Eligibility Criteria for Active Ulcerative Pyoderma Gangrenosum in Clinical Trials: A Delphi Consensus on Behalf of the UPGRADE (Understanding Pyoderma Gangrenosum: Review and Assessment of Disease Effects) Group.

At present, there are no standardized guidelines for determining patient eligibility for pyoderma gangrenosum (PG) clinical trials. Thus, we aim to determine which clinical features, histopathological features, or laboratory features should be included in active ulcerative PG clinical trial eligibility criteria for treatment-naïve patients and patients already treated with immunomodulating medications (treatment-exposed patients). This study employed 4 rounds of the Delphi technique. Electronic surveys were administered to 21 international board-certified dermatologists and plastic surgeon PG experts (June 2022-December 2022). Our results demonstrated that for a patient to be eligible for a PG trial, they must meet the following criteria: (i) presence of ulcer(s) with erythematous/violaceous undermining wound borders, (ii) presence of a painful or tender ulcer, (iii) history/presence of rapidly progressing disease, (iv) exclusion of infection and other causes of cutaneous ulceration, (v) biopsy for H&E staining, and (vi) a presence/history of pathergy. These criteria vary in importance for treatment-naïve versus treatment-exposed patients. Given the international cohort, we were unable to facilitate live discussions between rounds. This Delphi consensus study provides a set of specific, standardized eligibility criteria for PG clinical trials, thus addressing one of the main issues hampering progress toward Food and Drug Administration approval of medications for PG.

Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort.

OBJECTIVE: To determine eligibility for discontinuation of cervical cancer screening. METHODS: Women aged 64 with employer-sponsored insurance enrolled in a national database between 2016 and 2018, and those aged 64-66 receiving primary care at a safety net health center in 2019 were included. Patients were evaluated for screening exit eligibility by current guidelines: no evidence of cervical cancer or HIV-positive status and no evidence of cervical precancer in the past 25 years, and had evidence of either hysterectomy with removal of the cervix or evidence of fulfilling screening exit criteria, defined as two HPV screening tests or HPV plus Pap co-tests or three Pap tests within the past 10 years without evidence of an abnormal result. RESULTS: Of the 590,901 women in the national claims database, 131,059 (22.2%) were eligible to exit due to hysterectomy (1.6%) or negative screening (20.6%). Of the 1544 women from the safety net health center, 528 (34.2%) were eligible to exit due to hysterectomy (9.3%) or negative screening (24.9%). Most women did not have sufficient data available to fulfill exit criteria: 382,509 (64.7%) in the national database and 875 (56.7%) in the safety net hospital system. Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening. CONCLUSIONS: Examining insurance claims in a national database and electronic medical records at a safety net institution led to remarkably similar findings: two thirds of women fail to qualify for screening exit. Additional steps to ensure eligibility prior to screening exit may be necessary to decrease preventable cervical cancers among women aged >65. CLINICAL TRIAL REGISTRATION: N/A.

Association of the Comprehensive Care for Joint Replacement Model With Disparities in the Use of Total Hip and Total Knee Replacement.

