Antithrombin testing and treatment in pregnancy: Their real-world relationship to clinical outcomes.

BACKGROUND: Antithrombin (AT) deficiency is a severe thrombophilia associated with increased rates of maternal morbidity, mortality, and greater healthcare resource utilization during pregnancy and postpartum. METHODS: Two large U.S. healthcare databases were queried for women aged 15-44 with delivery-related encounters: Cerner Real-World Data (CRWD, 01/01/2000-12/31/2021) and Premier Healthcare Database (PHD, 01/01/2016-01/01/2019). Individuals receiving cardiopulmonary bypass were excluded. Three cohorts were created: 1) Individuals who had AT levels tested any time between 9-months pre- through 3-months post-delivery (CRWD Test Cohort); 2) individuals prescribed AT concentrate (ATc) within 1-year pre- or 1-year post-delivery in CRWD (CRWD Medication Cohort); and 3) the same criteria as 2) applied to PHD (PHD Medication Cohort). RESULTS: There were 5411 individuals in the CRWD Test Cohort, 13 in the CRWD Medication Cohort and 38 in the PHD Medication Cohort. Demographic and baseline clinical characteristics were similar across cohorts. AT level testing occurred pre-delivery in 47.9 % of the CRWD Test Cohort and 23.1 % of the CRWD Medication Cohort. ATc was administered during the delivery hospitalization to 0.1 %, 23.1 % and 50.0 % of the CRWD Test, CRWD Medication, and PHD Medication Cohorts, respectively. Across cohorts, 5.4-7.9 % of individuals experienced thrombosis during the delivery-related encounter. Mean (SD) total costs for delivery through 1-year post-delivery were $190,894 ($276,893) with $123,763 ($177,122) of total costs related to abnormal coagulation. CONCLUSION: Opportunities exist to enhance the care of pregnant individuals with low AT levels throughout pregnancy, aiming for optimal maternal outcomes.

Evaluation of Preanalytical Point-of-Care Testing Errors and Their Impact on Productivity in the Emergency Department in the United States.

BACKGROUND: Preanalytical errors due to poor sample quality or improper sample handling may occur with point-of-care testing (POCT). METHODS: A retrospective analysis was conducted using deidentified records for 15 479 i-STAT® cartridges run at the Oregon Health & Science University Emergency Department (ED) between December 2015 and August 2016. Data were collected from electronic health records and device middleware for CG4+, CHEM8+, and Troponin cartridges. The frequency of POCT errors was evaluated by cartridge type. The effect of user experience on error frequency, impact of error on hospital length of stay (LOS), and test turnaround time (TAT) were all evaluated. Direct costs incurred due to Chem8+ and Troponin cartridge waste and indirect costs as avoidable nursing staff labor were estimated over 2 years. RESULTS: A total of 935 erroneous results were identified (6.0% of all cartridges). Three hundred seventy-two (2.4%) were unusable results, and 563 (3.6%) were cartridge errors, of which 163 were classified by device error codes as poor sample quality/improper sample handling. Error rates were inversely correlated with user experience based on number of tests performed during the 9-month period. Compared to nonerroneous results, test TATs and LOS were significantly longer with erroneous results (P < 0.01). Over 2 years, direct costs incurred due to cartridge waste was $45 000, and indirect cost was estimated between 486 and 729 h in avoidable nursing labor. CONCLUSIONS: Preanalytical POCT errors were inversely correlated with user experience and significantly impacted clinical productivity in the ED based on LOS and test TAT.

Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding.

