Pragmatic strategies to address health disparities along the continuum of care in chronic liver disease.

Racial, ethnic, and socioeconomic disparities exist in the prevalence and natural history of chronic liver disease, access to care, and clinical outcomes. Solutions to improve health equity range widely, from digital health tools to policy changes. The current review outlines the disparities along the chronic liver disease health care continuum from screening and diagnosis to the management of cirrhosis and considerations of pre-liver and post-liver transplantation. Using a health equity research and implementation science framework, we offer pragmatic strategies to address barriers to implementing high-quality equitable care for patients with chronic liver disease.

Liver Transplant Costs and Activity After United Network for Organ Sharing Allocation Policy Changes.

Importance: A new liver allocation policy was implemented by United Network for Organ Sharing (UNOS) in February 2020 with the stated intent of improving access to liver transplant (LT). There are growing concerns nationally regarding the implications this new system may have on LT costs, as well as access to a chance for LT, which have not been captured at a multicenter level. Objective: To characterize LT volume and cost changes across the US and within specific center groups and demographics after the policy implementation. Design, Setting, and Participants: This cross-sectional study collected and reviewed LT volume from multiple centers across the US and cost data with attention to 8 specific center demographics. Two separate 12-month eras were compared, before and after the new UNOS allocation policy: March 4, 2019, to March 4, 2020, and March 5, 2020, to March 5, 2021. Data analysis was performed from May to December 2022. Main Outcomes and Measures: Center volume, changes in cost. Results: A total of 22 of 68 centers responded comparing 1948 LTs before the policy change and 1837 LTs postpolicy, resulting in a 6% volume decrease. Transplants using local donations after brain death decreased 54% (P < .001) while imported donations after brain death increased 133% (P = .003). Imported fly-outs and dry runs increased 163% (median, 19; range, 1-75, vs 50, range, 2-91; P = .009) and 33% (median, 3; range, 0-16, vs 7, range, 0-24; P = .02). Overall hospital costs increased 10.9% to a total of $46 360 176 (P = .94) for participating centers. There was a 77% fly-out cost increase postpolicy ($10 600 234; P = .03). On subanalysis, centers with decreased LT volume postpolicy observed higher overall hospital costs ($41 720 365; P = .048), and specifically, a 122% cost increase for liver imports ($6 508 480; P = .002). Transplant centers from low-income states showed a significant increase in hospital (12%) and import (94%) costs. Centers serving populations with larger proportions of racial and ethnic minority candidates and specifically Black candidates significantly increased costs by more than 90% for imported livers, fly-outs, and dry runs despite lower LT volume. Similarly, costs increased significantly (>100%) for fly-outs and dry runs in centers from worse-performing health systems. Conclusions and Relevance: Based on this large multicenter effort and contrary to current assumptions, the new liver distribution system appears to place a disproportionate burden on populations of the current LT community who already experience disparities in health care. The continuous allocation policies being promoted by UNOS could make the situation even worse.

Racial and Gender Disparities in Transplantation of Hepatitis C+ Hearts and Lungs.

BACKGROUND: Transplanting organs from hepatitis C virus (HCV)-infected donors into HCV-negative recipients has led to thousands of more transplants in the United States since 2016. Studies have demonstrated disparities in utilization of kidneys from these donors due to gender and education. It is still unknown, however, if the same disparities are seen in heart and lung transplantation. METHODS: We used Organ Procurement and Transplantation/United Network for Organ Sharing data on all isolated heart and lung transplants from November 1, 2018, to March 31, 2023, classifying donors based on their HCV nucleic acid test (NAT) result: HCV-NAT- vs HCV-NAT+. We fit separate mixed-effects logistic regression models (outcome: HCV-NAT+ donor) for heart and lung transplants. Primary covariates included (1) race/ethnicity, (2) sex, (3) education level, (4) insurance type, and (5) transplant year. RESULTS: The study included 26,108 adults (14,189 isolated heart transplant recipients and 11,919 isolated lung transplant recipients). A total of 993 (7.0%) heart transplants involved an HCV-NAT+ donor, compared to 457 (3.8%) lung transplants. In multivariable models among all isolated heart transplant recipients, women were significantly less likely to receive an HCV-NAT+ donor heart (odds ratio [OR]: 0.79, 95% confidence interval [CI]: 0.67-0.92, p = 0.003), as were Asian patients (OR: 0.52, 95% CI: 0.31-0.86, p = 0.01). In multivariable models among all isolated lung transplant recipients, Asians were significantly less likely to receive HCV-NAT+ transplants (OR: 0.31, 95% CI: 0.12-0.77, p = 0.01). CONCLUSIONS: There are disparities in utilization of heart and lungs from HCV-NAT+ donors, with women and Asian patients being significantly less likely to receive these transplants.

