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AB-2399 Pregnancy: prenatal blood testing.(2015-2016)

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AB2399:v97#DOCUMENT

Amended  IN  Assembly  May 31, 2016
Amended  IN  Assembly  March 28, 2016

CALIFORNIA LEGISLATURE— 2015–2016 REGULAR SESSION

Assembly Bill
No. 2399


Introduced by Assembly Member Nazarian

February 18, 2016


An act to amend Sections 1627, 1630, 102247, 103625, 123371, 125055, and Section 125092 of the Health and Safety Code, relating to public health.


LEGISLATIVE COUNSEL'S DIGEST


AB 2399, as amended, Nazarian. Pregnancy: umbilical cord blood: blood testing. prenatal blood testing.

(1)Existing law requires the State Department of Public Health to develop standardized, objective information about umbilical cord blood donation to enable a pregnant woman to make an informed decision regarding what she wants to do with the umbilical cord blood. Existing law requires that this information be made available in Cantonese, English, Spanish, and Vietnamese. Existing law prohibits public funds from being used by the department to provide awareness, assistance, and information regarding umbilical cord blood banking options and creates the Umbilical Cord Blood Education Account within the State Treasury, which is funded by private donations, to be used by the department for these purposes, as specified.

Existing law also requires a licensed physician and surgeon, or other person engaged in the prenatal care of a pregnant woman, to obtain a blood specimen from the woman for purposes of determining the presence of hepatitis B or human immunodeficiency virus (HIV). Existing law requires the department State Department of Public Health to develop culturally sensitive informational material in English, Spanish, and other languages to inform a pregnant woman about the purpose of obtaining this blood sample.

Existing law requires the department to develop an education program designed to educate physicians and the public concerning the uses of prenatal testing and the availability of the California Prenatal Screening Program. Existing law requires the department to include specified information in the patient educational information.

This bill would change the language requirements for the umbilical cord blood informational material, the prenatal testing informational material, and the patient educational information material to require the information to be informational material described above to require that it is provided in languages that meet a specified numeric threshold. The bill would also delete provisions that create the Umbilical Cord Blood Education Account and remove the prohibition against using public funds to provide information about umbilical cord blood banking.

(2)Existing law requests the University of California to establish and administer the Umbilical Cord Blood Collection Program for the purpose of collecting units of umbilical cord blood for public use, as defined, in transplantation and providing nonclinical units for specified research. Existing law provides that any funds made available for purposes of the program shall be deposited into the Umbilical Cord Blood Collection Program Fund and that moneys in the fund shall be made available, upon appropriation by the Legislature, for purposes of the program. Existing law provides the program and the program fund shall conclude no later than January 1, 2018.

This bill would extend the existence of the program and the program fund until January 1, 2023.

(3)Existing law requires, until January 1, 2018, the collection of an $18 fee for certified copies of birth certificates. Existing law requires $2 of this $18 fee to be paid to the Umbilical Cord Blood Collection Program Fund.

This bill would extend the $18 fee for certified copies of birth certificates until January 1, 2023. The bill would also extend the collection and deposit of the $2 portion of the fee into the Umbilical Cord Blood Collection Program Fund until January 1, 2023.

(4)Existing law creates the Health Statistics Special Fund which consists of revenues from several sources, including many funds collected by the State Registrar. Until January 1, 2018, Umbilical Cord Blood Program Fund fees are excluded from that fund. Existing law provides that moneys in the Health Statistics Special Fund shall be expended by the State Registrar, as specified, upon appropriation by the Legislature.

This bill would extend the existence of the fund until January 1, 2023.

This bill would include a change in state statute that would result in a taxpayer paying a higher tax within the meaning of Section 3 of Article XIII A of the California Constitution, and thus would require for passage the approval of 23 of the membership of each house of the Legislature.

Vote: TWO_THIRDSMAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.Section 1627 of the Health and Safety Code is amended to read:
1627.

