Low-income Subsidy Recipients Research Articles

Associations Between Annual Medicare Part D Low-Income Subsidy Loss and Prescription Drug Spending and Use

The Medicare Part D Low Income Subsidy (LIS) program provides millions of beneficiaries with drug plan premium and cost-sharing assistance. The extent to which LIS recipients experience subsidy losses with annual redetermination cycles and the resulting associations with prescription drug affordability and use are unknown. To examine how frequently annual LIS benefits are lost among Medicare Part D beneficiaries and how this is associated with prescription drug use and out-of-pocket costs. In this cohort study of Medicare Part D beneficiaries from 2007 to 2018, annual changes in LIS recipients among those automatically deemed eligible (eg, due to dual eligibility for Medicare and Medicaid) and nondeemed beneficiaries who must apply for LIS benefits were analyzed using Medicare enrollment and Part D event data. Subsidy losses were classified in 4 groups: temporary losses (<1 year); extended losses (≥1 year); subsidy reductions (change to partial LIS); and disenrollment from Medicare Part D after subsidy loss. Temporary losses could more likely represent subsidy losses among eligible beneficiaries. Multinomial logit models were used to examine associations between beneficiary characteristics and subsidy loss; linear regression models were used to compare changes in prescription drug cost and use in the months after subsidy losses vs before. Analyses were conducted between November 2022 and November 2023. Subsidy loss at the beginning of each year among subsidy recipients in December of the prior year. The main outcomes were out-of-pocket costs and prescription drug fills overall and for 4 classes: antidiabetes, antilipid, antidepressant, and antipsychotic drugs. In 2008, 731 070 full LIS beneficiaries (17%) were not deemed automatically eligible (39% were aged <65 years; 59% were female). Nearly all beneficiaries deemed automatically eligible (≥99%) retained the subsidy annually from 2007 to 2018, compared with 78% to 84% of nondeemed beneficiaries. Among nondeemed beneficiaries, disabled individuals younger than 65 years and racial and ethnic minority groups were more likely to have temporary subsidy losses vs none. Temporary losses were associated with an average 700% increase in out-of-pocket drug costs (+$52.72/mo [95% CI, 52.52-52.92]) and 15% reductions in prescription fills (-0.58 fills/mo [95% CI, -0.59 to -0.57]) overall. Similar changes were found for antidiabetes, antilipid, antidepressant, and antipsychotic prescription drug classes. Beneficiaries who retained their subsidy had few changes. The conclusions of this cohort study suggest that efforts to help eligible beneficiaries retain Medicare Part D subsidies could improve drug affordability, treatment adherence, and reduce disparities in medication access.

Unintended Consequences of Increased Out-of-Pocket Costs During Medicare Coverage Gap on Anticoagulant Discontinuation and Stroke.

This study aims to assess the risk of direct oral anticoagulant (DOAC) discontinuation among Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) who reach the Medicare coverage gap stratified by low-income subsidy (LIS) status and the impact of DOAC discontinuation on rates of stroke and systemic embolism (SE) among beneficiaries with increased out-of-pocket (OOP) costs due to not receiving LIS. In this retrospective cohort study, Medicare claims data (2015-2020) were used to identify beneficiaries with NVAF who initiated rivaroxaban or apixaban and entered the coverage gap during ≥ 1year. DOAC discontinuation rates during the coverage gap were stratified by receipt of Medicare Part D Low-Income Subsidy (LIS), a proxy for not experiencing increased OOP costs. Among non-LIS beneficiaries, incidence rates of stroke and SE during the subsequent 12months were compared between beneficiaries who did and did not discontinue DOAC in the coverage gap. Among 303,695 beneficiaries, mean age was 77.3years, and 28% received LIS. After adjusting for baseline differences, non-LIS beneficiaries (N = 218,838) had 78% higher risk of discontinuing DOAC during the coverage gap vs. LIS recipients (adjusted hazard ratio [aHR], 1.78; 95% CI [1.73, 1.82]). Among non-LIS beneficiaries, DOAC discontinuation during coverage gap (N = 91,397; 34%) was associated with 14% higher risk of experiencing stroke and SE during the subsequent 12months (aHR, 1.14; 95% CI [1.08, 1.20]). Increased OOP costs during Medicare coverage gap were associated with higher risk of DOAC discontinuation, which in turn was associated with higher risk of stroke and SE among beneficiaries with NVAF.

