Medicare Advantage Health Plan Research Articles

Active surveillance pharmacovigilance for Clostridioides difficile infection and gastrointestinal bleeding: an analytic framework based on case-control studies

Active surveillance pharmacovigilance is an emerging approach to identify medications with unanticipated effects. We previously developed a framework called pharmacopeia-wide association studies (PharmWAS) that limits false positive medication associations through high-dimensional confounding adjustment and set enrichment. We aimed to assess the transportability and generalizability of the PharmWAS framework by using medical claims data to reproduce known medication associations with Clostridioides difficile infection (CDI) or gastrointestinal bleeding (GIB). We conducted case-control studies using Optum's de-identified Clinformatics Data Mart Database of individuals enrolled in large commercial and Medicare Advantage health plans in the United States. Individuals with CDI (from 2010 to 2015) or GIB (from 2010 to 2021) were matched to controls by age and sex. We identified all medications utilized prior to diagnosis and analysed the association of each with CDI or GIB using conditional logistic regression adjusted for risk factors for the outcome and a high-dimensional propensity score. For the CDI study, we identified 55,137 cases, 220,543 controls, and 290 medications to analyse. Antibiotics with Gram-negative spectrum, including ciprofloxacin (aOR 2.83), ceftriaxone (aOR 2.65), and levofloxacin (aOR 1.60), were strongly associated. For the GIB study, we identified 450,315 cases, 1,801,260 controls, and 354 medications to analyse. Antiplatelets, anticoagulants, and non-steroidal anti-inflammatory drugs, including ticagrelor (aOR 2.81), naproxen (aOR 1.87), and rivaroxaban (aOR 1.31), were strongly associated. These studies demonstrate the generalizability and transportability of the PharmWAS pharmacovigilance framework. With additional validation, PharmWAS could complement traditional passive surveillance systems to identify medications that unexpectedly provoke or prevent high-impact conditions. U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

An assessment of the association between patient characteristics and timely lung cancer treatment.

Prior data have demonstrated relationships between patient characteristics, the use of surgery to treat lung cancer, and the timeliness of treatment. Our study examines whether these relationships were observable in 2019 in patients with Medicare Advantage health plans being treated for lung cancer. Claims data pertaining to patients with Medicare Advantage health plans who had received radiation therapy (RT) or surgery to treat lung cancer within 90days of diagnostic imaging were extracted. Other databases were used to determine patients' demographics, comorbidities, the urbanicity of their ZIP code, the median income of their ZIP code, and whether their treatment was ordered by a physician at a hospital. Multivariable logistic and Cox Proportional Hazards models were used to assess the association between patient characteristics, receipt of surgery, and time to non-systemic treatment (surgery or RT), respectively. A total of 2,682 patients were included in the analysis. In an adjusted analysis, patients were significantly less likely to receive surgery if their first ordering physician was based in a hospital, if they were older, if they had a history of congestive heart failure (CHF), if they had a history of chronic obstructive pulmonary disease, or if they had stage III lung cancer. Likewise, having stage III cancer was associated with significantly shorter time to treatment. Within a Medicare Advantage population, patient demographics were found to be significantly associated with the decision to pursue surgery, but factors other than stage were not significantly associated with time to non-systemic treatment.

Sex Disparities in Longitudinal Use and Intensification of Guideline-Directed Medical Therapy Among Patients With Newly Diagnosed Heart Failure With Reduced Ejection Fraction.

Guideline-directed medical therapies (GDMTs) are the mainstay of treatment for heart failure with reduced ejection fraction (HFrEF), but they are underused. Whether sex differences exist in the initiation and intensification of GDMT for newly diagnosed HFrEF is not well established. Patients with incident HFrEF were identified from the 2016 to 2020 Optum deidentified Clinformatics Data Mart Database, which is derived from a database of administrative health claims for members of large commercial and Medicare Advantage health plans. The primary outcome was the use of optimal GDMT within 12 months of HFrEF diagnosis. Consistent with the guideline recommendations during the time period of the study, optimal GDMT was defined as ≥50% of the target dose of evidence-based beta-blocker plus ≥50% of the target dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, or any dose of angiotensin receptor neprilysin inhibitor plus any dose of mineralocorticoid receptor antagonist. The probability of achieving optimal GDMT on follow-up and predictors of optimal GDMT were evaluated with time-to-event analysis with adjusted Cox proportional hazard models. The study cohort included 63 759 patients (mean age, 71.3 years; 15.2% non-Hispanic Black race; 56.6% male). Optimal GDMT use was achieved by 6.2% of patients at 12 months after diagnosis. Female (compared with male) patients with HFrEF had lower use across every GDMT class and lower use of optimal GDMT at each time point at follow-up. In an adjusted Cox model, female sex was associated with a 23% lower probability of achieving optimal GDMT after diagnosis (hazard ratio [HR], 0.77 [95% CI, 0.71-0.83]; P<0.001). The sex disparities in GDMT use after HFrEF diagnosis were most pronounced among patients with commercial insurance (females compared with males; HR, 0.66 [95% CI, 0.58-0.76]) compared with Medicare (HR, 0.85 [95% CI, 0.77-0.92]); Pinteraction sex×insurance status=0.005) and for younger patients (age <65 years: HR, 0.65 [95% CI, 0.58-0.74]) compared with older patients (age ≥65 years: HR, 87 [95% CI, 80-96]) Pinteraction sex×age=0.009). Overall use of optimal GDMT after HFrEF diagnosis was low, with significantly lower use among female (compared with male) patients. These findings highlight the need for implementation efforts directed at improving GDMT initiation and titration.

