Enrollment in High-Deductible Health Plans and Incident Diabetes Complications.

Importance: Preventing diabetes complications requires monitoring and control of hyperglycemia and cardiovascular risk factors. Switching to high-deductible health plans (HDHPs) has been shown to hinder aspects of diabetes care; however, the association of HDHP enrollment with microvascular and macrovascular diabetes complications is unknown. Objective: To examine the association between an employer-required switch to an HDHP and incident complications of diabetes. Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for US adults with diabetes enrolled in employer-sponsored health plans between January 1, 2010, and December 31, 2019. Data analysis was performed from May 26, 2022, to January 2, 2024. Exposures: Adults with a baseline year of non-HDHP enrollment who had to switch to an HDHP because their employer offered no non-HDHP alternative in that year were compared with adults who were continuously enrolled in a non-HDHP. Main Outcomes and Measures: Mixed-effects logistic regression models examined the association between switching to an HDHP and, individually, the odds of myocardial infarction, stroke, hospitalization for heart failure, lower-extremity complication, end-stage kidney disease, proliferative retinopathy, treatment for retinopathy, and blindness. Models were adjusted for demographics, comorbidities, and medications, with inverse propensity score weighting used to account for potential selection bias. Results: The study included 42 326 adults who switched to an HDHP (mean [SD] age, 52 [10] years; 19 752 [46.7%] female) and 202 729 adults who did not switch (mean [SD] age, 53 [10] years; 89 828 [44.3%] female). Those who switched to an HDHP had greater odds of experiencing all diabetes complications (odds ratio [OR], 1.11; 95% CI, 1.06-1.16 for myocardial infarction; OR, 1.15; 95% CI, 1.09-1.21 for stroke; OR, 1.35; 95% CI, 1.30-1.41 for hospitalization for heart failure; OR, 2.53; 95% CI, 2.38-2.70 for end-stage kidney disease; OR, 2.23; 95% CI, 2.17-2.29 for lower-extremity complication; OR, 1.17; 95% CI, 1.13-1.21 for proliferative retinopathy; OR, 2.35; 95% CI, 2.18-2.54 for blindness; and OR, 2.28; 95% CI, 2.15-2.41 for retinopathy treatment). Conclusions and Relevance: This study found that an employer-driven switch to an HDHP was associated with increased odds of experiencing all diabetes complications. These findings reinforce the potential harm associated with HDHPs for people with diabetes and the importance of affordable and accessible chronic disease management, which is hindered by high out-of-pocket costs incurred by HDHPs.

Evaluation of High-Deductible Health Plans and Acute Glycemic Complications Among Adults With Diabetes.

Importance: Optimal diabetes care requires regular monitoring and care to maintain glycemic control. How high-deductible health plans (HDHPs), which reduce overall spending but may impede care by increasing out-of-pocket expenses, are associated with risks of severe hypoglycemia and hyperglycemia is unknown. Objective: To examine the association between an employer-forced switch to HDHP and severe hypoglycemia and hyperglycemia. Design, Setting, and Participants: This retrospective cohort study used deidentified administrative claims data for privately insured adults with diabetes from a single insurance carrier with multiple plans across the US between January 1, 2010, and December 31, 2018. Analyses were conducted between May 15, 2020, and November 3, 2022. Exposures: Patients with 1 baseline year of enrollment in a non-HDHP whose employers subsequently forced a switch to an HDHP were compared with patients who did not switch. Main Outcomes and Measures: Mixed-effects logistic regression models were used to examine the association between switching to an HDHP and the odds of severe hypoglycemia and hyperglycemia (ascertained using diagnosis codes in emergency department [ED] visits and hospitalizations), adjusting for patient age, sex, race and ethnicity, region, income, comorbidities, glucose-lowering medications, baseline ED and hospital visits for hypoglycemia and hyperglycemia, and baseline deductible amount, and applying inverse propensity score weighting to account for potential treatment selection bias. Results: The study population was composed of 42 326 patients who switched to an HDHP (mean [SD] age: 52 [10] years, 19 752 [46.7%] women, 7375 [17.4%] Black, 5740 [13.6%] Hispanic, 26 572 [62.8%] non-Hispanic White) and 202 729 patients who did not switch (mean [SD] age, 53 [10] years, 89 828 [44.3%] women, 29 551 [14.6%] Black, 26 689 [13.2%] Hispanic, 130 843 [64.5%] non-Hispanic White). When comparing all study years, switching to an HDHP was not associated with increased odds of experiencing at least 1 hypoglycemia-related ED visit or hospitalization (OR, 1.01 [95% CI, 0.95-1.06]; P = .85), but each year of HDHP enrollment did increase these odds by 2% (OR, 1.02 [95% CI, 1.00-1.04]; P = .04). In contrast, switching to an HDHP did significantly increase the odds of experiencing at least 1 hyperglycemia-related ED visit or hospitalization (OR, 1.25 [95% CI, 1.11-1.42]; P < .001), with each year of HDHP enrollment increasing the odds by 5% (OR, 1.05 [95% CI, 1.01-1.09]; P = .02). Conclusions and Relevance: In this cohort study, employer-forced switching to an HDHP was associated with increased odds of potentially preventable acute diabetes complications, potentially because of delayed or deferred care. These findings suggest that employers should be more judicious in their health plan offerings, and health plans and policy makers should consider allowing preventive and high-value services to be exempt from deductible requirements.

