Senate Bill No. 224

Introduced by Senator Walters

February 11, 2013

An act to amend Sections 124977 and 125001 of the Health and Safety Code, relating to public health, and making an appropriation therefor.

LEGISLATIVE COUNSEL’S DIGEST

SB 224, as introduced, Walters. 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. Existing law 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 authorizes moneys in the GDTF to be used for the expansion of the Genetic Disease Branch Screening Information System, as specified, to include cystic fibrosis, biotinidase, and severe combined immunodeficiency. Existing law exempts the amendment of contracts for this purpose from provisions of the Public Contract Code that establish standards for contracts and require the Department of General Services to approve these contracts. Existing law also exempts the amendment of contracts for this purpose from standards for personal services contracts and from provisions that give the California Technology Agency authority over the application of information technology for state agencies.

This bill would require the department, until January 1, 2019, to expand statewide screening of newborns to include screening for 2 types of lysosomal storage diseases, Hurler syndrome and Krabbe disease, and would exempt the amendment of contracts for this purpose from provisions that establish standards for contracts, require the Department of General Services to approve contracts, and give the California Technology Agency authority over information technology projects, as described above.

By authorizing moneys in the continuously appropriated GDTF to be used for screening newborns for this additional disease, the 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 1.  

This act shall be known, and may be cited, as
Jacquelyn’s Law.

SEC. 2.  

Section 124977 of the Health and Safety Code is
amended to read:

124977.  

(a) It is the intent of the Legislature that, unless
otherwise specified, the genetic disease testing program carried
out pursuant to this chapter be fully supported from fees collected
for services provided by the program.

(b) (1) The department shall charge a fee to all payers for any
tests or activities performed pursuant to this chapter. The amount
of the fee shall be established by regulation and periodically
adjusted by the director in order to meet the costs of this chapter.
Notwithstanding any other provision of law, any fees charged for
prenatal screening and followup services provided to persons
enrolled in the Medi-Cal program, health care service plan
enrollees, or persons covered by health insurance policies, shall
be paid in full and deposited in the Genetic Disease Testing Fund
or the Birth Defects Monitoring begin insert Program end insert Fund consistent with
this section, subject to all terms and conditions of each enrollee’s
or insured’s health care service plan or insurance coverage,
whichever is applicable, including, but not limited to, copayments
and deductibles applicable to these services, and only if these
copayments, deductibles, or limitations are disclosed to the
subscriber or enrollee pursuant to the disclosure provisions of
Section 1363.

(2) The department shall expeditiously undertake all steps
necessary to implement the fee collection process, including
personnel, contracts, and data processing, so as to initiate the fee
collection process at the earliest opportunity.

(3) Effective for services provided on and after July 1, 2002,
the department shall charge a fee to the hospital of birth, or, for
births not occurring in a hospital, to families of the newborn, for
newborn screening and followup services. The hospital of birth
and families of newborns born outside the hospital shall make
payment in full to the Genetic Disease Testing Fund. The
department shall not charge or bill Medi-Cal beneficiaries for
services provided under this chapter.

(4) (A) The department shall charge a fee for prenatal screening
to support the pregnancy blood sample storage, testing, and
research activities of the Birth Defects Monitoring Program.

(B) The prenatal screening fee for activities of the Birth Defects
Monitoring Program shall be ten dollars ($10).

(5) The department shall set guidelines for invoicing, charging,
and collecting from approved researchers the amount necessary
to cover all expenses associated with research application requests
made under this section, data linkage, retrieval, data processing,
data entry, reinventory, and shipping of blood samples or their
components and related data management.

(6) The only funds from the Genetic Disease Testing Fund that
may be used for the purpose of supporting the pregnancy blood
sample storage, testing, and research activities of the Birth Defects
Monitoring Program are those prenatal screening fees assessed
and collected prior to the creation of the Birth Defects Monitoring
Program Fund specifically to support those Birth Defects
Monitoring Program activities.

(7) The Birth Defects Monitoring Program Fund is hereby
created as a special fund in the State Treasury. Fee revenues that
are collected pursuant to paragraph (4) shall be deposited into the
fund and shall be available upon appropriation by the Legislature
to support the pregnancy blood sample storage, testing, and
research activities of the Birth Defects Monitoring Program.
Notwithstanding Section 16305.7 of the Government Code, interest
earned on funds in the Birth Defects Monitoring Program Fund
shall be deposited as revenue into the fund to support the Birth
Defects Monitoring Program.

(c) (1) The Legislature finds that timely implementation of
changes in genetic screening programs and continuous maintenance
of quality statewide services requires expeditious regulatory and
administrative procedures to obtain the most cost-effective
electronic data processing, hardware, software services, testing
equipment, and testing and followup services.

(2) The expenditure of funds from the Genetic Disease Testing
Fund for these purposes shall not be subject to Section 12102 of,
and Chapter 2 (commencing with Section 10290) of Part 2 of
Division 2 of, the Public Contract Code, or to Division 25.2
(commencing with Section 38070). The department shall provide
the Department of Finance with documentation that equipment
and services have been obtained at the lowest cost consistent with
technical requirements for a comprehensive high-quality program.

