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HOUSE DOCKET, NO. 3273 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 2218
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Kay Khan
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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 :DATE ADDED:Kay Khan11th Middlesex1/17/2023Colleen M. Garry36th Middlesex2/8/2023Brian M. Ashe2nd Hampden2/9/2023Hannah Kane11th Worcester2/10/2023Samantha Montaño15th Suffolk2/13/2023Jack Patrick Lewis7th Middlesex2/13/2023Lindsay N. Sabadosa1st Hampshire2/14/2023David Henry Argosky LeBoeuf17th Worcester2/15/2023Ryan C. FattmanWorcester and Hampden2/16/2023Brian W. Murray10th Worcester2/16/2023Smitty Pignatelli3rd Berkshire2/22/2023Paul K. Frost7th Worcester2/24/2023Patrick M. O'ConnorFirst Plymouth and Norfolk3/1/2023Joseph D. McKenna18th Worcester3/6/2023Judith A. Garcia11th Suffolk3/10/2023Adrian C. Madaro1st Suffolk3/13/2023William C. Galvin6th Norfolk3/14/2023 1 of 5
HOUSE DOCKET, NO. 3273 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 2218
By Representative Khan of Newton, a petition (accompanied by bill, House, No. 2218) of Kay
Khan and others relative to newborn screenings for congenital cytomegalovirus. Public Health.
[SIMILAR MATTER FILED IN PREVIOUS SESSION
SEE HOUSE, NO. 2338 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 Chapter 111 of the General Laws is hereby amended by inserting after section 110C the
2following sections:-
3 Section 110D: Required Newborn Screening for Congenital Cytomegalovirus
4 For the purposes of this section, the following words shall, unless the context clearly
5requires otherwise, have the following meanings:-
6 “Birthing facility”, an inpatient or ambulatory health care facility licensed by the
7department of public health that provides birthing and newborn care services. 2 of 5
8 “Congenital Cytomegalovirus (hereinafter referred to as cCMV) screening”, the
9identification of a newborn who may have congenital CMV infection or has cCMV confirmed
10through the use of a saliva or urine test.
11 “Department”, the department of public health.
12 “Newborn,” any liveborn infant who has not yet attained the age of 21 days from a birth
13occurring in the commonwealth or from a birth prior to transfer to a hospital in the
14commonwealth.
15 The department, in consultation with the perinatal advisory committee, shall develop
16regulations for all hospitals and birthing facilities requiring cCMV screening within one year of
17the passage of this legislation. These regulations shall consider evidence-based guidance.
18 The cCMV screening shall be performed using a saliva PCR test unless one is
19unavailable in which case a urine PCR test may be used. If positive, a saliva PCR test would
20require a confirmatory urine PCR test. The department may approve another test to conduct
21cCMV screening; provided, however, that the test shall be, at the discretion of the department, at
22least as accurate, widely available and cost-effective as a saliva or urine PCR test. A screening
23shall be performed within 21 days from the date of birth and before the newborn infant is
24discharged from the birthing facility to the care of the parent or guardian; provided, however,
25that the screening shall not be performed if the parent or guardian of the newborn infant objects
26to the screening based upon a sincerely held religious belief of the parent or guardian. The
27cCMV educational materials outlined in section 70I(b) shall be provided to the parent or
28guardian of the infant at the time of cCMV screening. 3 of 5
29 A hospital that provides birthing and newborn services or a birthing facility shall adopt
30protocols for cCMV screening using a saliva or urine PCR test or another test approved by the
31department under this section for all newborns prior to discharge, and not to exceed 21 days from
32the date of birth, based on the department’s regulations, on or before January 1, 2025.
33 The cost of providing the newborn cCMV screening shall be a covered benefit
34reimbursable by all health insurers, except for supplemental policies that only provide coverage
35for specific diseases, hospital indemnity, Medicare supplement or other supplemental policies. In
36the absence of a third-party payer, the charges for the newborn cCMV screening shall be paid by
37the Commonwealth.
38 A hospital or birthing facility shall report annually to the department data including, but
39not limited to, the number of cCMV tests administered and the outcomes of said tests. The
40hospital or birthing facility shall inform, orally and in writing, a parent or guardian of the
41newborn infant the result of the cCMV screening test regardless of its outcome. This information
42shall also be provided in writing to the newborn infant's primary care physician and to the
43department through its electronic birth certificate system or such mechanism as specified by the
44department.
45 The department shall review the protocols required under this section and the
46implementation of these protocols as part of its birthing facility licensure review processes.
47 The department shall promulgate regulations to implement the cCMV screening program.
48 Nothing in this statute shall preclude newborns born at home from obtaining said cCMV
49screening. 4 of 5
50 Section 110E: Advisory Committee for CMV Screening Program
51 There is hereby established an advisory committee for the purpose of implementing the
52provisions of Section 110D. The advisory committee shall consist of the following members to
53be appointed by the commissioner of the department: a representative of the hospital industry; a
54primary care pediatrician or family practitioner; an otolaryngologist; a neonatologist; an
55infectious disease specialist; a clinician representing newborn nurseries; an audiologist; an
56ophthalmologist; an obstetrician-gynecologist; a representative of the commonwealth's early
57intervention program; 2 parents and/or guardians of a child impacted by cCMV; 2 medical
58professionals; a developer of preventative and/or therapeutic interventions for cCMV; a teacher
59of the deaf; and a representative of the department.
60 The advisory committee shall advise the department regarding the validity and cost of
61proposed cCMV regulations and/or cCMV screening, and shall recommend standards for
62performing and interpreting screening tests based on the most current technological methods, for
63documenting test results and follow-up, and for facilitating interaction between professionals and
64agencies that participate in follow-up care. Members of the advisory committee shall serve
65without compensation. The advisory committee shall be provided support services by the
66department.
67 Chapter 111 of the General Laws is hereby further amended by inserting after Section
6870H the following section:-
69 Section 70I: Congenital cytomegalovirus; public information program; annual report
70 (a) The commissioner of the department shall establish, promote, and maintain a public
71information program regarding congenital cytomegalovirus, hereinafter referred to as cCMV. 5 of 5
72Such program shall be conducted throughout the commonwealth, and under said program, a
73hospital or birthing facility as defined in section 70E or any healthcare provider, physician
74assistant, nurse or midwife who renders prenatal or postnatal care shall give expectant or new
75parents or guardians information provided by the department under subsection (b). Such
76information shall be made available at the first prenatal appointment or at a preconception visit if
77applicable, whichever is earliest.
78 (b) The department shall make available to any healthcare provider, physician assistant,
79nurse or midwife who renders prenatal or postnatal care or offers fertility counseling or care to a
80parent or guardian the following: (i) up-to-date evidence-based, written information about cCMV
81and universal cCMV screening that has been vetted by an appropriate group of medical experts
82as determined by the department in conjunction with the advisory committee as established in
83section 110E of said Chapter 111; provided, however, that the written information provided shall
84include preventative measures that can be taken throughout pregnancy, and (ii) contact or other
85referral information for additional educational and support resources. The department may also
86make such information available to any other person who seeks information about cCMV
87infections.