HMO Coverage Research Articles

Comprehensive computerized gait analysis: Barriers to access for children and adolescents

BackgroundComprehensive computerized gait analysis (CGA) alters orthopedic surgical plans and improves outcomes. Despite these documented benefits, CGA is not widely available to all patients who could be helped by it.Research Question: Do social determinants of health impact access to CGA? MethodsRetrospective review of patients seen for CGA from 2021 to 2022. Dates of referral, insurance approval and completion of CGA, demographics and insurance type were extracted from patient records. Zip codes were used to determine the neighborhood socioeconomic status (SES). Data were analyzed using non-parametric statistics. ResultsInsurance type affected time to authorization (private insurance/self-pay: median 9 days; HMO insurance: median 51.5 days; public insurance: median 27 days; p=0.0004). Once authorized, insurance type did not affect time to schedule and complete CGA (p=0.76). Lower neighborhood SES was associated with longer time to authorization but shorter time to complete CGA once authorized. Rescheduling was associated with longer time to complete CGA once authorized (median 29.5 vs. 16 days, p<0.0001). White, non-Hispanic families tended to reschedule more often than non-white or Hispanic families (35 % vs. 18 %, p=0.07). SignificanceKnowledge of barriers to CGA is necessary in order to design and implement effective strategies to widen its availability to all whom it could benefit. Social determinants of health and insurance type are associated with delays in authorization for CGA. Families with public insurance and HMO coverage experience delays in obtaining insurance authorization compared to PPO/self-pay patients, whose tests did not require prior authorization. However, there can also be delays in scheduling and completing CGA once authorized. This is a multi-faceted issue that requires further research.

Pharmacist-led review of empagliflozin and ertugliflozin following formulary update.

To evaluate the appropriateness of the medication management for anyone who might have been affected by the Horizon New Jersey Health Medicaid Health Maintenance Organization (HNJH Medicaid HMO) formulary update from empagliflozin to ertugliflozin and to then optimize drug selection and monitoring. This is a single-center, 2-phase, pilot project led by 2 pharmacy students and the lead clinical pharmacist at a federally qualified health center in Trenton, New Jersey. The primary outcome of the study is the number and percentage of patients whose prescription was changed inappropriately from empagliflozin to ertugliflozin. Secondary outcomes include the number and percentage of patients whose prescription was changed inappropriately because of failure to consider cardiovascular history and/or missed renal function checks and whether pharmacists were able to optimize therapy. Data were generated from electronic health record reports and analyzed in Microsoft Excel. A total of 126 unique patients were identified as receiving empagliflozin and/or ertugliflozin and 16 patients were switched from empagliflozin to ertugliflozin, all of whom had HNJH Medicaid HMO. Thirteen of the 16 (81.3%) patients were managed inappropriately based on their history of cardiovascular disease or inappropriate renal monitoring. Pharmacists recommended 22 interventions for patients who received empagliflozin and/or ertugliflozin, and all recommendations were accepted by providers. Following the HNJH Medicaid HMO's coverage update from empagliflozin to ertugliflozin, some patients received inappropriate therapy and providers accepted clinical pharmacists' recommendations to optimize therapy.

Association of Non-Hodgkin Lymphoma (NHL), Comorbidity and Death Due to Other Cancers in 30,000 Older Adults from SEER-Medicare

Introduction: NHL is a heterogeneous disease which frequently occurs in older adults. Patients (pts) with NHL have an increased risk of non-NHL malignancies (NNM; Morton, JCO, 2010) and published guidelines emphasize the importance of standard of care cancer screening in this population (Hallek, Blood, 2018). Comorbidities are associated with a more aggressive clinical course and shorter survival in pts with NHL. We hypothesized that comorbidities, measured using the three-factor risk estimate scale (TRES; Gordon, CCR, 2021), would be associated with increased risk of death due to NNM. These findings could have important implications for cancer screening in comorbid pts with NHL. Methods: We included pts in SEER-Medicare with NHL (ICD-O-3/WHO recodes 25012, 33041 and 33042) diagnosed between 2008-2017. Medicare claims were available through 2019. All cases had a pathologically confirmed diagnosis of NHL, age at cancer diagnosis >65 years and continuous coverage in Medicare parts A, B and D with no HMO coverage for the 12 months preceding diagnosis and for 12 months, or death if sooner, after diagnosis. Pts were excluded who were diagnosed on death certificate or at autopsy. Other cancers were identified in SEER. Comorbidities were assessed using the TRES comorbidity score, previously known as CLL-CI (Gordon, CCR, 2021). This index evaluates endocrine, vascular and upper gastrointestinal organ systems, assigning pts to low, intermediate and high-risk groups based on overall survival. Chi-square or t-test was used to compare pt characteristic distributions. Kaplan-Meier estimate and multivariable Cox regression with competing risk were used to test the association between NNM and TRES score. Results: Our cohort consisted of 40,486 pts with NHL. Median age was 77 years, 49.5% were female, 91% were white, 3.3% Hispanic and 2.5% black. 51% were unmarried. 62% received treatment for NHL during the study period, the most common type of treatment was chemoimmunotherapy (31%). TRES score was low in 41%, intermediate in 37% and high in 22%. 23.6% had a cancer diagnosis prior to NHL and 10.4% after. The most common types of cancer preceding NHL diagnosis were prostate (29%), breast (16%), melanoma (9%), colorectum (6%), bladder (6%) and lung (5%). The most common cancer types after NHL diagnosis were colorectal (16%), head and neck (11%), lung (7%), bladder (5%), MDS/AML (5%) and melanoma (5%). Cause of death was reported and analyzed in 30,155 pts which were included in the primary analysis of NNM specific survival. After a median follow up of 33 months, a total of 14,473 deaths occurred, 48% of all subjects in whom cause of death was reported. The most common cause of death was NHL (49%, N=7,110) followed by NNM in 36% (N=5,183) and other causes in 15% (N=2,180). Compared to pts with a low TRES score, intermediate and high-risk scores were associated with an increase in NNM (p<0.001, Figure 1). In multivariable models, hazard ratios (HR) were 1.41 (95%CI 1.32-1.51) for intermediate and 1.94 (95%CI 1.80-2.08) in high risk pts. Other variables associated with non-NHL cancer mortality were NHL subtype, stage, age, gender, marital status and initial treatment type. The most common NHL subtypes were chronic lymphocytic leukemia (CLL N=8,368), diffuse large B cell lymphoma (DLBCL, N=8,292), follicular lymphoma (FL, N=3,870), marginal zone lymphoma (MZL, N=2,597), mantle cell lymphoma (MCL, N=1,208), peripheral T cell lymphoma (PTCL, N=851), cutaneous T cell lymphoma (N=773) and lymphoplasmacytic lymphoma (LPL, N=495). TRES score was associated with NNM in all NHL subtypes, except for PTCL (Table 1). In pts who died, the percent due to NNM by NHL subtype was 50% in CLL, 25% in DLBCL, 40% in FL, 50% in MZL, 18% in MCL, 21% in PTCL, 39% in CTCL and 74% in LPL. The most frequently cited causes of death from NNM were MDS/AML, colorectal, lung and head and neck cancers. Discussion: Other cancers are a common cause of death in older adults with NHL, particularly in pts with indolent B cell subtypes (range, 40%-74%), and comorbidities further increase the risk of death from NNM. This may be due to the combinatorial effects of NHL and comorbidity on immunologic and metabolic regulation. These results have important implications for the treatment of older adults with NHL and highlight the need for close monitoring and the development of adapted cancer screening guidelines in this population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Race, Ethnicity, and Insurance: the Association with Opioid Use in a Pediatric Hospital Setting.

