AB 1559, as amended, Pan. Newborn screening program.
Existing law requires the State Department of Public Health to establish a program for the development, provision, and evaluation of genetic disease testing.
Existing law establishes the continuously appropriated Genetic Disease Testing Fund (GDTF), consisting of fees paid for newborn screening tests and states the intent of the Legislature that all costs of the genetic disease testing program be fully supported by fees paid for newborn screening tests, which are deposited in the GDTF. Existing law also authorizes moneys in the GDTF to be used for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, and severe combined immunodeficiency (SCID) and exempts the expansion of contracts for this purpose from certain provisions of the Public Contract Code, the Government Code, and the State Administrative Manual, as specified.
This billbegin delete would, until January 1, 2018,end deletebegin insert wouldend insert require the department to expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD)begin insert as soon as ALD is adopted by the federal Recommended Uniform Screening Panel (RUSP)end insert. By expanding the purposes for which moneys from the fund may be expended, this bill would make an appropriation.
Vote: majority. Appropriation: yes. Fiscal committee: yes. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 124977 of the Health and Safety Code
2 is amended to read:
(a) It is the intent of the Legislature that, unless
4otherwise specified, the genetic disease testing program carried
5out pursuant to this chapter be fully supported from fees collected
6for services provided by the program.
7(b) (1) The department shall charge a fee to all payers for any
8tests or activities performed pursuant to this chapter. The amount
9of the fee shall be established by regulation and periodically
10adjusted by the director in order to meet the costs of this chapter.
11Notwithstanding any other law, any fees charged for prenatal
12screening and followup services provided to persons enrolled in
13the Medi-Cal program, health care service plan enrollees, or
14
persons covered by health insurance policies, shall be paid in full
15and deposited in the Genetic Disease Testing Fund or the Birth
16Defects Monitoring Fund consistent with this section, subject to
17all terms and conditions of each enrollee’s or insured’s health care
18service plan or insurance coverage, whichever is applicable,
19including, but not limited to, copayments and deductibles
20applicable to these services, and only if these copayments,
21deductibles, or limitations are disclosed to the subscriber or enrollee
22pursuant to the disclosure provisions of Section 1363.
23(2) The department shall expeditiously undertake all steps
24necessary to implement the fee collection process, including
P3 1personnel, contracts, and data processing, so as to initiate the fee
2collection process at the earliest opportunity.
3(3) Effective for services provided on and after July 1, 2002,
4the department shall charge a fee to the hospital of birth, or, for
5births not occurring in a hospital, to families of the newborn, for
6newborn screening and followup services. The hospital of birth
7and families of newborns born outside the hospital shall make
8payment in full to the Genetic Disease Testing Fund. The
9department shall not charge or bill Medi-Cal beneficiaries for
10services provided under this chapter.
11(4) (A) The department shall charge a fee for prenatal screening
12to support the pregnancy blood sample storage, testing, and
13research activities of the Birth Defects Monitoring Program.
14(B) The prenatal screening fee for activities
of the Birth Defects
15Monitoring Program shall be ten dollars ($10).
16(5) The department shall set guidelines for invoicing, charging,
17and collecting from approved researchers the amount necessary
18to cover all expenses associated with research application requests
19made under this section, data linkage, retrieval, data processing,
20data entry, reinventory, and shipping of blood samples or their
21components, and related data management.
22(6) The only funds from the Genetic Disease Testing Fund that
23may be used for the purpose of supporting the pregnancy blood
24sample storage, testing, and research activities of the Birth Defects
25Monitoring Program are those prenatal screening fees assessed
26and collected prior to the creation of the Birth Defects Monitoring
27Program Fund specifically to
support those Birth Defects
28Monitoring Program activities.
29(7) The Birth Defects Monitoring Program Fund is hereby
30created as a special fund in the State Treasury. Fee revenues that
31are collected pursuant to paragraph (4) shall be deposited into the
32fund and shall be available upon appropriation by the Legislature
33to support the pregnancy blood sample storage, testing, and
34research activities of the Birth Defects Monitoring Program.
35Notwithstanding Section 16305.7 of the Government Code, interest
36earned on funds in the Birth Defects Monitoring Program Fund
37shall be deposited as revenue into the fund to support the Birth
38Defects Monitoring Program.
39(c) (1) The Legislature finds that timely implementation of
40changes in genetic screening programs and
continuous maintenance
P4 1of quality statewide services requires expeditious regulatory and
2administrative procedures to obtain the most cost-effective
3electronic data processing, hardware, software services, testing
4equipment, and testing and followup services.
5(2) The expenditure of funds from the Genetic Disease Testing
6Fund for these purposes shall not be subject to Section 12102 of,
7and Chapter 2 (commencing with Section 10290) of Part 2 of
8Division 2 of, the Public Contract Code, or to Division 25.2
9(commencing with Section 38070). The department shall provide
10the Department of Finance with documentation that equipment
11and services have been obtained at the lowest cost consistent with
12technical requirements for a comprehensive high-quality program.