Use of Radiation Therapy for the Treatment of Breast Cancer in 2019 Versus 2020

PurposeThe COVID-19 pandemic disrupted medical care. Little is known about how radiation therapy (RT) ordering behavior changed during the pandemic. This study examined: 1. whether there was a change in the rate at which orders for lumpectomy were followed by orders for RT, and 2. whether there was a change in the percentage of RT orders that were for hypofractionated (HF) RT, rather than conventionally fractionated (CF) RT. Materials and MethodsPrior authorization order data from 2019 and 2020, pertaining to patients with commercial and Medicare Advantage health plans were reviewed to determine whether patients had an order for RT in the 90 days following lumpectomy, and if it was for CF or HF RT. Univariate analyses were conducted using Chi-square tests, and adjusted analyses were conducted using multivariate logistic regression, controlling for patient age, urbanicity, local median income, region, if the lumpectomy facility was academic, and if the lumpectomy facility was a hospital. ResultsIn 2019, 47.7% (2,200/4,610) of included lumpectomy orders were followed by an RT order within 90 days, in contrast to 45.6% (1,944/4,263) in 2020 (P=0.048). Of the RT orders meeting this study's definition of CF or HF, 75.3% (1,387/1,843) of orders placed in 2019 and 79.0% (1,261/1,597) of orders placed in 2020 were for HF (P=0.011). Adjusted analysis found patients receiving a lumpectomy order in the 1st quarter of 2020 had significantly reduced odds (OR: 0.84; 95% CI: 0.71-0.99) of receiving an order for RT following lumpectomy relative to those with orders placed in the 1st quarter of 2019. Adjusted analysis likewise found significant evidence of increased use of HF RT during the pandemic. ConclusionIn the population examined, physicians were less likely to order RT following lumpectomy in 2020 than in 2019, and if they did, were more likely to order HF RT.

Durable Transfusion Independence in Lower-Risk Myelodysplastic Syndrome (LR-MDS) Is Associated with Better Survival: A Population Level Analysis Based on a Large US Health Insurance Claims Database

CONCLUSIONS Red blood cell (RBC) transfusions are commonly used to treat patients with LR-MDS and anemia. RBC transfusion dependence (TD) is an impairment on patients' quality of life and associated with worsened survival (Lemos et al. Sci Rep. 2021). The few approved therapeutic options for LR-MDS have limited efficacy and durability. In this study, the baseline RBC-TD before first-line (1L) and second-line (2L) of therapy, durability of transfusion independence (TI), and associated survival among patients with LR-MDS treated with current standard-of-care therapies were assessed in a large US health insurance claims database. Optum Clinformatics ®, a large single-payer database of administrative health claims for members of large commercial and Medicare Advantage health plans, includes approximately 17-19 million annual covered lives, for a total of &amp;gt;76 million unique lives over a 9-year period. Patients with LR-MDS were identified through 5 relevant International Classification of Diseases, Tenth Revision (ICD-10) diagnosis codes (D46.0, D46.1, D46.9, D46.A, and D46.B) between Oct 2015 and Jun 2022 and were required to have no MDS/acute myeloid leukemia (AML) diagnosis and no use of higher-risk MDS or AML medication before their respective index diagnosis dates. As revised International Prognostic Scoring System or other risk score classification information was not available in the database, ICD-10 diagnosis codes were used as a proxy for the identification of LR-MDS; these codes have been used previously in published studies (Zeidan et al. Leuk Lymphoma. 2019). Lines of treatment were determined based on claims for MDS treatments contained in the database: erythropoietin stimulating agents (ESAs; darbepoetin, epoetin alfa), hypomethylating agents (HMAs; azacitidine, decitabine, decitabine-cedazuridine), lenalidomide, luspatercept, eltrombopag, and cyclosporine. Outcomes of interest included transfusion burden (RBC units [U] in 8 weeks), proportion of patients who were transfusion independent before and after different lines of treatment, time to 8- and 16-week continuous TI, Kaplan-Meier analysis of real-world progression-free survival (starting a next line of treatment, progression to higher-risk MDS or AML, and death were considered events), and overall survival. The analysis included 5662 patients with LR-MDS (median age, 79 years; 57% male; 76% non-Hispanic White, primarily covered by Medicare Advantage) who received ≥1 line of treatment. Overall, 66% and 17% of patients received frontline monotherapy with ESAs and HMAs, respectively. In the 16 weeks before 1L treatment initiation, 35% of patients received ≥1 RBC transfusion. During 1L treatment, 45% of patients received ≥1 RBC transfusion, of whom 49% received &amp;gt;3 U and 24% received &amp;gt;6 U during any 8-week period. 2L treatment consisted of ESA monotherapy (40%), HMA monotherapy (21%), luspatercept (9%), or a combination thereof (19%). In the 16 weeks before 2L treatment initiation, 49% of patients received ≥1 RBC transfusion, and 55% received transfusions during 2L treatment (Table). Among patients receiving ≥1 transfusion during 2L treatment, 61% and 31% had &amp;gt;3 and &amp;gt;6 U/8 weeks, respectively. Transfusion burden was greater for patients with ring sideroblast-positive disease and increased with subsequent lines of therapy. Among 612 patients who received ≥1 transfusion in the 16-week period before 2L, 33% achieved 16-week TI with subsequent therapies. Median real-world progression-free survival from start of 2L was 20.0 months in patients who achieved 16-week TI and 4.1 months in patients who did not ( P &amp;lt; .0001). The median overall survival from start of 2L was 23.4 months overall, and 37.9 months vs 9.3 months among responders becoming RBC-TI vs nonresponders, respectively ( P &amp;lt; .0001; Figure). Among patients with LR-MDS, 35% and 49% were RBC-TD before 1L and 2L of therapy, respectively. Achievement of TI was associated with improved survival, suggesting that RBC-TD is a modifiable predictor of clinical outcomes in LR-MDS. Despite the currently available therapies, RBC-TD after any line of therapy is associated with poorer outcomes. Our study results show that novel therapies that provide durable TI are expected to yield decreased progression and improved survival.

