2005 Texas Health & Safety Code CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES, HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS

HEALTH & SAFETY CODE

CHAPTER 33. PHENYLKETONURIA, OTHER HERITABLE DISEASES, 
HYPOTHYROIDISM, AND CERTAIN OTHER DISORDERS

SUBCHAPTER A. GENERAL PROVISIONS


	§ 33.001. DEFINITIONS.  In this chapter:                                    
		(1)  "Heritable disease" means an inherited disease 
that may result in mental or physical retardation or death.
		(2)  "Hypothyroidism" means a condition that may cause 
severe mental retardation if not treated.
		(3)  "Other benefit" means a benefit, other than a 
benefit under this chapter, to which an individual is entitled for 
the payment of the costs of services.  The term includes:
			(A)  benefits available under:                                               
				(i)  an insurance policy, group health plan, 
or prepaid medical care plan;
				(ii)  Title XVIII of the Social Security Act 
(42 U.S.C. Section 1395);    
				(iii)  Title XIX of the Social Security Act 
(42 U.S.C. Section 1396);     
				(iv)  the Veterans' Administration;                                         
				(v)  the Civilian Health and Medical Program 
of the Uniformed Services;  or
				(vi)  workers' compensation or any other 
compulsory employers insurance program;
			(B)  a public program created by federal or state 
law or by ordinance or rule of a municipality or political 
subdivision of the state, except those benefits created by the 
establishment of a municipal or county hospital, a joint 
municipal-county hospital, a county hospital authority, a hospital 
district, or by the facilities of a publicly supported medical 
school;  and
			(C)  benefits resulting from a cause of action for 
health care expenses, or a settlement or judgment based on the cause 
of action, if the expenses are related to the need for services 
provided under this chapter.
		(4)  "Phenylketonuria" means an inherited condition 
that may cause severe mental retardation if not treated.
		(5)  "Screening test" means a rapid analytical 
procedure to determine the need for further diagnostic evaluation.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.002. DETECTION AND TREATMENT PROGRAM 
ESTABLISHED.  (a) The department shall carry out a program to 
combat morbidity, including mental retardation, and mortality in 
persons who have phenylketonuria, other heritable diseases, or 
hypothyroidism.
	(b)  The board shall adopt rules necessary to carry out the 
program, including a rule specifying other heritable diseases 
covered by this chapter.
	(c)  The department shall establish and maintain a 
laboratory to:            
		(1)  conduct experiments, projects, and other 
activities necessary to develop screening or diagnostic tests for 
the early detection of phenylketonuria, other heritable diseases, 
and hypothyroidism;
		(2)  develop ways and means or discover methods to be 
used to prevent or treat phenylketonuria, other heritable diseases, 
and hypothyroidism;  and
		(3)  serve other purposes considered necessary by the 
department to carry out the program.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.003. COOPERATION OF HEALTH CARE PROVIDERS AND 
GOVERNMENTAL ENTITIES.  (a) The department may invite all 
physicians, hospitals, and other health care providers in the state 
that provide maternity and newborn infant care to cooperate and 
participate in any program established by the department under this 
chapter.
	(b)  Other boards, agencies, departments, and political 
subdivisions of the state capable of assisting the department in 
carrying out the program may cooperate with the department and are 
encouraged to furnish their services and facilities to the program.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 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.

Text of subsec. (a-1) effective until January 1, 2007
	(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 screening program.  In adopting rules for the newborn 
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.

Text of subsec. (a-2) effective until January 1, 2007
	(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 screening program.

Text of subsec. (b-1) effective until January 1, 2007
	(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.

Added by Acts 2005, 79th Leg., ch. 940, § 2, eff. Sept. 1, 2005.           

SUBCHAPTER B. NEWBORN SCREENING


	§ 33.011. TEST REQUIREMENT.  (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, 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.
	(b)  The department may prescribe the screening test 
procedures to be used and the standards of accuracy and precision 
required for each test.
	(c)  The screening tests required by this section must be 
performed by the laboratory established by the department or by a 
laboratory approved by the department under Section 33.016.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 2005, 79th Leg., ch. 940, § 3, eff. Sept. 1, 2005.