Closed-system transfer devices mitigate occupational exposure risks associated with hazardous-drug handling. This study was conducted in a controlled laboratory to evaluate the effectiveness of a needle-free and a needle-based closed-system transfer device in minimizing surface contamination during simulated compounding, preparation, and administration. A needle-based and a needle-free closed-system transfer device underwent three trials per system. Each trial included reconstituting cyclophosphamide in a vial, withdrawing cyclophosphamide from the vial, and pushing cyclophosphamide into an intravenous bag. After every trial, wipe samples were collected from five sources: biological safety cabinet workbench (left and right sides), biological safety cabinet grill, biological safety cabinet airfoil, and technicians' gloves. Wipe samples were then analyzed using high-performance liquid chromatography with dual-mass spectrometry to measure cyclophosphamide concentrations. Surface contamination levels from 30 post-trial tests (15 per device) are reported, representing five different surface wipe samples from three trials for each device. Pre-trial samples of precleaned vials and work surfaces were obtained to ensure no cyclophosphamide contamination. Field blank samples were analyzed for quality-control purposes. Post-trial wipe sample analyses following each of the three needle- free trials did not detect cyclophosphamide on the biological safety cabinet workbench (both left/right), biological safety cabinet grill, biological safety cabinet airfoil, or the technician's gloves. For the needle-based closed-system transfer device, the wipe sample analyses after the first trial showed no contamination; however, cyclophosphamide was detected on the right biological safety cabinet workbench at concentrations of 0.223 ng/cm2 and 0.021 ng/cm2, respectively, following the second and third trials. No cyclophosphamide was found on the technician's gloves after any of the three needle- based closed-system transfer device trials. Based on surface contamination analyses, this study verified the ability of a needle-free closed-system transfer device in preventing the escape of cyclophosphamide during simulated compounding and preparation. Needle-free closed-system transfer devices warrant consideration for the handling of hazardous drugs.

Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding.

Closed-system transfer devices mitigate occupational exposure risks associated with hazardous-drug handling. This study was conducted in a controlled laboratory to evaluate the effectiveness of a needle-free and a needle-based closed-system transfer device in minimizing surface contamination during simulated compounding, preparation, and administration. A needle-based and a needle-free closed-system transfer device underwent three trials per system. Each trial included reconstituting cyclophosphamide in a vial, withdrawing cyclophosphamide from the vial, and pushing cyclophosphamide into an intravenous bag. After every trial, wipe samples were collected from five sources: biological safety cabinet workbench (left and right sides), biological safety cabinet grill, biological safety cabinet airfoil, and technicians' gloves. Wipe samples were then analyzed using high-performance liquid chromatography with dual-mass spectrometry to measure cyclophosphamide concentrations. Surface contamination levels from 30 post-trial tests (15 per device) are reported, representing five different surface wipe samples from three trials for each device. Pre-trial samples of precleaned vials and work surfaces were obtained to ensure no cyclophosphamide contamination. Field blank samples were analyzed for quality-control purposes. Post-trial wipe sample analyses following each of the three needle- free trials did not detect cyclophosphamide on the biological safety cabinet workbench (both left/right), biological safety cabinet grill, biological safety cabinet airfoil, or the technician's gloves. For the needle-based closed-system transfer device, the wipe sample analyses after the first trial showed no contamination; however, cyclophosphamide was detected on the right biological safety cabinet workbench at concentrations of 0.223 ng/cm2 and 0.021 ng/cm2, respectively, following the second and third trials. No cyclophosphamide was found on the technician's gloves after any of the three needle- based closed-system transfer device trials. Based on surface contamination analyses, this study verified the ability of a needle-free closed-system transfer device in preventing the escape of cyclophosphamide during simulated compounding and preparation. Needle-free closed-system transfer devices warrant consideration for the handling of hazardous drugs.

Driving Access and Quality: A Shift to Value-Based Behavioral Health Care.

Multiple barriers exist to accessing behavioral health care, and several are related to payment. The national shortage of behavioral health providers is exacerbated by their not joining health insurance networks, often shifting the cost of treatment to patients. In the face of high out-of-network expenses, deductibles, and copays, many insured patients forgo behavioral health treatment altogether. However, even when patients access care, health outcomes are not routinely measured, and there is reason to suspect that the quality of care is poor. To address these issues, value-based reimbursement for behavioral health care offers a sustainable pathway to increase payment for providers in return for improved population health outcomes and costs. This article describes a comprehensive collaborative effort between a payer and a health care technology and services organization to support behavioral health providers to enter into value-based care. This approach changes financial incentives to drive improvements in behavioral health care access and quality.