Out-of-Pocket Cost Burden Associated With Contemporary Management of Advanced Prostate Cancer Among Commercially Insured Patients.

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.

Longitudinal Cost of Septal Myectomy Versus Alcohol Septal Ablation for Hypertrophic Cardiomyopathy.

OBJECTIVE: To compare the postprocedural health care utilization and cost of septal myectomy (SM) and alcohol septal ablation (ASA). PATIENTS AND METHODS: Using the OptumLabs Data Warehouse, we analyzed de-identified claims data of adult patients undergoing SM and ASA for obstructive hypertrophic cardiomyopathy from January 1, 2006, through December 31, 2018. We used propensity score weighting to compare the 2-year incidence rates of emergency department visits and rehospitalizations after SM and ASA. RESULTS: We identified 953 patients in total: 660 underwent SM and 293 underwent ASA. There was no difference in the risk (odds ratio, 1.1; 95% CI, 0.6 to 1.8) or frequency (incidence rate ratio, 1.1; 95% CI, 0.8 to 1.5) of emergency department visits, but the annual risk of hospital readmission was 10.8% after SM and 25.9% after ASA during the second postoperative year (P=.004). In those who were ever readmitted, the average length of hospital stay within the first 2 years after ASA was 1.6 times as long as that after SM (incidence rate ratio, 1.6; 95% CI, 1.0 to 2.4). Overall, the 2-year cumulative postprocedural cost was significantly higher after ASA (P<.001). CONCLUSION: Compared with ASA, SM is associated with fewer hospital readmissions and lower 2-year postprocedural health care cost.

Trends in the Incidence and Treatment of Distal Radius Fractures in the United States in Privately Insured and Medicare Advantage Enrollees.

Background: This study aims to determine the trends in the treatment of distal radius fractures (DRFs) in patients aged 18 years and older. Methods: An administrative claims database of more than 100 million patients was used to identify patients aged 18 years and older with a DRF between 2005 and 2014. A total of 137 130 DRFs were identified in 135 128 patients. Results: The proportion and rate of fractures were more predominant in those aged 55 years and older compared with a decreasing incidence in patients younger than 55 years. Age-adjusted rates of surgical treatment have significantly increased in both women and men by 15.9% (absolute change, 4.8%) and 5.0% (absolute change, 1.7%) change over time, respectively. Conversely, age-adjusted rates of nonsurgical treatment have significantly decreased overtime in both women and men by 6.9% and 2.6%, respectively. Conclusions: These data provide better understanding of the epidemiology of DRF, which is important to develop preventive strategies targeting high-risk populations and to develop effective treatment strategies.

Sociodemographic, Clinical, and Treatment-Related Factors Associated With Hyperglycemic Crises Among Adults With Type 1 or Type 2 Diabetes in the US From 2014 to 2020.

