Mortality and morbidity ramifications of proposed retractions in healthcare coverage for the United States.

In the absence of universal healthcare in the United States, federal programs of Medicaid and Medicare are vital to providing healthcare coverage for low-income households and elderly individuals, respectively. However, both programs are under threat, with either enacted or proposed retractions. Specifically, raising Medicare age eligibility and the addition of work requirements for Medicaid qualification have been proposed, while termination of continuous enrollment for Medicaid was recently effectuated. Here, we assess the potential impact on mortality and morbidity resulting from these policy changes. Our findings indicate that the policy change to Medicare would lead to over 17,000 additional deaths among individuals aged 65 to 67 and those to Medicaid would lead to more than 8,000 deaths among those under the age of 65. To illustrate the implications for morbidity, we further consider a case study among those people with diabetes who would be likely to lose their health insurance under the policy changes. We project that these insurance retractions would lead to the loss of coverage for over 700,000 individuals with diabetes, including more than 200,000 who rely on insulin.

Air Pollution and Mortality at the Intersection of Race and Social Class.

BACKGROUND: Black Americans are exposed to higher annual levels of air pollution containing fine particulate matter (particles with an aerodynamic diameter of ≤2.5 µm [PM2.5]) than White Americans and may be more susceptible to its health effects. Low-income Americans may also be more susceptible to PM2.5 pollution than high-income Americans. Because information is lacking on exposure-response curves for PM2.5 exposure and mortality among marginalized subpopulations categorized according to both race and socioeconomic position, the Environmental Protection Agency lacks important evidence to inform its regulatory rulemaking for PM2.5 standards. METHODS: We analyzed 623 million person-years of Medicare data from 73 million persons 65 years of age or older from 2000 through 2016 to estimate associations between annual PM2.5 exposure and mortality in subpopulations defined simultaneously by racial identity (Black vs. White) and income level (Medicaid eligible vs. ineligible). RESULTS: Lower PM2.5 exposure was associated with lower mortality in the full population, but marginalized subpopulations appeared to benefit more as PM2.5 levels decreased. For example, the hazard ratio associated with decreasing PM2.5 from 12 µg per cubic meter to 8 µg per cubic meter for the White higher-income subpopulation was 0.963 (95% confidence interval [CI], 0.955 to 0.970), whereas equivalent hazard ratios for marginalized subpopulations were lower: 0.931 (95% CI, 0.909 to 0.953) for the Black higher-income subpopulation, 0.940 (95% CI, 0.931 to 0.948) for the White low-income subpopulation, and 0.939 (95% CI, 0.921 to 0.957) for the Black low-income subpopulation. CONCLUSIONS: Higher-income Black persons, low-income White persons, and low-income Black persons may benefit more from lower PM2.5 levels than higher-income White persons. These findings underscore the importance of considering racial identity and income together when assessing health inequities. (Funded by the National Institutes of Health and the Alfred P. Sloan Foundation.).

Racial Inequality in Receipt of Medications for Opioid Use Disorder.

BACKGROUND: Since 2010, Black persons in the United States have had a greater increase in opioid overdose-related mortality than other groups, but national-level evidence characterizing racial and ethnic disparities in the use of medications for opioid use disorder (OUD) is limited. METHODS: We used Medicare claims data from the 2016-2019 period for a random 40% sample of fee-for-service beneficiaries who were Black, Hispanic, or White; were eligible for Medicare owing to disability; and had an index event related to OUD (nonfatal overdose treated in an emergency department or inpatient setting, hospitalization with injection drug use-related infection, or inpatient or residential rehabilitation or detoxification care). We measured the receipt of medications to treat OUD (buprenorphine, naltrexone, and naloxone), the receipt of high-risk medications (opioid analgesics and benzodiazepines), and health care utilization, all in the 180 days after the index event. We estimated differences in outcomes according to race and ethnic group with adjustment for beneficiary age, sex, index event, count of chronic coexisting conditions, and state of residence. RESULTS: We identified 25,904 OUD-related index events among 23,370 beneficiaries, with 3937 events (15.2%) occurring among Black patients, 2105 (8.1%) among Hispanic patients, and 19,862 (76.7%) among White patients. In the 180 days after the index event, patients received buprenorphine after 12.7% of events among Black patients, after 18.7% of those among Hispanic patients, and after 23.3% of those among White patients; patients received naloxone after 14.4%, 20.7%, and 22.9%, respectively; and patients received benzodiazepines after 23.4%, 29.6%, and 37.1%, respectively. Racial differences in the receipt of medications to treat OUD did not change appreciably from 2016 to 2019 (buprenorphine receipt: after 9.1% of index events among Black patients vs. 21.6% of those among White patients in 2016, and after 14.1% vs. 25.5% in 2019). In all study groups, patients had multiple ambulatory visits in the 180 days after the index event (mean number of visits, 6.6 after events among Black patients, 6.7 after events among Hispanic patients, and 7.6 after events among White patients). CONCLUSIONS: Racial and ethnic differences in the receipt of medications to treat OUD after an index event related to this disorder among patients with disability were substantial and did not change over time. The high incidence of ambulatory visits in all groups showed that disparities persisted despite frequent health care contact. (Funded by the National Institute on Drug Abuse and the National Institute on Aging.).

