The Effect of Medicare Annual Wellness Visits on Breast Cancer Screening and Diagnosis.

OBJECTIVE: The Medicare Annual Wellness Visit (AWV)-a prevention-focused annual check-up-has been available to beneficiaries with Part B coverage since 2011. The objective of this study was to estimate the effect of Medicare AWVs on breast cancer screening and diagnosis. DATA SOURCES AND STUDY SETTING: The National Cancer Institute's Surveillance, Epidemiology, and End Results cancer registry data linked to Medicare claims (SEER-Medicare), HRSA's Area Health Resources Files, the FDA's Mammography Facilities database, and CMS "Mapping Medicare Disparities" utilization data from 2013 to 2015. STUDY DESIGN: Using an instrumental variables approach, we estimated the effect of AWV utilization on breast cancer screening and diagnosis, using county Welcome to Medicare Visit (WMV) rates as the instrument. DATA COLLECTION/EXTRACTION METHODS: 66,088 person-year observations from 49,769 unique female beneficiaries. PRINCIPAL FINDINGS: For every 1-percentage point increase in county WMV rate, the probability of AWV increased by 1.7 percentage points. Having an AWV was associated with a 22.4-percentage point increase in the probability of receiving a screening mammogram within 6 months ( P <0.001). There was no statistically significant increase in the probability of breast cancer diagnosis (overall or early stage) within 6 months of an AWV. Findings were robust to multiple model specifications. CONCLUSIONS: Performing routine cancer screening is an evidence-based practice for diagnosing earlier-stage, more treatable cancers. The AWV effectively increases breast cancer screening and may lead to more timely screening. Continued investment in Annual Wellness Visits supports breast cancer screening completion by women who are most likely to benefit, thus reducing the risk of overscreening and overdiagnosis.

Impact of the Affordable Care Act on access to accredited facilities for cancer treatment.

OBJECTIVE: To examine differential changes in receipt of surgery at National Cancer Institute (NCI)-designated comprehensive cancer centers (NCI-CCC) and Commission on Cancer (CoC) accredited hospitals for patients with cancer more likely to be newly eligible for coverage under Affordable Care Act (ACA) insurance expansions, relative to those less likely to have been impacted by the ACA. DATA SOURCES AND STUDY SETTING: Pennsylvania Cancer Registry (PCR) for 2010-2019 linked with discharge records from the Pennsylvania Health Care Cost Containment Council (PHC4). STUDY DESIGN: Outcomes include whether cancer surgery was performed at an NCI-CCC or a CoC-accredited hospital. We conducted a difference-in-differences analysis, estimating linear probability models for each outcome that control for residence in a county with above median county-level pre-ACA uninsurance and the interaction between county-level baseline uninsurance and cancer treatment post-ACA to capture differential changes in access between those more and less likely to become newly eligible for insurance coverage (based on area-level proxy). All models control for age, sex, race and ethnicity, cancer site and stage, census-tract level urban/rural residence, Area Deprivation Index, and year- and county-fixed effects. DATA COLLECTION/EXTRACTION METHODS: We identified adults aged 26-64 in PCR with prostate, lung, or colorectal cancer who received cancer-directed surgery and had a corresponding surgery discharge record in PHC4. PRINCIPAL FINDINGS: We observe a differential increase in receiving care at an NCI-CCC of 6.2 percentage points (95% CI: 2.6-9.8; baseline mean = 9.8%) among patients in high baseline uninsurance areas (p = 0.001). Our estimate of the differential change in care at the larger set of CoC hospitals is positive (3.9 percentage points [95% CI: -0.5-8.2; baseline mean = 73.7%]) but not statistically significant (p = 0.079). CONCLUSIONS: Our findings suggest that insurance expansions under the ACA were associated with increased access to NCI-CCCs.

Cancer diagnosis and treatment in working-age adults: Implications for employment, health insurance coverage, and financial hardship in the United States.