This study examined the association between race/ethnicity and health insurance payer type with pediatric opioid and non-opioid ordering in an inpatient hospital setting. Cross-sectional inpatient encounter data from June 2013 to June 2018 was retrieved from a pediatric children's hospital in Southern California (N = 55,944), and statistical analyses were performed to determine associations with opioid ordering. There was a significant main effect of race/ethnicity on opioid and non-opioid orders. Physicians ordered significantly fewer opioid medications, but a greater number of non-opioid medications, for non-Hispanic African American children than non-Hispanic Asian, Hispanic/Latinx, and non-Hispanic White pediatric patients. There was also a main effect of health insurance payer type on non-opioid orders. Patients with government-sponsored plans (e.g., Medi-Cal, Medicare) received fewer non-opioid prescriptions compared with patients with both HMO and PPO coverage. Additionally, there was a significant race/ethnicity by insurance interaction on opioid orders. Non-Hispanic White patients with "other" insurance coverage received the greatest number of opioid orders. In non-Hispanic African American patients, children with PPO coverage received fewer opioids than those with government-sponsored and HMO insurance. For non-Hispanic Asian patients, children with PPO were prescribed more opioids than those with government-sponsored and HMO coverage. Findings suggest that the relationship between race/ethnicity, insurance type, and physician decisions opioid prescribing is complex and multifaceted. Given that consistency in opioid prescribing should be seen regardless of patient background characteristics, future studies should continue to assess and monitor unequitable differences in care.

National practice trends for the surgical management of lung cancer in the CMS population: an atlas of care.

Video-assisted thoracoscopic surgery (VATS) has been established as a safe and effective alternative to an open approach for the treatment of early-stage lung cancer. Despite this, differences in utilization across the nation are present. The aims of this study were to: (I) characterize trends in the use of open surgery and VATS for the management of lung cancer across the United States, and (II) describe if particular regions of the country utilize minimally invasive surgery more frequently. We studied all Medicare beneficiaries from the ages of 65 to 99 years with full Part A and B coverage and no HMO coverage for the years of 2006 and 2014 (the most recent year available at the time of this analysis). Beneficiaries with a diagnosis of lung cancer (ICD-9 codes: 162.0 162.2 162.3 162.4 162.5 162.8 162.9) were selected. Rates of thoracoscopic surgery (CPT codes: 32663, 32666, 32667, 32668, 32669, 32670, 32671) and open lung resections (32505, 32506, 32507, 32608, 32440, 32442, 32445, 32480, 32482, 32484, 32486, 32488) were calculated by year and region. Rates in 2006 and 2014 with descriptive statistics and a univariate analysis were performed using Student's t-test and chi-square, as appropriate. A two-sided P value <0.05 was considered statistically significant. A total of 24,368,333 and 23,921,059 beneficiaries for the years of 2006 and 2014 were analyzed. A diagnosis of lung cancer was detected in claims of 167,418 patients (0.7%) in 2006 and 167,506 patients in 2014 (0.7%), which was not significantly different (P=0.7). Among these lung cancer patients, a surgical intervention was performed in 17,249 patients (10.3%) during 2006 and 18,603 patients (11.1%) in 2014 (P=0.01). Among those undergoing surgery, a VATS approach was performed in 2,512 patients (15%) during 2006 and 9,578 patients (54%) during 2014 (P=0.001). In 2006, California, New York, and New Jersey performed the most VATS procedures, in comparison to 2014, when New York, Florida, and California performed the highest number of VATS procedures. While the prevalence of lung cancer in the United States was unchanged between 2006 and 2014, the use of VATS techniques increased five-fold. Further studies to better understand the adoption or availability of new surgical techniques in lung cancer populations across geographic regions and patient populations are necessary.

Effect of treatment center volume on outcomes in gastroenteropancreatic neuroendocrine tumor patients.

502 Background: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are relatively rare tumors, where patients seek care at medical centers with varying levels of expertise. While treatment center volume is associated with better survival in multiple cancers, it remains unknown whether the same applies to GEP-NETs. The objective of this study was to assess the impact of center volume on GEP-NET treatment outcomes. Methods: We used the Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare claims data in this study. We included patients diagnosed between 1995-2010 who had no HMO coverage, participated in Medicare parts A and B, were older than 65 at diagnosis, had full tumor grade information, and had no secondary cancer. We used Medicare claims to identify the medical centers at which patients received GEP-NET treatment (surgery, chemotherapy, somatostatin analogues, or radiation therapy). Center volume was divided into tiers – low, medium, and high – based on the number of unique GEP-NET patients treated by a medical center over two years. Kaplan-Meier curves and Cox regression were used to assess the association between volume and disease-specific survival (DSS). Results: We identified 1025 GEP-NET patients, of whom 65%, 28%, and 7% received treatment at low, medium, and high volume centers, respectively. Surgery was the most common first treatment (84-90%). Comorbidity and tumor stage distribution were similar across tiers, but the distribution of patients with poorly-differentiated tumors differed significantly (p &lt; 0.001). Median DSS for patients at low and medium centers were 3.7 years and 6.6 years, respectively, but was not reached for patients at high volume centers. After adjusting for confounders, patients treated at high volume centers had better survival than those treated in low volume centers (HR: 0.55, 95% CI: 0.30-0.99). However, no difference in survival was noted at medium volume centers (HR: 0.98, 95% CI: 0.78-1.22). Conclusions: Our results suggest that centers with expertise in GEP-NET treatment have better patient outcomes. Thus, centralization of care, particularly of more difficult cases, may lead to improved patient outcomes.

