Assessing the Efficacy of Certificate of Need Laws Through Total Joint Arthroplasty.

ABSTRACT: Lawmakers suggest Certificate of Need (CON) laws' main goals are increasing access to healthcare, increasing quality of healthcare, and decreasing healthcare costs. This retrospective database study aims to evaluate the effectiveness of CON through analysis of total knee, hip, and shoulder arthroplasty (TKA, THA, and TSA, respectively). A review was performed using the Humana Insurance PearlDiver national database from 2007 to 2015. Access to care was approximated by the rates of total joint arthroplasty (TJA) in patients diagnosed with arthritis to the corresponding joint. The quality of care was assessed using complication rates after TJA. The total cost of TJA was approximated from average reimbursement to the healthcare facility per procedure. Patients in states without CON programs received TKA, THA, and TSA more frequently (p < .0001, p = .250, p = .019). No significant difference was found in studied complication rates between CON and non-CON states. Similarly, there was no trend found when comparing the cost of each procedure in CON versus non-CON states. These findings are consistent with other recent studies detailing the impact of CON regulation on THA and TKA. The apparent nonsuperiority of CON states in achieving their purported goals may call into question the effectiveness of additional bureaucracy and regulation, suggesting a need for further examination.

Medical Malpractice Litigation Following Primary Total Joint Arthroplasty: A Comprehensive, Nationwide Analysis of the Past Decade.

BACKGROUND: The purpose of this study is to (1) characterize the most common reasons of medical malpractice litigation against adult reconstruction surgeons and (2) report on the outcomes of these lawsuits. METHODS: The Westlaw legal research database was queried for cases between 2008 and 2018 related to total hip and knee arthroplasty (THA and TKA) in the United States. Causes of the lawsuit, patient characteristics, demographics, state/outcome of verdict or settlement, and indemnity payments were noted. RESULTS: A total of 148 records (81 females [55%], 67 males [45%]; 83 TKAs [56%], 65 THAs [44%]) were included in the final analysis. For all patients, infection was the leading cause for malpractice litigation (22%) followed by nerve injury (20%). For TKA, infection was the most common cause of lawsuit (33%). In THA cases, nerve injury was the most common reason for lawsuit (38%), followed by leg-length discrepancy (26%). Procedural errors were alleged in 72% of cases, while diagnostic and post-surgical errors were cited in 55% and 32% of cases. A defense verdict occurred in 74% of cases, plaintiff verdict in 21%, and parties settled in 5%. CONCLUSION: Infection and nerve injury were the most common reasons for litigation in TKA and THA, respectively. The most likely outcome of these lawsuits was a jury verdict in favor of the surgeon. Regardless, surgeons should be cognizant of the potential for lawsuit due to these complications and should ensure they inform patients of these potential complications of TJA preoperatively.

[Obesity in Revision Total Knee Arthroplasty - a Systematic Review and Legal Assessment]. / Adipositas in der Revisionsendoprothetik des Kniegelenks ­ eine systematische Literaturübersicht und rechtliche Bewertung.

BACKGROUND: In recent years, the incidence of overweight and obesity has increased in the German population. Thus the number of obese patients treated with primary total joint arthroplasty has also increased. It is therefore predicted that the number of obese patients undergoing revision total joint arthroplasty will also increase. Nevertheless almost every manufacturer of commercially available revision arthroplasty implants states in his product safety guarantee that obesity is a relative or absolute contraindication. Data on revision total joint arthroplasty in obese patients are sparse. The aim of this systematic review is to assess the current literature on re-revision rate, infection rate, postoperative clinical outcome, and implant survival rate in obese patients undergoing revision total knee arthroplasty. Moreover, potential legal consequences and aspects are discussed which are essential for the surgeon. MATERIAL AND METHODS: We conducted a systematic review of the online databases PubMed and identified clinical studies on obesity and overweight in revision total knee arthroplasty. Study quality was assessed using levels of evidence and the modified Jadad score. We also included descriptive data on case numbers, age, gender, height, weight and follow-up time. Current legal aspects were also analysed. RESULTS/DISCUSSION: Five studies met the inclusion criteria and were included in the systematic review. The average Jadad score was 1, the average level of evidence 3. In two studies, infection and revision occured more often in obese patients. Patients with morbid obesity had a higher risk of wound revision and periprosthetic joint infections. Three studies showed that obese patients had significantly lower scores for clinical outcome measures in function and pain. The legal aspect was not discussed in any of the five studies. Overall, published data are sparse and very heterogeneous. Therefore comparing these five studies is difficult. However, the results of our review suggest that obesity in revision total knee arthroplasty may have a negative influence on reoperation rate, infection rate and postoperative functional outcome. From a legal point of view, potential weight limitations of the implants intented for use have to be part of the oral preoperative discussion. The patient's informed consent has to be received and documented prior to revision total joint arthroplasty.

