Delay in prior authorization of biologic therapy: Another possible cause of healthcare disparity in IBD patients.

BACKGROUND: Biologics, a mainstay in inflammatory bowel disease (IBD) treatment, typically require prior authorization from insurance companies. Multiple studies show that African Americans are less likely to be prescribed biologics. The prior authorization process may perpetuate disparities in healthcare. This study evaluated the approval time for biologics in IBD. METHODS: A chart review of IBD patients seen in a university gastroenterology clinic over 5 years was performed. Patient gender, race, IBD subtype, biologic use, and insurance type were recorded. Insurance type was classified as private or public (Medicaid or Medicare). Biologic agents evaluated included infliximab, adalimumab, vedolizumab and ustekinumab. Length of time to approval (TTA) and length of time to first infusion or administration (TFI) were recorded. Analysis was performed using t-testing, Fisher's exact testing, and ANOVA with significance set at p<0.05. The study was IRB approved. RESULTS: 458 charts were analyzed. 66 patients were being treated with a biologic. 42 had private insurance, 16 Medicaid and 8 Medicare. 37 patients had ulcerative colitis, 27 Crohn's disease, and 2 indeterminate colitis. There were 38 men and 28 women. 32 patients were white, 26 African American, 1 Asian, 5 other, and 2 declined identification. Average TTA was 30.5 days (range 1-145) and average TFI was 45.3 days (range 2-166). African Americans were more often on public insurance compared to whites (p=0.0001). Crohn's disease compared to ulcerative colitis patients were more often on public insurance (p=0.017). Significantly more private compared to public insurance patients were on infliximab (p=0.001). Medicaid and Medicare patients had significantly longer mean TTAs than private insurance patients (49.1 and 52.7 vs 19.4 days, p=0.007). African Americans had significantly longer mean TTA compared to whites (45.9 vs 24.8 days, p=0.044). Crohn's disease compared to ulcerative colitis patients had significantly longer mean TTA (39.7 vs 21.8 days, p=0.050). DISCUSSION: This study shows that prior authorization for biologic therapy was longer for African Americans. Patients on public insurance also tend to have a longer TTA, and more African Americans were on public insurance compared to White patients in this study which may explain the difference in biologic access for African Americans.

African-Americans Are Less Frequently Assessed For Hereditary Colon Cancer.

INTRODUCTION: Colorectal cancer (CRC) is the third most common malignancy in the United States and disproportionately affects African-Americans. Approximately 5-10% of CRC results from hereditary cancer syndromes. A detailed family history is recommended as an initial component of cancer risk assessment to help determine initiation, frequency, screening method and genetic counselling referral. This study evaluated the rate of hereditary CRC risk assessment in African-American and white patients. METHODS: A chart review of all patients referred for CRC screening in a university gastroenterology clinic during a 3 month period was performed. Patient self-described race/ethnicity, gender, age, documentation of multi-generational family medical history (3+ generations) were obtained. Amsterdam II Criteria, Bethesda Criteria and Colorectal Cancer Risk Assessment Tool were used to determine which patients with family histories should receive referrals for genetic counselling. Statistical analysis was performed using Fisher's Exact Test with significance set at p < 0.05. The study was IRB approved. RESULTS: 872 medical records were reviewed, including 452 African-American (276 females, 176 males; mean age 60.2), 263 White (123 females, 140 males; mean age 59.4), 45 Hispanic, and 42 Asian. Multi-generational family history was obtained from 143 (16.4%); 62 African-American (13.7%; 47 females, 15 males), 58 White (22.1%; 37 females, 21 whites), 3 Hispanic (6.7%), and 4 Asian (9.5%). There was a significant difference (p = 0.0050) in the rate of detailed family history in African-Americans and whites. However, African-Americans and Whites similarly qualified for genetic counselling when family history was obtained (p = 0.7915); 58.1% African-Americans (36; 30 females, 6 males) and 50% Whites (29: 19 females, 10 males) qualified for genetic counselling. Overall referral rate to genetic counselling was 16.5% with no significant difference (p = 0.7586) between African-Americans and whites. CONCLUSIONS: CRC risk assessment with detailed family medical history was inconsistently performed in all patients. There was significantly lower rate of obtaining multi-generational family medical histories in African-Americans. Referrals of all patients for genetic counselling and testing were also insufficient. Appropriate identification of individuals at increased risk for hereditary cancer syndromes, particularly African-Americans, is critical to prevention, early detection, and treatment of CRC and improving disparities in care.

Comparison of creatinine and cystatin C for estimation of glomerular filtration rate in pediatric patients after Fontan operation.

BACKGROUND: There are several limitations when using creatinine to estimate glomerular filtration rate, especially in children with chronic medical conditions who are at high risk of kidney dysfunction. Cystatin C has been the recent focus of research as a replacement biomarker for creatinine. Our objective was to compare the 2 biomarkers in pediatric single-ventricle heart disease patients who have undergone the Fontan operation. We hypothesized that there would be poor correlation and agreement between the 2 estimates of renal function. METHODS: This was a single center retrospective chart review of 20 patients who had previously undergone Fontan operation. Demographic and clinical data were collected from medical records. Blood samples were collected as part of routine clinical care and simultaneously measured for serum creatinine and cystatin C. Glomerular filtration rate was calculated using the creatinine-based bedside Schwartz formula and cystatin C-based Zapatelli equation. Spearman correlation and Bland-Altman analysis were used to assess correlation and agreement. RESULTS: The median Schwartz-derived estimated glomerular filtration rate was 98.94 mL/min/1.73 m2 while the median Zappitelli-derived estimated glomerular filtration rate was 84.76 mL/min/1.73 m2 . The mean difference was -19.27 suggesting poor agreement. There was weak to moderate correlation between the Schwartz and cystatin C estimated glomerular filtration rate. CONCLUSION: The bedside Schwartz formula may be an overestimate of glomerular filtration rate in pediatric single-ventricle heart disease patients who have undergone the Fontan operation. While larger studies are necessary, cystatin C is a promising biomarker to replace creatinine and better estimate kidney function in this population.