Amended in Senate May 31, 2016

Senate Bill No. 1095

Introduced by Senator Pan

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(Coauthors: Senators Beall, McGuire, and Nielsen)

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February 17, 2016

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 1095, 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, severe combined immunodeficiency (SCID), and adrenoleukodystrophy (ALD) 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 would require the department to expand statewide screening of newborns to include screening for any disease begin insert that is detectable in blood samples end insert as soon as the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP). 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 1.  

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 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 Program Fund consistent with this section.

(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
begin delete (commencing with Section 38070). end delete begin insert (commencing with Section
38070) of this code. end insert 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 Tandem Mass Spectrometry
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,
regulations, 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, severe
combined immunodeficiency (SCID), begin delete and end delete adrenoleukodystrophy begin delete (ALD) and any other disease, end delete begin insert (ALD), and any other disease that
is detectable in blood samples, end insert as specified in subdivision (d) of
Section 125001, 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. 2.  

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 cost effective 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, 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 cost effective, 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.

(d) The department shall expand statewide screening of
newborns to include screening for adrenoleukodystrophy (ALD)
and any other disease begin insert that is detectable in blood samples end insert as soon
as the disease is adopted by the federal Recommended Uniform
Screening Panel (RUSP).