Diagnostic Biopsy May Not Affect Survival but May Increase Morbidity in Stage I Non–small Cell Lung Cancer

Biopsies carry significant risk of hemorrhage, pneumothorax and infection. Using the Surveillance, Epidemiology, and End Results (SEER) – Medicare database, we hypothesize that pre-treatment diagnostic biopsy may increase morbidity rates without affecting mortality rates in patients with stage I NSCLC treated with definitive external beam radiotherapy (EBRT), especially in more frail, oxygen (O2) dependent patients. Patients in our cohort were (1) 365 years old; (2) diagnosed with AJCC6 stage I NSCLC between 2002 and 2011; (3) covered by Part A and B one year before to one year after diagnosis without supplemental HMO coverage; (4) not in a nursing home at diagnosis; and (5) treated with definitive radiotherapy without surgery. Chi-square testing compared toxicity rates from date of diagnosis or biopsy to 6m after that date in (1) patients regardless of O2 dependency status that did and did not receive diagnostic biopsy, and (2) any biopsied patient with and without O2 dependency at diagnosis. Toxicities and O2 dependency were determined using Medicare claims and ICD-9 diagnosis codes (see Table). OS and CSS were compared using the Kaplan-Meier and log rank tests. 3,231 patients met criteria in the Methods, above. Of these, 68 (2%) were diagnosed clinically without confirmatory biopsy. Patients without a prior biopsy were more likely to be white (97 v 87%, p = 0.02) and have COPD (78 v 56%, p < 0.01). The groups did not differ in Charlson score (18 v 24% with Charlson > 2, p = 0.21); marital status (51 v 49%, p = 0.77); O2 dependency (60 v 54%, p = 0.27); socioeconomic status (p = 0.17); being homebound (4% v 4%, p = 0.83); lobe involved (p = 0.38); sex (53 v 50%, p = 0.67); or median age (77 v 76y, p = 0.22). Biopsied and O2 dependent patients suffered more toxicity (see Table). In unadjusted analysis, there was no difference in median OS (23 v 21m, p = 0.53) or CSS (30 v 30m, p = 0.35) in EBRT patients between the non-biopsy and biopsy arms.Abstract 2998; TableNo Biopsy n=68Biopsy n=3,163pNo O2 n=1,464O2 n=1,699pHemorrhage0 (0%)92 (3%)0.1533 (2%)59 (4%)0.04Intubation1 (1%)126 (4%)0.2933 (2%)94 (6%)<0.01MI-->0.2561 (4%)100 (6%)0.03Pneumothorax8 (12%)935 (30%)<0.01285 (19%)473 (28%)<0.01Pneumonia-->0.2519 (1%)64 (4%)<0.01Pulm Embolus1 (1%)41 (1%)0.911 (1%)31 (2%)0.01Pulm Insufficiency0 (0%)78 (3%)0.1925 (2%)53 (3%)0.01Sepsis2 (3%)229 (7%)0.1776 (5%)156 (9%)<0.01Ventilator1 (1%)138 (4%)0.2440 (3%)99 (6%)<0.01 Open table in a new tab We found increased morbidity in biopsied patients – especially O2 dependent ones – with similar mortality compared to unbiopsied or non-O2 dependent patients. Future studies should prospectively evaluate the efficacy of omitting diagnostic biopsies in select patient populations, particularly patients with multiple co-morbidities or baseline respiratory compromise.

Real-World Outcomes Among Elderly Acute Myeloid Leukemia Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Introduction: The incidence of acute myeloid leukemia (AML) increases with age, however treatment efficacy and tolerability in older patients are poor compared to younger patients. Without treatment, patients succumb to their illness within a few months of diagnosis. Further, disease relapse is inevitable in the majority of cases without additional post-remission therapy after successful induction of remission. The use of allogeneic hematopoietic stem cell transplantation (HSCT) is considered a potential cure for AML but its use is limited in older patients because of significant comorbidities and increased transplant-related morbidity and mortality. This retrospective study assessed outcomes of older AML patients treated with chemotherapy with or without HSCT.Methods: The linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, was utilized in this retrospective cohort analysis of 3327 first primary AML patients. Patients were diagnosed between January 1, 2000 to December 31, 2009, were >66 years, continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis and received treatment with chemotherapy with or without HSCT. Chi-square test for categorical variables and ANOVA or t-test for continuous variables was used to compare patient characteristics between treated patients with and without HSCT. Kaplan-Meier curves and Cox proportional hazards regression assessed overall survival. Date of last follow-up was December 31, 2010.Results: There were 276 (8%) patients who underwent HSCT therapy and 3051 (92%) who did not. HSCT patients were younger at diagnosis with mean age of 73 compared to the non-HSCT group (75 years; p<.0001). Seventy percent of HSCT patients compared to 55% of non-HSCT patients were under the age of 75 at diagnosis. HSCT patients were also more likely to be male. There were no statistical differences in comorbidity burden, poor performance indicators (PPI) or prior myelodysplastic syndrome (MDS) between both groups. The unadjusted median overall survival was higher for HSCT (9.7 months) compared to the non-HSCT group (4.7 months; log rank p=<0.0001). In multivariate survival analysis, patients who underwent HSCT had a 20% lower risk of death compared to those who did not receive HSCT (Table 1). Increasing age, male gender, increasing comorbidity score, prior MDS and PPI were significantly associated with higher risks of mortality. In a subset analysis stratified by age, the survival benefit with HSCT was only demonstrated in the younger age cohort ≤75 years old, and no difference in mortality risks were noted in the older age cohort >75 years (Table 1).Conclusions: In this real-world analysis of elderly AML patients treated in community oncology practice, only 8% of patients receiving chemotherapy underwent subsequent HSCT therapy. Chronologic age appears to be the driving factor in receiving HSCT. HSCT therapy was associated with a 20% lower risk of death compared to patients receiving chemotherapy only and the survival benefit was more pronounced among the younger cohort, age ≤75 years with a 36% reduction in mortality risk. These findings provide further insight into disease management and provide an important context for identifying opportunities to improve the quality of treatment strategies in the real world setting.Table 1:Multivariate Overall Survival AnalysisHSCTAll (N=3327)≤ 75 (n=1857)>75 years (n=1470)HR95% CIHR95% CIHR95% CINorefrefrefYes0.800.69-0.920.630.53-0.751.220.97-1.54 DisclosuresSatram-Hoang:Genentech, Inc.: Consultancy. Hurst:Genentech, Inc.: Employment. Reyes:Genentech, Inc.: Employment.