The rising costs of cancer care and subsequent medical financial hardship for cancer survivors and families are well documented in the United States. Less attention has been paid to employment disruptions and loss of household income after a cancer diagnosis and during treatment, potentially resulting in lasting financial hardship, particularly for working-age adults not yet age-eligible for Medicare coverage and their families. In this article, the authors use a composite patient case to illustrate the adverse consequences of cancer diagnosis and treatment for employment, health insurance coverage, household income, and other aspects of financial hardship. They summarize existing research and provide nationally representative estimates of multiple aspects of financial hardship and health insurance coverage, benefit design, and employee benefits, such as paid sick leave, among working-age adults with a history of cancer and compare them with estimates among working-age adults without a history of cancer from the most recently available years of the National Health Interview Survey (2019-2021). Then, the authors identify opportunities for addressing employment and health insurance coverage challenges at multiple levels, including federal, state, and local policies; employers; cancer care delivery organizations; and nonprofit organizations. These efforts, when informed by research to identify best practices, can potentially help mitigate the financial hardship associated with cancer.

Association of Traditional and Nontraditional Risk Factors in the Development of Strokes Among Young Adults by Sex and Age Group: A Retrospective Case-Control Study.

BACKGROUND: Despite women having fewer traditional risk factors (eg, hypertension, diabetes), strokes are more common in women than men aged ≤45 years. This study examined the contributions of traditional and nontraditional risk factors (eg, migraine, thrombophilia) in the development of strokes among young adults. METHODS: This retrospective case-control study used Colorado's All Payer Claims Database (2012-2019). We identified index stroke events in young adults (aged 18-55 years), matched 1:3 to stroke-free controls, by (1) sex, (2) age±2 years, (3) insurance type, and (4) prestroke period. All traditional and nontraditional risk factors were identified from enrollment until a stroke or proxy-stroke date (defined as the prestroke period). Conditional logistic regression models stratified by sex and age group first assessed the association of stroke with counts of risk factors by type and then computed their individual and aggregated population attributable risks. RESULTS: We included 2618 cases (52% women; 73.3% ischemic strokes) and 7827 controls. Each additional traditional and nontraditional risk factors were associated with an increased risk of stroke in all sex and age groups. In adults aged 18 to 34 years, more strokes were associated with nontraditional (population attributable risk: 31.4% men and 42.7% women) than traditional risk factors (25.3% men and 33.3% women). The contribution of nontraditional risk factors declined with age (19.4% men and 27.9% women aged 45-55 years). The contribution of traditional risk factors peaked among patients aged 35 to 44 years (32.8% men and 39.7% women). Hypertension was the most important traditional risk factor and increased in contribution with age (population attributable risk: 27.8% men and 26.7% women aged 45 to 55 years). Migraine was the most important nontraditional risk factor and decreased in contribution with age (population attributable risk: 20.1% men and 34.5% women aged 18-35 years). CONCLUSIONS: Nontraditional risk factors were as important as traditional risk factors in the development of strokes for both young men and women and have a stronger association with the development of strokes in adults younger than 35 years of age.

Much work to do about measuring work.

Work ability is a critical economic and well-being indicator in cancer care. Yet, work ability is understudied in clinical trials and observational research and is often undocumented in medical records. Despite agreement on the importance of work from well-being, health insurance, and financial perspectives, standardized approaches for collecting, measuring, and analyzing work outcomes are lacking in the health-care setting. The necessary components for closing the gap in patient and caregiver employment research in health-care settings involve a common set of measures, including those that replace or translate generic measures of mental and physical functioning into work outcomes in observational and clinical trial research, standardized approaches to data collection and documentation, and the use of longitudinal data to understand the consequences of reduced work ability over time. We present a conceptual framework for the inclusion of work ability in outcomes research. We cover constructs for employment and work ability measurement that can be adopted in research, recorded as patient-level data, and used to guide treatment decisions. The inclusion of return to work and hours worked, productivity, and ability to perform in a similar job can support conversations that guide treatment decisions and minimize economic consequences. Our hope is that by considering impact on work ability, improved treatments will be developed, health inequities reduced, and resources directed toward aiding patients and their caregivers in balancing work and health demands.

Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane + anthracycline versus taxane-based chemotherapy regimens: A SEER-medicare study.