Evaluation of Disparities in Higher-Risk Myelodysplastic Syndromes (HR-MDS) Patient Treatment Patterns in a Large US Health System

BACKGROUND Myelodysplastic syndromes (MDS) are a heterogenous group of myeloid neoplasms. Patients may present with nonspecific signs and symptoms such as fatigue, infections, bleeding, and bruising. Bone marrow aspiration and biopsy are used to confirm diagnosis and are critical in the evaluation of bone marrow cell morphology and cellularity necessary for risk classification. Patients stratified as higher-risk MDS (HR-MDS) have worse overall survival and a higher risk of transformation to acute myeloid leukemia (AML). Treatment of HR-MDS can be challenging. While hypomethylating agents azacitidine and decitabine are the only approved drugs for HR-MDS, there are clinical and translational studies for other treatment approaches. The only curative treatment at present is hematopoietic stem cell transplantation (HSCT), for which only a portion of patients may qualify. This study sought to identify potential missed opportunities in care, including time to diagnosis (Dx) and treatment, by evaluating differences based on underlying sociodemographic and clinical characteristics of newly diagnosed patients with HR-MDS. METHODS This is a retrospective cohort study of commercial and Medicare Advantage health plan members with evidence of newly diagnosed HR-MDS in the Optum Research Database (ORD). Additional Optum datasets were linked to the standard ORD to allow for the inclusion of additional socioeconomic (SES) and social determinants of health (SDoH) variables. The study period was 1 January 2016 to 31 July 2022. Adults with ≥1 inpatient claim for HR-MDS or ≥2 outpatient claims for either MDS or HR-MDS (requiring at least 1 to be HR-MDS) on 2 separate dates between 1 January 2017 and 30 April 2022 were eligible for inclusion. The earliest HR-MDS claim was the index date. A period of 12 months prior to the index date was used to assess baseline characteristics. Patients were followed for at least 3 months post-index until the earliest of AML Dx, death, end of continuous enrollment, or end of the study period. RESULTS The study criteria were met by 1710 patients. Median age at HR-MDS Dx was 77 years, and 40% of patients had baseline Charlson comorbidity score ≥3; 22% had no claim for a bone marrow biopsy or aspiration in the 12 months prior to index or during variable follow-up. Patients were categorized hierarchically based on level of treatment received: HSCT occurred in 4% of patients, 33% had evidence of active treatment, 26% received MDS supportive treatment, and 37% had no treatment in the variable follow-up period. Patients who received HSCT had the lowest Charlson score (mean 1.3), followed by those who received active treatment (mean 2.2), no treatment (mean 2.3), and MDS supportive treatment (mean 2.8). Patients who received active treatment and those who received no treatment appeared to have a similar average age (76 years), similarities in baseline comorbidities (autoimmune conditions, diabetes, and hepatic and renal diseases), and similarities in underlying SDoH and SES characteristics. Male patients made up 58% of the total study population; the prevalence by sex varied within treatment groups where male patients were 64% of the active treatment group but only 54% of the MDS supportive treatment group (Fig. 1a). HSCT patients had the least likelihood of unmet SDoH need, whereas those in MDS supportive care generally had the lowest chance of no unmet need (Fig. 1b). Few patients (7%) had claims indicative of clinical trial participation after index; clinical trial participants were healthier (mean Charlson score 1.9 vs 2.4) and younger (only 37% were aged 75+ vs 64% of non-participants in this age group). Patients not participating in clinical trials were more likely to have unmet financial or housing security and transportation access challenges. White and Asian patients had the highest rates of whole blood transfusions (5.4 and 5.7 per 100 person-months, respectively), while Hispanic patients had the lowest rate (2.5 per 100 person-months). CONCLUSION A large proportion of HR-MDS patients had no evidence of active treatment during the variable follow-up. HSCT and clinical trial participation were low in the study; these patients were younger, had fewer comorbidities, and did not experience financial, housing, or transportation issues. To ensure guideline concordant care, there is a need to further contextualize drivers of treatment in clinical practice, including patients' preferences.