(a)(1)On or before July 1, 2011, the University of California is requested to develop a plan to establish and administer the Umbilical Cord Blood Collection Program for the purpose of collecting units of umbilical cord blood for public use in transplantation and providing nonclinical units for research pertaining to biology and new clinical utilization of stem cells derived from the blood and tissue of the placenta and umbilical cord. The program shall conclude no later than January 1, 2023.

(2)For purposes of this article, “public use” means both of the following:

(A)The collection of umbilical cord blood units from genetically diverse donors that will be owned by the University of California. This inventory shall be accessible by the National Registry and by qualified California-based and other United States and international registries and transplant centers to increase the likelihood of providing suitably matched donor cord blood units to patients or research participants who are in need of a transplant.

(B)Cord blood units with a lower number of cells than deemed necessary for clinical transplantation and units that meet clinical requirements, but for other reasons are unsuitable, unlikely to be transplanted, or otherwise unnecessary for clinical use, may be made available for research.

(b)(1)In order to implement the collection goals of this program, the University of California may, commensurate with available funds appropriated to the University of California for this program, contract with one or more selected applicant entities that have demonstrated the competence to collect and ship cord blood units in compliance with federal guidelines and regulations.

(2)It is the intent of the Legislature that, if the University of California contracts with another entity pursuant to this subdivision, the following shall apply:

(A)The University of California may use a competitive process to identify the best proposals submitted by applicant entities to administer the collection and research objectives of the program, to the extent that the University of California chooses not to undertake these activities itself.

(B)In order to qualify for selection under this section to receive, process, cryopreserve, or bank cord blood units, the entity shall, at a minimum, have obtained an investigational new drug (IND) exemption from the FDA or a biologic license from the FDA, as appropriate, to manufacture clinical grade cord blood stem cell units for clinical indications.

(C)In order to qualify to receive appropriate cord blood units and placental tissue to advance the research goals of this program, an entity shall, at a minimum, be a laboratory recognized as having performed peer-reviewed research on stem and progenitor cells, including those derived from placental or umbilical cord blood and postnatal tissue.

(3)A medical provider or research facility shall comply with, and shall be subject to, existing penalties for violations of all applicable state and federal laws with respect to the protection of any medical information, as defined in Section 56.05 of the Civil Code, and any personally identifiable information contained in the umbilical cord blood inventory.

(c)The University of California is encouraged to make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.

(d)(1)All information collected pursuant to the program shall be confidential, and shall be used solely for the purposes of the program, including research. Access to confidential information shall be limited to authorized persons who are bound by appropriate institutional policies or who otherwise agree, in writing, to maintain the confidentiality of that information.

(2)Any person who, in violation of applicable institutional policies or a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section, may be denied further access to any confidential information maintained by the University of California, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided for in this section shall not be construed to limit or otherwise restrict any remedy, provisional or otherwise, provided by law for the benefit of the University of California or any other person covered by this section.

(3)Notwithstanding the restrictions of this section, an individual to whom the confidential information pertains shall have access to his or her own personal information.

(e)It is the intent of the Legislature that the plan and implementation of the program provide for both of the following:

(1)Limit fees for access to cord blood units to the reasonable and actual costs of storage, handling, and providing units, as well as for related services such as donor matching and testing of cord blood and other programs and services typically provided by cord blood banks and public use programs.

(2)The submittal of the plan developed pursuant to subdivision (a) to the health and fiscal committees of the Legislature.

(f)It is additionally the intent of the Legislature that the plan and implementation of the program attempt to provide for all of the following:

(1)Development of a strategy to increase voluntary participation by hospitals in the collection and storage of umbilical cord blood and identify funding sources to offset the financial impact on hospitals.

(2)Consideration of a medical contingency response program to prepare for and respond effectively to biological, chemical, or radiological attacks, accidents, and other public health emergencies where victims potentially benefit from treatment.

(3)Exploration of the feasibility of operating the program as a self-funding program, including the potential for charging users a reimbursement fee.

SEC. 2.Section 1630 of the Health and Safety Code is amended to read:
1630.