(3) The expenditure of funds from the Genetic Disease Testing
Fund for implementation of the begin delete Tandem Mass Spectrometry end delete begin insert tandem
mass spectrometry end insert screening for fatty acid oxidation, amino acid,
and organic acid disorders, and screening for congenital adrenal
hyperplasia may be implemented through the amendment of the
Genetic Disease Branch Screening Information System contracts
and shall not be subject to Chapter 3 (commencing with Section
12100) of Part 2 of Division 2 of the Public Contract Code, Article
4 (commencing with Section 19130) of Chapter 5 of Part 2 of
Division 5 of Title 2 of the Government Code, and any policies,
procedures, begin delete regulations end delete begin insert regulations, end insert or manuals authorized by
those laws.

(4) The expenditure of funds from the Genetic Disease Testing
Fund for the expansion of the Genetic Disease Branch Screening
Information System to include cystic fibrosis, biotinidase, begin delete and end delete
severe combined immunodeficiency begin delete (SCID) end delete begin insert (SCID), Hurler
syndrome, also known as mucopolysaccharidosis type I (MPSI),
and Krabbe disease end insert may be implemented through the amendment
of the Genetic Disease Branch Screening Information System
contracts, and shall not be subject to Chapter 2 (commencing with
Section 10290) or Chapter 3 (commencing with Section 12100)
of Part 2 of Division 2 of the Public Contract Code, Article 4
(commencing with Section 19130) of Chapter 5 of Part 2 of
Division 5 of Title 2 of the Government Code, or Sections 4800
to 5180, inclusive, of the State Administrative Manual as they
relate to approval of information technology projects or approval
of increases in the duration or costs of information technology
projects. This paragraph shall apply to the design, development,
and implementation of the expansion, and to the maintenance and
operation of the Genetic Disease Branch Screening Information
System, including change requests, once the expansion is
implemented.

(d) (1) The department may adopt emergency regulations to
implement and make specific this chapter in accordance with
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division
3 of Title 2 of the Government Code. For the purposes of the
Administrative Procedure Act, the adoption of regulations shall
be deemed an emergency and necessary for the immediate
preservation of the public peace, health and safety, or general
welfare. Notwithstanding Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code,
these emergency regulations shall not be subject to the review and
approval of the Office of Administrative Law. Notwithstanding
Sections 11346.1 and 11349.6 of the Government Code, the
department shall submit these regulations directly to the Secretary
of State for filing. The regulations shall become effective
immediately upon filing by the Secretary of State. Regulations
shall be subject to public hearing within 120 days of filing with
the Secretary of State and shall comply with Sections 11346.8 and
11346.9 of the Government Code or shall be repealed.

(2) The Office of Administrative Law shall provide for the
printing and publication of these regulations in the California Code
of Regulations. Notwithstanding Chapter 3.5 (commencing with
Section 11340) of Part 1 of Division 3 of Title 2 of the Government
Code, the regulations adopted pursuant to this chapter shall not be
repealed by the Office of Administrative Law and shall remain in
effect until revised or repealed by the department.

(3) The Legislature finds and declares that the health and safety
of California newborns is in part dependent on an effective and
adequately staffed genetic disease program, the cost of which shall
be supported by the fees generated by the program.

SEC. 3.  

Section 125001 of the Health and Safety Code is
amended to read:

125001.  

(a) The department shall establish a program for the
development, provision, and evaluation of genetic disease testing,
and may provide laboratory testing facilities or make grants to,
contract with, or make payments to, any laboratory that it deems
qualified and begin delete cost-effective end delete begin insert cost effective end insert to conduct testing or with
any metabolic specialty clinic to provide necessary treatment with
qualified specialists. The program shall provide genetic screening
and followup services for persons who have the screening.

(b) The department shall expand statewide screening of
newborns to include tandem mass spectrometry screening for fatty
acid oxidation, amino acid, and organic acid disorders and
congenital adrenal hyperplasia as soon as possible. The department
shall provide information with respect to these disorders and
available testing resources to all women receiving prenatal care
and to all women admitted to a hospital for delivery. If the
department is unable to provide this statewide screening by August
1, 2005, the department shall temporarily obtain these testing
services through a competitive bid process from one or more public
or private laboratories that meet the department’s requirements
for testing, quality assurance, and reporting. If the department
determines that contracting for these services is more begin delete cost-effective, end delete
begin insert cost effective, end insert and meets the other requirements of this chapter,
than purchasing the tandem mass spectrometry equipment
themselves, the department shall contract with one or more public
or private laboratories.

(c) The department shall expand statewide screening of
newborns to include screening for severe combined
immunodeficiency (SCID) as soon as possible. In implementing
the SCID screening test, the department shall also screen for other
T-cell lymphopenias that are detectable as a result of screening
for SCID, insofar as it does not require additional costs or
equipment beyond that needed to test for SCID.

begin insert

(d) Until January 1, 2019, the department shall expand statewide
screening of newborns to include screening for the following types
of lysosomal storage diseases: Hurler syndrome, also known as
mucopolysaccharidosis type I (MPSI), and Krabbe disease.

end insert