Concurrent Use of Prescription Opioids and Gabapentinoids in Older Adults

Concurrent use of prescription opioids with gabapentinoids may pose risks of serious drug interactions. Yet, little is known about the trends in and patient characteristics associated with concurrent opioid-gabapentinoid use among older Medicare opioid users with chronic noncancer pain. A cross-sectional study was conducted among Medicare older beneficiaries (aged ≥65 years) with chronic noncancer pain who filled ≥1 opioid prescription within 3 months after a randomly selected chronic noncancer pain diagnosis (index date) in a calendar year between 2011 and 2018. Patient characteristics were measured in the 6-month baseline before the index date, and concurrent opioid-gabapentinoid use for ≥1 day was measured in the 3-month follow-up after the index date. Multivariable modified Poisson regression hwas used to assess the trends and characteristics of concurrent opioid-gabapentinoid use. Analyses were conducted from January to June 2021. Among 464,721 eligible older beneficiaries with chronic noncancer pain and prescription opioids, the prevalence of concurrent opioid-gabapentinoid use increased from 17.0% in 2011 to 23.5% in 2018 (adjusted prevalence ratio=1.48, 95% CI=1.45, 1.53). Concurrent users versus opioid-only users tended to be non-Black, low-income subsidy recipients, and Southern residents. The clinical factors associated with concurrent opioid-gabapentinoid use included having a diagnosis of neuropathic pain, polypharmacy, and risk factors for opioid-related adverse events. Concurrent opioid-gabapentinoid use among older Medicare beneficiaries with chronic noncancer pain and prescription opioids has increased significantly between 2011 and 2018. Future studies are warranted to investigate the impact of concurrent use on outcomes in older patients. Interventions that reduce inappropriate concurrent use may target older patients with identified characteristics.

Factors associated with medication nonadherence among Medicare low-income subsidy beneficiaries with diabetes, hypertension, and/or heart failure.

BACKGROUND: Previous studies have documented factors influencing medication nonadherence among the Medicare population, but few studies have examined medication nonadherence among the Medicare low-income subsidy (LIS) population. Furthermore, little is known about the factors associated with nonadherence among this population, especially those with prevalent chronic conditions such as type 2 diabetes, hypertension, or heart failure. OBJECTIVE: To examine factors associated with the likelihood of medication nonadherence among Medicare LIS recipients with type 2 diabetes, hypertension, or heart failure. METHODS: This was a retrospective analysis of 2012-2013 Medicare Parts A, B, and D claims (most recent available for this research) linked to the Area Health Resources Files. Beneficiaries aged 65 years or older with continuous Medicare coverage and receiving any LIS were included. Individuals were categorized into full LIS or partial LIS groups. Nonadherence was determined by the proportion of days covered less than 80% for specified oral type 2 diabetes, hypertension, and heart failure medications, as defined by the Pharmacy Quality Alliance. A multivariate logistic regression was used to determine and compare individual-level and community-level characteristics associated with nonadherence among the entire study sample, the full LIS group, and the partial LIS group. RESULTS: The study sample included 505,771 Medicare beneficiaries, with 448,509 (88.7%) receiving full LIS and 57,262 (11.3%) receiving partial LIS. The proportion of individuals nonadherent was higher among the full LIS population (33.2%) than that of the partial LIS population (30.8%). Among the entire population, younger age was associated with nonadherence (OR = 0.98; 95% CI = 0.98-0.99). Men were more likely to be nonadherent than women (OR = 1.12; 95% CI = 1.11-1.14). Compared with non-Hispanic Whites, racial/ethnic minorities had higher nonadherence. Compared with beneficiaries who were non-Hispanic White, the ORs for those who were Black, Hispanic, Asian, and other were 1.41 (95% CI = 1.38-1.43), 1.58 (95% CI = 1.55-1.61), 1.08 (95% CI = 1.05-1.11), and 1.63 (95% CI = 1.56-1.70), respectively. There were higher nonadherence rates among patients living in communities with lower socioeconomic characteristics, such as a metropolitan statistical area (MSA vs non-MSA; OR = 1.05, 95% CI = 1.04-1.07). A higher risk adjustment summary score, indicating worse health status, was associated with an increased likelihood of medication nonadherence (OR = 1.21; 95% CI = 1.20-1.22). These patterns were similar among the full and partial LIS groups. CONCLUSIONS: Individual- and community-level characteristics were associated with the likelihood of medication nonadherence among Medicare LIS recipients with type 2 diabetes, hypertension, or heart failure. These characteristics included younger age, male sex, racial/ethnic minorities, living in lower socioeconomic communities, and a higher risk adjustment summary score. This study provided insight into medication nonadherence within the Medicare LIS population and identified the need to consider these factors when developing future policies to improve medication adherence. DISCLOSURES: This study was funded by the Pharmaceutical Research & Manufacturers of America (PhRMA), which was involved in the preparation and revision of the manuscript. Dougherty is employed by PhRMA. Todor was a PQA-CVS Health Foundation Scholar who was funded to work on this study. Hines is employed by Pharmacy Quality Alliance. Wang reports grants from AbbVie, Curo, Bristol Myers Squibb, and Pfizer, during the time of this study, and fees from the PhRMA Foundation for work on its Heath Outcomes Research Advisor Committee. The other authors have nothing to disclose. This study was presented as a poster at the online 2020 PQA Annual Meeting, May 7, 2020.