Big Data Analysis of Treatment Patterns and Outcomes Among Elderly Medicare Acute Myeloid Leukemia Patients

Introduction: Acute myeloid leukemia (AML) is the most common acute leukemia in adults with a median age at diagnosis of 66 years. Over half of the patients are diagnosed at age 65 or older and have shown no improvement in outcomes compared to younger patients in last few decades. The goal of the study was to examine the patient characteristics associated with receiving treatment and the survival outcomes in an older population in routine clinical practice.Methods: This retrospective cohort analysis utilized data from the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The database is a nationally representative collection of Medicare patients in 18 population-based SEER cancer registries from diverse geographic areas representative of about 26% of the United States population. The analysis included 8336 first primary AML patients diagnosed between January 1, 2000 to December 31, 2009, >66 years, and continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis. Chi-square test for categorical variables and ANOVA or t-test for continuous variables was used to assess differences in patient and disease related characteristics by treatment status. Kaplan-Meier curves and Cox proportional hazards regression assessed survival by treatment status adjusting for age, sex, race, prior myelodysplastic syndrome (MDS), poor performance indicators (PPI), comorbidity, income, education, marital status, year of diagnosis and geographic region. Logistic regression modelling assessed patient characteristics predictive of not receiving treatment.Results: There were 3327 (40%) patients who received treatment with chemotherapy within 3 months of diagnosis and 5009 (60%) patients who did not receive treatment. Treatment rates increased over the study time-period from 35% in the year 2000 to 50% in 2009 (p<.0001). Treated patients were younger (75 vs. 81 years), more likely male (55% vs. 50%), married (61% vs. 47%), lower incidence of antecedent hematologic malignancy (15% vs. 19% prior MDS), less likely to have poor performance indicators (7% vs. 17%) and had lower comorbidity score (p<.0001) than untreated patients. In the treated cohort, 57%, 25%, 10% and 8% had NCI comorbidity score of 0, 1, 2, and ≥3 respectively. In the untreated cohort, 47%, 25%, 14% and 14% had NCI comorbidity score of 0, 1, 2, and ≥3 respectively. The most common comorbidities were hypertension (51%), hyperlipidemia (33%), coronary artery disease (25%), diabetes (21%), and atrial fibrillation (19%). In the logistic regression analysis, increasing age, increasing comorbidity score, black race, prior MDS and PPI were shown to significantly decrease the likelihood of receiving treatment. The median unadjusted overall survival was 2.5 months for the overall population and was longer for treated patients (6.1 months) compared to untreated patients (1.5 months; log rank p <.0001; Figure 1). In multivariate survival analysis, treated patients exhibited a 43% lower risk of death compared to untreated patients (HR=0.57; 95% CI=0.54-0.60). Increasing age, increasing comorbidity score and PPI were significantly associated with higher mortality risks.Conclusions: Although therapy use has increased over time, this large observational study showed that about 60% of elderly AML patients remain untreated following diagnosis. In the multivariate survival analysis, use of anti-leukemic therapy was associated with significant survival benefit in this cohort of patients. These results suggest an opportunity to improve treatment strategies and delivery to optimize patient outcomes in elderly AML patients. [Display omitted] DisclosuresSatram-Hoang:Genentech, Inc.: Consultancy. Reyes:Genentech, Inc.: Employment. Hurst:Genentech, Inc.: Employment.

Benefit restrictions and gout treatment.

Gout is a chronic rheumatic disease that can have serious sequelae, including persistent pain, nerve compression, joint destruction and deformities if left untreated. Febuxostat, initially introduced in the United States in 2009, was the first new treatment option for gout in over 40 years. With the introduction of a new drug into a therapeutic class that is composed of generically available options, utilization management will be a common strategy employed in an effort to contain cost; however, the effects of these strategies are not known for chronic gout treatment. To evaluate the effect of utilization management strategies on chronic gout treatment. This retrospective analysis examined claims data from a large, national pharmacy benefits manager with a client base that includes commercial HMOs, Medicaid, Medicare Part D, and self-insurers. The study population included patients aged 18 years or older who had at least 1 rejected claim for febuxostat in the 16-month identification period from March 1, 2009, through June 30, 2010. Outcomes of interest were the proportion of patients who filled a febuxostat prescription and proportion of patients who filled a prescription for another chronic gout treatment within 1 month of the febuxostat claim rejection date (the index date). Multivariate logistic regression models were used to assess factors affecting patient response to a rejected febuxostat claim. Of 1,034 patients with rejected febuxostat claims, 95% had claims denied due to utilization management: 36% due to step therapy, 25% due to lack of drug coverage, 18% due to quantity or other limits (i.e., fill limit exceeded, days supply exceeding benefit maximum, or maximum days supply limit exceeded), 16% due to prior authorization requirements, while 5% were due to "other reasons" unrelated to the utilization management strategies of interest. "Other reasons" included over 100 possible rejection reasons such as fill dispensed too soon, missing/invalid days supply, group not having benefit, physician not covered, non-matched group, not a network pharmacy, non-matched member, claim/member birth date not matching, and missing/invalid prescriber identifier. Subsequently, 474 (46%) of these patients filled a febuxostat prescription within 1 month of a rejected claim; 364 (35%) had not filled a prescription for any chronic gout medication within a month of the febuxostat claim rejection. Those filling a febuxostat prescription had higher pre-index total 6-month pharmacy costs than those not filling a chronic gout prescription ($1,718 vs. $988; P < 0.001) . They also had a higher number of pre-index drug claims (25 vs. 18; P < 0.001). The regression model found the following variables to be statistically significant in positively influencing the likelihood of patients filling a febuxostat prescription within a month of a febuxostat claim rejection: (a) self-insured coverage (compared with commercial HMO coverage); (b) pre-index total prescription costs of at least $1,800; (c) claim rejection due to quantity or other limit (compared with lack of drug coverage); (d) claim rejection due to "other reason" (compared with lack of drug coverage); and (e) 1 and ≥1 pre-index colchicine claim. Patients with projected febuxostat copay of $100 to $149 were found to be less likely to fill febuxostat compared with patients with a projected copay of $0 to $19. Utilization management strategies likely result in gaps in gout treatment; 35% of patients with a denied febuxostat claim in this study population did not fill a prescription for any chronic gout therapy within a month of the claim denial. These findings are important in the consideration of benefit design in gout treatment.