This article shall remain in effect only until January 1, 2023, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2023, deletes or extends that date.

SEC. 3.Section 102247 of the Health and Safety Code, as amended by Section 169 of Chapter 296 of the Statutes of 2011, is amended to read:
102247.

(a)There is hereby created in the State Treasury the Health Statistics Special Fund. The fund shall consist of revenues, including, but not limited to, all of the following:

(1)Fees or charges remitted to the State Registrar for record search or issuance of certificates, permits, registrations, or other documents pursuant to Chapter 3 (commencing with Section 26801) of Part 3 of Division 2 of Title 3 of the Government Code, and Chapter 4 (commencing with Section 102525), Chapter 5 (commencing with Section 102625), Chapter 8 (commencing with Section 103050), and Chapter 15 (commencing with Section 103600) of Part 1 of Division 102 of this code.

(2)Funds remitted to the State Registrar by the federal Social Security Administration for participation in the enumeration at birth program.

(3)Funds remitted to the State Registrar by the National Center for Health Statistics pursuant to the federal Vital Statistics Cooperative Program.

(4)Any other funds collected by the State Registrar, except Children’s Trust Fund fees collected pursuant to Section 18966 of the Welfare and Institutions Code, Umbilical Cord Blood Collection Program Fund fees collected pursuant to Section 103625, and fees allocated to the Judicial Council pursuant to Section 1852 of the Family Code, all of which shall be deposited into the General Fund.

(b)Moneys in the Health Statistics Special Fund shall be expended by the State Registrar for the purpose of funding its existing programs and programs that may become necessary to carry out its mission, upon appropriation by the Legislature.

(c)Health Statistics Special Fund moneys shall be expended only for the purposes set forth in this section and Section 102249, and shall not be expended for any other purpose or for any other state program.

(d)It is the intent of the Legislature that the Health Statistics Special Fund provide for the following:

(1)Registration and preservation of vital event records and dissemination of vital event information to the public.

(2)Data analysis of vital statistics for population projections, health trends and patterns, epidemiologic research, and development of information to support new health policies.

(3)Development of uniform health data systems that are integrated, accessible, and useful in the collection of information on health status.

(e)This section shall remain in effect only until January 1, 2023, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2023, deletes or extends that date.

SEC. 4.Section 102247 of the Health and Safety Code, as amended by Section 170 of Chapter 296 of the Statutes of 2011, is amended to read:
102247.

(a)There is hereby created in the State Treasury the Health Statistics Special Fund. The fund shall consist of revenues, including, but not limited to, all of the following:

(1)Fees or charges remitted to the State Registrar for record search or issuance of certificates, permits, registrations, or other documents pursuant to Chapter 3 (commencing with Section 26801) of Part 3 of Division 2 of Title 3 of the Government Code, and Chapter 4 (commencing with Section 102525), Chapter 5 (commencing with Section 102625), Chapter 8 (commencing with Section 103050), and Chapter 15 (commencing with Section 103600) of Part 1 of Division 102 of this code.

(2)Funds remitted to the State Registrar by the federal Social Security Administration for participation in the enumeration at birth program.

(3)Funds remitted to the State Registrar by the National Center for Health Statistics pursuant to the federal Vital Statistics Cooperative Program.

(4)Any other funds collected by the State Registrar, except Children’s Trust Fund fees collected pursuant to Section 18966 of the Welfare and Institutions Code and fees allocated to the Judicial Council pursuant to Section 1852 of the Family Code, all of which shall be deposited into the General Fund.

(b)Moneys in the Health Statistics Special Fund shall be expended by the State Registrar for the purpose of funding its existing programs and programs that may become necessary to carry out its mission, upon appropriation by the Legislature.

(c)Health Statistics Special Fund moneys shall be expended only for the purposes set forth in this section and Section 102249, and shall not be expended for any other purpose or for any other state program.

(d)It is the intent of the Legislature that the Health Statistics Special Fund provide for the following:

(1)Registration and preservation of vital event records and dissemination of vital event information to the public.