The effect of out-of-pocket costs on initiation of disease-modifying therapies among medicare beneficiaries with multiple sclerosis

BackgroundMedicare beneficiaries with multiple sclerosis (MS) often face high out-of-pocket (OOP) costs for disease-modifying therapies (DMTs). It is unclear how cost-sharing affects therapy initiation. ObjectivesTo estimate the effects of patient cost-sharing on initiation of a DMT among Medicare beneficiaries with a new diagnosis code for MS. MethodsUsing Medicare claims data from 2010 to 2014, we identified a cohort of individuals with at least one inpatient or two outpatient diagnostic claims for MS. We restricted this group to beneficiaries with continuous Part A, B, and D coverage in the year before and after their initial diagnosis. To estimate the effect of cost-sharing on time to self-administered DMT initiation, we compared beneficiaries with a Low-Income Subsidy (LIS), who are shielded from cost-sharing, to those without LIS using multivariate Cox Proportional Hazards models adjusting for potential demographic and health-related confounders. ResultsThere were 39,661 Medicare beneficiaries who met inclusion criteria; 3827 had full LIS benefits throughout the study period. Beneficiaries were predominately White (36,447, 91.9%) and female (29,406, 74.1%). LIS recipients were generally younger (55 vs 67 years, p<0.001) and more likely to be enrolled through disability eligibility (79% vs 36%, p<0.001). In the year after their index diagnosis, 434 LIS recipients initiated DMT versus 1682 non-LIS (11% vs 5%; p<0.001). Among those who started a DMT, the average time to initiation was 115 days in those with LIS and 137 days for non-LIS (p<0.001). After adjustment for covariates, individuals with LIS benefits were significantly more likely to initiate a DMT in the year following their diagnosis (adjusted hazard ratio 1.4, 95% CI 1.25 to 1.57). The effect of OOP costs on initiation did not differ by demographic subgroups. ConclusionsMedicare beneficiaries with MS who are shielded from traditional cost-sharing are more likely to initiate a DMT in the year following receipt of their first diagnosis code. Future work should examine the effect of cost-related treatment delays on relapse rates and disability progression.

Association Between Medication Adherence and Healthcare Costs Among Patients Receiving the Low-Income Subsidy.