Certificate-of-Need State Laws and Total Knee Arthroplasty.

BACKGROUND: Many states in the United States have certificate-of-need (CON) programs designed to restrain health care costs and prevent overutilization of health care resources. The goal of this study was to characterize the associations between CON regulations and total knee arthroplasty (TKA) by comparing states with and without CON programs. METHODS: Publicly available data were used to classify states in to CON or non-CON categories. The 100% Medicare Standard Analytical Files from 2005 through 2014 were then used to compare primary TKA procedure volumes, charges, reimbursements, and distribution of procedures based on facility volumes between the groups. Adverse events such as infection and emergency room visits after TKA were also evaluated. RESULTS: Although CON status was associated with lower per capita utilization of TKA, the annual incidence of TKA appears to have increased over time more rapidly in states with CON laws compared with non-CON states (overall increase of 5.6% vs 2.3%, P < .01). When normalized to the Medicare population, the incidence of TKA increased 2.0% in CON states, whereas it actually decreased 7.2% in states without CON regulations (P = .011). Average reimbursement (and thus Medicare spend) was 5% to 10% lower in non-CON states at all time points (P < .0001). In non-CON states, relatively more TKAs appear to be performed in lower volume hospitals. Examination of adverse events rates did not reveal any strong associations between any adverse outcome and CON status. CONCLUSION: CON programs appear to have influenced the delivery of care for TKA. Although our data suggest that these laws are associated with lower per capita utilization of TKA and the use of higher-volume facilities, we were unable to detect any strong evidence that CON regulations have been associated with improved quality of care or have limited growth in the utilization of this procedure over time. Confounding population and geographic factors may influence these findings and further study is needed to determine whether or not these programs have served their purpose and should be retained.

Infection Following Total Joint Arthroplasty Is the Main Cause of Litigation: Data From One Metropolitan Area.

BACKGROUND: A prior survey of members of the American Association of Hip and Knee Surgeons revealed that 78% of responding surgeons were named as a defendant in at least 1 lawsuit, and 69% of these lawsuits were dismissed or settled out of court. The most common sources of litigation were nerve injury, limb-length discrepancy, and infection. This study examined common reasons for lawsuits after total joint arthroplasty (TJA) in a single metropolitan area. METHODS: A retrospective review of lawsuits filed between 2009 and 2015 in a 5-county metropolitan area was performed, including 30 hospitals and 113 TJA surgeons. Complaints underwent a manual review to determine the number of lawsuits and the specific allegations filed against each surgeon. RESULTS: Thirty-one (27.4%) surgeons were named as a defendant in at least 1 lawsuit. Eighty-three total lawsuits were filed during the period, 50 of which were dismissed or settled outside of court. Top reasons for lawsuits were, in descending order, infection, nerve injury, chronic pain, vascular injury, periprosthetic fracture, retention of foreign body, dislocation, limb-length discrepancy, venous thromboembolism, loosening, compartment syndrome, and other medical complaints. CONCLUSION: Infection appears to be the basis of most lawsuits after TJA. Surgeons should be aware of the potential for a lawsuit for complications and should strive to better communicate with patients regarding preoperative informed consent and disclosure after adverse events. Surgeons should minimize performing surgery in patients at high risk of complications, such as patients with a higher likelihood of developing postoperative infection or patients on chronic pain medications.

Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.

