Validation of Claims-Based Algorithm for Lyme Disease, Massachusetts, USA.

Compared with notifiable disease surveillance, claims-based algorithms estimate higher Lyme disease incidence, but their accuracy is unknown. We applied a previously developed Lyme disease algorithm (diagnosis code plus antimicrobial drug prescription dispensing within 30 days) to an administrative claims database in Massachusetts, USA, to identify a Lyme disease cohort during July 2000-June 2019. Clinicians reviewed and adjudicated medical charts from a cohort subset by using national surveillance case definitions. We calculated positive predictive values (PPVs). We identified 12,229 Lyme disease episodes in the claims database and reviewed and adjudicated 128 medical charts. The algorithm's PPV for confirmed, probable, or suspected cases was 93.8% (95% CI 88.1%-97.3%); the PPV was 66.4% (95% CI 57.5%-74.5%) for confirmed and probable cases only. In a high incidence setting, a claims-based algorithm identified cases with a high PPV, suggesting it can be used to assess Lyme disease burden and supplement traditional surveillance data.

Incidence and Outcomes of Non-Ventilator-Associated Hospital-Acquired Pneumonia in 284 US Hospitals Using Electronic Surveillance Criteria.

Importance: Non-ventilator-associated hospital-acquired pneumonia (NV-HAP) is a common and deadly hospital-acquired infection. However, inconsistent surveillance methods and unclear estimates of attributable mortality challenge prevention. Objective: To estimate the incidence, variability, outcomes, and population attributable mortality of NV-HAP. Design, Setting, and Participants: This cohort study retrospectively applied clinical surveillance criteria for NV-HAP to electronic health record data from 284 US hospitals. Adult patients admitted to the Veterans Health Administration hospital from 2015 to 2020 and HCA Healthcare hospitals from 2018 to 2020 were included. The medical records of 250 patients who met the surveillance criteria were reviewed for accuracy. Exposures: NV-HAP, defined as sustained deterioration in oxygenation for 2 or more days in a patient who was not ventilated concurrent with abnormal temperature or white blood cell count, performance of chest imaging, and 3 or more days of new antibiotics. Main Outcomes and Measures: NV-HAP incidence, length-of-stay, and crude inpatient mortality. Attributable inpatient mortality by 60 days follow-up was estimated using inverse probability weighting, accounting for both baseline and time-varying confounding. Results: Among 6 022 185 hospitalizations (median [IQR] age, 66 [54-75] years; 1 829 475 [26.1%] female), there were 32 797 NV-HAP events (0.55 per 100 admissions [95% CI, 0.54-0.55] per 100 admissions and 0.96 per 1000 patient-days [95% CI, 0.95-0.97] per 1000 patient-days). Patients with NV-HAP had multiple comorbidities (median [IQR], 6 [4-7]), including congestive heart failure (9680 [29.5%]), neurologic conditions (8255 [25.2%]), chronic lung disease (6439 [19.6%]), and cancer (5,467 [16.7%]); 24 568 cases (74.9%) occurred outside intensive care units. Crude inpatient mortality was 22.4% (7361 of 32 797) for NV-HAP vs 1.9% (115 530 of 6 022 185) for all hospitalizations; 12 449 (8.0%) were discharged to hospice. Median [IQR] length-of-stay was 16 (11-26) days vs 4 (3-6) days. On medical record review, pneumonia was confirmed by reviewers or bedside clinicians in 202 of 250 patients (81%). It was estimated that NV-HAP accounted for 7.3% (95% CI, 7.1%-7.5%) of all hospital deaths (total hospital population inpatient death risk of 1.87% with NV-HAP events included vs 1.73% with NV-HAP events excluded; risk ratio, 0.927; 95% CI, 0.925-0.929). Conclusions and Relevance: In this cohort study, NV-HAP, which was defined using electronic surveillance criteria, was present in approximately 1 in 200 hospitalizations, of whom 1 in 5 died in the hospital. NV-HAP may account for up to 7% of all hospital deaths. These findings underscore the need to systematically monitor NV-HAP, define best practices for prevention, and track their impact.