A semiautomated risk assessment method for consumer products.

In this study, we develop a model that assesses product risk using online reviews from Amazon.com. We first identify unique words and phrases capable of identifying hazards. Second, we estimate risk severity using hazard type weights and risk likelihood using total reviews as a proxy for sales volume. In addition, we obtain expert assessments of product hazard risk (risk likelihood and severity) from a sample of high- and low-risk consumer products identified by a computerized risk assessment model we have developed. Third, we assess the validity of our computerized product risk assessment scoring model by utilizing the experts' survey responses. We find that our model is especially consistent with expert judgments of hazard likelihood but not as consistent with expert judgments of hazard severity. This model helps organizations to determine the risk severity, risk likelihood, and overall risk level of a specific product. The model produced by this study is helpful for product safety practitioners in product risk identification, characterization, and mitigation.

Regional Social Vulnerability is Associated With Geographic Disparity in Waitlist Outcomes for Patients With Non-Hepatocellular Carcinoma Model for End-stage Liver Disease Exceptions in the United States.

OBJECTIVE: This study was undertaken to evaluate the role of regional social vulnerability in geographic disparity for patients listed for liver transplantation with non-hepatocellular carcinoma (HCC) model for end-stage liver disease (MELD) exceptions. SUMMARY AND BACKGROUND: Prior work has demonstrated regional variability in the appropriateness of MELD exceptions for diagnoses other than HCC. METHODS: Adults listed at a single center for first-time liver-only transplantation without HCC after June 18, 2013 in the Scientific Registry of Transplant Recipients database as of March 2021 were examined. Candidates were mapped to hospital referral regions (HRRs). Adjusted likelihood of mortality and liver transplantation were modeled. Advantaged HRRs were defined as those where exception patients were more likely to be transplanted, yet no more likely to die in adjusted analysis. The Centers for Disease Control's Social Vulnerability Index (SVI) was used as the measure for community health. Higher SVIs indicate poorer community health. RESULTS: There were 49,494 candidates in the cohort, of whom 4337 (8.8%) had MELD exceptions. Among continental US HRRs, 27.3% (n = 78) were identified as advantaged. The mean SVI of advantaged HRRs was 0.42 versus 0.53 in nonadvantaged HRRs ( P = 0.002), indicating better community health in these areas. Only 25.3% of advantaged HRRs were in spatial clusters of high SVI versus 40.7% of nonadvantaged HRRs, whereas 44.6% of advantaged HRRs were in spatial clusters of low SVI versus 38.0% of nonadvantaged HRRs ( P = 0.037). CONCLUSIONS: An advantage for non-HCC MELD exception patients is associated with lower social vulnerability on a population level. These findings suggest assigning similar waitlist priority to all non-HCC exception candidates without considering geographic differences in social determinants of health may actually exacerbate rather than ameliorate disparity.

A randomized trial of mailed outreach with behavioral economic interventions to improve liver cancer surveillance.

BACKGROUND: Surveillance rates for HCC remain limited in patients with cirrhosis. We evaluated whether opt-out mailed outreach increased uptake with or without a $20 unconditional incentive. METHODS: This was a pragmatic randomized controlled trial in an urban academic health system including adult patients with cirrhosis or advanced fibrosis, at least 1 visit to a specialty practice in the past 2 years and no surveillance in the last 7 months. Patients were randomized in a 1:2:2 ratio to (1) usual care, (2) a mailed letter with a signed order for an ultrasound, or (3) a mailed letter with an order and a $20 unconditional incentive. The main outcome was the proportion with completion of ultrasound within 6 months. RESULTS: Among the 562 patients included, the mean age was 62.1 (SD 11.1); 56.8% were male, 51.1% had Medicare, and 40.6% were Black. At 6 months, 27.6% (95% CI: 19.5-35.7) completed ultrasound in the Usual care arm, 54.5% (95% CI: 47.9-61.0) in the Letter + Order arm, and 54.1% (95% CI: 47.5-60.6) in the Letter + Order + Incentive arm. There was a significant increase in the Letter + Order arm compared to Usual care (absolute difference of 26.9%; 95% CI: 16.5-37.3; p<0.001), but no significant increase in the Letter + Order + Incentive arm compared to Letter + Order (absolute difference of -0.4; 95% CI: -9.7 to 8.8; p=0.93). CONCLUSIONS: There was an increase in HCC surveillance from mailed outreach with opt-out framing and a signed order slip, but no increase in response to the financial incentive.

