Medicare Advantage Prescription Drug Plan Research Articles

Medication adherence star ratings measures, health care resource utilization, and cost.

To examine the association between missed CMS Star Ratings quality measures for medication adherence over 3 years for diabetes, hypertension, and hyperlipidemia medications (9 measures) and health care utilization and relative costs. Retrospective cohort study. The study examined eligible patients who qualified for the diabetes, statin, and renin-angiotensin system antagonist medication adherence measures in 2018, 2019, and 2020 and were continuously enrolled in a Medicare Advantage prescription drug plan from 2017 through 2021. Atotal of 103,900 patients were divided into 4 groups based on the number of adherence measures missed (3 medication classes over 3 years): (1) missed 0 measures, (2) missed 1measure, (3) missed 2 or 3 measures, and (4) missed 4 or more measures. To achieve a quality measure, patients had to meet the Pharmacy Quality Alliance 80% threshold of proportion of days covered during the calendar year. The mean age of the cohort was 71.1 years, and 49.9% were female. Compared with patients who missed 0 of 9 adherence measures, those who missed 1 measure, 2 or 3 measures, and 4 or more measures experienced 12% to 26%, 22% to 42%, and 24% to 50% increased risks, respectively, of all-cause and diabetes-related inpatient stays and all-cause and diabetes-related emergency department visits (all P values < .01). Additionally, patients who missed 1, 2 or 3, and 4 or more adherence measures experienced 14%, 19%, and 20% higher monthly medical costs, respectively. Missing Star Ratings quality measures for medication adherence was associated with an increased likelihood of health care resource utilization and increased costs for patients taking medications to treat diabetes, hypertension, and hyperlipidemia.

Medicare Part D Plans Greatly Increased Utilization Restrictions On Prescription Drugs, 2011-20.

Drug utilization management tools can be employed to ensure that medicines are prescribed cost-effectively, but they can also be implemented in ways that reduce adherence and harm patient health. We examined trends in the prevalence of utilization restrictions on non-protected-class compounds in Medicare Part D plans during the period 2011-20, including prior authorization and step therapy requirements as well as formulary exclusions. Part D plans became significantly more restrictive over time, rising from an average of 31.9percent of compounds restricted in 2011 to 44.4percent restricted in 2020. The prevalence of formulary exclusions grew particularly fast: By 2020, plan formularies excluded an average of 44.7percent of brand-name-only compounds. Formulary restrictions were more common among brand-name-only compared with generic-available compounds, among more expensive compounds, and in stand-alone compared with Medicare Advantage prescription drug plans.

A comparison of clinical, utilization, and cost outcomes between oral treatments for multiple sclerosis.

Multiple sclerosis (MS) affects nearly 1 million people in the United States and causes significant disability and economic loss. Among the first available oral MS treatment options, clinical outcome comparisons and associated health care resource utilization are not clearly defined. To compare MS outcomes, health care resource utilization, and relative costs across treatment with dimethyl fumarate (DMF), fingolimod (FG), or teriflunomide (TERI) among Medicare Advantage Prescription Drug (MAPD) plan and commercially insured beneficiaries. This retrospective cohort study used the Humana Research Database. Eligible study patients had their first MS medication claim for oral DMG, FG, or TERI between January 1, 2013, and December 31, 2018. Patients were followed for a minimum of 12 months (mean follow-up = 3.8 years), until the earliest of the following occurred: health plan disenrollment, the end of the study period, or death. Study cohorts were balanced with inverse probability of treatment weighting. All-cause and MS-related health care resource utilization, time on therapy, and time after therapy were compared using inverse probability of treatment-adjusted multivariate generalized linear models across treatment groups. Relative costs were compared using a generalized linear model with a gamma distribution and log link. We identified 1,442 patients in 3 medication groups: DMF (n = 843), FG (n = 213), and TERI (n = 386). After weighting, there were no significant differences between the medication groups on demographic and clinical characteristics. Time on therapy (days) was significantly different across medication groups (P < 0.001). Time on therapy was longest for FG compared with the DM and TERI groups (644 vs 462 vs 521). The number discontinuing the index medication was significantly different for FG vs DMF vs TERI (74.7% vs 85.3% vs 80.7%; P < 0.001). FG had the lowest discontinuation rate. The mean (SD) annualized relapse rates (ARRs) were 0.47 (0.80), 0.42 (1.3), and 0.53 (1.3) (P = 0.037) for DMF, FG, and TERI, respectively. The percentage of those experiencing inpatient stays and the number of stays (mean [SD]) were significantly different among the FG group vs DMF vs TERI (29.9% vs 34.1% vs 40.9%; P < 0.001) and (0.57 [2.9] vs 0.74 [1.9] vs 0.91 [3.5]; P = 0.007), respectively. All-cause emergency department visits and the number of visits (mean [SD]) were significantly different for the FG cohort vs DMF vs TERI (46% vs 54.3% vs 61%; P < 0.001) and (1.84 [7.7] vs 2.38 [5.9] vs 2.87 [8.8]; P = 0.002), respectively. FG had the lowest impatient stays and emergency department visits of the 3 groups. Patients with MS initiated on FG used fewer health care resources and experienced lower ARR compared with patients on DMF and TERI.

