The California Joint Replacement Registry

The California Joint Replacement Registry Summary The California HealthCare Foundation (CHCF), the Pacific Business Group on Health (PBGH) and the California Orthopaedic Association (COA), have collaborated to develop, pilot and expand a statewide joint replacement registry, the California Joint Replacement Registry (CJRR). The specific goals of the registry are to: Collect and report scientifically valid data on the outcomes of hip and knee replacements performed in California, including device safety and effectiveness, post-operative complication and revision rates, and patient-reported assessments of outcomes. Promote the use of performance information to guide physician and patient decisions and support programs for provider recognition and reward, thus driving quality and cost improvements through marketplace mechanisms. Business Case for CJRR Joint replacements, which accounted for $41 billion in nationwide charges in 2007, have become one of the highest volume and highest cost surgeries for both Medicare and private payers. 1 From 1990 to 2002, the rate of primary hip replacements increased by approximately 50%, while the rate of primary knee replacements almost tripled. 2 Moreover, the volume of joint replacements is expected to continue its rapid growth, with a projected 174% increase in total hip arthroplasty (THA) and a 673% increase in total knee arthroplasty (TKA) by 2030. If these estimates prove correct, annual hospital and surgeon charges for joint replacements could top $70 billion within the next five years. 3 Joint replacement registries in Europe, Australia and within U.S. health care organizations have shown that registry activities can improve surgical practices, deliver timely safety alerts, and produce better outcomes for patients. In addition to the incalculable benefits to patients from such improvements in quality, registries also save health care dollars. Sweden a country that performs two thirds as many hip replacements as California has credited their Hip Registry with saving the national health system US $140 million in direct costs over a ten year period. 4 Information from a registry can: Provide Comparative Effectiveness Data on Prosthetic Devices. Over the last decade, there has been a rapid increase in the cost of implants, without evidence of improved effectiveness. Between 1998 and 2005, the average selling price of total hip replacement components grew by 43% - even after adjusting for medical cost inflation. The price increase has been attributed in part to the marketing of devices incorporating newer technologies, although studies available to date indicate new technology outcomes comparable to those of previous generations of THA implants. 5 In fact, joint registries in Sweden 6, Australia 7, England 8, and at Kaiser Permanente 9 have shown that cementless implants one of the more recent and more highly priced innovations are associated with significantly higher revision rates. California Joint Replacement Registry 1

Registries provide comparative data on the clinical effectiveness of different devices, allowing hospitals to undertake a value analysis of their implant choices and share those results with their surgeons. Kaiser compared a new implant technology to those in current use, found no difference in short term outcomes, and provided feedback to surgeons that changed practice with respect to implant selection. Another US registry, the HealthEast Registry, documented differences in longevity between two knee implant bearing surfaces and estimated a per patient savings of $724 for those with the longer lasting implant. 10` Reduce Complications. Periprosthetic joint infection is among the most challenging complications of total joint arthroplasty. Treating periprosthetic infections imposes significant physical and emotional burdens on patients and a significant economic burden on payors. A study of University of California, San Francisco cost center data found hospital costs for infection related re operations and treatment to average $96,000 three times greater than their average figure for revision surgeries overall. 11 Projected trends in deep infection present cautionary signs; by 2030, the overall incidence of deep infections for hip arthroplasty is projected to rise from 1.4% to 6.5%, and that for knee arthroplasty from 1.4% to 6.8%. 12 Venous thromboembolism (VTE) manifested via deep vein thrombosis (DVT) or pulmonary embolism (PE) provides similar treatment challenges. DVT and PE may cause long term complications including event recurrence and post thrombotic syndrome, which can lead to high rates of hospital readmission (5% 14%). 17 Although rates of prophylaxis administration to combat both infection and VTE have increased substantially over the last decade, substantial controversy remains over the appropriate VTE prophylaxis regimen for arthroplasty, with different specialty physician groups debating the risk of VTE versus those of major bleeds associated with various prophylaxis guidelines. 13 With the advent of new Medicare reimbursement policies on hospital acquired conditions including surgical site infections and VTE minimizing the rates of both has become a financial, as well as a quality of care, concern to hospitals. 20 The large population on which a statewide registry will be based provides sufficient sample size for measuring the outcomes of various prophylaxis regimens, and will provide evidence based data to inform adoption of guidelines that minimize the overall risk of these complications for joint replacement patients. Reduce Revision Rates. Between 1990 and 2002, the mean hip revision burden of 17.5% and the mean knee revision burden of 8.2% did not change substantially in the U.S. 3 In contrast, Sweden credits its registry programs for reducing the national hip revision rate to 7.5% and its knee revision rate to 6.4%. 1,7,21,22 Registries reduce revision rates by: Providing comparative data on the longevity of different implant types in different patient populations. Informed device selection can maximize implant life for each patient, and delay or feasibly alleviate the need for future revision surgeries. Estimates of average hospital costs for revision surgery range from $19,000 1 to $31,000 23. Identifying the patient, surgical, health system, and device-related factors associated with revision surgery. The top reasons for hip revision include dislocation (22.5% of revisions), mechanical loosening (19.7%), and deep infection (14%). 24 Enabling early identification of device specific failures. Implant failures account for 10% of all hip revision surgeries. 24 Twice since 2001, prostheses have been recalled after patients experienced highly adverse post operative outcomes often requiring immediate re operation. In the 2001 recall case, the Swedish registry was able to identify the faulty device after it had California Joint Replacement Registry 2