Importance: The Comprehensive Care for Joint Replacement (CJR) model is Medicare's mandatory bundled payment reform to improve quality and spending for beneficiaries who need total hip replacement (THR) or total knee replacement (TKR), yet it does not account for sociodemographic risk factors such as race/ethnicity and income. Results of this study could be the basis for a Medicare payment reform that addresses inequities in joint replacement care. Objective: To examine the association of the CJR model with racial/ethnic and socioeconomic disparities in the use of elective THR and TKR among older Medicare beneficiaries after accounting for the population of patients who were at risk or eligible for these surgical procedures. Design, Setting, and Participants: This cohort study used the 2013 to 2017 national Medicare data and multivariable logistic regressions with triple-differences estimation. Medicare beneficiaries who were aged 65 to 99 years, entitled to Medicare, alive at the end of the calendar year, and residing either in the 67 metropolitan statistical areas (MSAs) mandated to participate in the CJR model or in the 104 control MSAs were identified. A subset of Medicare beneficiaries with a diagnosis of arthritis underwent THR or TKR. Data were analyzed from March to December 2020. Exposures: Implementation of the CJR model in 2016. Main Outcomes and Measures: Outcomes were separate binary indicators for whether a beneficiary underwent THR or TKR. Key independent variables were MSA treatment status, pre- or post-CJR model implementation phase, combination of race/ethnicity (non-Hispanic White, non-Hispanic Black, and Hispanic beneficiaries) and dual eligibility, and their interactions. Logistic regression models were used to control for patient characteristics, MSA fixed effects, and time trends. Results: The 2013 cohort included 4 447 205 Medicare beneficiaries, of which 2 025 357 (45.5%) resided in MSAs with the CJR model. The cohort's mean (SD) age was 77.18 (7.95) years, and it was composed of 2 951 140 female (66.4%), 3 928 432 non-Hispanic White (88.3%), and 657 073 dually eligible (14.8%) beneficiaries. Before the CJR model implementation, rates were highest among non-Hispanic White non-dual-eligible beneficiaries at 1.25% (95% CI, 1.24%-1.26%) for THR use and 2.28% (95% CI, 2.26%-2.29%) for TKR use in MSAs with CJR model. Compared with MSAs without the CJR model and the analogous race/ethnicity and dual-eligibility group, the CJR model was associated with a 0.10 (95% CI, 0.05-0.15; P < .001) percentage-point increase in TKR use for non-Hispanic White non-dual-eligible beneficiaries, a 0.11 (95% CI, 0.004-0.21; P = .04) percentage-point increase for non-Hispanic White dual-eligible beneficiaries, a 0.15 (95% CI, -0.29 to -0.01; P = .04) percentage-point decrease for non-Hispanic Black non-dual-eligible beneficiaries, and a 0.18 (95% CI, -0.34 to -0.01; P = .03) percentage-point decrease for non-Hispanic Black dual-eligible beneficiaries. These CJR model-associated changes in TKR use were 0.25 (95% CI, -0.40 to -0.10; P = .001) percentage points lower for non-Hispanic Black non-dual-eligible beneficiaries and 0.27 (95% CI, -0.45 to -0.10; P = .002) percentage points lower for non-Hispanic Black dual-eligible beneficiaries compared with the model-associated changes for non-Hispanic White non-dual-eligible beneficiaries. No association was found between the CJR model and a widening of the THR use gap among race/ethnicity and dual eligibility groups. Conclusions and Relevance: Results of this study indicate that the CJR model was associated with a modest increase in the already substantial difference in TKR use among non-Hispanic Black vs non-Hispanic White beneficiaries; no difference was found for THR. These findings support the widespread concern that payment reform has the potential to exacerbate disparities in access to joint replacement care.

Struggle for the Soul of Medicaid.

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the "soul" of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

Gender as a principle of the organization of clinical sleep research.

In 2014 the National Institutes of Health required researchers to examine sex as a biological variable. While this approach is necessary to ensure adequate and appropriate female inclusion in research studies, it puts researchers at high risk for attributing their findings to biological sex differences when instead they may be more appropriately attributed to the influence and expectations of gender. In this paper, we specify how gender works as a principle of the social organization of symptoms, experiences, research, and clinical practice using obstructive sleep apnea symptomology to illustrate these patterns. We draw from psychologist Sandra Bem's account differentiating three specific mechanisms of gender: gender polarization, androcentrism, and biological essentialism.

Comorbidity Assessment Is Uneven Across Veterans Health Administration and Medicare for the Same Patient: Implications for Risk Adjustment.

OBJECTIVE: Compare comorbidity identification in Medicare and Veterans Health Administration (VA) data for the purposes of risk adjustment. DATA SOURCES: Analysis of Medicare and VA datasets for dually-enrolled Veterans receiving care in both settings, fiscal years 2010-2014. STUDY DESIGN: A retrospective analysis of administrative data for a national sample of cancer decedents. DATA EXTRACTION METHODS: Comorbidities were evaluated using Elixhauser and Charlson coding algorithms. PRINCIPAL FINDINGS: Clinical comorbidities were more likely to be recorded in Medicare than in VA datasets. Of 42 comorbidities, 36 (86%) were recorded at a different frequency. For example, congestive heart failure was recorded for 22.0% of patients in Medicare data and for 11.3% of patients in VA data (P<0.001). CONCLUSION: There are large differences in comorbidity assessment across VA and Medicare administrative data for the same patient, posing challenges for risk adjustment.

Center-related Bias in MELD Scores Within a Liver Transplant UNOS Region: A Call for Standardization.