Importance: Hyperglycemic crises (ie, diabetic ketoacidosis [DKA] and hyperglycemic hyperosmolar state [HHS]) are life-threatening acute complications of diabetes. Efforts to prevent these events at the population level have been hindered by scarce granular data and difficulty in identifying individuals at highest risk. Objective: To assess sociodemographic, clinical, and treatment-related factors associated with hyperglycemic crises in adults with type 1 or type 2 diabetes in the US from 2014 to 2020. Design, Setting, and Participants: This retrospective cohort study analyzed administrative claims and laboratory results for adults (aged ≥18 years) with type 1 or type 2 diabetes from the OptumLabs Data Warehouse from January 1, 2014, through December 31, 2020. Main Outcomes and Measures: Rates of emergency department or hospital visits with a primary diagnosis of DKA or HHS (adjusted for age, sex, race/ethnicity, and region, and for year when calculating annualized rates) were calculated separately for patients with type 1 diabetes and type 2 diabetes. The associations of sociodemographic factors (age, sex, race/ethnicity, region, and income), clinical factors (comorbidities), and treatment factors (glucose-lowering medications, hemoglobin A1c) with DKA or HHS in patients with type 1 or type 2 diabetes were assessed using negative binomial regression. Results: Among 20 156 adults with type 1 diabetes (mean [SD] age, 46.6 [16.5] years; 51.2% male; 72.6% White race/ethnicity) and 796 382 with type 2 diabetes (mean [SD] age, 65.6 [11.8] years; 50.3% female; 54.4% White race/ethnicity), adjusted rates of hyperglycemic crises were 52.69 per 1000 person-years (95% CI, 48.26-57.12 per 1000 person-years) for type 1 diabetes and 4.04 per 1000 person-years (95% CI, 3.88-4.21 per 1000 person-years) for type 2 diabetes. In both groups, factors associated with the greatest hyperglycemic crisis risk were low income (≥$200 000 vs <$40 000: type 1 diabetes incidence risk ratio [IRR], 0.61 [95% CI, 0.46-0.81]; type 2 diabetes IRR, 0.69 [95% CI, 0.56-0.86]), Black race/ethnicity (vs White race/ethnicity: type 1 diabetes IRR, 1.33 [95% CI, 1.01-1.74]; type 2 diabetes IRR, 1.18 [95% CI, 1.09-1.27]), high hemoglobin A1c level (≥10% vs 6.5%-6.9%: type 1 diabetes IRR, 7.81 [95% CI, 5.78-10.54]; type 2 diabetes IRR, 7.06 [95% CI, 6.26-7.96]), history of hyperglycemic crises (type 1 diabetes IRR, 7.88 [95% CI, 6.06-9.99]; type 2 diabetes IRR, 17.51 [95% CI, 15.07-20.34]), severe hypoglycemia (type 1 diabetes IRR, 2.77 [95% CI, 2.15-3.56]; type 2 diabetes IRR, 4.18 [95% CI, 3.58-4.87]), depression (type 1 diabetes IRR, 1.62 [95% CI, 1.37-1.92]; type 2 diabetes IRR, 1.46 [95% CI, 1.34-1.59]), neuropathy (type 1 diabetes IRR, 1.64 [95% CI, 1.39-1.93]; type 2 diabetes IRR, 1.25 [95% CI, 1.17-1.34]), and nephropathy (type 1 diabetes IRR, 1.22 [95% CI, 1.01-1.48]; type 2 diabetes IRR, 1.23 [95% CI, 1.14-1.33]). Age had a U-shaped association with hyperglycemic crisis risk in patients with type 1 diabetes (compared with patients aged 18-44 years: 45-64 years IRR, 0.72 [95% CI, 0.59-0.87]; 65-74 years IRR, 0.62 [95% CI, 0.47-0.80]; ≥75 years IRR, 0.96 [95% CI, 0.66-1.38]). In type 2 diabetes, risk of hyperglycemic crises decreased progressively with age (45-64 years IRR, 0.57 [95% CI, 0.51-0.63]; 65-74 years IRR, 0.44 [95% CI, .39-0.49]; ≥75 years IRR, 0.41 [95% CI, 0.36-0.47]). In patients with type 2 diabetes, higher risk was associated with sodium-glucose cotransporter 2 inhibitor therapy (IRR, 1.30; 95% CI, 1.14-1.49) and insulin dependency (compared with regimens with bolus insulin: regimens with basal insulin only, IRR, 0.69 [95% CI, 0.63-0.75]; and without any insulin, IRR, 0.36 [95% CI, 0.33-0.40]). Conclusions and Relevance: In this cohort study, younger age, Black race/ethnicity, low income, and poor glycemic control were associated with an increased risk of hyperglycemic crises. The findings suggest that multidisciplinary interventions focusing on groups at high risk for hyperglycemic crises are needed to prevent these dangerous events.