Pediatric surgical site infections in 287 hospitals in the United States, 2015-2018.

Among 287 US hospitals reporting data between 2015 and 2018, annual pediatric surgical site infection (SSI) rates ranged from 0% for gallbladder to 10.4% for colon surgeries. Colon, spinal fusion, and small-bowel SSI rates did not decrease with greater surgical volumes in contrast to appendix and ventricular-shunt SSI rates.

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

Importance: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment. Objective: To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs. Design, Setting, and Participants: The Implementation of a Randomized Controlled Trial to Improve Treatment With Oral Anticoagulants in Patients With Atrial Fibrillation (IMPACT-AFib) trial was a prospective, multicenter, open-label, pragmatic randomized clinical trial conducted from September 25, 2017, to May 1, 2019, embedded in health plans that participate in the US Food and Drug Administration's Sentinel System. It used the distributed database comprising health plan members to identify eligible patients, their clinicians, and outcomes. IMPACT-AFib enrolled patients with AF, a CHA2DS2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes, and stroke, transient ischemic attack or thromboembolism [2 points]-vascular disease, and sex category [female]) score of 2 or more, no evidence of OAC prescription dispensing in the preceding 12 months, and no hospitalization-related bleeding event within the prior 6 months. Interventions: Randomization to a single mailing of patient and/or clinician educational materials vs control. Main Outcomes and Measures: Analysis was performed on a modified intention-to-treat basis. The primary end point was the proportion of patients with at least 1 OAC prescription dispensed or at least 4 international normalized ratio test results within 1 year of the intervention. Results: Among 47 333 patients, there were 24 909 men (52.6%), the mean (SD) age was 77.9 (9.7) years, mean (SD) CHA2DS2-VASc score was 4.5 (1.7), 22 404 patients (47.3%) had an ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) bleeding risk score of 5 or more, and 8890 patients (18.8%) had a history of hospitalization for bleeding. There were 2328 of 23 546 patients (9.9%) in the intervention group with initiation of OAC at 1 year compared with 2330 of 23 787 patients (9.8%) in the control group (adjusted OR, 1.01 [95% CI, 0.95-1.07]; P = .79). Conclusions and Relevance: Among a large population with AF with a guideline indication for OACs for stroke prevention who were randomized to a mailed educational intervention or to usual care, there was no clinically meaningful, numerical, or statistically significant difference in rates of OAC initiation. More-intensive interventions are needed to try and address the public health issue of underuse of anticoagulation for stroke prevention among patients with AF. Trial Registration: ClinicalTrials.gov Identifier: NCT03259373.

Health Care-Associated Infections Among Critically Ill Children in the US, 2013-2018.

