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SENATE DOCKET, NO. 1958 FILED ON: 1/20/2023
SENATE . . . . . . . . . . . . . . No. 1405
The Commonwealth of Massachusetts
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PRESENTED BY:
Joan B. Lovely
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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 newborn screenings for congenital cytomegalovirus.
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PETITION OF:
NAME:DISTRICT/ADDRESS :Joan B. LovelySecond EssexSal N. DiDomenicoMiddlesex and Suffolk2/8/2023 1 of 5
SENATE DOCKET, NO. 1958 FILED ON: 1/20/2023
SENATE . . . . . . . . . . . . . . No. 1405
By Ms. Lovely, a petition (accompanied by bill, Senate, No. 1405) of Joan B. Lovely and Sal N.
DiDomenico for legislation relative to newborn screenings for congenital cytomegalovirus.
Public Health.
[SIMILAR MATTER FILED IN PREVIOUS SESSION
SEE SENATE, NO. 1471 OF 2021-2022.]
The Commonwealth of Massachusetts
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In the One Hundred and Ninety-Third General Court
(2023-2024)
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An Act relative to newborn screenings for congenital cytomegalovirus.
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. Chapter 111 of the General Laws, as appearing in the 2020 Official Edition,
2is hereby further amended by inserting after Section 70H the following section:-
3 Section 70I: Congenital cytomegalovirus; public information program; annual report
4 (a) The commissioner of the department shall establish, promote, and maintain a public
5information program regarding congenital cytomegalovirus, hereinafter referred to as cCMV.
6Such program shall be conducted throughout the commonwealth, and under said program, a
7hospital or birthing facility as defined in section 70E or any healthcare provider, physician
8assistant, nurse or midwife who renders prenatal or postnatal care shall give expectant or new
9parents or guardians information provided by the department under subsection (b). Such 2 of 5
10information shall be made available at the first prenatal appointment or at a preconception visit if
11applicable, whichever is earliest.
12 (b) The department shall make available to any healthcare provider, physician assistant,
13nurse or midwife who renders prenatal or postnatal care or offers fertility counseling or care to a
14parent or guardian the following: (i) up-to-date evidence-based, written information about cCMV
15and universal cCMV screening that has been vetted by an appropriate group of medical experts
16as determined by the department in conjunction with the advisory committee as established in
17section 110J of said Chapter 111; provided, however, that the written information provided shall
18include preventative measures that can be taken throughout pregnancy, and (ii) contact or other
19referral information for additional educational and support resources. The department may also
20make such information available to any other person who seeks information about cCMV
21infections.
22 SECTION 2. Said chapter 111 is hereby further amended by inserting after section 110C
23the following sections:-
24 Section 110D: Required Newborn Screening for Congenital Cytomegalovirus
25 For the purposes of this section, the following words shall, unless the context clearly
26requires otherwise, have the following meanings:-
27 “Birthing facility”, an inpatient or ambulatory health care facility licensed by the
28department of public health that provides birthing and newborn care services. 3 of 5
29 “Congenital Cytomegalovirus (hereinafter referred to as cCMV) screening”, the
30identification of a newborn who may have congenital CMV infection or has cCMV confirmed
31through the use of a saliva or urine test.
32 “Department”, the department of public health.
33 “Newborn,” any liveborn infant who has not yet attained the age of 21 days from a birth
34occurring in the commonwealth or from a birth prior to transfer to a hospital in the
35commonwealth.
36 The department, in consultation with the perinatal advisory committee, shall develop
37regulations for all hospitals and birthing facilities requiring cCMV screening within one year of
38the passage of this legislation. These regulations shall consider evidence-based guidance.
39 The cCMV screening shall be performed using a saliva PCR test unless one is
40unavailable in which case a urine PCR test may be used. If positive, a saliva PCR test would
41require a confirmatory urine PCR test. The department may approve another test to conduct
42cCMV screening; provided, however, that the test shall be, at the discretion of the department, at
43least as accurate, widely available and cost-effective as a saliva or urine PCR test. A screening
44shall be performed within 21 days from the date of birth and before the newborn infant is
45discharged from the birthing facility to the care of the parent or guardian; provided, however,
46that the screening shall not be performed if the parent or guardian of the newborn infant objects
47to the screening based upon a sincerely held religious belief of the parent or guardian. The
48cCMV educational materials outlined in section 70I(b) shall be provided to the parent or
49guardian of the infant at the time of cCMV screening. 4 of 5
50 A hospital that provides birthing and newborn services or a birthing facility shall adopt
51protocols for cCMV screening using a saliva or urine PCR test or another test approved by the
52department under this section for all newborns prior to discharge, and not to exceed 21 days from
53the date of birth, based on the department’s regulations, on or before January 1, 2025.
54 The cost of providing the newborn cCMV screening shall be a covered benefit
55reimbursable by all health insurers, except for supplemental policies that only provide coverage
56for specific diseases, hospital indemnity, Medicare supplement or other supplemental policies. In
57the absence of a third-party payer, the charges for the newborn cCMV screening shall be paid by
58the Commonwealth.
59 A hospital or birthing facility shall report annually to the department data including, but
60not limited to, the number of cCMV tests administered and the outcomes of said tests. The
61hospital or birthing facility shall inform, orally and in writing, a parent or guardian of the
62newborn infant the result of the cCMV screening test regardless of its outcome. This information
63shall also be provided in writing to the newborn infant's primary care physician and to the
64department through its electronic birth certificate system or such mechanism as specified by the
65department.
66 The department shall review the protocols required under this section and the
67implementation of these protocols as part of its birthing facility licensure review processes.
68 The department shall promulgate regulations to implement the cCMV screening program.
69 Nothing in this statute shall preclude newborns born at home from obtaining said cCMV
70screening. 5 of 5
71 Section 110E: Advisory Committee for CMV Screening Program
72 There is hereby established an advisory committee for the purpose of implementing the
73provisions of Section 110I. The advisory committee shall consist of the following members to be
74appointed by the commissioner of the department: a representative of the hospital industry; a
75primary care pediatrician or family practitioner; an otolaryngologist; a neonatologist; an
76infectious disease specialist; a clinician representing newborn nurseries; an audiologist; an
77ophthalmologist; an obstetrician-gynecologist; a representative of the commonwealth's early
78intervention program; 2 parents and/or guardians of a child impacted by cCMV; 2 medical
79professionals; a developer of preventative and/or therapeutic interventions for cCMV; a teacher
80of the deaf; and a representative of the department.
81 The advisory committee shall advise the department regarding the validity and cost of
82proposed cCMV regulations and/or cCMV screening, and shall recommend standards for
83performing and interpreting screening tests based on the most current technological methods, for
84documenting test results and follow-up, and for facilitating interaction between professionals and
85agencies that participate in follow-up care. Members of the advisory committee shall serve
86without compensation. The advisory committee shall be provided support services by the
87department.