S3975

An Act concerning screening newborn infants for congenital cytomegalovirus infection and supplementing Title 26 of the Revised Statutes.

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

1. a. All infants born in this State shall be tested for congenital cytomegalovirus infection (cCMV) beginning six months following the occurrence of all of the following:

(1) the development of a reliable test or series of tests for screening newborns for cCMV using dried blood spots and quality assurance testing methodology for cCMV testing;

(2) the availability of quality assurance materials for the cCMV test from the federal Centers for Disease Control and Prevention;

(3) 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, after the committee's evidence review of newborn screening for cCMV;

(4) the review by the Department of Health of the proposed test; and

(5) the acquisition of equipment necessary to implement the expanded screening tests by the State's Newborn Screening Laboratory.

b. The Department of Health may charge a reasonable fee and any reasonable increase in this fee as necessary, for the test performed pursuant to this section. The amount of the fee and the procedures for collecting the fee shall be determined by the Commissioner of Health.

2. a. The Commissioner of Health shall establish a public awareness campaign to educate pregnant persons about cytomegalovirus (CMV) and cCMV and the value of early detection of, interventions for, and possible treatments for, CMV and cCMV.

b. The commissioner, in establishing the public awareness campaign, shall develop outreach efforts and provide information and educational materials to pregnant persons on CMV and cCMV including, but not limited to:

(1) the cause and nature of CMV and cCMV;

(2) diagnostic procedures and appropriate indications for their use;

(3) lifestyle issues relating to how a pregnant person can pass cCMV to a developing fetus; and

(4) the availability of CMV and cCMV diagnostic and treatment services in the community.

c. The commissioner shall prepare, and make available on the Department of Health’s Internet website, in English and Spanish, and in a manner that is easily understandable by a pregnant person, information about the symptoms and treatment of CMV and cCMV and any other information that the commissioner deems to be necessary. This information may be revised by the department whenever new information about CMV and cCMV becomes available.

3. 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.), necessary to carry out the purposes of this act.

4. This act shall take effect immediately.

STATEMENT

This bill requires all infants born in the State to be tested for congenital cytomegalovirus infection (cCMV). The testing requirement will be contingent on the development and approval by both federal and State authorities of a cCMV test and the State acquiring the equipment necessary to conduct the test as part of its existing newborn screening program.

Cytomegalovirus (CMV) is a common viral infection that is spread through bodily fluids like saliva, blood, semen, urine and breast milk. The virus is mostly harmless and rarely causes illness. If a pregnant person is infected with CMV, that person can pass it to a developing infant, causing the cCMV infection. The virus affects one in every 200 newborns, or approximately 30,000 infants born each year, making it the most common congenital viral infection in the United States. Furthermore, one in every five children born with cCMV will develop permanent health problems, and as many as 400 infants die every year as a result of the disease.

The bill stipulates that the Commissioner of Health may charge a reasonable fee, as determined by the Commissioner of Health, and any reasonable increase in this fee as necessary, for the test performed pursuant to the bill.

The bill also requires the commissioner to establish a public awareness campaign to educate pregnant persons about cytomegalovirus (CMV) and cCMV and the value of early detection of, interventions for, and possible treatments for, CMV and cCMV.

The program is provide information and educational materials to pregnant persons on CMV and cCMV including, but not limited to: (1) the cause and nature of CMV and cCMV; (2) diagnostic procedures and appropriate indications for their use; (3) lifestyle issues relating to how a pregnant person can pass cCMV to a developing fetus; and (4) the availability of CMV and cCMV diagnostic and treatment services in the community.

The commissioner is to prepare, and make available on the DOH’s Internet website, in English and Spanish, and in a manner that is easily understandable by a pregnant person, information about the symptoms and treatment of CMV and cCMV and any other information that the commissioner deems to be necessary. This information may be revised by the DOH whenever new information about CMV and cCMV becomes available.