Massachusetts 2023-2024 Regular Session

Massachusetts Senate Bill S1405 Compare Versions

Only one version of the bill is available at this time.

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1	1	1 of 1
2	2	SENATE DOCKET, NO. 1958 FILED ON: 1/20/2023
3	3	SENATE . . . . . . . . . . . . . . No. 1405
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Joan B. Lovely
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act relative to newborn screenings for congenital cytomegalovirus.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :Joan B. LovelySecond EssexSal N. DiDomenicoMiddlesex and Suffolk2/8/2023 1 of 5
16	16	SENATE DOCKET, NO. 1958 FILED ON: 1/20/2023
17	17	SENATE . . . . . . . . . . . . . . No. 1405
18	18	By Ms. Lovely, a petition (accompanied by bill, Senate, No. 1405) of Joan B. Lovely and Sal N.
19	19	DiDomenico for legislation relative to newborn screenings for congenital cytomegalovirus.
20	20	Public Health.
21	21	[SIMILAR MATTER FILED IN PREVIOUS SESSION
22	22	SEE SENATE, NO. 1471 OF 2021-2022.]
23	23	The Commonwealth of Massachusetts
24	24	_______________
25	25	In the One Hundred and Ninety-Third General Court
26	26	(2023-2024)
27	27	_______________
28	28	An Act relative to newborn screenings for congenital cytomegalovirus.
29	29	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
30	30	of the same, as follows:
31	31	1 SECTION 1. Chapter 111 of the General Laws, as appearing in the 2020 Official Edition,
32	32	2is hereby further amended by inserting after Section 70H the following section:-
33	33	3 Section 70I: Congenital cytomegalovirus; public information program; annual report
34	34	4 (a) The commissioner of the department shall establish, promote, and maintain a public
35	35	5information program regarding congenital cytomegalovirus, hereinafter referred to as cCMV.
36	36	6Such program shall be conducted throughout the commonwealth, and under said program, a
37	37	7hospital or birthing facility as defined in section 70E or any healthcare provider, physician
38	38	8assistant, nurse or midwife who renders prenatal or postnatal care shall give expectant or new
39	39	9parents or guardians information provided by the department under subsection (b). Such 2 of 5
40	40	10information shall be made available at the first prenatal appointment or at a preconception visit if
41	41	11applicable, whichever is earliest.
42	42	12 (b) The department shall make available to any healthcare provider, physician assistant,
43	43	13nurse or midwife who renders prenatal or postnatal care or offers fertility counseling or care to a
44	44	14parent or guardian the following: (i) up-to-date evidence-based, written information about cCMV
45	45	15and universal cCMV screening that has been vetted by an appropriate group of medical experts
46	46	16as determined by the department in conjunction with the advisory committee as established in
47	47	17section 110J of said Chapter 111; provided, however, that the written information provided shall
48	48	18include preventative measures that can be taken throughout pregnancy, and (ii) contact or other
49	49	19referral information for additional educational and support resources. The department may also
50	50	20make such information available to any other person who seeks information about cCMV
51	51	21infections.
52	52	22 SECTION 2. Said chapter 111 is hereby further amended by inserting after section 110C
53	53	23the following sections:-
54	54	24 Section 110D: Required Newborn Screening for Congenital Cytomegalovirus
55	55	25 For the purposes of this section, the following words shall, unless the context clearly
56	56	26requires otherwise, have the following meanings:-
57	57	27 “Birthing facility”, an inpatient or ambulatory health care facility licensed by the
58	58	28department of public health that provides birthing and newborn care services. 3 of 5
59	59	29 “Congenital Cytomegalovirus (hereinafter referred to as cCMV) screening”, the
60	60	30identification of a newborn who may have congenital CMV infection or has cCMV confirmed
61	61	31through the use of a saliva or urine test.
62	62	32 “Department”, the department of public health.
63	63	33 “Newborn,” any liveborn infant who has not yet attained the age of 21 days from a birth
64	64	34occurring in the commonwealth or from a birth prior to transfer to a hospital in the
65	65	35commonwealth.
66	66	36 The department, in consultation with the perinatal advisory committee, shall develop
67	67	37regulations for all hospitals and birthing facilities requiring cCMV screening within one year of
