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.

[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.

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.

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.

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.

[Factors of successful integrated care settings for total knee and hip arthroplasty: findings of a qualitative process analysis]. / Erfolgsfaktoren integrierter Versorgungsprozesse in der Endoprothetik: Ergebnisse einer qualitativen Prozessanalyse.

AIMS: In Germany, introduction of the law on Integrated Health Care (IC) (section sign 140a-d SGB V) opened up the possibility of cross-sectoral health care settings and new forms of remuneration, and improved the conditions for a closer cooperation between health care providers. However, cross-institutional and interdisciplinary work contexts demand new organizational structures in order to assure the coordination of different competences, resources and interests. This study aims at identifying factors of successful integrated care settings for total hip and knee arthroplasty. Using the example of an integrated care setting between an orthopaedic hospital and a rehabilitation clinic it will be examined which factors lead to successful implementation of the services and measures designed. METHOD: A qualitative research design was developed comprising different methods of data assessment (participant observation, guided expert interviews, document analyses) enabling a comprehensive exploration. Overall, data were derived from six consultations with patients, two integrated care information sessions and various documents (17 patient files, information material, patient lists, etc.). RESULTS: First of all, the different phases of development and implementation of integrated care settings were described. In this context, clearly defined aims, structures and appropriate measures seem to be crucial for an ideal long-term cooperation. Furthermore, the staff perspective on the effects of the IC programme on their daily routines proved an essential basis for process reconstruction. The staff members pointed out four main aspects regarding IC settings, i. e., improved image, increased knowledge, intensity of relationship, and less and more work effort. Against this background, factors of successful IC settings could be generated such as the need for central coordination, a regular staff information systems as well as accompanying process monitoring. CONCLUSION: Several key factors of successful integrated care settings in arthroplasty could be generated which provide important clues for shaping future interdisciplinary and cross-sectoral cooperation settings in health care services in general.

Preventing lawsuits by noting and acting on key aspects in a patient's condition.

Nurses are often concerned about committing a wrong action that will result in a lawsuit. In reality, it is often omissions, failing to consistently and thoroughly perform the basic acts of nursing, that result in lawsuits. These include timely adequate assessments, following up on test or treatment results, and persistently notifying someone (up the chain of command, as necessary) when there is a significant abnormality. Red flags for concern include more severe pain than expected for the patient's condition, a sudden change in mental status, and a deteriorating trend. Institutional policies for standardized communication techniques and rapid response back-up assistance can be beneficial.

Medical malpractice in hip and knee arthroplasty.

A survey of the American Association of Hip and Knee Surgeons was performed to investigate the perceptions and experiences of medical malpractice litigation and related concerns among its active members. Responses showed that 78% of responding surgeons had been named as a defendant in at least 1 lawsuit alleging medical malpractice. Sixty-nine percent of lawsuits in the survey had been dismissed or settled out of court, and median settlement amounts were in the range of $51,000 to $99,000. Nerve injury was the most commonly cited source of litigation, followed by limb length discrepancy, infection, vascular injury, hip dislocation, compartment syndrome, deep vein thrombosis, chronic pain, and periprosthetic fracture. Survey data suggest that there are targets for surgeon education and awareness that could improve the quality of patient communication and the informed consent process.

[Experience in orthopaedic surgery with minimum provider volumes]. / Erfahrungen mit Mindestmengen in der Orthopädie.

The implementation of minimum provider volumes in orthopaedic surgery appears to be logically evident. A general volume outcome relationship could be found for total knee and hip replacement on a high level of evidence, but no definite threshold value could be identified. For other orthopaedic procedures the evaluated data hint at a volume outcome relationship but do not prove one. Preliminary model calculations on the effects of a regulation based on volume outcome considerations concerning medical care in Germany show that, though for total hip and knee replacement quite a large number of hospitals would be excluded from medical care, the number of patients to be reallocated would be small. Since 1 January 2007 a minimum provider volume of 50 total knee replacements per year per hospital has been mandatory in Germany. The further application of a minimum requirement regulation based on volume outcome considerations in the German health care system must be performed very carefully, because significant effects are to be expected.