ABSTRACT
Importance: High out-of-pocket costs and improper use of maintenance inhalers contribute to poor outcomes among patients with chronic obstructive pulmonary disease (COPD). There is limited evidence for how addressing these barriers could improve adherence and affect COPD exacerbations, spending, or racial disparities in these outcomes. Objective: To examine the effect of a national program to reduce beneficiary cost sharing for COPD maintenance inhalers and provide medication management services that included education on proper technique for inhaler use. Design, Setting, and Participants: This randomized clinical trial included individuals with COPD. All individuals were enrolled in Medicare Advantage. Data were collected from January 2019 to December 2021, and data were analyzed from January 2023 to May 2024. Intervention: Invitation to enroll in a program that reduced cost sharing for maintenance inhalers to $0 or $10 and provided medication management services. The random assignment of the invitation was used to estimate the effects of the invitation and program enrollment, overall and by race. Main Outcomes and Measures: Inhaler adherence measured as proportion of days covered (PDC), moderate-to-severe exacerbations, short-acting inhaler fills, total spending, and as an exploratory outcome, out-of-pocket spending. Results: Of 19â¯113 included patients, 55.2% were female; 9.5% were Black, 81.1% were White, and 9.4% were another or unknown race; and the median (IQR) age was 74 (69-80) years. Program enrollment was higher in the invited group (29.4%) than the control group (5.1%). The PDC for maintenance inhalers was higher in the invited group than the control group (32.0% vs 28.4%; adjusted invitation effect, 3.8 percentage points; 95% CI, 3.1-4.5); the adjusted effect of the program (the local average treatment effect) was 15.5 percentage points (95% CI, 12.8-18.1), a 55% relative increase in adherence. Mean (SD) out-of-pocket spending for prescriptions was lower in the invited group ($619.5 [$863.1]) than the control group ($675.0 [$887.3]; adjusted invitation effect, -$49.5; 95% CI, -68.9 to -30.0; adjusted program effect, -$203.0; 95% CI, -282.8 to -123.2), but there was no statistically significant difference in exacerbations, short-acting inhaler fills, or total spending. Among Black individuals, the adjusted invitation effect on maintenance inhaler PDC was 5.5 percentage points (95% CI, 3.3-7.7), and the adjusted program effect was 19.5 percentage points (95% CI, 12.4-26.7). Among White individuals, the adjusted invitation effect was 3.7 percentage points (95% CI, 2.9-4.4), and the adjusted program effect was 15.1 percentage points (95% CI, 12.1-18.1). The difference between the invitation effects by race was not statistically significant (1.8 percentage points; 95% CI, -0.5 to 4.1; P = .13). Conclusions and Relevance: Individuals in Medicare Advantage who received an invitation to enroll in a program that reduced cost sharing for maintenance inhalers and provided medication management services had higher inhaler adherence compared with the control group. The difference in the program's effect on inhaler adherence between Black and White individuals was substantial but not statistically significant. Trial Registration: ClinicalTrials.gov Identifier: NCT05497999.
ABSTRACT
Importance: Much of the evidence for bundled payments has been drawn from models in the traditional Medicare program. Although private insurers are increasingly offering bundled payment programs, it is not known whether they are associated with changes in episode spending and quality. Objective: To evaluate whether a voluntary bundled payment program offered by a national Medicare Advantage insurer was associated with changes in episode spending or quality of care for beneficiaries receiving lower extremity joint replacement (LEJR) surgery. Design, Setting, and Participants: Cross-sectional study of 23â¯034 LEJR surgical episodes that emulated a stepped-wedge design by using the time-varying, geographically staggered rollout of the bundled payment program from January 1, 2012, to September 30, 2019. Episode-level multivariable regression models were estimated within practice to compare changes before and after program participation, using episodes at physician practices that had not yet begun participating in the program during a given time period (but would go on to do so) as the control. Data analyses were performed from July 1, 2021, to June 30, 2022. Exposures: Physician practice participation in the bundled payment program. Main Outcomes and Measures: The primary outcome was episode spending (plan and beneficiary). Secondary outcomes included postacute care use (skilled nursing facility and home health care), surgical setting (inpatient vs outpatient), and quality (90-day complications [including deep vein thrombosis, wound infection, fracture, or dislocation] and readmissions). Results: The final analytic sample included 23â¯034 LEJR episodes (6355 bundled episodes and 16â¯679 control episodes) from 109 physician practices participating in the program. Of the beneficiaries, 7730 were male and 15â¯304 were female, 3057 were Black, 19â¯351 were White, 447 were of other race or ethnicity (assessed according to the Centers for Medicare & Medicaid Services beneficiary race and ethnicity code, which reflects data reported to the Social Security Administration), and 179 were of unknown race and ethnicity. The mean (SD) age was 70.9 (7.2) years. Participation in the bundled payment program was associated with a 2.7% (95% CI, 1.3%-4.1%) decrease in spending per episode (mean episodic spending, $21â¯964 [95% CI, $21â¯636-$22â¯296] vs $22â¯562 [95% CI, $22â¯346-$22â¯779]), as well as reductions in skilled nursing facility use after discharge (21.3% for bundled episodes vs 25.0% for control episodes; odds ratio [OR], 0.81 [95% CI, 0.67-0.98]) and increased use of the outpatient surgical setting (14.1% for bundled episodes vs 8.4% for control episodes; OR, 1.79 [95% CI, 1.53-2.09]). The program was not associated with changes in quality outcomes, including 90-day complications (8.8% for bundled episodes vs 8.6% for control episodes; OR, 1.02 [95% CI, 0.86-1.20]) and readmissions (4.3% for bundled episodes vs 4.6% for control episodes; OR, 0.92 [95% CI, 0.75-1.13]). Conclusions and Relevance: In this study of an LEJR bundled payment program offered by a national Medicare Advantage insurer, findings suggest that physician practice participation in the program was associated with a decrease in episode spending without changes in quality. Bundled payments offered by private insurers, including Medicare Advantage plans, are an alternate payment option to fee for service that may reduce spending for LEJR episodes while maintaining quality of care.