been implanted in thirty patients. In contrast, the prosthetic was implanted into 3,000 U.S. patients before the gravity of the problem was recognized. 26 In addition to providing an early warning system around problematic implants, registries can enable timely notification in the event of a recall. Governance The registry is governed by a Steering Committee, which includes representatives from the orthopedic surgeon community, hospitals, payers, purchasers and CHCF. The Steering Committee oversees all aspects of the data reporting program, which is designed to provide timely, confidential benchmarking reports to physicians and hospitals, aggregate reports evaluating outcomes associated with device and surgical technique, and after an interval to be determined by the Steering Committee, a select set of performance data to inform patient decisions and support provider recognition programs. In August, 2011, the CJRR concluded a three month pilot phase. Three sites, representing 12 surgeons, who perform 5 percent of the hip and knee replacements in California annually, participated in the pilot phase and continue to contribute data to the registry. During 2012, the CJRR will refine its operations and expand to include six additional hospital sites. Participation requirements Participating surgeons and the hospitals where they admit patients will collaborate to submit data to the CJRR. CJRR staff work with the hospital and, if relevant, the surgeon s office staff, to identify existing sources of information and arrange for ongoing, electronic transfers. The CJRR has a standard set of data elements that include patient demographics, clinical and procedure information, device information and patient reported outcomes measures. Participating providers submit this information set on an ongoing basis. Benefits to Hospitals and Surgeons Better information. The vast array of device implant options and the wide ranging needs of patients seeking joint replacement make treatment choices increasingly complex and costly. By providing comparative information on implants and surgical techniques, registries deliver evidence based data to inform practice. Responsible performance reporting. In a health care environment moving toward the increased use of performance-based reimbursement by both Medicare and the private sector the Registry offers California surgeons the opportunity to shape the quality measurement framework for orthopedic surgery. Mechanism for submitting data to Meaningful Use, PQRS and other performance programs. Both the government and private sector are ramping up their initiatives to pay for health care services based on the quality and efficiency of care provided, rather than making reimbursements based solely on the feefor-service model. Examples include: Incentives for compliance with Meaningful Use (MU) requirements California Joint Replacement Registry 3

Value Based Purchasing included in Accountable Care Act Centers for Medicare and Medicaid Services Hospital Compare CMS Physician Compare California Hospital Assessment and Reporting Taskforce (CHART) Physician Quality reporting System (1.5% bonus in 2011; changing to negative incentive in later years) For more information If you are interested in joining this effort, or for more information about the CJRR, please contact: Kate Chenok Phone: 415-615-6337 Email: kchenok@pbgh.org www.caljrr.org 1 The Agency for Healthcare Research and Quality. National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS). http://hcupnet.ahrq.gov/. Accessed November 20, 2009. 2 S Kurtz, F Mowat, K Ong, N Chan, E Lau, M Halpern, Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. Journal of Bone and Joint Surgery, 2005 Jul;87(7):1487 97. 3 S Kurtz, K Ong, E Lau, F Mowat, M Halpern, Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. Journal of Bone and Joint Surgery, 2007 Apr; 89(4):780 5. 4 Henrik Malchau, Peter Herberts, Thomas Eisler, Göran Garellick and Peter Söderman. The Swedish Total Hip Replacement Register. Journal of Bone and Joint Surgery Am. 2002;84:2 20. 5 MP Kelly, KJ Bozic. Cost drivers in total hip arthroplasty: effects of procedure volume and implant selling price. American Journal of Orthopedics, 2009 Jan;38(1):E1 4. 6 H Malchau, G Garellick, T Eisler, J Karrholm, P Herberts, The Swedish Hip Registry, Clinical Orthopedics and Related Research No.441, pp. 19 29, December 2005. 7 Australian Centre for Health Research, A Review of Joint Replacement Surgery and its Outcomes, October 2006. 8 N Sibanda, LP Copley, JD Lewsey, M Borroff, P Gregg, et al. Colleagues Revision Rates after Primary Hip and Knee Replacement in England between 2003 and 2006, PLoS Med 5(9): e179. doi:10.1371/journal.pmed.0050179. 9 EW Paxton, M Inacio, T Slipchenko, DC Fithian, The Kaiser Permanente National Total Joint Replacement Registry, The Permanente Journal/Summer 2008/Volume 12 No. 3. 10 T Gioe, K Killeen, S Mehle, K Grimm. Implementation and Application of a Community Total Joint Registry. Journal of Bone and Joint Surgery Am.2006; 88: 1399 1404. 11 Bozic KJ, Ries MD. The impact of infection after total hip arthroplasty on hospital and surgeon resource California Joint Replacement Registry 4

