Bill
H 4339
The bill requires coverage of biomarker testing for cancer care based on evidence-based criteria and guidelines, with timely prior authorization and accessible exception processes
H 4339 Summary: An Act relative to patient access to biomarker testing to provide appropriate therapy
Overview
- Purpose: To ensure that Massachusetts patients, including active/retired Commonwealth employees and Medicaid enrollees, have coverage for biomarker testing when medically warranted to guide cancer diagnosis, treatment, management, or monitoring. The bill ties coverage to evidence-based criteria and recognized clinical guidelines, and it creates timely decision-making processes for prior authorization and appeal.
Key Definitions and Concepts
- Biomarker: An objectively measured biological indicator (e.g., gene mutations, protein expression) used to inform therapy decisions.
- Biomarker testing: Analysis of tissue, blood, or other specimens for biomarkers (includes single analyte tests, multi-plex panels, protein expression, and broad sequencing approaches like whole exome/genome/transcriptome).
- Consensus statements and nationally recognized clinical practice guidelines: Statements and guidelines developed by independent expert panels or professional societies using transparent, evidence-based methods.
- Coverage criteria: Tests must be supported by medical and scientific evidence, including FDA-indicated tests, tests for FDA-approved drugs, drug label warnings/precautions, CMS national determinations or MAC determinations, or coverage per guidelines/consensus statements.
Provisions for GIC (Section 17AA)
- Who is covered: Active or retired Commonwealth employees insured under the Group Insurance Commission.
- What is covered: Biomarker testing for diagnosis, treatment, management, or monitoring when supported by the criteria described above.
- How coverage must be provided: In a manner consistent with nationally recognized guidelines and consensus statements; aim to limit care disruptions (e.g., avoid unnecessary repeat biopsies).
- Prior authorization: If required, carriers or utilization review organizations must decide within 72 hours; if significant risk to health and delay would occur, decision within 24 hours; if no response within the required timeframe, the request is deemed granted.
- Access to exceptions: Clear, readily accessible process for requesting exceptions or challenging adverse determinations, with information available on the carrier’s website.
Provisions for Medicaid Managed Care (Section 10AA)
- Who is covered: The Division of Insurance and its contracted Medicaid managed care organizations, health plans, HMOs, behavioral health managers, and third-party administrators.
- What is covered: Biomarker testing under the same evidence-based criteria as for GIC, for diagnosis, treatment, management, or monitoring.
- How coverage must be provided: In alignment with nationally recognized guidelines and consensus statements; designed to minimize care disruptions.
- Prior authorization and exceptions: Parallel requirements to ensure timely decisions and accessible exception processes (as indicated by the analogous structure in the bill text).
Impact and Scope
- Affects: Cancer patients and enrollees who undergo biomarker testing, healthcare providers administering such tests, and insurers/administrators processing coverage and prior authorization.
- Purpose-driven impact: Aims to streamline access to biomarker testing, reduce delays in care, and ensure tests used for therapy decisions are supported by credible evidence and guidelines.
Legislative Status and Process
- Introduced: July 31, 2025.
- Action: Reported favorably by the committee on Financial Services and referred to Health Care Financing; new draft identified as H 1227.
- Status: The bill is moving through committee review with a focus on health care financing implications.
Notes
- The enacted text may refine dates, exact timing for applicability, and any effective date. The summary reflects the provisions visible in the provided bill text, including definitions, coverage criteria, and prior authorization timelines.
Compiled from official sources — confirm details with the bill’s official record.
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