Significant literature exists on the effects of medication adherence on reducing healthcare costs, but less is known about the effect of medication adherence among Medicare low-income subsidy (LIS) recipients. This study examined the effects of medication adherence on healthcare costs among LIS recipients with diabetes, hypertension, and/or heart failure. This retrospective study analyzed Medicare claims data (2012-2013) linked to the Area Health Resources Files. Using measures developed by the Pharmacy Quality Alliance, adherence to 11 medication classes was studied among patients with 7 possible combinations of the diseases mentioned. Adherence was measured in 8 categories of proportion of days covered (PDC): ≥95%, 90% to <95%, 85% to <90%, 80% to <85%, 75% to <80%, 50% to <75%, 25% to <50%, and <25%. Annual Medicare costs were compared across adherence categories. A generalized linear model was used to control for patient/community characteristics. Among patients with only one disease, such as diabetes, patients with the lowest adherence (PDC < 25%) had $3152/year higher Medicare costs than patients with the highest adherence (PDC ≥ 95%; $11 101 vs $7949; P < .05). The adjusted costs among patients with PDC < 25% was $1893 higher than patients with PDC ≥ 95% ($9919 vs $8026; P < .05). Among patients with multiple chronic conditions, patients' adherence to medications for fewer diseases had higher costs. Greater medication adherence is associated with lower Medicare costs in the Medicare LIS population. Future policy affecting the LIS program should encourage better medication adherence among patients with chronic diseases.

Subsidies for Oral Chemotherapy and Use of Immunomodulatory Drugs Among Medicare Beneficiaries With Myeloma.

Purpose The low-income subsidy (LIS) substantially lowers out-of-pocket costs for qualifying Medicare Part D beneficiaries who receive orally administered chemotherapy. We examined the association of LIS with the use of novel oral immunomodulatory drugs (IMiDs; lenalidomide and thalidomide) among beneficiaries with myeloma, who can receive either orally administered or parenteral (bortezomib-based) therapy. Methods Using SEER-Medicare data, we identified Part D beneficiaries diagnosed with myeloma in 2007 to 2011. In multivariable models adjusted for sociodemographic and clinical characteristics, we analyzed associations between the LIS and use of IMiD-based therapy, delays between IMiD refills, and select health outcomes during the first year of therapy. Results Among 3,038 beneficiaries, 41% received first-line IMiDs. Median out-of-pocket cost for the first IMiD prescription was $3,178 for LIS nonrecipients and $3 for LIS recipients, whereas the respective median costs for the first year of therapy were $5,623 and $6, respectively. Receipt of the LIS was associated with a 32% higher (95% CI, 16% to 47%) probability of receiving IMiDs among beneficiaries age 75 to 84 years and a significantly lower risk of delays between refills in all age groups (adjusted relative risk, 0.54; 95% CI, 0.32 to 0.92). Duration of therapy did not significantly differ between LIS recipients and nonrecipients (median, 7.6 months). Patients treated with IMiDs had significantly fewer emergency department visits and hospitalizations compared with patients receiving bortezomib (without IMiDs), but 1-year overall survival and cumulative Medicare costs were similar. Conclusion Medicare beneficiaries with myeloma who do not receive LISs face a substantial financial barrier to accessing orally administered anticancer therapy, warranting urgent attention from policymakers. Limiting out-of-pocket costs for expensive anticancer drugs like the IMiDs may improve access to oral therapy for patients with myeloma.

Algorithm for Identifying Nursing Home Days Using Medicare Claims and Minimum Data Set Assessment Data.

No consensus exists about methods of measuring nursing home (NH) length-of-stay for Medicare beneficiaries to identify long-stay and short-stay NH residents. To develop an algorithm measuring NH days of stay to differentiate between residents with long and short stay (≥101 and <101 consecutive days, respectively) and to compare the algorithm with Minimum Data Set (MDS) alone and Medicare claims data. We linked 2006-2009 MDS assessments to Medicare Part A skilled nursing facility (SNF) data. This algorithm determined the daily NH stay evidence by MDS and SNF dates. NH length-of-stay and characteristics were reported in the total, long-stay, and short-stay residents. Long-stay residents identified by the algorithm were compared with the NH evidence from MDS-alone and Medicare parts A and B data. Of 276,844 residents identified by our algorithm, 40.8% were long stay. Long-stay versus short-stay residents tended to be older, male, white, unmarried, low-income subsidy recipients, have multiple comorbidities, and have higher mortality but have fewer hospitalizations and SNF services. Higher proportions of long-stay and short-stay residents identified by the MDS/SNF algorithm were classified in the same group using MDS-only (98.9% and 100%, respectively), compared with the parts A and B data (95.0% and 67.1%, respectively). NH length-of-stay was similar between MDS/SNF and MDS-only long-stay residents (mean±SD: 717±422 vs. 720±441 d), but the lengths were longer compared with the parts A and B data (approximately 474±393 d). Our MDS/SNF algorithm allows the differentiation of long-stay and short-stay residents, resulting in an NH group more precise than using Medicare claims data only.

