Current diagnosis-related group-based bundling for upper-extremity arthroplasty: a case of insufficient risk adjustment and misaligned incentives.

BACKGROUND: The current Centers for Medicare & Medicaid Services diagnosis-related group (DRG) bundled-payment model for upper-extremity arthroplasty does not differentiate between the type of arthroplasty (anatomic total shoulder arthroplasty [ATSA] vs. reverse total shoulder arthroplasty vs. total elbow arthroplasty [TEA] vs. total wrist arthroplasty) or the diagnosis and indication for surgery (fracture vs. degenerative osteoarthritis vs. inflammatory arthritis). METHODS: The 2011-2014 Medicare 5% Standard Analytical Files (SAF5) database was queried to identify patients undergoing upper-extremity arthroplasty under DRG-483 and -484. Multivariate linear regression modeling was used to assess the marginal cost impact of patient-, procedure-, diagnosis-, and state-level factors on 90-day reimbursements. RESULTS: Of 6101 patients undergoing upper-extremity arthroplasty, 3851 (63.1%) fell under DRG-484 and 2250 (36.9%) were classified under DRG-483. The 90-day risk-adjusted cost of an ATSA for degenerative osteoarthritis was $14,704 ± $655. Patient-level factors associated with higher 90-day reimbursements were male sex (+$777), age 75-79 years (+$740), age 80-84 years (+$1140), and age 85 years or older (+$984). Undergoing a TEA (+$2175) was associated with higher reimbursements, whereas undergoing a shoulder hemiarthroplasty (-$1000) was associated with lower reimbursements. Surgery for a fracture (+$2354) had higher 90-day reimbursements. Malnutrition (+$10,673), alcohol use or dependence (+$6273), Parkinson disease (+$4892), cerebrovascular accident or stroke (+$4637), and hyper-coagulopathy (+$4463) had the highest reimbursements. In general, states in the South and Midwest had lower 90-day reimbursements associated with upper-extremity arthroplasty. CONCLUSIONS: Under the DRG-based model piloted by the Centers for Medicare & Medicaid Services, providers and hospitals would be reimbursed the same amount regardless of the type of surgery (ATSA vs. hemiarthroplasty vs. TEA), patient comorbidity burden, and diagnosis and indication for surgery (fracture vs. degenerative pathology), despite each of these factors having different resource utilization and associated reimbursements. Lack of risk adjustment for fracture indications leads to strong financial disincentives within this model.

Appropriateness of thrombophilia testing in patients in the acute care setting and an evaluation of the associated costs.

Thrombophilia testing is rarely recommended in acute care settings due to the high likelihood of false-positive and false-negative results. Inappropriately performing these tests in the acute care setting is associated with inaccurate interpretation and an increased economic burden. In this retrospective analysis, the appropriateness of thrombophilia tests ordered for patients in an acute care setting was evaluated in terms of both clinical utility and economic costs. This analysis included adult inpatients discharged from an academic community medical center from November 1, 2016 to November 1, 2017 who received thrombophilia testing. Patients were stratified into two groups: appropriately tested and inappropriately tested based on data abstracted directly from the electronic health record. The primary outcome, the appropriateness of the tests, was based on published criteria for thrombophilia testing and included concurrent anticoagulation use, patient admitting diagnosis, and/or comorbidities associated with thrombosis risk. The secondary endpoint was the financial burden of inappropriate thrombophilia testing based on assay charges. The analytic sample included 200 patients and 1393 thrombophilia tests. In 179 patients (89.5%), 1168 tests (83.8%) were inappropriately conducted. From 179 patients, tests in 85 were inappropriate due to concurrent anticoagulant use and/or provoked venous thromboembolism (VTE), and tests in 94 were inappropriate due to a lack of 2 or more risk factors for thrombophilia. Only 21 patients (10.5%) had appropriate testing with 225 tests (16.2%). The financial impact of inappropriate testing was estimated as excess charges amounting to $148,151.16/year. Restricting testing to avoid unnecessary risks and costs warrants further analysis.

An Audit of Thrombophilia Testing in Patients with Ischemic Stroke or Transient Ischemic Attack: The Futility of Testing.