Comparison of Diabetes Medications Used by Adults With Commercial Insurance vs Medicare Advantage, 2016 to 2019.

Importance: Glucagonlike peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT2i), and dipeptidyl peptidase-4 inhibitors (DPP-4i) are associated with low rates of hypoglycemia, and postmarketing trials of GLP-1RA and SGLT2i demonstrated that these medications improved cardiovascular and kidney outcomes. Objective: To compare trends in initiation of treatment with GLP-1RA, SGLT2i, and DPP-4i by older adults with type 2 diabetes insured by Medicare Advantage vs commercial health plans. Design, Setting, and Participants: This retrospective cohort study used administrative claims data from a deidentified database of commercially insured and Medicare Advantage beneficiaries. Adults aged 58 to 66 years with type 2 diabetes who filled any medication prescription to lower glucose levels from January 1, 2016, to December 31, 2019, were compared between groups. Exposure: Enrollment in a Medicare Advantage or commercial health insurance plan. Main Outcomes and Measures: The odds of initiating GLP-1RA, SGLT2i, and DPP-4i treatment were examined for Medicare Advantage vs commercial insurance beneficiaries using 3 separate logistic regression models adjusted for year and demographic and clinical factors. These models were used to calculate adjusted annual rates of medication initiation by health plan. Results: A total of 382 574 adults with pharmacologically treated type 2 diabetes (52.9% men; mean [SD] age, 62.4 [2.7] years) were identified, including 172 180 Medicare Advantage and 210 394 commercial beneficiaries. From 2016 to 2019, adjusted rates of initiation of GLP-1RA, SGLT2i, and DPP-4i treatment increased among all beneficiaries, from 2.14% to 20.02% for GLP-1RA among commercial insurance beneficiaries and from 1.50% to 11.44% among Medicare Advantage beneficiaries; from 2.74% to 18.15% for SGLT2i among commercial insurance beneficiaries and from 1.57% to 8.51% among Medicare Advantage beneficiaries; and from 3.30% to 11.71% for DPP-4i among commercial insurance beneficiaries and from 2.44% to 7.68% among Medicare Advantage beneficiaries. Initiation rates for all 3 drug classes were consistently lower among Medicare Advantage than among commercial insurance beneficiaries. Within each calendar year, the odds of initiating GLP-1RA treatment ranged from 0.28 (95% CI, 0.26-0.29) to 0.70 (95% CI, 0.65-0.75) for Medicare Advantage and commercial insurance beneficiaries, respectively; SGLT2i, from 0.21 (95% CI, 0.20-0.22) to 0.57 (95% CI, 0.53-0.61), respectively; and DPP-4i, from 0.37 (95% CI, 0.34-0.39) to 0.73 (95% CI, 0.69-0.78), respectively (P < .001 for all). The odds of starting GLP-1RA and SGLT2i increased with income; for an income of $200 000 and higher vs less than $40 000, the odds ratio for GLP-1RA was 1.23 (95% CI, 1.15-1.32) and for SGLT2i was 1.16 (95% CI, 1.09-1.24). Conclusions and Relevance: These findings suggest that Medicare Advantage beneficiaries may be less likely than commercially insured beneficiaries to be treated with newer medications to lower glucose levels, with greater disparities among lower-income patients. Better understanding of nonclinical factors contributing to treatment decisions and efforts to promote greater equity in diabetes management appear to be needed.

National Patterns of Filled Prescriptions and Third-Line Treatment Utilization for Privately Insured Women With Overactive Bladder.

OBJECTIVE: The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. METHODS: We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. RESULTS: Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50-73], and median follow-up was 2.6 years (IQR, 1.6-4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1-15) vs 3.6 months (IQR, 1-10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% (P < 0.0001). CONCLUSIONS: Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.

Autologous Breast Reconstruction versus Implant-Based Reconstruction: How Do Long-Term Costs and Health Care Use Compare?

