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SD 1247

An Act relative to rapid whole genome sequencing

194th Legislature (2025-2026) Introduced by John Cronin

Massachusetts to cover rapid whole genome sequencing for eligible Medicaid inpatients 21 and under with acute/undiagnosed illness, enabling faster diagnosis and targeted treatment.

House concurred
0
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Bill Summary · SD 1247

Summary: An Act relative to rapid whole genome sequencing (Senate Docket No. 1247)

Overview

This proposed Massachusetts legislation, introduced February 27, 2025 by Senator John J. Cronin, seeks to require the Commonwealth to provide rapid whole genome sequencing (rWGS) under specific clinical criteria and to ensure Medicaid coverage for eligible pediatric patients. The bill aims to accelerate genetic diagnosis to guide urgent clinical decisions, while aligning data handling with federal privacy protections.

Purpose and intent

  • Establish a framework for rapid whole genome sequencing as a covered service for Medicaid beneficiaries, when clinical criteria indicate that timely genetic diagnosis is essential for patient management.
  • Define operational goals for turnaround times and clarify the scope of sequencing (including patient-only, duo, and trio sequencing).
  • Ensure that sequencing data is treated as protected health information in accordance with HIPAA and related federal regulations.

Key provisions

Definition and turnaround

  • “Rapid whole genome sequencing” covers sequencing of the entire genome (coding, non-coding regions, and mitochondrial DNA).
  • Turnaround times: preliminary positive results within 5 days; final results within 14 days.

Coverage and eligibility (Medicaid)

  • Coverage is available as a separately payable service for Medicaid beneficiaries who are:
    • 21 years of age or younger
    • Experiencing a complex or acute illness of unknown etiology not explained by environmental exposure, toxic ingestion, infection with typical response to therapy, or trauma
    • Receiving inpatient hospital care in an intensive care unit (ICU) or high-acuity pediatric care unit
  • Coverage is contingent on applicable evidence-based medical necessity criteria, including:
    • The patient has symptoms suggesting a broad differential diagnosis that would typically require multiple genetic tests if rWGS were not performed.
    • The treating provider has determined that a timely molecular diagnosis is necessary to guide treatment decisions.
    • The patient presents with a complex or acute illness meeting specific criteria (see enumerated conditions below).

Enumerated criteria (illustrative examples)

The bill lists multiple clinical scenarios that would support medical necessity, such as:
- Congenital anomalies involving two or more organ systems or complex congenital anomalies in one system
- Organ malformations highly suggestive of a genetic etiology
- Abnormal laboratory or metabolic indicators (e.g., abnormal newborn screen, severe metabolic derangements)
- Refractory seizures or severe vomiting/hypoglycemia/hyperglycemia
- Abnormal cardiac findings suggestive of channelopathies or cardiomyopathies
- Abnormal imaging or physiologic studies suggesting a genetic condition
- Relevant positive or informative family history

Data use and privacy

  • Genetic data obtained through rWGS shall primarily aid the ordering clinician and treatment team for the patient’s care.
  • Data must be protected as health information under HIPAA, HITECH, and related Privacy Rules.

Implementation and administration

  • The Executive Office of Health and Human Services (EOHHS), in coordination with MassHealth (Medicaid), shall implement the policy.
  • Actions may include:
    • Promulgation of rules and regulations for Medicaid coverage
    • Applications or amendments to federal waivers or Medicaid state plans to secure federal participation

Effective date

  • The act takes effect upon passage.

Who is affected

  • Medicaid beneficiaries who are 21 or younger with complex or acute undiagnosed illnesses and in inpatient ICU/high-acuity pediatric units.
  • Healthcare providers ordering and utilizing rWGS for eligible patients.
  • Massachusetts EOHHS and MassHealth, responsible for program implementation and waiver activities.
  • Federal partners (CMS) through potential waiver or state plan amendments necessary to fund coverage.

Legislative and procedural notes

  • Referred to the Joint Committee on Health Care Financing upon introduction.
  • Status indicates the House has concurred with the Senate amendment or position as of the listed actions.

Potential impact

  • Enhances access to rapid diagnostic information for seriously ill pediatric patients, potentially guiding earlier, targeted treatment.
  • May increase Medicaid expenditures in the near term due to coverage of a high-cost diagnostic tool, offset by potential reductions in other tests and reduced hospital stays if care becomes more precise.
  • Requires robust clinical criteria and turnaround capabilities to realize clinical benefits.
  • Depends on CMS approval and appropriate state actions to secure federal funding participation.

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

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