OBJECTIVES: Many patients admitted with an ischemic stroke or transient ischemic attack (TIA) undergo thrombophilia testing. There is limited evidence to support this practice. We examined the effect of thrombophilia testing on management of patients admitted with an ischemic stroke or TIA. MATERIALS AND METHODS: In this retrospective observational single-center study, we identified patients who were admitted with stroke or TIA and underwent thrombophilia testing over a 45-month period. We reviewed their electronic medical records to assess whether testing affected clinical management, defined as anticoagulation treatment by the time of discharge due to a positive test result. Secondary endpoints included potential misdiagnosis due to false positive results and cost of testing. RESULTS: Testing was performed in 143 patients with a stroke or TIA. Forty-four patients (31%) had at least 1 positive test result. The most common positive tests were an elevated factor VIII activity (18% of patients tested) and decreased protein S activity (11% of patients tested). Both of these tests are subject to acute phase effects. Testing altered clinical management in only 1 patient (1% of total patients tested). Thirty-three patients (75%) have the potential for carrying a misdiagnosis due to a positive test that was never repeated for confirmation or repeated too soon after the initial positive test. The annual cost of testing was approximately $62,000. CONCLUSIONS: Thrombophilia testing in the acute inpatient setting rarely impacted the clinical management of patients admitted with a stroke or TIA. By avoiding thrombophilia testing, both the potential for misdiagnosis and health care costs can be reduced. Therefore, we have discontinued thrombophilia testing in in-patients with a diagnosis of stroke.

Economic Evaluations of Thrombophilia Screening Prior to Prescribing Combined Oral Contraceptives: A Systematic and Critical Review.

BACKGROUND: Combined oral contraceptives (COCs) increase the risk of venous thromboembolism (VTE), particularly among women with inherited clotting disorders. The World Health Organization classifies combined hormonal contraception as an "unacceptable health risk" for women with thrombogenic mutations but advises against universal thrombophilia screening before prescribing COCs given the low prevalence of thrombophilia and high screening costs. OBJECTIVE: Through the lens of lifetime costs and benefits, this paper systematically and critically reviews all published economic evaluations of thrombophilia screening prior to prescribing COCs. METHODS: We searched relevant databases for economic evaluations of thrombophilia screening before prescribing COCs. After extracting the key study characteristics and economic variables, we evaluated each article using the Quality of Health Economic Studies (QHES) and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) instruments. RESULTS: Seven economic evaluations of thrombophilia screening before prescribing COCs met our inclusion criteria. Only the two economic evaluations focusing exclusively on selective screening exceeded the 75-point threshold for high-quality economic studies based on the QHES instrument, whereas only one of these exceeded the 85% CHEERS threshold. Only three of the seven economic evaluations performed sensitivity analysis on key parameters. Most studies underestimated the benefits of thrombophilia screening by comparing one-time costs of genetic screening against benefits per person-year, thus implicitly assuming a 1-year duration of COC use, neglecting the long-term implications of VTE and/or neglecting the lifetime benefits of awareness of inherited thrombophilia. CONCLUSION: Our review highlights the lack of methodologically rigorous economic evaluations of universal thrombophilia screening before prescribing COCs.

Thrombophilia testing in a tertiary paediatric hospital: Indications, outcomes and appropriateness.

AIM: The association between inherited thrombophilia and thrombotic disease in children is unclear. As a result, whether expensive thrombophilia tests are indicated in children is a contentious issue. This retrospective study aimed to assess the appropriateness of thrombophilia testing and the associated cost of inappropriate testing at a tertiary paediatric hospital. METHODS: We conducted a search for thrombophilia tests ordered at the Royal Children's Hospital between 1 January 2011 and 31 December 2013. Using pathology and clinical records, we collected data relating to demographics, clinical data, indications, requesting departments and impact on patient management. RESULTS: Over the 3-year period, 3867 tests were ordered for 613 patients costing the hospital $102 579. Tests were most commonly ordered by gastroenterology on patients receiving liver transplants, by neurology as part of the stroke protocol, and by cardiology and cardiac surgery for patients anticoagulated on heparin infusions. Testing for thrombosis-related indications was relatively uncommon. Thrombophilia testing only directly affected management in one-third of patients. Overall, 70% of thrombophilia tests ordered were considered appropriate. However, some departments were found to have rates of inappropriate testing in excess of 50%. CONCLUSION: With improvements in thrombophilia testing practices at the Royal Children's Hospital AU$29 645.40 could be saved over 3 years. While there are improvements to be made in this area, in the overall context of the hospital's pathology testing budget, review of other areas such as inappropriate use of low-cost, high-volume tests may be of greater value in reducing the cost of pathology testing.

