BILL NUMBER: SB 164	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Migden

                        JANUARY 31, 2007

   An act to amend Sections 124977 and 125002 of the Health and
Safety Code, relating to maternal and child health, and making an
appropriation therefor.



	LEGISLATIVE COUNSEL'S DIGEST


   SB 164, as introduced, Migden. Prenatal screening.
   Existing law imposes various responsibilities upon the State
Department of Public Health and prenatal care providers with respect
to prenatal care, screening, and counseling, and requires the
department to administer a statewide program for prenatal testing for
genetic disorders and birth defects, including, but not limited to,
ultrasound, amniocentesis, chorionic billus sampling, and blood
testing for genetic disorders and birth defects. Existing law
establishes the Birth Defects Monitoring Program in the department's
maternal, child and adolescent health program, and requires the
Deputy Director for Maternal, Child, and Adolescent Health to
maintain a system for the collection of prescribed information on
birth defects. Existing law also provides for an increase in prenatal
screening fees to support the program activities and specifies the
steps for release of pregnancy blood samples for research purposes.
Existing law requires that those fees be deposited in the
continuously appropriated Genetic Testing Fund.
   This bill would change the name of the Birth Defects Monitoring
Program to the Birth Defects Monitoring and Biomedical Resources
Program. The bill would require the department to also charge
investigators, who are approved by the department to use pregnancy
blood for research purposes, a fee for costs related to data linkage,
storage, retrieval, processing, data entry, reinventory, and
shipping of pregnancy blood or its components, and related data
management, as provided. The bill would require that the moneys
collected from the prenatal fee increase and the usage and retrieval
charge be deposited in the Birth Defects Monitoring and Biomedical
Resources Program Fund, which the bill would create, and that would
be continuously appropriated to support the activities of the
program.
   The bill would additionally require that the program develop blood
collection and processing protocols, determine conditions and
recommendations for the duration of blood storage, establish
exclusion criteria for blood specimens, and institute safe and secure
methods for the disposal of specimens, as determined by the program.
The bill would require the department to store the pregnancy blood
for research purposes, as prescribed, and analyze the costs of
pregnancy blood storage, and annual data linkage and management, and
to adjust the fee accordingly.
   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 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
directly to the Genetic Disease Testing Fund, 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) The director shall convene, in the most cost-efficient manner
and using existing resources, a working group comprised of health
insurance, health care service plan, hospital, consumer, and
department representatives to evaluate newborn and prenatal screening
fee billing procedures, and recommend to the department ways to
improve these procedures in order to improve efficiencies and enhance
revenue collections for the department and hospitals. In performing
its duties, the working group may consider models in other states.
The working group shall make its recommendations by March 1, 2005.
   (4) 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.
   (5)  (A)    The department shall charge 
a  an additional  fee for prenatal screening to
support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring  Program 
 and Biomedical Resources Program activities  . 
   (6) 
   (B)    The  initial  prenatal
screening fee increase for activities of the Birth Defects Monitoring
 and Biomedical Resources  Program shall be ten dollars
($10). 
   (7) 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 specifically to support those Birth Defects Monitoring
Program activities.  
   (C) The department shall also charge investigators who are
approved by the department a fee for costs related to data linkage,
storage, retrieval, processing, data entry, reinventory, and shipping
of pregnancy blood or its components and related data management.
The funds from fees collected pursuant to this subparagraph may be
charged by the department or by an entity authorized by the
department to defray or reduce those costs.  
   (D) The funds from fees collected pursuant to this paragraph shall
be deposited into the Birth Defects Monitoring and Biomedical
Resources Program Fund, which is hereby created as a special fund in
the State Treasury, to be continuously appropriated, to carry out the
purposes of the Birth Defects Monitoring and Biomedical Resources
Program. Notwithstanding Section 16305.7 of the Government Code,
interest earned on the moneys in the fund shall also be deposited as
revenue into the fund to support the 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
 and the Birth Defects Monitoring and Biomedical Resources
Program Fund  for  these  purposes  related
to prenatal and newborn screening  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 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 Section 11346.1 and Section 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 125002 of the Health and Safety Code is amended to
read:
   125002.  (a) In order to align closely related programs and in
order to facilitate research into the causes of, and treatment for,
birth defects, the Birth Defects Monitoring  and Biomedical
Resources  Program provided for pursuant to Chapter 1
(commencing with Section 103825) of Part 2 of Division 102 shall
become part of the Maternal, Child, and Adolescent Health program
provided for in Article 1 (commencing with Section 123225) of Chapter
1 of Part 2 of Division 106. 
   (b) The Birth Defects Monitoring and Biomedical Resources Program
shall develop blood collection and processing protocols, determine
conditions and duration of blood storage, establish exclusion
criteria for blood specimens, and institute safe and secure methods
of disposing of specimens, as determined by the program. In addition,
the Birth Defects Monitoring and Biomedical Resources Program or
another entity authorized by the department shall store the pregnancy
blood for research purposes from all or a statistically
representative sample population of pregnant women who provided a
positive consent.  
   (c) The department shall analyze the costs of pregnancy blood
storage and data linkage and management annually, and the amount of
the fee shall be adjusted by the department to meet the costs of the
Birth Defects Monitoring and Biomedical Resources Program activities.
 
   (b) 
    (d)    It is the intent of the Legislature that
pregnancy blood samples, taken for prenatal screening, shall be
stored and used only for the following purposes:
   (1) Research to identify risk factors for children's and women's
diseases.
   (2) Research to develop and evaluate screening tests.
   (3) Research to develop and evaluate prevention strategies.
   (4) Research to develop and evaluate treatments. 
   (c) 
    (e)    Before any pregnancy blood samples are
released for research purposes, all of the following conditions must
be met:
   (1) Individual consent at the time the sample is drawn to allow
confidential use of the sample for research purposes by the
department or the department's approved researchers.
   (2) Protocol review for scientific merit by the department or
another entity authorized by the department.
   (3) Protocol review by the State Committee for the Protection of
Human Subjects. 
   (d) 
    (f)    When pregnancy blood samples are stored,
analyzed or otherwise shared for research purposes with
nondepartment staff, no information may be released identifying the
person from whom the samples were obtained. 
   (e) 
    (g)    Since the pregnancy blood samples
described in this section will be stored by the  California
Birth Defects Monitoring   Birth Defects Monitoring and
Biomedical Resources  Program or another entity authorized by
the State Department of Health Services, Section 103850, pertaining
to confidentiality of information, is applicable.