How Low-Income Subsidy Recipients Respond to Medicare Part D Cost Sharing.

To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins. Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008. We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost. We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands. Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health.

Medicare Part D low-income subsidy and disparities in breast cancer treatment.

2 Background: Breast cancer outcomes are worse among black than white women, but the role of income and out-of-pocket costs (OOPCs) in these disparities is understudied. The Medicare D program provided medication insurance for older women and also included a low-income subsidy (LIS) which eliminated or reduced OOPCs among women with low assets and limited income (based on federal poverty level). We examined differences in adherence to HT by race/ethnicity among a Medicare D population, hypothesizing that LIS might reduce racial disparities in HT adherence. Methods: With data collected from a national sample of women enrolled in Medicare Parts A, B, and D, we identified Medicare Part D enrollees ≥65 years diagnosed with breast cancer who underwent mastectomy or breast conserving surgery in 2006-07 and received either tamoxifen or an AI (anastrozole, letrozole, or exemestane) within one year of surgery. Nonadherence rates (medication possession rate of &gt;0.80) were calculated by race and LIS status for each year after first fill up through December 2011. The association of race with HT adherence was examined in unadjusted Chi-square analyses and in regression models adjusted for age, comorbidity, chemotherapy use, and zip code level- income and education. All models utilized GEE to account for within-patient clustering. Results: Among a sample of 23,299 women (50.6% age 65-74, 40.9% age 75-84), 27.2% received LIS. LIS (but not AI use) varied substantially by race, so that 20.6% of white women and 69.7% of black women received the subsidy. In the first year of therapy, differences in adherence by race were statistically significant, but small (64.2% for white, 63.2% for black and 66.7% for Hispanic). Adherence dropped during years 2-3 of the study, but reductions were much smaller among LIS recipients. Results were confirmed in adjusted models. Conclusions: Enrollment in the Medicare D LIS was high among black and Hispanic breast cancer patients, and disparities in adherence to breast cancer HT among these women were small and remained so over three years. Our study offers important information about the role of medication subsidies and SES in adherence, and suggests their potential to reduce the breast cancer outcomes gap by race.

Assessing Medicare Beneficiaries' Willingness-to-Pay for Medication Therapy Management Services

To assess Medicare beneficiaries' willingness-to-pay (WTP) for medication therapy management (MTM) services and determine sociodemographic and clinical characteristics influencing this payment amount. A cross-sectional, descriptive study design was adopted to elicit Medicare beneficiaries' WTP for MTM. Nine outreach events in cities across Central/Northern California during Medicare's 2011 open-enrollment period. A total of 277 Medicare beneficiaries participated in the study. Comprehensive MTM was offered to each beneficiary. Pharmacy students conducted the MTM session under the supervision of licensed pharmacists. At the end of each MTM session, beneficiaries were asked to indicate their WTP for the service. Medication, self-reported chronic conditions, and beneficiary demographic data were collected and recorded via a survey during the session. The mean WTP for MTM was $33.15 for the 277 beneficiaries receiving the service and answering the WTP question. WTP by low-income subsidy recipients (mean ± standard deviation; $12.80 ± $24.10) was significantly lower than for nonsubsidy recipients ($41.13 ± $88.79). WTP was significantly (positively) correlated with number of medications regularly taken and annual out-of-pocket drug costs. The mean WTP for MTM was $33.15. WTP for MTM significantly varied by race, subsidy status, and number of prescription medications taken. WTP was significantly higher for nonsubsidy recipients than subsidy recipients, and significantly positively correlated with the number of medications regularly taken and the beneficiary rating of the delivered services.