Incident dementia and long-term exposure to constituents of fine particle air pollution: A national cohort study in the United States.

Growing evidence suggests that fine particulate matter (PM2.5) likely increases the risks of dementia, yet little is known about the relative contributions of different constituents. Here, we conducted a nationwide population-based cohort study (2000 to 2017) by integrating the Medicare Chronic Conditions Warehouse database and two independently sourced datasets of high-resolution PM2.5 major chemical composition, including black carbon (BC), organic matter (OM), nitrate (NO3-), sulfate (SO42-), ammonium (NH4+), and soil dust (DUST). To investigate the impact of long-term exposure to PM2.5 constituents on incident all-cause dementia and Alzheimer's disease (AD), hazard ratios for dementia and AD were estimated using Cox proportional hazards models, and penalized splines were used to evaluate potential nonlinear concentration-response (C-R) relationships. Results using two exposure datasets consistently indicated higher rates of incident dementia and AD for an increased exposure to PM2.5 and its major constituents. An interquartile range increase in PM2.5 mass was associated with a 6 to 7% increase in dementia incidence and a 9% increase in AD incidence. For different PM2.5 constituents, associations remained significant for BC, OM, SO42-, and NH4+ for both end points (even after adjustments of other constituents), among which BC and SO42- showed the strongest associations. All constituents had largely linear C-R relationships in the low exposure range, but most tailed off at higher exposure concentrations. Our findings suggest that long-term exposure to PM2.5 is significantly associated with higher rates of incident dementia and AD and that SO42-, BC, and OM related to traffic and fossil fuel combustion might drive the observed associations.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

United States Life Tables, 2021.

Objectives-This report presents complete period life tables for the United States by Hispanic origin and race and sex, based on age-specific death rates in 2021. Methods-Data used to prepare the 2021 life tables are 2021 final mortality statistics; July 1, 2021, population estimates based on the Blended Base population estimates produced by the U.S. Census Bureau; and 2021 Medicare data for people ages 66-99. The methodology used to estimate life tables for the Hispanic population remains unchanged from that developed for the publication of life tables by Hispanic origin for data year 2006. The same methodology is used to estimate life tables for the American Indian and Alaska Native non-Hispanic and Asian non-Hispanic populations. The methodology used to estimate the 2021 life tables for all other groups was first implemented with data year 2008. Results-In 2021, the overall expectation of life at birth was 76.4 years, decreasing 0.6 year from 77.0 in 2020. From 2020 to 2021, life expectancy at birth decreased by 0.7 year for males (from 74.2 to 73.5) and by 0.6 year for females (79.9 to 79.3). Between 2020 and 2021, life expectancy decreased by 1.5 years for the American Indian and Alaska Native non-Hispanic population (67.1 to 65.6), 0.7 year for the White non-Hispanic population (77.4 to 76.7), 0.3 year for the Black non-Hispanic population (71.5 to 71.2), 0.1 year for the Hispanic population (77.9 to 77.8), and 0.1 year for the Asian non-Hispanic population (83.6 to 83.5).

Real-world experience of CAR T-cell therapy in older patients with relapsed/refractory diffuse large B-cell lymphoma.