Reducing inpatient heritable thrombophilia testing using a clinical decision-making tool.

AIMS: To evaluate the impact of a clinical decision-making tool, designed to educate physicians regarding heritable thrombophilia (HT) testing, on the volume of testing in hospitalised patients in the tertiary care setting. METHODS: We performed a retrospective cohort study over a 6-year period (2007-2012) at a single tertiary care centre intervention site and two regional control sites. In January 2010, the intervention site instituted a policy change whereby physicians ordering HT testing on inpatients needed to complete a pre-preprinted order (PPO) form that outlined the limitations of HT testing in the hospitalised setting. Failure to complete the PPO within 24 h resulted in test cancellation. Our main outcome measure was the volume of HT testing performed at the three study sites. RESULTS: Introduction of the PPO resulted in a 79.4% (95% CI 71.2% to 87.6%) reduction in factor V Leiden (FVL) testing at the intervention site. This decrease was significantly greater compared with those in the two control teaching hospitals over the same time periods (33.7% and 43.6%; both p<0.001). Reductions in FVL testing postintervention were observed among all ordering specialists. Similar postintervention reductions in testing volumes were observed for antithrombin (57.4%), protein C (61.9%) and protein S (62.2%) activity assays. CONCLUSIONS: In a large tertiary care hospital, the introduction of a clinical decision-making tool significantly reduced HT testing in inpatients across clinical specialties. The impact on patient outcome should be assessed in further studies.

Genetic testing in the European Union: does economic evaluation matter?

OBJECTIVE: We review the published economic evaluation studies applied to genetic technologies in the EU to know the main diseases addressed by these studies, the ways the studies were conducted and to assess the efficiency of these new technologies. The final aim of this review was to understand the possibilities of the economic evaluations performed up to date as a tool to contribute to decision making in this area. METHODS: We have reviewed a set of articles found in several databases until March 2010. Literature searches were made in the following databases: PubMed; Euronheed; Centre for Reviews and Dissemination of the University of York-Health Technology Assessment, Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database; and Scopus. The algorithm was "(screening or diagnosis) and genetic and (cost or economic) and (country EU27)". We included studies if they met the following criteria: (1) a genetic technology was analysed; (2) human DNA must be tested for; (3) the analysis was a real economic evaluation or a cost study, and (4) the articles had to be related to any EU Member State. RESULTS: We initially found 3,559 papers on genetic testing but only 92 articles of economic analysis referred to a wide range of genetic diseases matched the inclusion criteria. The most studied diseases were as follows: cystic fibrosis (12), breast and ovarian cancer (8), hereditary hemochromatosis (6), Down's syndrome (7), colorectal cancer (5), familial hypercholesterolaemia (5), prostate cancer (4), and thrombophilia (4). Genetic tests were mostly used for screening purposes, and cost-effectiveness analysis is the most common type of economic study. The analysed gene technologies are deemed to be efficient for some specific population groups and screening algorithms according to the values of their cost-effectiveness ratios that were below the commonly accepted threshold of 30,000€. CONCLUSIONS: Economic evaluation of genetic technologies matters but the number of published studies is still rather low as to be widely used for most of the decisions in different jurisdictions across the EU. Further, the decision bodies across EU27 are fragmented and the responsibilities are located at different levels of the decision process for what it is difficult to find out whether a given decision on genetic tests was somehow supported by the economic evaluation results.

[Economic analysis of dalteparin use in knee surgery at Instituto Mexicano del Seguro Social]. / Análisis económico de dalteparina en la indicacióncirugía de rodilla en el Instituto Mexicano del Seguro Social.

