Impact of periodontal therapy on general health: evidence from insurance data for five systemic conditions.

BACKGROUND: Treatment of periodontal (gum) disease may lessen the adverse consequences of some chronic systemic conditions. PURPOSE: To estimate the effects of periodontal therapy on medical costs and hospitalizations among individuals with diagnosed type 2 diabetes (T2D); coronary artery disease (CAD); cerebral vascular disease (CVD); rheumatoid arthritis (RA); and pregnancy in a retrospective observational cohort study. METHODS: Insurance claims data from 338,891 individuals with both medical and dental insurance coverage were analyzed in 2011-2013. Inclusion criteria were (1) a diagnosis of at least one of the five specified systemic conditions and (2) evidence of periodontal disease. Subjects were categorized according to whether they had completed treatment for periodontal disease in the baseline year, 2005. Outcomes were (1) total allowed medical costs and (2) number of hospitalizations, per subscriber per year, in 2005-2009. Except in the case of pregnancy, outcomes were aggregated without regard to reported cause. Individuals who were treated and untreated for periodontal disease were compared independently for the two outcomes and five systemic conditions using ANCOVA; age, gender, and T2D status were covariates. RESULTS: Statistically significant reductions in both outcomes (p<0.05) were found for T2D, CVD, CAD, and pregnancy, for which costs were lower by 40.2%, 40.9%, 10.7%, and 73.7%, respectively; results for hospital admissions were comparable. No treatment effect was observed in the RA cohorts. CONCLUSIONS: These cost-based results provide new, independent, and potentially valuable evidence that simple, noninvasive periodontal therapy may improve health outcomes in pregnancy and other systemic conditions.

Algorithms for identification of Guillain-Barré Syndrome among adolescents in claims databases.

BACKGROUND: Health insurance claims databases can provide data for studies of vaccine-related Guillain-Barre' Syndrome (GBS), but not all patients with a diagnostic ICD-9-CM code for GBS have the disease. The objective of this study was to evaluate the positive predictive values (PPVs) of claims-based algorithms for identifying GBS cases in 4 claims database environments. METHODS: Potential cases were adolescents ages 11-21 with at least one claim for GBS (ICD-9-CM code 357.0). Medical record reviews by a panel of 3 neurologists were conducted for case confirmation. Claims data considered for inclusion in the case-ascertainment algorithm included coding position, physician specialty, visit type, diagnostic tests. PPVs were used to assess the contribution of study factors in predicting case status. RESULTS: Among 361 individuals with a GBS diagnosis code, 106 were confirmed overall (PPV=0.29), varying from 0.24 to 0.56 across the 4 sites. Requiring the GBS code to be associated with a neurologist visit (PPV=0.53) or to be in a primary position on an inpatient claim (0.56) improved the performance. A composite algorithm including a primary inpatient GBS code and a neurologist visit associated with any GBS code gave the highest PPV (0.70). Incorporating claims for diagnostic testing had little impact on the PPV. Findings were generally similar across study sites. CONCLUSIONS: Algorithms were able to identify GBS cases better than the single occurrence of the diagnostic code for GBS, and these algorithms may perform similarly in different claims environments.

Rectal cancer and teaching hospitals: hospital teaching status affects use of neoadjuvant radiation and survival for rectal cancer patients.

BACKGROUND: For rectal cancer, it is unknown how use of radiation, treatment cost, and survival differ based on hospital teaching designation. METHODS: Private insurance claims data linked with the Pennsylvania Cancer Registry were used to identify rectal cancer patients undergoing surgery from 2004 to 2006. Patients with missing data of interest were excluded. Hospitals were characterized as follows: large (≥200 beds) versus small size (<200 beds), teaching versus nonteaching, and urban versus rural. Logistic regression was used to model the use of neoadjuvant radiotherapy, and Cox proportional hazards models were used to compare cancer-specific survival between hospital types. RESULTS: A total of 432 patients were analyzed. There was no difference in the distribution of cancer stages among the various hospital types (all p > 0.20). Teaching hospitals were associated with significantly higher utilization of neoadjuvant radiotherapy for stage II and III cancers compared with nonteaching facilities (57 vs. 28 %; p < 0.0001). On multivariate analysis, teaching status was the only hospital designation associated with use of neoadjuvant radiation (p < 0.001); hospital size and rural/urban designation were not significant. Nonteaching hospitals were more likely to use adjuvant radiotherapy for stage II and III disease (13 vs. 30 %; p < 0.01). Teaching hospitals had lower odds of death from rectal cancer when evaluating all stages [hazard ratio (HR) = 0.35; p < 0.0001] with similar costs of inpatient treatment (teaching: US $30,769 versus nonteaching: US $26,892; p = 0.22). CONCLUSIONS: Teaching designation was associated with higher incidence of neoadjuvant radiotherapy for stage II and III disease, with improved cancer-specific survival compared with nonteaching hospitals, and with similar treatment costs.

Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.