Cost-effectiveness of long-term psychoanalytic psychotherapy for treatment-resistant depression: RCT evidence from the Tavistock Adult Depression Study (TADS).

BACKGROUND: Treatment-resistant depression (TRD) accounts for a large fraction of the burden of depression. The interventions currently used are mostly pharmacological and short-term psychotherapies, but their effectiveness is limited. The Tavistock Adult Depression Study found evidence for the effectiveness of long-term psychoanalytic psychotherapy (LTPP) plus treatment as usual (TAU), versus TAU alone, for TRD. Even after a 2-year follow-up, moderate effect sizes were sustained. This study assessed the cost-effectiveness of this LTPP + TAU. METHODS: We conducted a within-trial economic evaluation using a Bayesian framework. RESULTS: Quality-adjusted life years (QALYs) were 0.16 higher in the LTPP + TAU group compared with TAU. The direct cost of LTPP was £5500, with no substantial compensating savings elsewhere. Overall, average health and social care costs in the LTPP + TAU group were £5000 more than in the TAU group, employment rates were unchanged, and effects on other non-healthcare costs were uncertain. Accordingly, the incremental cost-effectiveness ratio was ≈£33,000/QALY; the probability that LTPP + TAU was cost-effective at a willingness to pay of £20,000/QALY was 18 %. LIMITATIONS: The sample size of this study was relatively small, and the fraction of missing service-use data was approximately 50 % at all time points. The study was conducted at a single site, potentially reducing generalizability. CONCLUSIONS: Although LTPP + TAU was found to be clinically effective for treating TRD, it was not found to be cost-effective compared with TAU. However, given the sustained effects over the follow-up period it is likely that the time horizon of this study was too short to capture all benefits of LTPP augmentation.

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

BACKGROUND AND OBJECTIVES: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. MATERIALS AND METHODS: For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. RESULTS: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. CONCLUSION: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

Racial, Ethnic, and Socioeconomic Inequities in Access to Left Atrial Appendage Occlusion.

Background Inequitable access to high-technology therapeutics may perpetuate inequities in care. We examined the characteristics of US hospitals that did and did not establish left atrial appendage occlusion (LAAO) programs, the patient populations those hospitals served, and the associations between zip code-level racial, ethnic, and socioeconomic composition and rates of LAAO among Medicare beneficiaries living within large metropolitan areas with LAAO programs. Methods and Results We conducted cross-sectional analyses of Medicare fee-for-service claims for beneficiaries aged 66 years or older between 2016 and 2019. We identified hospitals establishing LAAO programs during the study period. We used generalized linear mixed models to measure the association between zip code-level racial, ethnic, and socioeconomic composition and age-adjusted rates of LAAO in the most populous 25 metropolitan areas with LAAO sites. During the study period, 507 candidate hospitals started LAAO programs, and 745 candidate hospitals did not. Most new LAAO programs opened in metropolitan areas (97.4%). Compared with non-LAAO centers, LAAO centers treated patients with higher median household incomes (difference of $913 [95% CI, $197-$1629], P=0.01). Zip code-level rates of LAAO procedures per 100 000 Medicare beneficiaries in large metropolitan areas were 0.34% (95% CI, 0.33%-0.35%) lower for each $1000 zip code-level decrease in median household income. After adjustment for socioeconomic markers, age, and clinical comorbidities, LAAO rates were lower in zip codes with higher proportions of Black or Hispanic patients. Conclusions Growth in LAAO programs in the United States had been concentrated in metropolitan areas. LAAO centers treated wealthier patient populations in hospitals without LAAO programs. Within major metropolitan areas with LAAO programs, zip codes with higher proportions of Black and Hispanic patients and more patients experiencing socioeconomic disadvantage had lower age-adjusted rates of LAAO. Thus, geographic proximity alone may not ensure equitable access to LAAO. Unequal access to LAAO may reflect disparities in referral patterns, rates of diagnosis, and preferences for using novel therapies experienced by racial and ethnic minority groups and patients experiencing socioeconomic disadvantage.

