Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers.

BACKGROUND: There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study. METHODS: Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources. RESULTS: There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type. CONCLUSION: Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.

Health Services Utilization and Payments in Patients With Cancer Pain: A Comparison of Intrathecal Drug Delivery vs. Conventional Medical Management.

INTRODUCTION: To compare health services utilization and payments for cancer patients who received an implantable intrathecal drug delivery (IDD) system, consisting of a pump and catheter, vs. conventional medical management (CMM) for the treatment of cancer-related pain. METHODS: This retrospective claims-data analysis compared health services utilization and payments in a population of patients receiving either IDD or CMM for treatment of cancer pain. Patients were propensity score-matched 1:1 based on characteristics including, but not limited to, age, gender, cancer type, comorbid conditions, and health care utilization and payments. RESULTS: From a sample of 142 IDD patients and 3188 CMM patients who met all inclusion/exclusion criteria, 73 matched pairs were obtained. In the year following implant, IDD patients had a consistent trend of lower medical utilization, and total payments that were $3195 lower compared to CMM. CONCLUSIONS: Despite the high initial cost of IDD, this analysis suggests that patients with IDD incur lower medical utilization and payments over the first year post-implant. Further analysis comprised of a larger, longitudinal sample would contribute to health economics and outcomes research, and assist with future practice guideline development.

A comparison of service use and costs among adults with ADHD and adults with other chronic diseases.

OBJECTIVE: This study compared health service use and costs among adults with attention-deficit hyperactivity disorder (ADHD) and adults with depression, diabetes, or seasonal allergic rhinitis (seasonal allergy). METHODS: Pharmacy and medical claims data from January 1, 1999, to December 31, 2001, were obtained from a large U.S. managed care plan. Patients were divided into one of four mutually exclusive cohorts (ADHD, depression, diabetes, or seasonal allergy) on the basis of their diagnosis or prescriptions. Age, gender, comorbid conditions, and type of dominant provider were compared for the four groups. Thereafter, general linear models with post-hoc multiple comparison tests were used to compare health service use and costs by site of service. RESULTS: The study population included 143,561 patients. The four mutually exclusive groups included 58,017 with depression, 45,479 with diabetes, 33,272 with a seasonal allergy, and 6,793 had ADHD. Comorbid mental health conditions occurred with significantly greater frequency among patients with ADHD and among those with depression than among patients in the other groups. Patients with ADHD and those with depression received care from a mental health provider significantly more often than those with diabetes or a seasonal allergy. Patients with ADHD had fewer average outpatient, inpatient, and emergency department visits than patients with depression or diabetes, and office visit frequency for patients with ADHD was significantly different from that of patients with a seasonal allergy. Annual total costs were lowest among patients with a seasonal allergy ($2,743), which were not significantly different than the costs for patients with ADHD ($3,020). CONCLUSIONS: Adult ADHD poses an economic burden that is less than that of depression or diabetes but greater than that of a seasonal allergy.