PURPOSE: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barré syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. METHODS: Retrospective cohort study among 12.6 million 11- to 21-year-old members of five US health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. RESULTS: We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. CONCLUSIONS: Among members of five US health plans, MCV4 vaccination was not associated with increased GBS risk.

Longitudinal analysis of the costs associated with inpatient initiation and subsequent outpatient continuation of proton pump inhibitor therapy for stress ulcer prophylaxis in a large managed care organization.

BACKGROUND: Proton pump inhibitor (PPI) therapy is commonly initiatedin hospitals for a variety of reasons including stress ulcer prophylaxis. Outpatient use of inpatient-initiated PPI use may be medically unwarranted. OBJECTIVE: To (a) describe in a longitudinal analysis the incidence and reasons for hospital initiation of PPI therapy, (b) identify the proportion of members continued on PPI therapy at hospital discharge that is not medically warranted, and (c) estimate the total costs incurred by the managed care organization (MCO) and its members due to inappropriate continuation of hospital-initiated PPI therapy after discharge. METHODS: A retrospective review of de-identified medical and pharmacy claims was performed to identify commercial and Medicare patients with an acute care hospital admission and subsequent discharge on a PPI from January 1, 2003, through December 31, 2006, in an MCO with approximately 2.5 million members with medical and prescription drug coverage. Hospital-initiated PPI therapy was assumed based on the presence of a paid pharmacy claim for a PPI within the 30-day period following hospital discharge. All patients who during the study period had (a) no PPI claims during the 90 days prior to an inpatient admission, followed by (b) a hospital stay, and (c) at least 1 pharmacy claim for a PPI during 30 post-discharge days were included in this analysis. Patients with PPI claims during the 90 days prior to their inpatient admission were excluded from analysis as this use was assumed to be appropriate. Any member (a) initiated on PPI therapy during hospital admission without a medically appropriate diagnosis, either primary or secondary, 3 months prior to or during hospitalization and (b) continuing therapy after discharge, as determined by at least 1 pharmacy claim for a PPI during the first 30 post-discharge days, was categorized as an inappropriate user. For the sample subgroup with inappropriate PPI use, costs due to inappropriate PPI therapy were calculated as the total cost incurred by the MCO and its members-including ingredient cost, dispensing fees, member copayments, and coinsurance-for PPI claims during the first 30 days after hospital discharge. RESULTS: Of 29,348 study-eligible members, 68.8% (n = 20,197) were prescribed a PPI inappropriately at hospital discharge. Rates of inappropriate PPI use were approximately equal for patients who stayed in the intensive care unit or coronary care unit (ICU/CCU) versus non-ICU/CCU patients (68.7% vs. 68.9%, respectively, P = 0.796 using the Pearson chi-square test). Over the 4-year period of this analysis, the total cost to the MCO and its members associated with inappropriate continuation of PPI therapy during the first 30 days after hospital discharge was $3,013,069. CONCLUSION: Increased health care costs associated with the utilization of PPIs can result from the inappropriate prescribing and continuation of PPI therapy after hospital discharge. Education of health care practitioners regarding medication reconciliation in general, and regarding continuation of PPI therapy specifically, is needed to increase responsible postdischarge medication utilization.

Beta-blocker compliance, mortality, and reinfarction: validation of clinical trial association using insurer claims data.

Although randomized controlled trials show that long-term beta-blocker use post acute myocardial infarction (AMI) reduces mortality and subsequent cardiovascular events, and that increased compliance lowers mortality, there is limited published research on the effects of long-term beta-blocker compliance in observational community settings. The authors retrospectively study the effect of beta -blocker compliance on mortality and repeat reinfarction using claims records from a major health insurer of all patients who were discharged alive after AMI between January 2003 and June 2004, covered by that health insurer's prescription drug coverage, and prescribed beta-blockers (n = 3923). Using Cox proportional hazards regressions, they estimate both survival and AMI-free survival rates by compliance quartile. Both survival and AMI-free survival rates diverge rapidly and are robust to adjustments for demographics, DxCG risk score, and other baseline risk factors. Results suggest that patients whose post-AMI compliance with beta-blocker therapy is above average experience lower mortality and reinfarction. This is especially true for high-risk patients.

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

PURPOSE: We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. METHODS: This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. RESULTS: The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. CONCLUSION: This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system.

Analysis of a large cohort of health maintenance organization patients with congestive heart failure.

The aim of this article was to measure guideline compliance in the care of health plan members diagnosed with congestive heart failure (CHF). Chart review was conducted on members with a discharge diagnosis of CHF (n = 2,697). Information was entered onto a scannable form designed by the health plan, which was coupled to an optical character recognition reader and entered into a database. Eighty-four percent of the patients had an ejection fraction (EF) measured. An angiotensin-converting enzyme inhibitor was prescribed to 72% of patients with an EF less than 40%. Comorbidities and other measures were evaluated and based on guideline recommendations. Most of the CHF patients in this health plan are being treated appropriately during posthospitalization for CHF. The use of a novel, cost-effective method for data collection resulted in the rapid acquisition of clinical data for analysis.