S4615

An Act concerning newborn screening for congenital cytomegalovirus, supplementing Title 26 of the Revised Statutes, making an appropriation, and repealing P.L.2021, c.413.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. As used in this act:

"Commissioner" means the Commissioner of Health.

"Congenital cytomegalovirus" or "cCMV" means infection with cytomegalovirus acquired before birth.

"Department" means the Department of Health.

"Health care facility" means a general hospital, birthing center, or other health care facility licensed by the Department of Health that provides obstetrical or newborn services.

"Health care practitioner" means a physician, physician assistant, certified nurse midwife, advanced practice nurse, or any other health care professional licensed or otherwise authorized to provide care to a newborn infant.

"Newborn" means an infant not more than 21 days of age.

"Screening" means a laboratory screening test approved by the commissioner for the detection of congenital cytomegalovirus infection.

2. a. Unless a newborn's parent or legal guardian opts out of screening for any reason, every newborn born in this State shall receive a screening for congenital cytomegalovirus before discharge from a health care facility or, if medically appropriate, as soon thereafter as practicable. In all cases, screenings shall be completed within 21 days following birth.

b. (1) The screening required pursuant to subsection a. of this section shall be performed using a dried blood spot card that shall be sent to the State’s Public Health and Environmental Laboratories for testing.

(2) The State’s Public Health and Environmental Laboratories shall provide health care facilities with screening results in a timely manner.

(3) In a manner that is consistent with federal and State privacy laws, the State’s Public Health and Environmental Laboratories shall report positive screening results to the Department of Health in a manner and form prescribed by the department.

c. When a newborn receives a positive screening result for congenital cytomegalovirus, the health care practitioner responsible for the newborn's care shall ensure timely referral for:

(1) confirmatory diagnostic testing;

(2) evaluation by the newborn's primary care provider;

(3) audiologic evaluation;

(4) ophthalmologic evaluation, when clinically indicated; and

(5) consultation with a pediatric infectious disease specialist, when clinically indicated.

3. a. The commissioner shall develop educational materials concerning congenital cytomegalovirus.

b. The materials shall include, but need not be limited to, information concerning:

(1) congenital cytomegalovirus infection;

(2) methods of reducing maternal exposure during pregnancy;

(3) the purpose and benefits of newborn screening;

(4) recommended medical follow-up after a positive screening result;

(5) available treatment options;

(6) audiologic and developmental monitoring; and

(7) early intervention services available in this State.

c. The department shall make the educational materials available electronically and in printed form to hospitals, birthing centers, physicians, certified nurse midwives, advanced practice nurses, local health agencies, and other health care practitioners providing prenatal, obstetrical, or pediatric care.

d. (1) Health care practitioners shall provide the educational materials developed pursuant to this section to women who are pregnant or receiving preconception care.

(2) Health care practitioners shall discuss the educational materials developed pursuant to this section with women who are pregnant or receiving preconception care.

4. The Commissioner of Health shall adopt rules and regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), as necessary to effectuate the purposes of this act.

5. There is appropriated from the General Fund to the Department of Health such sums as may be necessary to compensate health care facilities and patients for the costs of complying with the provisions of this act.

6. P.L.2021, c.413 (C.26:2-111.9) is repealed.

7. This act shall take effect immediately.

STATEMENT

This bill requires universal newborn screening for congenital cytomegalovirus (cCMV) in New Jersey.

The bill requires every newborn born in this State to receive screening for congenital cytomegalovirus before discharge from a health care facility or, when medically appropriate, as soon thereafter as practicable, unless the parent or guardian opts out of testing for any reason. In all cases, the screening is to be completed within 21 days following birth. Screening is to be performed using a dried blood spot card that is to be sent to the State’s Public Health and Environmental Laboratories for testing. Positive screening results are to be reported to the Department of Health in a manner and form prescribed by the department.

The bill requires newborns with positive screening results to receive timely referral for confirmatory diagnostic testing and appropriate medical evaluation, including audiologic evaluation, ophthalmologic evaluation when clinically indicated, and consultation with a pediatric infectious disease specialist when clinically indicated.

Under the bill, health care practitioners are required to provide educational materials developed by the Department of Health to women who are pregnant or receiving preconception care and to discuss the materials with women who are pregnant or receiving preconception care.

The bill appropriates from the General Fund to the Department of Health such sums as may be necessary to compensate health care facilities and patients for the costs of complying with the bill’s provisions. Finally, the bill repeals P.L.2021, c.413, which made the newborn cCMV screening requirement contingent upon the availability of quality assurance materials for the cCMV test from the federal Centers for Disease Control and Prevention, and contingent upon the inclusion of newborn screening for cCMV in the Recommended Uniform Screening Panel of the United States Secretary of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children.