CGSA Advocacy

Safe Harbor for Genetic Testing

CGSA supports rulemaking to establish regulatory safe harbors under the federal Anti-Kickback Statute (AKS) for manufacturer-sponsored genetic testing and counseling programs that meet clearly defined criteria and serve a vital public health function.

CGSA Establishing a Federal AKS Safe Harbor for Genetic Testing: Frequently Asked Questions PDF
CGSA · 2026 Comment letter to the HHS Office of Inspector General on the Anti-Kickback Statute RFI PDF

Medicaid Coverage for Genetic Testing

CGSA advocates for Medicaid coverage of whole genome and whole exome sequencing as part of early and periodic screening, diagnostic, and treatment services.

Congress.gov H.R.7118 — Genomic Answers for Children’s Health Act of 2026
EveryLife Foundation Genomic Answers for Children’s Health Act of 2026 One-pager (PDF)

Federal Newborn Screening Programs

CGSA supports a more efficient and streamlined federal newborn screening program that embraces whole genome and whole exome sequencing.

Rady Children’s Institute for Genomic Medicine Evolution of Newborn Screening Timeline
HRSA About Newborn Screening
APHL Newborn Screening and Genetics Overview
Congress.gov S.1858 — Newborn Screening Saves Lives Act of 2007
GeneDx SAVES-Kids Study