Biomarker testing rates among metastatic cancer patients with receipt of anti-cancer systemic therapy: A real-world data analysis.

550 Background: Biomarker testing to direct individualized therapy options can optimize cancer patient outcomes, particularly for patients with advanced disease. Guideline-recommended molecular testing, comprehensive genomic profiling [CGP] and non-CGP testing, is covered by both Medicare and commercial private insurers (at least non-CGP).. This study examined real-world utilization of biomarker testing among cancer patients with metastatic disease who received anti-cancer systemic therapy. Methods: A retrospective analysis was conducted using de-identified administrative claims data from the Optum Labs Data Warehouse. Adults identified with 1 of 6 advanced cancer types from 1/2018 to 8/2021 were identified; index date was the first claim date for advanced disease. Patients with diagnosis codes indicating only lymph node involvement around the primary cancer were excluded. Continuous enrollment in a commercial (COM) or Medicare Advantage (MA) health plan with both medical and pharmacy benefits was required for 12 months prior to the index date (baseline), and ≥6 months after the index date (follow-up); patients with &lt;6 months follow-up due to death were included. Receipt of anti-cancer systemic therapy during the follow-up was required. Biomarker testing was captured using Current Procedural Terminology (CPT®) codes indicating CGP (&gt; 50 gene panels) or non-CGP (≤50 gene panels or single gene tests) during the study period. Rates of biomarker testing by cancer and insurance type, and receipt of targeted therapy and/ were assessed. Results: Result: There were 27,434 metastatic cancer patients meeting study criteria: 10,320 non-small cell lung (NSCLC), 5,525 breast (BC), 5,429 colorectal (CRC), 2,314 ovarian (OC), 872 gastric (GC) and 2,974 pancreatic (PC) cancer patients. 66% of patients were MA enrollees. The median age was 70 years and ranged from 67 years for BC patients to 71 years for NSCLC and PC patients. The median follow-up was 383 days, ranging from 246 days (for PC patients) to 564 days (for BC patients). Overall biomarker testing rates in the follow-up period were: 47% for NSCLC, 34% BC, 58% CRC, 61% OC, 48% GC, and 47% PC. Testing rates were lower among MA patients compared to COM patients (46% vs 53%). Receipt of targeted/monoclonal antibody therapy was higher (47% vs 33%, p&lt;0.01) among patients with biomarker testing compared to those without. Conclusions: Rates of biomarker testing across metastatic tumor types are far from optimal despite guideline recommendations and insurance coverage for testing, and may affect quality of care. To improve adherence to biomarker testing guidelines, interventions to help overcome obstacles to biomarker testing are needed. Future analysis with this cohort will examine patient management and outcomes by receipt of testing, timing of testing and type of therapy received.

Medicare Advantage enrollment by immigration and English proficiency status.

Complex Medicare Advantage (MA) health plan choices may overwhelm immigrants, especially for those facing decision-making constraints due to limited English proficiency (LEP). We examined the trends and patterns of MA enrollment by immigration and English proficiency status. We employed a cross-sectional design using data from the 2008-2019 Medical Expenditure Panel Survey. Our outcome was enrollment in an MA plan. Our primary independent variables were immigration and English proficiency status. We categorized the sample into 3 groups: LEP immigrants, non-LEP immigrants, and US-born residents. After adjusting for individual-level characteristics, we estimated the adjusted rates of MA enrollment for each group. Our adjusted analysis showed that MA enrollment was higher among immigrants than US-born residents, but the highest enrollment was found among LEP immigrants (LEP immigrants: 45.5%; 95% CI, 42.7%-48.2%; non-LEP immigrants: 42.1%; 95% CI, 39.4%-44.8%; US-born residents: 35.1%; 95% CI, 34.5%-35.6%). MA enrollment was higher among LEP immigrants with better health status (good self-reported health: 45.4%; 95% CI, 41.9%-48.8%; poor self-reported health: 41.4%; 95% CI, 37.7%-45.1%). However, we found small to no differences in the adjusted rates of MA enrollment between those with good vs poor self-reported health in both the non-LEP immigrants and US-born residents groups. We found no consistent enrollment patterns by socioeconomic status such as race/ethnicity, education, and income. Our findings suggest higher MA enrollment among immigrants, especially for LEP immigrants. Future research should study the care experience of immigrants in MA.

