Clinical Value of Timely Targeted Therapy for Patients With Advanced Non-Small Cell Lung Cancer With Actionable Driver Oncogenes.

BACKGROUND: A recent real-world study observed that 24% of patients with advanced non-small cell lung cancer (aNSCLC) with actionable driver oncogenes (ADOs) initiated nontargeted therapies before biomarker test results became available. This study assessed the clinical impact of the timing of first-line (1L) targeted therapies (TTs) in aNSCLC. MATERIALS AND METHODS: This retrospective analysis of a nationwide electronic health record-derived deidentified database included patients aged ≥18 years diagnosed with aNSCLC with ADOs (ALK, BRAF, EGFR, RET, MET, ROS-1, and NTRK) from January 1, 2015, to October 18, 2022, by biomarker testing within 90 days after advanced diagnosis and received 1L treatment. Cohorts were defined by treatment patterns ≤42 days after test results: "Upfront TT" received 1L TT ≤42 days; "Switchers" initiated 1L non-TT before or after testing but switched to TT ≤42 days; and "Non-switchers" initiated non-TT before or after testing and did not switch at any time. Adjusted multivariate Cox regression evaluated real-world progression-free survival, real-world time to next treatment or death, and real-world overall survival. RESULTS: A total of 3540 patients met the study criteria; 78% were treated in a community setting, and 50% underwent next-generation sequencing (NGS). There was no significant difference in outcomes between Switchers and Upfront TT; inferior outcomes were observed in Non-switchers versus Upfront TT. CONCLUSION: Our findings demonstrated improved outcomes with upfront 1L TT versus non-TT in patients with aNSCLC with ADOs and observed timely switching to TT after biomarker test result had similar outcomes to Upfront TT. Opportunities remain to improve the use of NGS for early ADO identification and determination of 1L TT.

Estimating the US Baseline Distribution of Health Inequalities Across Race, Ethnicity, and Geography for Equity-Informative Cost-Effectiveness Analysis.

OBJECTIVES: Information on how life expectancy, disability-free life expectancy, and quality-adjusted life expectancy varies across equity-relevant subgroups is required to conduct distributional cost-effectiveness analysis. These summary measures are not comprehensively available in the United States, given limitations in nationally representative data across racial and ethnic groups. METHODS: Through linkage of US national survey data sets and use of Bayesian models to address missing and suppressed mortality data, we estimate health outcomes across 5 racial and ethnic subgroups (non-Hispanic American Indian or Alaska Native, non-Hispanic Asian and Pacific Islander, non-Hispanic black, non-Hispanic white, and Hispanic). Mortality, disability, and social determinant of health data were combined to estimate sex- and age-based outcomes for equity-relevant subgroups based on race and ethnicity, as well as county-level social vulnerability. RESULTS: Life expectancy, disability-free life expectancy, and quality-adjusted life expectancy at birth declined from 79.5, 69.4, and 64.3 years, respectively, among the 20% least socially vulnerable (best-off) counties to 76.8, 63.6, and 61.1 years, respectively, among the 20% most socially vulnerable (worst-off) counties. Considering differences across racial and ethnic subgroups, as well as geography, gaps between the best-off (Asian and Pacific Islander; 20% least socially vulnerable counties) and worst-off (American Indian/Alaska Native; 20% most socially vulnerable counties) subgroups were large (17.6 life-years, 20.9 disability-free life-years, and 18.0 quality-adjusted life-years) and increased with age. CONCLUSIONS: Existing disparities in health across geographies and racial and ethnic subgroups may lead to distributional differences in the impact of health interventions. Data from this study support routine estimation of equity effects in healthcare decision making, including distributional cost-effectiveness analysis.

The Impact of Funding Inpatient Treatments for COVID-19 on Health Equity in the United States: A Distributional Cost-Effectiveness Analysis.