Impact of Medicaid Expansion on Incidence and Mortality from Gastric and Esophageal Cancer.

BACKGROUND AND AIMS: Individuals in Medicaid expanded states have increased access to treatment for medical conditions and other health care resources. Esophageal and gastric cancer are associated with several modifiable risk factors (e.g. smoking, drinking, Helicobacter pylori infection). The impact of Medicaid expansion on these cancers incidence and mortality remains uninvestigated. METHODS: We evaluated the association between Medicaid expansion and gastric and esophageal cancer incidence and mortality in adults aged 25-64. We employed an observational design using a difference-in-differences method with state level data, from 2010 to 2017. Annual, age-adjusted gastric and esophageal cancer incidence and mortality rates, from the CDC Wonder Database, were analyzed. Rates were adjusted for by several socio-demographic factors. RESULTS: Expansion and non-expansion states were similar in percent Hispanic ethnicity and female gender. The non-expansion states had significantly higher proportion of Black race, diabetics, obese persons, smokers, and those living below the federal poverty line. Adjusted analyses demonstrate that expansion states had significantly fewer new cases of gastric cancer: - 1.6 (95% CI 0.2-3.5; P = 0.08) per 1,000,000 persons per year. No significant association was seen between Medicaid expansion and gastric cancer mortality (0.46 [95% CI - 0.08 to 0.17; P = 0.46]) and esophageal cancer incidence (0.8 [95% CI - 0.08 to 0.24; P = 0.33]) and mortality (1.0 [95% CI - 0.06 to 0.26; P = 0.21]) in multivariable analyses. CONCLUSION: States that adopted Medicaid expansion saw a decrease in gastric cancer incidence when compared to states that did not expand Medicaid. Though several factors may influence gastric cancer incidence, this association is important to consider during health policy negotiations.

Recipient and Center Factors Associated With Immunosuppression Practice Beyond the First Year After Liver Transplantation and Impact on Outcomes.

BACKGROUND: Immunosuppression is a critical aspect of post-transplant management, yet practices at intermediate and late time points after liver transplantation (LT) are poorly characterized. METHODS: A retrospective cohort of 11 326 adult first LT alone recipients between 2007 and 2016 was identified by linking United Network for Organ Sharing transplant data to Medicare administrative claims. The immunosuppression regimen was obtained from Medicare billing claims. Factors associated with calcineurin inhibitor (CNI) monotherapy at 1-, 3-, and 5-y post-LT were investigated using mixed-effects logistic regression. Center practice heterogeneity was evaluated. The association of immunosuppression regimen (time-updating) with patient and graft survival was studied. RESULTS: CNI monotherapy was used in 51.9% at 1-y post-LT and 68.6% at 5-y post-LT. Center-specific rates ranged from 20.0%-79.9% to 15.4%-95.2%, respectively. CNI monotherapy at 1- and 3-y post-LT was less likely among Black recipients ( P = 0.027 and P = 0.015 versus White, respectively). CNI plus antimetabolite was associated with improved adjusted patient (hazard ratio, 0.59; P < 0.001) and graft (hazard ratio, 0.62; P < 0.001) survival versus CNI monotherapy. The benefit of CNI plus antimetabolite on patient and graft survival increased with older age. CONCLUSIONS: In this first longitudinal analysis of LT immunosuppression practices among Medicare beneficiaries, a CNI plus antimetabolite approach led to improved outcomes. Significant center heterogeneity in practice was observed.

Longitudinal assessment of vascular calcification in generalized arterial calcification of infancy.