The emergence of chimeric antigen receptor (CAR) T-cell therapy has changed the treatment landscape for diffuse large B-cell lymphoma (DLBCL); however, real-world experience reporting outcomes among older patients treated with CAR T-cell therapy is limited. We leveraged the 100% Medicare fee-for-service claims database and analyzed outcomes and cost associated with CAR T-cell therapy in 551 older patients (aged ≥65 years) with DLBCL who received CAR T-cell therapy between 2018 and 2020. CAR T-cell therapy was used in third line and beyond in 19% of patients aged 65 to 69 years and 22% among those aged 70 to 74 years, compared with 13% of patients aged ≥75 years. Most patients received CAR T-cell therapy in an inpatient setting (83%), with an average length of stay of 21 days. The median event-free survival (EFS) following CAR T-cell therapy was 7.2 months. Patients aged ≥75 years had significantly shorter EFS compared with patients aged 65 to 69 and 70 to 74 years, with 12-month EFS estimates of 34%, 43%, and 52%, respectively (P = .002). The median overall survival was 17.1 months, and there was no significant difference by age groups. The median total health care cost during the 90-day follow-up was $352 572 and was similar across all age groups. CAR T-cell therapy was associated with favorable effectiveness, but the CAR T-cell therapy use in older patients was low, especially in patients aged ≥75 years, and this age group had a lower rate of EFS, which illustrates the unmet need for more accessible, effective, and tolerable therapy in older patients, especially those aged ≥75 years.

Health Care Contact Days Among Older Adults in Traditional Medicare : A Cross-Sectional Study.

BACKGROUND: Days spent obtaining health care outside the home can represent not only access to needed care but also substantial time, effort, and cost, especially for older adults and their care partners. Yet, these "health care contact days" have not been characterized. OBJECTIVE: To assess composition of, variation and patterns in, and factors associated with contact days among older adults. DESIGN: Cross-sectional study. SETTING: Nationally representative 2019 Medicare Current Beneficiary Survey data linked to claims. PARTICIPANTS: Community-dwelling adults aged 65 years and older in traditional Medicare. MEASUREMENTS: Ambulatory contact days (days with a primary care or specialty care office visit, test, imaging, procedure, or treatment) and total contact days (ambulatory days plus institutional days in a hospital, emergency department, skilled-nursing facility, or hospice facility); multivariable mixed-effects Poisson regression to identify patient factors associated with contact days. RESULTS: In weighted results, 6619 older adults (weighted: 29 694 084) had means of 17.3 ambulatory contact days (SD, 22.1) and 20.7 total contact days (SD, 27.5) in the year; 11.1% had 50 or more total contact days. Older adults spent most contact days on ambulatory care, including primary care visits (mean [SD], 3.5 [5.0]), specialty care visits (5.7 [9.6]), tests (5.3 [7.2]), imaging (2.6 [3.9]), procedures (2.5 [6.4]), and treatments (5.7 [13.3]). Half of the test and imaging days were not on the same days as office visits (48.6% and 50.1%, respectively). Factors associated with more ambulatory contact days included younger age, female sex, White race, non-Hispanic ethnicity, higher income, higher educational attainment, urban residence, more chronic conditions, and care-seeking behaviors (for example, "go to the doctor…as soon as (I)…feel bad"). LIMITATION: Study population limited to those in traditional Medicare. CONCLUSION: On average, older adults spent 3 weeks in the year getting care outside the home. These contact days were mostly ambulatory and varied widely not only by number of chronic conditions but also by sociodemographic factors, geography, and care-seeking behaviors. These results show factors beyond clinical need that may drive overuse and underuse of contact days and opportunities to optimize this person-centered measure to reduce patient burdens, for example, via care coordination. PRIMARY FUNDING SOURCE: National Institute on Aging.

Where Are All the Specialists? Current Challenges of Integrating Specialty Care Into Population-Based Total Cost of Care Payment Models.

