H 5441

HOUSE . . . . . . . . No. 5441
   The Commonwealth of Massachusetts
  ________________________________________
  HOUSE OF REPRESENTATIVES, May 19, 2026.
    The committee on Ways and Means to whom was referred the Bill
relative to newborn screenings for congenital cytomegalovirus (House,
No. 4367), reports recommending that the same ought to pass with an
amendment substituting therefor the accompanying bill (House, No.
5441).
  For the committee,
  AARON MICHLEWITZ.
  FILED ON: 5/19/2026
 HOUSE . . . . . . . . . . . . . . . No. 5441
  The Commonwealth of Massachusetts
  _______________
  In the One Hundred and Ninety-Fourth General Court
  (2025-2026)
  _______________
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:
1SECTION 1. Section 110A of chapter 111 of the General Laws, as appearing in the 2024
2 Official Edition, is hereby amended by inserting after the word “dystrophy”, in line 3, the
3 following words:- , congenital cytomegalovirus.
4SECTION 2. Said chapter 111 is hereby further amended by inserting after section 110E
5 the following 3 sections:-
6Section 110F. (a) The commissioner shall establish, promote and maintain a public
7 information program to promote awareness of congenital cytomegalovirus.
8(b)(1) The department shall provide healthcare providers, physician assistants, nurses and
9 midwives who render prenatal or postnatal care or offer fertility counseling or care to an
10 expectant or new parent or guardian the following written information on:
11(i) congenital cytomegalovirus and universal congenital cytomegalovirus screening;
12 provided, that said information shall be up-to-date evidence-based information; provided further,
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13 that said information shall be vetted by an appropriate group of medical experts as determined by
14 the department, in consultation with the advisory committee established pursuant to section
15 110H;
16(ii) preventative measures that can be taken throughout pregnancy; and
17(iii) contact or other referral information for additional educational and support resources.
18(2) The department may make such information available to any other person who seeks
19 information about congenital cytomegalovirus.
20(c) Each hospital or birthing facility or any healthcare provider, physician assistant, nurse
21 or midwife who renders prenatal or postnatal care shall provide expectant or new parents or
22 guardians information provided by the department pursuant to subsection (b).
23(d) The information pursuant to subsection (b) shall be provided to parents or guardians
24 at the first prenatal appointment or at a preconception visit, whichever is earlier, and at the time
25 of any screening pursuant to subsection (f) of section 110G.
26Section 110G. (a) The department, in consultation with the perinatal advisory committee,
27 shall develop regulations for the congenital cytomegalovirus screening required pursuant to
28 section 110A. The regulations shall include evidence-based guidance. The department may
29 consult other stakeholders, including, but not limited to, parents, healthcare providers, the New
30 England Newborn Screening Program and birthing centers.
31(b)(1) The regulations pursuant to subsection (a) shall require screenings to be performed
32 using a saliva PCR test unless no saliva PCR test is available. If a saliva PCR test is unavailable,
33 a urine PCR test shall be used.
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34(2) If a saliva PCR test is positive, a confirmatory urine PCR test shall be required.
35(c) Notwithstanding subsection (b), the department may approve another test other than
36 those pursuant to subsection (b) to conduct the congenital cytomegalovirus screening if the test is
37 as accurate, cost effective and widely available as a saliva or urine PCR test.
38(d)(1) The regulations pursuant to subsection (a) shall provide notice requirements on the
39 congenital cytomegalovirus screening results, including, but not limited to, a requirement that the
40 hospital or birthing facility shall inform, orally and in writing, a parent or guardian of the
41 newborn the result of the congenital cytomegalovirus screening test regardless of its outcome.
42(2) The regulations pursuant to subsection (a) shall require notice of the results of the
43 congenital cytomegalovirus screening to be provided in writing to the newborn’s primary care
44 physician and to the department through its electronic birth certificate system or other
45 mechanism as specified by the department.
46(e) The regulations pursuant to subsection (a) shall require a congenital cytomegalovirus
47 screening to be performed not later than 21 days from the date of birth and before the newborn is
48 discharged from the hospital or birthing facility to the care of the parent or guardian. No
49 congenital cytomegalovirus screening shall be performed if the parent or guardian of the
50 newborn objects to the screening based upon a sincerely held religious belief of the parent or
51 guardian.
52(f) The congenital cytomegalovirus information pursuant to subsection (b) of section
53 110F shall be provided to the parent or guardian of the newborn at the time of the congenital
54 cytomegalovirus screening.
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55(g) Each hospital that provides birthing and newborn services and each birthing facility
56 shall adopt protocols for congenital cytomegalovirus screening using a saliva or urine PCR test
57 or another test approved by the department under subsection (c) for all newborns consistent with
58 this section and sections 110A and 110F.
59(h) The cost of providing the newborn congenital cytomegalovirus screenings shall be a
60 covered benefit reimbursable by all health insurers, except for supplemental policies that only
61 provide coverage for specific diseases, hospital indemnity, Medicare supplement or other
62 supplemental policies. In the absence of a third-party payer, the charges for the newborn
63 congenital cytomegalovirus screening shall be paid by the commonwealth.
64(i) Each hospital that provides birthing and newborn services and each birthing facility
65 shall report annually to the department data, including, but not limited to, the number of
66 congenital cytomegalovirus tests administered and the outcomes of the tests.
67(j) The department shall review the protocols required pursuant to subsection (g) and the
68 implementation of these protocols as part of its hospital or birthing facility licensure review
69 processes.
70(k) Nothing in this section shall preclude newborns born at home from obtaining
71 congenital cytomegalovirus screening.
72Section 110H. (a) There is hereby established an advisory committee for the purpose of
73 implementing section 110F. The advisory committee shall consist of the following 17 members
74 to be appointed by the commissioner: 1 representative of the hospital industry; 1 primary care
75 pediatrician or family practitioner; 1 otolaryngologist; 1 neonatologist; 1 infectious disease
76 specialist; 1 clinician representing newborn nurseries; 1 audiologist; 1 ophthalmologist; 1
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77 obstetrician-gynecologist; 1 representative of the commonwealth’s early intervention program; 2
78 parents or guardians of a child impacted by congenital cytomegalovirus; 2 medical professionals;
79 1 developer of preventative or therapeutic interventions for congenital cytomegalovirus; 1
80 teacher of the deaf; and 1 representative of the department.
81(b) The advisory committee shall advise the department regarding congenital
82 cytomegalovirus regulations and congenital cytomegalovirus screening and shall recommend
83 standards for: (i) performing and interpreting screening tests based on the most current
84 technological methods; (ii) documenting test results and follow-up care; and (iii) facilitating
85 interactions between professionals and agencies that participate in follow-up care. Members of
86 the advisory committee shall serve without compensation. The department may provide the
87 advisory committee support services.
88SECTION 3. Universal congenital cytomegalovirus screenings required pursuant to
89 section 110A of chapter 111 of the General Laws, inserted by section 1, shall be required not
90 later than July 1, 2027.
91SECTION 4. Not later than January 1, 2028, hospitals that provide birthing and newborn
92 services and birthing facilities shall adopt protocols pursuant to section 110G of chapter 111 of
93 the General Laws, inserted by section 2.
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