Importance: Central catheter-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) increase morbidity, mortality, and health care costs in pediatric patients. Objective: To examine changes over time in CLABSI and CAUTI rates between 2013 and 2018 in neonatal intensive care units (NICUs) and pediatric intensive care units (PICUs) using prospective surveillance data from community hospitals, children's hospitals, and pediatric units within general hospitals. Design, Setting, and Participants: This time series study included 176 US hospitals reporting pediatric health care-associated infection surveillance data to the National Healthcare Safety Network from January 1, 2013, to June 30, 2018. Patients aged 18 years or younger admitted to PICUs or level III NICUs were included in the analysis. Main Outcomes and Measures: The primary outcomes were device-associated rates of CLABSI in NICUs and PICUs and CAUTI in PICUs (infections per 1000 device-days). Secondary outcomes included population-based rates (infections per 10 000 patient-days) and device utilization (device-days per patient-days). Regression models were fit using generalized estimating equations to assess yearly changes in CLABSI and CAUTI rates, adjusted for birth weight (≤1500 vs >1500 g) in neonatal models. Results: Of the 176 hospitals, 132 hospitals with NICUs and 114 hospitals with PICUs contributed data. Of these, NICUs reported 6 064 172 patient-days and 1 363 700 central line-days and PICUs reported 1 999 979 patient-days, 925 956 central catheter-days, and 327 599 indwelling urinary catheter-days. In NICUs, there were no significant changes in yearly trends in device-associated (incidence rate ratio [IRR] per year, 0.99; 95% CI, 0.95-1.03) and population-based (IRR, 0.96; 95% CI, 0.92-1.00) CLABSI rates or central catheter utilization (odds ratio [OR], 0.97; 95% CI, 0.95-1.00). Results were similar in PICUs, with device-associated (IRR, 1.03; 95% CI, 0.99-1.07) and population-based (IRR, 1.03; 95% CI, 0.99-1.07) CLABSI rates and central catheter utilization (OR, 0.99; 95% CI, 0.97-1.01) remaining stable. While device-associated CAUTI rates in PICUs also remained unchanged over time (IRR, 0.97; 95% CI, 0.91-1.03), population-based CAUTI rates significantly decreased by 8% per year (IRR, 0.92; 95% CI, 0.86-0.98) and indwelling urinary catheter utilization significantly decreased by 6% per year (OR, 0.94; 95% CI, 0.91-0.96). Conclusions and Relevance: Recent trends in CLABSI rates noted in this study among critically ill neonates and children in a large cohort of US hospitals indicate that past gains have held, without evidence of further improvements, suggesting novel approaches for CLABSI prevention are needed. Modest improvements in population-based CAUTI rates likely reflect more judicious use of urinary catheters.

Association Between Federal Value-Based Incentive Programs and Health Care-Associated Infection Rates in Safety-Net and Non-Safety-Net Hospitals.

Importance: In the US, federal value-based incentive programs are more likely to penalize safety-net institutions than non-safety-net institutions. Whether these programs differentially change the rates of targeted health care-associated infections in safety-net vs non-safety-net hospitals is unknown. Objective: To assess the association of Hospital-Acquired Condition Reduction Program (HACRP) and Hospital Value-Based Purchasing (HVBP) implementation with changes in rates of targeted health care-associated infections and disparities in rates among safety-net and non-safety-net hospitals. Design, Setting, and Participants: This interrupted time series included all US acute care hospitals enrolled in the Preventing Avoidable Infectious Complications by Adjusting Payment study that participated in mandatory reporting to the National Healthcare Safety Network from January 1, 2013, through June 30, 2018. Hospital characteristics were obtained from the 2015 American Hospital Association annual survey. Penalty statuses for 2015 to 2018 were obtained from Hospital Compare. Data were analyzed between July 9, 2018, and October 1, 2019. Exposures: HACRP and HVBP implementation in fiscal year 2015 or 2016. Main Outcomes and Measures: The primary outcomes were rates of 4 health care-associated infections: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), surgical site infection (SSI) after colon surgical procedures, and SSI after abdominal hysterectomy procedures. Regression models were fit using generalized estimating equations to assess the association of HACRP and HVBP implementation with health care-associated infection rates and disparities in infection rates. Results: Of the 618 acute care hospitals included in this study, 473 (76.5%) were non-safety net and 145 (23.5%) were considered safety net. In these hospitals, HACRP and HVBP implementation was not associated with improvements in level or trend for any health care-associated infection examined (eg, CAUTI in safety-net hospitals: incidence rate ratio [IRR] for level change, 0.98 [95% CI, 0.79-1.23; P = .89]; IRR for change in slope, 1.00 [95% CI, 0.97-1.03; P = .80]). Before program implementation, infection rates were statistically significantly higher for safety-net than for non-safety-net hospitals for CLABSI (IRR, 1.23; 95% CI, 1.07-1.42; P = .004), CAUTI (IRR, 1.38; 95% CI, 1.16-1.64; P < .001), and SSI after colon surgical procedure (odds ratio [OR], 1.26; 95% CI, 1.06-1.50; P = .009). The disparity persisted over time when comparing the last year of the study with the first year (CLABSI: ratio of ratios [ROR], 0.93 [95% CI, 0.77-1.13; P = .48]; CAUTI: ROR, 0.90 [95% CI, 0.73-1.10; P = .31]; SSI after colon surgical procedures: ROR, 0.96 [95% CI, 0.78-1.20; P = .75]). Rates of SSI after abdominal hysterectomy procedure were similar in safety-net and non-safety-net hospitals before implementation (OR, 1.13; 95% CI, 0.91-1.40; P = .27) but higher after implementation (OR, 1.43; 95% CI, 1.11-1.83; P = .006), although this change was not significant (ROR, 1.20; 95% CI, 0.91-1.59; P = .20). Conclusions and Relevance: This study found that HACRP and HVBP implementation was not associated with any improvements in targeted health care-associated infections among safety-net or non-safety-net hospitals or with changes in disparities in infection rates. Given the persistent health care-associated infection rate disparities, these programs appear to function as a disproportionate penalty system for safety-net hospitals that offer no measurable benefits for patients.