An assessment of the association between patient race and prior authorization program determinations in the context of radiation therapy

BackgroundWhen a physician determines that a patient needs radiation therapy (RT), they submit an RT order to a prior authorization program which assesses guideline-concordance. A rule-based clinical decision support system (CDSS) evaluates whether the order is appropriate or potentially non-indicated. If potentially non-indicated, a board-certified oncologist discusses the order with the ordering physician. After discussion, the order is authorized, modified, withdrawn, or recommended for denial. Although patient race is not captured during ordering, bias prior to and during ordering, or during the discussion, may influence outcomes. This study evaluated if associations existed between race and order determinations by the CDSS and by the overall prior authorization program. MethodsRT orders placed in 2019, pertaining to patients with Medicare Advantage health plans from one national organization, were analyzed. The association between race and prior authorization outcomes was examined for RT orders for all cancers, and then separately for breast, lung, and prostate cancers. Analyses controlled for the patient’s age, urbanicity, and the median income in the patient’s ZIP code. Adjusted analyses were conducted on unmatched and racially-matched samples. ResultsOf the 10,145 patients included in the sample, 8,061 (79.5%) were White and 2,084 (20.5%) were Black. Race was not found to have a significant association with CDSS or prior authorization outcomes in any of the analyses. ConclusionsCDSS and prior authorization outcomes suggested similar rates of clinical appropriateness of orders for patients, regardless of race. ImplicationsPrior authorization utilizing rule-based CDSS was capable of enforcing guidelines without introducing racial bias.

Lung Cancer Treatment Trends During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Claims and Order Data Analysis (2019–2021)

IntroductionLung cancer is treated using systemic therapy, radiation therapy (RT), and surgery. This study evaluates how utilization of these modalities and cancer stage at initial treatment shifted from 2019 to 2021. MethodsClaims for lung cancer treatment were extracted from the database of a national health care organization offering Medicare Advantage health plans and paired with enrollment data to determine utilization rates. Seasonally adjusted rates were trended, with monotonicity evaluated using Mann-Kendall tests. Using contemporaneous prior authorization order data, the association between year and the patient’s cancer stage at the time of the initial RT or surgery order was evaluated through univariable and multivariable analyses. ResultsThe study considered 140.9 million beneficiary-months of data. There were negative and significantly monotonic trends in utilization of RT (p = 0.033) and systematic therapy (p = 0.003) for initial treatment between January 2020 and December 2021. Analysis of RT and surgery order data revealed that the patients were significantly (p < 0.001) more likely to have advanced (stage III or IV) cancer at the time of their surgery order in 2020 and 2021 than in 2019. After adjusting for urbanicity, age, and local income, a significant relationship between year of the initial order and presence of advanced cancer at the time of ordering was found for surgery orders placed in 2020 (p < 0.001) and 2021 (p < 0.01), but not for RT orders. ConclusionsThere was a per-capita reduction in lung cancer treatment in 2020 and 2021, and patients receiving initial orders for surgery after the onset of the pandemic had more advanced cancer.

785-P: Comparative Effectiveness of Second-Line Glucose-Lowering Medications—Emulation of a Target Trial Using Real-World Data

The comparative effectiveness of commonly used 2nd-line type 2 diabetes medications with respect to lowering hemoglobin A1c (HbA1c) is unknown, as the GRADE trial did not include a SGLT2 inhibitor arm and was limited to patients with moderately uncontrolled HbA1c. We used claims and laboratory data OptumLabs® Data Warehouse (a de-identified dataset of enrollees in private and Medicare Advantage health plans across the U.S.) between 3/29/13 and 6/30/21 to compare the effectiveness of initiating glimepiride, sitagliptin, liraglutide, canagliflozin, and insulin glargine by adults with type 2 diabetes, treatment-naïve or on metformin monotherapy, with respect to time to HbA1c ≥7.0%. Propensity scores were estimated using the gradient boosting method and inverse propensity score weighting was used to emulate randomization to the treatment groups, which were then compared using Cox proportional hazards regression. Liraglutide initiators had the lowest 1-year cumulative incidence rate of achieving HbA1c ≥7.0% (0.31 [95% CI, 0.27-0.35]) followed by sitagliptin (0.42 [95% CI, 0.40-0.43]), canagliflozin (0.43 [95% CI, 0.40-0.46]), and glimepiride (0.43 [95% CI, 0.42-0.44]); Figure. The glargine arm was excluded due to insufficient control of confounding, reflecting limitations of emulating trials using real-world data if study conditions are not represented in practice. Disclosure Y.Deng: None. E.Polley: None. J.D.Wallach: Consultant; Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC, Other Relationship; Johnson &amp; Johnson, Research Support; NIH - National Institutes of Health, Arnold Ventures. J.Herrin: Consultant; Johnson &amp; Johnson Medical Devices Companies. J.Ross: Research Support; Johnson &amp; Johnson. R.G.Mccoy: Consultant; Emmi. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK114497)