13(3) The expenditure of funds
from the Genetic Disease Testing
14Fund for implementation of the Tandem Mass Spectrometry
15screening for fatty acid oxidation, amino acid, and organic acid
16disorders, and screening for congenital adrenal hyperplasia may
17be implemented through the amendment of the Genetic Disease
18Branch Screening Information System contracts and shall not be
19subject to Chapter 3 (commencing with Section 12100) of Part 2
20of Division 2 of the Public Contract Code, Article 4 (commencing
21with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title
222 of the Government Code, and any policies, procedures,
23regulations, or manuals authorized by those laws.
24(4) The expenditure of funds from the Genetic Disease Testing
25Fund for the expansion of the Genetic Disease Branch Screening
26Information System to include cystic fibrosis, biotinidase, severe
27combined
immunodeficiency (SCID), and adrenoleukodystrophy
28(ALD) may be implemented through the amendment of the Genetic
29Disease Branch Screening Information System contracts, and shall
30not be subject to Chapter 2 (commencing with Section 10290) or
31Chapter 3 (commencing with Section 12100) of Part 2 of Division
322 of the Public Contract Code, Article 4 (commencing with Section
3319130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the
34Government Code, or Sections 4800 to 5180, inclusive, of the
35State Administrative Manual as they relate to approval of
36information technology projects or approval of increases in the
37duration or costs of information technology projects. This
38paragraph shall apply to the design, development, and
39implementation of the expansion, and to the maintenance and
40operation of the Genetic Disease Branch Screening Information
P5 1System, including change requests, once the expansion is
2implemented.
3(d) (1) The department may adopt emergency regulations to
4implement and make specific this chapter in accordance with
5Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
63 of Title 2 of the Government Code. For the purposes of the
7Administrative Procedure Act, the adoption of regulations shall
8be deemed an emergency and necessary for the immediate
9preservation of the public peace, health and safety, or general
10welfare. Notwithstanding Chapter 3.5 (commencing with Section
1111340) of Part 1 of Division 3 of Title 2 of the Government Code,
12these emergency regulations shall not be subject to the review and
13approval of the Office of Administrative Law. Notwithstanding
14Sections 11346.1 and 11349.6 of the Government Code, the
15department shall submit these regulations directly to the Secretary
16of State for
filing. The regulations shall become effective
17immediately upon filing by the Secretary of State. Regulations
18shall be subject to public hearing within 120 days of filing with
19the Secretary of State and shall comply with Sections 11346.8 and
2011346.9 of the Government Code or shall be repealed.
21(2) The Office of Administrative Law shall provide for the
22printing and publication of these regulations in the California Code
23of Regulations. Notwithstanding Chapter 3.5 (commencing with
24Section 11340) of Part 1 of Division 3 of Title 2 of the Government
25Code, the regulations adopted pursuant to this chapter shall not be
26repealed by the Office of Administrative Law and shall remain in
27effect until revised or repealed by the department.
28(3) The Legislature finds and declares that the health and
safety
29of California newborns is in part dependent on an effective and
30adequately staffed genetic disease program, the cost of which shall
31be supported by the fees generated by the program.
32(e) This section shall remain in effect only until January 1, 2018,
33and as of that date is repealed, unless a later enacted statute, that
34is enacted before January 1, 2018, deletes of extends that date.
Section 124977 is added to the Health and Safety Code,
36to read:
(a) It is the intent of the Legislature that, unless
38otherwise specified, the genetic disease testing program carried
39out pursuant to this chapter be fully supported from fees collected
40for services provided by the program.
P6 1(b) (1) The department shall charge a fee to all payers for any
2tests or activities performed pursuant to this chapter. The amount
3of the fee shall be established by regulation and periodically
4adjusted by the director in order to meet the costs of this chapter.
5Notwithstanding any other provision of law, any fees charged for
6prenatal screening and followup services provided to persons
7enrolled in the Medi-Cal program, health care service plan
8enrollees, or persons covered by health insurance
policies, shall
9be paid in full and deposited in the Genetic Disease Testing Fund
10or the Birth Defects Monitoring Fund consistent with this section,
11subject to all terms and conditions of each enrollee’s or insured’s
12health care service plan or insurance coverage, whichever is
13applicable, including, but not limited to, copayments and
14deductibles applicable to these services, and only if these
15copayments, deductibles, or limitations are disclosed to the
16subscriber or enrollee pursuant to the disclosure provisions of
17Section 1363.
18(2) The department shall expeditiously undertake all steps
19necessary to implement the fee collection process, including
20personnel, contracts, and data processing, so as to initiate the fee
21collection process at the earliest opportunity.