BACKGROUND: Model for End-Stage Liver Disease (MELD) score-based liver transplant allocation was implemented as a fair and objective measure to prioritize patients based upon disease severity. Accuracy and reproducibility of MELD is an essential assumption to ensure fairness in organ access. We hypothesized that variability in laboratory methodology between centers could impact allocation scores for individuals on the transplant waiting list. METHODS: Aliquots of 30 patient serum samples were analyzed for creatinine, bilirubin, and sodium in all transplant centers within United Network for Organ Sharing (UNOS) region 9. Descriptive statistics, intraclass correlation coefficients (ICCs), and linear mixed-effects regression were used to determine the relationship between center, bilirubin, and calculated MELD-sodium (MELD-Na) score. RESULTS: The mean MELD-Na score per sample ranged from 14 to 38. The mean range in MELD-Na per sample was 3 points, but 30% of samples had a range of 4-6 points. Correlation plots and intraclass correlation coefficient analysis confirmed bilirubin interfered with creatinine, with worsening agreement in creatinine at high bilirubin levels. Center and bilirubin were independently associated with creatinine reported in mixed-effects models. Unbiased hierarchical clustering suggested that samples from specific centers have consistently higher creatinine and MELD-Na values. CONCLUSIONS: Despite implementation of creatinine standardization, centers within a single UNOS region report clinically significant differences in MELD-Na on an identical sample, with differences of up to 6 points in high MELD-Na patients. The bias in MELD-Na scores based upon center choice within a region should be addressed in the current efforts to eliminate disparities in liver transplant access.

Identifying Disadvantaged Groups for Cochlear Implantation: Demographics from a Large Cochlear Implant Program.

OBJECTIVE: To identify demographic predictors of patients undergoing cochlear implantation evaluation and surgery. METHODS: Consecutive adult patients between 2009 and 2018 who underwent cochlear implantation evaluation at a university cochlear implantation program were retrospectively identified to determine (1) cochlear implantation qualification rate and (2) pursuit of surgery rate with respect to age, gender, race, primary spoken language, marital status, insurance type, and distance to the cochlear implantation center. RESULTS: A total of 823 cochlear implantation evaluations were analyzed. Overall, 76.3% of patients qualified for cochlear implantation and 61.5% of these patients pursued surgery. Age was the only independent predictor for cochlear implantation qualification, such that, for each year younger, the odds of qualifying for cochlear implantation increased by 2.5% (OR 0.98; 95% CI: 0.96-0.99). Age, race, marital status, and insurance type were each independent predictors of the decision to pursue surgery. The odds of pursuing surgery increased by 2.8% for each year younger (OR 1.03; 95% CI: 1.01-1.05). Compared to White patients, non-Whites were half as likely to pursue surgery (OR 0.47; 95% CI: 0.25-0.88). Single (OR 0.49; 95% CI: 0.26-0.94) and widowed patients (OR 0.46; 95% CI: 0.23-0.95) were about half as likely to pursue surgery as compared to married patients. Patients with military insurance were 13 times more likely to pursue surgery as compared to patients with Medicare (OR 13.0; 95% CI: 1.67-101.4). CONCLUSION: Younger age is an independent predictor for a higher cochlear implantation qualification rate, suggesting the possibility for delayed candidacy referral. Rate of surgical pursuit in qualified cochlear implantation candidates is lower for racial minorities, single and widowed patients, and older patients.

State variation in the characteristics of Medicare-Medicaid dual enrollees: Implications for risk adjustment.

OBJECTIVE: To examine between-state differences in the socioeconomic and health characteristics of Medicare beneficiaries dually enrolled in Medicaid, focusing on characteristics not observable to or used by policy makers for risk adjustment. DATA SOURCE: 2010-2013 Medicare Current Beneficiary Survey. STUDY DESIGN: Retrospective analyses of survey-reported health and socioeconomic status (SES) measures among low-income Medicare beneficiaries and low-income dual enrollees. We used hierarchical linear regression models with state random effects to estimate the between-state variation in respondent characteristics and linear models to compare the characteristics of dual enrollees by state Medicaid policies. PRINCIPAL FINDINGS: Between-state differences in health and socioeconomic risk among low-income Medicare beneficiaries, as measured by the coefficient of variation, ranged from 17.5 percent for an index of socioeconomic risk to 20.3 percent for an index of health risk. Between-state differences were comparable among the subset of low-income beneficiaries dually enrolled in Medicare and Medicaid. Dual enrollees with incomes below the Federal Poverty Level were in better health and had higher SES in states that offered Medicaid to individuals with relatively higher incomes. Duals' average incomes were higher in states with Medically Needy programs. CONCLUSIONS: Characteristics of dual enrollees differ substantially across states, reflecting differences in states' low-income Medicare populations and Medicaid policies. Risk-adjustment methods using dual enrollment to proxy for poor health and low SES should account for this state-level heterogeneity.

Targeting subsidised inpatient services to the poor in a setting with limited state capacity: proxy means testing in Myanmar's hospital equity fund scheme.