(2)Data analysis of vital statistics for population projections, health trends and patterns, epidemiologic research, and development of information to support new health policies.

(3)Development of uniform health data systems that are integrated, accessible, and useful in the collection of information on health status.

(e)This section shall become operative on January 1, 2023.

SEC. 5.Section 103625 of the Health and Safety Code, as amended by Section 5 of Chapter 402 of the Statutes of 2011, is amended to read:
103625.

(a)A fee of twelve dollars ($12) shall be paid by the applicant for a certified copy of a fetal death or death record.

(b)(1)A fee of twelve dollars ($12) shall be paid by a public agency or licensed private adoption agency applicant for a certified copy of a birth certificate that the agency is required to obtain in the ordinary course of business. A fee of eighteen dollars ($18) shall be paid by any other applicant for a certified copy of a birth certificate. Four dollars ($4) of any eighteen-dollar ($18) fee is exempt from subdivision (e) and shall be paid either to a county children’s trust fund or to the State Children’s Trust Fund, in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code. Two dollars ($2) of any eighteen-dollar ($18) fee is exempt from subdivision (e) and shall be paid to the Umbilical Cord Blood Collection Program Fund in conformity with Section 1628.

(2)The board of supervisors of any county that has established a county children’s trust fund may increase the fee for a certified copy of a birth certificate by up to three dollars ($3) for deposit in the county children’s trust fund in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.

(c)A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage record, that has been filed with the county recorder or county clerk, that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage record that has been filed with the county recorder or county clerk. Three dollars ($3) of any six-dollar ($6) fee is exempt from subdivision (e) and shall be transmitted monthly by each local registrar, county recorder, and county clerk to the state for deposit into the General Fund as provided by Section 1852 of the Family Code.

(d)A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage dissolution record obtained from the State Registrar that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage dissolution record obtained from the State Registrar.

(e)Each local registrar, county recorder, or county clerk collecting a fee pursuant to subdivisions (a) to (d), inclusive, shall do the following:

(1)Transmit 15 percent of the fee for each certified copy to the State Registrar by the 10th day of the month following the month in which the fee was received.

(2)Retain 85 percent of the fee for each certified copy solely to support the issuing agency for all activities related to the issuance of certified copies of records pursuant to subdivisions (a) to (d), inclusive.

(f)In addition to the fees prescribed pursuant to subdivisions (a) to (d), inclusive, all applicants for certified copies of the records described in those subdivisions shall pay an additional fee of three dollars ($3), that shall be collected by the State Registrar, the local registrar, county recorder, or county clerk, as the case may be.

(g)The local public official charged with the collection of the additional fee established pursuant to subdivision (f) may create a local vital and health statistics trust fund. The fees collected by local public officials pursuant to subdivision (f) shall be distributed as follows:

(1)Forty-five percent of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.

(2)The remainder of the fee collected pursuant to subdivision (f) shall be deposited into the collecting agency’s vital and health statistics trust fund, except that in any jurisdiction in which a local vital and health statistics trust fund has not been established, the entire amount of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.

(3)Moneys transmitted to the State Registrar pursuant to this subdivision shall be deposited in accordance with Section 102247.

(h)Moneys in each local vital and health statistics trust fund shall be available to the local official charged with the collection of fees pursuant to subdivision (f) for the applicable jurisdiction for the purpose of defraying the administrative costs of collecting and reporting with respect to those fees and for other costs as follows:

(1)Modernization of vital record operations, including improvement, automation, and technical support of vital record systems.

(2)Improvement in the collection and analysis of health-related birth and death certificate information, and other community health data collection and analysis, as appropriate.

(i)Funds collected pursuant to subdivision (f) shall not be used to supplant funding in existence on January 1, 2002, that is necessary for the daily operation of vital record systems. It is the intent of the Legislature that funds collected pursuant to subdivision (f) be used to enhance service to the public, to improve analytical capabilities of state and local health authorities in addressing the health needs of newborn children and maternal health problems, and to analyze the health status of the general population.