68	68	38the passage of this legislation. These regulations shall consider evidence-based guidance.
69	69	39 The cCMV screening shall be performed using a saliva PCR test unless one is
70	70	40unavailable in which case a urine PCR test may be used. If positive, a saliva PCR test would
71	71	41require a confirmatory urine PCR test. The department may approve another test to conduct
72	72	42cCMV screening; provided, however, that the test shall be, at the discretion of the department, at
73	73	43least as accurate, widely available and cost-effective as a saliva or urine PCR test. A screening
74	74	44shall be performed within 21 days from the date of birth and before the newborn infant is
75	75	45discharged from the birthing facility to the care of the parent or guardian; provided, however,
76	76	46that the screening shall not be performed if the parent or guardian of the newborn infant objects
77	77	47to the screening based upon a sincerely held religious belief of the parent or guardian. The
78	78	48cCMV educational materials outlined in section 70I(b) shall be provided to the parent or
79	79	49guardian of the infant at the time of cCMV screening. 4 of 5
80	80	50 A hospital that provides birthing and newborn services or a birthing facility shall adopt
81	81	51protocols for cCMV screening using a saliva or urine PCR test or another test approved by the
82	82	52department under this section for all newborns prior to discharge, and not to exceed 21 days from
83	83	53the date of birth, based on the department’s regulations, on or before January 1, 2025.
84	84	54 The cost of providing the newborn cCMV screening shall be a covered benefit
85	85	55reimbursable by all health insurers, except for supplemental policies that only provide coverage
86	86	56for specific diseases, hospital indemnity, Medicare supplement or other supplemental policies. In
87	87	57the absence of a third-party payer, the charges for the newborn cCMV screening shall be paid by
88	88	58the Commonwealth.
89	89	59 A hospital or birthing facility shall report annually to the department data including, but
90	90	60not limited to, the number of cCMV tests administered and the outcomes of said tests. The
91	91	61hospital or birthing facility shall inform, orally and in writing, a parent or guardian of the
92	92	62newborn infant the result of the cCMV screening test regardless of its outcome. This information
93	93	63shall also be provided in writing to the newborn infant's primary care physician and to the
94	94	64department through its electronic birth certificate system or such mechanism as specified by the
95	95	65department.
96	96	66 The department shall review the protocols required under this section and the
97	97	67implementation of these protocols as part of its birthing facility licensure review processes.
98	98	68 The department shall promulgate regulations to implement the cCMV screening program.
99	99	69 Nothing in this statute shall preclude newborns born at home from obtaining said cCMV
100	100	70screening. 5 of 5
101	101	71 Section 110E: Advisory Committee for CMV Screening Program
102	102	72 There is hereby established an advisory committee for the purpose of implementing the
103	103	73provisions of Section 110I. The advisory committee shall consist of the following members to be
104	104	74appointed by the commissioner of the department: a representative of the hospital industry; a
105	105	75primary care pediatrician or family practitioner; an otolaryngologist; a neonatologist; an
106	106	76infectious disease specialist; a clinician representing newborn nurseries; an audiologist; an
107	107	77ophthalmologist; an obstetrician-gynecologist; a representative of the commonwealth's early
108	108	78intervention program; 2 parents and/or guardians of a child impacted by cCMV; 2 medical
109	109	79professionals; a developer of preventative and/or therapeutic interventions for cCMV; a teacher
110	110	80of the deaf; and a representative of the department.
111	111	81 The advisory committee shall advise the department regarding the validity and cost of
112	112	82proposed cCMV regulations and/or cCMV screening, and shall recommend standards for
113	113	83performing and interpreting screening tests based on the most current technological methods, for
114	114	84documenting test results and follow-up, and for facilitating interaction between professionals and
115	115	85agencies that participate in follow-up care. Members of the advisory committee shall serve
116	116	86without compensation. The advisory committee shall be provided support services by the
117	117	87department.