Anticipating Part D Phase Changes: How Heart Failure Patients Respond to the Medicare Drug Benefit Design

Background: Much has been written about the impact of the Part D coverage gap on prescription filling behavior of Medicare beneficiaries with cardiovascular disease. However, we do not know if beneficiaries anticipating gap entry also cut spending in order to delay or avoid being in the gap. Methods and Results: We tracked 16,272 pairs of Part D enrollees with heart failure from 2006 through 2008 (half with full cost-sharing and half low-income subsidy recipients) matched on characteristics predictive of future drug spending. We estimated differences between the groups in drug spending, probability of reaching the gap and catastrophic thresholds, and December/January differences in spending. The highest drug spenders (>$600 per month) were least affected by phase transitions. Among lower spenders, 2.8% to 3.8% (p<0.05) avoided the gap through anticipatory cutbacks in 2007, rising to 6.1% to 7.7% (p<0.05) in 2008. Total reductions in drug spending attributable to Part D design features were 4.4% to 8.7% in 2007 and 11.8 to 17.1% in 2008 (p<0.05). Beneficiaries deflected part of the gap impact by shifting prescription fills from December 2007 to January 2008. The Part D design had little effect on heart failure medication spending. Conclusions: Filling the Part D coverage gap under provisions of the Affordable Care Act will provide economic benefits to most heart failure patients with mid- to high-level drug spending, but the biggest effect on drug utilization is likely among beneficiaries who anticipated entry into the coverage gap under the original benefit design.

Abstract P1-09-01: The effect of generic anastrozole on adherence to adjuvant endocrine therapy

Abstract Background: Endocrine therapies, particularly aromatase inhibitors, substantially reduce breast cancer mortality in clinical trials. High rates of cost-related nonadherence to these long-term oral medications, however, have reduced their population-wide impact. While the 2006 Medicare Part D introduction promised to improve this situation, most Part D enrollees’ out-of pocket aromatase inhibitor costs actually remained high and rose steadily over subsequent years. We examined the effect of a natural experiment which lowered these costs—anastrozole patent expiration—upon endocrine therapy adherence among a nationwide sample of breast cancer patients. Methods:Our sample included all female Medicare beneficiaries aged &amp;gt; = 66 identified (using a validated Medicare claims algorithm) as having incident breast cancer surgery in 2006-07 who also had one or more Part D claim for an aromatase inhibitor or tamoxifen between 7/1-12/30/2008. Part D claims were used to calculate adherence, defined as medication possession ratio (MPR)&amp;gt;80%, and medication out-of-pocket costs. A binary outcome regression model with a logit link was estimated using generalized estimating equations to study the effect of FDA approval of generic anastrozole (7/1/2010) upon adherence. The model was also adjusted for patient sociodemographic and health characteristics (age, race, comorbidities), time since surgery, low-income subsidy (LIS) (which lowers copays and eliminates the Medicare D “donut hole”) and temporal trend. Results: The mean out-of-pocket medication cost for the 22,203 cohort members (85% white, 47% age &amp;gt; = 75, 31% low income subsidy recipients, 45% anastrozole users) was $205 in the first quarter of 2009. Cohort members’ adherence to endocrine therapies dropped 15.8% from 72% in the first quarter to 61% in the last quarter during the pre-generic year (2009). In contrast, adherence was reduced by less than half that amount (-6.3%) between the same time periods in 2010 once anastrozole went generic. In adjusted models, both generic anastrozole availability and receipt of a low income subsidy were strongly associated with greater adherence to hormonal therapy (table). White race, younger age, and lower comorbidity all had smaller but statistically significant associations with greater adherence. There were no significant interactions between variables. Adherence to Adjuvant Endocrine Therapy with Availability of Generic AnastrozoleFactorOdds Ratio95 CIP valueGeneric Anastrozole2.642.38 to 2.94.001Low Income Subsidy1.961.76 to 2.20.001also adjusted for year, quarter of year, comorbidity, race, age Conclusions and Implications: The introduction of generic anastrozole was associated with a substantial and clinically significant improvement in endocrine therapy adherence among Medicare Part D enrollees. Such results have generally not been observed in studies of generic medications for chronic diseases, and may partly reflect increasing out-of-pocket demands by insurers. These findings, along with our findings of better adherence among low income subsidy recipients, highlight the importance of regulatory and subsidy policies for patients requiring long-term cancer medications. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-09-01.