OBJECTIVES: We conducted a distributional cost-effectiveness analysis (DCEA) to evaluate how Medicare funding of inpatient COVID-19 treatments affected health equity in the United States. METHODS: A DCEA, based on an existing cost-effectiveness analysis model, was conducted from the perspective of a single US payer, Medicare. The US population was divided based on race and ethnicity (Hispanic, non-Hispanic black, and non-Hispanic white) and county-level social vulnerability index (5 quintile groups) into 15 equity-relevant subgroups. The baseline distribution of quality-adjusted life expectancy was estimated across the equity subgroups. Opportunity costs were estimated by converting total spend on COVID-19 inpatient treatments into health losses, expressed as quality-adjusted life-years (QALYs), using base-case assumptions of an opportunity cost threshold of $150 000 per QALY gained and an equal distribution of opportunity costs across equity-relevant subgroups. RESULTS: More socially vulnerable populations received larger per capita health benefits due to higher COVID-19 incidence and baseline in-hospital mortality. The total direct medical cost of inpatient COVID-19 interventions in the United States in 2020 was estimated at $25.83 billion with an estimated net benefit of 735 569 QALYs after adjusting for opportunity costs. Funding inpatient COVID-19 treatment reduced the population-level burden of health inequality by 0.234%. Conclusions remained robust across scenario and sensitivity analyses. CONCLUSIONS: To the best of our knowledge, this is the first DCEA to quantify the equity implications of funding COVID-19 treatments in the United States. Medicare funding of COVID-19 treatments in the United States could improve overall health while reducing existing health inequalities.

The impact of severe obesity on home health care agency admission: An organizational perspective.

Home health care is a growing treatment option for older adults who wish to remain in their homes and communities. However, the growing number of older adults with severe obesity presents a challenge for home health professionals. This study utilizes survey data from 128 home health care agencies in Arkansas and Pennsylvania to explore home health care agencies' decision-making in admitting patients with severe obesity. The responding agencies indicated that concerns about adequate staffing levels were the primary barriers to entry for severe obesity patients. Existing research on the intersection of obesity and home health care is sparse, and this study adds an organizational perspective to the scant literature on the topic. Additional research on this topic is advised to accommodate the expected growth in home health care utilization and rising obesity rates among older adults.

The mental health burden of food allergies: Insights from patients and their caregivers from the Food Allergy Research & Education (FARE) Patient Registry.

Background: Food allergies impose a large psychosocial burden, including mental, emotional, and social aspects, on both patients and their caregivers. Patients, caregivers, and their families often experience anxiety, isolation, and fear around food allergies. Objective: To assess the real-world mental health burden of food allergies, using the Food Allergy Research & Education (FARE) Patient Registry (NCT04653324). Methods: Self-reported data from patients with food allergies, and their caregivers, were analyzed from the FARE Food Allergy History and Mental Health Concerns surveys. Odds ratios were also calculated as a measure of association between patient food allergy characteristics and the likelihood of having mental health concerns or a formal mental health diagnosis. Results: The FARE Patient Registry included 1680 patients/caregivers. Anxiety (54%) and panic (32%) were the most common emotions that patients reported as a result of eating the food that produced an allergic reaction. About two-thirds of patients reported mental health concerns related to food allergies (62%), including anxiety after an allergic reaction, anxiety about living with food allergies, and concerns about food avoidance. Caregivers also experienced fear for the safety of their children, and often sought mental health care to cope with worry related to caring for patients with food allergies. The likelihood of having food allergy-related mental health concerns was increased for patients experiencing more than 1 reaction per year (OR 1.68-1.90) and was lowered for patients having a formal mental health diagnosis (OR 0.43). Caregivers filling out the FARE survey for pediatric patients (OR 4.03) and experiencing food allergy-related mental health concerns (OR 2.36) were both significant predictors for having a formal mental health diagnosis. Conclusion: Our study highlights a continuing unmet need for mental health screening and support as part of the management of patients with food allergies.

