SECTION 1. Section 110A of chapter 111 of the General Laws, as appearing in the 2024 Official Edition, is hereby amended by inserting after the word “dystrophy”, in line 3, the following words:- , congenital cytomegalovirus.
SECTION 2. Said chapter 111 is hereby further amended by inserting after section 110E the following 3 sections:-
Section 110F. (a) The commissioner shall establish, promote and maintain a public information program to promote awareness of congenital cytomegalovirus.
(b)(1) The department shall provide healthcare providers, physician assistants, nurses and midwives who render prenatal or postnatal care or offer fertility counseling or care to an expectant or new parent or guardian the following written information on:
(i) congenital cytomegalovirus and universal congenital cytomegalovirus screening; provided, that said information shall be up-to-date evidence-based information; provided further, that said information shall be vetted by an appropriate group of medical experts as determined by the department, in consultation with the advisory committee established pursuant to section 110H;
(ii) preventative measures that can be taken throughout pregnancy; and
(iii) contact or other referral information for additional educational and support resources.
(2) The department may make such information available to any other person who seeks information about congenital cytomegalovirus.
(c) Each hospital or birthing facility or any healthcare provider, physician assistant, nurse or midwife who renders prenatal or postnatal care shall provide expectant or new parents or guardians information provided by the department pursuant to subsection (b).
(d) The information pursuant to subsection (b) shall be provided to parents or guardians at the first prenatal appointment or at a preconception visit, whichever is earlier, and at the time of any screening pursuant to subsection (f) of section 110G.
Section 110G. (a) The department, in consultation with the perinatal advisory committee, shall develop regulations for the congenital cytomegalovirus screening required pursuant to section 110A. The regulations shall include evidence-based guidance. The department may consult other stakeholders, including, but not limited to, parents, healthcare providers, the New England Newborn Screening Program and birthing centers.
(b)(1) The regulations pursuant to subsection (a) shall require screenings to be performed using a saliva PCR test unless no saliva PCR test is available. If a saliva PCR test is unavailable, a urine PCR test shall be used.
(2) If a saliva PCR test is positive, a confirmatory urine PCR test shall be required.
(c) Notwithstanding subsection (b), the department may approve another test other than those pursuant to subsection (b) to conduct the congenital cytomegalovirus screening if the test is as accurate, cost effective and widely available as a saliva or urine PCR test.
(d)(1) The regulations pursuant to subsection (a) shall provide notice requirements on the congenital cytomegalovirus screening results, including, but not limited to, a requirement that the hospital or birthing facility shall inform, orally and in writing, a parent or guardian of the newborn the result of the congenital cytomegalovirus screening test regardless of its outcome.
(2) The regulations pursuant to subsection (a) shall require notice of the results of the congenital cytomegalovirus screening to be provided in writing to the newborn’s primary care physician and to the department through its electronic birth certificate system or other mechanism as specified by the department.
(e) The regulations pursuant to subsection (a) shall require a congenital cytomegalovirus screening to be performed not later than 21 days from the date of birth and before the newborn is discharged from the hospital or birthing facility to the care of the parent or guardian. No congenital cytomegalovirus screening shall be performed if the parent or guardian of the newborn objects to the screening based upon a sincerely held religious belief of the parent or guardian.
(f) The congenital cytomegalovirus information pursuant to subsection (b) of section 110F shall be provided to the parent or guardian of the newborn at the time of the congenital cytomegalovirus screening.
(g) Each hospital that provides birthing and newborn services and each birthing facility shall adopt protocols for congenital cytomegalovirus screening using a saliva or urine PCR test or another test approved by the department under subsection (c) for all newborns consistent with this section and sections 110A and 110F.
(h) The cost of providing the newborn congenital cytomegalovirus screenings shall be a covered benefit reimbursable by all health insurers, except for supplemental policies that only provide coverage for specific diseases, hospital indemnity, Medicare supplement or other supplemental policies. In the absence of a third-party payer, the charges for the newborn congenital cytomegalovirus screening shall be paid by the commonwealth.
(i) Each hospital that provides birthing and newborn services and each birthing facility shall report annually to the department data, including, but not limited to, the number of congenital cytomegalovirus tests administered and the outcomes of the tests.
(j) The department shall review the protocols required pursuant to subsection (g) and the implementation of these protocols as part of its hospital or birthing facility licensure review processes.
(k) Nothing in this section shall preclude newborns born at home from obtaining congenital cytomegalovirus screening.
Section 110H. (a) There is hereby established an advisory committee for the purpose of implementing section 110F. The advisory committee shall consist of the following 17 members to be appointed by the commissioner: 1 representative of the hospital industry; 1 primary care pediatrician or family practitioner; 1 otolaryngologist; 1 neonatologist; 1 infectious disease specialist; 1 clinician representing newborn nurseries; 1 audiologist; 1 ophthalmologist; 1 obstetrician-gynecologist; 1 representative of the commonwealth’s early intervention program; 2 parents or guardians of a child impacted by congenital cytomegalovirus; 2 medical professionals; 1 developer of preventative or therapeutic interventions for congenital cytomegalovirus; 1 teacher of the deaf; and 1 representative of the department.
(b) The advisory committee shall advise the department regarding congenital cytomegalovirus regulations and congenital cytomegalovirus screening and shall recommend standards for: (i) performing and interpreting screening tests based on the most current technological methods; (ii) documenting test results and follow-up care; and (iii) facilitating interactions between professionals and agencies that participate in follow-up care. Members of the advisory committee shall serve without compensation. The department may provide the advisory committee support services.
SECTION 3. Universal congenital cytomegalovirus screenings required pursuant to section 110A of chapter 111 of the General Laws, inserted by section 1, shall be required not later than July 1, 2027.
SECTION 4. Not later than January 1, 2028, hospitals that provide birthing and newborn services and birthing facilities shall adopt protocols pursuant to section 110G of chapter 111 of the General Laws, inserted by section 2.
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