Medicare Supplemental Research Articles

Preoperative β-Blocker Therapy and Stroke or Major Adverse Cardiac Events in Major Abdominal Surgery: A Retrospective Cohort Study.

Perioperative β-blocker therapy has been associated with increased risk of stroke. However, the association between β-blocker initiation before the day of surgery and the risk of stroke is unknown. The authors hypothesized there would be no association between preoperative β-blocker initiation within 60 days of surgery or chronic β-blockade (more than 60 days) and the risk of stroke in patients undergoing major abdominal surgery. Data on elective major abdominal surgery were obtained from the IBM (USA) Truven Health MarketScan 2005 to 2015 Commercial and Medicare Supplemental Databases. Patients were stratified by β-blocker dispensing exposure: (1) β-blocker-naïve, (2) preoperative β-blocker initiation within 60 days of surgery, and (3) chronic β-blocker dispensing (more than 60 days). The authors compared in-hospital stroke and major adverse cardiac events between the different β-blocker therapy exposures. There were 204,981 patients who underwent major abdominal surgery. β-Blocker exposure was as follows: perioperative initiation within 60 days of surgery for 4,026 (2.0%) patients, chronic β-blocker therapy for 45,424 (22.2%) patients, and β-blocker-naïve for 155,531 (75.9%) patients. The unadjusted frequency of stroke for patients with β-blocker initiation (0.4%, 17 of 4,026) and chronic β-blocker therapy (0.4%, 171 of 45,424) was greater than in β-blocker-naïve patients (0.2%, 235 of 155,531; P < 0.001). After propensity score weighting, patients initiated on a β-blocker within 60 days of surgery (odds ratio, 0.90; 95% CI, 0.31 to 2.04; P = 0.757) or on chronic β-blocker therapy (odds ratio, 0.86; 95% CI, 0.65 to 1.15; P = 0.901) demonstrated similar stroke risk compared to β-blocker-naïve patients. Patients on chronic β-blocker therapy demonstrated lower adjusted risk of major adverse cardiac events compared to β-blocker-naïve patients (odds ratio, 0.81; 95% CI, 0.72 to 0.91; P = 0.007), despite higher unadjusted absolute event rate (2.6% [1,173 of 45,424] vs. 0.6% [872 of 155,531]). Among patients undergoing elective major abdominal surgery, the authors observed no association between preoperative β-blocker initiation within 60 days of surgery or chronic β-blocker therapy and stroke.

Risk, Determinants, and Pharmacologic Treatment of Depression Following Acute Ischemic Stroke.

Background and Purpose: We assessed risk and determinants of new-onset depression in acute ischemic stroke (AIS) patients of all ages and no known history of depression. Additionally, we assessed patterns of post-stroke depression (PSD) treatment with pharmacotherapy. Methods: Retrospective cohort study of de-identified Marketscan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Datasets for adults age ≥18years admitted with AIS from July 1, 2016-July 1, 2017. We created Kaplan-Meier curves of cumulative risk of PSD up to 1.5years following index AIS admission. We performed Cox regression to report hazard ratios for determinants of PSD up to 1.5years following AIS. We summarized proportions treated with pharmacotherapy and identified the most commonly prescribed medications. Results: Of 8089 AIS patients, 1059 were diagnosed with PSD. At 1 year, cumulative risk of PSD was 13.4% (standard error .4) and 15.3% (standard error .5) at 1.5years. History of anxiety was most strongly associated with PSD and discharge home least. Among those with PSD, 68.8% were prescribed an antidepressant and 8.4% an antipsychotic. The most commonly prescribed antidepressant was sertraline (28.5%). Conclusions: Among AIS patients of all ages, there is a persistently elevated cumulative risk of new diagnosis of PSD in the 1.5years following AIS. Of the >2/3 treated with an antidepressant, sertraline was most commonly prescribed. Screening and treatment strategies for PSD require further study.

Heterogeneity of the long-term economic burden of severe sickle cell disease: a 5-year longitudinal analysis

Background Sickle cell disease (SCD) is a lifelong burdensome disorder of heterogenic expression. This study investigated the longer-term economic burden of severe presentation of SCD. As SCD treatment landscapes evolve toward curative intent gene therapies, understanding how SCD-associated costs may change over the patient lifetime will be important for medical decision-making. Methods Patients with severe presentation of SCD (presence of acute vaso-occlusive events [VOEs] or history of stroke and/or other disease-related sequelae), were identified within the MarketScan Commercial and Medicare Supplemental and Multi-state Medicaid Databases from 1/1/2010 to 12/31/2018. The first SCD claim served as the index date and patients were followed over a 5-year post-period. Clinical characteristics and healthcare resource utilization and costs were assessed over follow-up for eligible cohorts of commercial and Medicaid patients with severe SCD presentation and age-based subgroups (<18, 18–30, and ≥31). Results A total of 4,487 patients, primarily insured via Medicaid (79.2%), qualified for the analysis. Patients evidenced persistent VOEs over follow-up; prevalence of most comorbidities increased with age. Mean total healthcare costs over the 5-year follow-up were $275,143 (SD± $406,770) and $362,728 (SD± $620,189) in the commercial and Medicaid samples, respectively. Disease severity, assessed by the number of VOEs and utilization of inpatient and emergency services, peaked in the 18–30 year group in both samples. These groups also evidenced the highest mean healthcare costs over the 5-year follow-up at $344,776 (SD± $434,521) and $671,321 (SD± $938,764) in the commercial and Medicaid samples respectively. Conclusion Results indicate high clinical need and economic burden among patients with severe presentation of SCD. These findings not only highlight the need for improved therapeutic options to limit or prevent disease progression, but also start to provide insight on lifetime costs of SCD that will be needed in the evaluation of emerging curative intent therapies.