	§ 33.012. EXEMPTION.  (a) Screening tests may not be 
administered to a newborn child whose parents, managing 
conservator, or guardian objects on the ground that the tests 
conflict with the religious tenets or practices of an organized 
church of which they are adherents.
	(b)  If a parent, managing conservator, or guardian objects 
to the screening tests, the physician or the person attending the 
newborn child that is not attended by a physician shall ensure that 
the objection of the parent, managing conservator, or guardian is 
entered into the medical record of the child.  The parent, managing 
conservator, or guardian shall sign the entry.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.013. LIMITATION ON LIABILITY.  A physician, 
technician, or other person administering the screening tests 
required by this chapter is not liable or responsible because of the 
failure or refusal of a parent, managing conservator, or guardian 
to consent to the tests for which this chapter provides.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.014. DIAGNOSIS;  FOLLOW-UP.  (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, 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 further 
testing when 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.  
	(b)  If a screening test indicates that a newborn child is at 
high risk, the department shall recommend that the child be placed 
under the medical care of a licensed physician for diagnosis and 
provide the name of a consultant pediatric specialist in the 
child's geographic area.
	(c)  The department, the health authority, and the 
consulting pediatric specialist may follow up a positive test with 
the attending physician or with a parent of the newborn child if the 
child was not attended by a physician at birth.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 2005, 79th Leg., ch. 940, § 4, eff. Sept. 1, 2005.


	§ 33.015. REPORTS;  RECORD KEEPING.  (a) Each physician, 
health authority, or other individual who has the information of a 
confirmed case of a disorder for which a screening test is required 
that has been detected by a mechanism other than identification 
through a screening of a specimen by the department's diagnostic 
laboratory shall report the confirmed case to the department.
	(b)  The department may collect data to derive incidence and 
prevalence rates of disorders covered by this chapter from the 
information on the specimen form submitted to the department for 
screening determinations.
	(c)  The department shall maintain a roster of children born 
in this state who have been diagnosed as having one of the disorders 
for which the screening tests are required.
	(d)  The department may cooperate with other states in the 
development of a national roster of individuals who have been 
diagnosed as having one of the disorders for which the screening 
tests are required if:
		(1)  participation in the national roster encourages 
systematic follow-up in the participating states;
		(2)  incidence and prevalence information is made 
available to participating newborn screening programs in other 
states;  and
		(3)  each participating newborn screening program 
subscribes to an agreement to protect the identity and diagnosis of 
the individuals whose names are included in the national roster.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.016. APPROVAL OF LABORATORIES.  (a) The department 
may develop a program to approve any laboratory that wishes to 
perform the tests required to be administered under this chapter.  
To the extent that they are not otherwise provided in this chapter, 
the board may adopt rules prescribing procedures and standards for 
the conduct of the program.
	(b)  The department may prescribe the form and reasonable 
requirements for the application and the procedures for processing 
the application.
	(c)  The department may prescribe the test procedure to be 
employed and the standards of accuracy and precision required for 
each test.
	(d)  The department may extend or renew any approval in 
accordance with reasonable procedures prescribed by the board.
	(e)  The department may for good cause, after notice to the 
affected laboratory and a hearing if requested, restrict, suspend, 
or revoke any approval granted under this section.
	(f)  Hearings under this section shall be conducted in 
accordance with the hearing rules adopted by the board and the 
applicable provisions of Chapter 2001, Government Code.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 1995, 74th Leg., ch. 76, § 5.95(49), eff. Sept. 1, 1995.

SUBCHAPTER C. NEWBORN SCREENING PROGRAM SERVICES


	§ 33.031. COORDINATION WITH CHILDREN WITH SPECIAL HEALTH 
CARE NEEDS SERVICES.  (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.
	(b)  An individual who is determined to be eligible for 
services under the services program for children with special 
health care needs shall be given approved services through that 
program.  An individual who does not meet that eligibility criteria 
shall be referred to the newborn screening program for a 
determination of eligibility for newborn screening program 
services.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 1999, 76th Leg., ch. 1505, § 3.11, eff. Sept. 1, 1999;  Acts 
2005, 79th Leg., ch. 940, § 5, eff. Sept. 1, 2005.


	§ 33.032. PROGRAM SERVICES.  (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, hypothyroidism, or another disorder for which 
the screening tests are required.
	(b)  The board may adopt:                                                      
		(1)  rules specifying the type, amount, and duration of 
program services to be offered;
		(2)  rules establishing the criteria for eligibility 
for services, including the medical and financial criteria;
		(3)  rules establishing the procedures necessary to 
determine the medical, financial, and other eligibility of the 
individual;
		(4)  substantive and procedural rules for applying for 
program services and processing those applications;
		(5)  rules for providing services according to a 
sliding scale of financial eligibility;
		(6)  substantive and procedural rules for the denial, 
modification, suspension, and revocation of an individual's 
approval to receive services;  and
		(7)  substantive and procedural rules for the approval 
of providers to furnish program services.
	(c)  The department may select providers according to the 
criteria in the board's rules.
	(d)  The board may charge fees for the provision of services, 
except that services may not be denied to an individual because of 
the individual's inability to pay the fees.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 2005, 79th Leg., ch. 940, § 6, eff. Sept. 1, 2005.