(j)Each county shall annually submit a report to the State Registrar by March 1 containing information on the amount of revenues collected pursuant to subdivision (f) in the previous calendar year and on how the revenues were expended and for what purpose.

(k)Each local registrar, county recorder, or county clerk collecting the fee pursuant to subdivision (f) shall transmit 45 percent of the fee for each certified copy to which subdivision (f) applies to the State Registrar by the 10th day of the month following the month in which the fee was received.

(l)The nine dollar ($9) increase to the base fee authorized in subdivision (a) for a certified copy of a fetal death record or death record and subdivision (b) for a certified copy of a birth certificate shall be applied incrementally as follows:

(1)A five dollar ($5) increase applied as of January 1, 2012.

(2)An additional two dollar ($2) increase applied as of January 1, 2013.

(3)An additional two dollar ($2) increase applied as of January 1, 2014.

(m)In providing for the expiration of the surcharge on birth certificate fees on June 30, 1999, the Legislature intends that juvenile dependency mediation programs pursue ancillary funding sources after that date.

(n)This section shall remain in effect only until January 1, 2023, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2023, deletes or extends that date.

SEC. 6.Section 103625 of the Health and Safety Code, as amended by Section 6 of Chapter 402 of the Statutes of 2011, is amended to read:
103625.

(a)A fee of twelve dollars ($12) shall be paid by the applicant for a certified copy of a fetal death or death record.

(b)(1)A fee of twelve dollars ($12) shall be paid by a public agency or licensed private adoption agency applicant for a certified copy of a birth certificate that the agency is required to obtain in the ordinary course of business. A fee of sixteen dollars ($16) shall be paid by any other applicant for a certified copy of a birth certificate. Four dollars ($4) of any sixteen-dollar ($16) fee is exempt from subdivision (e) and shall be paid either to a county children’s trust fund or to the State Children’s Trust Fund, in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.

(2)The board of supervisors of any county that has established a county children’s trust fund may increase the fee for a certified copy of a birth certificate by up to three dollars ($3) for deposit in the county children’s trust fund in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.

(c)A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage record, that has been filed with the county recorder or county clerk, that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage record that has been filed with the county recorder or county clerk. Three dollars ($3) of any six-dollar ($6) fee is exempt from subdivision (e) and shall be transmitted monthly by each local registrar, county recorder, and county clerk to the state for deposit into the General Fund as provided by Section 1852 of the Family Code.

(d)A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage dissolution record obtained from the State Registrar that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage dissolution record obtained from the State Registrar.

(e)Each local registrar, county recorder, or county clerk collecting a fee pursuant to subdivisions (a) to (d), inclusive, shall do the following:

(1)Transmit 15 percent of the fee for each certified copy to the State Registrar by the 10th day of the month following the month in which the fee was received.

(2)Retain 85 percent of the fee for each certified copy solely to support the issuing agency for all activities related to the issuance of certified copies of records pursuant to subdivisions (a) to (d), inclusive.

(f)In addition to the fees prescribed pursuant to subdivisions (a) to (d), inclusive, all applicants for certified copies of the records described in those subdivisions shall pay an additional fee of three dollars ($3), that shall be collected by the State Registrar, the local registrar, county recorder, or county clerk, as the case may be.

(g)The local public official charged with the collection of the additional fee established pursuant to subdivision (f) may create a local vital and health statistics trust fund. The fees collected by local public officials pursuant to subdivision (f) shall be distributed as follows:

(1)Forty-five percent of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.

(2)The remainder of the fee collected pursuant to subdivision (f) shall be deposited into the collecting agency’s vital and health statistics trust fund, except that in any jurisdiction in which a local vital and health statistics trust fund has not been established, the entire amount of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.

(3)Moneys transmitted to the State Registrar pursuant to this subdivision shall be deposited in accordance with Section 102247.

