Publications

2024

Alba, Christopher, ZhaoNian Zheng, and Rishi K Wadhera. (2024) 2024. “Changes in Health Care Access and Preventive Health Screenings by Race and Ethnicity.”. JAMA Health Forum 5 (2): e235058. https://doi.org/10.1001/jamahealthforum.2023.5058.

IMPORTANCE: The COVID-19 pandemic led to unprecedented disruptions in health care. Little is known about whether health care access and preventive health screenings among US adults have recovered to prepandemic levels, and how patterns varied by race and ethnicity.

OBJECTIVE: To evaluate health care access and preventive health screenings among eligible US adults in 2021 and 2022 compared with prepandemic year 2019, overall and by race and ethnicity.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from US adults aged 18 years or older who participated in the National Health Interview Survey in 2021 and 2022. Survey weights provided by the National Health Interview Survey were used to generate nationally representative estimates. Data were analyzed from May 23 to November 13, 2023.

MAIN OUTCOMES AND MEASURES: Measures of health care access included the proportion of adults with a usual place for care, those with a wellness visit, and those who delayed or did not receive medical care due to cost within the past year. Preventive health screening measures included eligible adults who received blood pressure, cholesterol, or blood glucose screening within the past year (2021), as well as colorectal, cervical, breast, and prostate cancer screenings based on US Preventive Services Task Force guidelines.

RESULTS: The unweighted study population included 89 130 US adults. The weighted population included 51.6% females; 16.8% Hispanic, 5.9% non-Hispanic Asian (hereafter, Asian), 11.8% non-Hispanic Black (hereafter, Black), 62.8% non-Hispanic White (hereafter, White) individuals; and 2.9% individuals of other races and ethnicities (including American Indian, Alaska Native, Native Hawaiian or other Pacific Islander, or multiracial). After adjusting for age and sex, having a usual place for health care did not differ among adults in 2021 or 2022 vs 2019 (adjusted rate ratio [ARR] for each year, 1.00; 95% CI, 0.99-1.01). However, fewer participants had wellness visits in 2022 compared with 2019 (ARR, 0.98; 95% CI, 0.97-0.99), with the most pronounced decline among Asian adults (ARR, 0.95; 95% CI, 0.92-0.98). In addition, adults were less likely to delay medical care (ARR, 0.79; 95% CI, 0.73-0.87) or to not receive care (ARR, 0.76; 95% CI, 0.69-0.83) due to cost in 2022 vs 2019. Preventive health screenings in 2021 remained below 2019 levels (blood pressure: ARR, 0.95 [95% CI, 0.94-0.96]; blood glucose: ARR, 0.95 [95% CI, 0.93-0.96]; and cholesterol: ARR, 0.93 [95% CI, 0.92-0.94]). Eligible adults were also significantly less likely to receive colorectal cancer screening (ARR, 0.88; 95% CI, 0.81-0.94), cervical cancer screening (ARR, 0.86; 95% CI, 0.83-0.89), breast cancer screening (ARR, 0.93; 95% CI, 0.90-0.97), and prostate cancer screening (ARR, 0.86 [0.78-0.94]) in 2021 vs 2019. Asian adults experienced the largest relative decreases across most preventive screenings, while Black and Hispanic adults experienced large declines in colorectal cancer screening (ARR, 0.78; 95% CI, 0.67-0.91) and breast cancer screening (ARR, 0.83; 95% CI, 0.75-0.91), respectively. Differences in preventive screening rates across years persisted after additional adjustment for socioeconomic factors (income, employment status, and insurance coverage).

CONCLUSIONS AND RELEVANCE: Results of this cohort study suggest that, in the US, wellness visits and preventive health screenings have not returned to prepandemic levels. These findings support the need for public health efforts to increase the use of preventive health screenings among eligible US adults.

Oddleifson, August, ZhaoNian Zheng, and Rishi K Wadhera. (2024) 2024. “Out-of-Pocket Prescription Drug Costs for Adults With Cardiovascular Risk Factors under Amazon’s Direct-to-Consumer Pharmacy Service.”. American Heart Journal 271: 20-27. https://doi.org/10.1016/j.ahj.2024.02.004.

BACKGROUND: US adults often overpay for generic prescription medications, which can lead to medication nonadherence that negatively impacts cardiovascular outcomes. As a result, new direct-to-consumer online medication services are growing in popularity nationwide. Amazon recently launched a $5/month direct-to-consumer medication subscription service (Amazon RxPass), but it is unclear how many US adults could save on out-of-pocket drug costs by using this new service.