BACKGROUND: The authors compared long-term health care use and cost in women undergoing immediate autologous breast reconstruction and implant-based breast reconstruction. METHODS: This study was conducted using the OptumLabs Data Warehouse, which contains deidentified retrospective administrative claims data, including medical claims and eligibility information from a large U.S. health insurance plan. Women who underwent autologous or implant-based breast reconstruction between January of 2004 and December of 2014 were included. The authors compared 2-year use rates and predicted costs of care. Comparisons were tested using the t test. RESULTS: Overall, 12,296 women with immediate breast reconstruction were identified; 4257 with autologous (35 percent) and 8039 with implant-based (65 percent) breast reconstruction. The proportion of autologous breast reconstruction decreased from 47.2 percent in 2004 to 32.7 percent in 2014. The mean predicted reconstruction cost of autologous reconstruction was higher than that of implant-based reconstruction in both unilateral and bilateral surgery. Similar results for mean predicted 2-year cost of care were seen in bilateral procedures. However, in unilateral procedures, the 2-year total costs were higher for implant-based than for autologous reconstruction. Two-year health care use rates were higher for implant-based reconstruction than for autologous reconstruction for both unilateral and bilateral procedures. Women undergoing unilateral implant-based reconstruction had higher rates of hospital admissions (30.3 versus 23.1 per 100; p < 0.01) and office visits (2445.1 versus 2283.6 per 100; p < 0.01) than those who underwent autologous reconstruction. Emergency room visit rates were similar between the two methods. Bilateral procedures yielded similar results. CONCLUSION: Although implant-based breast reconstruction is a less expensive index operation than autologous breast reconstruction, it was associated with higher health care use, resulting in similar total cost of care over 2 years.

Risk of De Novo Hepatocellular Carcinoma Following Use of Direct Acting Antiviral Medications for Treatment of Chronic Hepatitis C.

Direct-acting antivirals (DAA) are now the mainstay of treatment for patients with chronic hepatitis C virus (HCV); however, there is some controversy over whether use of DAAs for HCV, as compared with IFN-based regimens, leads to an increased risk for hepatocellular carcinoma (HCC) development. We investigated the association between use of DAAs and subsequent development of HCC in longitudinal data from patients with HCV from diverse backgrounds (various ages, ethnicities, and geographic regions) across the United States. The design was a retrospective study performed using medical and pharmacy claims from OptumLabs. HCV treatment exposure was categorized as DAA-only, DAA + IFN, any-DAA, or IFN-only. To account for confounding by indication, inverse probability of treatment weighting was performed. Cox proportional hazard models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). We identified 5,781 patients with HCV with no history of HCC at baseline. Compared with IFN-only regimen, no significant increase in HCC risk was found for use of DAA-only (HR, 1.53; 95% CI, 0.73-3.23), DAA + IFN (HR, 1.02; 95% CI, 0.51-2.06), or any-DAA (HR, 1.04; 95% CI, 0.65-1.65). When stratified by sustained virological response (SVR), we noted a higher HCC risk for DAA-only among patients who achieved SVR post-treatment (HR, 7.53; 95% CI, 1.48-38.34), but the CIs were wide, which might be due to the small sample size of the subgroups. Among those who did not achieve SVR, no association was found for use of DAA-only (HR, 0.59; 95% CI, 0.19-1.91). These findings do not provide compelling evidence for the conception that use of DAAs for HCV is associated with increased risk of HCC development.

Healthcare Cost and Utilization in Nonalcoholic Fatty Liver Disease: Real-World Data From a Large U.S. Claims Database.

