Work

Consideration of the Beneficiary Inducement Statute on Access to Health Care Systems’ Population Genetic Screening Programs

Year: 2023

Type: article

Abstract: This article examines how the federal Beneficiary Inducement Statute (BIS) and related anti-kickback laws shape access to population genetic screening (PGS) programs, particularly for Medicare and Medicaid beneficiaries, during a critical early-adoption phase in public health genomics. While PGS for Tier 1 conditions—such as hereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemia—offers significant opportunities for early detection and prevention, large-scale implementation remains limited by cost barriers, uneven insurance coverage, and statutory restrictions that can unintentionally hinder equitable participation. The authors explain how BIS constraints complicate efforts by health systems to offer low- or no‑cost genomic screening, survey legally permissible pathways such as preventive-care exemptions, financial-need determinations, research-based offerings, and self-pay models, and discuss how existing OIG advisory opinions illuminate the potential for compliant program design. They argue that attention to BIS is essential to avoid exacerbating disparities among low-income and older adults, who already underutilize preventive services, and conclude that achieving equitable PGS dissemination will likely require multi-pronged strategies—including research-based access, organizational subsidies, and longer-term policy or insurance reforms—to ensure that emerging genomic innovations benefit diverse populations from the outset.

Source: Public Health Genomics

DOI: 10.1159/000534365