The Centers for Medicare & Medicaid Services Innovation Center (CMMI) has set the goal for 100% of traditional Medicare beneficiaries to be part of an accountable care relationship by 2030. Lack of meaningful financial incentives, intolerable or unpredictable risk, infrastructure costs, patient engagement, voluntary participation, and operational complexity have been noted by the provider and health care delivery community as barriers to participation or reasons for exiting programs. In addition, most piloted and implemented population-based total cost of care (PB-TCOC) payment models have focused on the role of the primary care physician being the accountability (that is, attributable) leader of a patient's multifaceted care team as well as acting as the mayor of the "medical neighborhood," leaving the role of specialty care physicians undefined. Successful provider specialist integration into PB-TCOC models includes meaningful participation of specialists in achieving whole-person, high-value care where all providers are financially motivated to participate; there is unambiguous prospective attribution and clearly defined accountability for each participating party throughout the care journey or episode; there is a known care attribution transition accountability plan; there is actionable, transparent, and timely data available with appropriate data development and basic analytic costs covered; and there is advanced payment to the accountable person or entity for management of the care episode that is part of a longitudinal care plan. Payment models should be created to address the 7 challenges raised here if specialists are to be incented to join TCOC models that achieve CMMI's goal.

Comparison of Hospital Mortality and Readmission Rates by Physician and Patient Sex.

BACKGROUND: Little is known as to whether the effects of physician sex on patients' clinical outcomes vary by patient sex. OBJECTIVE: To examine whether the association between physician sex and hospital outcomes varied between female and male patients hospitalized with medical conditions. DESIGN: Retrospective observational study. SETTING: Medicare claims data. PATIENTS: 20% random sample of Medicare fee-for-service beneficiaries hospitalized with medical conditions during 2016 to 2019 and treated by hospitalists. MEASUREMENTS: The primary outcomes were patients' 30-day mortality and readmission rates, adjusted for patient and physician characteristics and hospital-level averages of exposures (effectively comparing physicians within the same hospital). RESULTS: Of 458 108 female and 318 819 male patients, 142 465 (31.1%) and 97 500 (30.6%) were treated by female physicians, respectively. Both female and male patients had a lower patient mortality when treated by female physicians; however, the benefit of receiving care from female physicians was larger for female patients than for male patients (difference-in-differences, -0.16 percentage points [pp] [95% CI, -0.42 to 0.10 pp]). For female patients, the difference between female and male physicians was large and clinically meaningful (adjusted mortality rates, 8.15% vs. 8.38%; average marginal effect [AME], -0.24 pp [CI, -0.41 to -0.07 pp]). For male patients, an important difference between female and male physicians could be ruled out (10.15% vs. 10.23%; AME, -0.08 pp [CI, -0.29 to 0.14 pp]). The pattern was similar for patients' readmission rates. LIMITATION: The findings may not be generalizable to younger populations. CONCLUSION: The findings indicate that patients have lower mortality and readmission rates when treated by female physicians, and the benefit of receiving treatments from female physicians is larger for female patients than for male patients. PRIMARY FUNDING SOURCE: Gregory Annenberg Weingarten, GRoW @ Annenberg.

Gene Therapy Versus Common Care for Eligible Individuals With Sickle Cell Disease in the United States : A Cost-Effectiveness Analysis.

BACKGROUND: Sickle cell disease (SCD) and its complications contribute to high rates of morbidity and early mortality and high cost in the United States and African heritage community. OBJECTIVE: To evaluate the cost-effectiveness of gene therapy for SCD and its value-based prices (VBPs). DESIGN: Comparative modeling analysis across 2 independently developed simulation models (University of Washington Model for Economic Analysis of Sickle Cell Cure [UW-MEASURE] and Fred Hutchinson Institute Sickle Cell Disease Outcomes Research and Economics Model [FH-HISCORE]) using the same databases. DATA SOURCES: Centers for Medicare & Medicaid Services claims data, 2008 to 2016; published literature. TARGET POPULATION: Persons eligible for gene therapy. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. health care sector and societal. INTERVENTION: Gene therapy versus common care. OUTCOME MEASURES: Incremental cost-effectiveness ratios (ICERs), equity-informed VBPs, and price acceptability curves. RESULTS OF BASE-CASE ANALYSIS: At an assumed $2 million price for gene therapy, UW-MEASURE and FH-HISCORE estimated ICERs of $193 000 per QALY and $427 000 per QALY, respectively, under the health care sector perspective. Corresponding estimates from the societal perspective were $126 000 per QALY and $281 000 per QALY. The difference in results between models stemmed primarily from considering a slightly different target population and incorporating the quality-of-life (QOL) effects of splenic sequestration, priapism, and acute chest syndrome in the UW model. From a societal perspective, acceptable (>90% confidence) VBPs ranged from $1 million to $2.5 million depending on the use of alternative effective metrics or equity-informed threshold values. RESULTS OF SENSITIVITY ANALYSIS: Results were sensitive to the costs of myeloablative conditioning before gene therapy, effect on caregiver QOL, and effect of gene therapy on long-term survival. LIMITATION: The short-term effects of gene therapy on vaso-occlusive events were extrapolated from 1 study. CONCLUSION: Gene therapy for SCD below a $2 million price tag is likely to be cost-effective when applying a societal perspective at an equity-informed threshold for cost-effectiveness analysis. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Effect of Health Service Area on Primary Care Physician Provision of Low-Value Cancer Screening.

