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SENATE DOCKET, NO. 1247 FILED ON: 1/16/2025
SENATE . . . . . . . . . . . . . . No. 847
The Commonwealth of Massachusetts
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PRESENTED BY:
John J. Cronin
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To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act relative to rapid whole genome sequencing.
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PETITION OF:
NAME:DISTRICT/ADDRESS :John J. CroninWorcester and Middlesex 1 of 4
SENATE DOCKET, NO. 1247 FILED ON: 1/16/2025
SENATE . . . . . . . . . . . . . . No. 847
By Mr. Cronin, a petition (accompanied by bill, Senate, No. 847) of John J. Cronin for
legislation relative to converge for rapid whole genome sequencing. Health Care Financing.
The Commonwealth of Massachusetts
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In the One Hundred and Ninety-Fourth General Court
(2025-2026)
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An Act relative to rapid whole genome sequencing.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 SECTION 1. Notwithstanding any general or special law to the contrary, the Executive
2Office of Health and Human Service in conjunction with the Office of MassHealth shall ensure
3the provision of rapid whole genome sequencing when the following clinical criteria are met.
4 For purposes of this section, “rapid whole genome sequencing” is defined as an
5investigation of the entire human genome, including coding and non-coding regions and
6mitochondrial deoxyribonucleic acid, to identify disease-causing genetic changes that returns the
7preliminary positive results within 5 days and final results within 14 days. When used in this
8section “rapid whole genome sequencing” includes patient-only whole genome sequencing and
9duo and trio whole genome sequencing of the patient and biological parent or parents.
10 Subject to any required approval of the Centers for Medicare and Medicaid Services, the
11Commonwealth shall include coverage of rapid whole genome sequencing as a separately
12payable service for Medicaid beneficiaries when all of the following criteria are met: (i) the 2 of 4
13beneficiary is twenty-one years of age or younger (ii) the beneficiary has a complex or acute
14illness of unknown etiology, that is not confirmed to be caused by an environmental exposure,
15toxic ingestion, infection with normal response to therapy, or trauma, and (iii) the beneficiary is
16receiving inpatient hospital services in an intensive care unit or high acuity pediatric care unit.
17 The coverage provided pursuant to this Section may be subject to applicable evidence-
18based medical necessity criteria that shall be based on all of the following: (i) the patient has
19symptoms that suggest a broad differential diagnosis that would require an evaluation by
20multiple genetic tests if rapid whole genome sequencing is not performed, (ii) the patient’s
21treating healthcare provider has determined that timely identification of a molecular diagnosis is
22necessary to guide clinical decision-making and testing results may guide the treatment or
23management of the patient’s condition, (iii) complex or acute illness of unknown etiology
24including at least one of the following conditions:
25 i) Congenital anomalies involving at least 2 organ systems or complex/multiple
26congenital anomalies in one organ system.
27 ii) Specific organ malformations highly suggestive of a genetic etiology.
28 iii) Abnormal laboratory tests or abnormal chemistry profiles suggesting the presence of a
29genetic disease, complex metabolic disorder, or inborn error of metabolism like but not limited to
30an abnormal newborn screen, hyperammonemia, or severe lactic acidosis not due to poor
31perfusion.
32 iv) Refractory or severe hypoglycemia or hyperglycemia. 3 of 4
33 v) Abnormal response to therapy related to an underlying medical condition affecting
34vital organs or bodily systems.
35 vi) Severe muscle weakness, rigidity, or spasticity.
36 vii) Refractory seizures.
37 viii) A high-risk stratification on evaluation for a brief resolved unexplained event with
38any of the following:
39 (1) A recurrent event without respiratory infection.
40 (2) A recurrent event witnessed seizure-like event.
41 (3) A recurrent cardiopulmonary resuscitation.
42 ix) Abnormal cardiac diagnostic testing results suggestive of possible channelopathies,
43arrhythmias, cardiomyopathies, myocarditis, or structural heart disease.
44 x) Abnormal diagnostic imaging studies suggestive of underlying genetic condition.
45 xi) Abnormal physiologic function studies suggestive of an underlying genetic etiology.
46 xii) Family genetic history related to the patient’s condition.
47 Genetic data generated as a result of performing rapid whole genome sequencing,
48covered pursuant to this Section, shall have a primary use of assisting the ordering health care
49professional and treating care team to diagnose and treat the patient, and as protected health
50information it shall be subject to the to the requirements applicable to protected health
51information as set forth in the Health Information Portability and Accountability Act (“HIPAA”), 4 of 4
52the Health Information Technology for Economic and Clinical Health Act, and their attendant
53regulations, including but not limited to the HIPAA Privacy Rule as promulgated at 45 CFR Part
54160 and Subparts A and E of 45 CFR Part 164.
55 The Executive Office of Health and Human Services shall take any actions necessary to
56implement the provisions of this Section, which can include, if deemed necessary, the following:
57(i) promulgation of rules and regulations to provide for Medicaid coverage pursuant to this
58Section, (ii) submission to the Centers for Medicare and Medicaid Services of any new waiver
59application, amendment to an existing waiver, or Medicaid state plan amendment necessary to
60ensure federal financial participation for Medicaid coverage pursuant to this Section, or (iii) any
61other administrative action determined by the Secretary as necessary to implement the
62requirements of this Section.
63 SECTION 2. This act shall take effect upon passage.