	§ 33.033. CONSENT.  The department may not provide 
services without the consent of the individual or, if the 
individual is a minor, the minor's parent, managing conservator, or 
guardian.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.034. DENIAL, MODIFICATION, SUSPENSION, AND 
REVOCATION OF APPROVAL TO PROVIDE SERVICES.  (a) After notice and 
an opportunity for a fair hearing, the department may deny the 
approval or modify, suspend, or revoke the approval of a person to 
provide services under this chapter.
	(b)  Notice shall be given and the hearing shall be conducted 
in accordance with the department's informal hearing procedures.
	(c)  Chapter 2001, Government Code, does not apply to the 
notice and hearing required by this section.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 1995, 74th Leg., ch. 76, § 5.95(66), eff. Sept. 1, 1995;  
Acts 2005, 79th Leg., ch. 728, § 9.001, eff. Sept. 1, 2005.


	§ 33.035. INDIVIDUALS ELIGIBLE FOR SERVICES.  (a) An 
individual is not eligible to receive the services authorized by 
this chapter at no cost or reduced cost to the extent that the 
individual or the parent, managing conservator, guardian, or other 
person with a legal obligation to support the individual is 
eligible for some other benefit that would pay for all or part of 
the services.
	(b)  The department may waive ineligibility under Subsection 
(a) if the department finds that:
		(1)  good cause for the waiver is shown;  and                                 
		(2)  enforcement of the requirement would tend to 
defeat the purpose of this chapter or disrupt the administration or 
prevent the provision of services to an otherwise eligible 
recipient.
	(c)  When an application for services is filed or at any time 
that an individual is eligible for or receiving services, the 
applicant or recipient shall inform the department of any other 
benefit to which the applicant, recipient, or person with a legal 
obligation to support the applicant or recipient may be entitled.
	(d)  The board by rule shall provide criteria for actions 
taken under this section.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.036. DENIAL, MODIFICATION, SUSPENSION, AND 
REVOCATION OF ELIGIBILITY TO RECEIVE SERVICES.  (a) After notice to 
the individual or, if the individual is a minor, the individual's 
parent, managing conservator, or guardian and an opportunity for a 
fair hearing, the department may deny, modify, suspend, or revoke 
the determination of a person's eligibility to receive services at 
no cost or at reduced cost under this chapter.
	(b)  Notice shall be given and the hearing shall be conducted 
in accordance with the department's informal hearing procedures.
	(c)  Chapter 2001, Government Code, do  not apply to the 
notice and hearing required by this section.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991;  
Acts 1995, 74th Leg., ch. 76, § 5.95(66), eff. Sept. 1, 1995.


	§ 33.037. REIMBURSEMENT.  (a) The board may require an 
individual or, if the individual is a minor, the minor's parent, 
managing conservator, or guardian, or other person with a legal 
obligation to support the individual to pay or reimburse the 
department for all or part of the cost of the services provided.
	(b)  The recipient or the parent, managing conservator, 
guardian, or other person with a legal obligation to support an 
individual who has received services from the department that are 
covered by some other benefit shall, when the other benefit is 
received, reimburse the department for the cost of services 
provided.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.          


	§ 33.038. RECOVERY OF COSTS.  (a) The department is 
entitled to recover an expenditure for services provided under this 
chapter from:
		(1)  a person who does not reimburse the department as 
required by this chapter;  or
		(2)  a third party with a legal obligation to pay other 
benefits and who has received prior written notice of the 
department's interests in the other benefits.
	(b)  This section creates a separate and distinct cause of 
action, and the commissioner may request the attorney general to 
bring suit in the appropriate court of Travis County on behalf of 
the department.
	(c)  In a judgment in favor of the department, the court may 
award attorney fees, court costs, and interest accruing from the 
date on which the department provides the service to the date on 
which the department is reimbursed.
	(d)  The board by rule shall provide criteria for actions 
taken under this section.

Amended by Acts 1991, 72nd Leg., ch. 14, § 8, eff. Sept. 1, 1991.