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Section 125000 Of Article 2. Newborn Screening From California Health And Safety Code >> Division 106. >> Part 5. >> Chapter 1. >> Article 2.
125000
. (a) It is the policy of the State of California to make
every effort to detect, as early as possible, phenylketonuria and
other preventable heritable or congenital disorders leading to
intellectual disability or physical defects.
The department shall establish a genetic disease unit, that shall
coordinate all programs of the department in the area of genetic
disease. The unit shall promote a statewide program of information,
testing, and counseling services and shall have the responsibility of
designating tests and regulations to be used in executing this
program.
The information, tests, and counseling for children shall be in
accordance with accepted medical practices and shall be administered
to each child born in California once the department has established
appropriate regulations and testing methods. The information, tests,
and counseling for pregnant women shall be in accordance with
accepted medical practices and shall be offered to each pregnant
woman in California once the department has established appropriate
regulations and testing methods. These regulations shall follow the
standards and principles specified in Section 124980. The department
may provide laboratory testing facilities or contract with any
laboratory that it deems qualified to conduct tests required under
this section. However, notwithstanding former Section 125005,
provision of laboratory testing facilities by the department shall be
contingent upon the provision of funding therefor by specific
appropriation to the Genetic Disease Testing Fund enacted by the
Legislature. If moneys appropriated for purposes of this section are
not authorized for expenditure to provide laboratory facilities, the
department may nevertheless contract to provide laboratory testing
services pursuant to this section and shall perform laboratory
services, including, but not limited to, quality control,
confirmatory, and emergency testing, necessary to ensure the
objectives of this program.
(b) The department shall charge a fee for any tests performed pursuant to this section. The amount of the fee shall be established and periodically adjusted by the director in order to meet the costs of this section.
(c) The department shall inform all hospitals or physicians and surgeons, or both, of required regulations and tests and may alter or withdraw any of these requirements whenever sound medical practice so indicates. To the extent practicable, the department shall provide notice to hospitals and other payers in advance of an increase in the fees charged for the program.
(d) This section shall not apply if a parent or guardian of the newborn child objects to a test on the ground that the test conflicts with his or her religious beliefs or practices.
(e) The genetic disease unit is authorized to make grants or contracts or payments to vendors approved by the department for all of the following:
(1) Testing and counseling services.
(2) Demonstration projects to determine the desirability and feasibility of additional tests or new genetic services.
(3) To initiate the development of genetic services in areas of need.
(4) To purchase or provide genetic services from any sums as are appropriated for this purpose.
(f) The genetic disease unit shall evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases, including, but not limited to, biotinidase deficiency and cystic fibrosis. The genetic disease unit shall also evaluate and prepare recommendations on the availability and effectiveness of preventative followup interventions, including the use of specialized medically necessary dietary products. It is the intent of the Legislature that funds for the support of the evaluations and recommendations required pursuant to this subdivision, and for the activities authorized pursuant to subdivision (e), shall be provided in the annual Budget Act appropriation from the Genetic Disease Testing Fund.
(g) Health care providers that contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the department, any or all of the testing and counseling services required to be provided under this section or the regulations adopted pursuant thereto, if the services meet the quality standards and adhere to the regulations established by the department and the plan pays that portion of a fee established under this section that is directly attributable to the department's cost of administering the testing or counseling service and to any required testing or counseling services provided by the state for plan members. The payment by the plan, as provided in this subdivision, shall be deemed to fulfill any obligation the provider or the provider's patient may have to the department to pay a fee in connection with the testing or counseling service.
(h) The department may appoint experts in the area of genetic screening, including, but not limited to, cytogenetics, molecular biology, prenatal, specimen collection, and ultrasound to provide expert advice and opinion on the interpretation and enforcement of regulations adopted pursuant to this section. These experts shall be designated agents of the state with respect to their assignments. These experts shall receive no salary, but shall be reimbursed for expenses associated with the purposes of this section. All expenses of the experts for the purposes of this section shall be paid from the Genetic Disease Testing Fund.
(b) The department shall charge a fee for any tests performed pursuant to this section. The amount of the fee shall be established and periodically adjusted by the director in order to meet the costs of this section.
(c) The department shall inform all hospitals or physicians and surgeons, or both, of required regulations and tests and may alter or withdraw any of these requirements whenever sound medical practice so indicates. To the extent practicable, the department shall provide notice to hospitals and other payers in advance of an increase in the fees charged for the program.
(d) This section shall not apply if a parent or guardian of the newborn child objects to a test on the ground that the test conflicts with his or her religious beliefs or practices.
(e) The genetic disease unit is authorized to make grants or contracts or payments to vendors approved by the department for all of the following:
(1) Testing and counseling services.
(2) Demonstration projects to determine the desirability and feasibility of additional tests or new genetic services.
(3) To initiate the development of genetic services in areas of need.
(4) To purchase or provide genetic services from any sums as are appropriated for this purpose.
(f) The genetic disease unit shall evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases, including, but not limited to, biotinidase deficiency and cystic fibrosis. The genetic disease unit shall also evaluate and prepare recommendations on the availability and effectiveness of preventative followup interventions, including the use of specialized medically necessary dietary products. It is the intent of the Legislature that funds for the support of the evaluations and recommendations required pursuant to this subdivision, and for the activities authorized pursuant to subdivision (e), shall be provided in the annual Budget Act appropriation from the Genetic Disease Testing Fund.
(g) Health care providers that contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the department, any or all of the testing and counseling services required to be provided under this section or the regulations adopted pursuant thereto, if the services meet the quality standards and adhere to the regulations established by the department and the plan pays that portion of a fee established under this section that is directly attributable to the department's cost of administering the testing or counseling service and to any required testing or counseling services provided by the state for plan members. The payment by the plan, as provided in this subdivision, shall be deemed to fulfill any obligation the provider or the provider's patient may have to the department to pay a fee in connection with the testing or counseling service.
(h) The department may appoint experts in the area of genetic screening, including, but not limited to, cytogenetics, molecular biology, prenatal, specimen collection, and ultrasound to provide expert advice and opinion on the interpretation and enforcement of regulations adopted pursuant to this section. These experts shall be designated agents of the state with respect to their assignments. These experts shall receive no salary, but shall be reimbursed for expenses associated with the purposes of this section. All expenses of the experts for the purposes of this section shall be paid from the Genetic Disease Testing Fund.
