Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single-gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non-Small-cell Lung Cancer: A Single-center Analysis.

INTRODUCTION: First-line targeted therapies have been developed for advanced non-small-cell lung cancer (NSCLC). However, small biopsy samples pose a challenge to testing all relevant biomarkers. The present study characterized clinician-ordered single-gene lung cancer testing and evaluated tissue stewardship and the ability to successfully determine mutation status with single-gene testing or investigational use of the Oncomine Dx Target Test. MATERIALS AND METHODS: Clinician-submitted orders for 3659 single-gene tests (EGFR, ALK, ROS1, BRAF, KRAS, ERBB2, MET, RET, FGFR1) across 1402 samples at a large US-based commercial reference laboratory and 169 investigational Oncomine Dx Target Tests were retrospectively evaluated. The testing success rates and tissue consumption were evaluated by sample type, test type, and number of single-gene tests per sample. RESULTS: The large majority of lung tissue samples submitted for clinical testing were small (70.5% core needle biopsies; 10.0% fine needle aspirations). With single-gene testing, mutation status was successfully reported for ≥ 1 biomarker for 88.4% of the clinical samples. The success rates decreased and tissue consumption increased with testing of additional biomarkers. Investigational Oncomine Dx Target Tests were permitted 1 tissue slide each and demonstrated success rates similar to single-gene testing for ≥ 5 biomarkers on core needle biopsies, ≥ 4 biomarkers on fine needle aspirations, and ≥ 2 biomarkers on surgical resection specimens. CONCLUSION: Tissue stewardship is important to enable successful completion of genetic testing and informed NSCLC treatment decisions. Preliminary assessment of the investigational Oncomine Dx Target Test suggests it could facilitate access to multiple biomarker testing using small tissue samples to support therapy decisions for patients with advanced NSCLC.

Comparison between Surgical and Endovascular Hemodialysis Arteriovenous Fistula Interventions and Associated Costs.

PURPOSE: To compare: (i) rate of arteriovenous fistula (AVF) interventions in both incident and prevalent end-stage kidney disease patients; (ii) their associated costs; and (iii) intervention-free survival between patients with surgical hemodialysis arteriovenous fistula (SAVF) versus those with an endovascularly created fistula (endoAVF). MATERIALS AND METHODS: Data from the United States Renal Data System (USRDS) were abstracted to determine the rate of AVF interventions performed in the first year and associated costs (based on Medicare payment rates) for SAVFs created from 2011 to 2013 in the incident and prevalent patient cohorts. Comparative data for endoAVF were obtained from the Novel Endovascular Access Trial (NEAT). Event rates, intervention-free survival, and costs were compared between endoAVF and SAVF cohorts after 1:1 propensity score (PS) matching. RESULTS: In the matched incident patients, the event rate was 0.74 per patient-year (PY) for endoAVF versus 7.22/PY for SAVF (P < .0001), with a difference in expenditures of $16,494. Similarly, in matched prevalent patients the event rate was 0.46/PY for endoAVF vs 4.10/PY for SAVF (P < .0001), resulting in a cost difference of $13,389. Time-to-event analysis showed that at 1 year, 70% of endoAVF patients experienced freedom from intervention versus only 18% of SAVF patients for incident patients; these numbers were 62% and 18% for endoAVF and SAVF prevalent patients, respectively (P < .0001 for both). CONCLUSIONS: Both incident and prevalent patients with endoAVF required fewer interventions and had lower costs within the first year compared with matched patients with SAVF.

Cost impact of monitoring exhaled nitric oxide in asthma management.