Impact of Risk Adjustment Using Clinical vs Administrative Data on Hospital Sepsis Mortality Comparisons.

BACKGROUND: A reliable risk-adjusted sepsis outcome measure could complement current national process metrics by identifying outlier hospitals and catalyzing additional improvements in care. However, it is unclear whether integrating clinical data into risk adjustment models identifies similar high- and low-performing hospitals compared with administrative data alone, which are simpler to acquire and analyze. METHODS: We ranked 200 US hospitals by their Centers for Disease Control and Prevention Adult Sepsis Event (ASE) mortality rates and assessed how rankings changed after applying (1) an administrative risk adjustment model incorporating demographics, comorbidities, and codes for severe illness and (2) an integrated clinical and administrative model replacing severity-of-illness codes with laboratory results, vasopressors, and mechanical ventilation. We assessed agreement between hospitals' risk-adjusted ASE mortality rates when ranked into quartiles using weighted kappa statistics (к). RESULTS: The cohort included 4 009 631 hospitalizations, of which 245 808 met ASE criteria. Risk-adjustment had a large effect on rankings: 22/50 hospitals (44%) in the worst quartile using crude mortality rates shifted into better quartiles after administrative risk adjustment, and a further 21/50 (42%) of hospitals in the worst quartile using administrative risk adjustment shifted to better quartiles after incorporating clinical data. Conversely, 14/50 (28%) hospitals in the best quartile using administrative risk adjustment shifted to worse quartiles with clinical data. Overall agreement between hospital quartile rankings when risk-adjusted using administrative vs clinical data was moderate (к = 0.55). CONCLUSIONS: Incorporating clinical data into risk adjustment substantially changes rankings of hospitals' sepsis mortality rates compared with using administrative data alone. Comprehensive risk adjustment using both administrative and clinical data is necessary before comparing hospitals by sepsis mortality rates.

The impact of measurement changes on evaluating hospital performance: The case of catheter-associated urinary tract infections.

Catheter-associated urinary tract infections in 592 hospitals immediately declined after federal value-based incentive program implementation, but this was fully attributable to a concurrent surveillance case definition revision. Post revision, more hospitals had favorable standardized infection ratios, likely leading to artificial inflation of their performance scores unrelated to changes in patient safety.

Kawasaki disease and 13-valent pneumococcal conjugate vaccination among young children: A self-controlled risk interval and cohort study with null results.

