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SB 961

County clerks; requiring certain notification by county clerk. Effective date.

2025 Regular Session Introduced by David Bullard and 1 co-sponsor

Requires private carriers and Maryland Medicaid/MCOs to cover pharmacogenomic testing in defined depression/anxiety treatment scenarios, with streamlined prior authorization.

Placed on General Order
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Bill Summary · SB 961

SB 961 — Maryland Medical Assistance Program and Health Insurance: Pharmacogenomic Testing — Required Coverage

Status: Introduced Jan 28, 2025; assigned to the Senate Finance Committee. Bill effective dates in text: carriers — Oct 1, 2025; Medicaid/MCOs — July 1, 2026.

Main purpose

Require private health carriers and the Maryland Medical Assistance Program (Medicaid, including MCOs) to cover single‑gene and multigene pharmacogenomic testing in defined clinical circumstances and to limit prior authorization barriers for access. Establish enforcement, reporting, and monetary penalties for noncompliance.

Key provisions

  • Definition: “Pharmacogenomic testing” = laboratory genetic testing (single‑gene and multigene panels) to evaluate how an individual’s genetic profile may affect medication efficacy, safety, or toxicity.
  • Mandatory coverage for carriers (insurers, nonprofit health plans, HMOs) beginning Oct 1, 2025, and for Medicaid/MCOs beginning July 1, 2026, when all conditions are met:
    • Test is ordered by a treating provider for an insured/enrollee with a diagnosis of depression or anxiety; and
    • The provider is considering a medication change, dose adjustment, or augmentation for a medication that has a known gene–drug interaction.
  • Prior authorization limits:
    • Must provide a clear, timely coverage pathway.
    • Require only the minimum documentation necessary.
    • Allow adequate authorization timeframe after specimen collection for submission of prior authorization requests and related claims.
    • Permit prior authorization requests to be submitted by either the treating provider or the laboratory.
    • May not impose undue administrative burdens or delays that create barriers to care.
  • Enforcement and reporting:
    • Maryland Insurance Commissioner must audit carriers, establish a reporting process for patients/prescribers/labs, and may require corrective action plans.
    • Medicaid (MDH) will audit MCOs and operate an analogous reporting/enforcement process for MCOs.
  • Monetary penalties:
    • Up to $10,000 per instance of noncompliance plus up to $1,000 per day for continued noncompliance after notice.
    • Entities may request administrative hearings; corrective action plans may be required and enforced.

Who is affected

  • Insurers, nonprofit health service plans, and HMOs issuing coverage in Maryland (carriers).
  • Maryland Medical Assistance Program and its managed care organizations (MCOs).
  • Patients with depression or anxiety whose clinicians are considering medication adjustments involving drugs with known gene–drug interactions.
  • Treating providers and clinical laboratories involved in ordering/submitting tests.
  • Potential indirect impacts on fully insured local government plans and payers covering state employee plans.

Fiscal impact (as analyzed)

  • Maryland Insurance Administration: minimal special fund revenue (one‑time rate/form filing fee) and manageable workload.
  • State agencies: likely no material net cost; many programs already cover some testing.
  • Local governments: possible increases in fully insured plan costs if coverage did not already exist.
  • Penalty receipts: potential minimal general fund revenue if penalties are assessed.

Relation to existing law

  • Adds Insurance Art. §15‑861 (new pharmacogenomic coverage rules).
  • Extends comparable requirements to Medicaid via amendments to Health‑Gen. sections (implementation for MCOs).
  • Builds on existing statutory coverage of biomarker testing by narrowing application to pharmacogenomic tests under specified clinical circumstances.

Next steps / procedural notes

  • Assigned to Senate Finance; subject to committee consideration and floor action. Current text sets carrier effective date Oct 1, 2025 and Medicaid effective date July 1, 2026.

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

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