Antiparkinson Drug Use and Adherence in Medicare Part D Beneficiaries With Parkinson’s Disease

BackgroundAntiparkinson drugs (APDs) are the mainstay of managing Parkinson’s disease (PD). However, there is paucity of evidence documenting patterns of APD use and examining factors associated with adherence to APDs. ObjectivesOur goal was to provide updated, comprehensive population-based data on APD use and adherence and to examine characteristics associated with adherence behaviors. MethodsWe analyzed data from 7583 beneficiaries with PD who had ≥2 APD prescription fills and were continuously enrolled in Medicare Parts A, B, and D for up to 19 months (from June 1, 2006, through December 31, 2007) or until death in 2007. We assessed 5 patterns of APD use: (1) concurrent use of ≥2 APD classes for ≥30 days; (2) switching of APDs from 1 to another; (3) augmentation of the existing regimen with a new APD; (4) duration of therapy, defined as days of APD treatment; and (5) adherence measured by using the medication possession ratio (MPR). We corrected for sample selection bias inherent in patients’ self-selection into either a Part D plan or a Medicare Advantage Prescription Plan by using Heckman’s 2-stage procedures. ResultsAPD users were pre-dominantly aged ≥65 years (93.6%), female (59.9%), and white (89.3%). Almost one half (43.2%) of APD users concurrently used ≥2 APD classes. One in 4 APD users experienced changes in their APD regimen, with 16.4% switching medications and 21.1% augmenting their current regimen. Three quarters of APD users had therapy lasting ≥436 days (75.3%) and an MPR ≥0.8 (72.7%). Multivariate analyses revealed that patients aged ≥65 years, of non-white race, non–low-income subsidy recipients, late Part D enrollees, cognitively impaired, highly comorbid, and who experienced multiple changes in APD therapy were less likely to adhere to APD therapy. We were able to generalize our findings to all Part D enrollees by correcting for sample selection bias using the Heckman approach. These population-level, generalizable observations provide better understanding of APD use and adherence and assist in the design of interventions for poor adherence. Limitations include cross-sectional study design and constraints in administrative data that preclude measurement of other potential factors related to adherence. ConclusionsA substantial proportion of these Medicare beneficiaries with PD used multiple APDs concurrently, experienced switching and/or augmentation of APDs, and had poor adherence to APDs. Patient characteristics and clinical and drug-related factors were important predictors of APD adherence.

Association of Medicare Part D Medication Out‐of‐Pocket Costs with Utilization of Statin Medications

To examine the association between statin out-of-pocket (OOP) costs and utilization among the Medicare Part D population. 2006-2008 administrative claims and enrollment data for the 5 percent Medicare sample. Sample included 346,583 beneficiary-year observations of statin users enrolled in stand-alone prescription drug plans, excluding low-income subsidy recipients. We estimated the association between a plan's OOP statin costs and statin utilization using an instrumental variable approach to account for potential bias due to plan selection. Adherence was defined as percentage of days covered (PDC) of at least 80 percent. Plan OOP costs were constructed for a representative market basket of statin medications. Analyses controlled for demographic characteristics, cardiovascular disease risk, co-morbidity presence, and regional characteristics. About 67 percent of the sample had a PDC of at least 80 percent. An increase in annual statin OOP from $200 (50th percentile) to $240 (75th percentile) was associated with a reduction in the rate of adherent beneficiaries from 67 percent to 56 percent (p<.001). Greater OOP costs for statins are associated with reductions in statin utilization.

Medicare Prescription Drug Coverage and Home Use of Erythropoiesis-Stimulating Agents for MDS-Associated Anemia: A Medicare-Database Analysis.