Managing comorbidities in chronic kidney disease reduces utilization and costs

BackgroundEffective management of comorbid diabetes and hypertension in patients with chronic kidney disease (CKD) is important for optimal outcomes. However, little is known about this relationship from a health plan perspective. The objective of this study was to evaluate the association of effective management of comorbid diabetes and/or hypertension with healthcare resource utilization (HCRU) in patients with chronic kidney disease (CKD).MethodsThis retrospective cohort study used the Humana Research Database to identify patients with CKD Stage ≥ 3a in 2017. Eligible patients were enrolled in a Medicare Advantage Prescription Drug plan for ≥ 12 months before and after the index date (first observed evidence of CKD). Patients with end-stage renal disease, kidney transplant, or hospice election preindex were excluded. Recommended comorbid disease management included hemoglobin A1c monitoring; adherence to glucose-lowering, cardiovascular, and angiotensin-converting enzyme inhibitors/angiotensin receptor blocker medications; and nephrologist/primary care provider (PCP) visits. HCRU was evaluated for 12 months postindex.ResultsThe final cohort of 241,628 patients was 55% female and 77% White, with an average age of 75 years. Approximately 90% of patients had Stage 3 CKD. Half had both diabetes and hypertension, and most of the remaining half had hypertension without diabetes. Patients meeting the criteria for good disease management, compared with patients not meeting those criteria, were less likely to experience an inpatient hospitalization, by as much as 40% depending on the criterion and the comorbidities present, or an emergency department visit, by as much as 30%. Total monthly healthcare costs were as much as 17% lower.ConclusionsManagement of comorbid diabetes and hypertension in patients with CKD was associated with lower HCRU and costs. Care coordination programs targeting patients with CKD must give careful attention to glucose and blood pressure control.Trial registrationNot applicable.

HIV preexposure prophylaxis treatment patterns in a national health plan population.

Medication nonadherence diminishes the benefits of preexposure prophylaxis (PrEP) for the 1.2 million Americans at risk for HIV exposure. To describe HIV PrEP treatment patterns among Medicare Advantage Prescription Drug (MAPD) plan and commercially insured beneficiaries. This retrospective cohort study identified patients aged 16 to 89 years with at least 1 dispensing of emtricitabine-tenofovir disoproxil fumarate from July 2012, through December 2020, or emtricitabine-tenofovir alafenamide from October 2019 through December 2020, and who were continuously enrolled at least 12 months prior to and following the earliest PrEP claim. Outcomes were HIV PrEP adherence measured by proportion of days covered (PDC) using 2 binary thresholds of 0.60 (4 doses/week) and 0.80 (5-6 doses/week) and duration of index treatment episode, total time on treatment, and total number of prescription fills. The study cohort of 707 (292 MAPD plan, 415 commercial) was predominantly made up of male patients (90.0%) and resided in the South (78.9%) with a mean age of 46.2 years (MAPD plan: 54.5, commercial: 40.4). Both populations engaged in high-risk sexual behavior (All: 18.7%, MAPD plan: 16.8%, commercial: 20.0%) and experienced sexually transmitted infections (All: 3.3%, MAPD plan: 2.1%, commercial: 4.1%). The mean index treatment episode length was 297.0 days (MAPD plan: 283.6, commercial: 306.5). Total time on treatment was 477.3 days (MAPD plan: 450.7, commercial 496.0). At 3 months, 84.9% (MAPD plan: 83.6%, commercial: 85.8%) and at 12 months, 58.7% (MAPD plan: 57.2, commercial: 59.8) of patients achieved a PDC of at least 0.80. At 3 months, 100.0% (MAPD plan: 100.0%, commercial: 100.0%), and at 12 months, 74.3% (MAPD plan: 70.2%, commercial: 76.9%) of patients achieved a PDC of at least 0.60. The cohort had a mean of 16.4 fills of 30 days (MAPD plan: 16.4, commercial: 16.3) supply. There is an opportunity for clinical programs to focus on improving longer-term PrEP adherence among individuals at risk for HIV exposure.

Association of medication adherence quality measures for diabetes, hypertension, and hyperlipidemia with cognitive decline.