BACKGROUND: Asthma guidelines recommend periodic assessment of impairment and risk factors to prevent exacerbations, which can lead to hospitalization and increased health care utilization and cost. According to recent meta-analysis data, fractional exhaled nitric oxide (FeNO) monitoring is associated with a 40-50% reduction in the risk of exacerbations. OBJECTIVE: Cost modeling of these data indicates the potential for significant cost savings with FeNO use. Therefore, we attempted to verify this potential for cost savings within a real-world data base of Medicare beneficiaries. METHODS: This retrospective observational study investigated asthma-related claims from a Medicare data base. Beneficiaries were included who had 2 years of records after an asthma-related inpatient hospitalization (IP) or emergency department (ED) claim. A case-crossover analysis was completed of asthma-related IP or ED events before and after FeNO use during the 2-year study period. RESULTS: Of the 5911 asthma beneficiaries who met the inclusion criteria within the data base, 101 had an FeNO test during the 2-year study period. During the period before FeNO use, 98 of 101 (97%) beneficiaries had an asthma-related IP or ED event compared with 46 of 101 (46%) during the FeNO period. Asthma-related IP or ED claims and charges per beneficiary per day during the period before FeNO were 0.004 and $16.21 compared with 0.002 and $6.46 during the FeNO period (p = 0.0433 and p = 0.0133, respectively). CONCLUSION: FeNO monitoring in beneficiaries with a history of exacerbations was associated with a substantial reduction in asthma-related IP and ED claims and charges. These data supported cost modeling estimates and demonstrated that FeNO use in asthma management was associated with significant cost savings.

Cost-comparison of two trabecular micro-bypass stents versus selective laser trabeculoplasty or medications only for intraocular pressure control for patients with open-angle glaucoma.

AIM: Patients with open-angle glaucoma (OAG) whose intraocular pressure is not adequately controlled by one medication have several treatment options in the US. This analysis evaluated direct costs of unilateral eye treatment with two trabecular micro-bypass stents (two iStents) compared to selective laser trabeculoplasty (SLT) or medications only. MATERIALS AND METHODS: A population-based, annual state-transition, probabilistic, cost-of-care model was used to assess OAG-related costs over 5 years. Patients were modeled to initiate treatment in year zero with two iStents, SLT, or medications only. In years 1-5, patients could remain on initial treatment or move to another treatment option(s), or filtration surgery. Treatment strategy change probabilities were identified by a clinician panel. Direct costs were included for drugs, procedures, and complications. RESULTS: The projected average cumulative cost at 5 years was lower in the two-stent treatment arm ($4,420) compared to the SLT arm ($4,730) or medications-only arm ($6,217). Initial year-zero costs were higher with two iStents ($2,810) than with SLT ($842) or medications only ($996). Average marginal annual costs in years 1-5 were $322 for two iStents, $777 for SLT, and $1,044 for medications only. The cumulative cost differences between two iStents vs SLT or medications only decreased over time, with breakeven by 5 or 3 years post-initiation, respectively. By year 5, cumulative savings with two iStents over SLT or medications only was $309 or $1,797, respectively. LIMITATIONS: This analysis relies on clinical expert panel opinion and would benefit from real-world evidence on use of multiple procedures and treatment switching after two-stent treatment, SLT, or polypharmaceutical initial approaches. CONCLUSIONS: Despite higher costs in year zero, annual costs thereafter were lowest in the two-stent treatment arm. Two-stent treatment may reduce OAG-related health resource use, leading to direct savings, especially over medications only or at longer time horizons.

Prolonged length of stay associated with air leak following pulmonary resection has a negative impact on hospital margin.

BACKGROUND: Protracted hospitalizations due to air leaks following lung resections are a significant source of morbidity and prolonged hospital length of stay (LOS), with potentially significant impact on hospital margins. This study aimed to evaluate the relationship between air leaks, LOS, and financial outcomes among discharges following lung resections. MATERIALS AND METHODS: The Medicare Provider Analysis and Review file for fiscal year 2012 was utilized to identify inpatient hospital discharges that recorded International Classification of Diseases (ICD-9) procedure codes for lobectomy, segmentectomy, and lung volume reduction surgery (n=21,717). Discharges coded with postoperative air leaks (ICD-9-CM codes 512.2 and 512.84) were defined as the air leak diagnosis group (n=2,947), then subcategorized by LOS: 1) <7 days; 2) 7-10 days; and 3) ≥11 days. Median hospital charges, costs, payments, and payment-to-cost ratios were compared between non-air leak and air leak groups, and across LOS subcategories. RESULTS: For identified patients, hospital charges, costs, and payments were significantly greater among patients with air leak diagnoses compared to patients without (P<0.001). Hospital charges and costs increased substantially with prolonged LOS, but were not matched by a proportionate increase in hospital payments. Patients with LOS <7, 7-10, and ≥11 days had median hospital charges of US $57,129, $73,572, and $115,623, and costs of $17,594, $21,711, and $33,786, respectively. Hospital payment increases were substantially lower at $16,494, $16,307, and $19,337, respectively. The payment-to-cost ratio significantly lowered with each LOS increase (P<0.001). Higher inpatient hospital mortality was observed among the LOS ≥11 days subgroup compared with the LOS <11 days subgroup (P<0.001). CONCLUSION: Patients who develop prolonged air leaks after lobectomy, segmentectomy, or lung volume reduction surgery have the best clinical and financial outcomes. Hospitals experience markedly lower payment-to-cost ratios as LOS increases. Interventions minimizing air leak or allowing outpatient management will improve financial performance and hospital margins for lung surgery.