BACKGROUND: Using a health systems approach to investigate low-value care (LVC) may provide insights into structural drivers of this pervasive problem. OBJECTIVE: To evaluate the influence of service area practice patterns on low-value mammography and prostate-specific antigen (PSA) testing. DESIGN: Retrospective study analyzing LVC rates between 2008 and 2018, leveraging physician relocation in 3-year intervals of matched physician and patient groups. SETTING: U.S. Medicare claims data. PARTICIPANTS: 8254 physicians and 56 467 patients aged 75 years or older. MEASUREMENTS: LVC rates for physicians staying in their original service area and those relocating to new areas. RESULTS: Physicians relocating from higher-LVC areas to low-LVC areas were more likely to provide lower rates of LVC. For mammography, physicians staying in high-LVC areas (LVC rate, 10.1% [95% CI, 8.8% to 12.2%]) or medium-LVC areas (LVC rate, 10.3% [CI, 9.0% to 12.4%]) provided LVC at a higher rate than physicians relocating from those areas to low-LVC areas (LVC rates, 6.0% [CI, 4.4% to 7.5%] [difference, -4.1 percentage points {CI, -6.7 to -2.3 percentage points}] and 5.9% [CI, 4.6% to 7.8%] [difference, -4.4 percentage points {CI, -6.7 to -2.4 percentage points}], respectively). For PSA testing, physicians staying in high- or moderate-LVC service areas provided LVC at a rate of 17.5% (CI, 14.9% to 20.7%) or 10.6% (CI, 9.6% to 13.2%), respectively, compared with those relocating from those areas to low-LVC areas (LVC rates, 9.9% [CI, 7.5% to 13.2%] [difference, -7.6 percentage points {CI, -10.9 to -3.8 percentage points}] and 6.2% [CI, 3.5% to 9.8%] [difference, -4.4 percentage points {CI, -7.6 to -2.2 percentage points}], respectively). Physicians relocating from lower- to higher-LVC service areas were not more likely to provide LVC at a higher rate. LIMITATION: Use of retrospective observational data, possible unmeasured confounding, and potential for relocating physicians to practice differently from those who stay. CONCLUSION: Physicians relocating to service areas with lower rates of LVC provided less LVC than physicians who stayed in areas with higher rates of LVC. Systemic structures may contribute to LVC. Understanding which factors are contributing may present opportunities for policy and interventions to broadly improve care. PRIMARY FUNDING SOURCE: National Cancer Institute of the National Institutes of Health.

Peritoneal Dialysis Catheter Complications after Insertion by Surgeons, Radiologists, or Nephrologists.

