ICL Illuminates the Cost-value Equation in Orthopaedic Care
During the Instructional Course Lecture “Costing for the Clinician: How to Understand Cost in Orthopaedic Care,” moderator Brian Cunningham, MD, FAAOS, discussed the challenges of identifying the costs associated with orthopaedic care.
During the Instructional Course Lecture (ICL) titled “Costing for the Clinician: How to Understand Cost in Orthopaedic Care,” moderator Brian Cunningham, MD, FAAOS, vice chair and director of inpatient orthopaedics at Methodist Hospital in Minneapolis, Minn., led a lively discussion on the factors impacting costs associated with care of musculoskeletal conditions.
The event also featured presentations from Joseph Levy, PhD, assistant professor at Johns Hopkins Bloomberg School of Public Health; Prakash Jayakumar, MD, PhD, assistant professor in the Department of Surgery and Perioperative Care and director of clinical research and outcome measurement at the University of Texas at Austin Dell Medical School; and Karl M. Koenig, MD, MS, FAAOS, associate professor, chief of orthopaedic surgery, and executive director of the Musculoskeletal Institute at Dell Medical School.
“The challenges with cost in orthopaedic care are so rich and so complicated,” Dr. Cunningham said during his introduction. One of the challenges in the cost-value equation to care is the multitude of perspectives that come into play (i.e., payer versus patient versus clinician versus hospital). For the clinician, Dr. Cunningham noted, a major challenge is the limited education for orthopaedic surgeons regarding costs despite an interest in the business side of orthopaedic care. “More and more resident want training on these topics. They want to understand the business and the economics,” he said.
Principles and challenges of cost
Following Dr. Cunningham’s introduction, Dr. Levy tackled the question of why orthopaedic surgeons should care about cost. According to Dr. Levy, “Accurately capturing and understanding the costs and effects [of treatment] can aid in the discussion of value” from both the clinician’s perspective and the individual patient’s perspective. Cost data, despite limitations in availability and measurement, can be leveraged to inform clinical practice, aid patient-level decision making, and influence payment and policy changes.
He explained that the “price” of something in well-functioning markets is an estimate of cost. “Unfortunately, healthcare is not a super well-functioning market,” he quipped. Dr. Levy expanded by noting that, in well-functioning markets, buyers and sellers have perfect pricing information, allowing for efficiency and transparency in the shared decision-making process.
Some of the challenges associated with cost data, as detailed by Dr. Levy, include billing for services, outpatient utilization, work loss, and economic evaluation in the United States. Billing data is often lacking, and the cost-to-charge ratios are imprecise. The generalizability of outpatient claims data to derive cost estimates is low, and claims data typically only offer information about a small subset of privately insured patients.
Time-driven, activity-based cost
Dr. Jayakumar began by emphasizing the importance of defining total costs of care, referring to the idea as “mission critical.”
“Value-based healthcare strategies are at the forefront of people’s mind,” Dr. Jayakumar said. “The aim is to refocus on patient-centered health outcomes that matter relative to the costs of achieving these outcomes.”
More commonly used cost accounting models work from the top down and are based on reimbursement, Dr. Jayakumar explained. “While relatively simple to calculate, the method can be inconsistent, and it doesn’t really support cost reduction.”
Time-driven, activity-based costing (TDABC), however, is a bottom-up approach. TDABC is based on cost of care pathways and which resources are used by patients. TDABC consists of seven steps: identifying the medical condition; defining the care-delivery chain; developing process maps; obtaining time estimates; estimating cost of resources; estimating capacities and capacity cost rates; and calculating the total cost of patient care.
“Aligning reimbursement with clinical and quality costs is essential,” he stated. “The basics principles of TDABC are not rocket science, and it can be pretty easily done in a simple, cost-effective way.”
Integrating cost data into clinical decision making
Rounding out the ICL was Dr. Koenig, who discussed the integration of cost data into clinical and patient-centered decision making. “I think the things we do in orthopaedic surgery are some of the most important things ever done in medicine,” he began, “and we have got to stay at the forefront.”
