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 bill wouldbegin insert, until January 1, 2018,end insert require the department to expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD). 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
25personnel, contracts, and data processing, so as to initiate the fee
26collection process at the earliest opportunity.
P3 1(3) Effective for services provided on and after July 1, 2002,
2the department shall charge a fee to the hospital of birth, or, for
3births not occurring in a hospital, to families of the newborn, for
4newborn screening and followup services. The hospital of birth
5and families of newborns born outside the hospital shall make
6payment in full to the Genetic Disease Testing Fund. The
7department shall not charge or bill Medi-Cal beneficiaries for
8services provided under this chapter.
9(4) (A) The department shall charge a fee for prenatal screening
10to support the pregnancy blood sample storage, testing, and
11research activities of the Birth Defects Monitoring Program.
12(B) The prenatal screening fee for activities of the Birth Defects
13Monitoring Program shall be ten
dollars ($10).
14(5) The department shall set guidelines for invoicing, charging,
15and collecting from approved researchers the amount necessary
16to cover all expenses associated with research application requests
17made under this section, data linkage, retrieval, data processing,
18data entry, reinventory, and shipping of blood samples or their
19components, and related data management.
20(6) The only funds from the Genetic Disease Testing Fund that
21may be used for the purpose of supporting the pregnancy blood
22sample storage, testing, and research activities of the Birth Defects
23Monitoring Program are those prenatal screening fees assessed
24and collected prior to the creation of the Birth Defects Monitoring
25Program Fund specifically to support those Birth Defects
26Monitoring Program
activities.
27(7) The Birth Defects Monitoring Program Fund is hereby
28created as a special fund in the State Treasury. Fee revenues that
29are collected pursuant to paragraph (4) shall be deposited into the
30fund and shall be available upon appropriation by the Legislature
31to support the pregnancy blood sample storage, testing, and
32research activities of the Birth Defects Monitoring Program.
33Notwithstanding Section 16305.7 of the Government Code, interest
34earned on funds in the Birth Defects Monitoring Program Fund
35shall be deposited as revenue into the fund to support the Birth
36Defects Monitoring Program.
37(c) (1) The Legislature finds that timely implementation of
38changes in genetic screening programs and continuous maintenance
39of quality statewide services
requires expeditious regulatory and
40administrative procedures to obtain the most cost-effective
P4 1electronic data processing, hardware, software services, testing
2equipment, and testing and followup services.
3(2) The expenditure of funds from the Genetic Disease Testing
4Fund for these purposes shall not be subject to Section 12102 of,
5and Chapter 2 (commencing with Section 10290) of Part 2 of
6Division 2 of, the Public Contract Code, or to Division 25.2
7(commencing with Section 38070). The department shall provide
8the Department of Finance with documentation that equipment
9and services have been obtained at the lowest cost consistent with
10technical requirements for a comprehensive high-quality program.
11(3) The expenditure of funds from the Genetic Disease Testing
12Fund for
implementation of the Tandem Mass Spectrometry
13screening for fatty acid oxidation, amino acid, and organic acid
14disorders, and screening for congenital adrenal hyperplasia may
15be implemented through the amendment of the Genetic Disease
16Branch Screening Information System contracts and shall not be
17subject to Chapter 3 (commencing with Section 12100) of Part 2
18of Division 2 of the Public Contract Code, Article 4 (commencing
19with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title
202 of the Government Code, and any policies, procedures,
21regulations, or manuals authorized by those laws.
22(4) The expenditure of funds from the Genetic Disease Testing
23Fund for the expansion of the Genetic Disease Branch Screening
24Information System to include cystic fibrosis, biotinidase, severe
25combined immunodeficiency (SCID), and adrenoleukodystrophy
26(ALD)
may be implemented through the amendment of the Genetic
27Disease Branch Screening Information System contracts, and shall
28not be subject to Chapter 2 (commencing with Section 10290) or
29Chapter 3 (commencing with Section 12100) of Part 2 of Division
302 of the Public Contract Code, Article 4 (commencing with Section
3119130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the
32Government Code, or Sections 4800 to 5180, inclusive, of the
33State Administrative Manual as they relate to approval of
34information technology projects or approval of increases in the
35duration or costs of information technology projects. This
36paragraph shall apply to the design, development, and
37implementation of the expansion, and to the maintenance and
38operation of the Genetic Disease Branch Screening Information
39System, including change requests, once the expansion is
40implemented.