BACKGROUND: Knee surgery is a risk factor for thromboembolic disease. Prophylaxis reduces the risk of this condition. METHODS: Economic and health consequences of drugs preventing and treating thromboembolic disease in patients undergoing knee surgery from the institutional perspective (time horizon: 1 year) were estimated. The measures of effectiveness were: reduction in the number of cases (per 1,000 patients) of deep vein thrombosis, pulmonary embolism, hospital admissions and deaths. Transition probabilities were estimated by meta-analysis. The alternatives were: warfarin (reference), dalteparin, enoxaparin, nadroparin, unfractionated heparin + warfarin, and non-prophylaxis. Data on resources use and costs corresponds to the Instituto Mexicano del Seguro Social (IMSS). Acceptability curves were constructed. RESULTS: No prophylaxis implied three times higher cost ($18,835.10 versus $5,967.10) and less effectiveness in comparison with warfarin. The incremental cost-effectiveness ratios for enoxaparin were $3, $13, $17 and $3 per each additional case of deep vein thrombosis, pulmonary embolism, death and hospital admission avoided. Results of nadroparin and unfractionated heparin were inferior to warfarin (59.1% and 72.9% more costly and less effective in three measures of effectiveness, respectively). Dalteparin showed higher health outcomes and lower cost compared with warfarin (-20.6%). Dalteparin had a higher probability of being cost-effective than enoxaparin. DISCUSSION: thromboprophylaxis is a clinically and economically favorable alternative. The identification of a pharmacoeconomic profile of alternatives to perform it becomes relevant given the increasing pressure on institutional budgets. CONCLUSIONS: Dalteparin would be a cost-saving alternative in thromboprophylaxis of patients undergoing knee surgery at IMSS.

Hospital budget implications of substituting dabigatran for warfarin in an anticoagulation service.

The aim of our study was to assess hospital budget implications of substituting dabigatran for warfarin in patients enrolled in a large anticoagulation service. The study population was identified using criteria from randomized controlled trials of dabigatran. We obtained labor costs ($483 per patient) from the hospital's anticoagulation service budget, laboratory costs of international normalized ratio (INR) tests ($267 per patient), and wholesale costs of warfarin 5 mg tablets ($31 per patient) and dabigatran 150 mg capsules ($2464 per patient). A total of 1774 (93.5%) of 1898 patients were eligible to substitute dabigatran for warfarin. The annual projected hospital expense for anticoagulation with dabigatran was $4,371,136, attributable to drug cost alone. The annual projected cost of warfarin management was $1,385,494. This was comprised of $856,842 for labor, $473,658 for INR testing, and $54,994 for the drug cost of warfarin. Substitution will result in increased expense due to drug cost.

Thrombophilia testing in people with venous thromboembolism: systematic review and cost-effectiveness analysis.

OBJECTIVES: To assess whether thrombophilia testing following a venous thrombotic event is clinically effective and cost-effective in the management of thrombosis compared with no testing for thrombophilia. DATA SOURCES: Major electronic databases were searched from September to November 2006. REVIEW METHODS: A systematic review of the clinical effectiveness and cost-effectiveness literature was undertaken according to standard methods. A discrete event simulation model was constructed to assess the cost-effectiveness of changing the standard 3-month duration of warfarin treatment to 10 years, 20 years or lifelong. RESULTS: No clinical studies were identified that met the inclusion criteria for the systematic review. Further literature searches and clinical opinion were therefore used to inform the cost-effectiveness analysis. Thrombophilia testing in patients with pulmonary embolism (PE) had an estimated mean cost per quality-adjusted life-year (QALY) of below 20,000 pounds regardless of sex or age. In patients with a previous deep vein thrombosis (DVT), thrombophilia testing had an estimated mean cost per QALY of below 20,000 pounds in men aged 69 years or less and in women aged 49 years or less. The estimated duration of warfarin treatment (lifelong, 20 years, 10 years or no extended treatment) that was most cost-effective is presented for each age, sex, initial venous thromboembolism (VTE) event and type of thrombophilia. CONCLUSIONS: In terms of determining the duration of anticoagulation management, scenarios were found in which the cost per QALY of thrombophilia testing was below 20,000 pounds. However, these results are subject to great uncertainty, largely because of lack of knowledge about the increased risk of recurrence with each type of thrombophilia. Results are influenced by the fact that men have a greater risk of recurrence than women and by the fact that the frequency of adverse events associated with warfarin treatment increases with age. Further research, for example on the likely sensitivity and specificity of the tests for specific types of thrombophilia, is needed to reduce the uncertainty associated with these results. Studies comparing patients with VTE tested for thrombophilia with those whose risk assessment was based on personal and family history of thrombosis would also be beneficial.