While diabetes, hypertension, and hyperlipidemia each are associated with increased risk of cognitive decline, little is known regarding how nonadherence to medications for these conditions is associated with cognitive decline risk. We identified patients enrolled in a Medicare Advantage Prescription Drug plan who were eligible for inclusion in the CMS Star Medication Adherence quality measures for diabetes, hypertension, and hyperlipidemia in 2018, 2019, and 2020. To achieve an adherence quality measure, patients had to meet 80% of the proportion of days for the medication. We used propensity score with inverse probability of treatment weighting to balance outcomes for baseline characteristics and logistic regression models to compare odds of cognitive decline outcomes across patient groups. The study population of 99,774 individuals had a mean age of 71.0 years and was 49.1% female, 73.9% White, and 17.8% Black, with 62.0% living in an urban setting. Compared with patients who missed zero adherence measures, those who missed one measure had 23%-33% increased odds of cognitive decline (any decline OR = 1.23; dementia OR = 1.33; Alzheimer's disease OR = 1.27; all P values <0.01). Patients who missed 2-3 measures had 37%-96% increased odds of cognitive decline (any decline OR = 1.37; dementia OR = 1.58; Alzheimer's disease OR = 1.96; all P values <0.01). Patients who missed ≥4 adherence measures had the greatest odds of cognitive decline (any decline OR = 1.64; dementia OR = 2.05; Alzheimer's disease OR = 2.48; all P values <0.01). Not achieving CMS Star Medication Adherence quality measures for diabetes, hypertension, and hyperlipidemia therapies was associated with increased risk of cognitive decline outcomes.

Comparison of a second TNFi vs other biologic or targeted synthetic DMARD following an initial TNFi.

BACKGROUND: Patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis may require treatment with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Often, a tumor necrosis factor inhibitor (TNFi) is the initial b/tsDMARD. The TNFi may not be effective or may not be well tolerated, so patients will opt for a different TNFi or switch to a non-TNFi b/tsDMARD. No preference for a TNFi or non-TNFi has been established and guidelines are unclear. OBJECTIVE: To evaluate effectiveness by comparing patients using a second TNFi vs a non-TNFi after initial use of TNFi based on treatment patterns and health care utilization. METHODS: This retrospective analysis used Medicare Advantage prescription drug (MAPD) plan, Medicaid, and commercial plan claims data from Humana's Research Database (Louisville, KY). The first claim for TNFi or non-TNFi (July 1, 2016, to June 30, 2018) following earlier TNFi was the index date. Patients were required to have pre-index enrollment of 6 months and 12 months post-index along with diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, or psoriasis. During the 12-month follow-up, persistence to the index TNFi or non-TNFi was measured as continued therapy without a gap exceeding 45 days (81 days for intravenous infusions). Adherence was proportion of days covered at least 0.8. Addition of a nonbiologic DMARD or corticosteroid was also identified. Inpatient admissions and emergency department visits were observed. Inverse probability of treatment weights was used to balance cohorts. Logistic regression models were fit to TNFi vs non-TNFI on treatment and utilization measures. RESULTS: Of identified patients, 1,022 were indexed to a second TNFi and 1,024 were indexed to non-TNFi. Weighted cohorts were balanced, with mean age 56.5 vs 56.4 years, 70.5% vs 70.7% female sex, and 68.0% vs 67.9% MAPD plan. No differences were observed on persistence or adherence, with adjusted odds ratios (OR) of 1.05 (95% CI = 0.91-1.20) and 1.04 (0.91-1.20), respectively. No differences were observed for changes in therapy via switching to another TNFi/non-TNFi (OR = 0.93; 95% CI = 0.54-1.62), via nonbiologic DMARD addition (OR = 0.95; 95% CI = 0.83-1.11), or corticosteroid addition (OR = 1.09; 95% CI = 0.92-1.88). No differences were observed for hospitalization (OR = 1.16; 95% CI = 0.99-1.37) or emergency department visits (OR = 1.02; 95% CI = 0.89-1.18). CONCLUSIONS: No differences were found between a second TNFi vs a non-TNFi. As a result, choice of TNFi or non-TNFi following an initial TNFi may be driven by relevant patient-specific considerations. At the population level, policies that prefer either TNFi or non-TNFi appear reasonable. DISCLOSURES: The study was funded by Humana Inc. Mr Racsa is an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc. Drs Asante and Bloomfield are employees of Humana Inc. Dr Schwab was an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc., and is now an employee of RTI Health Solutions. Dr Cornett was an employee of Humana Inc. and is now an employee of ImmunoGen Inc.

Effects of star ratings bonus payments on disparities in medication utilization issues

