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By: Crownover, Luna, Eissler, Zedler, et al. H.B. No. 790
A BILL TO BE ENTITLED
AN ACT
relating to the conduct of newborn screening by the Department of
State Health Services.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The heading to Chapter 33, Health and Safety
Code, is amended to read as follows:
CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES, [AND]
HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS
SECTION 2. Subchapter A, Chapter 33, Health and Safety
Code, is amended by adding Section 33.004 to read as follows:
Sec. 33.004. STUDY ON NEWBORN SCREENING METHODOLOGY AND
EQUIPMENT. (a) Not later than March 1, 2006, the department shall:
(1) conduct a study to determine the most
cost–effective method of conducting newborn screening, including
screening for disorders listed in the core uniform panel of newborn
screening conditions recommended in the 2005 report by the American
College of Medical Genetics entitled "Newborn Screening: Toward a
Uniform Screening Panel and System" or another report determined by
the department to provide more appropriate newborn screening
guidelines, to protect the health and welfare of this state's
newborns and to maximize the number of newborn screenings that may
be conducted with the funding available for the screening;
(2) determine the disorders to be studied under
Subdivision (1) and ensure the study does not examine screening and
services provided under Chapter 47; and
(3) obtain proposals or information regarding the
conduct of newborn screening and compare the costs of the
department performing newborn screening services to the costs of
outsourcing screening to a qualified laboratory with at least two
years' experience performing newborn screening tests.
(a-1) Not later than October 1, 2005, the department shall
review and study the National Newborn Screening and Genetics
Resources Center's assessment of the screening program in this
state. Based on the findings and recommendations in the assessment,
the executive commissioner of the Health and Human Services
Commission may adopt rules for the department to implement a
newborn genetic screening program. In adopting rules for the
newborn genetic screening program, the department and the executive
commissioner:
(1) may seek input during the rulemaking process from
individuals and groups with an interest or expertise in newborn
screening;
(2) may use informal conferences or consultations to
obtain opinions on the program as provided by Section 2001.031,
Government Code; and
(3) must provide an opportunity for the individuals
and groups described by Subdivision (1) to appear before the
department before a notice of proposed rules is given as required by
Section 2001.023, Government Code.
(a-2) This subsection and Subsection (a-1) expire January
1, 2007.
(b) In accordance with rules adopted by the executive
commissioner of the Health and Human Services Commission, the
department may implement a newborn genetic screening program.
(b-1) Not later than March 1, 2006, the department shall
file with the governor's office a written report of the results and
conclusions of the study conducted by the department under
Subsection (a). This subsection expires January 1, 2007.
(c) If the department determines under Subsection (a) that
the department's performance of newborn screening services is more
cost-effective than outsourcing newborn screening, the department
shall obtain the use of screening methodologies, including tandem
mass spectrometers, and hire the employees necessary to administer
newborn screening under this chapter.
(d) If the department determines under Subsection (a) that
outsourcing of newborn screening is more cost-effective, the
department shall contract for the resources and services necessary
to conduct newborn screening using a competitive procurement
process.
(e) The department shall periodically review the newborn
screening program as revised under this section to determine the
efficacy and cost-effectiveness of the program and determine
whether adjustments to the program are necessary to protect the
health and welfare of this state's newborns and to maximize the
number of newborn screenings that may be conducted with the funding
available for the screening.
(f) The department may adjust the amounts charged for
newborn screening fees, including fees assessed for follow-up
services, tracking confirmatory testing, and diagnosis.
SECTION 3. Section 33.011, Health and Safety Code, is
amended by amending Subsection (a) and adding Subsection (a-1) to
read as follows:
(a) The physician attending a newborn child or the person
attending the delivery of a newborn child that is not attended by a
physician shall subject the child to screening tests approved by
the department for phenylketonuria, other heritable diseases,
[and] hypothyroidism, and other disorders for which screening is
required by the department.
(a-1) To the extent funding is available for the screening,
the department shall require newborn screening tests to screen for
disorders listed in the core uniform panel of newborn screening
conditions recommended in the 2005 report by the American College
of Medical Genetics entitled "Newborn Screening: Toward a Uniform
Screening Panel and System" or another report determined by the
department to provide more appropriate newborn screening
guidelines to protect the health and welfare of this state's
newborns.
SECTION 4. Section 33.014(a), Health and Safety Code, is
amended to read as follows:
(a) If, because of an analysis of a specimen submitted under
Section 33.011, the department reasonably suspects that a newborn
child may have phenylketonuria, another heritable disease, [or]
hypothyroidism, or another disorder for which the screening tests
are required, the department shall notify the person who submits
the specimen that the results are abnormal and provide the test
results to that person. The department may notify one or more of
the following that the results of the analysis are abnormal and
recommend [that] further testing when [is] necessary:
(1) the physician attending the newborn child or the
physician's designee;
(2) the person attending the delivery of the newborn
child that was not attended by a physician;
(3) the parents of the newborn child;
(4) the health authority of the jurisdiction in which
the newborn child was born or in which the child resides, if known;
or
(5) physicians who are cooperating pediatric
specialists for the program.
SECTION 5. Section 33.031(a), Health and Safety Code, is
amended to read as follows:
(a) All newborn children and other individuals under 21
years of age who have been screened, have been found to be
presumptively positive through the newborn screening program for
phenylketonuria, other heritable diseases, hypothyroidism, or
another disorder for which the screening tests are required, and
may be financially eligible may be referred to the department's
services program for children with special health care needs.
SECTION 6. Section 33.032(a), Health and Safety Code, is
amended to read as follows:
(a) Within the limits of funds available for this purpose
and in cooperation with the individual's physician, the department
may provide services directly or through approved providers to
individuals of any age who meet the eligibility criteria specified
by board rules on the confirmation of a positive test for
phenylketonuria, other heritable diseases, [or] hypothyroidism, or
another disorder for which the screening tests are required.
SECTION 7. Not later than November 1, 2006, the Department
of State Health Services shall implement the expanded newborn
screening program using the most cost-effective methods as
determined by the department under Section 33.004, Health and
Safety Code, as added by this Act.
SECTION 8. This Act takes effect September 1, 2005.