Diabetic Macular Edema Diagnosis and Treatment in the Real World: An Analysis of Medicare Claims Data (2008 to 2010).

BACKGROUND AND OBJECTIVE: To characterize vascular endothelial growth factor (VEGF) inhibitor treatment patterns in patients with diabetic macular edema (DME) using a Medicare Standard Analytic Files Part B or Outpatient Claims database to understand treatment frequency and DME persistence. PATIENTS AND METHODS: A retrospective analysis of treatment patterns for patients diagnosed with DME receiving their first anti-VEGF injection was performed. RESULTS: The average number of anti-VEGF injection claims for DME per patient rose from 3.1 to 4.6 per year (mean: 4.2). Within 1 year of diagnosis, 46% of patients received their final DME diagnosis (mean: 1.9 anti-VEGF claims), and 65% of patients received their final anti-VEGF treatment for DME. Patients who received treatment for DME through years 2 and 3 submitted a mean of four and 7.2 anti-VEGF claims, respectively. CONCLUSION: VEGF inhibitor treatment was less frequent than in landmark trials, but did resolve DME in a proportion of patients.

Cost Analysis and Clinical Outcomes of Ambulatory Care Monitoring in Medicare Patients: Describing the Diagnostic Odyssey.

Objectives: The diagnostic sequence and costs for arrhythmia detection utilizing Holter ambulatory ECG monitoring have not been well studied. The objective of the current study was to characterize the number of patients and associated costs incurred in the diagnosis, additional monitoring, clinical events and sequelae after an initial Holter monitor in Medicare patients with arrhythmia-the diagnostic odyssey. Methods: We performed a retrospective, longitudinal claims analysis using a 5% random sample of Medicare beneficiaries' claims from the Fee-for-Service (FFS) Standard Analytic Files. The analysis was limited to patients with full benefits for 1 year prior and 2 years post the index 24- or 48-hour Holter event, no prior arrhythmia or Holter. Results: The group of greatest interest was the "No results" category, since these 1,976 patients (11.1% of the total 17,887 patients evaluated) reflected the failure of repeat Holter monitoring to either detect clinical events or diagnose disease. In spite of this failure, there was a total allowed charge of more than $45 million or slightly more than $23,000 per involved patient. When extrapolated over the entire Medicare FFS population, this category was estimated to cost more than $900 million over the 2-year study period. Conclusions: Additional diagnostic paradigms need to be explored to improve upon these patient and system outcomes, where repeat monitoring frequently did not yield a diagnosis and patients continued to experience clinical events.

Cost of placement and complications associated with osseointegrated bone-conducting hearing prostheses: a retrospective analysis of medicare billing data.

OBJECTIVE: To report the cost of placement and complications related to osseointegrated bone-conducting hearing prostheses (OBHPs) in a Medicare population. MATERIALS AND METHODS: We performed a retrospective analysis of nationwide Medicare claims data for operative and nonoperative complications associated with the placement of percutaneous OBHPs between the first quarter of 2007 and the second quarter of 2009 for which there were 6 subsequent quarters of follow-up. We used Medicare Standard Analytical Files (SAF), which contain a 5% random sample of Medicare fee-for-service beneficiaries, excluding those that also were enrolled in a managed-care organization. RESULTS: We identified 118 patients who had OBHPs placed in the requisite period. Their complication billing data were analyzed for the six-quarters after initial placement. Seventy patients (59%) had no billing codes for complications or repeat procedures after receiving the implant, whereas 48 patients (41%) had such codes. The total adjusted mean cost with repeat/revision operations or complications was $7,812 per patient compared with $6,733 for those without these issues, an increase of $1,079 or 16%. DISCUSSION: We estimate that complications associated with the implantation of percutaneous OBHPs led to $417,616 in additional costs in the entire Medicare fee-for-service population during the study period and that the total cost of placement of these devices together with the cost of their complications totaled $6,789,248. In conclusion, the Medicare SAF database suggests that complications associated with OBHP increased the overall cost of placement by 16%. Like all surgical procedures, these complications and their associated costs should be taken into account when considering treatment options for patients who experience hearing loss.