BACKGROUND: Triple-negative breast cancer (TNBC) is more aggressive as compared to other subtypes of breast cancer with characteristic metastatic patterns and a poor prognosis. The standard of care for early-stage TNBC is historically anthracycline and taxane-based chemotherapy (ATAX). Despite the effectiveness of this regimen, anthracyclines carry a small but important risk of cardiotoxicity, which is specifically a concern in the older population. This study evaluates major adverse cardiovascular events (MACE) in older women with TNBC treated with ATAX compared to taxane-based chemotherapy (TAX). METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we identified women aged 66 and older with TNBC diagnosed between 2010 and 2015 (N = 2215). We compared patient and clinical characteristics according to adjuvant chemotherapy regimen (chemotherapy versus no chemotherapy and ATAX versus TAX). Logistic regression was performed to estimate the odds ratios (OR) and 95% confidence intervals (CIs), Kaplan-Meier survival curves were generated to estimate three-year overall survival (OS) and cancer specific survival (CSS). Cox proportional hazards models were used to analyze OS and CSS while controlling for patient and tumor characteristics. MACE was defined as acute myocardial infarction, heart failure, potentially fatal arrhythmia, and cerebral vascular incidence. Few patients experienced a cardiac death and therefore this was excluded in the analysis. RESULTS: Of the 2215 patients in our cohort, most patients (n = 1334; 60.26%) received TAX compared to ATAX (n = 881; 39.78%). Patients who received ATAX were not statistically significantly more likely than those who received TAX to experience acute myocardial infarction, cerebral vascular accident (CVA), or potentially fatal arrhythmia when controlling for traditional risk factors. Among patients who experienced MACE, there was no difference in OS or CSS in patients who received TAX vs ATAX. Patients who received ATAX were less likely to develop heart failure than those who received TAX (OR 0.63, 95% CI [0.45-0.88], p < 0.01). Patients who developed MACE and who were > 76 years old had worse OS compared to those who experienced MACE and were age 66-75 years old (HR 1.67, 95% CI [1.07-2.62], p = 0.02). CONCLUSION: Among older women with TNBC, receipt of adjuvant chemotherapy with ATAX was not associated with increased risk of major adverse cardiac events. For those who experienced a cardiac event, there was no difference in survival amongst those who received TAX vs ATAX. Other factors including additional chemotherapy toxicities should be investigated as a potential etiology for the inferior OS previously observed with ATAX vs TAX in older women with node negative or 1-3 positive lymph nodes.

Implementation science for cancer control: One center's experience addressing context, adaptation, equity, and sustainment.

Implementation science (IS) has great potential to enhance the frequency, speed, and quality of the translation of evidence-based programs, policies, products, and guidelines into practice. Progress has been made, but with some notable exceptions, this promise has not been achieved for cancer prevention and control. We discuss five interrelated but conceptually distinct, crosscutting issues important to accelerate IS for cancer prevention and control and how our Colorado Implementation Science Center in Cancer Control (COISC3) addressed these issues. These needs and opportunities include more fully addressing changing, multi-level context; guiding rapid, iterative adaptations; evaluating innovative approaches to engagement and health equity; greater attention to costs and economic issues; and sustainability. We summarize conceptual issues; evaluation needs and capacity building activities and then provide examples of how our IS center addressed these five needs for cancer prevention and control. We discuss changes made to address priorities of (i) guiding adaptations of implementation strategies to address changing context and (ii) working on issues identified and prioritized by our primary care partners rather than the research team. We conclude with discussion of lessons learned, limitations, and directions for future research and practice in IS to enhance cancer prevention and control as well as translational behavioral medicine more generally.

Implementation science (IS) has made advances in translating research to practice but has not achieved the initial promise for cancer prevention and control (CPC). We discuss five crosscutting issues to enhance CPC that implementation and behavioral science are well positioned to address. These include more fully addressing changing, multi-level context; guiding rapid, iterative program adaptations; innovative approaches to engagement and health equity; greater attention to costs and economic issues; and sustainability. We then detail changes made in our research approach from studying specific interventions and strategies from the research literature to working on issues identified and prioritized by our primary care partners. In summary, progress in achieving lasting equitable improvements in health and healthcare will be greatly aided by use of flexible, accessible conceptual models, and approaches that help guide collaborators to design and adapt programs. We conclude with discussion of lessons learned, limitations, and directions for future research and practice of translational behavioral medicine.

Building Data Infrastructure for Disease-Focused Health Economics Research.