Systematic review and meta-analysis of patient race/ethnicity, socioeconomics, and quality for adult type 2 diabetes.

OBJECTIVE: To review the evidence of the association between performance in eight indicators of diabetes care and a patient's race/ethnicity and socioeconomic characteristics. DATA SOURCE: Studies of adult patients with type 2 diabetes in MEDLINE published between January 1, 2000, and December 31, 2018. STUDY DESIGN: Systematic review and meta-analysis of regression-based studies including race/ethnicity and income or education as explanatory variables. Meta-analysis was used to quantify differences in performance associated with patient race/ethnicity or socioeconomic characteristics. The systematic review was used to identify potential mechanisms of disparities. DATA COLLECTION: Two coauthors separately conducted abstract screening, study exclusions, data extraction, and scoring of retained studies. Estimates in retained studies were extracted and, where applicable, were standardized and converted to odds ratios and standard errors. PRINCIPAL FINDINGS: Performance in intermediate outcomes and process measures frequently exhibited differences by race/ethnicity even after adjustment for socioeconomic, lifestyle, and health factors. Meta-analyses showed black patients had lower odds of HbA1c and blood pressure (BP) control (OR range: 0.67-0.68, P < .05) but higher odds of receiving eye or foot examination (OR range: 1.22-1.47, P < .05) relative to white patients. A high school degree or more was associated with higher odds of HbA1c control and receipt of eye examinations compared to patients without a degree. Meta-analyses of income included a handful of studies and were inconsistently associated with diabetes care performance. Differences in diabetes performance appear to be related to access-related factors such as uninsurance or lacking a usual source of care; food insecurity and trade-offs at very low incomes; and lower adherence among younger and healthier diabetes patients. CONCLUSIONS: Patient race/ethnicity and education were associated with differences in diabetes quality measures. Depending on the approach used to rate providers, not adjusting for these patient characteristics may penalize or reward providers based on the populations they serve.

Promoting Value and Reducing Costs in Medicaid Transformation.

The success of Medicaid transformation in North Carolina depends on participating health plans' ability to bring about better value to deliver on the Triple Aim of health care. Blue Cross and Blue Shield of North Carolina, working in collaboration with Amerigroup Partnership Plan, LLC, is making value-based care a cornerstone of its approach to serving the state's Medicaid population.

A preliminary evaluation of glial cell line-derived neurotrophic factor (GDNF) levels in cerebrospinal fluid across various gestational ages and clinical conditions of the neonate.

BACKGROUND: This study aims to investigate glial cell derived neurotrophic factor (GDNF) levels in newborns' umbilical cord blood and cerebrospinal fluid across various perinatal growth parameters and clinical conditions. METHODS: Cord blood from 20 newborns and 58 residual CSF samples (stored after completion of clinical testing) were collected. GDNF levels were determined using GDNF ELISA kits from R&D Systems in triplicates with appropriate controls to eliminate background. RESULTS: Cord blood GDNF levels were significantly higher (p=0.004) in preterm newborns (n=6) (115.05±57.17,pg/ml) when compared to term newborns (n=14) (19.67±10.67,pg/ml). GDNF levels in CSF trended (p=0.07) higher in term newborns (n=10) (19.56±9.11,pg/ml) when compared to preterm newborns at term or post term corrected gestational ages (n=5) (14.49±3.53,pg/ml). CONCLUSIONS: GDNF levels in preterm newborns were higher in cord blood and lower in CSF as compared to term newborns. It is important to further study circulating and CSF-GDNF levels in newborns at different gestational ages and clinical conditions.

Design Challenges of an Episode-Based Payment Model in Oncology: The Centers for Medicare & Medicaid Services Oncology Care Model.

