Collection of economic data using UB-04s: Is it worth the effort? Evidence from two clinical trials.

Cost collection using UB-04 forms for economic evaluation is challenging, as UB-04 collection is time and effort intensive and compliance is imperfect. Alternative data sources could overcome those challenges. The objective of this study is to determine the usefulness of UB-04 data in estimating hospital costs compared to clinical case report form (CRF) data. Health care utilization costs were compared from financial information in UB-04s and from an assignment process using CRF data, from the WRAP-IT (23 infections) and the Micra IDE trials (61 adverse events and 108 implants). Charge-based costs were calculated by multiplying charges in UB-04s and hospital-specific Cost-to-Charge ratios from the Centers for Medicare and Medicaid Services cost reports. The cost assignment process used clinical information to find comparable encounters in real world data and assigned an average cost. Paired difference tests evaluated whether both methods yield similar results. The mean difference in total infection related costs between methods in the WRAP-IT trial was $152 +/-$22,565. In the Micra IDE trial, the mean difference in total adverse event related costs between methods was -$355 +/-$8,298 while the mean difference in total implant related costs between methods was $-3,488 +/-$13,859. Wilcoxon tests and generalized linear models could not reject the difference in costs between methods in the first two cases. Cost assignment methods achieve results similar to costs obtained through UB-04s, without the additional investment in time and effort. The use of UB-04 information for services that are not mature in a health care system may present unexpected challenges, necessitating a tradeoff with other methods of cost assignment.

Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker.

Importance: The safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined. Objective: To compare patient characteristics and complications among patients implanted with leadless VVI and transvenous VVI pacemakers. Design, Setting, Participants: The Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted between March 9, 2017, and December 1, 2018, were identified and included. All Medicare patients implanted with leadless VVI and transvenous VVI pacemakers during the study period were enrolled. Patients with less than 12 months of continuous enrollment in Medicare prior to leadless VVI or transvenous VVI implant and with evidence of a prior cardiovascular implantable electronic device were excluded, leaving 5746 patients with leadless VVI pacemakers and 9662 patients with transvenous VVI pacemakers. Data were analyzed from May 2018 to April 2021. Exposures: Medicare patients implanted with leadless VVI pacemakers or transvenous VVI pacemakers. Main Outcomes and Measures: The main outcomes were acute (30-day) complications and 6-month complications. Results: Of 15 408 patients, 6701 (43.5%) were female, and the mean (SD) age was 81.0 (8.7) years. Compared with patients with transvenous VVI pacemakers, patients with leadless VVI pacemakers were more likely to have end-stage kidney disease (690 [12.0%] vs 226 [2.3%]; P < .001) and a higher mean (SD) Charlson Comorbidity Index score (5.1 [3.4] vs 4.6 [3.0]; P < .001). The unadjusted acute complication rate was higher in patients with leadless VVI pacemakers relative to transvenous VVI pacemakers (484 of 5746 [8.4%] vs 707 of 9662 [7.3%]; P = .02). However, there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%; risk difference, 0.3; 95% CI, -0.6 to 1.3; P = .49). Pericardial effusion and/or perforation within 30 days was significantly higher among patients with leadless VVI pacemakers compared with patients with transvenous VVI pacemakers in both unadjusted and adjusted models (unadjusted, 47 of 5746 [0.8%] vs 38 of 9662 [0.4%]; P < .001; adjusted, 0.8% vs 0.4%; risk difference, 0.4; 95% CI, 0.1 to 0.7; P = .004). Patients implanted with leadless VVI pacemakers had a lower rate of 6-month complications compared with patients implanted with transvenous VVI pacemakers (unadjusted hazard ratio, 0.84; 95% CI, 0.68-1.03; P = .10; adjusted hazard ratio, 0.77; 95% CI, 0.62-0.96; P = .02). Conclusions and Relevance: In this study, despite significant differences in patient characteristics, patients in whom a leadless pacemaker was implanted were observed to have higher rates of pericardial effusion and/or perforation but lower rates of other device-related complications and requirements for device revision at 6 months. Understanding the benefits and risks associated with leadless VVI pacemakers compared with transvenous VVI pacemakers can help clinicians and patients make informed treatment decisions.

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer.

Aims: Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective.Materials and Methods: A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members ≥18 years with ≥1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy - pacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan-Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs.Results: A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG = 0.91%; ICD = 1.63%; CRT-p = 1.50%; CRT-D = 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) = 2.1-2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572-$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) = 11.356; 95% CI = 7.923-16.276], undergoing a CIED replacement procedure (OR = 1.644; 95% CI = 1.361-1.987), implantation of a high-power device (OR = 1.354; 95% CI = 1.115-1.643), and younger age (age < 65) (OR = 1.607; 95% CI = 1.307-1.976).Conclusions: The CDI rate at one year ranged from 0.91%-2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.

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.

Successful Discontinuation of Systemic Opioids After Implantation of an Intrathecal Drug Delivery System.