BACKGROUND: Data infrastructure for cancer research is centered on registries that are often augmented with payer or hospital discharge databases, but these linkages are limited. A recent alternative in some states is to augment registry data with All-Payer Claims Databases (APCDs). These linkages capture patient-centered economic outcomes, including those driven by insurance and influence health equity, and can serve as a prototype for health economics research. OBJECTIVES: To describe and assess the utility of a linkage between the Colorado APCD and Colorado Central Cancer Registry (CCCR) data for 2012-2017. RESEARCH DESIGN, PARTICIPANTS, AND MEASURES: This cohort study of 91,883 insured patients evaluated the Colorado APCD-CCCR linkage on its suitability to assess demographics, area-level data, insurance, and out-of-pocket expenses 3 and 6 months after cancer diagnosis. RESULTS: The linkage had high validity, with over 90% of patients in the CCCR linked to the APCD, but gaps in APCD health plans limited available claims at diagnosis. We highlight the advantages of the CCCR-APCD, such as granular race and ethnicity classification, area-level data, the ability to capture supplemental plans, medical and pharmacy out-of-pocket expenses, and transitions in insurance plans. CONCLUSIONS: Linked data between registries and APCDs can be a cornerstone of a robust data infrastructure and spur innovations in health economics research on cost, quality, and outcomes. A larger infrastructure could comprise a network of state APCDs that maintain linkages for research and surveillance.

Assessing characteristics of populations seen at Commission on Cancer facilities using Pennsylvania linked data.

Commission on Cancer (CoC) accreditation certifies facilities provide quality care. We assessed differences among patients who do and do not visit CoC facilities using Pennsylvania Cancer Registry data linked to facility records for patients diagnosed with cancer between 2018 and 2019 (n = 87 472). Predicted probabilities from multivariable logistic regression indicated patients in the most advantaged Area Deprivation Index quartiles were more likely to visit CoC facilities (78.0%, 95% confidence interval [CI] = 77.5% to 78.6%) compared with other quartiles. Urban patients (74.1%, 95% CI = 73.8% to 74.4%) were more likely than rural to be seen at a CoC facility (62.7%, 95% CI = 61.2% to 64.2%) as were Hispanic patients (88.0%, 95% CI = 86.7% to 89.3%) and non-Hispanic Black patients (79.1%, 95% CI = 78.1% to 80.0%) compared with White patients (72.0%, 95% CI = 71.7% to 72.4%). Differences in demographics suggest CoC data may underrepresent some groups, including low-income and rural patients.

Instrumental variable analysis for cost outcome: Application to the effect of primary care visit on medical cost among low-income adults.

Medical cost data often consist of zero values as well as extremely right-skewed positive values. A two-part model is a popular choice for analyzing medical cost data, where the first part models the probability of a positive cost using logistic regression and the second part models the positive cost using a lognormal or Gamma distribution. To address the unmeasured confounding in studies on cost outcome under two-part models, two instrumental variable (IV) methods, two-stage residual inclusion (2SRI) and two-stage prediction substitution (2SPS) are widely applied. However, previous literature demonstrated that both the 2SRI and the 2SPS could fail to consistently estimate the causal effect among compliers under standard IV assumptions for binary and survival outcomes. Our simulation studies confirmed that it continued to be the case for a two-part model, which is another nonlinear model. In this article, we develop a model-based IV approach, Instrumental Variable with Two-Part model (IV2P), to obtain a consistent estimate of the causal effect among compliers for cost outcome under standard IV assumptions. In addition, we develop sensitivity analysis approaches to allow the evaluation of the sensitivity of the causal conclusions to potential quantified violations of the exclusion restriction assumption and the randomization of IV assumption. We apply our method to a randomized cash incentive study to evaluate the effect of a primary care visit on medical cost among low-income adults newly covered by a primary care program.

Comparison of primary payer in cancer registry and discharge data.

OBJECTIVES: To determine agreement between variables capturing the primary payer at cancer diagnosis across the Pennsylvania Cancer Registry (PCR) and statewide facility discharge records (Pennsylvania Health Care Cost Containment Council [PHC4]) for adults younger than 65 years, and to specifically examine factors associated with misclassification of Medicaid status in the registry given the role of managed care. STUDY DESIGN: Cross-sectional analysis of the primary cancer cases among adults aged 21 to 64 years in the PCR from 2010 to 2016 linked to the PHC4 facility visit records. METHODS: We assessed agreement of payer at diagnosis (Medicare, Medicaid, private, other, uninsured, unknown) across data sources, including positive predictive value (PPV) and sensitivity, using the PHC4 records as the gold standard. The probability of misclassifying Medicaid in registry was estimated using multivariate logit models. RESULTS: Agreement of payers was high for private insurance (PPV, 89.7%; sensitivity, 83.6%), but there was misclassification and/or underreporting of Medicaid in the registry (PPV, 80%; sensitivity, 58%). Among cases with "other" and "unknown" insurance, 73.8% and 62.1%, respectively, had private insurance according to the PHC4 records. Medicaid managed care was associated with a statistically significant increase of 12.6 percentage points (95% CI, 9.4-15.8) in the probability of misclassifying Medicaid enrollment as private insurance in the registry. CONCLUSIONS: Findings suggest caution in conducting and interpreting research using insurance variables in cancer registries.

