An Act concerning screening for disorders in newborn infants, amending P.L.1977, c.321, and supplementing Title 26 of the Revised Statutes.

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

1. Section 1 of P.L.1977, c.321 (C.26:2-110) is amended to read as follows:

1. [It is hereby declared to be the public policy of this State that in the interests of public health every effort should be made to detect in newborn infants, hypothyroidism, galactosemia, phenylketonuria, and other preventable biochemical disorders which may cause mental retardation or other permanent disabilities and to treat affected individuals.]

The Legislature finds and declares that:

a. Newborn screening is an essential public health activity that strives to screen every newborn infant for a variety of congenital disorders, which, if not detected and managed early, can result in significant morbidity, mortality, and disability. The State's newborn screening system must provide the infrastructure for universal access and rapid and effective follow-up;

b. Ongoing advances in technologies and treatment modalities make it possible to screen newborn infants for a wide array of disorders. It is imperative that the State adjust its newborn screening program annually to incorporate these disorders to ensure that the program remains at the forefront of these advances; and

c. It is the intent of this act to protect the health and quality of life of newborn infants born in this State by enhancing the capacity to screen for congenital disorders and by guaranteeing that: all newborn infants are screened for certain core conditions and receive appropriate referrals and early medical intervention when warranted; and newborn data collection is standardized, and conditions detected by newborn screening are tracked and monitored. Further, information on newborn screening and conditions for which a newborn can be screened should be readily accessible, current, and understandable to both health care providers and parents or guardians.

(cf: P.L.1988, c.24, s.2)

2. Section 2 of P.L.1977, c.321 (C.26:2-111) is amended to read as follows:

2. [All] There is established the Newborn Screening program in the Department of Health and Senior Services. Under this
program, all infants born in this State shall be [tested] screened for [hypothyroidism, galactosemia and phenylketonuria] the list of disorders promulgated by the Newborn Screening Advisory Committee and approved by the Commissioner of Health and Senior Services, pursuant to section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill). This list shall be reviewed and revised annually. The Commissioner of Health and Senior Services shall issue regulations to assure that newborns are [so tested] screened in a manner approved by the commissioner. The commissioner shall ensure that treatment services are available to all identified individuals.

The [State] Department of Health and Senior Services [may] shall charge a [reasonable] fee of at least $100 for the [tests] screening, follow-up, treatment, and education performed pursuant to this act. The amount of the fee [and the] shall be adjusted by the commissioner as necessary to support the screening, follow-up, and treatment of newborn infants, and the education of physicians, hospital staffs, nurses, and the public as required by this act. The procedures for collecting the fee shall be determined by the commissioner. The commissioner shall apply all revenues collected from the fees to the [testing] screening, follow-up, education, and treatment procedures performed pursuant to this act. A portion of the fee shall be earmarked for ongoing infrastructure upgrades, including providing electronic access to physicians to obtain screening results, follow-up recommendations, and information on the treatment provided by the Newborn Screening program.

[The] Based on the recommendations of the Newborn Screening Advisory Committee established pursuant to section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill), the commissioner may also require [testing] the screening of newborn infants for other [preventable biochemical] disorders if reliable and efficient [testing] screening techniques are available. If the commissioner determines that an additional test shall be required, the commissioner, at least [90] 60 days prior to requiring the test [he], shall so advise the President of the Senate [,] and the Speaker of the General Assembly [and chairmen of the standing reference committees on Revenue, Finance and Appropriations and Institutions, Health and Welfare of his determination].

The commissioner shall provide a program of reviewing and following up on positive cases in order that measures may be taken to prevent death, mental retardation, or other permanent disabilities. The program shall provide timely intervention and referral to specialists and treatment centers for newborn infants with confirmed positive diagnoses of disorders screened for pursuant to this section. The commissioner shall adopt regulations establishing criteria for qualification as a treatment center, including, but not limited to, specific services that each center shall offer to affected newborn infants. The commissioner shall also adopt regulations establishing qualifications for medical staff employed by such centers.