P5 1(d) (1) The department may adopt emergency regulations to
2implement and make specific this chapter in accordance with
3Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
43 of Title 2 of the Government Code. For the purposes of the
5Administrative Procedure Act, the adoption of regulations shall
6be deemed an emergency and necessary for the immediate
7preservation of the public peace, health and safety, or general
8welfare. Notwithstanding Chapter 3.5 (commencing with Section
911340) of Part 1 of Division 3 of Title 2 of the Government Code,
10these emergency regulations shall not be subject to the review and
11approval of the Office of Administrative Law. Notwithstanding
12Sections 11346.1 and 11349.6 of the Government Code, the
13department shall submit these regulations directly to the Secretary
14of State for filing. The regulations shall become effective
15immediately
upon filing by the Secretary of State. Regulations
16shall be subject to public hearing within 120 days of filing with
17the Secretary of State and shall comply with Sections 11346.8 and
1811346.9 of the Government Code or shall be repealed.
19(2) The Office of Administrative Law shall provide for the
20printing and publication of these regulations in the California Code
21of Regulations. Notwithstanding Chapter 3.5 (commencing with
22Section 11340) of Part 1 of Division 3 of Title 2 of the Government
23Code, the regulations adopted pursuant to this chapter shall not be
24repealed by the Office of Administrative Law and shall remain in
25effect until revised or repealed by the department.
26(3) The Legislature finds and declares that the health and safety
27of California newborns is in part dependent on an
effective and
28adequately staffed genetic disease program, the cost of which shall
29be supported by the fees generated by the program.
30(e) This section shall remain in effect only until January 1, 2018,
31and as of that date is repealed, unless a later enacted statute, that
32is enacted before January 1, 2018, deletes of extends that date.
begin insertSection 124977 is added to the end insertbegin insertHealth and Safety Codeend insertbegin insert,
34to read:end insert
(a) It is the intent of the Legislature that, unless
36otherwise specified, the genetic disease testing program carried
37out pursuant to this chapter be fully supported from fees collected
38for services provided by the program.
39(b) (1) The department shall charge a fee to all payers for any
40tests or activities performed pursuant to this chapter. The amount
P6 1of the fee shall be established by regulation and periodically
2adjusted by the director in order to meet the costs of this chapter.
3Notwithstanding any other provision of law, any fees charged for
4prenatal screening and followup services provided to persons
5enrolled in the Medi-Cal program, health care service plan
6enrollees, or persons covered by health insurance
policies, shall
7be paid in full and deposited in the Genetic Disease Testing Fund
8or the Birth Defects Monitoring Fund consistent with this section,
9subject to all terms and conditions of each enrollee’s or insured’s
10health care service plan or insurance coverage, whichever is
11applicable, including, but not limited to, copayments and
12deductibles applicable to these services, and only if these
13copayments, deductibles, or limitations are disclosed to the
14subscriber or enrollee pursuant to the disclosure provisions of
15Section 1363.
16(2) The department shall expeditiously undertake all steps
17necessary to implement the fee collection process, including
18personnel, contracts, and data processing, so as to initiate the fee
19collection process at the earliest opportunity.
20(3) Effective for services provided on and after July 1, 2002,
21the department shall charge a fee to the hospital of
birth, or, for
22births not occurring in a hospital, to families of the newborn, for
23newborn screening and followup services. The hospital of birth
24and families of newborns born outside the hospital shall make
25payment in full to the Genetic Disease Testing Fund. The
26department shall not charge or bill Medi-Cal beneficiaries for
27services provided under this chapter.
28(4) (A) The department shall charge a fee for prenatal screening
29to support the pregnancy blood sample storage, testing, and
30research activities of the Birth Defects Monitoring Program.
31(B) The prenatal screening fee for activities of the Birth Defects
32Monitoring Program shall be ten dollars ($10).
33(5) The department shall set guidelines for invoicing, charging,
34and collecting from approved researchers the amount necessary
35to cover all
expenses associated with research application requests
36made under this section, data linkage, retrieval, data processing,
37data entry, reinventory, and shipping of blood samples or their
38components and related data management.