BACKGROUND: Kawasaki disease is an acute vasculitis that primarily affects children younger than 5 years of age. Its etiology is unknown. The United States Vaccine Safety Datalink conducted postlicensure safety surveillance for 13-valent pneumococcal conjugate vaccine (PCV13), comparing the risk of Kawasaki disease within 28 days of PCV13 vaccination with the historical risk after 7-valent PCV (PCV7) vaccination and using chart-validation. A relative risk (RR) of 2.38 (95% CI 0.92-6.38) was found. Concurrently, the Food and Drug Administration (FDA) conducted a postlicensure safety review that identified cases of Kawasaki disease through adverse event reporting. The FDA decided to initiate a larger study of Kawasaki disease risk following PCV13 vaccination in the claims-based Sentinel/Postlicensure Rapid Immunization Safety Monitoring (PRISM) surveillance system. The objective of this study was to determine the existence and magnitude of any increased risk of Kawasaki disease in the 28 days following PCV13 vaccination. METHODS AND FINDINGS: The study population included mostly commercially insured children from birth to <24 months of age in 2010 to 2015 from across the US. Using claims data of participating Sentinel/PRISM data-providing organizations, PCV13 vaccinations were identified by means of current procedural terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and National Drug Code (NDC) codes. Potential cases of Kawasaki disease were identified by first-in-365-days International Classification of Diseases 9th revision (ICD-9) code 446.1 or International Classification of Diseases 10th revision (ICD-10) code M30.3 in the inpatient setting. Medical records were sought for potential cases and adjudicated by board-certified pediatricians. The primary analysis used chart-confirmed cases with adjudicated symptom onset in a self-controlled risk interval (SCRI) design, which controls for time-invariant potential confounders. The prespecified risk interval was Days 1-28 after vaccination; a 28-day-long control interval followed this risk interval. A secondary analytic approach used a cohort design, with alternative potential risk intervals of Days 1-28 and Days 1-42. The varying background risk of Kawasaki disease by age was adjusted for in both designs. In the primary analysis, there were 43 confirmed cases of Kawasaki disease in the risk interval and 44 in the control interval. The age-adjusted risk estimate was 1.07 (95% CI 0.70-1.63; p = 0.76). In the secondary, cohort analyses, which included roughly 700 potential cases and more than 3 million person-years, the risk estimates of potential Kawasaki disease in the risk interval versus in unexposed person-time were 0.84 (95% CI 0.65-1.08; p = 0.18) for the Days 1-28 risk interval and 0.97 (95% CI 0.79-1.19; p = 0.80) for the Days 1-42 risk interval. The main limitation of the study was that we lacked the resources to conduct medical record review for all the potential cases of Kawasaki disease. As a result, potential cases rather than chart-confirmed cases were used in the cohort analyses. CONCLUSIONS: With more than 6 million doses of PCV13 administered, no evidence was found of an association between PCV13 vaccination and Kawasaki disease onset in the 4 weeks after vaccination nor of an elevated risk extending or concentrated somewhat beyond 4 weeks. These null results were consistent across alternative designs, age-adjustment methods, control intervals, and categories of Kawasaki disease case included.

Risk Adjustment for Sepsis Mortality to Facilitate Hospital Comparisons Using Centers for Disease Control and Prevention's Adult Sepsis Event Criteria and Routine Electronic Clinical Data.

Variability in hospital-level sepsis mortality rates may be due to differences in case mix, quality of care, or diagnosis and coding practices. Centers for Disease Control and Prevention's Adult Sepsis Event definition could facilitate objective comparisons of sepsis mortality rates between hospitals but requires rigorous risk-adjustment tools. We developed risk-adjustment models for Adult Sepsis Events using administrative and electronic health record data. DESIGN: Retrospective cohort study. SETTING: One hundred thirty-six U.S. hospitals in Cerner HealthFacts (derivation dataset) and 137 HCA Healthcare hospitals (validation dataset). PATIENTS: A total of 95,154 hospitalized adult patients (derivation) and 201,997 patients (validation) meeting Centers for Disease Control and Prevention Adult Sepsis Event criteria. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We created logistic regression models of increasing complexity using administrative and electronic health record data to predict in-hospital mortality. An administrative model using demographics, comorbidities, and coded markers of severity of illness at admission achieved an area under the receiver operating curve of 0.776 (95% CI, 0.770-0.783) in the Cerner cohort, with diminishing calibration at higher baseline risk deciles. An electronic health record-based model that integrated administrative data with laboratory results, vasopressors, and mechanical ventilation achieved an area under the receiver operating curve of 0.826 (95% CI, 0.820-0.831) in the derivation cohort and 0.827 (95% CI, 0.824-0.829) in the validation cohort, with better calibration than the administrative model. Adding vital signs and Glasgow Coma Score minimally improved performance. CONCLUSIONS: Models incorporating electronic health record data accurately predict hospital mortality for patients with Adult Sepsis Events and outperform models using administrative data alone. Utilizing laboratory test results, vasopressors, and mechanical ventilation without vital signs may achieve a good balance between data collection needs and model performance, but electronic health record-based models must be attentive to potential variability in data quality and availability. With ongoing testing and refinement of these risk-adjustment models, Adult Sepsis Event surveillance may enable more meaningful comparisons of hospital sepsis outcomes and provide an important window into quality of care.