The clinical burden of food allergies: Insights from the Food Allergy Research & Education (FARE) Patient Registry.

Background: Food allergies are serious and potentially life-threatening, and often place a large burden on patients and their caregivers, including impacts on quality of life. Objective: To assess the real-world patient burden of food allergies, using self-reported data available from the Food Allergy Research & Education (FARE) Patient Registry (NCT04653324). Methods: The FARE Patient Registry is voluntary and captures real-world experiences of adults and pediatric patients in the United States, and their caregivers, through a series of surveys assessing patient health and experiences with food allergies. Self-reported data were descriptively analyzed. Results: The FARE study cohort included 5587 patients with food allergies; 82% had multiple food allergies and 62% were aged <18 years. About half of the patients were first diagnosed by an allergist/immunologist (53%), most commonly with a skin prick test (71%) or a serum immunoglobulin E test (62%). This analysis found that food allergies (most commonly peanut [66%], tree nuts [61%], egg [43%], and milk [37%]) impart a large clinical burden on patients, many of whom experience food-related allergic reactions and comorbidities. Many patients experienced >1 food-related allergic reaction per year (42%), with 46% experiencing food-induced anaphylaxis. Half of all food-related allergic reactions occurred at home. Accidental exposures to food allergens were experienced by 77% of patients. The most common allergic comorbidities reported by patients with food allergies were atopic dermatitis (48%), asthma (46%), and allergic rhinitis (39%). The clinical burden of food allergies were found to be greater in patients with multiple food allergies, and different for adults versus pediatric patients. Conclusion: This is the first study to assess patient experience and disease burden information from patients contributing to the FARE Patient Registry, thus providing a unique insight into the lives of patients in the United States with food allergies. These insights may assist clinicians and other public health stakeholders in the management of patients with food allergies.

Geographic variation in Medicare home health expenditures.

OBJECTIVES: To quantify geographic variation in home health expenditures per Medicare home health beneficiary and investigate factors associated with this variation. STUDY DESIGN: Retrospective study design analyzing US counties in which at least 1 home health agency served 11 or more beneficiaries in 2016. Several sources of 2016 national public data were used. METHODS: The key variable is county-level Medicare home health expenditures per home health beneficiary. Counties were grouped into quintiles based on per-beneficiary expenditures. Analyses included calculation of coefficients of variation, computation of the ratio of 90th percentile to 10th percentile in expenditures, and linear regression predicting expenditure. The control variables included characteristics of patients, agencies, and communities. RESULTS: Significant variation in home health expenditures was identified across county quintiles, with a 90th-to-10th-percentile expenditure ratio of 2.5. The percentage of for-profit agencies in the lowest quintile was 15.7 compared with 81.7 in the highest quintile of spending. Unadjusted spending differed by $3864 (95% CI, $3793-$3936), compared with $3611 (95% CI, $3514-$3708) in the adjusted model, between counties in spending quintiles 1 and 5. Although state fixed effects explained nearly 20% of the variation in home health expenditures, 42% of the variation remained unexplained. CONCLUSIONS: Home health care exhibits considerable unwarranted variation in per-patient expenditures across counties, signifying inefficiency and waste. Given the expected growth in home health demand, strategies to reduce unwarranted geographic variation are needed.

How Have Hospitals in the Mississippi Delta Fared Under the 2019 Revised Hospital Readmissions Reduction Program?