Trends in Urethral Suspension With Robotic Prostatectomy Procedures Following Medicare Payment Policy Changes

In 2016, the Centers for Medicare and Medicaid Services cut payments for robotic prostatectomy performed for Medicare beneficiaries. Although regulations mandate that billing for urethral suspension is only acceptable for preexisting urinary incontinence, reductions in reimbursement may incentivize billing for the use of this procedure in other scenarios. To assess trends and geographic variations in payments for urethral suspension with robotic prostatectomy in the context of Medicare payment policy. This US population-based retrospective cohort study analyzed data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Database for men with employer-based insurance (primary commercial or Medicare supplemental coverage) who underwent robotic prostatectomy (Current Procedural Terminology [CPT] code 55866) between 2009 and 2019. Time period and metropolitan statistical area of patient residence. Payment for urethral suspension (CPT code 51990) with robotic prostatectomy. We identified 87 774 men with prostate cancer treated with robotic prostatectomy; 3352 (3.8%) had undergone urethral suspension. The mean (SD) patient age was 59.7 (6.5) years; 16 870 patients (19.2%) had Medicare supplemental coverage. From 2015 to 2016, median payments for robotic prostatectomy changed by -$358 (-17.0%) for Medicare beneficiaries vs -$9 (0%) for commercially insured patients. With urethral suspension vs without, median (IQR) episode payments for robotic prostatectomy were higher for commercially insured men ($3678 [$3090-$4503] vs $3322 [$2601-$4306]) and Medicare beneficiaries ($2927 [$2450-$3909] vs $2379 [$2014-$3512]). Compared with men treated between 2013 and 2015, those treated between 2016 and 2017 were twice as likely to undergo urethral suspension (8.5% vs 4.1%; odds ratio, 2.17 [95% CI, 1.96-2.38]). The proportion of patients who underwent urethral suspension was stable for 2018 to 2019 and 2016 to 2017 (8.5% vs 9.0%; odds ratio, 1.06 [95% CI, 0.96-1.18]). From 2015 to 2019, the proportion of patients who underwent urethral suspension was highest in Charleston, South Carolina (92.0%), Knoxville, Tennessee (66.0%), and Columbia, South Carolina (58.0%). These regions neighbored high-volume areas without patients who underwent prostatectomy with urethral suspension (eg, 146 patients in Greenville, South Carolina, and 173 in Nashville, Tennessee). In this study, urethral suspension was associated with increased costs for patients with both commercial insurance and Medicare. Patients treated between 2016 and 2017 were more likely than those treated between 2013 and 2015 to undergo this procedure. Geographic variation in use exceeded what was expected for the preexisting condition for which billing is permitted for Medicare beneficiaries. Policy statements from professional societies highlighting appropriate billing for urethral suspension may have tempered, but not reversed, the broad adoption of this procedure.

Association of Appendicitis Incidence With Warmer Weather Independent of Season

Acute appendicitis is a common cause of abdominal pain and the most common reason for emergency surgery in several countries. Increased cases during summer months have been reported. To investigate the incidence of acute appendicitis by considering local temperature patterns in geographic regions with different climate over several years. This cohort study used insurance claims data from the MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database from January 1, 2001, to December 31, 2017. The cohort included individuals at risk for appendicitis who were enrolled in US insurance plans that contribute data to the MarketScan databases. Cases of appendicitis in the inpatient, outpatient, and emergency department settings were identified using International Classification of Diseases, Ninth Revision, Clinical Modification or International Statistical Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. Local weather data were obtained for individuals living in a metropolitan statistical area (MSA) from the Integrated Surface Database. Associations were characterized using a fixed-effects generalized linear model based on a negative binomial distribution. The model was adjusted for age, sex, and day of week and included fixed effects for year and MSA. The generalized linear model was fit with a piecewise linear model by searching each 0.56 °C in temperature for change points. To further isolate the role of temperature, observed temperature was replaced with the expected temperature and the deviation of the observed temperature from the expected temperature for a given city on a given day of year. Data were analyzed from October 1, 2021, to July 31, 2022. The primary outcome was the daily number of appendicitis cases in a given city stratified by age and sex, with mean temperature in the MSA over the previous 7 days as the independent variable. A total of 450 723 744 person-years at risk and 689 917 patients with appendicitis (mean [SD] age, 35 [18] years; 347 473 male [50.4%] individuals) were included. Every 5.56 °C increase in temperature was associated with a 1.3% increase in the incidence of appendicitis (incidence rate ratio [IRR], 1.01; 95% CI, 1.01-1.02) when temperatures were 10.56 °C or lower and a 2.9% increase in incidence (IRR, 1.03; 95% CI, 1.03-1.03) for temperatures higher than 10.56 °C. In terms of temperature deviations, a higher-than-expected temperature increase greater than 5.56 °C was associated with a 3.3% (95% CI, 1.0%-5.7%) increase in the incidence of appendicitis compared with days with near-0 deviations. Results of this cohort study observed seasonality in the incidence of appendicitis and found an association between increased incidence and warmer weather. These results could help elucidate the mechanism of appendicitis.

The economic burden of HIV-associated wasting in the era of modern antiretroviral therapy.