Variation in Identifying Sepsis and Organ Dysfunction Using Administrative Versus Electronic Clinical Data and Impact on Hospital Outcome Comparisons.

OBJECTIVES: Administrative claims data are commonly used for sepsis surveillance, research, and quality improvement. However, variations in diagnosis, documentation, and coding practices for sepsis and organ dysfunction may confound efforts to estimate sepsis rates, compare outcomes, and perform risk adjustment. We evaluated hospital variation in the sensitivity of claims data relative to clinical data from electronic health records and its impact on outcome comparisons. DESIGN, SETTING, AND PATIENTS: Retrospective cohort study of 4.3 million adult encounters at 193 U.S. hospitals in 2013-2014. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Sepsis was defined using electronic health record-derived clinical indicators of presumed infection (blood culture draws and antibiotic administrations) and concurrent organ dysfunction (vasopressors, mechanical ventilation, doubling in creatinine, doubling in bilirubin to ≥ 2.0 mg/dL, decrease in platelets to < 100 cells/µL, or lactate ≥ 2.0 mmol/L). We compared claims for sepsis prevalence and mortality rates between both methods. All estimates were reliability adjusted to account for random variation using hierarchical logistic regression modeling. The sensitivity of hospitals' claims data was low and variable: median 30% (range, 5-54%) for sepsis, 66% (range, 26-84%) for acute kidney injury, 39% (range, 16-60%) for thrombocytopenia, 36% (range, 29-44%) for hepatic injury, and 66% (range, 29-84%) for shock. Correlation between claims and clinical data was moderate for sepsis prevalence (Pearson coefficient, 0.64) and mortality (0.61). Among hospitals in the lowest sepsis mortality quartile by claims, 46% shifted to higher mortality quartiles using clinical data. Using implicit sepsis criteria based on infection and organ dysfunction codes also yielded major differences versus clinical data. CONCLUSIONS: Variation in the accuracy of claims data for identifying sepsis and organ dysfunction limits their use for comparing hospitals' sepsis rates and outcomes. Using objective clinical data may facilitate more meaningful hospital comparisons.

Comparison of hospital surgical site infection rates and rankings using claims versus National Healthcare Safety Network surveillance data.

National policies target healthcare-associated infections using medical claims and National Healthcare Safety Network surveillance data. We found low concordance between the 2 data sources in rates and rankings for surgical site infection following colon surgery in 155 hospitals, underscoring the limitations in evaluating hospital quality by claims data.

Impact of the 2012 Medicaid Health Care-Acquired Conditions Policy on Catheter-Associated Urinary Tract Infection and Vascular Catheter-Associated Infection Billing Rates.

In July 2012, the Centers for Medicare & Medicaid Services ceased hospital Medicaid reimbursements for certain health care-acquired conditions. Using billing data from 2008-2014, we found no impact of this policy on rates of 2 targeted conditions, vascular catheter-associated infections and catheter-associated urinary tract infections, among Medicaid or non-Medicaid patients.

Centers for medicare and medicaid services hospital-acquired conditions policy for central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) shows minimal impact on hospital reimbursement.

