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Computer navigation in knee arthroplasty still needs reimbursement validation
Some surgeons are already married to the concept; however, insurers may have cold feet in terms of providing reimbursements.
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Applications of computer assisted navigation in orthopedics is continuing to be more widely used. It offers the potential to improve accuracy and reduce outlier surgical results. It gives the orthopedic surgeon real time confirmation and documentation of surgical techniques and the time needed to make adjustments or check the precision of a proposed cut. It offers the potential for smaller incisions in some procedures and has the possibility of evaluating intraoperative kinematics. The data may give assistance with rotation considerations, soft tissue balancing, bi-planar assessments and the potential to obtain results closer to the normal knee anatomy.
This promising technology helps individualize patient anatomy to a specific procedure and may potentiate less invasive procedures. It would seem that most surgeons would want to embrace this technology in their total knee replacement surgery. However, that has not happened. Why?
Currently there are two considerations that have slowed computerized navigation’s wider acceptance: The additional time it takes to do the procedure and the current financial costs to purchase and utilize this technology. Hence, reimbursement has become a limiting factor.
In this roundtable, I have asked three experts about their current utilization of this technology for knee replacement surgery and what their experience has been with gaining reimbursement for its use.
Douglas W. Jackson, MD
Chief Medical Editor
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Douglas W. Jackson, MD
William J. Hozack, MD
William J. Robb III, MD
William H. Warden III, MD
Blaine Warkentine, MDDouglas W. Jackson, MD: What is the current role of the evolving technology of CAOS (computer-assisted orthopedic surgery) navigation in primary total knee replacement (TKR)?
William J. Hozack, MD: CAOS has the unique ability to teach surgeons about the quality of their surgical technique.
The accuracy and reproducibility of the operation is improved for the surgeon as they adopt CAOS technology.
In the beginning, it is a daunting task to adapt CAOS to an already smooth and efficient operation. Furthermore, CAOS is disruptive in nature because it provides surgeons with information not previously available and which may be somewhat unsettling.
I feel that CAOS technology is more likely to be adopted by the younger generation who will be getting their training as CAOS technology develops.
The technological state of CAOS for knee replacement is such that there are actually fewer steps and less instrumentation is required to complete the surgical procedure. Furthermore, there is no increase in the number of personnel needed for the surgical procedure.
William J. Robb III, MD: CAOS appears to add reliability for several important aspects of TKR surgery. Over the past 5 years, nearly 50 peer reviewed articles in the worldwide orthopedic literature demonstrate added reliability for limb alignment, component alignment and component sizing.
In a recently completed retrospective study in my own practice, CAOS also appears to additionally normalize some of the medical aspects of surgical recovery. Post operative CAOS/TKR patients demonstrated trends: less fever (P=1.1), lower white counts (P=.04), less confusion, fewer allogeneic transfusions (P=.30), and fewer and less serious cardiac arrhythmias (P=.06).
These CAOS/TKR patients also walked further sooner (50 feet further prior to hospital discharge (P=.007) and at 8 weeks required fewer walking aides (58% required no walking aids at 6 weeks, P=.01).
Jackson: How do you currently use navigation in your clinical practice?
Hozack: I use computer assisted technology for 100% of my knee replacement surgeries.
Robb: I currently use CAOS for all patients undergoing primary TKR. I have no absolute contraindications for CAOS.
Relative contraindications may include: patients with significant osteoporosis, because of the added risk of perioperative fracture from stress risers associated with reference array pin sites; and patients with significant hip or ankle deformity due to the inability to readily establish hip and/or ankle center.
Jackson: What is your feeling and what has your experience been like in obtaining additional reimbursement for using CAOS in primary TKR?
Hozack: I am using CAOS to improve the quality of life for my patient. I believe that I am doing a better job using CAOS and that my patients benefit from this technology. Reimbursements are not likely to change in the short term.
However, as data are revealed about quality outcomes, CAOS techniques may be adopted as the standard of care. This may be reflected in a differential in reimbursement.
Robb: I currently submit emerging technology (T) codes for all cases in which I use CAOS for TKR.
T codes assist the American Medical Association (AMA) and the American Academy of Orthopaedic Surgeons (AAOS) tracking technology introduction and help determine when work values should be established to recommend formal CPT code adoption by the RUC.
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Seven commercial payers in my area reimburse for CAOS. Charges and reimbursements have been modest, but generally reflect the added surgical time and complexity of CAOS used for TKR. My hospital has not charged or been additionally reimbursed for CAOS.
Jackson: Dr. Warkentine, at this point in time and within the evolving field of computer-assisted surgery (CAS), what is the range of costs to an institution to have the hardware and software available in order to perform navigation in primary TRK?
Blaine Warkentine, MD: Acquiring CAS for TKR can be affordable for the hospital. The per-case cost can be cheaper than a saw blade ($200) if it is used regularly and depreciated over the life of the system. In other words, the cost of the system will be much more expensive if it is underutilized.