The prevalence of nonalcoholic fatty liver disease (NAFLD) is increasing. The health care burden resulting from the multidisciplinary management of this complex disease is unknown. We assessed the total health care cost and resource utilization associated with a new NAFLD diagnosis, compared with controls with similar comorbidities. We used OptumLabs Data Warehouse, a large national administrative claims database with longitudinal health data of over 100 million individuals enrolled in private and Medicare Advantage health plans. We identified 152,064 adults with a first claim for NAFLD between 2010 and 2014, of which 108,420 were matched 1:1 by age, sex, metabolic comorbidities, length of follow-up, year of diagnosis, race, geographic region, and insurance type to non-NAFLD contemporary controls from the OptumLabs Data Warehouse database. Median follow-up time was 2.6 (range 1-6.5) years. The final study cohort consisted of 216,840 people with median age 55 (range 18-86) years, 53% female, 78% white. The total annual cost of care per NAFLD patient with private insurance was $7,804 (interquartile range [IQR] $3,068-$18,688) for a new diagnosis and $3,789 (IQR $1,176-$10,539) for long-term management. These costs are significantly higher than the total annual costs of $2,298 (IQR $681-$6,580) per matched control with similar metabolic comorbidities but without NAFLD. The largest increases in health care utilization that may account for the increased costs in NAFLD compared with controls are represented by liver biopsies (relative risk [RR] = 55.00, 95% confidence interval [CI] 24.48-123.59), imaging (RR = 3.95, 95% CI 3.77-4.15), and hospitalizations (RR = 1.87, 95% CI 1.73-2.02). Conclusion: The costs associated with the care for NAFLD independent of its metabolic comorbidities are very high, especially at first diagnosis. Research efforts shouldfocus on identification of underlying determinants of use, sources of excess cost, and development of cost-effective diagnostic tests.

Risk factors for severe anaphylaxis in the United States.

BACKGROUND: Anaphylaxis is an acute systemic allergic reaction and may be life-threatening. OBJECTIVE: To assess risk factors associated with severe and near-fatal anaphylaxis in a large observational cohort study. METHODS: We analyzed administrative claims data from Medicare Advantage and privately insured enrollees in the United States from 2005 to 2014. Severe anaphylaxis was defined as anaphylaxis resulting in hospital or intensive care unit (ICU) admission, requiring endotracheal intubation, or meeting criteria for near-fatal anaphylaxis. RESULTS: Of 38,695 patients seen in the emergency department for anaphylaxis during the study period, 4,431 (11.5%) required hospitalization, 2,057 (5.3%) were admitted to the ICU, 567 (1.5%) required endotracheal intubation, and 174 (0.45%) were classified as having a near-fatal episode. Multivariable analysis revealed that medication-related anaphylaxis (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.38-1.63; P < .001), age of 65 years or older (OR, 3.15; 95% CI, 2.88-3.44; P < .001), and the presence of cardiac disease (OR, 1.56; 95% CI, 1.50-1.63; P < .001) or lung disease (OR, 1.23; 95% CI, 1.16-1.30; P < .001) were associated with increased odds of severe anaphylaxis requiring any hospital admission, ICU admission, or intubation or being a near-fatal reaction. CONCLUSION: In this large contemporary cohort study, 11.6% of patients had severe anaphylaxis. Age of 65 years or older, medication as a trigger, and presence of comorbid conditions (specifically cardiac and lung disease) were associated with significantly higher odds of severe anaphylaxis. Additional studies examining risk factors for severe anaphylaxis are needed to define risk assessment strategies and establish a framework for management.

Photon and Proton Radiation Therapy Utilization in a Population of More Than 100 Million Commercially Insured Patients.

PURPOSE: To characterize the changes in the use of radiation therapy (RT), specifically proton beam radiation therapy (PBRT), among adult and pediatric patients over a 11-year period in a very large population of insured patients. METHODS AND MATERIALS: We conducted a retrospective analysis of the OptumLabs Data Warehouse claims database of more than 100 million insured US enrollees. Descriptive analyses were undertaken to evaluate the characteristics of patients receiving RT from 2002 to 2012. RESULTS: There were 474,533 patients treated with RT from 2002 to 2012. The percentage of patients treated with 3-dimensional conformal radiation therapy, 2-dimensional RT/brachytherapy, intensity modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), and PBRT was 34.5%, 63.4%, 2.1%, 0.0%, and 0.1% and 40.4%, 36.0%, 21.9%, 1.1%, and 0.6% in 2002 and 2012, respectively. The greatest increase in utilization was of IMRT for prostate cancer, growing from 3.5% to 64.0%. For non-prostate cancer adults, IMRT use grew from 1.7% to 16.4%. For children, PBRT utilization increased from 0.3% to 9.7%. For prostate cancer patients, PBRT increased from 0.0% to 2.6%. For all patients, advanced technology (SBRT and PBRT) use was very low at <2%, versus 22% for IMRT. CONCLUSIONS: This is the largest and most geographically diverse description of RT utilization. Proton beam RT utilization remains very low and has had little impact on overall RT utilization compared with IMRT. The largest shift has occurred in IMRT for prostate cancer. Our findings indicate that overall utilization of proton therapy has been low and that its use has likely had little impact on national expenditures on cancer care in the current environment.