INTRODUCTION: This article presents an audit cycle supported quality improvement project addressing best practice in the consent process for lower limb arthroplasty which takes into account the new standard in surgical consent and the importance of material risks. METHODS: 50 consecutive total hip and total knee replacement consent forms over a 3-month period were reviewed for legibility and completeness. Following the introduction of a new, pre-printed but customizable consent form the review process was repeated. RESULTS: The introduction of a customizable, pre-printed consent form that can be adjusted to reflect the individualized material risks of each patient increased legibility, reduced inappropriate human error variation and abolished the use of abbreviations and medical jargon. CONCLUSIONS: When used as part of an extended consent process, the authors feel that the use of pre-printed but customizable consent forms improves legibility, completeness and consistency and also provides the ability to highlight those complications that are of particular importance for that patient to satisfy the new accepted standard in surgical consent.

Reported Litigation Associated With Primary Hip and Knee Arthroplasty.

BACKGROUND: Greater than 75% of arthroplasty surgeons report having been the subject of a malpractice lawsuit. Despite this, few studies have analyzed the causes of litigation following total joint arthroplasty in the United States. METHODS: This study is a retrospective analysis of malpractice lawsuits following total hip and knee arthroplasty using VerdictSearch, a database encompassing legal cases compiled from February 1988 to May 2015. Complications leading to litigation were categorized and assessed for patient, surgeon, and lawsuit factors. All monetary awards were reflected for inflation. RESULTS: A total of 213 lawsuits were analyzed (119 total hip and 94 total knee arthroplasty cases). Overall, 15.0% of cases ended in settlement and 29.6% ended in a verdict in favor of the plaintiff (physician loss). The average payment for cases lost in court ($1,929,822 ± $3,679,572) was significantly larger than cases that ended in settlement ($555,347 ± $822,098) (P = .006). The most common complication following hip arthroplasty was "nerve injury" (29 cases, settlement rate: 10.3%, physician loss rate: 53.9%, and average payment: $1,089,825). The most common complication following knee arthroplasty was "pain or weakness" (17 cases, settlement rate: 5.9%, physician loss rate: 6.3%, and average payment: $451,867). Technical complications were the most likely complications to result in a physician loss (P = .019). CONCLUSION: While complications like "pain and weakness" are less likely to result in favorable litigation for patients, the presence of an objective technical complication or nerve injury was associated with an increased risk of a physician loss and a higher payment.

Reimbursement Based on Value in Knee Surgery: What You Need to Know about the Medicare Access and Children's Health Insurance Program Reauthorization Act of 2015.

Health care cost is consuming a large portion of the nation's gross domestic product while placing added economic burdens on physicians and their patients. With total joint replacement being one of the early-targeted procedures in the evolving health care environment, knee surgeons will benefit from developing a critical knowledge on health care reforms and their financial implications. The Medicare Access and Children's Health Insurance Program Reauthorization Act represents a cohesive movement toward value-based payment reform and contains several unchartered rulings that require detailed attention by knee surgeons. In this article, we provide a contextual framework of health care legislation that has led to the formation of the current health policy, and present a comprehensive summary and update on the Merit-Based Incentive Payment Systems and Alternative Payment Models reimbursement models.

Pre-discharge postoperative radiographs after primary total knee replacement : tradition or science?

Consistent evidence exists on the inutility of immediate postoperative radiographs after a total knee replacement (TKR). We hypothesized that eliminating the pre-discharge film would not have any effect on the postoperative patient outcomes. Retrospective analysis of prospectively collected data was performed on 220 knees. Patients undergoing a simple primary TKR operated by 2 surgeons (Surgeon A and B) from January 2013 to July 2015 were divided into 2 groups (Groups 1 and 2 having 112 and 108 knees respectively). While Surgeon A routinely asked for the second postoperative day pre-discharge radiograph, Surgeon B directly performed weight bearing radiographs 6 weeks postoperatively. Greater knee pain was seen in Group 1 (p = 0.01). No changes in rehabilitation protocols based on pre-discharge radiographs, complications, medico-legal issues or revision surgery could be identified in any patient. The quality of the pre-discharge radiographs was adequate in 65 of the 112 knees (58%). A cost reduction of approximately $220 per patient was observed with the exclusion of the pre-discharge film. Eliminating routine inpatient pre-discharge radio-graphs after simple primary TKR does not alter the rehabilitation protocol, identify any of the standard complication or have any medico-legal implications. On the contrary, these films seem to increase postoperative pain and costs.