It is important that the hospital looks at this as a long-term investment and attempts to attain consensus as to which system the interested surgeons can be dedicated towards using. The cost can vary from appearing to be free from an implant company willing to provide the system in exchange for the use of their implants, to an outright capital purchase of just over $100,000.
Other things to consider in terms of price are the per-case cost of disposables to use with the system. These can cost as low as $100 per case to as much as $800 for products using electromagnetic tracking.
Lastly, many of these systems need upgrades to stay abreast in this quickly evolving field. Often, it can make financial sense to include a service contract with the purchase.
There has been some talk that the cost will continue to come down. I would argue that this will not likely occur as we would all like.
You can look at the neurosurgical and ENT navigation markets, where navigation has been considered standard of care for some years now, as a benchmark.
The prices of those systems have remained relatively constant since 1995. This has occurred for several reasons:
- The infrared tracking technology that is similar across all platforms costs nearly $30,000 alone;
- The R&D efforts of some of these companies can be twice that of their biomedical counterparts; and
- There is a need for direct sales and expensive education including trial use through an extensive clinical evaluation. This will continue to put pressure on keeping the price where it is today.
Many of the companies selling CAS use the sale of the systems as an adjunct to the sale of their implants.
They realize that the long-term profitability will not be derived from selling the system, but more from establishing the long-term relationship to implant sales within the hospital. The companies that have remained exclusively oriented towards orthopedic CAS do not subsidize the costs of a navigation system with recurring implant revenue, but rather partner with the implant companies to provide a solution for the hospital regarding the surgeons’ preferred implant choice.
This inevitably leads to some extensive discussions between surgeons, implant representatives, and hospital administration regarding which system to buy and why.
Jackson: What are the codes surgeons can use to bill for the additional time and training it takes to perform computer assisted TKR?
Warkentine: The AMA originally created the surgical navigation CPT code for brain surgery; in 2000 they amended the code to include extracranial and spinal procedures. In 2004 they created CPT III codes for certain applications.
The use of orthopedic CAS for total joint replacement is not experimental, but merely the application of this technology to a new area of the body.
Other codes:
- Code 0054T is for use with fluoroscopic image guidance;
- Code 0055T is for use with CT/MRI image guidance; and
- Code 0056T is for use with “image free” guidance (most TKR applications).
Possible charges would be $710-$1,620 for physician reimbursement, which is highly dependent on insurance carrier at this time, but several surgeons have been successful in filing an appeal of denied claims even to Medicare.
The CPT committees of the AAOS and the AMA are currently reviewing these codes. If accepted this year, they will then go to the RUC to be assigned work values with more global reimbursement possible for 2008.
Jackson: Dr. Warkentine, are there ways in which the institution can rationalize their investment of CAS for TKR as a business decision?
Warkentine: Hospitals must take a good look at the real cost of this technology and how it can play a role in their operative care. They should also realize that the time will come when they will likely need to make this financial commitment to retain quality surgeons as well as to remain competitive in their individual markets.
However, the time to adopt will most likely be driven by surgeons championing the adoption within the hospitals.
The need for the surgeon to use the equipment to improve outcomes will be the driving force behind the eventual purchase of the navigation system.
The supporting data is starting to appear for its clinical utility as well as for its cost-effectiveness.
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An example is a recent publication in International Journal of Technology Assessment in Health Care in which Dong and Buxton used a Markov model with probabilistic sensitivity analysis of computer-assisted TKR.
They found when comparing conventional TKR to computer-assisted TKR, the CAS is a cost-saving technology in the long term and may offer small additional Quality Adjusted Life Years. Though, more long-term studies are certainly needed. It remains important for hospitals to concentrate their efforts on utilization to maximize their investment with the navigation units.
There is growing interest in applications for surface arthroplasty, unicondylar knees, ACL reconstruction, trauma, hip arthroscopy, shoulder reconstruction and osteotomies.
Much of this development is occurring with the companies solely focused on navigation as a solution for the surgeon and not focused on implant revenue.
The hospital should also be well aware that consensus with other departments such as neurosurgery, otolaryngology, and spine, can potentially bring the per-case cost down through higher utilization.
Jackson: Dr. Warden, what has been your experience with insurance companies and how they justify denying reimbursement for computer assisted navigation in TKR surgery?
William H. Warden III, MD: I recently reviewed the Blue Cross Medical Policy Statement on computer aided navigation for total knee arthroplasty. As expected, it does not support reimbursement for navigation as it is considered “investigational/not medically necessary.”
However, upon reading the document, I was quite surprised at the poor quality of the research the authors of the statement had done to support their position. I feel that two of the three references that are at the heart of the position are misquoted or misrepresented.
Jackson: What are the areas in these articles do you feel were misquoted?
Warden: According to the position statement: “Regarding TKA, one randomized trial was identified. A total of 25 patients were randomized to receive computer assisted TKA or 25 to conventional TKA.
The principle outcome of the procedure was the achievement of target alignment of the prosthesis. There was no significant difference in outcomes between the two groups; both met the target orientation Hofstetter (2000).”