(h)Moneys in each local vital and health statistics trust fund shall be available to the local official charged with the collection of fees pursuant to subdivision (f) for the applicable jurisdiction for the purpose of defraying the administrative costs of collecting and reporting with respect to those fees and for other costs as follows:

(1)Modernization of vital record operations, including improvement, automation, and technical support of vital record systems.

(2)Improvement in the collection and analysis of health-related birth and death certificate information, and other community health data collection and analysis, as appropriate.

(i)Funds collected pursuant to subdivision (f) shall not be used to supplant funding in existence on January 1, 2002, that is necessary for the daily operation of vital record systems. It is the intent of the Legislature that funds collected pursuant to subdivision (f) be used to enhance service to the public, to improve analytical capabilities of state and local health authorities in addressing the health needs of newborn children and maternal health problems, and to analyze the health status of the general population.

(j)Each county shall annually submit a report to the State Registrar by March 1 containing information on the amount of revenues collected pursuant to subdivision (f) in the previous calendar year and on how the revenues were expended and for what purpose.

(k)Each local registrar, county recorder, or county clerk collecting the fee pursuant to subdivision (f) shall transmit 45 percent of the fee for each certified copy to which subdivision (f) applies to the State Registrar by the 10th day of the month following the month in which the fee was received.

(l)In providing for the expiration of the surcharge on birth certificate fees on June 30, 1999, the Legislature intends that juvenile dependency mediation programs pursue ancillary funding sources after that date.

(m)This section shall become operative on January 1, 2023.

SEC. 7.Section 123371 of the Health and Safety Code is amended to read:
123371.

(a)(1)The State Department of Public Health shall develop standardized, objective information about umbilical cord blood donation that is sufficient to allow a pregnant woman to make an informed decision on whether to participate in a private or public umbilical cord blood banking program. The information developed by the department shall enable a pregnant woman to be informed of her option to do any of the following:

(A)Discard umbilical cord blood.

(B)Donate umbilical cord blood to a public umbilical cord blood bank.

(C)Store the umbilical cord blood in a family umbilical cord blood bank for the use by immediate and extended family members.

(D)Donate umbilical cord blood to research.

(2)The information developed pursuant to paragraph (1) shall include, but not be limited to, all of the following:

(A)The current and potential future medical uses of stored umbilical cord blood.

(B)The benefits and risks involved in umbilical cord blood banking.

(C)The medical process involved in umbilical cord blood banking.

(D)Medical or family history criteria that can impact a family’s consideration of umbilical cord banking.

(E)An explanation of the differences between public and private umbilical cord blood banking.

(F)The availability and costs of public or private umbilical cord blood banks.

(G)Medical or family history criteria that can impact a family’s consideration of umbilical cord blood banking.

(H)An explanation that the practices and policies of blood banks may vary with respect to accreditation, cord blood processing and storage methods, costs, and donor privacy.

(I)An explanation that pregnant women are not required to donate their umbilical cord blood for research purposes.

(b)The information provided by the department pursuant to subdivision (a) shall be made available in the languages that meet the numeric threshold described in Section 14029.91 of the Welfare and Institutions Code, and shall be updated by the department as needed.

(c)The information provided by the department pursuant to subdivision (a) shall be made available on the Internet Web sites of the licensing boards that have oversight over primary prenatal care providers.

(d)(1)A primary prenatal care provider of a woman who is known to be pregnant may, during the first prenatal visit, provide the information required by subdivision (a) to the pregnant woman.

(2)For purposes of this article, a “prenatal care provider” means a health care provider licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, or pursuant to an initiative act referred to in that division, who provides prenatal medical care within his or her scope of practice.

SEC. 8.Section 125055 of the Health and Safety Code is amended to read:
125055.

The department shall:

(a)Establish criteria for eligibility for the prenatal testing program. Eligibility shall include definition of conditions and circumstances that result in a high risk of a detectable genetic disorder or birth defect.

(b)(1)Develop an education program designed to educate physicians and surgeons and the public concerning the uses of prenatal testing and the availability of the program.

