H.R. 5355 — Ian Kalvinskas Pediatric Liver Cancer Early Detection and Screening Act

This section states congressional findings on the urgent need for earlier detection of pediatric liver disease and improved transplant access, citing the case of Ian Kalvinskas; rising hepatoblastoma incidence of approximately 2% per year to 1.7 cases per million children, with overall five-year survival at 77% but below 60% for adolescents and distant metastases; biliary atresia prevalence of 1 in 12,000 live births and doubled transplant-free survival from Kasai portoenterostomy before 60 days of life; 100% detection of biliary atresia via direct-bilirubin newborn screening in U.S. pilots; waitlist mortality exceeding 1 in 10 infants and 1 in 20 older children; superior outcomes from living-donor liver transplantation; and the role of physician advocacy for listing exceptions in rare diseases.

This section directs the Comptroller General of the United States to conduct a study on (1) federally funded initiatives to improve early detection and treatment of pediatric liver tumors, including provider education and research on risk factors and therapies; (2) trends in pediatric liver-transplant wait-list mortality, broken out by geography, race, insurance status, diagnosis, and illness severity (to the extent reliable data are available); and (3) the cost-effectiveness of adding direct-bilirubin screening for biliary atresia and other cholestatic liver diseases to state newborn screening panels (to the extent reliable data are available). The Comptroller General must submit a report on the study to Congress within one year of enactment.

This section directs the Secretary of Health and Human Services, acting through the Health Resources and Services Administration (HRSA) Administrator and in consultation with the Centers for Disease Control and Prevention (CDC) Director, to carry out a public education program developing and disseminating plain-language materials on (1) early signs of pediatric liver disease and (2) the option and safety of living liver donation. In implementing the program, the Secretary may coordinate with CDC programs, including the National Comprehensive Cancer Control Program (or successor), and disseminate materials through other Department of Health and Human Services public-education initiatives promoting liver-disease prevention, pediatric cancer awareness, or living-organ donation. Not later than three years after program initiation, the Comptroller General of the United States must report to Congress on program results. No additional funds are authorized to carry out this section.