The 72-Hour Medicare Mandate After Total Joint Arthroplasty: Is This Medically Necessary?

INTRODUCTION: Currently, Medicare total joint arthroplasty patients are required to stay postoperatively 3 days in the hospital before discharge to a skilled nursing facility (SNF). We evaluated Medicare's mandated 3-night hospital stay rule to find out how many total joint arthroplastic patients are safe for discharge to SNFs on postoperative day 2 (POD2). METHODS: This is a retrospective case series analyzing Medicare primary total hip or total knee arthroplastic patients at a single hospital over 1 year. Patients meeting 15 separate criteria by POD2 were considered safe for discharge home rather than to a SNF. RESULTS: Of 259 patients, 47.88% met discharge criteria to SNF POD2. 31.66% did not meet 1, 13.13% did not meet 2, and 6.95% did not meet ≥3 criteria on POD2. Common criteria delaying discharge were blood pressure abnormalities, increasing or elevated white blood cell count, cardiac abnormalities, and fever. Thirty-day readmission rate for patients in the group safe for discharge POD2 was 1.75%. CONCLUSION: Of the total, 47.88% of patients required to stay by the Medicare 3-night stay rule were safe for discharge to SNF on POD2 without an increase in readmission rate at 30 days when compared to our institutional mean.

Does the Medicare 3-Day Rule Increase Length of Stay?

Medicare will only cover a stay in a skilled nursing facility (SNF) after TKA if the patient stays for at least 3 days at the inpatient hospital. The 3-day stay rule was instituted in 1965, to prevent over utilization of Medicare. We retrospectively reviewed 800 consecutive TKA, identifying patients that were discharged to rehab after surgery. 322 patients were discharged to SNF after surgery (209 Medicare, 113 private insurances). The LOS was 2.3 days for privately insured patients and 3.02 for Medicare recipients (P<0.05). No difference was found with regard to age, BMI, and ASA score. The Medicare 3-day rule independently increased the LOS in patients who required inpatient rehab, leading to increased cost. We suggest that this rule must be revised.

The cost of adverse events from knee surgery in the United Kingdom: an in-depth review of the National Health Service Litigation Authority database.

BACKGROUND: There has been a significant rise in the number and value of claims against the National Health Service (NHS), with limited studies on litigation in orthopaedic surgery and none in knee surgery alone. We aimed to examine claims against the NHS involving all aspects of knee surgery with respect to costs and trends. CLINICAL RELEVANCE: To raise awareness of the reasons for litigation in knee surgery, thus potentially improve patient care and reduce future claims. METHODS: We analysed the NHS litigation authority (NHSLA) database for all orthopaedic surgery claims reported to the NHSLA between 2005 and 2010, with calculation of litigation success rates and odds ratios for those relating to knee surgery. RESULTS: There were 515 cases identified from the 4609 orthopaedic cases in the NHSLA database (11.2%): 298 (58%) involving total knee replacements (TKRs), 11 (2%) involving unicondylar knee replacements, and 90 cases (30%) remaining open. The total pay out for closed cases was £10.45 million and amputation following TKR resulted in the highest single pay out. Litigation success rates for claimants were highest for retained drains (100%), incorrect prosthesis/prosthesis size (78%), renal failure (75%), poor outcome requiring further surgery (74%) and malalignment (71%). There were also 60 cases of delayed diagnosis which resulted in pay outs totalling £2.90 million. Based on these data, projected future pay out costs for the open TKR cases were estimated to be £2.71 million. CONCLUSION: Litigation success rates for TKR were highest following technical errors such as malalignment compared to events less under the surgeon's control, such as infection. The number of claims involving incorrect prosthesis/size continues to be of concern. Despite the increased availability of imaging modalities, missed diagnosis also resulted in substantial pay outs.

Knee arthroplasty and lawsuits: the experience in France.