The Centers for Medicare & Medicaid Services developed the Oncology Care Model as an episode-based payment model to encourage participating practitioners to provide higher-quality, better-coordinated care at a lower cost to the nearly three-quarter million fee-for-service Medicare beneficiaries with cancer who receive chemotherapy each year. Episode payment models can be complex. They combine into a single benchmark price all payments for services during an episode of illness, many of which may be delivered at different times by different providers in different locations. Policy and technical decisions include the definition of the episode, including its initiation, duration, and included services; the identification of beneficiaries included in the model; and beneficiary attribution to practitioners with overall responsibility for managing their care. In addition, the calculation and risk adjustment of benchmark episode prices for the bundle of services must reflect geographic cost variations and diverse patient populations, including varying disease subtypes, medical comorbidities, changes in standards of care over time, the adoption of expensive new drugs (especially in oncology), as well as diverse practice patterns. Other steps include timely monitoring and intervention as needed to avoid shifting the attribution of beneficiaries on the basis of their expected episode expenditures as well as to ensure the provision of necessary medical services and the development of a meaningful link to quality measurement and improvement through the episode-based payment methodology. The complex and diverse nature of oncology business relationships and the specific rules and requirements of Medicare payment systems for different types of providers intensify these issues. The Centers for Medicare & Medicaid Services believes that by sharing its approach to addressing these decisions and challenges, it may facilitate greater understanding of the model within the oncology community and provide insight to others considering the development of episode-based payment models in the commercial or government sectors.

Effects of maternal medication use on NGF and IL-6 levels in human breast milk.

BACKGROUND: The objective of this study was to evaluate the effect of maternal medications on nerve growth factor (NGF) and interleukin-6 (IL-6) levels in human breast milk (HBM). METHODS: A total of 30 samples of HBM were collected after consent from consecutively born term newborns. NGF and IL-6 concentrations were analyzed using ELISA assays from R&D Systems. The HBM samples were centrifuged, and the clear portion of the HBM after discarding the fat was analyzed and cytokine data were expressed as NGFC or IL-6C. Ten samples of HBM, which were not centrifuged, were also used in ELISA assays and cytokine data were expressed as NGFF or IL-6F. RESULTS: After exposure to NSAIDs (7636 ± 9610, mean ± SD, pg/mL), the NGFC levels in HBM were significantly higher as compared to those who were exposed to narcotics (522 ± 1000) (p = 0.008). NGFC and IL-6C levels positively correlated with each other in HBM (R = 0.194 p < 0.0001). NGFC levels (360 ± 237) were significantly lower than NGFF levels (888 ± 751) (p < 0.0001). IL-6F was higher than IL-6C levels without statistical significance. CONCLUSION: Further studies are warranted to elucidate effect of maternal medications on cytokine changes in HBM and effect of these cytokine changes on newborn gastrointestinal milieu.

Association Between Hospital Participation in a Medicare Bundled Payment Initiative and Payments and Quality Outcomes for Lower Extremity Joint Replacement Episodes.