39(6) The only funds from the Genetic Disease Testing Fund that
40may be used for the purpose of supporting the pregnancy blood
P7 1sample storage, testing, and research activities of the Birth Defects
2Monitoring Program are those prenatal screening fees assessed
3and collected prior to the creation of the Birth Defects Monitoring
4Program Fund specifically to support those Birth Defects
5Monitoring Program activities.
6(7) The Birth Defects Monitoring Program Fund is hereby
7created as a special fund in the State Treasury. Fee revenues that
8are collected pursuant to paragraph (4) shall be deposited into
9the fund and shall be available upon appropriation by the
10
Legislature to support the pregnancy blood sample storage, testing,
11and research activities of the Birth Defects Monitoring Program.
12Notwithstanding Section 16305.7 of the Government Code, interest
13earned on funds in the Birth Defects Monitoring Program Fund
14shall be deposited as revenue into the fund to support the Birth
15Defects Monitoring Program.
16(c) (1) The Legislature finds that timely implementation of
17changes in genetic screening programs and continuous
18maintenance of quality statewide services requires expeditious
19regulatory and administrative procedures to obtain the most
20cost-effective electronic data processing, hardware, software
21services, testing equipment, and testing and followup services.
22(2) The expenditure of funds from the Genetic Disease Testing
23Fund for these purposes shall not be subject to Section 12102 of,
24and Chapter 2 (commencing
with Section 10290) of Part 2 of
25Division 2 of, the Public Contract Code, or to Division 25.2
26(commencing with Section 38070). The department shall provide
27the Department of Finance with documentation that equipment
28and services have been obtained at the lowest cost consistent with
29technical requirements for a comprehensive high-quality program.
30(3) The expenditure of funds from the Genetic Disease Testing
31Fund for implementation of the Tandem Mass Spectrometry
32screening for fatty acid oxidation, amino acid, and organic acid
33disorders, and screening for congenital adrenal hyperplasia may
34be implemented through the amendment of the Genetic Disease
35Branch Screening Information System contracts and shall not be
36subject to Chapter 3 (commencing with Section 12100) of Part 2
37of Division 2 of the Public Contract Code, Article 4 (commencing
38with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title
392 of the Government Code, and any policies,
procedures,
40regulations or manuals authorized by those laws.
P8 1(4) The expenditure of funds from the Genetic Disease Testing
2Fund for the expansion of the Genetic Disease Branch Screening
3Information System to include cystic fibrosis, biotinidase, and
4severe combined immunodeficiency (SCID) may be implemented
5through the amendment of the Genetic Disease Branch Screening
6Information System contracts, and shall not be subject to Chapter
72 (commencing with Section 10290) or Chapter 3 (commencing
8with Section 12100) of Part 2 of Division 2 of the Public Contract
9Code, Article 4 (commencing with Section 19130) of Chapter 5 of
10Part 2 of Division 5 of Title 2 of the Government Code, or Sections
114800 to 5180, inclusive, of the State Administrative Manual as
12they relate to approval of information technology projects or
13approval of increases in the duration or costs of information
14technology projects. This paragraph shall apply to the design,
15development,
and implementation of the expansion, and to the
16maintenance and operation of the Genetic Disease Branch
17Screening Information System, including change requests, once
18the expansion is implemented.
19(d) (1) The department may adopt emergency regulations to
20implement and make specific this chapter in accordance with
21Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
223 of Title 2 of the Government Code. For the purposes of the
23Administrative Procedure Act, the adoption of regulations shall
24be deemed an emergency and necessary for the immediate
25preservation of the public peace, health and safety, or general
26welfare. Notwithstanding Chapter 3.5 (commencing with Section
2711340) of Part 1 of Division 3 of Title 2 of the Government Code,
28these emergency regulations shall not be subject to the review and
29approval of the Office of Administrative Law. Notwithstanding
30Sections 11346.1 and 11349.6 of the Government Code,
the
31department shall submit these regulations directly to the Secretary
32of State for filing. The regulations shall become effective
33immediately upon filing by the Secretary of State. Regulations
34shall be subject to public hearing within 120 days of filing with
35the Secretary of State and shall comply with Sections 11346.8 and
3611346.9 of the Government Code or shall be repealed.