The commissioner shall collect information on newborn infants and their families in a standardized manner and develop a system for quality assurance which includes the periodic assessment of indicators that are measurable, functional, and appropriate to the conditions for which newborn infants are screened pursuant to this section. The commissioner shall use the information collected to track and monitor newborn infants and children with confirmed positive diagnoses until they reach 21 years of age, and to evaluate the long-term outcomes of treatment. Information on newborn infants and their families compiled pursuant to this section [may] shall be used by the department and agencies designated by the commissioner for the purposes of carrying out this act, but otherwise the information shall be confidential and not divulged or made public so as to disclose the identity of any person to which it relates, except as provided by law.

The department shall conduct an intensive educational and training program among physicians, [hospitals] hospital staffs, [public health] nurses, and the public concerning [those biochemical disorders] newborn screening. This program shall include, but need not be limited to, the following:

a. information concerning the nature of the disorders, [testing] screening for the detection of these disorders and treatment modalities for these disorders;

b. the distribution of educational materials prepared by the department which explain the purposes of newborn screening and the possible disorders for which a newborn infant can be screened; and

c. information on follow-up, rehabilitative, medical, and early intervention services available for newborn infants with confirmed positive diagnoses of disorders.

The provisions of this section shall not apply if the parents of a newborn infant object in writing to the [testing] screening on the grounds that it would conflict with their religious tenets or practices.

(cf: P.L.1988, c.24, s.3)

3. (New section) The Commissioner of Health and Senior Services shall establish a Newborn Screening Advisory Committee and convene a meeting of the committee at least once a year to review the disorders included in the Newborn Screening program, screening technologies, treatment options, and educational and follow-up procedures. The committee shall include, but need not be limited to, medical, hospital, and public health professionals, scientific experts, and consumer representatives and advocates. The committee shall allow for public input in the course of conducting its review and issue recommendations to the commissioner on the improvement of the Newborn Screening program.

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

5. This act shall take effect on the 180th day following enactment, except that the Commissioner of Health and Senior Services shall take such anticipatory action in advance as shall be necessary for its implementation.

STATEMENT

This bill revises the State's newborn screening program for congenital disorders by requiring the Commissioner of Health and Senior Services to annually review a list of disorders recommended by an advisory committee (established in the bill) to determine the disorders for which newborn infants will be screened by the department. The bill also makes several other changes to the program, including formally designating it as the "Newborn Screening" program.

According to information from the March of Dimes and the CARES Foundation, Inc., the State is currently screening newborns for 50 disorders. This legislation ensures that the disorders included in the Newborn Screening program will be evaluated on a yearly basis and that the program will expand to include more disorders as technology and State resources allow.

Specifically, the bill makes the following changes to the screening, follow-up, treatment, and education components of the Newborn Screening program:

� the commissioner is directed to establish a Newborn Screening Advisory Committee consisting of medical, hospital, and public health professionals, as well as scientific experts and consumer representatives, and convene a meeting of the committee at least once a year to make recommendations on the disorders screened for, screening technologies, treatment options, and educational and follow-up procedures;

� the commissioner is required to annually review a list of disorders promulgated by the advisory committee and to determine, based on the list, the disorders for which newborn infants will be screened;

� the commissioner, within 60 days of adding a new disorder to the program, must advise the President of the Senate and the Speaker of the General Assembly;

� the commissioner is required to provide timely intervention and referral to specialists and treatment centers for newborn infants with confirmed positive diagnoses of the disorders screened for pursuant to the bill;

� the commissioner is required to adopt regulations establishing qualifications for centers that receive grants to provide treatment for newborns that are diagnosed with certain disorders through the program, and to establish qualifications for medical personnel working at the centers;

� the commissioner is required to systematically collect data to track and monitor newborns and children with confirmed positive diagnoses of disorders screened for through the program until they reach 21 years of age, and evaluate the long-term outcomes of treatment;

� the educational program on newborn screening shall provide materials and information on follow-up, rehabilitative, medical, and early intervention services for newborn infants with confirmed positive diagnoses of disorders;

� the fee charged to hospitals by the department is increased from $71 to a minimum of $100, to support the screening, follow-up, and treatment of newborns, and the education of physicians, nurses, and the public;

� a portion of the fee charged to hospitals by the department is to be used for infrastructure upgrades, including providing electronic access to physicians to obtain screening results, follow-up recommendations, and information on the treatment provided by the Newborn Screening program; and

� parents of newborn infants are required to provide notice in writing if they object to screening on the grounds that it would conflict with their religious tenets or practices.