OBJECTIVES: To estimate out-of-pocket savings on generic prescription medications achievable through Amazon's new direct-to-consumer subscription medication service for adults with cardiovascular risk factors and/or conditions.

METHODS: Cross-sectional study of adults 18-64 years in the 2019 Medical Expenditure Panel Survey.

RESULTS: Of the 25,280,517 (SE ± 934,809) adults aged 18-64 years with cardiovascular risk factors or conditions who were prescribed at least 1 medication available in the Amazon RxPass formulary, only 6.4% (1,624,587 [SE ± 68,571]) would achieve savings. Among those achieving savings, the estimated average out-of-pocket savings would be $140 (SE ± $15.8) per person per year, amounting to a total savings of $228,093,570 (SE ± $26,117,241). In multivariable regression models, lack of insurance coverage (adjusted odds ratio [OR] 3.5, 95%CI 1.9-6.5) and being prescribed a greater number of RxPass-eligible medications (2-3 medications versus 1 medication: OR 5.6, 95%CI 3.0-10.3; 4+ medications: OR 21.8, 95%CI 10.7-44.3) were each associated with a higher likelihood of achieving out-of-pocket savings from RxPass.

CONCLUSIONS: Changes to the pricing structure of Amazon's direct-to-consumer medication service are needed to expand out-of-pocket savings on generic medications to a larger segment of the working-age adults with cardiovascular risk factors and/or diseases.

Liu, Michael, Sahil Sandhu, Karen E Joynt Maddox, and Rishi K Wadhera. (2024) 2024. “Health Equity Adjustment and Hospital Performance in the Medicare Value-Based Purchasing Program.”. JAMA. https://doi.org/10.1001/jama.2024.2440.

IMPORTANCE: Medicare's Hospital Value-Based Purchasing (HVBP) program will provide a health equity adjustment (HEA) to hospitals that have greater proportions of patients dually eligible for Medicare and Medicaid and that offer high-quality care beginning in fiscal year 2026. However, which hospitals will benefit most from this policy change and to what extent are unknown.

OBJECTIVE: To estimate potential changes in hospital performance after HEA and examine hospital patient mix, structural, and geographic characteristics associated with receipt of increased payments.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed all 2676 hospitals participating in the HVBP program in fiscal year 2021. Publicly available data on program performance and hospital characteristics were linked to Medicare claims data on all inpatient stays for dual-eligible beneficiaries at each hospital to calculate HEA points and HVBP payment adjustments.

EXPOSURES: Hospital Value-Based Purchasing program HEA.

MAIN OUTCOMES AND MEASURES: Reclassification of HVBP bonus or penalty status and changes in payment adjustments across hospital characteristics.

RESULTS: Of 2676 hospitals participating in the HVBP program in fiscal year 2021, 1470 (54.9%) received bonuses and 1206 (45.1%) received penalties. After HEA, 102 hospitals (6.9%) were reclassified from bonus to penalty status, whereas 119 (9.9%) were reclassified from penalty to bonus status. At the hospital level, mean (SD) HVBP payment adjustments decreased by $4534 ($90 033) after HEA, ranging from a maximum reduction of $1 014 276 to a maximum increase of $1 523 765. At the aggregate level, net-positive changes in payment adjustments were largest among safety net hospitals ($28 971 708) and those caring for a higher proportion of Black patients ($15 468 445). The likelihood of experiencing increases in payment adjustments was significantly higher among safety net compared with non-safety net hospitals (574 of 683 [84.0%] vs 709 of 1993 [35.6%]; adjusted rate ratio [ARR], 2.04 [95% CI, 1.89-2.20]) and high-proportion Black hospitals compared with non-high-proportion Black hospitals (396 of 523 [75.7%] vs 887 of 2153 [41.2%]; ARR, 1.40 [95% CI, 1.29-1.51]). Rural hospitals (374 of 612 [61.1%] vs 909 of 2064 [44.0%]; ARR, 1.44 [95% CI, 1.30-1.58]), as well as those located in the South (598 of 1040 [57.5%] vs 192 of 439 [43.7%]; ARR, 1.25 [95% CI, 1.10-1.42]) and in Medicaid expansion states (801 of 1651 [48.5%] vs 482 of 1025 [47.0%]; ARR, 1.16 [95% CI, 1.06-1.28]), were also more likely to experience increased payment adjustments after HEA compared with their urban, Northeastern, and Medicaid nonexpansion state counterparts, respectively.