A real-world approach to cost consciousness can be executed in a few simple steps, Dr. Koenig explained. First, surgeons should ask themselves questions such as, “What are my comparative costs?” Additionally, clinicians should take into account factors such as surgical costs (e.g., OR time, types of implants used, etc.) and clinical costs (e.g., biologics, casting versus splinting, etc.). Understanding these factors will help orthopaedic surgeons establish a baseline of costs, Dr. Koenig explained.
Surgeons should also consider the exploration of costs and cost-saving strategies. He noted strategies such as being aware of available cost-saving resources, gaining access to cost data, and normalizing discussions of cost with the clinical team, OR managers, and vendors.
One of the key takeaways, according to Dr. Koenig, is that “patients come first.” Surgeons should be mindful of avoiding waste, recognizing that costs should inform utilization, eschewing the fear of outside societal perspectives, and understanding technological innovation prior to changing the focus of one’s practice.
AAOS Webinar Surveys the State of Augmented Reality
In an AAOS webinar titled “The Current State of Augmented Reality (AR) in Orthopaedics,” clinicians and representatives from the FDA and from the industry offered information and insights on the use of AR and their perspectives on the benefits and risks of the technology.
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Following an introduction from program director David Jevsevar, MD, MBA, FAAOS, chair of the AAOS Committee on Devices, Biologics, and Technology, Christopher Harner, MD, FAAOS, FAOA, an FDA clinical deputy director in the Office of Orthopedic Devices, said the October webinar—offered free to AAOS members—was intended to “increase awareness of AR technology in orthopaedic stereotaxic—sometimes referred to as 'stereotactic'—navigation systems,” which make use of a three-dimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, or radiosurgery. Among the topics to be covered were the clinical and technological challenges associated with orthopaedic AR applications, the scope of possible adverse events and reporting limitations, and the process for implementing adverse-event reporting by surgeons in a timely and accurate way.
The basics
Dr. Harner clarified the distinctions between virtual reality (VR)—“a completely artificial environment accepted as real by users”—and AR, which is “an integrated technique of image processing.” In an AR system, he explained, “Real objects and virtual (computer-generated) objects are combined in a real environment.” Furthermore, in AR, “Real and virtual objects are aligned with each other and run interactively in real-time.”
Currently, VR is not used in surgical practice, Dr. Harner noted; its main orthopaedic use is in training and education for residents, fellows, practicing surgeons, and other allied health professionals.
AR is in active use for surgical procedures (Table 1), he explained, with some 10 AR device submissions having been cleared by the FDA in the past four years. The literature now includes numerous publications on AR, although most studies are smaller clinical trials (<50 patients), and most were conducted outside the United States. Collected data are on device usage, techniques, and accuracy, but not patient-recorded outcomes, and therefore “are not truly clinical studies,” Dr. Harner said. To this point, reported complications are rare, and the most common documented consequence is increased surgical time.
Describing the technological setup for AR (Fig. 1), Dr. Harner said that obtaining an image to be projected in the OR for the end user, the surgeon, requires multiple steps. Failure at any step of the process—from radiographic imaging to visualization, whether due to hardware, software, OR inadequacies, or failure of the user—can adversely affect patient outcomes.
He noted that the Office of Orthopedic Devices has seen a marked increase in the number of stereotaxic “system” submissions over the past five years.
The challenges
Following Dr. Harner was another FDA representative, CDR Michel Janda, MS, of the agency’s Stereotaxic, Bone Growth Stimulators, and Fracture Fixation Devices Team in the Office of Orthopedic Devices. Mr. Janda addressed the “Regulatory Paradigm and Challenges.”
He explained that the product code “OLO” was established to cover stereotaxic guidance during orthopaedic surgery procedures for joints and spine; this code is the current regulatory basis for which limited applications of AR technology are introduced, including robotics and AR systems. Stereotaxic navigation systems, he noted, may use various technologies, including physical, optical, or inertial patient and instrument tracking. From these technologies arrived robotically assisted surgical systems, including robotic arms that connect passively or actively to directly affect the patient.