SIGNIFICANCE STATEMENT: The Advancing American Kidney Health Initiative aims to increase rates of utilization of peritoneal dialysis (PD) in the United States. One of the first steps to PD is successful catheter placement, which can be performed by surgeons, interventional radiologists, or nephrologists. We examined the association between operator subspecialty and risk of needing a follow-up procedure in the first 90 days after initial PD catheter implantation. Overall, we found that 15.5% of catheters required revision, removal, or a second catheter placement within 90 days. The odds of requiring a follow-up procedure was 36% higher for interventional radiologists and 86% higher for interventional nephrologists compared with general surgeons. Further research is needed to understand how to optimize the function of catheters across different operator types. BACKGROUND: The US government has implemented incentives to increase the use of PD. Successful placement of PD catheters is an important step to increasing PD utilization rates. Our objective was to compare initial outcomes after PD catheter placement by different types of operators. METHODS: We included PD-naïve patients insured by Medicare who had a PD catheter inserted between 2010 and 2019. We examined the association between specialty of the operator (general surgeon, vascular surgeon, interventional radiologist, or interventional nephrologist) and odds of needing a follow-up procedure, which we defined as catheter removal, replacement, or revision within 90 days of the initial procedure. Mixed logistic regression models clustered by operator were used to examine the association between operator type and outcomes. RESULTS: We included 46,973 patients treated by 5205 operators (71.1% general surgeons, 17.2% vascular surgeons, 9.7% interventional radiologists, 2.0% interventional nephrologists). 15.5% of patients required a follow-up procedure within 90 days of the initial insertion, of whom 2.9% had a second PD catheter implanted, 6.6% underwent PD catheter removal, and 5.9% had a PD catheter revision within 90 days of the initial insertion. In models adjusted for patient and operator characteristics, the odds of requiring a follow-up procedure within 90 days were highest for interventional nephrologists (HR, 1.86; 95% confidence interval [CI], 1.56 to 2.22) and interventional radiologists (odds ratio, 1.36; 95% CI, 1.17 to 1.58) followed by vascular surgeons (odds ratio, 1.06; 95% CI, 0.97 to 1.14) compared with general surgeons. CONCLUSIONS: The probability of needing a follow-up procedure after initial PD catheter placement varied by operator specialty and was higher for interventionalists and lowest for general surgeons.

Alzheimer incidence and prevalence with and without asthma: A Medicare cohort study.

BACKGROUND: International data suggest that asthma, like other inflammatory diseases, might increase Alzheimer disease (AD) risk. OBJECTIVE: We sought to explore risk pathways and future mitigation strategies by comparing diagnostic claims-based AD incidence and prevalence among US patients with asthma with those without asthma. METHODS: This cohort study included a national Medicare 20% random sample (2013-2015). Adult patients with asthma with more than 12 months continuous Medicare were compared with subjects without asthma overall and as matched. Asthma was defined by 1 inpatient or 2 outpatient codes for asthma. The main outcomes were 2-year incident or prevalent AD defined by International Classification of Diseases, Ninth Revision code 331.0 or Tenth Revision code G30.0, G30.1, G30.8, or G30.9. RESULTS: Among 5,460,732 total beneficiaries, 678,730 patients were identified with baseline asthma and more often identified as Black or Hispanic, were Medicaid eligible, or resided in a highly disadvantaged neighborhood than those without asthma. Two-year incidence of AD was 1.4% with asthma versus 1.1% without asthma; prevalence was 7.8% versus 5.4% (both P ≤ .001). Per 100,000 patients over 2 years, 303 more incident AD diagnoses occurred in those with asthma, with 2,425 more prevalent cases (P < .001). Multivariable models showed that asthma had greater odds of 2-year AD incidence (adjusted odds ratio, 1.33 [95% CI, 1.29-1.36]; matched 1.2 [95% CI, 1.17-1.24]) and prevalence (adjusted odds ratio, 1.48 [95% CI, 1.47-1.50]; matched 1.25 [95% CI, 1.22-1.27]). CONCLUSIONS: Asthma was associated with 20% to 33% increased 2-year incidence and 25% to 48% increased prevalence of claims-based AD in this nationally representative US sample. Future research should investigate risk pathways of underlying comorbidities and social determinants as well as whether there are potential asthma treatments that may preserve brain health.

Changes in Cardiovascular Spending, Care Utilization, and Clinical Outcomes Associated With Participation in Bundled Payments for Care Improvement - Advanced.

