LCO \\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06821-R01- HB.docx 1 of 5 General Assembly Substitute Bill No. 6821 January Session, 2023 AN ACT CONCERNING CYTOMEGALOVIRUS. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Section 19a-55 of the general statutes is repealed and the 1 following is substituted in lieu thereof (Effective October 1, 2023): 2 (a) There is established a newborn screening program. The 3 Commissioner of Public Health shall (1) administer the newborn 4 screening program, (2) direct persons identified through the screening 5 program to appropriate specialty centers for treatments, consistent 6 with any applicable confidentiality requirements, and (3) set the fees to 7 be charged to institutions to cover all expenses of the comprehensive 8 screening program including testing, tracking and treatment, subject to 9 the approval of the Secretary of the Office of Policy and Management. 10 The fees to be charged pursuant to subdivision (3) of this subsection 11 shall be set at a minimum of ninety-eight dollars. 12 (b) The administrative officer or other person in charge of each 13 institution caring for newborn infants, a nurse-midwife licensed 14 pursuant to chapter 377 or a midwife shall cause to have administered 15 to every such newborn infant in his or her care a blood spot specimen 16 and an HIV-related test, as defined in section 19a-581, except that the 17 person responsible for testing may omit such test if the mother has had 18 Substitute Bill No. 6821 LCO {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06821- R01-HB.docx } 2 of 5 an HIV-related test pursuant to section 19a-90 or 19a-593. The blood 19 spot specimen shall be collected not earlier than twenty-four hours 20 after the birth of the newborn infant and not later than forty-eight 21 hours after the birth of such infant, unless the institution caring for 22 newborn infants, nurse-midwife licensed pursuant to chapter 377 or 23 midwife determines that a situation exists to warrant an early 24 collection of the specimen or if collection of the specimen is medically 25 contraindicated. Situations that warrant early collection of the 26 specimen shall include, but not be limited to, the imminent transfusion 27 of blood products, dialysis, early discharge of the newborn infant from 28 the institution, transfer of the newborn infant to another institution or 29 imminent death. If the newborn infant dies before a blood spot 30 specimen can be obtained, the specimen shall be collected as soon as 31 practicable after death. The institution licensed to care for newborn 32 infants, nurse-midwife or midwife shall notify the Department of 33 Public Health when a specimen is not collected within forty-eight 34 hours after the birth of such infant due to: (1) The infant's medical 35 fragility, (2) refusal by the parents when newborn infant screening is in 36 conflict with their religious tenets and practice, (3) the newborn infant 37 receiving comfort measures only, or (4) any other reason. Such 38 notification shall be documented in the department's newborn 39 screening system pursuant to section 19a-53 by the institution caring 40 for newborn infants, nurse-midwife or midwife or sent in writing to 41 the department not later than seventy-two hours after the birth of the 42 newborn infant. The institution caring for newborn infants, nurse-43 midwife or midwife shall send the blood spot specimen to the state 44 public health laboratory not later than twenty-four hours after the time 45 of collection. The department may request an additional blood spot 46 specimen if: (A) There was an early collection of the specimen, (B) the 47 specimen was collected following a transfusion of blood products, (C) 48 the specimen is unsatisfactory for testing, or (D) the department 49 determines that there is an abnormal result. The state public health 50 laboratory shall make and maintain a record of the date and time of its 51 receipt of each blood spot specimen and make such record available 52 for inspection by the institution caring for newborn infants, nurse-53 Substitute Bill No. 6821 LCO {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06821- R01-HB.docx } 3 of 5 midwife or midwife that sent the blood spot specimen not later than 54 forty-eight hours after such institution, nurse-midwife or midwife 55 submits a request to inspect such record. 56 (c) The Commissioner of Public Health shall publish a list of all the 57 abnormal conditions for which the department screens newborns 58 under the newborn screening program, which shall include, but need 59 not be limited to, testing for amino acid disorders, including 60 phenylketonuria, organic acid disorders, fatty acid oxidation disorders, 61 including, but not limited to, long-chain 3-hydroxyacyl CoA 62 dehydrogenase (L-CHAD) and medium -chain acyl-CoA 63 dehydrogenase (MCAD), hypothyroidism, galactosemia, sickle cell 64 disease, maple syrup urine disease, homocystinuria, biotinidase 65 deficiency, congenital adrenal hyperplasia, severe combined 66 immunodeficiency disease, adrenoleukodystrophy, spinal muscular 67 atrophy and any other disorder included on the recommended 68 uniform screening panel pursuant to 42 USC 300b-10, as amended 69 from time to time, and as prescribed by the Commissioner of Public 70 Health. 71 (d) In addition to the testing requirements prescribed in subsection 72 (b) of this section, the administrative officer or other person in charge 73 of each institution caring for newborn infants shall cause to have 74 administered to [(1)] every such infant in its care a screening test for 75 [(A)] (1) cystic fibrosis, [and (B)] (2) critical congenital heart disease, 76 [(2) any newborn infant who fails a newborn hearing screening, as 77 described in section 19a-59, a screening test for] and (3) 78 cytomegalovirus. Such screening tests shall be administered as soon 79 after birth as is medically appropriate. 80 (e) (1) The clinical laboratory that completes the testing for cystic 81 fibrosis [,] shall report the number of newborn infants screened and the 82 results of such testing, not less than annually, to the Department of 83 Public Health into the newborn screening system pursuant to section 84 19a-53. The administrative officer or other person in charge of each 85 institution caring for newborn infants who performs the testing for 86 Substitute Bill No. 6821 LCO {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06821- R01-HB.docx } 4 of 5 critical congenital heart disease shall enter the results of such test into 87 the newborn screening system pursuant to section 19a-53. 88 (2) The administrative officer or other person in charge of each 89 institution caring for newborn infants shall enter any case of 90 cytomegalovirus that is confirmed as a result of a screening test 91 administered pursuant to subdivision [(2)] (3) of subsection (d) of this 92 section to the Department of Public Health into the newborn screening 93 system pursuant to section 19a-53. The provisions of this subsection 94 shall apply regardless of the patient's insurance status or source of 95 payment, including self-pay status. 96 (f) The provisions of this section shall not apply to any infant whose 97 parents object to the test or treatment as being in conflict with their 98 religious tenets and practice. The commissioner shall adopt 99 regulations, in accordance with the provisions of chapter 54, to 100 implement the provisions of this section. 101 Sec. 2. (Effective from passage) Not later than January 1, 2024, the 102 Department of Public Health shall disseminate educational materials 103 regarding the symptoms, diagnosis and treatment of cytomegalovirus 104 to (1) each gynecologist, obstetrician and pediatrician in the state for 105 provision by such health care providers to their pregnant and 106 postpartum patients, and (2) the Office of Early Childhood to 107 disseminate to child care centers, group child care homes and family 108 child care homes for provision by such centers and homes to the 109 parent or guardian of each newborn receiving care from the center or 110 home. 111 This act shall take effect as follows and shall amend the following sections: Section 1 October 1, 2023 19a-55 Sec. 2 from passage New section Substitute Bill No. 6821 LCO {\\PRDFS1\HCOUSERS\BARRYJN\WS\2023HB-06821- R01-HB.docx } 5 of 5 Statement of Legislative Commissioners: In Section 1(e)(2), "subdivision (2)" was changed to "subdivision [(2)] (3)" for accuracy. PH Joint Favorable Subst.