OBJECTIVE: In 2008, the Centers for Medicare and Medicaid Services (CMS) stopped reimbursing for hospital-acquired conditions (HACs) not present on admission (POA). We sought to understand why this policy did not impact central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) trends. DESIGN: Retrospective cohort study. SETTING: Acute-care hospitals in the United States.ParticipantsFee-for-service Medicare patients discharged January 1, 2007, through December 31, 2011. METHODS: Using inpatient Medicare claims data, we analyzed billing practices before and after the HAC policy was implemented, including the use and POA designation of codes for CLABSI or CAUTI. For the 3-year period following policy implementation, we determined the impact on diagnosis-related groups (DRG) determining reimbursement as well as hospital characteristics associated with the reimbursement impact. RESULTS: During the study period, 65,205,607 Medicare fee-for-service hospitalizations occurred at 3,291 acute-care, nonfederal US hospitals. Based on coding, CLABSI and CAUTI affected 0.23% and 0.06% of these hospitalizations, respectively. In addition, following the HAC policy, 82% of the CLABSI codes and 91% of the CAUTI codes were marked POA, which represented a large increase in the use of this designation. Finally, for the small numbers of CLABSI and CAUTI coded as not POA, financial impacts were detected on only 0.4% of the hospitalizations with a CLABSI code and 5.7% with a CAUTI code. CONCLUSIONS: Part of the reason the HAC policy did not have its intended impact is that billing codes for CLABSI and CAUTI were rarely used, were commonly listed as POA in the postpolicy period, and infrequently impacted hospital reimbursement.

The Impact of the Medicaid Healthcare-Associated Condition Program on Mediastinitis Following Coronary Artery Bypass Graft.

OBJECTIVEIn 2012, the Centers for Medicare and Medicaid Services expanded a 2008 program that eliminated additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) to include Medicaid. We aimed to evaluate the impact of this Medicaid program on mediastinitis rates reported by the National Healthcare Safety Network (NHSN) compared with the rates of a condition not targeted by the program, deep-space surgical site infection (SSI) after knee replacement.DESIGNInterrupted time series with comparison group.METHODSWe included surveillance data from nonfederal acute-care hospitals participating in the NHSN and reporting CABG or knee replacement outcomes from January 2009 through June 2017. We examined the Medicaid program's impact on NHSN-reported infection rates, adjusting for secular trends. The data analysis used generalized estimating equations with robust sandwich variance estimators.RESULTSDuring the study period, 196 study hospitals reported 273,984 CABGs to the NHSN, resulting in 970 mediastinitis cases (0.35%), and 294 hospitals reported 555,395 knee replacements, with 1,751 resultant deep-space SSIs (0.32%). There was no significant change in incidence of either condition during the study. Mediastinitis models showed no effect of the 2012 Medicaid program on either secular trend during the postprogram versus preprogram periods (P=.70) or an immediate program effect (P=.83). Results were similar in sensitivity analyses when adjusting for hospital characteristics, restricting to hospitals with consistent NHSN reporting or incorporating a program implementation roll-in period. Knee replacement models also showed no program effect.CONCLUSIONSThe 2012 Medicaid program to eliminate additional payments for mediastinitis following CABG had no impact on reported mediastinitis rates.Infect Control Hosp Epidemiol 2018;39:694-700.

Impact of Hospital Operating Margin on Central Line-Associated Bloodstream Infections Following Medicare's Hospital-Acquired Conditions Payment Policy.

In October 2008, Medicare ceased additional payment for hospital-acquired conditions not present on admission. We evaluated the policy's differential impact in hospitals with high vs low operating margins. Medicare's payment policy may have had an impact on reducing central line-associated bloodstream infections in hospitals with low operating margins. Infect. Control Hosp. Epidemiol. 2015;37(1):100-103.

Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.

PURPOSE: To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini-Sentinel Pilot), a Food and Drug Administration-sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly. METHODS: Three Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self-controlled risk interval design (primary) and a cohort design (secondary). After each data update, we conducted sequential analysis for inactivated (IIV) and live (LAIV) influenza vaccines using the Maximized Sequential Probability Ratio Test, adjusting for data-lag. RESULTS: Most of the 10 sequential analyses were conducted within 6 weeks of the last care-date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 doses of LAIV were captured. The primary analyses did not identify any statistical signals following IIV or LAIV. In secondary analysis, the risk of seizures was higher following concomitant IIV and PCV13 than historically after IIV in 6- to 23-month-olds (relative risk = 2.7), which requires further investigation. CONCLUSIONS: The Sentinel System can implement a sequential analysis system that uses fresh data for medical product safety surveillance. Active surveillance using sequential analysis of fresh data holds promise for detecting clinically significant health risks early. Limitations of employing fresh data for surveillance include cost and the need for careful scrutiny of signals. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females.