BACKGROUND: Bundled Payments for Care Improvement - Advanced (BPCI-A) is a Medicare initiative that aims to incentivize reductions in spending for episodes of care that start with a hospitalization and end 90 days after discharge. Cardiovascular disease, an important driver of Medicare spending, is one of the areas of focus BPCI-A. It is unknown whether BPCI-A is associated with spending reductions or quality improvements for the 3 cardiovascular medical events or 5 cardiovascular procedures in the model. METHODS: In this retrospective cohort study, we conducted difference-in-differences analyses using Medicare claims for patients discharged between January 1, 2017, and September 30, 2019, to assess differences between BPCI-A hospitals and matched nonparticipating control hospitals. Our primary outcomes were the differential changes in spending, before versus after implementation of BPCI-A, for cardiac medical and procedural conditions at BPCI-A hospitals compared with controls. Secondary outcomes included changes in patient complexity, care utilization, healthy days at home, readmissions, and mortality. RESULTS: Baseline spending for cardiac medical episodes at BPCI-A hospitals was $25 606. The differential change in spending for cardiac medical episodes at BPCI-A versus control hospitals was $16 (95% CI, -$228 to $261; P=0.90). Baseline spending for cardiac procedural episodes at BPCI-A hospitals was $37 961. The differential change in spending for cardiac procedural episodes was $171 (95% CI, -$429 to $772; P=0.58). There were minimal differential changes in physicians' care patterns such as the complexity of treated patients or in their care utilization. At BPCI-A versus control hospitals, there were no significant differential changes in rates of 90-day readmissions (differential change, 0.27% [95% CI, -0.25% to 0.80%] for medical episodes; differential change, 0.31% [95% CI, -0.98% to 1.60%] for procedural episodes) or mortality (differential change, -0.14% [95% CI, -0.50% to 0.23%] for medical episodes; differential change, -0.36% [95% CI, -1.25% to 0.54%] for procedural episodes). CONCLUSIONS: Participation in BPCI-A was not associated with spending reductions, changes in care utilization, or quality improvements for the cardiovascular medical events or procedures offered in the model.

Historical Redlining, Socioeconomic Distress, and Risk of Heart Failure Among Medicare Beneficiaries.

BACKGROUND: The association of historical redlining policies, a marker of structural racism, with contemporary heart failure (HF) risk among White and Black individuals is not well established. METHODS: We aimed to evaluate the association of redlining with the risk of HF among White and Black Medicare beneficiaries. Zip code-level redlining was determined by the proportion of historically redlined areas using the Mapping Inequality Project within each zip code. The association between higher zip code redlining proportion (quartile 4 versus quartiles 1-3) and HF risk were assessed separately among White and Black Medicare beneficiaries using generalized linear mixed models adjusted for potential confounders, including measures of the zip code-level Social Deprivation Index. RESULTS: A total of 2 388 955 Medicare beneficiaries (Black n=801 452; White n=1 587 503; mean age, 71 years; men, 44.6%) were included. Among Black beneficiaries, living in zip codes with higher redlining proportion (quartile 4 versus quartiles 1-3) was associated with increased risk of HF after adjusting for age, sex, and comorbidities (risk ratio, 1.08 [95% CI, 1.04-1.12]; P<0.001). This association remained significant after further adjustment for area-level Social Deprivation Index (risk ratio, 1.04 [95% CI, 1.002-1.08]; P=0.04). A significant interaction was observed between redlining proportion and Social Deprivation Index (Pinteraction<0.01) such that higher redlining proportion was significantly associated with HF risk only among socioeconomically distressed regions (above the median Social Deprivation Index). Among White beneficiaries, redlining was associated with a lower risk of HF after adjustment for age, sex, and comorbidities (risk ratio, 0.94 [95% CI, 0.89-0.99]; P=0.02). CONCLUSIONS: Historical redlining is associated with an increased risk of HF among Black patients. Contemporary zip code-level social determinants of health modify the relationship between redlining and HF risk, with the strongest relationship between redlining and HF observed in the most socioeconomically disadvantaged communities.

Supervised Exercise Training for Chronic Heart Failure With Preserved Ejection Fraction: A Scientific Statement From the American Heart Association and American College of Cardiology.

