted surgery and minimally invasive surgery for total hip arthroplasty. Expert Rev Med Devices, November 2007; 4(6): 873-883.
40. Van Royen BJ, Baayen JC, Pijpers R, et al. Osteoid osteoma of the spine: a novel technique using combined computer-assisted and gamma probe-guided high-speed intralesional drill excision. Spine (Phila Pa 1976). Feb 01 2005; 30(3): 369-73.
41. Villard J, Ryang YM, Demetriades AK, et al. Radiation exposure to the surgeon and the patient during posterior lumbar spinal instrumentation: a prospective randomized comparison of navigated versus non-navigated freehand techniques. Spine (Phila Pa 1976). Jun 01 2014; 39(13): 1004-9.
42. Webb ML, Hutchison CE, Sloan M, et al. Reduced postoperative morbidity in computer-navigated total knee arthroplasty: A retrospective comparison of 225,123 cases. Knee. Jun 2021; 30: 148-156. 
43. Xie C, Liu K, Xiao L et al. Clinical outcomes after computer-assisted versus conventional total knee arthroplasty. Orthopedics 2012; 35(5):e647-653.
44. Yaffe M, Chan P, Goyal N et al. Computer-assisted versus manual TKA: no difference in clinical or functional outcomes at 5-year follow-up. Orthopedics 2013; 36(5):e627-632.
45. Yavari E, Moosa S, Cohen D, et al. Technology-assisted anterior cruciate ligament reconstruction improves tunnel placement but leads to no change in clinical outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. Oct 2023; 31(10): 4299-4311.

POLICY HISTORY:

Medical Policy Group, June 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, June 2007 (1)

Medical Policy Group, February 2008

Medical Policy Group, February 2010 (1): Updated Key Points and References

Medical Policy Group, May 2011 (1): Updated Key Points and References

Medical Policy Group, July 2012 (4): Updated Key Points and References. Policy statement remained unchanged.

Medical Policy Panel, July 2013

Medical Policy Group, July 2013 (3):  Updated Key Points and References; no change in policy statement

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (2): 2015 Updates to Description, Key Points, Key Words, and References; no change to policy statement.

Medical Policy Group, November 2015: 2016 Annual Coding update. Added CPT code 0396T

Medical Policy Group, December 2016 (7): Clarification to Policy Statement- added “including but not limited to.” No change in policy intent.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Title, Description, Key Points & References. Clarification to Policy Statement- removed “musculoskeletal.” No change in policy intent.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7): Updates to Key Points and Approved by Governing Bodies. No new literature to add. Previous Coding section deleted. No change in Policy Statement.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (7): Updates to Description, Key Points, Key Words, and References. No change to policy statement.  Added new Key Words: NuVasive Pulse System, NuVasive Next Generation NVM5 System, JointPoint, Exactech GPS, Verasense Knee System, IAssist Knee System, CTC TCAT®-TPLAN® Surgical System, Digimatch orthodoc Robodoc Encore Surgical System.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Minor updates to Key Points. No new literature to add. No change in Policy Statement.

Medical Policy Group, October 2020 Annual Coding Update. Moved CPT 0396T from Current coding section. Created Previous Coding section to include code 0396T.

Medical Policy Panel, May 2021

Medical Policy Group, July 2021 (7): Updated Key Points, Approved by Governing Bodies and References. Removed “not medically necessary” verbiage from Policy Statement. No change in intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (7): Updates to Key Points, Benefit Application, and References. No change in Policy Statement.

Medical Policy Panel, April 2024

Medical Policy Group, May 2024 (7): Updates to Description, Key Points and References. Removed Previous Coding section, CPT 0396T was deleted, effective 12/31/2020. No change in Policy Statement.

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.