BackgroundPrevious literature suggested that the consequences of inappropriate medication use may be borne disproportionately by racial/ethnic minorities. It is, therefore, essential to examine if quality improvement initiatives, such as Medicare Part D Star Ratings (Star Ratings), can improve these disparities. ObjectiveTo assess the impact of Star Ratings bonus payments to Medicare Advantage prescription drug plans (MAPDs) implemented in 2012 on racial/ethnic disparities in medication utilization issues (MUIs). MethodsThis study mainly used secondary data from Medicare administrative data linked to Area Health Resources Files for years before (2010–2011) and after MAPD bonus payment implementation (2016–2017). Patients in MAPDs were treated as the intervention group, and those in independent prescription drug plans (PDPs) were used as the comparison group because PDPs were ineligible for bonuses. MUIs targeted and not targeted in Star Ratings were both examined to determine spillover effects. A difference-in-differences approach was applied by including in a logistic regression a 3-way interaction term for dummy variables for racial/ethnic minorities, later period of 2016–2017, and MAPD plan. ResultsRacial/ethnic minorities experienced more MUIs: e.g., the odds of MUIs targeted in Star Ratings among MAPD enrollees were 83% higher (odds ratio [OR] = 1.83; 95% confidence interval [CI] = 1.71–1.96) for Black than White patients. Black-White disparities in MUIs targeted in Star Ratings decreased 16% more (OR = 0.84; 95% = CI 0.78–0.91) over time among MAPD enrollees than those in PDPs. This pattern was not found for non-Star Ratings measures. Changes in Hispanic-White disparities were similar between MAPD and PDP enrollees for MUIs targeted and not-targeted by Star Ratings. Asian-White and Other-White disparities in MUIs did not experience a higher reduction among MAPD enrollees than PDP enrollees. ConclusionsPart D bonus payments are associated with lower Black-White disparities in MUIs targeted by Star Ratings. However, Part D bonus payments may not have reduced Hispanic-White or Asian-White disparities. Future research should explore the causes of the bonus payments' heterogeneous effects across racial/ethnic groups.

Home versus outpatient hospital intravenous immunoglobulin infusion and health care resource utilization

BackgroundHome health care delivery is projected to increase. Intravenous immunoglobulin (IVIG) therapy has high potential to move from the outpatient hospital (OPH) setting to home delivery. ObjectiveThis study examined the relationship between home and OPH IVIG infusions and health care utilization. MethodsWe used a retrospective cohort study design and the Humana Research Database to identify patients with 1 or more medical or pharmacy claims for an IVIG infusion agent from January 1, 2017, to December 31, 2018. Eligible patients were enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan, with at least 12 months of continuous enrollment before and after their first infusion (i.e., index date) received in the home or OPH setting. We measured the odds of experiencing an inpatient (IP) stay or emergency department (ED) visit, adjusted for baseline differences in age, sex, race, region, population density, low-income, and dual eligibility status, MAPD or commercial health plan, plan type, treatment-naïve status, home health use, RxRisk-V comorbidity burden score, and indications for IVIG use. ResultsA total of 208 and 1079 patients received IVIG infusions in the home and OPH setting, respectively. The odds for an IP stay (odds ratio [OR] 0.56 [95% CI 0.38–0.82]) and ED visit (OR 0.62 [95% CI 0.41–0.93]) were significantly lower in patients who received IVIG infusion in the home than patients receiving infusion in the OPH setting. ConclusionsOur findings suggest there may be value to increasing referrals for IVIG home infusion. Decreased health care utilization provides value to the system in cost savings and to patients and families owing to less disruption and improved clinical outcomes. Further study can help inform health policy designed to maximize the benefits of IVIG home infusion while minimizing potential risks.

Comparison of Out-of-Pocket Spending on Ultra-Expensive Drugs in Medicare Part D vs Commercial Insurance

Little is known about how out-of-pocket burden differs between Medicare and commercial insurance for ultra-expensive drugs. To investigate out-of-pocket spending for ultra-expensive drugs in the Medicare Part D program vs commercial insurance. This was a retrospective, population-based cohort study of individuals using ultra-expensive drugs included in a 20% nationally random sample of prescription drug claims from Medicare Part D and individuals aged 45 to 64 years using ultra-expensive drugs included in a large national convenience sample of outpatient pharmaceutical claims from commercial insurance plans. Claims data from 2013 through 2019 were used, and data were analyzed in February 2023. Claims-weighted mean out-of-pocket spending per beneficiary per drug by insurance type, plan, and age. In 2019, 37 324 and 24 159 individuals using ultra-expensive drugs were identified in the 20% Part D and commercial samples, respectively (mean [SD] age, 66.2 [11.7] years; 54.9% female). A statistically significant higher share of commercial enrollees vs Part D beneficiaries were female (61.0% vs 51.0%; P < .001), and a statistically significantly lower share were using 3 or more branded medications (28.7% vs 42.6%; P < .001). Mean out-of-pocket spending per beneficiary per drug in 2019 was $4478 in Part D (median [IQR], $4169 [$3369-$5947]) compared with $1821 for commercial (median [IQR], $1272 [$703-$1924]); these differences were statistically significant every year. Differences in out-of-pocket spending comparing commercial enrollees aged 60 to 64 years and Part D beneficiaries aged 65 to 69 years exhibited similar magnitudes and trends. By plan, mean out-of-pocket spending per beneficiary per drug in 2019 was $4301 (median [IQR], $4131 [$3000-$6048]) in Medicare Advantage prescription drug (MAPD) plans, $4575 (median [IQR], $4190 [$3305-$5799]) in stand-alone prescription drug plans (PDPs), $1208 (median [IQR], $752 [$317-$1240]) in health maintenance organization plans, $1569 (median [IQR], $838 [$481-$1472]) in preferred provider organization plans, and $4077 (median [IQR], $2882 [$1075-$4226]) in high-deductible health plans. There were no statistically significant differences between MAPD plans and stand-alone PDPs in any study year. Mean out-of-pocket spending was statistically significantly higher in MAPD plans compared with health maintenance organization plans and in stand-alone PDPs compared with preferred provider organization plans in each study year. This cohort study demonstrated that the $2000 out-of-pocket cap included in the Inflation Reduction Act may substantially moderate the potential increase in spending faced by individuals who use ultra-expensive drugs when moving from commercial insurance to Part D coverage.