CONCLUSIONS AND RELEVANCE: Medicare's implementation of HEA in the HVBP program will significantly reclassify hospital performance and redistribute program payments, with safety net and high-proportion Black hospitals benefiting most from this policy change. These findings suggest that HEA is an important strategy to ensure that value-based payment programs are more equitable.

Secemsky, Eric A, Jay Giri, Marianne Brodmann, Yann Gouëffic, Weiguo Fu, Alexandra J Greenberg-Worisek, Michael R Jaff, Lee Kirksey, and Maureen P Kohi. (2024) 2024. “Implementing Methods in the ELEGANCE Registry to Increase Diversity in Clinical Research.”. Journal of Vascular Surgery 79 (1): 136-145.e3. https://doi.org/10.1016/j.jvs.2023.08.131.

OBJECTIVE: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research.

METHODS: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year.

RESULTS: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008).

CONCLUSIONS: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.

Paraskevas, Kosmas I, Martin M Brown, Brajesh K Lal, Piotr Myrcha, Sean P Lyden, Peter A Schneider, Pavel Poredos, et al. (2024) 2024. “Recent Advances and Controversial Issues in the Optimal Management of Asymptomatic Carotid Stenosis.”. Journal of Vascular Surgery 79 (3): 695-703. https://doi.org/10.1016/j.jvs.2023.11.004.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS.

METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS.

RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking.

CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

Paraskevas, Kosmas I, Dimitri P Mikhailidis, Peter Arthur Ringleb, Martin M Brown, Alan Dardik, Pavel Poredos, William A Gray, et al. (2024) 2024. “An International, Multispecialty, Expert-Based Delphi Consensus Document on Controversial Issues in the Management of Patients With Asymptomatic and Symptomatic Carotid Stenosis.”. Journal of Vascular Surgery 79 (2): 420-435.e1. https://doi.org/10.1016/j.jvs.2023.09.031.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear.

METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response.

RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence.

CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Secemsky, Eric A, Lee Kirksey, Elina Quiroga, Claire M King, Melissa Martinson, James T Hasegawa, Nick E J West, and Rishi K Wadhera. (2024) 2024. “Impact of Intensity of Vascular Care Preceding Major Amputation Among Patients With Chronic Limb-Threatening Ischemia.”. Circulation. Cardiovascular Interventions 17 (1): e012798. https://doi.org/10.1161/CIRCINTERVENTIONS.122.012798.

BACKGROUND: Lower-limb amputation rates in patients with chronic limb-threatening ischemia vary across the United States, with marked disparities in amputation rates by gender, race, and income status. We evaluated the association of patient, hospital, and geographic characteristics with the intensity of vascular care received the year before a major lower-limb amputation and how intensity of care associates with outcomes after amputation.

METHODS: Using Medicare claims data (2016-2019), beneficiaries diagnosed with chronic limb-threatening ischemia who underwent a major lower-limb amputation were identified. We examined patient, hospital, and geographic characteristics associated with the intensity of vascular care received the year before amputation. Secondary objectives evaluated all-cause mortality and adverse events following amputation.

RESULTS: Of 33 036 total Medicare beneficiaries undergoing major amputation, 7885 (23.9%) were due to chronic limb-threatening ischemia; of these, 4988 (63.3%) received low-intensity and 2897 (36.7%) received high-intensity vascular care. Mean age, 76.6 years; women, 38.9%; Black adults, 24.5%; and of low income, 35.2%. After multivariable adjustment, those of low income (odds ratio, 0.65 [95% CI, 0.58-0.72]; P<0.001), and to a lesser extent, men (odds ratio, 0.89 [95% CI, 0.81-0.98]; P=0.019), and those who received care at a safety-net hospital (odds ratio, 0.87 [95% CI, 0.78-0.97]; P=0.012) were most likely to receive low intensity of care before amputation. High-intensity care was associated with a lower risk of all-cause mortality 2 years following amputation (hazard ratio, 0.79 [95% CI, 0.74-0.85]; P<0.001).

CONCLUSIONS: Patients who were of low-income status, and to a lesser extent, men, or those cared for at safety-net hospitals were most likely to receive low-intensity vascular care. Low-intensity care was associated with worse long-term event-free survival. These data emphasize the continued disparities that exist in contemporary vascular practice.