Contralateral Prophylactic Mastectomy with Immediate Breast Reconstruction Increases Healthcare Utilization and Cost.

BACKGROUND: The rates of contralateral prophylactic mastectomy (CPM) in women with unilateral breast cancer continue to rise, especially in women undergoing immediate breast reconstruction (IBR). METHODS: We utilized administrative claims data from a large US commercial insurance database (OptumLabs) to identify women age 18-64 years who underwent IBR between January 2004 and December 2013. We compared 2-year unadjusted utilization rates and total costs of care between unilateral mastectomy (UM) and bilateral mastectomy (BM) for implant-based and autologous reconstruction. Comparisons were tested using t-test and differences in cost were estimated using the Wilcoxon rank-sum test. RESULTS: Overall, 11,235 women undergoing mastectomy with IBR were identified; 7319 with implant reconstruction [1923 UM (26%) and 5396 BM (74%)] and 3916 with autologous reconstruction [1687 UM (43%) and 2229 BM (57%)]. The overall rate of office visits (2386 vs. 2391 per 100 women, p = 0.42) and hospital readmission rate (29.1 per 100 women vs. 27.4, p = 0.06) were similar between BM + IBR and UM + IBR. Women undergoing BM + IBR had a higher emergency room (ER) visit rate (34.1 per 100 women vs. 29.8, p < 0.0001). The total 2-year cost of care was higher for BM + IBR than UM + IBR for implant reconstruction ($106,711 vs. $97,218, p < 0.0001) and for autologous reconstruction ($114,725 vs. $87,874, p < 0.0001). CONCLUSIONS: BM + IBR (autologous or implant) was associated with increased ER visits and higher total cost of care over 2 years compared with UM + IBR. Patients considering CPM should be counseled on the additional risks and costs associated with BM + IBR.

Impact of treatment regimen on acute care use during and after adjuvant chemotherapy for early-stage breast cancer.

PURPOSE: The Oncology Care Model was developed, in part, to reduce acute care use during the 6 months after chemotherapy initiation. However, little is known about the impact of chemotherapy regimen on acute care needs, or about later acute care. We sought to assess acute care use over 2 years in patients receiving four contemporary adjuvant chemotherapy regimens for breast cancer. METHODS: Administrative claims data from a large U.S. commercial insurance database (OptumLabs Data Warehouse) were used to retrospectively identify women with early-stage breast cancer who received adjuvant doxorubicin-cyclophosphamide (AC), AC followed or preceded by docetaxel or paclitaxel (AC-T), AC concurrent with docetaxel or paclitaxel (TAC), or docetaxel-cyclophosphamide (TC) between 2008 and 2014. Rates of hospitalizations and emergency department (ED) visits that did not lead to hospitalizations were compared during four sequential 6-month periods among recipients of these four regimens using negative binomial regression (TC = reference). RESULTS: We identified 8621 eligible patients, 87.2% younger than 65. Over 6 months, 11.9% were hospitalized and 17.1% had ED visits. Over 24 months, 17.9% were hospitalized and 28.3% visited the ED. Adjusted rates of hospitalizations/100 patients were significantly higher in AC-T and TAC compared to TC recipients in the first 6 months (14.9, 21.9, and 11.3, respectively, p < 0.001). There were no hospitalization rate differences among regimens later. ED visit rates did not differ significantly by regimen during any 6-month period. CONCLUSION: Higher rates of hospitalizations in recipients of AC-T and TAC were restricted to the chemotherapy administration period, and did not persist afterwards.

Increasing Emergency Department Visits for Anaphylaxis, 2005-2014.