Clinical characteristics and health care resource use of patients at risk for wild-type transthyretin amyloid cardiomyopathy identified by machine learning model

BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, life-threatening systemic disorder that is an underrecognized cause of heart failure (HF). When the diagnosis of wild-type ATTR-CM (ATTRwt-CM) is delayed, patients often undergo additional assessments, deferring appropriate management as symptoms potentially worsen. Prompt recognition of patients at risk for ATTRwt-CM is essential to facilitate earlier diagnosis and disease-modifying treatment. A previously developed machine learning model performed well in identifying ATTRwt-CM in patients with HF vs controls with nonamyloid HF using medical claims/electronic health records, providing a systematic framework to raise disease suspicion. OBJECTIVE: To further evaluate this model's performance in identifying ATTRwt-CM using a large claims database of older adults with HF and confirmed ATTRwt-CM or nonamyloid HF; and to explore the characteristics and health care resource utilization (HCRU) of patients with confirmed and suspected ATTRwt-CM. METHODS: In this retrospective study, the prior model was applied using Humana administrative claims for patients diagnosed with ATTRwt-CM (cases) and nonamyloid HF (controls [1:1]). Patients were aged 65-89 years, had at least 2 claims for HF diagnosis (2015-2020), and were continuously enrolled in a Medicare Advantage prescription drug plan for at least 12 months before and at least 6 months after HF diagnosis. For the assessment of characteristics and HCRU, the suspected risk level was categorized based on the predicted probability (PP) from model output (high, moderate, and low risk: PP≥0.70; ≥0.50 and < 0.70; and < 0.50, respectively). RESULTS: Of 267,025 eligible patients, 119 (0.04%) had confirmed ATTRwt-CM; of 266,906 patients with nonamyloid HF, 10,997 (4.1%), 68,174 (25.5%), and 187,735 (70.3%) were categorized as high, moderate, and low risk for ATTRwt-CM, respectively. The model demonstrated sensitivity/specificity/accuracy/receiver operating characteristic area under the concentration-time curve of 88%/65%/77%/0.89, respectively, in differentiating ATTRwt-CM from nonamyloid HF. In patients with confirmed ATTRwt-CM, the mean (SD) time between HF and ATTRwt-CM diagnoses was 751 (528) days; 65% and 48% were hospitalized before and after ATTRwt-CM diagnosis, respectively. Atrial fibrillation was more common in patients with confirmed ATTRwt-CM and high risk (39% and 55%) vs low risk (27%). Hospitalization and emergency department visits after HF diagnosis were reported in 57% and 46% of patients with high ATTRwt-CM risk, respectively. CONCLUSIONS: The ATTRwt-CM predictive model performed well in identifying disease risk in the Humana Research Database. Patients at high risk for ATTRwt-CM had high HCRU and may benefit from the earlier suspicion of ATTRwt-CM. The model may be used as a tool to identify patients with a suspected high risk for the disease to facilitate earlier detection and treatment. DISCLOSURES: This study was sponsored by Pfizer. Medical writing support was provided by Donna McGuire of Engage Scientific Solutions and funded by Pfizer. Drs Bruno and Schepart and Mr Casey are currently employees of Pfizer and equity holders in this publicly traded company. Dr Reed was an employee of Pfizer at the time that this analysis was planned and conducted. Mr Sheer and Dr Simmons are currently employees of Humana, which received research funding from Pfizer. Dr Nair was an employee of Humana at the time that this analysis was planned and conducted.

Early vs late filling of new heart failure prescription and its association with avoidable hospital admissions.