BACKGROUND: HIV-associated wasting (HIVAW) is associated with increased morbidity and mortality in people living with HIV (PWH). Evaluating health care resource utilization and cost predictors of HIVAW is important in understanding the overall economic burden of the disease. OBJECTIVE: To evaluate the economic burden and cost predictors associated with HIVAW. METHODS: This analysis of the IBM MarketScan Commercial, Medicare Supplemental, and Medicaid databases included members with a claim for HIV (using International Classification of Diseases, Ninth Revision and Tenth Revision, Clinical Modification codes) between July 2012 and September 2018, with the HIV index date defined as the first HIV diagnosis claim in the dataset. PWH were excluded if they were aged less than 18 years, had any malignancy claim, or had less than 6 months of enrollment data pre-HIV or post-HIV index date. Members were defined as having HIVAW using an algorithm of claims for weight loss-related diagnoses, appetite stimulant or nontestosterone anabolic agents, or enteral/parenteral nutrition at any time post-HIV index. Taking antiretroviral therapy (ART) was defined as having at least 1 pharmacy claim of any ART 12 months post-HIV index. Total all-cause costs were calculated as the sum of payments for hospitalizations, emergency department visits, outpatient visits, and pharmacy use. A multivariate generalized linear model with log-link and γ distribution was used to estimate the impact of HIVAW predictors of total all-cause costs. RESULTS: Among 42,587 members with HIV included in the study (64.6% male; mean age: 44 years; 67.5% insured with Medicaid; and 63.9% taking ART), the overall prevalence of HIVAW was 18.3% during the study period. HIVAW prevalence was 17.9% for those taking ART and 19.1% for those not taking ART. Prevalence by payer type was 7.5% for Commercial ± Medicare Supplemental and 23.5% for Medicaid. Members with HIVAW had more comorbidities and opportunistic infections compared with members without HIVAW. Members with HIVAW were also more than twice as likely to be hospitalized (71.1% vs 32.1%) and had 5 times the number of hospitalizations (1.0 vs 0.2) and twice the number of emergency department visits (3.0 vs 1.3) per year post-index compared with members without HIVAW (P < 0.01). HIVAW was associated with 1.3-times-higher mean annualized total all-cause costs per member (95% CI = 1.26-1.36). CONCLUSIONS: HIVAW remains prevalent despite advances in ART and is associated with additional health care resource utilization and costs. Further research is needed to better understand the relationship between HIVAW and comorbidity burden and ART utilization and payer types. DISCLOSURES: This study was sponsored by EMD Serono, Inc., Rockland, MA, USA (CrossRef Funder ID: 10.13039/100004755). Dr Siddiqui has received consulting and speaking fees from AbbVie, BioFire, Cumberland, EMD Serono, Inc., Rockland, MA, USA, and Merck. Dr Samuel, Ms Hayward, Ms Wirka, Dr Phillips, and Dr Harbour are employees of EMD Serono, Inc., Rockland, MA, USA. Drs Deering and Harshaw are employees of EPI-Q, Inc., which received payment from EMD Serono, Inc., Rockland, MA, USA, for the development and execution of this study.

MPN-386 Real-World Ruxolitinib Treatment Pattern in Myelofibrosis Patients With Thrombocytopenia.

Ruxolitinib, the standard treatment for patients with myelofibrosis to reduce splenomegaly and improve myelofibrosis-associated symptoms, is associated with high rates of cytopenia effect. Thrombocytopenia, common in myelofibrosis patients, is associated with poor clinical outcomes, and its treatment confers a unique challenge. This real-world study characterized the disease and ruxolitinib treatment pattern in myelofibrosis patients with thrombocytopenia using US insurance claims data. Data from the IBM MarketScan® Medicare Supplemental Database were retrospectively analyzed to identify patients aged ≥18 years with ≥1 claim for ruxolitinib and ≥2 non-diagnostic medical claims for myelofibrosis from 2017 to 2019. The first ruxolitinib claim on or after the first myelofibrosis claim defined the index date. Patients who continuously enrolled in a health plan for 3 months before and 6 months after the index date were included. Clinical characteristics and ruxolitinib treatments were compared in myelofibrosis patients with or without a history of thrombocytopenia prior to ruxolitinib initiation. Overall, 136 myelofibrosis patients who received ruxolitinib treatment were included in the analysis. The median age was 61 years, 61% were male, 62% had primary myelofibrosis, and 38% had post-polycythemia vera or essential thrombocythemia myelofibrosis. Prior to ruxolitinib treatment, 57% of patients had a diagnosis of splenomegaly, 56% had anemia, 25% had thrombocytopenia, 19% had received RBC transfusion, and 7% had neutropenia. During ruxolitinib treatment, 25% of patients had a new diagnosis of thrombocytopenia, 22% had neutropenia, and 19% had anemia. Patients with versus without history of thrombocytopenia had more anemia (79% vs. 48%, P=0.001), more red blood cell transfusions (44% vs. 11%, P<0.001), and a lower mean starting dose of ruxolitinib (20 mg vs. 27 mg, P=0.005). History of anemia, leukocytosis, neutropenia, myelofibrosis type, and splenomegaly had no effect on the ruxolitinib starting dose. Myelofibrosis patients with versus without history of thrombocytopenia continued ruxolitinib treatment at lower doses. During ruxolitinib treatment, 57% of patients with versus 42% without history of thrombocytopenia experienced anemia (OR=1.88, P=0.43). History of thrombocytopenia was a major factor influencing ruxolitinib dose and was associated with history of anemia and neutropenia. Our findings underscore the need for more treatment options to manage myelofibrosis patients with thrombocytopenia.