PURPOSE: Data regarding knee arthroplasty and lawsuit are scarce. With the expected increase in knee arthroplasty over the next 25 years, the number of claims might follow the same trend. Therefore, the most frequent causes of litigation after knee arthroplasty in France, and what is considered as malpractice by the expert, were determined. METHODS: Over 8-year period, data gathered from a French private insurance company specializing in malpractice for private practitioners were analyzed. Demographics, type of knee arthroplasty, reason for claim, details of the legal procedure and the expert's decision were reviewed. RESULTS: One hundred and five claims were processed by four jurisdictions. Most of the cases concerned primary total knee arthroplasty. Surgeons and anesthesiologists were charged in 84 and 16 % of claims, respectively. The most frequent causes of litigation were infection, neurological deficit and unsatisfactory result, whereas the most common reasons for the surgeon's liability, as stated by the expert, were delay in diagnosis or treatment of a complication, infection and technical error. CONCLUSION: Our findings show that frequent complications are not those which raise most of the claims. Patients sue the surgeon when the outcome of the surgery is different from what they were expecting. An unsatisfactory result, according to the patient's point of view, is the second most frequent cause of claim. LEVEL OF EVIDENCE: IV, Economic and Decision Analysis. See the Guidelines for Authors for a complete description of levels of evidence.

Patient-specific instruments: industry's innovation with a surgeon's interest.

PURPOSE: The aim of this study was (1) to survey the orthopaedic companies about the volume of patient-specific instruments (PSI) used in Europe and worldwide; (2) to survey a group of knee arthroplasty surgeons on their acceptance of PSI and finally; (3) to survey a medico-legal expert on PSI-related issues. METHODS: Seven orthopaedic implant manufacturers were contacted to obtain their sales figures (in volume) of PSI in Europe and worldwide for the 2011 and 2012 period. During the Open Meeting of the Belgian Knee Society, a survey by a direct voting system was submitted to a selection of knee surgeons. Finally, a number of medico-legal 'PSI-related' questions were submitted to an adult reconstruction surgeon/legal expert. RESULTS: The total volume, for all contacted companies, of PSI in Europe for 2012 was 17,515 total knee arthroplasty (TKA) and 82,556 TKA worldwide. Biomet (Warsaw, USA) was the number one in volume, both in Europe as worldwide with their Signature system. Biomet represented 27 % of the market share in PSI worldwide. Stryker preferred not to reply to the survey because of the FDA class 1 recall on ShapeMatch cutting guides. Eighty per cent of the Belgian knee surgeons expressed a great interest in PSI and especially, for 58 % of them, if it would increase their surgical accuracy. They valued it even more in unicompartmental arthroplasty, and 55 % was ready to use single-use instruments. Surprisingly, 47 % of surgeons thought it was the company's responsibility if something goes wrong with a PSI-assisted case. The medico-legal expert concluded that PSI is a complex process that exposes surgeons to new risks in case of failure and stated that companies should not produce surgical guides without validation of the planning by the surgeon. CONCLUSION: Patient-specific instruments is of great interest if it can proof to increase the surgical accuracy in knee arthroplasty to the level surgeons are expecting and if in the same time it would make the surgical process more efficient. LEVEL OF EVIDENCE: V.

Litigation after hip and knee replacement in the National Health Service.

The results of hip and knee replacement surgery are generally regarded as positive for patients. Nonetheless, they are both major operations and have recognised complications. We present a review of relevant claims made to the National Health Service Litigation Authority. Between 1995 and 2010 there were 1004 claims to a value of £41.5 million following hip replacement surgery and 523 claims to a value of £21 million for knee replacement. The most common complaint after hip surgery was related to residual neurological deficit, whereas after knee replacement it was related to infection. Vascular complications resulted in the highest costs per case in each group.Although there has been a large increase in the number of operations performed, there has not been a corresponding relative increase in litigation. The reasons for litigation have remained largely unchanged over time after hip replacement. In the case of knee replacement, although there has been a reduction in claims for infection, there has been an increase in claims for technical errors. There has also been a rise in claims for non-specified dissatisfaction. This information is of value to surgeons and can be used to minimise the potential mismatch between patient expectation, informed consent and outcome.

System dynamics to model the unintended consequences of denying payment for venous thromboembolism after total knee arthroplasty.