1234-P: Derivation of a Claims-Computable Major Adverse Cardiovascular Event Estimator (ACME) in Adults with Type 2 Diabetes

Major adverse cardiovascular events (MACE) are a major cause of morbidity and mortality among adults with type 2 diabetes. Currently available risk prediction models estimate long-term risk (typically 10-year) and require clinical data not routinely available in real-world data sources, which limit their use on population level. Using de-identified claims data from OptumLabs® Data Warehouse for enrollees in private and Medicare Advantage health plans linked to 100% sample of Medicare fee-for-service beneficiaries between 2014 and 2021, we derived ACME to estimate annualized risk of non-fatal myocardial infarction, non-fatal stroke, or all-cause mortality in patients with type 2 diabetes aged ≥21 years (N=6,623,526). The Cox proportional hazards model, combined with an estimate of the baseline hazard using the Nelson-Aalen estimator to allow conditional survival predictions, included 28 covariates available in claims (age, sex, cardiovascular comorbidities, and cardiovascular medications). The study population had mean age 68.1 (SD, 10.6) years, 49.8% were women, and 73.0% were non-Hispanic White. ACME’s concordance index was 0.74 (se = 0.0002) and it performed comparably in all racial and ethnic groups. Strongest predictors of MACE were acute myocardial infarction and stroke within the past 3 months, heart failure hospitalization within the past year, and end-stage kidney disease. Overall, 4.2% of patients were predicted to have low (&amp;lt;1%) annualized MACE risk, 62.8% were predicted to have moderate (≥1 to &amp;lt;5%) annualized risk, and 33.0% were predicted to have high (≥5%) annualized risk. Other thresholds can be chosen for individualized applications. ACME can support population risk stratification and health management efforts at the health system and payer levels, participant identification for decentralized pragmatic clinical trials of cardiovascular disease and its prevention, and risk-stratified observational studies using real-world data. Disclosure R.G.Mccoy: Consultant; Emmi. G.Umpierrez: Research Support; Abbott, Dexcom, Inc., Baxter. R.J.Galindo: Consultant; Novo Nordisk, Eli Lilly and Company, Sanofi, Pfizer Inc., Bayer Inc., WW (Weight Watchers), Research Support; Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. J.Brito: None. M.Mickelson: None. E.Polley: None. K.Swarna: None. Y.Deng: None. J.Herrin: Consultant; Johnson &amp; Johnson Medical Devices Companies. J.Ross: Research Support; Johnson &amp; Johnson. D.M.Kent: Research Support; W.L. Gore. B.Borah: Consultant; Boehringer Ingelheim Inc., Exact Sciences. W.Crown: Consultant; Janssen Scientific Affairs, LLC, UnitedHealth Group, Viatris Inc. V.M.Montori: None. Funding Patient-Centered Outcomes Research Institute (DB-2020C2-20306)

Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.

There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes. We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials. Information is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned. Studies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.

HSD50 Landscape and Management Strategies of Obesity in Older Adults Enrolled in Humana Medicare Advantage Plans

To describe the characteristics and obesity management approaches of older adults enrolled in nationally representative Medicare Advantage (MA) health plans.

Patient Cost-Sharing and Utilization of Breast Cancer Diagnostic Imaging by Patients Undergoing Subsequent Testing After a Screening Mammogram