22(3) Effective for services provided on and after July 1, 2002,
23the department shall charge a fee to the hospital of
birth, or, for
24births not occurring in a hospital, to families of the newborn, for
25newborn screening and followup services. The hospital of birth
26and families of newborns born outside the hospital shall make
27payment in full to the Genetic Disease Testing Fund. The
28department shall not charge or bill Medi-Cal beneficiaries for
29services provided under this chapter.
30(4) (A) The department shall charge a fee for prenatal screening
31to support the pregnancy blood sample storage, testing, and
32research activities of the Birth Defects Monitoring Program.
33(B) The prenatal screening fee for activities of the Birth Defects
34Monitoring Program shall be ten dollars ($10).
35(5) The department shall set guidelines for invoicing, charging,
36and collecting from approved researchers the amount necessary
37to cover all
expenses associated with research application requests
38made under this section, data linkage, retrieval, data processing,
39data entry, reinventory, and shipping of blood samples or their
40components and related data management.
P7 1(6) The only funds from the Genetic Disease Testing Fund that
2may be used for the purpose of supporting the pregnancy blood
3sample storage, testing, and research activities of the Birth Defects
4Monitoring Program are those prenatal screening fees assessed
5and collected prior to the creation of the Birth Defects Monitoring
6Program Fund specifically to support those Birth Defects
7Monitoring Program activities.
8(7) The Birth Defects Monitoring Program Fund is hereby
9created as a special fund in the State Treasury. Fee revenues that
10are collected pursuant to paragraph (4) shall be deposited into the
11fund and shall be available upon appropriation by the
Legislature
12to support the pregnancy blood sample storage, testing, and
13research activities of the Birth Defects Monitoring Program.
14Notwithstanding Section 16305.7 of the Government Code, interest
15earned on funds in the Birth Defects Monitoring Program Fund
16shall be deposited as revenue into the fund to support the Birth
17Defects Monitoring Program.
18(c) (1) The Legislature finds that timely implementation of
19changes in genetic screening programs and continuous maintenance
20of quality statewide services requires expeditious regulatory and
21administrative procedures to obtain the most cost-effective
22electronic data processing, hardware, software services, testing
23equipment, and testing and followup services.
24(2) The expenditure of funds from the Genetic Disease Testing
25Fund for these purposes shall not be subject to Section 12102 of,
26and Chapter 2 (commencing
with Section 10290) of Part 2 of
27Division 2 of, the Public Contract Code, or to Division 25.2
28(commencing with Section 38070). The department shall provide
29the Department of Finance with documentation that equipment
30and services have been obtained at the lowest cost consistent with
31technical requirements for a comprehensive high-quality program.
32(3) The expenditure of funds from the Genetic Disease Testing
33Fund for implementation of the Tandem Mass Spectrometry
34screening for fatty acid oxidation, amino acid, and organic acid
35disorders, and screening for congenital adrenal hyperplasia may
36be implemented through the amendment of the Genetic Disease
37Branch Screening Information System contracts and shall not be
38subject to Chapter 3 (commencing with Section 12100) of Part 2
39of Division 2 of the Public Contract Code, Article 4 (commencing
40with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title
P8 12 of the Government Code, and any policies,
procedures,
2regulations or manuals authorized by those laws.
3(4) The expenditure of funds from the Genetic Disease Testing
4Fund for the expansion of the Genetic Disease Branch Screening
5Information System to include cystic fibrosis, biotinidase, and
6severe combined immunodeficiency (SCID) may be implemented
7through the amendment of the Genetic Disease Branch Screening
8Information System contracts, and shall not be subject to Chapter
92 (commencing with Section 10290) or Chapter 3 (commencing
10with Section 12100) of Part 2 of Division 2 of the Public Contract
11Code, Article 4 (commencing with Section 19130) of Chapter 5
12of Part 2 of Division 5 of Title 2 of the Government Code, or
13Sections 4800 to 5180, inclusive, of the State Administrative
14Manual as they relate to approval of information technology
15projects or approval of increases in the duration or costs of
16information technology projects. This paragraph shall apply to the
17design, development,
and implementation of the expansion, and
18to the maintenance and operation of the Genetic Disease Branch
19Screening Information System, including change requests, once
20the expansion is implemented.
21(d) (1) The department may adopt emergency regulations to
22implement and make specific this chapter in accordance with
23Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
243 of Title 2 of the Government Code. For the purposes of the
25Administrative Procedure Act, the adoption of regulations shall
26be deemed an emergency and necessary for the immediate
27preservation of the public peace, health and safety, or general
28welfare. Notwithstanding Chapter 3.5 (commencing with Section
2911340) of Part 1 of Division 3 of Title 2 of the Government Code,
30these emergency regulations shall not be subject to the review and
31approval of the Office of Administrative Law. Notwithstanding
32Sections 11346.1 and 11349.6 of the Government Code,
the
33department shall submit these regulations directly to the Secretary
34of State for filing. The regulations shall become effective
35immediately upon filing by the Secretary of State. Regulations
36shall be subject to public hearing within 120 days of filing with
37the Secretary of State and shall comply with Sections 11346.8 and
3811346.9 of the Government Code or shall be repealed.