Which treatment options impact outcomes in elderly chronic lymphocytic leukemia patients with high prevalence of comorbidity?

7016 Background: Therapy selection in chronic lymphocytic leukemia (CLL) patients is based on disease severity as well as patient characteristics such as age and comorbidity. While treatment outcomes are mostly available from clinical trial data in younger patients, less is known about the effect of comorbidities on outcomes in elderly CLL patients in the real-world setting. Methods: The linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database was utilized in this retrospective cohort analysis of 3,366 first primary CLL patients. Patients were diagnosed between 1/1/1998-12/31/2007, were &gt;66 years, continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis and received first-line treatment with any oral or infused therapy. CLB is covered by Medicare Part D and data for its use were only available from 2007-2009 in the dataset. Cox regression with backward elimination and propensity score weighted Cox regression estimated the relative risk of death. Date of last follow-up was 12/31/2009. Results: There were 153 CLB, 606 R-mono, 702 R+IV Chemo, and 1,905 IV Chemo-only patients. CLB and R-mono patients were older at diagnosis with mean age of 77 compared to R+IV Chemo (73 years) and IV Chemo-only (76 years; p&lt;.0001). Patients administered R-mono had a higher comorbidity burden and more advanced disease compared with other treatment groups. In the survival analysis we compared CLB to R-mono during the time period 2007-2009 and R+IV Chemo to IV Chemo-only during the time period 1998-2009. The adjusted multivariate survival analysis revealed a significant mortality risk reduction with R+IV Chemo compared with IV Chemo-only patients (HR, 0.72; 95% CI, 0.62-0.84) while a non-significant mortality risk reduction was noted with R-mono compared to CLB patients (HR, 0.47; 95% CI, 0.21-1.05). Older age and increasing comorbidity score were significantly associated with higher mortality. Conclusions: These findings suggest that chemo-immunotherapy is more effective than chemotherapy in an elderly population with a high prevalence of comorbidity. This extends the conclusions from clinical trials in younger, medically fit patients.

Which Patient Characteristics Impact Treatment Choice in Elderly Patients with Chronic Lymphocytic Leukemia?

AbstractAbstract 967 Introduction:Therapy selection in chronic lymphocytic leukemia (CLL) patients is based on the severity of the disease as well as patient characteristics such as age and comorbidity. National Comprehensive Cancer Network guidelines suggest that frail patients or those with significant comorbidity can be treated with oral chlorambucil (CLB) or single agent rituximab (R-mono). While treatment outcomes are mostly available from clinical trial data in younger patients, less is known about the effect of comorbidities on outcomes in elderly CLL patients in the real-world setting. Methods:The linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, was utilized in this retrospective cohort analysis of 3366 first primary CLL patients. Patients were diagnosed between January 1, 1998 to December 31, 2007, were >66 years, continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis and received first-line treatment with any oral or infused therapy. CLB is covered by Medicare Part D and data for its use were only available from 2007–2009 in the SEER-Medicare dataset. The NCI comorbidity index, a widely used and validated measure of comorbidity in cancer patients was assessed using claims in the year prior to diagnosis for each patient. Kaplan-Meier curves and Cox proportional hazards regression assessed survival by treatment type. Date of last follow-up was December 2009. Results:There were 153 CLB, 606 R-mono, 702 R+IV Chemo, and 1905 IV Chemo-only patients. CLB and R-mono patients were older at diagnosis with mean age of 77 compared to R+IV Chemo (73 years) and IV Chemo-only (76 years; p<.0001). 31% of R-mono patients were over the age of 80 at diagnosis (Table 1). CLB patients were more likely to be female and non-white compared to the other treatment groups (Table 1). R-mono patients had a higher comorbidity burden and were diagnosed with more advanced stage disease compared to other treatment groups (Table 1). R-mono patients also had a significantly higher amount of pre-existing anemia (95% vs. 77–88%; p<.0001) and thrombocytopenia (81% vs. 48–72%; p=0.0184) compared to other treatment groups. In the multivariate survival analysis we compared CLB to R-mono during the time period 2007–2009 and R+IV Chemo to IV Chemo-only during the time period 1998–2009. The unadjusted overall survival was higher for R-mono compared to CLB (log rank p=0.0478). The unadjusted overall survival was higher for R+IV Chemo compared to IV Chemo-only (log rank p <.0001) with 5-year overall survival rates of 72% (SE=1.09) versus 52% (SE=1.03) respectively. In multivariate survival analysis, adjusting for age, sex, race, stage, comorbidity, income, diagnosis year and geographic region, IV Chemo-only patients had a 39% higher risk of death compared to R+IV Chemo patients (HR=1.39; 95% CI=1.18-1.62) and CLB patients had a non-significant 2-fold higher risk of death compared to R-mono patients (HR=2.27; 95%CI=0.96-5.38). Increasing age and increasing comorbidity score were significantly associated with higher risks of mortality. Conclusions:Patient characteristics such as age, comorbidity burden and gender appear to be important factors in prescribing treatment for CLL. R-mono patients were the oldest with more advanced stage disease at diagnosis and highest comorbidity burden while R+IV Chemo patients were the youngest with earlier stage disease and lowest comorbidity burden. R-containing regimens exhibited a greater survival benefit compared to oral or infused chemo-only regimens.Table 1:Demographic Characteristics by Treatment CohortCLB (N=153)R-mono (N=606)R+Chemo (N=702)IV Chemo-only (N=1905)p-valuen(%)n(%)n(%)n(%)Age66–702717.612120.025235.938820.4< 0.000171–753422.214523.920228.852927.876–805032.715225.117524.952027.3> 804227.518831.07310.446824.6SexMale6945.132854.143562.0113059.30.0002Female8454.927845.926738.077540.7RaceWhite12783.056092.664892.4175292.10.0007Non-White2617.0457.4537.61507.9StageNon-advanced7851.022537.136752.389146.8< 0.0001Advanced7549.038162.933547.7101453.2NCI Co-morbidity Score09662.733655.448669.2114960.3< 0.000112919.015525.614821.145223.72149.26711.1456.41819.5>=3149.2487.9233.31236.5 Disclosures:Satram-Hoang:Genentech, Inc.: Consultancy. Reyes:Genentech, Inc.: Employment, Roche Stock Other. Skettino:Genentech, Inc. : Employment, Roche Stock Other.