Out-of-pocket costs (OOPCs) have been largely eliminated for screening mammography. However, patients still face OOPCs when undergoing subsequent diagnostic tests after the initial screening, which represents a potential barrier to those who require follow-up testing after initial testing. To examine the association between the degree of patient cost-sharing and the use of diagnostic breast cancer imaging after undergoing a screening mammogram. This retrospective cohort study used medical claims from Optum's deidentified Clinformatics Data Mart Database, a commercial claims database derived from a database of administrative health claims for members of large commercial and Medicare Advantage health plans. The large commercially insured cohort included female patients aged 40 years or older with no prior history of breast cancer undergoing a screening mammogram examination. Data were collected from January 1, 2015, to December 31, 2017, and analysis was conducted from January 2021 to September 2022. A k-means clustering machine learning algorithm was used to classify patient insurance plans by dominant cost-sharing mechanism. Plan types were then ranked by OOPCs. A multivariable 2-part hurdle regression model was used to examine the association between patient OOPCs and the number and type of diagnostic breast services undergone by patients observed to undergo subsequent testing. In our sample, 230 845 women (220 023 [95.3%] aged 40 to 64 years; 16 810 [7.3%] Black, 16 398 [7.1%] Hispanic, and 164 702 [71.3%] White) underwent a screening mammogram in 2016. These patients were covered by 22 828 distinct insurance plans associated with 6 025 741 enrollees and 44 911 473 distinct medical claims. Plans dominated by coinsurance were found to have the lowest mean (SD) OOPCs ($945 [$1456]), followed by balanced plans ($1017 [$1386]), plans dominated by copays ($1020 [$1408]), and plans dominated by deductibles ($1186 [$1522]). Women underwent significantly fewer subsequent breast imaging procedures in dominantly copay (24 [95% CI, 11-37] procedures per 1000 women) and dominantly deductible (16 [95% CI, 5-28] procedures per 1000 women) plans compared with coinsurance plans. Patients from all plan types underwent fewer breast magnetic resonance imaging (MRI) scans than patients in the lowest OOPC plan (balanced, 5 [95% CI, 2-12] MRIs per 1000 women; copay, 6 [95% CI, 3-6] MRI per 100 women; deductible, 6 [95% CI, 3-9] MRIs per 1000 women. Despite policies designed to remove financial barriers to access for breast cancer screening, significant financial barriers remain for women at risk of breast cancer.

Use of Radiation Therapy for the Treatment of Breast Cancer in 2019 vs. 2020

Purpose/Objective(s)The COVID-19 pandemic disrupted medical care and reduced access to elective procedures. While prior claims-based research has shown that patients received more conservative care, little is known about how radiation therapy (RT) ordering behavior changed during the pandemic. This study examines whether the rate at which orders for lumpectomy were followed by orders for RT changed from 2019 to 2020, and whether there were changes in the percentage of RT orders that were for hypofractionated (HF) RT, rather than conventional (CF) RT.Materials/MethodsPrior authorization order data pertaining to patients from one national organization's commercial and Medicare Advantage health plans were used to perform the analysis. Included patients were females, aged 18 to 89, who had an order for a lumpectomy in 2019 or 2020. Patients were excluded if they were not continuously enrolled in their health plan for 90 days following lumpectomy. Orders were reviewed to determine whether patients had an order for RT in the 90 days following lumpectomy. Orders were classified as HF if they were for 5 to 21 fractions, CF if they were for 28 or more fractions, and as neither if they were for other numbers of fractions. Univariate analyses were conducted using Chi-square tests, and adjusted analyses were conducted using multivariate logistic regression, controlling for patient age, urbanicity, local median income (<$40,000, $40,000-$80,000, or >$80,000), region (top four CMS regions by enrollment versus all other regions), if the designated lumpectomy facility's name implied an academic affiliation, and if the designated lumpectomy facility was a hospital.ResultsThere were 4,689 patients meeting inclusion criteria in 2019 and 4,383 in 2020, for a total of 9,072. In 2019, 47.1% (2,208/4,689) of patients had an RT order following lumpectomy, versus 44.6% (1,953/4,383) in 2020, a significant difference (P=0.02). Of the patients receiving RT orders meeting the definition of HF or CF, 76.3% (1,475/1,933) of orders in 2019 were for HF, and 80.5% (1,383/1,719) of orders in 2020 were for HF, a significant difference (P<0.01). Adjusted analysis found that patients in 2020 were at significantly reduced odds (OR: 0.91; 95% CI: 0.83-0.99) of receiving an order for RT following lumpectomy, and among orders meeting the definition of HF or CF, there were significantly increased odds that the order was for HF (OR: 1.29; 95% CI: 1.10-1.52). Patient age, region, and receipt of an order for treatment at an academic facility were significantly associated with receipt of an order for RT. Patient age, local median income, and region were all significantly associated with whether CF versus HF RT was ordered.ConclusionIn the population examined, physicians were less likely to order RT following lumpectomy in 2020 than in 2019, and if they did, were more likely to order HF in 2020 than in 2019. This suggests that physician ordering became more conservative in response to the pandemic.

Getting the Most From Payments to Medicare Advantage Health Plans—Thoughts on the Controversy

Getting the Most From Payments to Medicare Advantage Health Plans—Thoughts on the Controversy

The Association Between the Use of Low-Slice Computed Tomography Machines and Downstream Care: Comparative Study of 16-Slice and 64-Slice Computed Tomography Angiography.