Abstract 3176 Background:Erythropoiesis-stimulating agents (ESAs) are a key component of chronic anemia management, particularly in lower-risk myelodysplastic syndromes (MDS). Our prior research indicates that patients (pts) with limited mobility, financial resources, and social supports are less likely to receive ESAs. ESAs administered in a physician office are covered by Medicare Part B. Qualifying MDS pts may benefit from the option of home injection, which can be reimbursed by Medicare only under the prescription drug benefit (Part D). Part D may require substantial cost sharing, particularly during the coverage gap, while pts receiving the low income subsidy (LIS) face limited out-of-pocket (OOP) cost sharing. The need for prior authorization is common in Part D plans, unlike Medicare Part B. We examined the association between patient and Part D plan characteristics and receipt of ESAs through Medicare Part D. We hypothesized that pts with lower cost sharing, poor functional status and greater financial resources would be more likely to receive ESAs covered through Part D. Methods:Using 100% Medicare enrollment and claims data from 2005–2008, we selected beneficiaries assigned MDS diagnostic codes. The study cohort consisted of the subset of MDS pts enrolled in Medicare Parts A and B from 12 months before MDS diagnosis, and Part D enrolled from MDS diagnosis forward. Pts with Medicare Advantage (HMO enrollment) or with renal disease were excluded. Part D plan characteristics were linked to patient-level observations. Type and level of cost-sharing associated with the highest branded drug tier was used to proxy the OOP payment associated with a Part D claim for ESA. ESA use within 6 months of MDS diagnosis was identified from Part B claims and Part D event files. We used a 2-part modeling strategy, examining receipt of any ESA, and receipt of any Part D covered ESA among beneficiaries who received ESAs. The analysis was operationalized using multivariate logistic regression, with explanatory variables including measures of LIS receipt, Part D cost sharing, pt demographics, MDS risk group, and health status [Charlson Comorbidity Index (CCI), predicted poor performance status (PS)]. Results:The cohort included 19,504 patients, with 11,480 (59%) receiving any ESAs; 1,009 (5.2%) or 9% of those receiving ESAs had at least 1 Part D claim. LIS was received by 37% of the study cohort. Mean Part D coinsurance rate for branded drugs was 28%, with a mean copay of $41. Multivariate regression results indicated that, among pts with any ESA, those with LIS were 12% more likely to receive ESAs through Part D (p<0.01). Among those without LIS, a $10 increase in copay levels was associated with a 0.5 percentage point lower probability of receiving ESAs covered through Part D (p<0.05). Increasing age and greater CCI (more comorbidities) were associated with both greater probabilities of any ESA, and receiving them through Part D. In contrast, patients with poor PS and/or residing in a nursing home were less likely to receive any ESA, but if they received ESAs they were more likely to receive them through Part D. Higher income was associated with a greater probability of Part D coverage of ESA. For patients without LIS who received ESAs through Part D, mean OOP payment per claim was $462 (median $238), and prior authorization was required for 80% of claims. For a standard claim for 60,000 units of epoetin-alfa, we calculated an OOP payment of $245 under Part D vs. $112 under Part B. Conclusions:Our results indicate that relatively few MDS pts received ESAs at home through Part D. Pts were responsive to cost sharing under Part D, with LIS recipients more likely to receive ESAs covered by Part D; increased copayments were associated with reduced use of Part D-covered ESAs. OOP payments required under Part D were substantially higher than requirements under Part B. In addition, Part D use is commonly subject to prior authorization, while Part B is not, further limiting home administration. The Medicare program may need to consider changes to Part D plan incentives to improve access to therapies such as ESAs that can be administered safely at home. Disclosures:Davidoff:Novartis: Research Funding; Celgene: Research Funding; National Institutes of Health: Research Funding; GlaskoSmithKline: Research Funding. Off Label Use: Erythropoiesis-Stimulating Agents (ESAs) are indicated for the treatment of anemia associated with chronic renal failure and myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. The current research explores the use of ESAs as an off-label indication within patients diagnosed with myelodysplastic syndrome. Stuart:GlaskoSmithKline: Research Funding. Shenolikar:GlaskoSmithKline: Employment. Gore:Celgene Corporation: Consultancy, Research Funding.