The Hofstetter reference is actually titled “Computer-assisted fluoroscopy-based reduction of femoral fractures and anteversion correction.” It has nothing to do with TKA.
Another erroneous statement was as follows: “Decking and colleagues (2005) conducted a randomized, controlled trial comparing alignment after computer navigated TKA … Clinical and radiological evaluations were conducted preoperatively and 3 months postoperatively. The differences between the group that had a manually implanted prosthesis compared with the group who had a computer navigated procedure were not significant.”
That conclusion is not supported by the referenced article. In the actual article, Decking and colleagues concluded “ … the mechanical alignment of the leg reached the desired straight axis in more cases with the computer-navigated implantation. This difference was statistically significant.”
They then go on to say, “The femoral and tibial mechanical anteroposterior axis and the femoral and tibial sagittal tilt (slope) measured on sagittal X-rays were not significantly improved in this patient group”
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The third reference appears to be correctly quoted: “Jenny and Boeri compared the outcomes of 30 patients undergoing computer assisted TKA with 30 matched paired patients … The authors concluded that those in the computer-assisted group showed an improved quality of implantation …” This would seem to support the use of computer assisted navigation.
Jackson: Should CAS be the standard of care in TKR?
Warden: It is still difficult to make a case that CAS should be the standard of care based on long-term outcome studies.
However, it certainly seems reasonable to use CAS in a problem case where it may be difficult for the surgeon to assess the overall limb alignment visually due to obesity or extra-articular deformity.
The articles that are referenced in the Blue Cross policy statement on computer-assisted surgery and navigation, which is being used to deny payment for navigated TKR, do not support the conclusions of the statement.
While there are no long-term outcomes data demonstrating the superiority of CAS surgery in primary TKR, a number of studies in the literature indicate CAS leads to better coronal plane limb alignment and/or fewer outliers than manual techniques.
For more information:
- William J. Hozack, MD, can be contacted at the Rothman Institute, 925 Chestnut St., 5th Floor, Philadelphia, PA 19107; 267-339-3622; e-mail: William.hozack@mail.tju.edu. He indicated he is a consultant to Stryker Orthopedics.
- Douglas W. Jackson, MD, can be reached at Memorial Orthopedic Surgical Group, 2760 Atlantic Ave., Long Beach, CA 90806-2755; 562-424-6666; e-mail: jacksondw@aol.com.
- William J. Robb III, MD, can be reached at Evanston Hospital, Walgreen Building, 2650 Ridge Ave., Suite 2505, Evanston, IL 60201; 847-570-2959; e-mail: wrobb@ibji.com.
- William H. Warden III, MD, can be reached at Memorial Orthopedic Surgical Group, 2760 Atlantic Ave., Long Beach, CA 90806; 562-424-6666; e-mail: drwarden@whwiii.net.
- Blaine Warkentine, MD, can be reached at 15007 S. Eagle Crest Drive, Draper, UT 84020; 610 310 8104; e-mail: orthoblaino@msn.com. He indicated that he is the ersearch and development director for BrainLAB, Inc., a computer navigation developer.
References:
- Bathis H, Perlick L, Tingart M, et al. Alignment in total knee arthroplasty. A comparison of computer-assisted surgery with the conventional technique. J Bone Joint Surg Br. 2004;86(5):682-687.
- Chin PL, Yang KY, Yeo SJ, Lo NN. Randomized control trial comparing radiographic total knee arthroplasty implant placement using computer navigation versus conventional technique. J Arthroplasty. 2005;20(5):618-626.
- Decking R, Markmann Y, Fuchs J, et al. Leg axis after computer-navigated total knee arthroplasty: a prospective randomized trial comparing computer-navigated and manual implantation. J Arthroplasty. 2005;20(3):282-288.
- Dong H, Buxton M. Early assessment of the likely cost-effectiveness of a new technology: A Markov model with probabilistic sensitivity analysis of computer-assisted total knee replacement. Int J Technol Assess Health Care. 206;22(2):191-202.
- Haaker RG, Stockheim M, Kamp M, et al. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005;433:152-159.
- Hofstetter R, Slomczykowski M, Krettek C, et al. Computer-assisted fluoroscopy-based reduction of femoral fractures and antetorsion correction. Comput Aided Surg. 2000;5(5):311-325.
- Jenny JY, Boeri C. Computer-assisted implantation of total knee prostheses: a case-control comparative study with classical instrumentation. Comput Aided Surg. 2001;6(4):217-220.
- Matziolis G, Krocker D, Weiss U, et al. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007;89(2):236-243.
- Medical Policy. Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures. Blue Cross of California Web site. Available at http://medpolicy.bluecrossca.com/policies/SURG/comp_asstd_surg_nav_ortho_proc.html. Accessed April 4, 2007.
- Perlick L, Bathis H, Tingart M, et al. Navigation in total-knee arthroplasty: CT-based implantation compared with the conventional technique. Acta Orthop Scand. 2004;75:464-470.
- Sparmann M, Wolke B, Czupalla H, et al. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003;85:830-835.