BILL NUMBER: AB 395 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MAY 27, 2011
AMENDED IN ASSEMBLY APRIL 7, 2011
AMENDED IN ASSEMBLY MARCH 31, 2011
INTRODUCED BY Assembly Member Pan
FEBRUARY 14, 2011
An act to amend Sections 124977 and 125001 of the Health and
Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 395, 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. 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 also authorizes moneys in the
GDTF to be used for the expansion of the Genetic Disease Branch
Screening Information System to include cystic fibrosis and
biotinidase 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 severe combined
immunodeficiency (SCID) and , insofar as it does not require
additional costs, other T-cell lymphopenias detectable as a result of
screening for SCID, and would make related changes.
Vote: majority. Appropriation: no. 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 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 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 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, and
severe combined immunodeficiency (SCID) 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, 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 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.