Is screening for thrombophilia cost-effective?

PURPOSE OF REVIEW: The aim of this review was to examine the current evidence on the cost-effectiveness of screening for thrombophilia. RECENT FINDINGS: Few studies have attempted to evaluate the cost-effectiveness of screening for thrombophilia. The direct medical costs associated with screening, in order to detect one case of thrombophilia and indeed to prevent a subsequent venous thromboembolism, are high. Irrespective of patient groups, selective history-based thrombophilia screening has been shown to be more cost-effective than universal or unselected population screening. When comparing across the high-risk patient groups, screening women prior to prescribing combined oral contraceptives was the least cost-effective strategy. SUMMARY: Although thrombophilia is associated with a substantial increase in relative risk of venous thromboembolism, the absolute risk and the absolute numbers of expected events, and the subsequent estimated number of prevented events remain low. Based on existing evidence, screening for thrombophilia is unlikely to be cost-effective. However, the potential cost-effectiveness of thrombophilia screening may be improved if the screening strategies were to be refined through more accurate assessment of personal or family history of venous thromboembolism or the introduction of a more global coagulation test for screening.

Role of prostacyclin (epoprostenol) as anticoagulant in continuous renal replacement therapies: efficacy, security and cost analysis.

BACKGROUND: Heparin remains the drug most commonly used for anticoagulation in continuous renal replacement therapies (CRRTs). However, in patients with hypercoagulability, heparin is insufficient or, in cases with an increased risk of bleeding or thrombocytopenia, it may be contraindicated. Epoprostenol, a potent vasodilator, antithrombotic and antiplatelet agent, could be an alternative. PATIENTS AND METHODS: We studied the records of patients treated under continuous venovenous hemodiafiltration in an academic tertiary hospital of 900 beds, between January 2000 and June 2003. Epoprostenol was prescribed to patients with (i) filter hypercoagulability, defined as consumption of 2 or more filters in the last 24 hours; (ii) low platelet count; or (iii) recent severe hemorrhage. RESULTS: Thirty-eight out of 248 (15%) patients who were under CRRT received epoprostenol for more than 72 hours. Epoprostenol was indicated due to filter hypercoagulability in 48%, thrombocytopenia in 68% (7 patients both) and hemorrhage in 3% of cases. The overall time for epoprostenol therapy was 9,749 hours. The mean filter duration previous to epoprostenol was 23 +/- 12 hours and after administering this drug 38.2 +/- 11.9 hours (p = 0.0001). In 6 patients, heparin and epoprostenol were simultaneously administered. The adverse effects were hemorrhage, which presented in 7 patients (18%) and a fall in blood pressure in another 7 (18%), which recovered in the next 24 hour after starting treatment. Cost analysis demonstrates some advantage with epoprostenol in patients with increased tendency to clotting. CONCLUSIONS: Epoprostenol may be safely used to prevent clotting of the extracorporeal circuits, either alone in patients with thrombocytopenia and/or increased risk of bleeding, or in combination with heparin in states of hypercoagulability.

The John Charnley Award: heritable thrombophilia and development of thromboembolic disease after total hip arthroplasty.

