Bill Text: CA SB1099 | 2023-2024 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Newborn screening: genetic diseases: blood samples collected.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Engrossed) 2024-05-20 - Referred to Com. on HEALTH. [SB1099 Detail]
Download: California-2023-SB1099-Introduced.html
Bill Title: Newborn screening: genetic diseases: blood samples collected.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Engrossed) 2024-05-20 - Referred to Com. on HEALTH. [SB1099 Detail]
Download: California-2023-SB1099-Introduced.html
CALIFORNIA LEGISLATURE—
2023–2024 REGULAR SESSION
Senate Bill
No. 1099
| Introduced by Senator Nguyen |
February 13, 2024 |
An act to amend Sections 124977 and 125055 of the Health and Safety Code, relating to newborn screening.
LEGISLATIVE COUNSEL'S DIGEST
SB 1099, as introduced, Nguyen.
Newborn screening: genetic diseases: blood samples collected.
Existing law requires the State Department of Public Health to administer a statewide program for prenatal testing for genetic disorders and birth defects, including, but not limited to, ultrasound, amniocentesis, chorionic villus sampling, and blood testing. Existing law requires the department to expand prenatal screening to include all tests that meet or exceed the current standard of care as recommended by national recognized medical or genetic organizations. Existing law establishes the continuously appropriated Birth Defects Monitoring Program Fund, consisting of fees paid for prenatal screening, and states the intent of the Legislature that all costs of the genetic disease testing program be fully supported by fees paid for prenatal screening tests, which are deposited in the fund. Existing law requires funds to be available, upon appropriation by the Legislature, in order to
support pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.
This bill would require the department, commencing January 1, 2026, and each January 1 thereafter, as part of its research activities, to report various data to the Legislature, including the number of research projects utilizing residual screening samples from the program and the number of inheritable conditions identified by the original screening tests the previous calendar year. The bill would also require the annual report to be made available to the public on the department’s internet website.
This bill would make other conforming changes.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOBill Text
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 test or activity 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
fee charged for prenatal screening and followup services provided to persons a person enrolled in the Medi-Cal program, health care service plan enrollees, enrollee, or persons person
covered by a health insurance policies, policy 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,
birth or, for births not occurring in a hospital, to families of the newborn, 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 pursuant to 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 pursuant to 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) (A) 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 activities, including reporting,
of the Birth Defects Monitoring Program. Notwithstanding
(B) 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
is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code, Code or to Division 25.2 (commencing with Section 38070) of this code. 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
hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be is not 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
policy, procedure, regulation, or manual authorized by those laws.
(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 cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts,
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
(B) This paragraph shall apply to the design, development, and implementation of the expansion,
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) (A) 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
(B) 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
(C) 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
(D) 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
(E) The regulations shall become effective immediately upon filing by the Secretary of State. Regulations
(F) 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) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations. Notwithstanding
(B) 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 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. internet website.
(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.
(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.
(h) Commencing January 1, 2026, and each January 1 thereafter, the department shall provide a report to the Legislature that includes each of the following:
(1) The total number of any residual screening specimens stored at the California Biobank.
(2) The number of new residual screening specimens collected the previous calendar year.
(3) The number of inheritable conditions identified by the original screening tests the previous calendar year.
(4) The number of projects utilizing specimens from the California Biobank.
(5) The identity of each entity performing a research project, the specific nature of the research they are performing, whether any of the research may be used for commercial profit, and the potentially substantial public health benefit from the research.
(6) The
number of specimens provided by the California Biobank for each research project.
(7) The number of screening tests waived for religious purposes the previous calendar year.
(8) The number of residual screening specimens destroyed at the request of a parent or adult the previous calendar year.
(9) The number of residual screening samples remaining to be destroyed pursuant to a request in paragraph (8).
(i) Commencing January 1, 2026, the report in subdivision (h) shall be made available to the public on the department’s internet website.
(j) The report submitted to the Legislature pursuant to subdivision (h) shall be submitted in compliance with Section 9795 of the Government Code.
