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SB 3509

INS CD-BIOMARKER TESTING

104th Regular Session Introduced by Christopher Belt and 13 co-sponsors

Illinois insurers must cover biomarker testing when medically evidenced, with faster approvals, clear exceptions, and Dept. of Insurance oversight.

Added as Co-Sponsor Sen. Mary Edly-Allen
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Bill Summary · SB 3509

Overview

SB3509, introduced in the Illinois Senate during the 104th General Assembly (2025-2026), amends the Illinois Insurance Code to strengthen coverage, accessibility, and oversight of biomarker testing by health insurers, nonprofit health service plans, and health maintenance organizations. The bill aims to ensure broader and more transparent coverage for biomarker testing when supported by medical evidence, streamline prior authorization and utilization review, and empower the Department of Insurance to monitor compliance.

Main purpose and intent

  • Improve access to biomarker testing for diagnosis, treatment, and ongoing management of health conditions.
  • Align coverage with current evidence and recognized guidelines, reducing unnecessary delays and repeated testing.
  • Increase transparency of coverage decisions and expand oversight to ensure insurers comply with coverage criteria.

Key provisions and changes

  • Definitions (Section (a)):
    • Expands and clarifies terms related to biomarker, biomarker testing, consensus statements, and nationally recognized clinical practice guidelines.
  • Coverage requirements (Section (b), (c), (d)):
    • Group or individual policies issued or renewed on/after January 1, 2022 must include coverage for biomarker testing according to criteria in subsection (d).
    • Biomarker testing should be covered and conducted efficiently to provide a full range of results without requiring multiple biopsies or delays.
    • Coverage triggers include tests supported by medical and scientific evidence, including:
    • FDA-labeled indications for tests or drugs, FDA-approved or cleared tests, or drug-specific indications.
    • Medicare national coverage determinations and Local Coverage Determinations.
    • Recommendations from nationally recognized clinical practice guidelines or consensus statements.
    • Professional society recommendations, peer-reviewed literature, biomedical compendia meeting NIH/NLM indexing criteria, and peer-reviewed scientific studies meeting recognized standards.
  • Access to exceptions (Section (e)):
    • Patients and prescribing practitioners must have access to a clear process to request coverage exceptions, publicly accessible on insurer websites.
  • Policy updates (Section (f)):
    • Insurers/plans must update and publicly post medical policies and coverage guidelines within 90 days after the Act’s effective date.
    • Updates impacting coverage must be publicly available 30 days before the effective date of the updated policy.
  • Denials and documentation (Section (g)):
    • If a claim for biomarker testing is denied despite supporting evidence, the insurer/plan must provide a detailed written justification specific to the individual case.
  • Prior authorization and utilization review (Section (h), (i)):
    • If utilization review or prior authorization is required, the entity must decide and notify within:
    • 72 hours for nonurgent requests
    • 24 hours for urgent requests
    • Requests for prior authorization may be submitted by the ordering or treating provider, the rendering laboratory, or the enrollee or their representative.
  • Department oversight (Section (j)):
    • The Illinois Department of Insurance may conduct periodic audits and reviews to ensure compliance with the statute.

Who and what is affected

  • Affected entities: health insurers, nonprofit health service plans, health carriers, and health benefit plans operating in Illinois.
  • Affected individuals: enrollees/patients requiring biomarker testing, and their ordering physicians or labs.
  • Healthcare providers and laboratories: involved in ordering, performing, and seeking coverage for biomarker tests, including those requiring prior authorization.

Procedural and timeline aspects

  • Effective timing:
    • Health plans issued or renewed on/after January 1, 2022 must align with the statute’s coverage criteria.
    • Medical policies must be updated within 90 days after the amendatory Act’s effective date; any policy changes affecting coverage must be posted 30 days before the updated policy takes effect.
  • Appeals and documentation:
    • Detailed written justification required for denied coverage cases related to specific individuals.
    • Clear exception process available on insurer websites.
  • Oversight:
    • The Department of Insurance has authority to conduct periodic audits to verify compliance.

Potential impact

  • Improved access to biomarker testing where clinically warranted, potentially speeding diagnosis and treatment decisions.
  • Greater transparency in coverage decisions and faster, clearer communication when denials occur.
  • Reduced administrative barriers due to standardized prior authorization timelines.
  • Increased insurer accountability through formal audits and publicly available policies.

Compiled from official sources — confirm details with the bill’s official record.

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