BACKGROUND: Anaphylaxis is a potentially life-threatening systemic allergic reaction. Studies suggest that the incidence of anaphylaxis is increasing; however, recent trends in emergency department (ED) visits for anaphylaxis in the United States have not been studied. OBJECTIVE: To examine trends in the incidence and rates of anaphylaxis-related ED visits from 2005 through 2014. METHODS: We retrospectively analyzed data from a national administrative claims database including commercially insured and Medicare Advantage patients. We identified all ED visits for anaphylaxis and calculated rates as number of anaphylaxis-related ED visits per 100,000 enrollees. Rates were compared over time and by age and trigger. RESULTS: During the 10-year time period, 56,212 ED visits for anaphylaxis were identified. The median (interquartile range) age was 36 (17-52 years) years, and 58% were female. Most cases (57%) were due to unspecified triggers, 27% were associated with food, 12% were medication related, and 4% were due to insect venom. The overall rate of anaphylaxis per 100,000 enrollees increased by 101%, from 14.2 in 2005 to 28.6 in 2014 (P < .001). Rates of ED visits for anaphylaxis increased in all age groups, but the greatest increase was in children aged 5 to 17 years (196% increase; P < .001). The rate of food-related anaphylaxis increased by 124% (P < .001), and the rate of medication-related anaphylaxis increased by 212% (P < .001). CONCLUSIONS: ED visits for anaphylaxis increased between 2005 and 2014. Increases in ED visits were greatest among children.

Outcomes and total costs of outpatient vs. inpatient peri-procedural anticoagulation management of mechanical prosthetic heart valve patients.

BACKGROUND/OBJECTIVES: The most cost-effective periprocedural management of patients with mechanical heart valves (MHV) is uncertain. The objective was to compare the effectiveness, safety and costs for inpatient intravenous unfractionated heparin (IVUH) vs. outpatient low molecular weight heparin (LMWH) "bridging" as periprocedural anticoagulation management for MHV patients. METHODS: In a case-cohort study, Olmsted County, MN residents with MHV who received outpatient periprocedural LMWH management (cases) over the 11-year period, 1997-2007, were matched to residents with MHV who received inpatient IVUH periprocedural management on valve location and type, and on procedure type. Patients were followed for 3 months following hospitalization to identify thromboembolism (TE) and major bleeding. Total costs from 30 days before to 90 days after the procedure were determined from the Olmsted County Healthcare Expenditure and Utilization Database. Outcomes were compared using survival analysis and costs were compared using the Wilcoxon rank sum. RESULTS: 149 cases (100 aortic, 29 mitral, 20 both; 64% bileaflet) were compared to 149 cohort members (100 aortic, 29 mitral, 20 both; 75% bileaflet). While the 3-month cumulative incidence of TE did not differ significantly among cases (2.7%) and cohort members (4.7%; p = 0.36), major bleeding was significantly lower in cases (5.4% vs. 15.4%; p < 0.005). Total costs were significantly higher for cohort members ($50,984 vs. $39,347; p = 0.002) due to higher inpatient costs ($47,729 vs. $34,860; p = 0.0002). CONCLUSIONS: Outpatient bridging LMWH therapy is equally effective, but safer and less costly than inpatient IVUH as periprocedural anticoagulation management for MHV patients.

Health plan utilization and costs of specialty drugs within 4 chronic conditions.

BACKGROUND: Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. OBJECTIVE: To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. METHODS: This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. RESULTS: Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD (13.7%) and highest for MS (71.8%). The lowest total annual cost of care was for psoriasis ($14,815), and the highest total annual cost was for MS ($36,901). The most commonly used specialty drugs for each of the conditions were as follows: glatiramer (MS), etanercept (RA and psoriasis), and infliximab (IBD). The total annual costs were more than double for the specialty drug users for psoriasis compared with all the psoriasis members ($29,565 vs. $14,815). The total costs were only somewhat higher among MS members using specialty drugs ($41,760 vs. $36,901). Among specialty drug users for each of the cohorts, the annual costs of specialty drugs accounted for 50% or more of the total annual costs. The annual spending growth rate for specialty drugs ranged from 4.4% to 18.0%. CONCLUSIONS: Although specialty drug utilization varied widely across the 4 chronic conditions analyzed, when specialty drugs were used they accounted for the majority of the annual total direct cost of care. Because specialty drugs are accounting for a growing portion of chronic disease total cost of care, health insurers will need to become more vigilant regarding specialty drug use and focus on 4 cost saving management opportunities: drug distribution channel, utilization management, contracting activities, and care coordination.