What Is the Impact of Comorbidity Burden On Treatment Patterns and Outcomes in Elderly Chronic Lymphocytic Leukemia Patients?

AbstractAbstract 758 Introduction:Chronic lymphocytic leukemia (CLL) is a disease of the elderly with over 70% of patients diagnosed over the age of 65. Age and comorbidity are considered when prescribing individualized therapies. Little is known about the spectrum or frequency of comorbidities in CLL patients. Methods:Using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we conducted a retrospective cohort analysis of 8343 first primary CLL patients diagnosed between January 1, 1998 to December 31, 2007, >66 years, and continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis. Comorbidity was examined using two definitions: the National Cancer Institute (NCI) comorbidity index and the numbers of involved organs systems in the Cumulative Illness Rating Scale (CIRS-SYS) since severity data was not available to calculate the total CIRS score. Claims one year prior to diagnosis were used to assess the baseline comorbidity burden for each patient. Chi-square test for categorical variables and ANOVA or t-test for continuous variables was used to assess differences in patient and disease related characteristics by treatment status. Kaplan-Meier curves and Cox proportional hazards regression assessed survival by treatment status adjusting for age, sex, race, stage, comorbidity, income, year of diagnosis and geographic region. Results:There were 3366 (40%) treated patients and 4977 (60%) not treated. Treated patients were younger (76 vs. 79 years), more likely male (58% vs. 51%), more advanced stage (65% vs. 48%) and had lower comorbidity score than not treated patients (p<.0001). In the treated cohort, 61%, 23%, 9% and 6% had NCI comorbidity score of 0, 1, 2, and ≥3 respectively. In the not treated cohort, 55%, 25%, 11% and 9% had NCI comorbidity score of 0, 1, 2, and ≥3 respectively. The most common comorbidities were hypertension (53%), hyperlipidemia (38%), coronary artery disease (24%), diabetes (21%), and osteoarthritis (21%). As CIRS-SYS and NCI comorbidity score increased, unadjusted overall survival decreased (log rank p <.0001; Figure 1). In multivariate survival analysis, treated patients had an 8% lower risk of death compared to untreated patients (HR=0.92; 95% CI=0.85–0.98). Increasing age and increasing NCI & CIRS-SYS comorbidity score were significantly associated with higher risk of mortality (p<.0001). In a subset of 4,213 patients diagnosed with advanced stage disease, 1805 (43%) received treatment and 2408 (57%) were not treated. Similar to the overall treated population; advanced stage treated patients were also younger, more likely male and had lower comorbidity score compared to advanced stage not treated (p<.0001). Advanced stage patients who received treatment had a 17% lower risk of death compared to those not treated (HR=0.83; 95%CI=0.75–0.91). Conclusions:This observational study showed that about 60% of CLL patients are not receiving treatment. Among patients with advanced stage disease 57% were not being treated, possibly due to older age and/or higher comorbidity burden. However, after adjusting for these factors in the multivariate survival analysis, there was a significant survival benefit with receiving treatment, especially among those with advanced stage disease. These results suggest an opportunity to improve treatment strategies to optimize patient outcomes in elderly CLL patients with a higher comorbidity burden. [Display omitted] Disclosures:Reyes:Genentech, Inc.: Employment, Roche Stock Other. Satram-Hoang:Genentech, Inc.: Consultancy. Skettino:Genentech, Inc.: Employment, Roche Stock Other.

