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H 1368

An Act to provide rapid whole genome sequencing

194th Legislature (2025-2026) Introduced by Danielle Gregoire and 2 co-sponsors

Mass. H 1368 requires rapid whole genome sequencing (rWGS) for qualifying pediatric inpatients, with Medicaid coverage pursued (CMS approval) to speed diagnosis and treatment.

Accompanied a new draft, see H5385
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Bill Summary · H 1368

Comprehensive Summary: H 1368 — An Act to provide rapid whole genome sequencing

Overview

H 1368 is a Massachusetts bill that would require the Commonwealth’s Executive Office of Health and Human Services (in conjunction with MassHealth) to ensure rapid whole genome sequencing (rWGS) when clinical criteria are met. It also seeks to establish Medicaid coverage for rWGS as a separately payable service for eligible pediatric patients, subject to federal approval and medical necessity criteria. The act takes effect upon passage.

Key Provisions

  • Definition of rapid whole genome sequencing (rWGS): rWGS is an investigation of the entire human genome, including coding and non-coding regions and mitochondrial DNA, designed to return preliminary positive results within 5 days and final results within 14 days. The bill covers patient-only sequencing as well as duo (patient plus one parent) and trio (patient plus two parents) sequencing.

  • Clinical criteria for rWGS use: rWGS would be provided when specific clinical criteria are met, including cases with complex or acute illness of unknown etiology not explained by environmental exposure, toxic ingestion, infection with typical treatment response, or trauma.

  • Medicaid coverage and payment: The Commonwealth would aim to cover rWGS as a separately payable service for Medicaid beneficiaries, pending Centers for Medicare and Medicaid Services (CMS) approval. Eligibility criteria include:

    • Beneficiary age: 21 years or younger
    • Inpatient status: in an intensive care unit (ICU) or high-acuity pediatric care unit
    • Illness: complex or acute illness of unknown etiology that could be genetic in nature

  • Medical necessity criteria: Coverage would be subject to evidence-based medical necessity criteria, based on:

    • Broad differential diagnoses that would require multiple genetic tests if rWGS were not performed
    • Clinician determination that rapid molecular diagnosis is necessary to guide treatment
    • Presence of one or more of the listed conditions suggesting genetic etiology (e.g., congenital anomalies across multiple organ systems, abnormal lab/chemistry tests, refractory seizures, abnormal cardiac tests, high-risk findings on imaging, abnormal physiology, or pertinent family history)

  • Data protection: Genetic data generated via rWGS would be primarily used to diagnose and treat the patient and would be protected under HIPAA and related regulations (including HITECH), with HIPAA Privacy Rule protections reaffirmed.

  • Implementation: EOHHS would implement the provisions, including potential rulemaking for Medicaid coverage, pursuing waivers or state plan amendments necessary for federal financial participation, and other actions needed to execute the measure.

  • Effective date: The act would take effect upon passage.

Who is Affected

  • Pediatric Medicaid beneficiaries (21 years or younger) requiring rapid genetic diagnosis in hospital settings (ICU or high-acuity pediatric units).
  • Healthcare providers and facilities coordinating acute/genetic care.
  • The Massachusetts Medicaid program (MassHealth) and the state’s health and human services agencies, which would administer coverage and implementation.

Timeline and Status

  • Introduced: February 27, 2025
  • Referred to: Health Care Financing
  • Hearing: July 15, 2025 (Gardner Auditorium)
  • Reporting date: Extended, with current extension to March 18, 2026
  • Sponsors: Primary – Danielle W. Gregoire; Co-sponsor – Vanna Howard
  • Related: Similar matter previously filed (House 1197 of 2023-2024)

Impact and Considerations

  • Potential to shorten time to diagnosis for critically ill pediatric patients and streamline treatment decisions.
  • Financial implications depend on CMS approval and successful waiver/state plan amendments.
  • Balances rapid diagnostic capability with privacy protections and medical necessity criteria.

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

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