Transition to a novel advanced integrated vitrectomy platform: comparison of the surgical impact of moving from the Accurus vitrectomy platform to the Constellation Vision System for microincisional vitrectomy surgery.

BACKGROUND: Microincisional vitrectomy surgery (MIVS) is the current standard surgical approach for pars plana vitrectomy. Historically, the most common surgical platform for vitrectomy surgery, since its introduction in 1997, has been the Accurus vitrectomy system. Recent introduction of the next generation of vitrectomy platforms has generated concerns associated with transitioning to new technology in the operating room environment. This study compared, in a matched fashion, surgical use of the Accurus vitrectomy system and the next generation Constellation Vision System to evaluate surgical efficiencies, complications, and user perceptions of this transition. METHODS: Electronic health records were abstracted as a hospital quality assurance activity and included all vitreoretinal surgical procedures at the Bascom Palmer Eye Institute, Anne Bates Leach Eye Hospital, during two discrete 12-month time periods. These two periods reflected dedicated usage of the Accurus (June 2008-May 2009) and Constellation Vision (July 2009-June 2010) systems. Data were limited to a single surgeon and evaluated for operating room (OR) total time usage/day, OR case time/case, and OR surgical time/case. Further analysis evaluated all patients undergoing combined MIVS and clear cornea phacoemulsification/intraocular lens (IOL) implantation during each individual time period to determine the impact of the instrumentation on these parameters. All records were evaluated for intraoperative complications. RESULTS: Five hundred and fourteen eligible patients underwent MIVS during the 2-year study windows, with 281 patients undergoing surgery with the Accurus system and 233 patients undergoing surgery with the Constellation system. Combined MIVS and phacoemulsification with IOL implantation was performed 141 times during this period with the Accurus and 158 times during the second study period with the Constellation. Total number of patients operated per day increased from 7.55 with Accurus to 8.53 with Constellation. Surgical room time decreased from 56 minutes with Accurus to 52 minutes with Constellation, and procedure time decreased from 35 minutes with Accurus to 31 minutes with Constellation (P < 0.004). Combined MIVS/phacoemulsification surgery saw similar declines in surgical room time and procedure time (P < 0.001). Subset analysis of procedures limited by case number per day (eg, four cases/day, five cases/day, six cases/day, and seven or more cases/day) showed similar outcomes with a decrease in surgical room time and procedure time. No increases in surgery-related complications were noted by quality assurance review during these time periods. DISCUSSION: Transitioning to advanced surgical technology is a complex issue for the surgeon, the hospital team, and the hospital administration. This study documents improvement in three significant measures of surgical efficiency: operative number of patients per day, operative room time, and surgical procedure time that reflect the positive impact of the novel, combined, integrated, posterior and anterior, ophthalmologic surgical platform of the Constellation Vision System. These data are imperative to evaluate the impact of transition from one surgical platform to another. During this transition, hospital quality assurance review and surgeon evaluation of operative complications showed no increased concerns for the shift from the Accurus to the Constellation Vision System surgical platform. Further, both operative staff and surgeons felt that the transition to the Constellation was not associated with increases in difficulty with setup, turnover, or use and that the Constellation decreased safety concerns for surgical usage. Ultimately, in this case, new technology benefited the surgeon, the patient, and the hospital.

Budget impact model: epigenetic assay can help avoid unnecessary repeated prostate biopsies and reduce healthcare spending.