The Under-Treatment of Elderly Medicare Diffuse Large B-Cell Lymphoma Patients

AbstractAbstract 237 Introduction:Prior real-world data show that a large proportion of the elderly population with diffuse large b-cell lymphoma (DLBCL) are not receiving the recommended therapy for their disease. Over half of the patients diagnosed with DLBCL are over the age of 60 and clinical trials show that patients over the age of 60 respond well to current guideline-based therapy. We set out to examine the patient characteristics associated with receiving recommended therapy and the survival outcomes in an older population in routine clinical practice. Methods:We conducted a retrospective cohort analysis of 9866 DLBCL patients in the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Patients were diagnosed between January 1, 2000 to December 31, 2007, were >66 years, and continuously enrolled in Medicare Part A and B with no HMO coverage in the year prior to diagnosis. Chi-square test for categorical variables and ANOVA or t-test for continuous variables were used to assess differences in patient and disease characteristics by treatment status. Logistic regression modeling assessed the patient characteristics predictive of not receiving treatment. Kaplan-Meier curves and Cox proportional hazards regression assessed survival by treatment type. Date of last follow-up was December 31, 2009. Results:There were 7832 (80%) patients who received treatment and 2034 (20%) who did not receive treatment during the study time period. Untreated patients were older at diagnosis with mean age of 81 compared to 76 years in treated patients (p<.0001). As age increased, the treatment rate significantly decreased especially among patients >80 years (Table 1). Untreated patients were also more likely non-white (15% vs. 12%; p<.01), diagnosed with stage IV disease (33% vs. 29%; p<.0001), had higher comorbidity burden, and lived in areas of lower socioeconomic status than treated patients (p<.0001). In the adjusted logistic regression model, increasing age, non-white race, higher comorbidity score, and lower income were predictive of not receiving treatment. The multivariate survival analysis, adjusting for age, sex, race, stage, histology, comorbidity, income, and year of diagnosis, demonstrated a 3-fold higher risk of death in the untreated patients (HR=2.98; 95%CI=2.81–3.16) compared to treated patients. Conclusions:This real-world analysis of elderly DLBCL patients confirmed that 20% of them are not receiving treatment, and the rate of under-treatment is even more pronounced among those >80 years. As a consequence, untreated patients had a 3-fold higher risk of death compared to those who received treatment.Table 1Age by treatment statusAge at DiagnosisTreated (N=7832)Not Treated (N=2034)p-valuen%n%66-70169489.919010.1<.000171-75198785.434114.676-80198581.744618.381-85142274.149725.9>8574457.156042.9 Disclosures:Satram-Hoang:Genentech, Inc.: Consultancy. Skettino:Genentech, Inc.: Employment, Roche Stock Other. Reyes:Genentech, Inc.: Employment, Roche Stock Other.

HMO Coverage Reduces Variations In The Use Of Health Care Among Patients Under Age Sixty-Five

Variation in the use of hospital and physician services among Medicare beneficiaries is well documented. However, less is known about the younger, commercially insured population. Using data from the Community Tracking Study to investigate this issue, we found significant variation in the use of both inpatient and outpatient services across twelve metropolitan areas. HMO insurance reduces, but does not eliminate, the extent of this variation. Our results suggest that health plan spending to better organize delivery systems and manage care may be efficient, and regulations that arbitrarily cap plans' spending on administration, such as minimum medical loss ratios, could undermine efforts to achieve better value in health care.

Costs to Medicare of Treating Chronic Lymphocytic Leukemia Patients with Alemtuzumab.

Abstract 2477Poster Board II-454 Background:Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia in the Western world, comprising over one-third of all new leukemia cases. Alemtuzumab is a humanized monoclonal antibody targeted to lymphocytes through the CD52 receptor that has been demonstrated to reduce the amount of malignant lymphocytes in patients with CLL. Alemtuzumab is, however, associated with various adverse events (AEs) including cytopenia, infections, and cardiac dysfunction. The current study aimed to quantify the incremental cost to Medicare of treating CLL patients with alemtuzumab. Methods:An analysis of patients' electronic health insurance claims records (1999-2007) from the Medicare 5% national sample was conducted. Patients with continuous enrollment for 3 or more months prior to their first observed claim with a CLL diagnosis, no more than two malignancies (by ICD-9 diagnostic codes associated with claims), and 1 or more claim for alemtuzumab were included in the analysis. Patients who had HMO coverage under Medicare were excluded from the analysis to ensure data completeness. A pre-post design was used to quantify the incremental costs associated with alemtuzumab by calculating health care costs within 6 months after alemtuzumab initiation relative to the 6-month period before alemtuzumab initiation. Mean monthly (per-patient per-month, PPPM) costs were calculated and were grouped by sites of care, service type, tests and procedures, treatment and drugs, and by AEs. To estimate the costs of AEs, claims with ICD-9 diagnostic codes for the AE of interest were grouped and mean PPPM costs were calculated for those groups. These groups were not mutually exclusive: claims could be associated with more than one diagnostic code. Statistical comparisons between the pre- and post-treatment periods were based on paired Student t-tests. Results:A total of 81 CLL patients treated with alemtuzumab formed the study population. The mean age (SD) was 75.2 (7.5) years and females represented 38.3% of the cohort. Patients were observed for an average of 50 months and mean time between the first observed CLL diagnosis and initiation of alemtuzumab treatment was 36 months. After alemtuzumab initiation, mean total healthcare costs increased from $4,272 to $10,385 PPPM (cost difference: $6,113, P<0.0001). Patients had a mean of 11.8 claims for alemtuzumab and the mean cost (SD) for alemtuzumab was $4,006 ($3,277) PPPM in the post-alemtuzumab period or 39% of total costs. Costs associated with diagnostic codes for cytopenia were $1,658 pre-alemtuzumab compared with $4,114 post-alemtuzumab (P<0.0001). In the pre- alemtuzumab period, costs with infection-related diagnostic codes were $107 PPPM compared with $841 in the post-alemtuzumab period (P=0.0005). Costs associated with cardiac dysfunction diagnostic codes were $766 PPPM in the pre-alemtuzumab period and $1,692 in the post-alemtuzumab period (P=0.0172) (Table 1). Note that these cost categories are not mutually exclusive.Table 1Pre-Alemtuzumab (N=81) Average monthly cost per patient [A]Post-Alemtuzumab (N=81) Average monthly cost per patient [B]Monthly cost difference [B] - [A]P valueTotal cost$4,272$10,385$6,113<.0001CytopeniaAnemia$1,313$3,167$1,854.0005Neutropenia$485$1,083$598.1075Thrombocytopenia$188$804$617.0116Total Cytopenia$1,658$4,114$2,455<.0001Infections$107$841$734.0021Cardiac dysfunctionsHypertensive disease$434$1,001$567.0511Ischemic heart disease$317$290−$27.8970Diseases of pulmonary circulation$29$31$2.9225Cardiac dysrhythmias$340$317−$23.9219Tachycardia$0$0Other forms of heart disease$471$655$184.5249Total cardiac dysfunctions$766$1,692$926.0172 Conclusions:Amongst a cohort of Medicare fee-for-service patients with CLL, alemtuzumab was associated with a significant increase in healthcare costs in the 6 months after initiation of therapy of which the costs of alemtuzumab, oncology services, cytopenias, infections, and cardiac dysfunctions were large components. Disclosures:Lafeuille:Groupe d'analyse: Employment; GlaxoSmithKline: Research Funding. Vekeman:Groupe d'analyse: Employment; GlaxoSmithKline: Research Funding. Kerrigan:GlaxoSmithKline: Employment. Wang:Analysis Group: Employment; GlaxoSmithKline: Research Funding. Duh:GlaxoSmithKline: Research Funding; Analysis Group: Employment.