OBJECTIVES: Many low- and middle-income countries (LMICs) provide subsidised access to health services for the poor. Proxy means tests (PMTs) for income are typically employed to identify eligible beneficiaries for subsidised services but often result in significant mistargeting of benefits. We assessed the PMT approach used in Myanmar's hospital equity fund (HEF). METHODS: We analysed inclusion/exclusion errors by comparing household eligibility under the PMT used for HEF with household consumption (the gold standard proxy for income in LMICs). We assessed receipt of benefits post-hospitalisation against HEF eligibility rules and household income. Focus groups/interviews were conducted to understand administrative factors that influence targeting. We modelled (linear regression) predictors of household consumption to improve PMT accuracy. RESULTS: We found large targeting errors (86% of households in the bottom consumption quartile would be excluded and 15% of households in the top consumption quartile deemed eligible). HEF scores for PMT held little explanatory power for household income: 93% of individuals meeting the HEF eligibility criteria did not receive benefits post-hospitalisation, while 23% of ineligible individuals received programme support. Re-weighting PMT indicators on electricity access, land ownership and livestock ownership, and assigning weights to home-ownership, households with elderly/disabled members and household head education levels could significantly improve targeting accuracy. Poor programme awareness and uneven adherence to official eligibility determination procedures among staff likely affected targeting. CONCLUSIONS: Re-weighting PMT indicators and increasing training and communication about qualification procedures could improve allocation of limited funds, though accurate targeting may continue to be challenging in contexts of low state capacity.

OBJECTIFS: De nombreux pays à revenu faible ou intermédiaire (PRFI) offrent un accès subventionné aux services de santé pour les pauvres. Les tests des proxys moyens (TPM) de revenus sont généralement utilisés pour identifier les bénéficiaires éligibles pour les services subventionnés, mais aboutissent souvent à un ciblage erroné important des avantages. Nous avons évalué l'approche TPM utilisée dans le fonds d'équité des hôpitaux (FEH) du Myanmar. MÉTHODES: Nous avons analysé les erreurs d'inclusion/exclusion en comparant l'éligibilité d'un ménage selon le TPM utilisé pour le FEH avec la consommation du ménage (indicateur de référence par excellence du revenu dans les PRFI). Nous avons évalué la réception des prestations après l'hospitalisation par rapport aux règles d'éligibilité du FEH et au revenu du ménage. Des discussions de groupes ont été menées pour comprendre les facteurs administratifs qui influencent le ciblage. Nous avons modélisé (régression linéaire) les prédicteurs de la consommation des ménages afin d'améliorer la précision du TPM. RÉSULTATS: Nous avons constaté d'importantes erreurs de ciblage (86% des ménages du quartile de consommation le plus bas seraient exclus et 15% des ménages du quartile de consommation le plus haut jugés éligibles). Les scores FEH du TPM ont peu de pouvoir explicatif sur le revenu du ménage: 93% des personnes répondant aux critères d'éligibilité du FEH ne bénéficiaient pas de prestations post hospitalisation, tandis que 23% des personnes non éligibles recevaient un soutien du programme. La repondération des indicateurs du TPM sur l'accès à l'électricité, la propriété foncière et la propriété du bétail, et l'attribution de pondérations à la propriété du logement, aux ménages composés de personnes âgées/handicapées et au niveau d'éducation des chefs de ménage pourraient améliorer considérablement la précision du ciblage. La faible sensibilisation du programme et le respect inégal des procédures officielles de détermination de l'éligibilité parmi le personnel ont probablement affecté le ciblage. CONCLUSIONS: Une repondération des indicateurs du TPM et une augmentation de la formation et de la communication sur les procédures de qualification pourraient améliorer l'allocation de fonds limités, bien qu'un ciblage précis puisse continuer à être un défi dans des contextes de faible capacité de l'Etat.

Comparative Effectiveness of Medication Therapy Management Eligibility Criteria Across Racial/Ethnic Groups.