The FDA, Mr. Janda said, has identified technical and clinical challenges attendant to AR. Among these are technical characteristics, including:
non-rigid patient tracking
lack of continuous patient tracking
completely immersive VR
excessive obstruction of the user’s field of view
soft-tissue navigation/robotics
AR technology expands on these systems, with the simplest iteration using a head-mounted display to replicate the same information as traditionally shown to the user via a TV monitor. Some technical characteristics are considered outside of the governing regulation—including luminance, contrast, temporal and spatial resolution, the field of view, dynamic range, refresh rate, latency, transmission, and optical aberrations such as distortion—as well as acceptance criteria for technical characterization parameters. The limited number of current AR systems and the limited literature on the technology contribute to the challenge. Gauging the accuracy of the displayed information (i.e., the heads-up display) is another aspect of the evaluation process, with the FDA requesting the same validation as it would for a stereotaxic system.
For a system intended to provide an anchored 3D model corresponding to the patient’s anatomy, developers are asked to provide additional quantitative validation of the model’s spatial accuracy.
“Developing this validation protocol for anchored 3D models is challenging, as these virtual models are intended to be observed and interpreted from a user’s perspective,” Mr. Janda said. “Therefore, objective validation requires observation from an independent exterior method that has the same perspective as the user.”
Emerging technical challenges and considerations that the FDA is observing, Mr. Janda said, include user interaction issues with control mechanisms, such as the technician using a mouse on a separate station, foot pedals, hand gestures, vocal commands, and head movements (dwell pointer). “For example, systems that use a commercial off-the-shelf head-mounted display with hand gestures as a control interface may experience difficulties when used in a medical environment,” he said. “This [difficulty] may be due to the required learning curve and also to use of the interface in this environment” versus a commercial setting.
The FDA is also interested in learning about possible negative effects on a user (patient or surgeon), including eye and neck strain, surgery time, and potentially compromised sterility and biocompatibility.
In general, Mr. Janda noted, novel technologies are associated with a training and learning curve, and the FDA expects challenges to arise in this regard.
In the category of higher-level testing, for stereotaxic systems, the FDA reviews quantitative system-level validation testing which compares the accuracy of a planned implant placement and the final implant placement as executed by the system in a cadaver model; this requirement is also applied to AR systems. Additionally, the agency evaluates human factors and usability testing, including adjunctive use versus integral use of the system, as well as “the ability to discontinue use in a convenient way,” Mr. Janda said.
A new FDA request for approval of an AR system, he said, must be accompanied by a submission of a video or step-by-step illustration of the projected imagery to demonstrate what is intended to be seen by the user. Clinical data, or a redefinition of clinically meaningful endpoints, “has not been found to be routinely necessary as of yet but maybe warranted upon future applications of the technology.”
Finally, Mr. Janda summarized the FDA’s protocol and processes for reporting adverse events. The FDA uses post-market surveillance to monitor device performance. Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems that may cause or contribute to adverse events.
“The FDA also encourages healthcare professionals, patients, caregivers, and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures,” he said. “With regard to AR technology, the agency is interested in using medical device reporting to assess real-world performance.” The FDA looks to monitor medical device reporting directly associated with AR systems, such as that detailing patient reference movement, loss of virtual image registration, and implant malalignment.
The agency is also concerned that adverse effects may be underreported; these may include user fatigue or distraction, surgical delay, and cognitive overload. These occurrences “may not be reported to us because they may not be obviously associated with an adverse effect,” Mr. Janda said. “We encourage those attending this webinar to use the FDA’s online voluntary reporting program to report real-world experience with this technology.”
The other speakers at the webinar were Francesco Siccardi, MS; Barton Sachs, MD, MBA, FAAOS; and Laurence Coyne, PhD. The webinar is accessible to AAOS members at learn.aaos.org.