BACKGROUND: Individuals with heart failure (HF) are at increased risk for hospitalization and readmission after discharge. The impact of timing to new prescription filling on avoidable HF hospitalization is understudied in HF management. The Agency of Healthcare Research and Quality identifies HF-related inpatient admissions as potentially avoidable if they could be managed successfully in outpatient settings. OBJECTIVE: To compare avoidable HF hospitalization rate and all-cause and HF-related costs in patients who were early fillers (≤30 days) vs late fillers (>30 days) of newly prescribed HF medications following an HF-related inpatient stay or emergency department visit. METHODS: This retrospective cohort study used the Humana Research Database to identify patients with at least 1 claim for a new HF medication from January 1, 2018, to June 30, 2019. Eligible patients were enrolled in a Medicare Advantage Prescription Drug plan for at least 12 months pre-index and 6-months post-index (ie, first new HF prescription). Individuals who were early (n = 794) vs late fillers (n = 397) were propensity-score matched in a 2:1 ratio to balance baseline characteristics. A logistic regression model was fitted to compare avoidable HF hospitalization in those who were late fillers vs early fillers. Mean cost differences were compared using paired t-test. Outcomes were measured 6-months post-index. RESULTS: Late fillers had greater odds of experiencing an avoidable HF hospitalization compared with early fillers (odds ratio = 1.65; P = 0.001). Late filling was associated with a 49.5% increase in average all-cause medical costs (P < 0.0001), a 13.6% decrease in average all-cause pharmacy costs (P = 0.0929), and a 39.4% increase in average all-cause total costs (P < 0.0001). HF-related costs showed similar trends. CONCLUSION: Compared with patients who filled their prescription within 30 days of discharge following an HF admission, those who delayed the filling of a new HF prescription experienced increased likelihood of an avoidable readmission, and late filling was associated with increased 6-month total and medical costs. DISCLOSURES: Humana Healthcare Research, Inc., funded the research and article development. No external funds were used in the creation of this work. All authors are/were employees of Humana Inc. and/or Humana Healthcare Research, Inc., at the time of the work.

Transition-to-dialysis planning, health care use, and mortality in end-stage renal disease.

To evaluate the association of dialysis transition planning factors (eg, nephrologist care, vascular access placement, place of dialysis) with inpatient (IP) stays, emergency department (ED) visits, and mortality. Retrospective cohort study. We used the Humana Research Database to identify 7026 patients with a diagnosis of end-stage renal disease (ESRD) in 2017 who were enrolled in a Medicare Advantage Prescription Drug plan with at least 12 months preindex enrollment, with first ESRD evidence as the index date. Patients with kidney transplant, hospice election, or dialysis preindex were excluded. Transition-to-dialysis planning was defined as optimal (vascular access placed), suboptimal (nephrologist care, but no vascular access), or unplanned (first dialysis in IP stay or ED visit). The cohort was 41% female and 66% White, with a mean age of 70 years. Optimally planned, suboptimally planned, and unplanned transition to dialysis occurred for 15%, 34%, and 44% of the cohort, respectively. Among patients with preindex chronic kidney disease (CKD) stages 3a and 3b, 64% and 55%, respectively, had an unplanned dialysis transition. For patients with preindex CKD stages 4 and 5, 68% and 84%, respectively, had a planned transition. In adjusted models, patients with a suboptimally or optimally planned transition were 57% to 72% less likely to die, 20% to 37% less likely to experience an IP stay, and 80% to 100% more likely to experience an ED visit than patients with an unplanned dialysis transition. A planned transition to dialysis was associated with reduced odds of IP stays and lower mortality.

Evolution of the Comprehensive Medication Review Completion Rate for Medicare Part D Plans: What Do the Stars Tell Us?

Objective To describe changes in the Medicare Part D Comprehensive Medication Review (CMR) completion rate within the Centers for Medicare & Medicaid Services (CMS) Star Ratings program since its inception. Methods Publicly available information for Star Ratings years 2014 to 2021 was obtained from the CMS website and through indexed literature and internet searches. Data elements for the CMR completion measure were extracted for Medicare Advantage prescription drug plans (MA-PDs) and prescription drug plans (PDPs) and included the annual weighted value, cut-points for star rating, completion rates, and star achievement. Results In 2014 and 2015, the CMR completion rate was a display measure in the Star Ratings program with rates between 10 and 16%. This measure was added in 2016 with a weighted value of 1 that has remained the same. The cut-points when comparing 2016 with 2021 have increased from less than 13.6 to less than 48% for 1 star and 76 to 89% or more for 5 stars for MA-PDs and from less than 8.5 to less than 24% for 1 star and 36.7 to 61% or more for 5 stars for PDPs. From 2016 to 2021, the average Star Ratings for CMR completion increased from 2.3 to 3.7 for MA-PDs and 2.3 to 3.6 for PDPs. Conclusion Since the inception of the CMR completion rate as a quality measure, an increasing proportion of eligible beneficiaries has received a CMR with MA-PDs consistently providing this service to more beneficiaries than PDPs. The cut-points for star achievement have also risen, requiring higher CMR completion rates to achieve higher star ratings. Further evolution of the CMR quality measure is needed for improving medication management.

Financial incentives tied to Medicare star ratings: impact on influenza vaccination uptake in Medicare beneficiaries.