Real-world treatment patterns among patients with non-muscle invasive bladder cancer (NMIBC) treated with intravesical Bacillus Calmette-Guerin (BCG).

404 Background: Intravesical BCG is a common treatment in high-risk NMIBC patients; however supply constraints and regimen demands for patients have been reported and may impact long term patient outcomes. This study examined treatment patterns in NMIBC patients receiving intravesical BCG. Methods: Adults with NMIBC treated with intravesical BCG during any line of therapy (LOT) on or after the index date (first date for transurethral resection of the bladder tumor [TURBT] or initiation of intravesical therapy) were selected from de-identified IBM MarketScan Commercial and Medicare Supplemental Databases (1/1/2010-2/28/2021) and Multi-State Medicaid Database (1/1/2010-12/31/2019). Classification of NMIBC on the index date required that patients have no prior systemic antineoplastic therapy, radiotherapy, or cystectomy. Treatment patterns were evaluated from the index date until the end of the NMIBC phase (earliest of initiation of systemic antineoplastic therapy, cystectomy, radiotherapy, diagnosis for metastatic cancer, end of insurance eligibility, or end of data availability). Discontinuation of a LOT was defined as having a treatment gap &gt; 180 days for BCG (90 days for other agents) or switching to a new LOT. During each LOT, adequate BCG treatment was defined as having ≥5 claims during induction (first 42 days of treatment) and ≥2 claims during maintenance (beyond the first 42 days). Results: There were 5,410 NMIBC patients treated with BCG over a mean (median) follow up of 25.5 (18.9) months. The population was 79% male; mean age was 67 years. The majority of patients only received a single LOT (76%; TABLE). The predominant first LOT was BCG (93.1% of NMIBC patients); however, the majority (69.8%) did not receive adequate BCG induction/maintenance in first LOT. Nearly half (46.4%) of first LOT patients had reassessment for disease progression by TURBT. BCG retreatment after a six-month lapse was observed as the predominant second LOT, with &gt; 90% receiving inadequate BCG induction/maintenance. Conclusions: While intravesical BCG remains the most common therapy for NMIBC, less than a third of patients receive adequate BCG treatment in the first LOT; with this percentage further decreasing in the few patients who receive a subsequent LOT. In light of supply and demand constraints, results of this study further emphasize a need for additional treatment options that are effective, safe, and tolerable for patients with NMIBC.[Table: see text]

Direct health care costs associated with COVID-19 in the United States.

BACKGROUND: Data on the real-world health care burden of COVID-19 in the United States are limited. OBJECTIVE: To compare health care resource use (HRU), direct health care costs, and long-term COVID-19-related complications between patients with vs patients without COVID-19 diagnoses. METHODS: Using IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits administrative claims databases (January 1, 2018, to March 1, 2021), this retrospective, matched cohort study compared patients with a recorded COVID-19 diagnosis to control subjects with no recorded diagnosis for COVID-19, personal history of COVID-19, or pneumonia due to COVID-19. To capture typical health care utilization, the control group was analyzed in 2019 (prepandemic); their index date was assigned as 1 year before the index date (first observed COVID-19 diagnosis) of their matched COVID-19 patient. All patients had continuous health plan coverage for at least 6 months pre-index (baseline) and at least 6 months post-index (allowing censoring during month 6). Separately for commercial and Medicare cohorts, COVID-19 and control patients were matched 1:1 using propensity scores, number of followup months, and indicator of age 18 years or older. During each month of the 6-month follow-up, all-cause HRU, health care costs, and COVID-19-related complications were compared between patients with COVID-19 and controls. RESULTS: After matching COVID-19 and control patients 1:1, a total of 150,731 commercial matched pairs and 1,862 Medicare matched pairs were retained; baseline characteristics were similar between patients with COVID-19 and controls. Patients with COVID-19 and controls had mean ages of 38.9 and 39.7 years in the commercial cohort and 74.3 and 75.3 years in the Medicare cohort, respectively. In month 1 of follow-up, patients with COVID-19 relative to controls were significantly more likely to have at least 1 inpatient admission (commercial: 6.9% vs 0.5%; Medicare: 29.1% vs 1.3%; both P < 0.001) and at least 1 emergency department visit (commercial: 37.3% vs 3.4%; Medicare: 26.2% vs 4.1%; both P < 0.001). Total health care costs in month 1 were significantly higher among patients with COVID-19 than controls (mean differences: $3,706 for commercial; $10,595 for Medicare; both P < 0.001), driven by inpatient costs. Though the incremental HRU and cost burden of COVID-19 decreased over time, patients with COVID-19 continued to have significantly higher total costs through month 5 (all P < 0.001 for both commercial and Medicare). During follow-up, patients with COVID-19 had significantly higher rates of complications than controls (commercial: 52.8% vs 29.0% with any; Medicare: 74.5% vs 47.9% with any; both P < 0.001), most commonly cough, dyspnea, and fatigue. CONCLUSIONS: COVID-19 was associated with significant economic and clinical burden, both in the short-term and over 6 months following diagnosis. DISCLOSURES: Jessica K DeMartino is an employee of Janssen Scientific Affairs, LLC. Elyse Swallow, Debbie Goldschmidt, Karen Yang, Marta Viola, Tyler Radtke, and Noam Kirson are employees of Analysis Group, Inc., which has received consulting fees from Janssen Scientific Affairs, LLC. This study was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design, interpretation of the results, manuscript review, and the decision to publish the article.