INTRODUCTION: An implantable drug delivery system (IDDS) provides an alternate route of opioid administration for patients with chronic pain. We collected data on systemic opioid use before and after IDDS implantation; patients who successfully discontinued systemic opioids; and physician support of discontinuation. METHODS: This was a single-center, retrospective chart review of 99 consecutive patients who used IDDSs for at least six months. Data collection included pre/postimplant systemic opioid use and pain scores, and patient demographic and clinical characteristics. RESULTS: The study population averaged 67 years of age, was 68% women, and 77% were Medicare beneficiaries. Ninety-five percent of patients had low back pain, and 86% had limb pain. The majority (81%) had pain for >5 years. Failed treatments included epidural injections (74%), lumbar spine surgery (46%), spinal cord stimulation (14%), and facet joint injections (11%), with 84% also reporting significant systemic opioid side-effects. All patients taking long-acting opioids discontinued these within one month of implant. Total systemic opioid elimination was accomplished by 68% of patients at one month postimplant, 84% at one year, and 92% at five years. At one month postimplant, 60% of patients reported decreased pain (mean change: -4.07), and at one year, 64% did (mean change: -3.42). CONCLUSIONS: IDDS can provide significant and lasting pain relief and an alternate route of delivery compared with systemic opioids with their associated side-effects. We demonstrated that systemic opioid elimination could be accomplished after IDDS implantation in the majority of cases through appropriate patient selection, monitoring, and participation.

Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures.

OBJECTIVE: To compare health-care expenditures over a 12-month horizon for chronic pain patients with implanted intrathecal drug delivery systems (IDDS) who eliminated or continued systemic opioids postimplant. METHODS: Claims data from commercial and Medicare databases were searched for patients who had an IDDS, used systemic opioids before implant, and had 12 months pre- and 13 months postimplant continuous medical and pharmacy coverage. The number and characteristics of patients who eliminated or continued systemic opioids were determined at four times postimplant: 30 days (allowing a systemic opioid washout period), 120 days, 150 days, and 210 days. Multivariable models evaluated the effect of eliminating opioids on health-care expenditures at each of those times. RESULTS: Three hundred eighty-nine patients met inclusion criteria, and 51% completely eliminated systemic opioids (12% within the 30-day washout and an additional 39% by the end of the one-year horizon). Systemic opioid elimination within 120 to 210 days postimplant was associated with a reduction of $3,388 to $4,465 in inpatient and outpatient expenditures, and $4,689 to $5,571 in inpatient, outpatient, and drug expenditures. CONCLUSIONS: Fifty-one percent of patients completely eliminated systemic opioids in the year after IDDS implant. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.

Medical cost impact of intrathecal baclofen therapy for severe spasticity.

OBJECTIVES: To evaluate the economic effects of intrathecal baclofen (ITB) for patients with severe spasticity based on costs of care before and after implantation of an intrathecal drug delivery system. MATERIALS AND METHODS: An actuarial projection of post-implant experience in the absence of ITB intervention was used to simulate a continued conventional medical management protocol (ITB-free) by assuming a reasonable trend rate based on health-care industry standards. Cost projections were developed over a 30-year time horizon at various reimplantation rates. The model was informed by retrospective analysis of commercial administrative claims data from 409 pediatric and adult spasticity patients who received a pump implant (ITB-experienced) within a 3-year service period (January 2006 to January 2009). Common indications associated with pump implant included multiple sclerosis (N = 124), cerebral palsy (N = 131), and spinal cord injury (N = 40). RESULTS: ITB was less costly than the conventional protocol over our baseline implantation cycle. Costs in the month of implant and in the year following were cumulatively $26,375 more than with the conventional protocol. However, ITB financial break-even occurs between the second and third years post-implant. The lifetime analysis indicates that savings for ITB are $8009 per patient per year compared with conventional therapy. Most of the savings are derived from reductions in inpatient admissions, physician office visits, and outpatient physiotherapy. CONCLUSIONS: The results suggest that spasticity patients receiving ITB would expect to experience a reduction in cumulative future medical costs relative to anticipated costs in the absence of a pump implant. This finding complements the existing literature on the cost-effectiveness of ITB.

Medical cost impact of intrathecal drug delivery for noncancer pain.

INTRODUCTION: As healthcare budgets continue to contract, there is increased payer scrutiny on the use of implantable intrathecal drug-infusion devices. This study utilizes claims data to evaluate the economic effects of intrathecal drug delivery (IDD) based on health services utilization and costs of care before and after implantation. METHODS: We performed a retrospective database study involving 555 noncancer pain patients that received an IDD system implant within a 3-year service period (1/2006-1/2009). IDD patient costs were temporally aligned to implant month and repriced to a standardized, national pricing schedule over a 6-year episode cycle (3 years preimplant, implant month, and 3 years postimplant). Additionally, we made an actuarial projection of postimplant experience, in the absence of IDD intervention, simulating a conventional pain therapy (CPT) protocol by assuming the same slope in costs prior to implantation at standardized, national price levels. Cost projections were produced over a 30-year time horizon at various reimplantation rates. RESULTS: IDD therapy was less costly than the CPT protocol over our baseline implantation cycle. Costs in the month of IDD implantation, and in the year following, are cumulatively $17,317 more than the CPT protocol; however, IDD financial break-even occurs soon after the second year postimplant. The lifetime analysis indicates that IDD per patient per year savings is $3,111 compared with CPT. CONCLUSION: The authors found that patients receiving an implantable IDD system may experience reduced cumulative future medical costs relative to anticipated costs in the absence of receiving IDD. This finding complements published literature on the cost-effectiveness of IDD.

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.