To evaluate the impact of the star rating bonus payment policy on annual influenza vaccination rates before and after the policy was adopted for Medicare Advantage (MA) plans in 2012. Observational study using data from the Medicare Current Beneficiary Survey from 2007 to 2015 to test whether the bonus payment policy led to higher flu vaccination rates in MA prescription drug (MAPD) plans vs fee-for-service prescription drug plans (PDPs), which were ineligible for bonus payments. Mean preperiod (2007-2011) and postperiod (2012-2015) influenza vaccination rates were compared for enrollees in both types of plans using descriptive and multivariate difference-in-difference (DID) equations. The experimental effect of the MA bonus payment policy was estimated as the interaction between plan type (MAPD plan vs PDP) and period (pre- vs post period) controlling for the main effects of plan type (MAPD vs PDP), timing of the observation (pre- vs post period), and other potential confounders. The study sample included 40,369 person-years of data in the preperiod and 27,703 person-years of data in the post period. Vaccination rates increased by 3.8% in MAPD plans compared with 2.7% in PDPs, leading to a relative MAPD-favored difference that was nonsignificant (P = .31). However, the effect was statistically significant (odds ratio [OR], 1.12; P = .03) in the main multivariate DID model. A larger relative difference was observed among beneficiaries 75 years and older (OR, 1.18; P = .03). The Medicare bonus payment policy led to a small increase in beneficiaries' flu vaccination rates, suggesting that expanding the star measure set could be an effective way to increase uptake for other recommended adult vaccines.

401-P: Development of Predictive Models for Health Care Outcomes of Patients with Chronic Kidney Disease and Type 2 Diabetes

Progression of chronic kidney disease (CKD) is associated with increased risk of cardiovascular or renal events that contribute to increasing healthcare costs. The purpose of this study was to develop predictive models for rapid progression of CKD, days out of the home, and high costs for patients with both CKD and type 2 diabetes (T2D) . This retrospective observational cohort study used administrative claims data for patients with CKD (stage 3-4) and T2D aged 65-89 years enrolled in a Humana Medicare Advantage Prescription Drug plan 1/1/2012-12/31/2017. Patients were enrolled ≥1 year pre-index and followed up to one year post-index. Outcomes included rapid progression of CKD (&amp;gt;1 decrease in estimated glomerular filtration rate [eGFR] &amp;gt;5 mL/min/1.73m2 per year) , days out of the home (days spent out of their residence [e.g., hospital]; ≥2% days out of the home) and high costs (75-90th and &amp;gt;90th percentiles) post-index. Pre-index demographic and clinical characteristics, selected based on the LASSO technique, were included in logistic regression models to generate parameter estimates and model performance statistics. We identified 169,876 patients with CKD stage 3-4 and T2D. The C-statistics for the models ranged from 0.694 to 0.745. Lower initial eGFR led to incrementally higher risk for more days out of the home and high costs. Patients with urinary albumin to creatinine ratio (UACR) ≥300 mg/g had three times increased risk for rapid progression of CKD, 57% higher risk of more days out of the home, and, among those in the 75-90th cost percentile, had 38% higher costs than patients with UACR&amp;lt;30 mg/g. The presence of congestive heart failure, anemia, or higher pre-index utilization (≥5 physician visits) increased the risk for all outcomes. The predictive models developed in this study can be potentially used as decision support tools for clinicians and payers, and the risk scores from these models can be applied to future outcomes studies focused on patients with T2D and CKD. Disclosure R. Nair: None. M.K. Pasquale: Consultant; Bayer AG. T. Evers: Employee; Bayer AG. M.M. Cockrell: Employee; Humana. Stock/Shareholder; Humana. A. Gay: Employee; Bayer AG. R. Singh: None. N. Schmedt: Employee; Bayer AG. Funding This study was funded by Bayer.

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.

IntroductionSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT).MethodsThis was a retrospective study using the Optum Clinformatics® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting β2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT.ResultsThe study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA.ConclusionIn this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.

Effects of an out-of-pocket maximum in Medicare Part D.

Three different out-of-pocket (OOP) maximums in Medicare Part D have been proposed: $2000 by the House of Representatives, $3100 by the Senate Finance Committee, and the beginning of catastrophic coverage by the Medicare Payment Advisory Commission. However, little is known about how beneficiaries would be affected. We estimated multivariate linear regression models to determine which beneficiary characteristics were associated with the greatest savings under each proposed OOP maximum and simulated a potential behavioral response by beneficiaries. Using Part D 2017 claims data for beneficiaries in stand-alone prescription drug plans (PDPs) and Medicare Advantage prescription drug (MA-PD) plans, we estimated the number of beneficiaries affected, their demographic characteristics, and their drug utilization patterns. We then simulated a potential behavioral response by beneficiaries. Under the $2000 OOP proposed threshold, only 7% of PDP and 4% of MA-PD plan beneficiaries would have spending high enough to reach the OOP maximum. Annual mean (SD) savings would be $1301 ($1849) for PDP beneficiaries and $1363 ($1888) for MA-PD plan beneficiaries, concentrated among beneficiaries taking specialty drugs. As the threshold increases, fewer beneficiaries would accrue savings, but savings would increase. For the highest proposed OOP maximum, mean (SD) savings would be $2720 ($3465) and $2473 ($2805) for PDP and MA-PD plan beneficiaries, respectively. In our simulations, we estimated that the number of beneficiaries affected by an OOP maximum could increase by 2% to 11%, depending on the magnitude of response, but changes in savings would be minimal. As currently drafted, proposed OOP maximums would reduce OOP spending for a small population of Part D beneficiaries, with savings concentrated among beneficiaries with the very highest costs who are taking specialty medications.