BackgroundAlthough computed tomography (CT) studies on machines with more slices have reported higher positive and negative predictive values, the impact of using low-slice (16-slice) CT machines on downstream testing has not been well studied. In community outpatient settings, low-slice CT machines remain in use, although many hospitals have adopted higher-slice machines.ObjectiveThis study examines the association between the use of low-slice CT machines and downstream invasive testing in the context of the CT angiography of the neck.MethodsIncluded health insurance claims pertained to adults with commercial or Medicare Advantage health plans who underwent the CT angiography of the neck. Site certification data were used to assign counts of slices to claims. Claims that were made in the 60 days after CT were examined for cervicocerebral angiography. The association between the number of slices and cervicocerebral angiography was evaluated by using a chi-square test and multivariate logistic regression.ResultsClaims for 16-slice CT had a 5.1% (33/641) downstream cervicocerebral angiography rate, while claims for 64-slice CT had a 3.1% (35/1125) rate, and a significant difference (P=.03) was observed. An analysis that was adjusted for patient demographics also found a significant relationship (odds ratio 1.64, 95% CI 1.00-2.69; P=.047).ConclusionsThe use of low-slice CT machines in the community may impact the quality of care and result in more downstream testing.

Skeletal muscle relaxant drug-drug-drug interactions and unintentional traumatic injury: Screening to detect three-way drug interaction signals.

The aim of this study was to identify skeletal muscle relaxant (SMR) drug-drug-drug interaction (3DI) signals associated with increased rates of unintentional traumatic injury. We conducted automated high-throughput pharmacoepidemiologic screening of 2000-2019 healthcare data for members of United States commercial and Medicare Advantage health plans. We performed a self-controlled case series study for each drug triad consisting of an SMR base-pair (i.e., concomitant use of an SMR with another medication), and a co-dispensed medication (i.e., candidate interacting precipitant) taken during ongoing use of the base-pair. We included patients aged ≥16 years with an injury occurring during base-pair-exposed observation time. We used conditional Poisson regression to calculate adjusted rate ratios (RRs) with 95% confidence intervals (CIs) for injury with each SMR base-pair + candidate interacting precipitant (i.e., triad) versus the SMR-containing base-pair alone. Among 58 478 triads, 29 were significantly positively associated with injury; confounder-adjusted RRs ranged from 1.39 (95% CI = 1.01-1.91) for tizanidine + omeprazole with gabapentin to 2.23 (95% CI = 1.02-4.87) for tizanidine + diclofenac with alprazolam. Most identified 3DI signals are new and have not been formally investigated. We identified 29 SMR 3DI signals associated with increased rates of injury. Future aetiologic studies should confirm or refute these SMR 3DI signals.

Racial disparities in stage 3 lung cancer treatment.

e18574 Background: In the 1990s, it was demonstrated that Black patients were less likely to receive timely treatment for Stage 3 lung cancer than White patients. While contemporary work has found racial disparities in accessing insurance, diagnostics, and treatments, we wished to explore whether patients faced disparities once in treatment. To do this, we examined whether racial disparities were observable in a 2019 cohort of Medicare Advantage beneficiaries receiving treatment for lung cancer. Methods: This retrospective, observational study used health plan claims data to identify Black and White patients aged 18 to 89 years with a Medicare Advantage health plan in calendar year 2019 who received diagnostic imaging (computed tomography or positron emission tomography) followed by lung cancer treatment (radiation therapy [RT] or surgery claims mentioning a diagnosis of lung cancer) within 90 days. Only patients treated in 2019 were considered so that the findings would reflect the state of care immediately preceding the COVID-19 pandemic. Patients were excluded if they had a history of RT or lung surgery in the year prior to the diagnostic imaging date. Other databases were used to determine cancer stage, patient demographics, comorbidities, the urbanicity and median income of patients’ home ZIP code, and whether treatment was ordered by a hospital-based physician. A multivariate logistic model was used to examine the association between race and surgery, and a multivariate negative binomial model was used to examine the association between race and days to treatment (surgery or RT). Results: We identified 823 patients, 83.8% White (690), and 16.2% (133) Black. Surgery was received by 3.1% [4/133] of Black patients and 9.7% [61/690]) of White patients. Black patients received treatment on average 36.9 days after diagnosis, versus 35.1 days for White patients. Adjusted analysis did not find a significant association between race and receipt of surgery (P = 0.07) or race and days to treatment (P = 0.77). No covariate was significantly associated with receipt of surgery. Residence in a state with a higher obesity rate was associated with fewer days to treatment (P = 0.02). Conclusions: In a uniformly insured population that successfully received treatment, adjusted analysis found no evidence of a Black / White racial disparity in use of lung surgery for Stage 3 lung cancer or in timeliness of treatment. Given the directionality of the findings, they could potentially have been significant if the sample size had been increased by extending the enrollment period. The implication of these findings is that it may be most fruitful to address racial disparities at the frontend of the care process; working to ensure that patients have access to insurance, diagnostics, and treatments, as disparities were not observed in a population that had accessed treatment. Further research is needed to assess whether racial disparities in lung cancer treatment have dissipated over time.