39(2) The Office of Administrative Law shall provide for the
40printing and publication of these regulations in the California Code
P9 1of Regulations. Notwithstanding Chapter 3.5 (commencing with
2Section 11340) of Part 1 of Division 3 of Title 2 of the Government
3Code, the regulations adopted pursuant to this chapter shall not be
4repealed by the Office of Administrative Law and shall remain in
5effect until revised or repealed by the department.
6(3) The Legislature finds and declares that the health and safety
7of
California newborns is in part dependent on an effective and
8adequately staffed genetic disease program, the cost of which shall
9be supported by the fees generated by the program.
10(e) This section shall become operative on January 1, 2018.
Section 125001 of the Health and Safety Code is
13amended to read:
(a) The department shall establish a program for the
15development, provision, and evaluation of genetic disease testing,
16and may provide laboratory testing facilities or make grants to,
17contract with, or make payments to, any laboratory that it deems
18qualified and cost effective to conduct testing or with any metabolic
19specialty clinic to provide necessary treatment with qualified
20specialists. The program shall provide genetic screening and
21followup services for persons who have the screening.
22(b) The department shall expand statewide screening of
23newborns to include tandem mass spectrometry screening for fatty
24acid oxidation, amino acid, organic acid disorders, and congenital
25
adrenal hyperplasia as soon as possible. The department shall
26provide information with respect to these disorders and available
27testing resources to all women receiving prenatal care and to all
28women admitted to a hospital for delivery. If the department is
29unable to provide this statewide screening by August 1, 2005, the
30department shall temporarily obtain these testing services through
31a competitive bid process from one or more public or private
32laboratories that meet the department’s requirements for testing,
33quality assurance, and reporting. If the department determines that
34contracting for these services is more cost effective, and meets the
35other requirements of this chapter, than purchasing the tandem
36mass spectrometry equipment themselves, the department shall
37contract with one or more public or private laboratories.
38(c) The department shall expand statewide screening of
39newborns to include screening for severe combined
40immunodeficiency (SCID) as soon as possible. In implementing
P10 1the SCID screening test, the department shall also screen for other
2T-cell lymphopenias that are detectable as a result of screening
3for SCID, insofar as it does not require additional costs or
4equipment beyond that needed to test for SCID.
5(d) The department shall expand statewide screening of
6newborns to include screening for adrenoleukodystrophy (ALD)
7as soon asbegin delete possible.end deletebegin insert ALD is adopted by the federal Recommended
8Uniform Screening Panel (RUSP).end insert
9(e) This section shall remain in effect only until January 1, 2018,
10and as of that date is repealed, unless a later enacted statute, that
11is enacted before January 1, 2018, deletes of extends that date.
Section 125001 is added to the Health and Safety Code,
13to read:
(a) The department shall establish a program for the
15development, provision, and evaluation of genetic disease testing,
16and may provide laboratory testing facilities or make grants to,
17contract with, or make payments to, any laboratory that it deems
18qualified and cost-effective to conduct testing or with any
19metabolic specialty clinic to provide necessary treatment with
20qualified specialists. The program shall provide genetic screening
21and followup services for persons who have the screening.
22(b) The department shall expand statewide screening of
23newborns to include tandem mass spectrometry screening for fatty
24acid oxidation, amino acid, and organic acid disorders and
25congenital adrenal hyperplasia as soon as possible. The department
26shall
provide information with respect to these disorders and
27available testing resources to all women receiving prenatal care
28and to all women admitted to a hospital for delivery. If the
29department is unable to provide this statewide screening by August
301, 2005, the department shall temporarily obtain these testing
31services through a competitive bid process from one or more public
32or private laboratories that meet the department’s requirements
33for testing, quality assurance, and reporting. If the department
34determines that contracting for these services is more cost-effective,
35and meets the other requirements of this chapter, than purchasing
36the tandem mass spectrometry equipment themselves, the
37department shall contract with one or more public or private
38laboratories.
39(c) The department shall expand statewide screening of
40newborns to include screening for severe combined
P11 1immunodeficiency (SCID) as soon as possible. In implementing
2the SCID
screening test, the department shall also screen for other
3T-cell lymphopenias that are detectable as a result of screening
4for SCID, insofar as it does not require additional costs or
5equipment beyond that needed to test for SCID.
6(d) This section shall become operative on January 1, 2018.
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