utilization. Journal of Bone and Joint Surgery Am. 2005 Aug;87(8):1746 51. 12 Steven M. Kurtz et al. Future Clinical and Economic Impact of Revision Total Hip and Knee Arthroplasty, The Journal of Bone and Joint Surgery. 2007; 89 (Supple 3): 144 51. 13 Eikelboom JW, Karthikeyan G, Fagel N, Hirsh J. American Association of Orthopedic Surgeons and American College of Chest Physicians guidelines for venous thromboembolism prevention in hip and knee arthroplasty differ: what are the implications for clinicians and patients? Chest. 2009 Feb;135(2):513 20. 14 SooHoo NF, Lieberman JR, Ko CY, Zingmond DS. Factors predicting complication rates following total knee replacement. Journal of Bone and Joint Surgery Am. 2006 Mar;88(3):480 5. 15 Zhan C, Kaczmarek R. Loyo Berrios N, Sangl J, Bright RA. Incidence and Short Term Outcomes of Primary and Revision Hip Replacement in the United States. Journal of Bone and Joint Surgery Am. 2007; 89:526 33. 16 White RH, Henderson MC. Risk factors for venous thromboembolism after total hip and knee replacement surgery. Current Opinions in Pulmonary Medicine. 2002 Sep;8(5):365 71. 17 Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. Journal of Managed Care Pharmacy. 2007 Jul Aug;13(6):475 86. 18 MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep vein thrombosis, pulmonary embolism, and post thrombotic syndrome. American Journal of Health Systems Pharmacy. 2006 Oct 15;63(20 Suppl 6):S5 15. 19 Bullano MF, Willey V, Hauch O, Wygant G, Spyropoulos AC, Hoffman L. Longitudinal evaluation of health plan cost per venous thromboembolism or bleed event in patients with a prior venous thromboembolism event during hospitalization. J Managed Care Pharmacy. 2005 Oct;11(8):663 73. 20 The Federal Register. May 22, 2009: 24104 24106. http://www.access.gpo.gov/su_docs/fedreg/a090522c.html. 21 P. Herberts and H. Malchau. The Value of the Swedish National THR Register Improved Quality and Significant Cost Reduction. European Federation of National Associations of Orthopaedics and Traumatology (EFORT): Symposium Abstracts: SCANDINAVIAN ORTHOPEDIC REGISTERS, Helsinki 4 10 June, 2003. 22 William J. Maloney, MD. National Joint Replacement Registries: Has the Time Come? The Journal of Bone and Joint Surgery (American) 83:1582 1585 (2001). 23 Bozic KJ, Katz P, Cisternas M, Ono L, Ries MD, Showstack J. Hospital resource utilization for primary and revision total hip arthroplasty. J Bone Joint Surg Am. 2005 Mar;87(3):570 6. 24 KJ Bozic, SM Kurtz, E Lau, K Ong, TP Vail, DJ Berry, MD The Epidemiology of Revision Total Hip Arthroplasty in the United States. The Journal of Bone and Joint Surgery (Am). 2009; 91: 128 133. 25 Smart Implants Could Eradicate Joint Replacement Infections Orthopaedic Research and Education Foundation, http://www.oref.org/site/ pagename=practical_feature_parvizi. Accessed: November 22, 2009. 26 B Meier, A Call for a Warning System on Artificial Joints, New York Times, July 29, 2008. California Joint Replacement Registry 5