• Expand equitable coverage for biomarker testing across Medicaid and commercial insurance.
• Ensure patients can access testing without excessive prior authorization or administrative delays.
• Require payer alignment with evidence-based guidelines to avoid inappropriate denials.
• Invest in provider education and workforce capacity, including genetic counselors and specialists.
• Protect patient privacy and ensure secure handling of biomarker and genetic data.
• Promote health equity by addressing geographic, racial, and socioeconomic barriers to testing.

Policy Guidelines

1. Ensure timely and equitable access across all insurance types.

Coverage should align with evidence-based clinical guidelines, ensuring all patients—regardless of income or geography—can access appropriate biomarker tests.

2. Require comprehensive coverage and limit financial barriers.

Policies should mandate coverage for medically necessary biomarker testing and restrict high out-of-pocket cost-sharing that prevents timely diagnosis.

3. Strengthen provider education and interpretation capacity.

States should invest in expanding access to genetic counselors, molecular pathologists, and specialists to ensure accurate test ordering and interpretation.

4. Protect patient privacy and data security.

Clear standards should define how biomarker and genetic data are collected, stored, and used, ensuring strong protections and informed consent.

5. Reduce administrative barriers, including prior authorization.

Administrative hurdles must not delay necessary testing. Streamlined processes or exemptions should be required when biomarker testing is guideline-supported.

6. Promote alignment with clinical evidence and FDA/CMS standards.

Coverage criteria should be tied to established guidelines and proven clinical utility, avoiding restrictive policies that limit access to needed diagnostics.

7. Address health equity and disparities in access.

Policies should focus on reducing disparities for rural, low-income, and underserved populations, ensuring all communities can benefit from precision diagnostics.

8. Support federal and state collaboration to advance precision medicine.

Collaboration can improve research, coverage consistency, and adoption of emerging biomarker technologies across states.

9. Expand coverage for related services, including genetic counseling.

Testing is only meaningful when patients have access to experts who can explain results and guide next steps.

10. Center patient and caregiver voices in policymaking.

Patients and rare disease advocates should be meaningfully involved in shaping testing policies, determining coverage criteria, and evaluating implementation effectiveness.