37(2) The Office of Administrative Law shall provide for the
38printing and publication of these regulations in the California
39Code of Regulations. Notwithstanding Chapter 3.5 (commencing
40with Section 11340) of Part 1 of Division 3 of Title 2 of the
P9 1Government Code, the regulations adopted pursuant to this chapter
2shall not be repealed by the Office of Administrative Law and shall
3remain in effect until revised or repealed by the department.
4(3) The Legislature finds and declares that the health and safety
5of
California newborns is in part dependent on an effective and
6adequately staffed genetic disease program, the cost of which shall
7be supported by the fees generated by the program.
8(e) This section shall become operative on January 1, 2018.
Section 125001 of the Health and Safety Code is
11amended to read:
(a) The department shall establish a program for the
13development, provision, and evaluation of genetic disease testing,
14and may provide laboratory testing facilities or make grants to,
15contract with, or make payments to, any laboratory that it deems
16qualified and cost effective to conduct testing or with any metabolic
17specialty clinic to provide necessary treatment with qualified
18specialists. The program shall provide genetic screening and
19followup services for persons who have the screening.
20(b) The department shall expand statewide screening of
21newborns to include tandem mass spectrometry screening for fatty
22acid oxidation, amino acid, organic acid disorders, and congenital
23
adrenal hyperplasia as soon as possible. The department shall
24provide information with respect to these disorders and available
25testing resources to all women receiving prenatal care and to all
26women admitted to a hospital for delivery. If the department is
27unable to provide this statewide screening by August 1, 2005, the
28department shall temporarily obtain these testing services through
29a competitive bid process from one or more public or private
30laboratories that meet the department’s requirements for testing,
31quality assurance, and reporting. If the department determines that
32contracting for these services is more cost effective, and meets the
33other requirements of this chapter, than purchasing the tandem
34mass spectrometry equipment themselves, the department shall
35contract with one or more public or private laboratories.
36(c) The department shall expand statewide screening of
37newborns to include screening for severe combined
38immunodeficiency (SCID) as soon as possible. In implementing
39the SCID screening test, the department shall also screen for other
40T-cell lymphopenias that are detectable as a result of screening
P10 1for SCID, insofar as it does not require additional costs or
2equipment beyond that needed to test for SCID.
3(d) The department shall expand statewide screening of
4newborns to include screening for adrenoleukodystrophy (ALD)
5as soon as possible.
6(e) This section shall remain in effect only until January 1, 2018,
7and as of that date is repealed, unless a later enacted statute, that
8is enacted before January 1, 2018, deletes of extends that date.
begin insertSection 125001 is added to the end insertbegin insertHealth and Safety Codeend insertbegin insert,
10to read:end insert
(a) The department shall establish a program for the
12development, provision, and evaluation of genetic disease testing,
13and may provide laboratory testing facilities or make grants to,
14contract with, or make payments to, any laboratory that it deems
15qualified and cost-effective to conduct testing or with any metabolic
16specialty clinic to provide necessary treatment with qualified
17specialists. The program shall provide genetic screening and
18followup services for persons who have the screening.
19(b) The department shall expand statewide screening of
20newborns to include tandem mass spectrometry screening for fatty
21acid oxidation, amino acid, and organic acid disorders and
22congenital adrenal hyperplasia as soon as possible. The
23department shall
provide information with respect to these
24disorders and available testing resources to all women receiving
25prenatal care and to all women admitted to a hospital for delivery.
26If the department is unable to provide this statewide screening by
27August 1, 2005, the department shall temporarily obtain these
28testing services through a competitive bid process from one or
29more public or private laboratories that meet the department’s
30requirements for testing, quality assurance, and reporting. If the
31department determines that contracting for these services is more
32cost-effective, and meets the other requirements of this chapter,
33than purchasing the tandem mass spectrometry equipment
34themselves, the department shall contract with one or more public
35or private laboratories.
36(c) The department shall expand statewide screening of
37newborns to include screening for severe combined
38immunodeficiency (SCID) as soon as possible. In implementing
39the SCID
screening test, the department shall also screen for other
40T-cell lymphopenias that are detectable as a result of screening
P11 1for SCID, insofar as it does not require additional costs or
2equipment beyond that needed to test for SCID.
3(d) This section shall become operative on January 1, 2018.
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