Heart failure with preserved ejection fraction (HFpEF) is one of the most common forms of heart failure; its prevalence is increasing, and outcomes are worsening. Affected patients often experience severe exertional dyspnea and debilitating fatigue, as well as poor quality of life, frequent hospitalizations, and a high mortality rate. Until recently, most pharmacological intervention trials for HFpEF yielded neutral primary outcomes. In contrast, trials of exercise-based interventions have consistently demonstrated large, significant, clinically meaningful improvements in symptoms, objectively determined exercise capacity, and usually quality of life. This success may be attributed, at least in part, to the pleiotropic effects of exercise, which may favorably affect the full range of abnormalities-peripheral vascular, skeletal muscle, and cardiovascular-that contribute to exercise intolerance in HFpEF. Accordingly, this scientific statement critically examines the currently available literature on the effects of exercise-based therapies for chronic stable HFpEF, potential mechanisms for improvement of exercise capacity and symptoms, and how these data compare with exercise therapy for other cardiovascular conditions. Specifically, data reviewed herein demonstrate a comparable or larger magnitude of improvement in exercise capacity from supervised exercise training in patients with chronic HFpEF compared with those with heart failure with reduced ejection fraction, although Medicare reimbursement is available only for the latter group. Finally, critical gaps in implementation of exercise-based therapies for patients with HFpEF, including exercise setting, training modalities, combinations with other strategies such as diet and medications, long-term adherence, incorporation of innovative and more accessible delivery methods, and management of recently hospitalized patients are highlighted to provide guidance for future research.

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.

BACKGROUND: Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries. METHODS: The SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft). RESULTS: Of 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0±6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior P value of 1.00; median follow-up, 3.4 years). Falsification end points were negligibly different between groups. In the subgroup treated with contemporary unibody aortic stent grafts, the cumulative incidence of the primary end point occurred in 37.5% of unibody device-treated patients and 32.7% of non-unibody device-treated patients (hazard ratio, 1.06 [95% CI, 0.98-1.14]). CONCLUSIONS: In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

Achieving Equity in Hospital Performance Assessments Using Composite Race-Specific Measures of Risk-Standardized Readmission and Mortality Rates for Heart Failure.

BACKGROUND: The contemporary measures of hospital performance for heart failure hospitalization and 30-day risk-standardized readmission rate (RSRR) and risk-standardized mortality rate (RSMR) are estimated using the same risk adjustment model and overall event rate for all patients. Thus, these measures are mainly driven by the care quality and outcomes for the majority racial and ethnic group, and may not adequately represent the hospital performance for patients of Black and other races. METHODS: Fee-for-service Medicare beneficiaries from January 2014 to December 2019 hospitalized with heart failure were identified. Hospital-level 30-day RSRR and RSMR were estimated using the traditional race-agnostic models and the race-specific approach. The composite race-specific performance metric was calculated as the average of the RSRR/RMSR measures derived separately for each race and ethnicity group. Correlation and concordance in hospital performance for all patients and patients of Black and other races were assessed using the composite race-specific and race-agnostic metrics. RESULTS: The study included 1 903 232 patients (75.7% White [n=1 439 958]; 14.5% Black [n=276 684]; and 9.8% other races [n=186 590]) with heart failure from 1860 hospitals. There was a modest correlation between hospital-level 30-day performance metrics for patients of White versus Black race (Pearson correlation coefficient: RSRR=0.42; RSMR=0.26). Compared with the race-agnostic RSRR and RSMR, composite race-specific metrics for all patients demonstrated stronger correlation with RSRR (correlation coefficient: 0.60 versus 0.74) and RSMR (correlation coefficient: 0.44 versus 0.51) for Black patients. Concordance in hospital performance for all patients and patients of Black race was also higher with race-specific (versus race-agnostic) metrics (RSRR=64% versus 53% concordantly high-performing; 61% versus 51% concordantly low-performing). Race-specific RSRR and RSMR metrics (versus race-agnostic) led to reclassification in performance ranking of 35.8% and 39.2% of hospitals, respectively, with better 30-day and 1-year outcomes for patients of all race groups at hospitals reclassified as high-performing. CONCLUSIONS: Among patients hospitalized with heart failure, race-specific 30-day RSMR and RSRR are more equitable in representing hospital performance for patients of Black and other races.

Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial.

BACKGROUND: In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. METHODS: Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. RESULTS: Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, -$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, -0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. CONCLUSIONS: For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective.