Document Type
Article
Publication Date
2023
Publication
Public Health Genomics
Volume
26
Abbreviation
Pub. Health Genomics
First Page
183
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.