BILL NUMBER: AB 395	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 31, 2011

INTRODUCED BY   Assembly Member Pan

                        FEBRUARY 14, 2011

   An act to amend  Section 125000   Sections
124977 and 125000  of the Health and Safety Code, relating to
public health.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 395, as amended, Pan. Newborn screening program.
   Existing law  establishes the Birth Defects Monitoring
Program   requires the genetic disease unit  within
the State Department of Public Health to  detect, as early
as possible, preventable heritable or congenital disorders leading to
mental retardation or physical defects   promote a
statewide program of information, testing, and counseling services to
detect specified heritable disorders  . Existing law requires
the genetic disease unit to evaluate and prepare recommendations on
the implementation of tests for the detection of hereditary and
congenital diseases, as specified. 
   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 add severe combined immuno deficiency (SCID) to
the list of diseases for which the genetic disease unit is required
to evaluate and prepare recommendations 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  and 
 ,  biotinidase  , and severe combined immuno deficiency
(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.
   SECTION 1.   SEC. 2.   Section 125000 of
the Health and Safety Code is amended to read:
   125000.  (a) It is the policy of the State of California to make
every effort to detect, as early as possible, phenylketonuria and
other preventable heritable or congenital disorders leading to mental
retardation or physical defects.
   The department shall establish a genetic disease unit, that shall
coordinate all programs of the department in the area of genetic
disease. The unit shall promote a statewide program of information,
testing, and counseling services and shall have the responsibility of
designating tests and regulations to be used in executing this
program.
   The information, tests, and counseling for children shall be in
accordance with accepted medical practices and shall be administered
to each child born in California once the department has established
appropriate regulations and testing methods. The information, tests,
and counseling for pregnant women shall be in accordance with
accepted medical practices and shall be offered to each pregnant
woman in California once the department has established appropriate
regulations and testing methods. These regulations shall follow the
standards and principles specified in Section 124980. The department
may provide laboratory testing facilities or contract with any
laboratory that it deems qualified to conduct tests required under
this section. However, notwithstanding Section 125005, provision of
laboratory testing facilities by the department shall be contingent
upon the provision of funding therefor by specific appropriation to
the Genetic Disease Testing Fund enacted by the Legislature. If
moneys appropriated for purposes of this section are not authorized
for expenditure to provide laboratory facilities, the department may
nevertheless contract to provide laboratory testing services pursuant
to this section and shall perform laboratory services, including,
but not limited to, quality control, confirmatory, and emergency
testing, necessary to ensure the objectives of this program.
   (b) The department shall charge a fee for any tests performed
pursuant to this section. The amount of the fee shall be established
and periodically adjusted by the director in order to meet the costs
of this section.
   (c) The department shall inform all hospitals or physicians and
surgeons, or both, of required regulations and tests and may alter or
withdraw any of these requirements whenever sound medical practice
so indicates. To the extent practicable, the department shall provide
notice to hospitals and other payers in advance of any increase in
the fees charged for the program.
   (d) This section shall not apply if a parent or guardian of the
newborn child objects to a test on the ground that the test conflicts
with his or her religious beliefs or practices.
   (e) The genetic disease unit is authorized to make grants or
contracts or payments to vendors approved by the department for all
of the following:
   (1) Testing and counseling services.
   (2) Demonstration projects to determine the desirability and
feasibility of additional tests or new genetic services.
   (3) To initiate the development of genetic services in areas of
need.
   (4) To purchase or provide genetic services from any sums as are
appropriated for this purpose.
   (f) The genetic disease unit shall evaluate and prepare
recommendations on the implementation of tests for the detection of
hereditary and congenital diseases, including, but not limited to,
biotinidase deficiency, severe combined immuno deficiency (SCID), and
cystic fibrosis. The genetic disease unit shall also evaluate and
prepare recommendations on the availability and effectiveness of
preventative followup interventions, including the use of specialized
medically necessary dietary products.
   It is the intent of the Legislature that funds for the support of
the evaluations and recommendations required pursuant to this
subdivision,  including, but not limited to, costs associated
with the expansion and ongoing administration required to test for
SCID,  and for the activities authorized pursuant to subdivision
(e), shall be provided in the annual Budget Act appropriation from
the Genetic Disease Testing Fund.
   (g) Health care providers that contract with a prepaid group
practice health care service plan that annually has at least 20,000
births among its membership, may provide, without contracting with
the department, any or all of the testing and counseling services
required to be provided under this section or the regulations adopted
pursuant thereto, if the services meet the quality standards and
adhere to the regulations established by the department and the plan
pays that portion of a fee established under this section that is
directly attributable to the department's cost of administering the
testing or counseling service and to any required testing or
counseling services provided by the state for plan members. The
payment by the plan, as provided in this subdivision, shall be deemed
to fulfill any obligation the provider or the provider's patient may
have to the department to pay a fee in connection with the testing
or counseling service.
   (h) The department may appoint experts in the area of genetic
screening, including, but not limited to, cytogenetics, molecular
biology, prenatal, specimen collection, and ultrasound to provide
expert advice and opinion on the interpretation and enforcement of
regulations adopted pursuant to this section. These experts shall be
designated agents of the state with respect to their assignments.
These experts shall receive no salary, but shall be reimbursed for
expenses associated with the purposes of this section. All expenses
of the experts for the purposes of this section shall be paid from
the Genetic Disease Testing Fund.