BACKGROUND: Generalized arterial calcification of infancy (GACI), also known as idiopathic infantile arterial calcification, is a very uncommon genetic disorder characterized by calcifications and stenoses of large- and medium-size arteries that can lead to end-organ damage. OBJECTIVE: To describe changes in imaging findings in 10 children with GACI at a single institution from 2010 to 2021. MATERIALS AND METHODS: In this retrospective study we reviewed initial and follow-up body imaging in children with genetic confirmation of GACI at our hospital. All initial images were analyzed for the presence and distribution of arterial calcifications, stenoses and wall thickening/irregularity within the chest, abdomen and pelvis. We compared available follow-up studies to the initial imaging findings. We extracted clinical information including prenatal and postnatal treatment from the children's medical records. RESULTS: We evaluated 10 children (five boys) with a diagnosis of GACI. Median age at first body imaging was 8 days (range: 1 day to 5 years). Six children were identified prenatally and four postnatally. Postnatal presentation included cardiac failure, seizures and hypertension. Images in newborns (n = 8) most commonly showed diffuse arterial calcifications (6/8; 75%), while stenoses were less common (2/8; 25%) during this period. Two children were diagnosed after the neonatal period - one in infancy and one during childhood. In total, half the children (5/10; 50%) had arterial stenoses - three cases visualized at first imaging and two identified on follow-up images during infancy. Stenoses had completely resolved in one child (1/5; 20%) at last follow-up. Eight children received prenatal or postnatal treatment or both. All children who received both prenatal and postnatal treatment (n = 4) had completely resolved calcifications at last follow-up. CONCLUSION: Children with GACI might have characteristic vascular calcifications at birth that raise the suspicion of this disease. Arterial calcifications decrease or disappear spontaneously or after treatment, but arterial stenoses usually persist. Calcifications and arterial stenoses can be easily identified and followed with non-contrast CT and CT angiography.

Impact of Medicaid Expansion on Liver-Related Mortality.

BACKGROUND & AIMS: The Affordable Care Act provided the opportunity for states to expand Medicaid for low-income individuals. Not all states adopted Medicaid expansion, and the timing of adoption among expansion states varied. Prior studies have shown that Medicaid expansion improved mortality rates for several chronic conditions. Although there are data on the association between Medicaid expansion on insurance type among patients waitlisted for a liver transplant, there are no published data to date on its impact on liver disease-related mortality in the broader population. We therefore sought to evaluate the association between Medicaid expansion and state-level liver disease-related mortality using a quasi-experimental study design. METHODS: We evaluated age-adjusted, state-level, liver disease-related mortality rates using the Centers for Disease Control and Prevention data. We fit multivariable linear regression models that accounted for sociodemographic, clinical, and access-to-care variables at the state level, and a difference-in-difference estimator to evaluate the association between Medicaid expansion and liver disease-related mortality. RESULTS: In multivariable linear regression models, there was a significant association between Medicaid expansion and liver disease-related mortality (P = .02). Medicaid expansion was associated with 8.3 (95% CI, 1.6-15.1) fewer deaths from liver disease per 1,000,000 adult residents per year after Medicaid expansion compared with what would have been expected to occur if those states followed the same trajectory as nonexpansion states. The impact of Medicaid expansion translated to 870 fewer liver-related deaths per year in expansion states (4350 in the postexpansion study period from 2014 to 2018). CONCLUSIONS: These data support the contention that Medicaid expansion has been associated with significantly decreased liver disease-related mortality. Universal Medicaid expansion could further decrease liver disease-related mortality in the United States.

Changes in County-Level Economic Prosperity Are Associated With Liver Disease-Related Mortality Among Working-Age Adults.

BACKGROUND & AIMS: There is significant variability in county-level rates of liver disease-related mortality. Although this variability is explained partly by demographics, risk factors for liver disease, and access to specialty liver care, little is known about temporal changes in mortality, and its association with economic prosperity. Therefore, we sought to explore the association between changes in county-level economic prosperity and liver disease-related mortality. METHODS: We performed a retrospective cohort study using county-level mortality data from the Centers for Disease Control and Prevention, economic prosperity measures from the Distressed Communities Index, and county-level markers of demographics, risk factors for liver disease, and access to health care. Primary analyses focused on adults aged 20 to 64 years of age. We used generalized linear mixed models (outcome = annual percentage change in age-adjusted liver disease-related mortality), with the primary exposure being an interaction between year and change in economic prosperity. RESULTS: There was an inverse relationship between county-level changes in economic prosperity and changes in county-level age-adjusted liver disease-related mortality rates (eg, counties with the smallest increase in economic prosperity had the biggest annual increase in liver disease-related mortality). In generalized linear mixed models accounting for county-level covariates, there was a significant association between economic prosperity and liver disease-related mortality, that is, for every 10-point higher mean rank for change in economic prosperity, there was an additional 0.65% decrease (95% CI, 0.19%-1.10%; P = .006) in mortality per year. CONCLUSIONS: County-level changes in economic prosperity, independent of other county-level clinical, demographic, and access-to-care variables, may play a role in population-level trends in liver disease-related deaths among the working age population.