BACKGROUND: The Hospital Acquired Condition Strategy (HACS) denies payment for venous thromboembolism (VTE) after total knee arthroplasty (TKA). The intention is to reduce complications and associated costs, while improving the quality of care by mandating VTE prophylaxis. We applied a system dynamics model to estimate the impact of HACS on VTE rates, and potential unintended consequences such as increased rates of bleeding and infection and decreased access for patients who might benefit from TKA. METHODS AND FINDINGS: The system dynamics model uses a series of patient stocks including the number needing TKA, deemed ineligible, receiving TKA, and harmed due to surgical complication. The flow of patients between stocks is determined by a series of causal elements such as rates of exclusion, surgery and complications. The number of patients harmed due to VTE, bleeding or exclusion were modeled by year by comparing patient stocks that results in scenarios with and without HACS. The percentage of TKA patients experiencing VTE decreased approximately 3-fold with HACS. This decrease in VTE was offset by an increased rate of bleeding and infection. Moreover, results from the model suggest HACS could exclude 1.5% or half a million patients who might benefit from knee replacement through 2020. CONCLUSION: System dynamics modeling indicates HACS will have the intended consequence of reducing VTE rates. However, an unintended consequence of the policy might be increased potential harm resulting from over administration of prophylaxis, as well as exclusion of a large population of patients who might benefit from TKA.

Can patient injury claims be utilised as a quality indicator?

OBJECTIVES: To examine the association between patient injury claims and well-known quality indicators and to assess whether claims can be utilised in performance measurement. METHODS: Data were derived from administrative registers and comprised hip and knee replacement patients (n=34181) in Finland from 1998 to 2003. Hospital-level correlations were calculated between claims and quality indicators (5-year revision rate, 1-year deep infection rate, and 14-day readmission rate), while logistic regression analysis was used to analyze patient-level data for an association between claims and quality indicators. RESULTS: Correlations between claims and revisions as well as claims and infections were statistically significant, with correlation coefficients ranging from 0.21 to 0.62. In the regression analysis, both the revision and the infection indicator had a positive and statistically significant association with filing a claim (OR 1.002; 95% CI 1.001-1.003 and 1.001; 1.00005-1.001, respectively) and obtaining compensation (1.003; 1.001-1.005 and 1.001; 1.0003-1.002, respectively). CONCLUSIONS: A claims indicator has the potential to be applied as a quality indicator. It should be complemented, however, with other indicators or actions to improve its acceptability by health professionals and to mitigate its possible undesirable effects.

Consent process for elective total hip and knee arthroplasty.

PURPOSE: To assess the consent process for elective primary total hip replacement (THR) and total knee replacement (TKR) in our hospital. METHODS: Consent processes of 47 THR and 53 TKR patients performed by 11 surgeons were reviewed. Complications that were documented were recorded, as was the grade of surgeon (consultant or specialist trainee) performing consent, and the location at which this took place. Comparisons were made between rates of documented, clinically significant complications discussed during consent, and those listed in the British Orthopaedic Association (BOA), in the literature, and other joint registries. RESULTS: The consent processes of 37, 57, and 6 patients were conducted by consultants, specialist trainees, and both, respectively. 13% and 21% of THR patients had 'revision' and 'heterotropic ossification', respectively, documented as complications, neither of which were listed on the BOA consent form. Similarly 4% and 11% of TKR patients had 'revision' and 'dissatisfaction', respectively, documented as complications, neither of which were listed on the BOA consent form. In 23% of THR and 32% of TKR patients, none of the BOA-listed complications was documented. In 13% of THR and 15% of TKR patients, no complications were documented. In 13% of THR and 17% of TKR patients, only nonspecific descriptions of complications (e.g. morbidity, mortality and medical complications) were used in their consent forms. CONCLUSION: Documentation of complications for THR and TKR patients was often incomplete and variable. The use of structured, procedure-specific consent forms is recommended.

Trends in joint arthroplasty litigation over five years: the British experience.

INTRODUCTION: Increasing numbers of joint arthroplasty are performed in Britain. While associated complications are well documented, it is not known which of those initiate malpractice claims. METHOD: A five-year period was assessed for trends to highlight areas for further improvement in patient information and surgical management. RESULTS: The National Health Service paid out almost £14 million for 598 claims. Forty per cent of this was for legal costs. The number of claims increased over time while the rate of successful claims decreased. CONCLUSIONS: A failure to consent adequately and to adhere to policies and standard practice can result in a successful malpractice claim. Protecting patients intraoperatively and maintaining high technical expertise while implementing policies and obtaining informed consent decreases the litigation burden.