UNLABELLED: We retrospectively assessed whether heritable thrombophilia-hypofibrinolysis was more common in patients developing venous thromboembolism after total hip replacement than among control patients who did not develop venous thromboembolism, as an approach to better identify causes of venous thromboembolism after total hip arthroplasty. Twenty patients with proximal deep venous thrombosis after THA and 23 patients with symptomatic pulmonary embolism were compared with 43 control patients who did not have postoperative venous thromboembolism. Five of 42 patients with venous thromboembolism (12%) and 0 of 43 control patients (0%) had antithrombin III deficiency (< 75%). Nine of 42 patients with venous thromboembolism (21%) and 2 of 43 control patients (4.7%) had protein C deficiency (< 70%). Ten of 43 patients with venous thromboembolism (9 heterozygous, 1 homozygous; 23%) and 1 of 43 control patients (heterozygous; 2%) had the prothrombin gene mutation. Patients who had venous thromboembolism after total hip arthroplasty were more likely than matched control patients to have heritable thrombophilia with antithrombin III or protein C deficiency, or homo-heterozygosity for the prothrombin gene mutation. Screening for these three tests of heritable thrombophilia before total hip arthroplasty should improve the identification of patients with a reduced risk of venous thromboembolism who may need only mild thromboprophylaxis, and of those patients with heritable thrombophilia in whom prophylaxis should be more aggressive. LEVEL OF EVIDENCE: Prognostic study, Level II-1 (lesser-quality RCT). See the Guidelines for Authors for a complete description of levels of evidence.

[Thrombophilias in patients with ischemic stroke. Indication and calculated costs for evidence-based diagnostics and treatment]. / Thrombophilien bei Patienten mit ischämischem Schlaganfall. Indikation und Kostenermittlung einer evidenzbasierten Diagnostik und Therapie.

Patients with ischemic stroke are sometimes found to have an underlying inherited (deficiency of protein C, protein S, antithrombin III, activated protein C resistance, prothrombin gene mutation, hyperhomocysteinemia) or acquired thrombophilia (lupus anticoagulant and anticardiolipin antibodies, hyperhomocysteinemia). Patient selection for thrombophilia screening is, therefore, a frequent question in managing patients with ischemic stroke. In this review we discuss patient selection and timing for laboratory tests for thrombophilia screening in stroke patients based on a literature review and we calculated overall costs per year in Germany for testing patients older than 18 years with an ischemic stroke of undetermined cause. As there is a lack of studies comparing anticoagulation with antiplatelet therapy in patients with diagnosed thrombophilia, laboratory screening for thrombophilia even in a selected group of patients with cryptogenic ischemic stroke remains of questionable value at present. An exception appears to be testing for lupus anticoagulant and anticardiolipin antibodies in younger patients with suspected antiphospholipid syndrome (two positive test results necessary), because anticoagulation seems to be superior to aspirin in patients with antiphospholipid syndrome.

Cost-effectiveness of testing for hypercoagulability and effects on treatment strategies in patients with deep vein thrombosis.

PURPOSE: Among patients with deep vein thrombosis, hypercoagulable conditions impart a substantial risk of recurrent thrombosis. We sought to determine the cost-effectiveness of testing for these disorders, as well as which tests should be selected and how results should be used. METHODS: Using a Markov state-transition model, strategies of testing or not testing for a hypercoagulable state followed by anticoagulation for 6 to 36 months were compared in a hypothetical cohort of patients with apparently idiopathic deep vein thrombosis who were followed for life. Strategies were compared based on lifetime costs, quality-adjusted life-years (QALYs), and marginal cost-effectiveness. RESULTS: In the base case, testing followed by 24 months of anticoagulation in patients with a hypercoagulable condition was more cost-effective ($54,820; 23.76 QALYs) than usual care, which comprised 6 months of anticoagulation without testing ($55,260; 23.72 QALYs). All hypercoagulable conditions tested were common enough and associated with a sufficient risk of recurrence to justify inclusion in a test panel. Twenty-four months of initial anticoagulation was preferred (<$50,000/QALY) for most conditions, whereas lifetime anticoagulation was preferred for patients with antiphospholipid antibody syndrome ($2928/QALY) or homozygous factor V Leiden mutation ($3804/QALY). Models using newer evidence on recurrence suggested 18 to 36 months of anticoagulation without testing as the preferred approach. CONCLUSION: Testing for hypercoagulable disorders in patients with idiopathic deep vein thrombosis followed by 2 years of anticoagulation in affected patients is cost-effective. A simpler approach of treating all patients with prolonged anticoagulation without testing is justified if data confirm the persistent risk of recurrent thrombosis.