BACKGROUND/OBJECTIVES: Previous research indicates that eligibility criteria for medication therapy management (MTM) services in Medicare prescription drug (Part D) plans, defined under the Medicare Modernization Act (MMA), are associated with racial/ethnic disparities and ineffective in identifying individuals with medication utilization issues. Our study's objective was to determine the comparative effectiveness of MTM eligibility criteria under MMA and in the Affordable Care Act (ACA) in identifying patients with medication utilization issues across racial/ethnic groups. DESIGN: ACA and MMA MTM eligibility criteria were compared on proportions of eligible individuals among patients with medication utilization issues. Multinomial logistic regression was conducted to control for patient/community characteristics. Need-based and demand-based analyses were used to determine disparities due to need and demand for healthcare. Main/sensitivity analyses were conducted for the range of eligibility thresholds. SETTING: Medicare data (2012-2013) linked to Area Health Resources Files. PARTICIPANTS: A total of 964 610 patients 65 years or older. MEASUREMENTS: Medication safety/adherence measures, developed primarily by the Pharmacy Quality Alliance, were used to determine medication utilization issues. RESULTS: Higher proportions of patients were eligible based on ACA than MMA MTM eligibility criteria. For example, in 2013, proportions based on ACA and MMA MTM eligibility criteria would be 99.7% and 26.2%, respectively, in the main analysis (p < .001); in the demand-based main analysis, ACA criteria were associated with 13.6% and 9.8%, respectively, higher effectiveness than MMA criteria among non-Hispanic blacks and Hispanics than non-Hispanic whites. CONCLUSION: ACA MTM eligibility criteria are more effective than MMA criteria in identifying older patients needing MTM, particularly among minorities. J Am Geriatr Soc 67:581-587, 2019.

The Uneven Foci of Work Disability Research Across Cause-based and Comprehensive Social Security Systems.

This scoping review identified what kinds of work disability policy issues are critiqued in articles published in countries with cause-based versus comprehensive welfare systems. Drawing on a review of work disability policy research, we identified 74 English-language, peer-reviewed articles that focused on program adequacy and design. Articles on cause-based systems dwelled on system fairness and policies of proof of entitlement, while those on comprehensive systems focused more on system design complexities relating to worker inclusion and scope of medical certificates. Overall, we observed a clear difference in the nature of problems examined in the different systems. Gaps in work disability policy literature are identified, and challenges for comparative policy research are discussed.

Work Requirements That Don't Work.

Early in 2018, the Trump administration's Centers for Medicare and Medicaid Services issued a guidance letter outlining a new and controversial kind of Medicaid waiver proposal. The administration invited states to propose waivers that would impose work (or other "community engagement") requirements as a condition of eligibility for Medicaid. The Trump administration and state proponents of work requirements want to force able-bodied Medicaid beneficiaries into the workplace. Critics allege that this is because they mistakenly believe that low-income individuals are not working because they're lazy or because aid programs provide them with a disincentive to work. Proponents respond that the requirements can lower the public programs' costs while helping its recipients. Medicaid data seems to show that the work-requirement proposals are a solution in search of a real-life problem.

National evaluation of policies governing funding for wheelchairs and scooters in Canada: Évaluation nationale des politiques régissant le financement des fauteuils roulants, des triporteurs et des quadriporteurs au Canada.

BACKGROUND: Wheelchairs, scooters, and related equipment are essential for the well-being of individuals with limited mobility and impact participation, health, and quality of life. PURPOSE: Our objective was to identify and evaluate policies governing equipment funding for Canadian adults. We reviewed funding legislation and program documentation for adult Canadians (≥18 years of age) covered by their provincial, territorial, or federal health care plan. Documents were obtained online or through administrative staff. Policy evaluation was guided by the Disability Policy Lens from the Canadian Disability Policy Alliance. KEY ISSUES: Coverage ranges from full funding for all individuals within the jurisdiction to programs limited by strict eligibility criteria. Each jurisdiction defines "disability" or "basic/essential need" differently, contributing to further funding disparities. IMPLICATIONS: Funding policies differ substantially across Canada, resulting in unequal access to equipment dependent on province or territory. We identified eligibility, funding, definitions of mobility, repair and replacement, and prescriber requirement benchmarks that represent policy targets for improved access.

Changing Attitudes and Knowledge Toward SNAP Application.

PURPOSE: To examine effectiveness of an educational intervention on attitude and knowledge related to accessing and qualifying for the Supplemental Nutrition Assistance Program (SNAP). DESIGN: Cross-sectional survey. SETTING: Community sites (38) in North Carolina. PARTICIPANTS: Low-income adult participants who provided data (n = 558). INTERVENTION: Participants completed pre- and postsurveys for the 45-minute program. MEASURES: Theoretically based surveys measured knowledge requisite to the decision to apply for SNAP benefits. ANALYSIS: Paired sample t tests tested the hypothesis of "no difference" in postintervention knowledge. RESULTS: Knowledge gains were statistically significant on all questions ( P < .01) including the amount of food a minimum benefit could purchase, how to apply for SNAP, how the electronic benefit transfer card and benefits work, eligibility restrictions, and how to receive application assistance. Subsequent percentage change analyses revealed the strongest intervention effects to be how to apply and accessing application assistance. CONCLUSION: Effective theory-based programs can improve knowledge and dispel myths concerning SNAP participation among low-income participants.