170. Utilizing big data to determine the safety profile of recombinant human BMP-2 in spinal fusion surgery: an analysis of 5 databases from 2003 to 2017

<h3>BACKGROUND CONTEXT</h3> The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion remains controversial. While rhBMP-2 safety concerns revealed misrepresentations in industry-sponsored research, previous observational studies reached conflicting conclusions regarding rhBMP-2 safety and effectiveness. rhBMP-2 is FDA approved for lumbar fusion with specific fusion devices. <h3>PURPOSE</h3> The purpose of the study was to investigate the complications associated with the use of rhBMP-2 for spinal fusion at a population-based level to determine its risk. <h3>STUDY DESIGN/SETTING</h3> The study design was a retrospective observational comparative cohort design comparing a target group to a comparator group for the risk of an outcome. <h3>PATIENT SAMPLE</h3> The patient sample comprised of two groups. Our target group consisted of first-time recipients of any spinal fusion procedure, of at least 18 years of age at the time of procedure, who received rhBMP-2 at the time of the procedure. Our comparator group consisted of first-time recipients of any spinal fusion procedure, who did not receive rhBMP-2. We restricted the study dates from 1/1/2003, when rhBMP-2 was introduced to the market, to 12/31/2017. <h3>OUTCOME MEASURES</h3> The outcome measures investigated included any reoperations requiring refusion and postoperative complications, which comprised of infection, seroma/hematoma, radiculitis, heterotopic ossification and cancer. The analysis of cancer included 18 subtypes of benign and malignant neoplasms. The observation period for these outcomes started after the date of surgery and concluded at the end of the study period. <h3>METHODS</h3> We utilized research tools developed in the Observational Health Data Sciences and Informatics (OHDSI) community (Hripcsak et al, 2015) to develop a common research protocol and data vocabulary encompassing the four claims databases and one electronic records database. The four insurance claims databases were IBM MarketScan Commercial Claims and Encounters (US employer-based private payer; patient aged 65 years or older), Optum ClinFormatics (US private payer; primarily aged 65 years or younger), IBM MarketScan Medicare Supplemental Beneficiaries (US retirees; patients aged > 65 years), IBM MarketScan Multi-state Medicaid (US Medicaid enrollees; all ages). The electronic health record database is Optum Pan-Therapeutic (US health systems; all ages). We then implemented a suite of methods and analyses to address confounding and bias inherent to observation studies, including propensity scoring and estimation of hazard ratios using a stratified Cox proportional hazard model. We combined the estimates from the data sources into a summary HR using a random effects model meta-analysis. To control for unmeasured confounding, we employed negative and positive controls to quantify the systemic bias in the system and compute adjusted HR estimates and confidence intervals. <h3>RESULTS</h3> Across all five databases, 60,427 patients were identified in the target group and 349,771 patients were identified in the comparator group, totaling 161,213 and 923,822 years of patient observation, respectively. rhBMP-2 was associated with statistically significantly fewer postoperative infections, with a hazard ratio of 0.88 (95% CI: 0.78-0.99). No significant difference was seen with the other outcomes, including reoperations for refusion, seroma/hematoma, radiculitis, heterotopic ossification, and development of benign or malignant neoplasms. Substantial control of measured confounding was demonstrated by propensity score adjustment, and negative and positive controls revealed noticeable residual bias that was controlled for through confidence interval calibration. <h3>CONCLUSIONS</h3> In the largest longitudinal observational study to date, rhBMP-2 was determined to be safe and effective as compared to non-rhBMP-2 usage in spinal fusion, with lower rate of postoperative infections. Importantly, no increased rates of cancer were detected. Coding error and the retrospective design may be an important source of bias. Despite these limitations, the large population size and statistical design give considerable significance to the results and conclusions of this study. <h3>FDA DEVICE/DRUG STATUS</h3> Medtronic Infuse (Approved for this indication).

Real-world Medicare Healthcare Costs of Patients with Dupuytren's Contracture Treated with Collagenase or Fasciectomy.

Background:Our study aimed to compare real-world healthcare resource utilization (HRU) and healthcare cost (HC) of Medicare-insured patients (≥65 years old) with Dupuytren’s contracture (DC) treated with Clostridium histolyticum (collagenase) or fasciectomy.Methods:DC patients treated with collagenase or fasciectomy between July 2011 and June 2017 were identified using the IBM MarketScan Medicare Supplemental Database. The index date was the date of the first procedure. Demographic characteristics were captured on the index date, and comorbidities were assessed during the 24-month preindex period. HRU and HC were analyzed throughout the 12-month postindex period. Patients were matched using propensity score weights. Gamma log-linked generalized linear models were used to evaluate HC drivers.Results:Out of 37,374 DC patients, 2911 received collagenase, while 6258 underwent fasciectomy. Postmatching, the total average annual HC was similar between collagenase and fasciectomy ($7271 versus $6220, P = 0.357). When HCs were stratified by the service provider, outpatient facility and physician office costs were lower in the collagenase cohort ($850 versus $1284, P = 0.047 and $546 versus $1001, P < 0.001). The costs of professional services were significantly higher than in the fasciectomy cohort due to the cost of collagenase injection ($1682 versus $629, P < 0.001). The HRU was similar between cohorts, except for more frequent outpatient facility visits in fasciectomy patients (12.3 versus 22.9, P < 0.001). Generalized linear model revealed Charlson comorbidity index, plan type, patients’ residence region, sleep disorder, and hyperlipidemia as significant predictors of total HC.Conclusion:This study found comparable total annual HC and HRU between collagenase- and fasciectomy-treated Medicare patients.