In 2013, the Centers for Medicare and Medicaid Services (CMS) implemented the Hospital Readmissions Reduction Program (2013 HRRP), which financially penalized hospitals if their 30-day readmissions were higher than the national average. Without adjusting for socioeconomic status of patients, the 2013 HRRP overly penalized hospitals caring for the poor, especially hospitals in the Mississippi Delta region, one of the poorest regions in the U.S. In 2019, CMS revised the HRRP (2019 Revised HRRP) to stratify hospitals into quintiles based on the proportion of patients that are dual-eligible Medicare and Medicaid beneficiaries. This study aimed to examine the effect of the 2019 Revised HRRP on financial penalties for Delta hospitals using a difference-in-difference (DID) approach with data from the 2018 and 2019 HRRP Supplemental Files. The DID analysis found that relative to non-Delta hospitals, penalties in Delta hospitals were reduced by 0.08 percentage points from 2018 to 2019 (95% CI for the coefficient: -0.15, -0.01; P = .02), and the probability of a penalty was reduced by 6.64 percentage points (95% CI for the coefficient: -9.54, -3.75; P < .001). The stratification under the 2019 Revised HRRP is an important first step in reducing unfair penalties to hospitals that serve poor populations.

Reply to "Risk adjustment in Home Health Care CAHPS".

The authors of "CMS HCC Risk Scores and Home Health Patient Experience Measures" respond to a letter to the editor.

Quality Performance of Rural and Urban Home Health Agencies: Implications for Rural Add-On Payment Policies.

PURPOSE: To examine the differences in quality performance among agencies in urban areas and those in high utilization, low population density, and all other rural areas, defined in the Bipartisan Budget Act (BBA). METHODS: We conducted a retrospective study using 2015 data: the Home Health Compare, the Home Health Agency Utilization and Payment Use, the Provider of Services, and the Area Health Resources Files, and a file with rural categories in BBA. The quality measures included (1) hospitalizations, (2) emergency visits, (3) patient experience, (4) composite scores for improvement in activities of daily living (ADL), (5) improvement in pain and treating symptoms, (6) preventing harm, and (7) treating wounds and preventing pressure sores. We applied weighted least squares regression. FINDINGS: Among all quality measures, differences in emergency visits of the 3 rural categories from urban agencies were the largest. The adjusted mean emergency visit for urban agencies was 12.42%, with agencies in rural areas having 1.01-1.96 percentage points higher rates than urban agencies (95% CI: 0.72-1.29 for high utilization areas, 95% CI: 0.51-3.42 for low population areas, and 95% CI: 1.28-1.78 for all other areas). CONCLUSIONS: The differences in the quality of care among agencies in 3 categories of rural areas were small, except for emergency visits. Given policies to reduce rural add-on payments for home health services, continued monitoring of the services provided and the quality of care by home health agencies in rural areas is recommended.

CMS HCC risk scores and home health patient experience measures.

OBJECTIVES: To understand the association between agency-level CMS Hierarchical Condition Categories (HCC) risk scores and patient experience measures for home health. STUDY DESIGN: This was a cross-sectional study. METHODS: We extracted variables from the 2014 Medicare Provider Utilization and Payment Data for Home Health Agencies and Home Health Compare file. We applied fixed-effects models for the analyses. Our dependent variables included both global and composite patient experience measures. The 2 global patient experience measures were the patient's overall rating of care provided by the agency (rating) and the patient's willingness to recommend the home health agency to others (recommendation). The 3 composite patient experience measures were how often the patient felt the provider gave care in a professional way (professional way), how well the home health team communicated with the patient (communication), and whether the home health team discussed medicines, pain, and home safety with the patient (discussion). RESULTS: Increased agency-level CMS HCC risk scores were negatively associated with all patient experience measures: rating (-2.04; P ≤.001), recommendation (-2.75; P <.001), professional way (-1.56; P <.001), communication (-1.67; P <.001), and discussion (-1.69; P ≤.001). Several covariates, including the percentage of racial/ethnic minority beneficiaries, ownership of the agency, and number of tenured years with the Medicare program, were significantly associated with patient experience measures. CONCLUSIONS: A negative association exists between CMS HCC risk scores and patient experience measures. To avoid unintended consequences, patient experience measures need further risk adjustment under the CMS 5-star patient survey rating system and the Home Health Value-Based Purchasing pilot program.