Procurement characteristics of high- and low-performing OPOs as seen in OPTN/SRTR data.

To meet new Centers for Medicare and Medicaid Services (CMS) metrics, organ procurement organizations (OPOs) will benefit from understanding performance across decedent and hospital types. We sought to determine the utility of existing data-reporting structures for this purpose by reviewing Scientific Registry of Transplant Recipient (SRTR) OPO-Specific Reports (OSRs) from 2013 to 2019. OSRs contain both the Standardized donation rate ratio (SDRR) metric and OPO-reported numbers of "eligible deaths" and donors by hospital. Donor hospitals were characterized using information from Homeland Infrastructure Foundation-Level Data, Dartmouth Atlas Hospital Service Area data, and the US Census Bureau. Hospital data reported by OPOs showed 51% higher eligible death donors and 140% higher noneligible death donors per 100 inpatient beds in CMS ranked top versus bottom-quartile OPOs. Top-quartile OPOs by the CMS metric recovered 78% more donors than those in the bottom quartile, but were indistinguishable by SDRR rankings. These differences persisted across hospital sizes, trauma case mix, and area demographics. OPOs with divergent performance were indistinguishable over time by SDRR, but showed changes to hospital-level recovery patterns in SRTR data. Contemporaneous recognition of underperformance across hospitals may provide important and actionable data for regulators and OPOs for focused quality improvement projects.

Prevalent pharmacotherapy of US Fontan survivors: A study utilizing data from the MarketScan Commercial and Medicaid claims databases.

BACKGROUND: Survivors of Fontan palliation are at life-long risk of thrombosis, arrhythmia, and circulatory failure. To our knowledge, no studies have evaluated current United States pharmaceutical prescription practice in this population. METHODS: A retrospective observational study evaluating the prevalent use of prescription medications in children and adolescents with hypoplastic left heart syndrome or tricuspid atresia after Fontan completion (identified using ICD9/10 codes) was performed using data contained in the MarketScan Commercial and Medicaid databases for the years 2013 through 2018. Cardiac pharmaceuticals were divided by class. Anticoagulant agents other than platelet inhibitors, which are not uniformly a prescription medication, were also studied. Associations between increasing age and the likelihood of a filled prescription for each class of drug were evaluated. Annualized retail costs of pharmaceutical regimens were calculated. RESULTS: A cohort of 4,056 subjects (median age 12 years [interquartile range: 8-16], 61% male, 60% commercial insurance) was identified. Of the cohort, 50% received no prescription medications. Angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB) (38%), diuretics (15%), and mineralocorticoid receptor antagonists (8%) were prescribed with the highest frequency. Pulmonary vasodilators were received by 6% of subjects. Older age was associated with increased likelihood of filled prescriptions for anticoagulants (P = .008), antiarrhythmic agents, digoxin, ACEi/ARB, and beta blockers (each P < .0001), but also lower likelihood of filled prescriptions for pulmonary vasodilators, conventional diuretics (both P < .0001), and mineralocorticoid receptor antagonists (P = .02). CONCLUSIONS: Pharmaceuticals typically used to treat heart failure and pulmonary hypertension are the most commonly prescribed medications following Fontan palliation. While the likelihood of treatment with a particular class of medication is associated with the age of the patient, determining the optimal regimen for individual patients and the population at large is an important knowledge gap for future research.

Should Clinical Guidelines Incorporate Cost Pathways for Persons With Financial Hardship?

The American Diabetes Association 2020 Standards of Care for the treatment of hyperglycemia in type 2 diabetes includes a treatment pathway when "cost is a major issue." This pathway recommends use of 2 generic drug classes, thereby codifying differential treatment for those with financial hardship. This article explores 4 implications of incorporating the cost pathway into clinical recommendations: (1) the presence of a cost pathway might create the appearance of an evidence-based quality difference through activation of implicit bias; (2) screening for financial hardship to guide therapy has potential harms for patients; (3) concern that financial hardship warrants differing care might impact overall quality of care and patient-clinician relationships; and (4) applying the guidelines when caring for patients with financial hardship might demoralize clinicians.