Burden of influenza in patients with cardiovascular disease who receive antiviral treatment for influenza

Aims Cardiovascular disease (CVD) increases the risk of complications from respiratory viruses, including influenza. Moreover, respiratory viruses may increase the risk of CV events. Antiviral medication may reduce healthcare resource utilization (HRU), but more data is needed in CVD populations to explore relationships between influenza antiviral treatment, CVD-related complications, HRU, and costs. Materials and methods This retrospective claims analysis examined data extracted from IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases during three influenza seasons: 2016–2017, 2017–2018, or 2018–2019. Propensity score matching was used to compare HRU outcomes and costs among CVD patients treated with influenza antivirals and untreated patients. Results Across all influenza seasons, patients with CVD and influenza who received antiviral treatment had fewer all-cause emergency department (ED) visits (p < .01), respiratory-related HRU (p < .01), respiratory-related outpatient and ED visits (both p < .01), CVD-related HRU (p < .01), heart failure-related HRU visits (p < .01), and kidney failure-related HRU (p < .01) 180 days post-treatment fill date than CVD patients untreated for influenza. CVD patients treated with antivirals also had a lower mean number of all-cause inpatient, outpatient, and ED visits and days of stay (all p < .01) and fewer mean respiratory-related outpatient and ED visits (both p < .01). HRU patterns were generally consistent over time and across individual influenza seasons. Finally, treated CVD patients incurred lower all-cause outpatient costs 180 days post-treatment fill date (p < .05) than CVD patients untreated for influenza. Conclusion CVD patients who contract influenza and take antiviral medication have fewer short- and long-term influenza-related complications and less overall HRU compared with CVD patients who were not prescribed antiviral treatments. Antiviral treatment may be an important tool in reducing complications in CVD patients with influenza.

Lead and Pulse Generator Migration After Spinal Cord Stimulation Implantation: Insights From an Analysis of 7322 Patients

ObjectivesLead migration (LM) after spinal cord stimulation (SCS) implantation surgery is the most common device-related complication. Our study of lead and implantable pulse generator (IPG) migration using a large administrative claims data base aims to understand rates, risk factors, and outcomes after SCS implantation. Materials and MethodsThis retrospective cohort study used the IBM® MarketScan® (Armonk, NY) Commercial and Medicare Supplemental Databases from 2016 to 2018. Adult patients who underwent SCS surgical procedures with at least 90 days of follow-up were identified using Current Procedural Terminology (CPT®) codes. Patients with LM and IPG migration after SCS surgery were identified using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10 CM) codes. Patients who underwent revision surgery after SCS implantation were identified using the CPT codes and ICD-10 CM codes. In addition, patient characteristics associated with LM or IPG migration, the temporal relationship of migration diagnosis, and revision surgery were evaluated in the cohort. Continuous outcomes were compared between groups using the two-sample Student t-test. The Fisher exact test was used to compare categorical outcomes between groups. ResultsA total of 7322 patients (64.4% percutaneous SCS) underwent SCS surgery during the study period. A total of 141 patients (1.9%) had LM or IPG migration. Of those, 116 patients (1.6%) had LM only; 18 patients (0.2%) had IPG migration; and seven patients (0.1%) had LM and IPG migration. The mean duration for migration diagnosis after initial SCS implantation was 168 (±163.1) days. The mean duration to revision surgery after the migration diagnosis was 12.3 (±35.2) days only. Most patients with migration (105, 74.5%) underwent revision surgery. Only younger age (p = 0.02) was associated with migration in this study. ConclusionsLM and pulse generator migration that required revision surgery occurred in a small proportion of patients who underwent SCS surgical procedures.

Association Between Bio-Fermentation Derived Hyaluronic Acid and Healthcare Costs Following Knee Arthroplasty.

BackgroundLimiting access to intra-articular knee injections, including hyaluronic acid (HA), has been advocated as a cost-containment measure in the treatment of knee osteoarthritis. The association between presurgical injections and post-surgical complications such as early periprosthetic joint infection and revision remained to be investigated. This study evaluated pre- and post-surgical costs and rates of post-surgical complications in knee arthroplasty (KA) patients with or without prior HA use.MethodsCommercial and Medicare Supplemental Claims Data (IBM MarketScan Research Databases) from January 1, 2012 to December 31, 2018 were used to identify unilateral KA patients. Those who completed a course of bio-fermentation derived HA (Bio-HA) as the first-line HA therapy comprised of the test group (n = 4091), while the control group did not use HA prior to KA (n = 118,659). Using multivariable regression with propensity score (PS) weighting, overall healthcare costs, readmission rates, and revision rates were assessed at six months following KA.ResultsHealthcare costs following KA were significantly lower for the Bio-HA group ($10,021 ± $22,796) than No HA group ($12,724 ± $32,966; PS p < 0.001). Bio-HA patients had lower readmission rates (8.9% vs 14.0%; PS p < 0.001) and inpatient costs per readmitted patient ($43,846 ± $50,648 vs $50,533 ± $66,150; PS p = 0.005). There were no differences in revision rate for any reason (Bio-HA: 0.78% vs No HA: 0.67%; PS p = 0.361) and with PJI (Bio-HA: 0.42% vs No HA: 0.33%; PS p = 0.192). Costs in the six months up to and including the KA were similar for both groups (Bio-HA: $49,759 ± $40,363 vs No HA: $50,532 ± $43,183; PS p = 0.293).ConclusionBio-HA use prior to knee arthroplasty did not appear to increase overall healthcare costs in the six months before and after surgery. Allowing access to HA injections provides a non-surgical therapeutic option without increasing cost or risk of post-surgical complications.