Access To Oncology Services In Rural Areas: Influence Of The 340B Drug Pricing Program.

Rural-urban cancer disparities, including greater mortality rates, are partially attributable to the limited availability of oncology services in rural communities. Without these services, rural residents may experience delays in timely treatment and may be less likely to complete recommended care. The 340B Drug Pricing Program allows eligible not-for-profit and public hospitals to purchase covered outpatient drugs, including high-cost oncology drugs, at discounted prices. Using 2011-20 data, we evaluated the relationship between new enrollment in the 340B program and oncology services initiation in rural general acute care hospitals that lacked oncology services in 2011. Compared with hospitals that remained unenrolled in the 340B program through 2020, hospitals that enrolled during 2012-18 were 8.3 percentage points more likely to have added oncology services as of 2020. The newly participating hospitals that added oncology services were disproportionately located in Medicaid expansion states and in counties with lower uninsurance rates. These findings suggest that the 340B program facilitates expanded access to oncology services in some rural communities, but opportunities remain to address disparities in the most disadvantaged service areas.

Treatment Disparities in Radiation and Hormone Therapy Among Women Covered by Medicaid vs Private Insurance in Cancer Registry and Claims Data.

Importance: Prior research has reported undertreatment among patients with cancer who are insured by Medicaid, but this finding may be due, in part, to incomplete data in cancer registries. Objective: To compare disparities in radiation and hormone therapy between women with breast cancer covered by Medicaid and those with private insurance using the Colorado Central Cancer Registry (CCCR) and CCCR data supplemented with All Payer Claims Data (APCD). Design, Setting, and Participants: This observational cohort study included women aged 21 to 63 years who received breast cancer surgery. We linked the CCCR and Colorado APCD to identify Medicaid and privately insured women who were newly diagnosed with invasive, nonmetastatic breast cancer between January 1, 2012, and December 31, 2017. In the radiation treatment analysis, we narrowed the sample to women who received breast-conserving surgery (Medicaid, n = 1408; private, n = 1984) and in the hormone therapy analysis, we selected women who were hormone-receptor positive (Medicaid, n = 1156; private, n = 1667). Main Outcomes and Measures: We used logistic regression to estimate the likelihood of treatment within 12 months to assess whether the results varied between data sources. Results: There were 3392 and 2823 participants in the radiation and hormone therapy cohorts, respectively. The mean (SD) age was 51.71 (8.30) years in the radiation therapy cohort, and 52.00 (8.16) years in the hormone therapy cohort. Among the participants, there were 140 (4%) and 105 (4%) who were Black non-Hispanic, 499 (15%) and 406 (14%) who were Hispanic, 2602 (77%) and 2190 (78%) were White, and 151 (4%) and 122 (4%) were other/unknown in the radiation and hormone therapy cohorts, respectively. A higher percentage of women were aged 50 years or younger in the Medicaid samples (40% vs 34% in the privately insured sample) and identified as non-Hispanic Black (about 7%) or Hispanic (approximately 24%). Treatment was underreported in both sources, but to a lesser extent in the APCD (2.5% and 2.0% for Medicaid and private insurance, respectively) compared with CCCR (19.5% and 13.3% for Medicaid and private insurance, respectively). Using CCCR data, Women with Medicaid insurance were 4 (95% CI, -8 to -1; P = .02) and 10 (95% CI, -14 to -6; P < .001) percentage points less likely to have a record of radiation and hormone therapy compared with privately insured women, respectively. Using combined CCCR and APCD, no statistically significant disparity was observed in radiation or hormone therapy between Medicaid-insured and privately insured women. Conclusions and Relevance: Among women with breast cancer covered by Medicaid vs private insurance, cancer treatment disparities may be overestimated if based solely on cancer registry data.