(2)(A)Include information regarding environmental health in the California Prenatal Screening Program patient educational information. This environmental health information shall include the following statement:

“We encounter chemicals and other substances in everyday life that may affect your developing fetus. Fortunately, there are steps you can take to reduce your exposure to these potentially harmful substances at home, in the workplace, and in the environment. Many Californians are unaware that a number of everyday consumer products may pose potential harm. Prospective parents should talk to their doctor and are encouraged to read more about this topic to learn about simple actions to promote a healthy pregnancy.”

(B)The department shall include in the patient educational information links to educational materials derived from peer-reviewed materials based on the best available evidence relating to environmental health and reproductive toxins.

(C)The department shall post the environmental health information described in subparagraphs (A) and (B) on its Internet Web site.

(D)The department shall send a notice to all distributors of the patient educational information informing them of the change to that information. In the notice, the department shall encourage obstetrician-gynecologists and midwives to discuss environmental health with their patients and to direct their patients to the appropriate page or pages in the patient educational information to provide their patients with additional information.

(E)In order to minimize costs, the environmental health information described in this paragraph shall be included when the patient educational information is otherwise revised and reprinted.

(F)The department may modify the language in the patient educational information after consultation with medical and scientific experts in the field of environmental health and reproductive toxins.

(G)The patient educational information shall be made available in the languages that meet the numeric threshold described in Section 14029.91 of the Welfare and Institutions Code, and shall be updated by the department as needed.

(c)Ensure that genetic counseling be given in conjunction with prenatal testing at the approved prenatal diagnosis centers.

(d)Designate sufficient prenatal diagnosis centers to meet the need for these services. Prenatal diagnosis centers shall have equipment and staff trained and capable of providing genetic counseling and performing prenatal diagnostic procedures and tests, including the interpretation of the results of the procedures and tests.

(e)Administer a program of subsidy grants for approved nonprofit prenatal diagnosis centers. The subsidy grants shall be awarded based on the reported number of low-income women referred to the center, the number of prenatal diagnoses performed in the previous year at that center, and the estimated size of unmet need for prenatal diagnostic procedures and tests in its service area. This subsidy shall be in addition to fees collected under other state programs.

(f)Establish any rules, regulations, and standards for prenatal diagnostic testing and the allocation of subsidies as the director deems necessary to promote and protect the public health and safety and to implement the Hereditary Disorders Act (Section 27).

(g)(1)The department shall expand prenatal screening to include all tests that meet or exceed the current standard of care as recommended by nationally recognized medical or genetic organizations, including, but not limited to, inhibin.

(2)The prenatal screening fee increase for expanding prenatal screening to include those tests described in paragraph (1) is forty dollars ($40).

(3)The department shall report to the Legislature regarding the progress of the program with regard to implementing prenatal screening for those tests described in paragraph (1) on or before July 1, 2007. The report shall include the costs of screening, followup, and treatment as compared to costs and morbidity averted by this testing under the program.

(4)(A)The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include the expansion of prenatal screenings, pursuant to paragraph (1), 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.

(B)(i)The department may adopt emergency regulations to implement and make specific the amendments to this section made during the 2006 portion of the 2005–06 Regular Session 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.

(ii)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.

SEC. 9.SECTION 1.

 Section 125092 of the Health and Safety Code is amended to read:

125092.
 (a) The department, in consultation with the Office of AIDS and with other stakeholders, including, but not limited to, representatives of professional medical and public health advocacy groups, providers of health care to women and infants infected with or exposed to HIV, and women living with HIV, shall develop culturally sensitive informational material adequate to fulfill the requirements of subdivisions (c) and (d) of Section 125090.
(b) This material shall be made available in the languages that meet the numeric threshold described in Section 14029.91 of the Welfare and Institutions Code when providing information to clients under the Medi-Cal program, and shall be updated by the department as necessary.
(c) This material shall also include information on available referral and consultation resources of experts in prenatal HIV treatment.