A. Seth Greenwald
It was the best of times, it was the worst of times, it was a season of progress and concern. Advances in orthopedic technology and device development will be significantly influenced by the health care reform process now enjoined by our elected Congressional legislators and the lobbying interests that attend them. The economics of “new age arthroplasty” and whether it can be afforded by the American public are of concern for medical device manufacturers, the Food and Drug Administration (FDA), the Center for Medicaid and Medicare Services (CMS), the insurance industry, and lest we forget the orthopedic surgeon and the patients they serve.
The above not withstanding advances in orthopedic product innovation continue with the goals of improved patient function and outcome. This annual September issue of ORTHOPEDICS contains a number of hip and knee arthroplasty papers presented at the 25th Annual Current Concepts in Joint Replacement (CCJR) meeting, and contributes to an appreciation of the state-of-the-art.
The Constancy of Change
The Perils of Pauline!
In March, the Department of Justice monitors left the big 5 medical device companies billions of dollars lighter for their presence, but with business practice systems in place that will have a profound impact on device development, the role of the orthopedic surgeon consultant in this process, and the corporate support of continuing medical education. The focus has now shifted to second-tier orthopedic corporations along with the increasing involvement of Congressional oversight committees and the Office of the Inspector General into individual corporate/surgeon relationships. Relationship transparency, now the order of the day, should be applied equally to the monitored as well as the monitor.
A National Insurance Action Plan
The year 2009 will stand in memory as a determined government insurance initiative takes root, both stumbling and confrontational in its creation, and hopefully it will emerge as a “living document” that covers the majority of the under- and noninsured American populous. But what costs and what cost savings will emerge and what impact will it have on the orthopedic community? If a national insurance option allows for portability, pre-existing conditions and maintenance of the doctor/patient relationship at a lower cost, the comfortable paradigm of private insurers collecting premiums and denying claims for the benefit of administrators and shareholders will be challenged. Whatever plan emerges, it must include an educational provision returning the nation’s emergency rooms to their original purpose. They should no longer be used as the first line of treatment for the uninsured, which currently accounts for 34% of patient visitations. Both private practice general practitioners and specialists must appreciate that a government insurance card will augment MasterCard and Visa.
Payers and Payees
On 31 July 2009, CMS published its 2010 DRG Orthopaedic Codes, which include a 3.3% payment increase for hip and knee reconstructive procedures. Concurrently, an unwillingness to pay for hospital-acquired surgical site infections, decubitus, and thromboembolic complications following these procedures, which are felt to be less than the expected standard of care, shifts accountability and the fiscal burden to the treating facility, suggesting a redistribution of government reimbursement.
Increasing pressures on dollar availability should also be a focus of concern to manufacturers of orthopedic devices whose annual mantra is to continue producing the latest and greatest. Using marketing claims without the benefit of outcome data to justify additional product cost will find CMS reimbursement more challenging. Beyond the burden of increased taxation to pay for a government option, hard looks at the efficiencies to be rendered by CMS may include the direct purchase of orthopedic implant systems from suppliers and their consignment to Medicare and Medicaid reimbursed facilities.
No Product Before Its Time?
Recent Congressional hearings have called into question pre-mature FDA product approvals without adequate establishment of safety and effectiveness. The impact, particularly to the 510[k] product approval process, bodes ill for assuring the continued introduction of orthopedic technologies in a reasonable time frame. Accusations of overstaffing, incompetency and internal discord have unfairly tarnished the agency.
Charged with assuring the public health of the nation, the FDA operates under statutory mandate from Congress. In contrast to perceptions, the agency is understaffed and underpaid for this mandate while its personnel in aggregate possess competencies and a selflessness of purpose in working for the government. Leaving the agency for the greener pastures of industry more than doubles their compensation while reducing their workloads. The FDA continually re-engineers itself for purposes of efficiency and review, a fact often overlooked by its critics. These hearings would do well to appreciate this calculus.
The exponential growth of orthopedic device information readily available through internet access has altered the surgeon/patient dialogue. Media reports and the claimed procedural uniqueness of hospital and surgeon websites can be misleading, giving rise to unrealistic patient demand. It is rare that the patient has read the peer-reviewed literature where outcomes and the level of evidence are described. Managing the confusion by recommending the best treatment option for his/her pathology is an increasing time challenge for the joint reconstructive surgeon. Giving the patient what he/she wants may compromise outcome where direct procedural experience should logically be the determining factor.
Advancing Orthopedic Technologies
Metal–Metal Reactivity: Have We Passed the Epoch?
The world of metal–metal articulations has gained prominence for both total and surface replacement hip designs. Large femoral heads are seen as the preferred solution for the active patient and reducing the potential for dislocation, but have been associated with an increased incidence of metal hypersensitive-like reactions leading to pain, pseudotumors, bone loss, and component loosening. Radiolucency and abnormal fluid aspirate are associated findings suggestive of aseptic lymphocyte-dominated vasculitis associated lesions.
Whether metal hypersensitivity causes implant failure or whether implant failure triggers metal hypersensitivity due to the prodigious production of particulate, which overwhelms an individual’s immune system, is a need of urgent study. It would seem a requirement to identify those patients most susceptible to these phenomena. Does explanatory lie in the metallurgy, manufacturing process, the larger surface areas involved in articulation and the nuances of component placement? Given the contemporary didactic, have we reached the epoch of metal–metal articulation use and will they fade from the marketplace almost as quickly as they have re-arisen?
Patient-Specific Total Knee Arthroplasty
It has long been felt that ensuring optimal alignment in total knee arthroplasty procedures is a requisite of an enduring outcome. While computer navigation has enhanced procedural accuracy by assisting the elimination of outliers, it has an associated learning curve, increased operative time, risk of fracture, and high cost. Alternatively, rapid prototyping techniques based on preoperative magnetic resonance imaging and computed tomography scans to create custom cutting blocks for unicompartmental, posterior stabilized, and cruciate retaining knee designs are patient specific. Concurrently, the use of robotic arms has filtered into the process to optimize component placement while minimizing bone resection.
These evolving technologies may prove to be beyond computer navigation as experience is gained in their application. Again, both cost and outcome will be determining factors in their application.
Whether the increasing debt burden borne by the citizenry through the massive stimulus package will assist the restoration of a faltering economy while overhauling our health care system so that all citizens are adequately covered, is a conundrum facing the nation. Its impact on the advancement of orthopedic technologies, the doctor/patient relationship, the fee-for-service paradigm and the historical role of the private health care insurer is being scrutinized. Whatever emerges from these discussions, the endpoints must be in the best interest of patients going forward.
This September issue of ORTHOPEDICS contains an assemblage of commentaries on contemporary topics of orthopedic interest in 2009. It is hoped that the reader will gain from the experiences of the contributors and their continuing dedication to orthopedic education.
Dr Greenwald is Course Director, Current Concepts in Joint Replacement.
Dr Greenwald has no relevant financial relationships to disclose.
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