Comparison of oral anticoagulation use and adherence among Medicare beneficiaries enrolled in stand-alone prescription drug plans vs Medicare Advantage prescription drug plans.

BACKGROUND: For atrial fibrillation (AF) patients, oral anticoagulants (OACs) can reduce the risk of stroke by 60%; however, nearly 50% of patients recommended to receive OACs do not receive therapy. Integrated insurers that cover pharmacy and medical benefits may be incentivized to improve OAC use and adherence because they benefit from offsets in medical costs associated with prevented strokes. OBJECTIVE: To compare OAC use and adherence between AF patients enrolled in Medicare stand-alone prescription drug plans (PDPs), which only cover pharmacy benefits, and those enrolled in Medicare Advantage prescription drug (MAPD) plans, which cover medical and pharmacy benefits. METHODS: This was a retrospective cohort study, conducted using 2014-2016 Medicare claims data from the Centers for Medicare & Medicaid Services and a large regional health plan in Pennsylvania. Primary outcomes included OAC use and OAC adherence. OAC use was measured as filling at least 1 prescription for an OAC after AF diagnosis. OAC adherence was defined as having greater than or equal to 80% of days covered with an OAC. We constructed conditional logistic regression models in propensity score-matched samples to test the association between enrollment in PDPs or MAPD plans and outcomes. RESULTS: There were 2,551 AF patients enrolled in PDPs and 4,502 in MAPD plans before propensity score matching. The propensity score-matched sample included 2,537 patients in each group. OAC use was higher among MAPD beneficiaries (74%-76%) compared with PDP beneficiaries (70%; P < 0.001), and 41%-42% of MAPD beneficiaries were adherent to OACs, compared with 34% of PDP beneficiaries (P < 0.001). In adjusted analyses among propensity score-matched samples, PDP enrollment was associated with lower odds of OAC use (OR = 0.67, 95% CI = 0.56-0.81) and adherence (OR = 0.68, 95% CI = 0.59-0.78) compared with MAPD enrollment. CONCLUSIONS: AF patients enrolled in MAPD plans were more likely to use and adhere to OACs compared with PDP enrollees. These results may reflect the financial incentives of MAPD plans to improve guideline-recommended OAC use, since MAPD insurers bear the risk of pharmacy and medical costs and thus may benefit from cost savings associated with averted stroke events. As efforts to improve use and adherence of OACs in AF patients increase, focus should be given to how insurance benefit designs can affect medication use. DISCLOSURES: No outside funding supported this study. Hernandez has received personal fees from BMS and Pfizer, unrelated to this study. The other authors have nothing to disclose.

Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D

In response to scrutiny over high drug prices, manufacturers of insulin and direct-acting antiviral agents for treating hepatitis C have recently introduced authorized generic alternatives to their patented brand-name products. These authorized generic drugs have list prices at least 50% lower than the list price of the brand-name drugs, which should result in savings to patients. However, it is unclear whether these authorized generic drugs are offered on Medicare Part D formularies because they may not provide savings to plans or Medicare. To assess Medicare Part D formulary coverage for 4 brand-name formulations of insulin and direct-acting antiviral agents and their authorized generic formulations. This cross-sectional study used Medicare Prescription Drug Plan Formulary and Pricing Information Files from quarter 3 of 2020 and Medicare Part D plan enrollment for September 2020. Four patented brand-name drugs (sofosbuvir and velpatasvir fixed-dose combination tablets [Epclusa], ledipasvir and sofosbuvir tablets [Harvoni], insulin lispro [Humalog], and insulin aspart [Novolog]) and their authorized generic formulations for all Part D stand-alone prescription drug plans (n = 959) and Medicare Advantage prescription drug plans (n = 3148) were studied. Beneficiary-weighted formulary coverage of brand-name and authorized generic products; beneficiary out-of-pocket costs; and prerebate plan, manufacturer, and Medicare spending on brand-name and authorized generic products. In quarter 3 of 2020, 97% of beneficiaries were in plans that covered brand-name drugs only or both brand-name and authorized generic drugs; approximately 3% were in plans that covered authorized generic drugs only. Observed authorized generic drug list prices were 67%, 62%, and 50% lower than list prices for Epclusa, Harvoni, and each brand-name insulin product, respectively. Medicare beneficiaries using authorized generic drugs could save $270 per year for 12 vials of Humalog and $2974 for a full course of Harvoni. Plans, however, have limited incentives to encourage authorized generic drug use because rebates for brands likely exceed savings available with authorized generic drugs, particularly for beneficiaries with spending that reaches the Medicare Part D coverage gap. The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.