The Association of Medicare Drug Coverage with Use of Evidence-Based Medications in the Veterans Health Administration

Veterans with Medicare managed-care plans have access to pharmacy benefits outside the Veterans Health Administration (VA), but how this coverage affects use of medications for specific disease conditions within the VA is unclear. To examine patterns of pharmacotherapy among patients with diabetes mellitus, ischemic heart disease, and chronic heart failure enrolled in fee-for-service (FFS) or managed-care (HMO) plans and to test whether pharmacy benefit coverage within Medicare is associated with the receipt of evidence-based medications in the VA. A retrospective analysis of veterans dually enrolled in the VA and Medicare healthcare systems was conducted. We used VA and Medicare administrative data from 2002 in multivariable logistic regression analysis to determine the unique association of enrollment in Medicare FFS or managedcare plans on the use of medications, after adjusting for sociodemographic, geographic, and patient clinical factors. A total of 369,697 enrollees met inclusion criteria for diabetes, ischemic heart disease, or chronic heart failure. Among patients with diabetes, adjusted odds ratios (ORs) of receiving angiotensin-converting enzyme (ACE) inhibitors and oral hypoglycemics in the FFS group were, respectively, 0.86 and 0.80 (p < 0.001). Among patients with ischemic heart disease, FFS patients were generally less likely to receive beta-blockers, antianginals, and statins. Among patients with chronic heart failure, adjusted ORs of receiving ACE inhibitors, angiotensin-receptor blockers, and statins in the FFS group were, respectively, 0.90, 0.78, and 0.79 (all p < 0.05). There were few systematic differences within HMO coverage levels. FFS-enrolled veterans were generally less likely to be receiving condition-related medications from the VA, compared with HMO-enrolled veterans with lower levels of prescription drug coverage. Pharmacy prescription coverage within Medicare affects the use of evidence-based medications for specific disease conditions in the VA.

Frequency and predictors of prescription‐related issues after hospital discharge

In the period immediately following hospital discharge, patients often experience difficulty with medication management. The problems related to patients' handling of discharge prescriptions are not well characterized. We conducted a large observational study of patients discharged from 170 community hospitals in 2005. By combining clinical, administrative, and call center data, we were able to examine independent predictors of prescription-related issues in the 48-72 hours after hospital discharge. Issues included: not picking up prescribed discharge medications, not knowing if these medications had been picked up, not taking discharge medications, and not understanding how to take the medications. More than half (57.0%) of the 31,199 subjects in the study were women, and the mean age was 61.1 years. Overall, 7.2% of patients (n = 2253) reported prescription-related issues, most often not filling discharge prescriptions. In multivariable analyses, prescription-related issues were more common among adults age 35-49; women; patients with Medicare HMO coverage, Medicaid, or no insurance; adults with higher severity of illness ratings; and patients prescribed 6 or more medications or an inhaler. Predictors of fewer problems were being age 65 or older; having HMO or commercial insurance; being prescribed antibiotics, anticoagulants, or angiotensin II receptor blockers; and having a major diagnosis in the skin or musculoskeletal categories. About 7% of patients reported prescription-related issues within a few days of hospital discharge. High-risk patients should be identified and offered additional assistance prior to discharge and receive a follow-up phone call to assess if discharge prescriptions have been filled.

Financial Barriers to Mammography: Who Pays Out-of-Pocket?

This study investigates how out-of-pocket payments for mammograms vary according to the characteristics of women and the states where they reside. We conducted a cross-sectional analysis for women >or=40 years using data from the 2000 National Health Interview Survey (NHIS) Cancer Control Module linked with state characteristics. Descriptive tabulations and logistic regressions were used to examine characteristics associated with out-of-pocket payment for a woman's most recent mammogram for the subset of approximately 7000 women reporting a mammogram within the past 2 years. In 2000, the majority of women who received a mammogram within the past 2 years paid no out-of-pocket costs: 68% among those aged 40-64 and 85% among those aged >or=66. Among women aged 40-64 with a recent mammogram, characteristics associated with paying out-of-pocket for the last mammogram were white, non-Hispanic race/ethnicity, being uninsured, having non-HMO private coverage, place of residence outside the Northeast, in a non-metropolitan county, and in a state with low HMO penetration. Public insurance and HMO coverage have been especially effective in eliminating financial barriers to mammography, but women 40-64 years with public coverage still lag behind their privately insured counterparts in using mammography. Out-of-pocket costs remain a barrier to use for uninsured women. Older women, although less likely than younger women to pay out-of-pocket for mammograms, remain less likely to use mammography than younger women.

Do well-publicized risk-adjusted outcomes reports affect hospital volume?

Report cards on hospital performance are common but have uncertain impact. The objective of this study was to determine whether hospitals recognized as performance outliers experience volume changes after publication of a report card. Secondary objectives were to test whether favorable outliers attract more patients with related conditions, or from outside their catchment areas; and whether disadvantaged groups are less responsive to report cards. We used a time-series analysis using linear and autoregressive models. We studied patients admitted to nonfederal hospitals designated as outliers in reports on coronary bypass surgery (CABG) mortality in New York, acute myocardial infarction (AMI) mortality in California, and postdiskectomy complications in California. We studied observed versus expected hospital volume for topic and related conditions and procedures, by month/quarter after a report card, with and without stratification by age, race/ethnicity, insurance, and catchment area. Potential confounders included statewide prevalence, prereport hospital volume and market share, and unrelated volume. In California, low-mortality and high-mortality outliers did not experience changes in AMI volume after adjusting for autocorrelation. Low-complication outliers for lumbar diskectomy experienced slightly increased volume in autoregressive models. No other cohorts demonstrated consistent trends. In New York, low-mortality outliers experienced significantly increased CABG volume in the first month after publication, whereas high-mortality outliers experienced decreased volume in the second month. The strongest effects were among white patients and those with HMO coverage in California, and among white or other patients and those with Medicare in New York. Volume effects were modest, transient, and largely limited to white Medicare patients in New York.