Subject(s)
Arthroplasty, Replacement , Medicare Part C , Humans , Male , Female , Aged , United States , Cross-Sectional Studies , Fee-for-Service Plans , Lower ExtremityABSTRACT
Importance: Low-value care in the Medicare program is prevalent, costly, potentially harmful, and persistent. Although Medicare Advantage (MA) plans can use managed care strategies not available in traditional Medicare (TM), it is not clear whether this flexibility is associated with lower rates of low-value care. Objectives: To compare rates of low-value services between MA and TM beneficiaries and explore how elements of insurance design present in MA are associated with the delivery of low-value care. Design, Setting, and Participants: This cross-sectional study analyzed beneficiaries enrolled in MA and TM using claims data from a large, national MA insurer and a random 5% sample of TM beneficiaries. The study period was January 1, 2017, through December 31, 2019. All analyses were conducted from July 2021 to March 2022. Exposures: Enrollment in MA vs TM. Main Outcomes and Measures: Low-value care was assessed using 26 claims-based measures. Regression models were used to estimate the association between MA enrollment and rates of low-value services while controlling for beneficiary characteristics. Stratified analyses explored whether network design, product design, value-based payment, or utilization management moderated differences in low-value care between MA and TM beneficiaries and among MA beneficiaries. Results: Among a study population of 2â¯470â¯199 Medicare beneficiaries (mean [SD] age, 75.6 [7.0] years; 1â¯346â¯777 [54.5%] female; 229â¯107 [9.3%] Black and 2â¯126â¯353 [86.1%] White individuals), 1â¯527â¯763 (61.8%) were enrolled in MA and 942â¯436 (38.2%) were enrolled in TM. Beneficiaries enrolled in MA received 9.2% (95% CI, 8.5%-9.8%) fewer low-value services in 2019 than TM beneficiaries (23.1 vs 25.4 total low-value services per 100 beneficiaries). Although MA beneficiaries enrolled in health management organization and preferred provider organization products received fewer low-value services than TM beneficiaries, the difference was largest for those enrolled in health management organization products (2.6 fewer [95% CI, 2.4-2.8] vs 2.1 fewer [95% CI, 1.9-2.3] services per 100 beneficiaries, respectively). Across primary care payment arrangements, MA beneficiaries received fewer low-value services than TM beneficiaries, with the largest difference observed for MA beneficiaries whose primary care physicians were reimbursed within 2-sided risk arrangements. Conclusions and Relevance: In this cross-sectional study of Medicare beneficiaries, those enrolled in MA had lower rates of low-value care than those enrolled in TM; elements of insurance design present in the MA program and absent in TM were associated with reduction in low-value care.
Subject(s)
Medicare Part C , Aged , Cross-Sectional Studies , Female , Humans , Male , United StatesABSTRACT
BACKGROUND: Diets rich in fruits and vegetables (F/V) can reduce the inflammatory profile of circulating cytokines and potentially decrease the risk of breast cancer. However, the extent to which a diet rich in F/V alters cytokine levels in breast tissue remains largely unknown. Breast milk provides a means of assessing concentrations of secreted cytokines in the breast microenvironment and is a potential tool for studying the effects of diet on inflammation in breast tissue and breast cancer risk. OBJECTIVE: The aim of this pilot randomized trial was to test the feasibility of increasing F/V intake in breastfeeding women and of measuring changes in markers of inflammation in breast milk. DESIGN AND INTERVENTION: Participants randomized to the intervention (n=5) were provided weekly boxes of F/V, along with dietary counseling, to increase consumption of F/V to 8 to 10 daily servings for 12 consecutive weeks. Controls (n=5) were directed to the US Department of Agriculture's "ChooseMyPlate" diet for pregnancy and breastfeeding. PARTICIPANTS/SETTING: Ten breastfeeding women consuming fewer than five servings of F/V per day, as estimated by the National Institutes of Health "All-Day" Fruit and Vegetable Screener (F/V Screener), were recruited through flyers and a lactation consultant between February and May 2016 in the Western Massachusetts area. MAIN OUTCOME MEASURES: Baseline demographic and F/V intake data were collected during enrollment. At week 1 and week 13 (final) home visits, participants provided milk samples and anthropometric measurements were recorded. Participants completed F/V screeners at baseline and at study end. Adiponectin, leptin, C-reactive protein, and 11 additional cytokines were measured in breast milk collected at weeks 1 and 13. STATISTICAL ANALYSES: F/V consumption at baseline and after the final visit, and between controls and intervention groups, was compared with dependent and independent t tests, respectively. Differences between cytokine levels at weeks 1 and 13 were assessed with a mixed-effects repeated-measures model. RESULTS: All women in the intervention increased F/V intake and were consuming more servings than controls by week 13; daily serving of F/V at baseline and final visit: controls=1.6 and 2.0, diet=2.6 and 9.9. Most cytokines were detected in the majority of milk samples: 12 were detected in 90% to 100% of samples, one was detected in 75% of samples, and one was detected in 7.5% of samples; coefficients of variation were below 14% for 11 of the cytokines. CONCLUSIONS: These preliminary findings indicate that it is feasible to significantly increase F/V intake in breastfeeding women and provide support for conducting a larger diet intervention study in breastfeeding women, in which longer-term benefits of the intervention are assessed.