Disease burden of primary biliary cholangitis and associated pruritus based on a cross-sectional US claims analysis

ObjectiveIn order to identify areas of unmet need in patients with primary biliary cholangitis (PBC), this study sought to use real-world observational healthcare data to characterise the burden in patients...

Association between gabapentinoids and oedema treated with loop diuretics: A pooled sequence symmetry analysis from the USA and Denmark.

To assess the gabapentinoid-oedema-loop diuretic prescribing cascade in adults using large administrative health care databases from the USA and Denmark. This study used a sequence symmetry analysis to assess loop diuretic initiation before and after the initiation of gabapentinoids among patients aged 20 years or older without heart failure or chronic kidney disease. Data from MarketScan Commercial and Medicare Supplemental Claims databases (2005 to 2019) and Danish National Prescription Register (2005 to 2018) were analyzed. Use of loop diuretics associated with initiation of selective norepinephrine reuptake inhibitors (SNRI) was used as a negative control. We assessed the pooled temporality of loop diuretic initiation relative to gabapentinoid or SNRI initiation across the 2 countries. Secular trend-adjusted sequence ratios (aSRs) with 95% confidence intervals (CIs) were calculated using data from 90 days before and after initiation of gabapentinoids. Pooled ratio of aSRs were calculated by comparing gabapentinoids to SNRIs. Among the 1 511 493 gabapentinoid initiators (Denmark [n= 338 941]; USA [n= 1 172 552]), 20 139 patients had a new loop diuretic prescription 90 days before or after gabapentinoid initiation, resulting in a pooled aSR of 1.33 (95% CI 1.06-1.67). The pooled aSR for the negative control (i.e., SNRI) was 0.84 (95% CI 0.75-0.94), which resulted in a pooled ratio of aSRs of 1.58 (95% CI 1.23-2.04). Pooled estimated incidence of the gabapentinoid-loop diuretic prescribing cascade was 8.14 (95% CI, 1.92-34.49) events per 1000 patient-years. We identified evidence of the gabapentinoid-oedema-loop diuretic prescribing cascade in 2 countries.

Pneumococcal vaccination coverage among adults newly diagnosed with underlying medical conditions and regional variation in the U.S.

BackgroundThe Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends pneumococcal vaccination for adults with chronic or immunocompromising conditions to prevent pneumococcal disease, yet vaccination rates are low and have limited information on regional variation. This study examines factors associated with pneumococcal vaccination in adults with underlying conditions and describes regional variation in vaccination across the U.S. MethodsUsing IBM MarketScan Commercial Database and Medicare Supplemental Database, this retrospective cohort study included adults ages 19–64 newly diagnosed with chronic (i.e. diabetes, chronic heart, lung, or liver disease, alcohol or tobacco dependence) or immunocompromising (i.e. cancer, chronic renal disease, organ transplant, HIV/AIDS, and asplenia) conditions in 2013. Adults were followed up until the time of pneumococcal vaccination, death, or December 31, 2019, whichever came first. Cox proportional hazards model was used to examine factors associated with vaccination. Vaccination rate was calculated by metropolitan statistical area (MSA) and visually represented on a U.S. map. Results255,330 adults were included. Vaccination rate increased from 6.0% to 21.1% among adults with one year and five years of follow-up, respectively. It took 2.4 years on average for adults to receive vaccination after initial diagnosis. Adults ages 50–64, 35–49 (relative to 19–34) or receiving influenza vaccination were more likely to receive pneumococcal vaccinations. Adults with HIV/AIDS were more likely and those with other conditions were less likely to be vaccinated than those with diabetes. Adults being diagnosed by other providers were less likely to be vaccinated than those diagnosed by primary care providers. Vaccination rate varied largely across MSAs, ranging from 0.0% (Ames, IA; Cheyenne, WY) to 34.0% (Ann Arbor, MI). ConclusionPneumococcal vaccination remains low and most adults with underlying conditions are unvaccinated. Insights into factors associated with vaccination, including regional variability, can help to increase pneumococcal vaccination.

The Economic Burden of Eosinophilic Gastritis and Eosinophilic Enteritis in the United States.