BACKGROUND: The diagnosis of prostate cancer involves invasive, sometimes harmful, procedures that can entail negative quality-of-life implications to individuals and high additional costs to the US healthcare system when these procedures result in retesting and iatrogenic harms. It is estimated that $1.86 billion is spent annually on prostate-specific antigen (PSA) testing alone. An advanced epigenetic molecular diagnostic test that uses methylation-specific polymerase chain reaction to assess the DNA methylation status of GSTP1, APC, and RASSF1 genes associated with oncogenesis enables a higher degree of accuracy (previously unattainable through prostate biopsy procedures alone) and produces clinical, financial, and health benefits by reducing the number of medically unnecessary and costly repeated biopsies that are part of today's standard of care. OBJECTIVES: The purpose of this study is to quantify, using a budget impact model, the effect of a relatively new epigenetic assay on healthcare costs for commercial health plans that reimburse for the assay, by avoiding unnecessary repeated prostate biopsy procedures. METHODS: A budget impact model was developed to test the hypothesis that the epigenetic assay can produce cost-saving benefits to health plans, as well as clinical benefits to urologists and patients with prostate cancer, by providing guidance on how to offer patients more appropriate, and less costly, care. The budget impact model is presented from the perspective of a hypothetical commercial health plan, and direct costs are calculated over a 1-year time horizon, using 2013 Medicare fee-for-service rates. Using a plan of 1 million members, the model compares 1-year costs in a "reference scenario," in which the epigenetic assay is not used for the screening and diagnosis of prostate cancer, to costs in a "new scenario," in which the epigenetic assay is used to distinguish true-negative prostate biopsy results from false-negative biopsy results. RESULTS: Based on this analysis, administering the epigenetic assay to patients with histopathologically negative biopsies would result in a reduction of 1106 unnecessary biopsies for a health plan with 1 million members. The total 1-year cost of repeated prostate cancer biopsies to the health plan was found to be $2,864,142 in the reference scenario and $2,333,341 in the new scenario. This translates to a total budget impact, or an annual savings, of $530,801 to the plan. The total diagnostic cost was calculated to be $2584 per patient in the new scenario (using the genetic assay) compared with $3172 per patient in the reference scenario (that did not use the assay), resulting in a savings of $588 per patient management. CONCLUSION: This analysis shows that the net cost to a commercial health plan with 1 million members would be reduced by approximately $500,000 if patients with histopathologically negative biopsies were managed with the use of the epigenetic assay to differentiate patients who should undergo repeated biopsy and those who should not. Using this genetic-based assay can save costs to health plans and to the US healthcare and improve the clinical management of patients with elevated PSA levels.

The economic impact of aspergillosis: analysis of hospital expenditures across patient subgroups.

OBJECTIVE: To measure the impact of invasive aspergillosis infection on US hospital costs and financial performance across different patient populations. METHODS: Hospital discharge data for patients with a primary or secondary diagnosis of aspergillosis were extracted from the 2003 Nationwide Inpatient Sample (NIS) and the fiscal year 2003 (FYO3) Medicare Provider Analysis and Review (MedPAR) file. The data on patient demographics, length of stay (LOS), hospital charges, estimated costs, and reimbursement levels were reported. After controlling for comorbidities, operative procedures, and diagnosis-related group (DRG) assignment, the clinical and economic outcomes were compared for patients with and without aspergillosis. RESULTS: The NIS contains a total of over 38 million projected hospital discharges. From these, 10400 aspergillosis cases were identified across 171 DRGs, resulting in a US incidence rate of 36 per million per year. The mean age of aspergillosis patients was 55.6 years, with 53.4% male and 67.9% Caucasian. The median (mean) LOS per aspergillosis patient was 10 (17.7) days, with a median (mean) total hospital charge (THC) of $44,845 ($96,731). Among the patient subgroups analyzed, the median (mean) THC per patient ranged from $47,252 ($82,946) for HIV to $413,200 ($442,233) for bone marrow transplant (BMT). When compared to the non-aspergillosis patient population, the data showed a significant increase in LOS, THC, and hospital costs. Furthermore, the higher hospital costs associated with aspergillosis patients were not matched by similar increases in reimbursements, resulting in a greater financial loss for hospitals. The mean reimbursement-to-cost ratio for aspergillosis cases across the DRGs analyzed was 0.80. CONCLUSIONS: Aspergillosis affects a wide range of patient groups and has a negative economic impact across many DRGs. Improved prevention, diagnosis, and patient management strategies can help mitigate these effects on hospital financial performance.