IMPORTANCE: Bundled Payments for Care Improvement (BPCI) is a voluntary initiative of the Centers for Medicare & Medicaid Services to test the effect of holding an entity accountable for all services provided during an episode of care on episode payments and quality of care. OBJECTIVE: To evaluate whether BPCI was associated with a greater reduction in Medicare payments without loss of quality of care for lower extremity joint (primarily hip and knee) replacement episodes initiated in BPCI-participating hospitals that are accountable for total episode payments (for the hospitalization and Medicare-covered services during the 90 days after discharge). DESIGN, SETTING, AND PARTICIPANTS: A difference-in-differences approach estimated the differential change in outcomes for Medicare fee-for-service beneficiaries who had a lower extremity joint replacement at a BPCI-participating hospital between the baseline (October 2011 through September 2012) and intervention (October 2013 through June 2015) periods and beneficiaries with the same surgical procedure at matched comparison hospitals. EXPOSURE: Lower extremity joint replacement at a BPCI-participating hospital. MAIN OUTCOMES AND MEASURES: Standardized Medicare-allowed payments (Medicare payments), utilization, and quality (unplanned readmissions, emergency department visits, and mortality) during hospitalization and the 90-day postdischarge period. RESULTS: There were 29 441 lower extremity joint replacement episodes in the baseline period and 31 700 in the intervention period (mean [SD] age, 74.1 [8.89] years; 65.2% women) at 176 BPCI-participating hospitals, compared with 29 440 episodes in the baseline period (768 hospitals) and 31 696 episodes in the intervention period (841 hospitals) (mean [SD] age, 74.1 [8.92] years; 64.9% women) at matched comparison hospitals. The BPCI mean Medicare episode payments were $30 551 (95% CI, $30 201 to $30 901) in the baseline period and declined by $3286 to $27 265 (95% CI, $26 838 to $27 692) in the intervention period. The comparison mean Medicare episode payments were $30 057 (95% CI, $29 765 to $30 350) in the baseline period and declined by $2119 to $27 938 (95% CI, $27 639 to $28 237). The mean Medicare episode payments declined by an estimated $1166 more (95% CI, -$1634 to -$699; P < .001) for BPCI episodes than for comparison episodes, primarily due to reduced use of institutional postacute care. There were no statistical differences in the claims-based quality measures, which included 30-day unplanned readmissions (-0.1%; 95% CI, -0.6% to 0.4%), 90-day unplanned readmissions (-0.4%; 95% CI, -1.1% to 0.3%), 30-day emergency department visits (-0.1%; 95% CI, -0.7% to 0.5%), 90-day emergency department visits (0.2%; 95% CI, -0.6% to 1.0%), 30-day postdischarge mortality (-0.1%; 95% CI, -0.3% to 0.2%), and 90-day postdischarge mortality (-0.0%; 95% CI, -0.3% to 0.3%). CONCLUSIONS AND RELEVANCE: In the first 21 months of the BPCI initiative, Medicare payments declined more for lower extremity joint replacement episodes provided in BPCI-participating hospitals than for those provided in comparison hospitals, without a significant change in quality outcomes. Further studies are needed to assess longer-term follow-up as well as patterns for other types of clinical care.

Patterns of care for clinically distinct segments of high cost Medicare beneficiaries.

BACKGROUND: Efforts to improve the efficiency of care for the Medicare population commonly target high cost beneficiaries. We describe and evaluate a novel management approach, population segmentation, for identifying and managing high cost beneficiaries. METHODS: A retrospective cross-sectional analysis of 6,919,439 Medicare fee-for-service beneficiaries in 2012. We defined and characterized eight distinct clinical population segments, and assessed heterogeneity in managing practitioners. RESULTS: The eight segments comprised 9.8% of the population and 47.6% of annual Medicare payments. The eight segments included 61% and 69% of the population in the top decile and top 5% of annual Medicare payments. The positive-predictive values within each segment for meeting thresholds of Medicare payments ranged from 72% to 100%, 30% to 83%, and 14% to 56% for the upper quartile, upper decile, and upper 5% of Medicare payments respectively. Sensitivity and positive-predictive values were substantially improved over predictive algorithms based on historical utilization patterns and comorbidities. The mean [95% confidence interval] number of unique practitioners and practices delivering E&M services ranged from 1.82 [1.79-1.84] to 6.94 [6.91-6.98] and 1.48 [1.46-1.50] to 4.98 [4.95-5.00] respectively. The percentage of cognitive services delivered by primary care practitioners ranged from 23.8% to 67.9% across segments, with significant variability among specialty types. CONCLUSIONS: Most high cost Medicare beneficiaries can be identified based on a single clinical reason and are managed by different practitioners. IMPLICATIONS: Population segmentation holds potential to improve efficiency in the Medicare population by identifying opportunities to improve care for specific populations and managing clinicians, and forecasting and evaluating the impact of specific interventions.