IntroductionEosinophilic gastritis and eosinophilic enteritis (EoG/EoN) are associated with a substantial clinical burden. However, limited information is available regarding the economic burden of EoG/EoN. This study was conducted to compare healthcare resource use (HRU) and costs among patients with EoG/EoN versus without EoG/EoN in the USA.MethodsAdministrative claims data from the IBM MarketScan® Commercial Claims and Encounters (CCAE) and Medicare Supplemental and Coordination of Benefits Databases (2009–2019) was used to identify two cohorts of patients. Patients without EoG/EoN were matched 3:1 to patients with EoG/EoN on sex, year of birth, and healthcare plan type. Study measures included demographic characteristics, select comorbidities, all-cause HRU, and costs. Comparisons were made over a 1-year period following EoG/EoN diagnosis for patients with EoG/EoN and an eligible date for patients without EoG/EoN.ResultsA total of 2219 patients with EoG/EoN and 6657 patients without EoG/EoN were analyzed. Significantly higher proportions of patients with EoG/EoN versus without EoG/EoN had comorbid conditions. Rates of all-cause HRU were significantly higher among patients with EoG/EoN versus patients without EoG/EoN (adjusted rate ratio [95% confidence interval]: inpatient visits, 6.26 [5.26, 7.46]; outpatient visits, 1.17 [1.16, 1.19]; emergency department visits, 2.11 [1.98, 2.25]; all p < 0.001). Patients with EoG/EoN incurred significantly higher costs versus patients without EoG/EoN (adjusted mean cost difference $31,180; p < 0.001). Cost differences were largely due to outpatient (adjusted mean cost difference $14,018; p < 0.001) and inpatient (adjusted mean cost difference $11,224; p < 0.001) costs.ConclusionThe economic burden associated with EoG/EoN is substantial, with patients with EoG/EoN having a higher rate of HRU and incurring $31,180 more than patients without EoG/EoN on average. Most of the cost difference was attributable to outpatient and inpatient costs. Cost-saving strategies to lower the burden of illness in this patient population are needed.

Healthcare resource utilization and costs in individuals with Huntington’s disease by disease stage in a US population

Aims To quantify healthcare resource utilization (HRU) and costs by disease stage in individuals with Huntington’s disease (HD) in a US population. Materials and methods This retrospective cohort study used administrative claims data from the IBM MarketScan Commercial, Multi-State Medicaid, and Medicare Supplemental Databases between 1 January 2009 and 31 December 2018. Individuals with an HD claim between 1 January 2010 and 31 December 2017 were selected. Index date was the date of first HD diagnosis. Individuals were required to have continuous enrollment for ≥ 12 months pre-index, 3 months post-index, and have no pre-index HD claims. All-cause HRU and costs per patient per month (PPPM) (overall and stratified by disease stage) were assessed for individuals with HD. Results A total of 2,669 individuals with HD were identified. Of these, 1,432 (53.7%), 689 (25.8%), and 548 (20.5%) had early-, middle-, and late-stage HD at baseline, respectively. Mean HRU PPPM by post-index HD stage increased with disease stage for outpatient visits, pharmacy claims, and HD-related pharmacy claims (p < 0.05 for all). Mean inpatient visits and emergency room visits PPPM were highest in individuals with middle-stage HD (p <0.05 for all). Mean total all-cause healthcare cost PPPM for individuals with HD was $2,889, and it was significantly higher in middle-stage individuals, at $7,988, compared with early- and late-stage individuals, at $3,726 and $5,125, respectively; p <0.0001. Limitations In the absence of disease staging information in administrative claims data, staging was based on the presence of clinical markers in claims. Our evaluations didn’t include the indirect costs of HD, which may be substantial as HD typically affects people at their peak earning potential. Conclusions HRU and costs of care are high among individuals with HD, particularly among those with middle- and late-stage disease. This indicates that the disease burden in HD increases with disease stage, highlighting the need for interventions that can slow or prevent disease progression.

Burden of insomnia among cancer patients undergoing treatment: A retrospective claims database analysis.

e18816 Background: Almost half of all cancer patients have trouble sleeping, usually insomnia or other sleep-wake disorders. Cancer treatment can exacerbate sleep problems. This study evaluated all-cause healthcare resource utilization (HCRU) and costs in cancer patients undergoing treatment who also have insomnia relative to a matched cohort of cancer patients undergoing treatment who do not have insomnia. Methods: This retrospective study used the IBM MarketScan Commercial and Medicare Supplemental Databases (Jan 2014-Dec 2019) to identify patients: (1) age ≥18 years; (2) with ≥1 ICD-9/ICD-10 codes for insomnia OR with ≥2 prescriptions for zolpidem immediate release (IR) OR trazodone ≤150mg OR benzodiazepine; (3) with ≥12 months of continuous enrollment pre-/post-index date (earliest diagnosis or medication fill date); (4) with ≥2 ICD-9/ICD-10 codes for any cancer; and (5) ≥1 claim for oncology treatment. Patients with sleep disorders other than insomnia were excluded. The resulting patients (“insomnia cohort”) were 1:1 matched on age, sex and Elixhauser Comorbidity Index (ECI) score to patients with cancer undergoing treatment without insomnia or other sleep disorders (“control cohort”). HCRU and costs were reported per patient per month (PPPM). Generalized linear models were used to compare adjusted outcomes between cohorts. Results: For each cohort, 7,132 patients (mean age 60.8 years, 69.5% female, 13.6 ECI score) were identified. In adjusted analyses, significantly more patients in the insomnia cohort had at least one inpatient visit per month, inpatient stays were significantly longer, and mean outpatient visits were significantly higher (all p &lt; 0.001) relative to the control cohort. The insomnia cohort had higher mean number of emergency department (ED) visits (p &lt; 0.05); however, mean number of inpatient visits was not significantly different between cohorts. Adjusted analyses also showed significantly higher mean total PPPM costs for the insomnia cohort than the control cohort ($4,864 and $3,302, respectively; mean ratio = 1.47; p &lt; 0.0001). Mean PPPM costs for inpatient visits, ED visits, and outpatient costs were also higher for the insomnia cohort (p &lt; 0.001). Conclusions: Cancer patients undergoing treatment who have insomnia had more intensive HCRU and higher costs relative to those without insomnia. These results suggest that better managing insomnia in this population may have a beneficial impact on both patients and payers.