After the Food and Drug Administration (FDA) licensed quadrivalent human papillomavirus vaccine (HPV4) in 2006, reports suggesting a possible association with venous thromboembolism (VTE) emerged from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink. Our objective was to determine whether HPV4 increased VTE risk. The subjects were 9-26-year-old female members of five data partners in the FDA's Mini-Sentinel pilot project receiving HPV4 during 2006-2013. The outcome was radiologically confirmed first-ever VTE among potential cases identified by diagnosis codes in administrative data during Days 1-77 after HPV4 vaccination. With a self-controlled risk interval design, we compared counts of first-ever VTE in risk intervals (Days 1-28 and Days 1-7 post-vaccination) and control intervals (Days 36-56 for Dose 1 and Days 36-63 for Doses 2 and 3). Combined hormonal contraceptive use was treated as a potential confounder. The main analyses were: (1) unadjusted for time-varying VTE risk from contraceptive use, (2) unadjusted but restricted to cases without such time-varying risk, and (3) adjusted by incorporating the modeled risk of VTE by week of contraceptive use in the analysis. Of 279 potential VTE cases identified following 1,423,399 HPV4 doses administered, 225 had obtainable charts, and 53 were confirmed first-ever VTE. All 30 with onsets in risk or control intervals had known risk factors for VTE. VTE risk was not elevated in the first 7 or 28 days following any dose of HPV in any analysis (e.g. relative risk estimate (95% CI) from both unrestricted analyses, for all-doses, 28-day risk interval: 0.7 (0.3-1.4)). Temporal scan statistics found no clustering of VTE onsets after any dose. Thus, we found no evidence of an increased risk of VTE associated with HPV4 among 9-26-year-old females. A particular strength of this evaluation was its control for both time-invariant and contraceptive-related time-varying potential confounding.

Impact of the Centers for Medicare and Medicaid Services Hospital-Acquired Conditions Policy on Billing Rates for 2 Targeted Healthcare-Associated Infections.

BACKGROUND: The 2008 Centers for Medicare & Medicaid Services hospital-acquired conditions policy limited additional payment for conditions deemed reasonably preventable. OBJECTIVE: To examine whether this policy was associated with decreases in billing rates for 2 targeted conditions, vascular catheter-associated infections (VCAI) and catheter-associated urinary tract infections (CAUTI). STUDY POPULATION: Adult Medicare patients admitted to 569 acute care hospitals in California, Massachusetts, or New York and subject to the policy. DESIGN We used an interrupted times series design to assess whether the hospital-acquired conditions policy was associated with changes in billing rates for VCAI and CAUTI. RESULTS: Before the policy, billing rates for VCAI and CAUTI were increasing (prepolicy odds ratio per quarter for VCAI, 1.17 [95% CI, 1.11-1.23]; for CAUTI, 1.19 [1.16-1.23]). The policy was associated with an immediate drop in billing rates for VCAI and CAUTI (odds ratio for change at policy implementation for VCAI, 0.75 [95% CI, 0.69-0.81]; for CAUTI, 0.87 [0.79-0.96]). In the postpolicy period, we observed a decreasing trend in the billing rate for VCAI and a leveling-off in the billing rate for CAUTI (postpolicy odds ratio per quarter for VCAI, 0.98 [95% CI, 0.97-0.99]; for CAUTI, 0.99 [0.97-1.00]). CONCLUSIONS: The Centers for Medicare & Medicaid Services hospital-acquired conditions policy appears to have been associated with immediate reductions in billing rates for VCAI and CAUTI, followed by a slight decreasing trend or leveling-off in rates. These billing rates, however, may not correlate with changes in clinically meaningful patient outcomes and may reflect changes in coding practices.