25 TAC §§37.51 - 37.65
STATUTORY AUTHORITY
The proposed new sections are authorized by Health and Safety Code, §§33.002(b)
and 33.032(b), which require the department to adopt rules necessary to carry
out the program; and Government Code, §531.0055, and Health and Safety
Code, §1001.075, which authorize the Executive Commissioner of the Health
and Human Services Commission to adopt rules and policies necessary for the
operation and provision of health and human services by the department and
for the administration of Health and Safety Code, Chapter 1001.
The proposed new sections affect the Health and Safety Code, Chapters 33
and 1001; and Government Code, Chapter 531.
§37.51.Purpose.
These sections describe the Newborn Screening Program administered
by the Department of State Health Services. Each newborn delivered in the
state must be subjected to two screens for multiple disorders to identify
the newborn that may be at risk of having phenylketonuria (PKU), other heritable
diseases, or hypothyroidism. Abnormal screens are reported to the newborn's
health care practitioner. These sections also identify program services which
are available to individuals who have a confirmed diagnosis of a heritable
disease or hypothyroidism and establish eligibility criteria, financial participation
requirements and procedures for the orderly provision of the identified services
to eligible individuals.
§37.52.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
21-hydroxylase deficiency--An inherited disorder, which
if not treated, may lead to serious illness and death.
(2)
Amino acid disorder--An inherited disorder, which if not
treated, may cause mental retardation or death.
(3)
Biotidinase deficiency--An inherited disorder, which if
not treated, may cause mental retardation, hearing loss, poor muscle control,
or death.
(4)
Bona fide resident--A person who:
(A)
is physically present within the geographic boundaries
of the state;
(B)
has an intent to remain within the state;
(C)
maintains an abode within the state (i.e., house or apartment,
not merely a post office box);
(D)
has not come to Texas from another country for the purpose
of obtaining medical care, with the intent to return to the person's native
country;
(E)
does not claim residency in any other state or country;
and
(i)
is a minor child residing in Texas whose parent, managing
conservator, or guardian is a bona fide resident;
(ii)
is a person residing in Texas who is the legally dependent
spouse of a bona fide resident; or
(iii)
is an adult residing in Texas, including an adult whose
parent, managing conservator, or guardian is a bona fide resident or who is
his/her own guardian.
(5)
Commissioner--The commissioner of the Department of State
Health Services or his successor.
(6)
Department--The Department of State Health Services or
its successor.
(7)
Diagnostic test--A medical evaluation to confirm results
of a screen.
(8)
Fatty acid oxidation disorder--An inherited disorder, which
if not treated, may cause mental retardation or death.
(9)
Galactose-1-phosphate uridyltransferase deficiency--An
inherited disorder, which if not treated, may cause fatal infection or mental
retardation.
(10)
Health care practitioner--A registered nurse recognized
as an advanced practice nurse by the Board of Nurse Examiners, a physician
assistant licensed by the Texas State Board of Physician Assistant Examiners,
a midwife who has met licensing requirements and standards of the Texas Midwifery
Board, or a physician who is licensed by the Texas State Board of Medical
Examiners.
(11)
Heritable disease--An inherited disease that may result
in mental or physical retardation or death.
(12)
Hypothyroidism--A disorder, which if not treated, leads
to mental and physical retardation.
(13)
Newborn--A child through 30 days of age.
(14)
Newborn screen--One or more tests to identify a newborn
who may be at risk of having phenylketonuria, other heritable diseases, or
hypothyroidism.
(15)
Organic acidemia--An inherited disorder, which if not
treated, may cause mental retardation or death.
(16)
Physician--A person licensed to practice medicine by the
Texas State Board of Medical Examiners.
(17)
Provider--The hospital, birthing facility, health care
practitioner, midwife, clinic, or laboratory that collects and submits the
newborn screen blood specimen.
(18)
Satisfactory specimen--A blood specimen obtained by uniform
absorption of capillary blood onto a filter paper target such that the target
is completely filled with blood and soaked through from back to front of the
paper. The blood specimen must be completely dry before shipping and be submitted
with the accurate and fully completed demographic information sheet.
(19)
Screen--One or more tests that identify an increased risk
for a disorder, which must be confirmed by diagnostic tests. A screen may
produce false positive or false negative results and should not be relied
upon as "diagnostic".
(20)
Sickling hemoglobinopathy, including sickle cell anemia,
hemoglobin S/C disease, and sickle betathalassemia--An inherited disorder
which, if not treated, may cause fatal infection and interrupted blood supply
to vital organs.
(21)
Specimen collection form--The specimen collection form
consists of a patient demographic information sheet (original and carbonless
copy) with an attached filter paper collection device.
(22)
Specimen collection kits.
(A)
Single screen specimen collection kit--a single department-approved
bar-coded, quality controlled filter paper collection device, demographic
information sheet, and envelope which may be used to submit a newborn's blood
specimen for the first or second screen, repeat or follow-up testing.
(B)
Two screen specimen collection kit--two connected, department
approved bar-coded, quality controlled filter paper collection devices, demographic
information sheets and envelopes which allows the first and second screens
to be linked. The kit is designed so that the two collection devices are easily
separated such that when the first specimen is collected, the remaining collection
device and an envelope will be given to the mother to take to the first doctor's
visit for collection of the second newborn screening blood specimen.
§37.53.Disorders for Which Newborn Screens Are Required.
Except as permitted in §37.54 of this title (relating to Exemption
from Screens), all newborns delivered in Texas shall receive two screens for
the following disorders:
(1)
galactose-1-phosphate uridyltransferase deficiency;
(2)
sickling hemoglobinopathies;
(3)
21-hydroxylase deficiency;
(4)
hypothyroidism;
(5)
amino acid disorders, including argininosuccinic acidemia,
citrullinemia, homocystinuria, maple syrup urine disease, phenylketonuria,
and tyrosinemia type I;
(6)
fatty acid oxidation disorders, including carnitine uptake
defect, long-chain hydroxyacyl-CoA dehydrogenase deficiency, medium-chain
acyl-CoA dehydrogenase deficiency, trifunctional protein deficiency, and very-long-chain
acyl-CoA dehydrogenase deficiency;
(7)
organic acidemias, including 3-methylcrotonyl-CoA carboxylase
deficiency, beta-ketothiolase deficiency, glutaric acidemia type I, hydroxymethylglutaric
aciduria, isovaleric acidemia, methylmalonic acidemia (Cbl A and Cbl B forms),
methylmalonic acidemia (mutase deficiency form), multiple carboxylase deficiency,
and propionic acidemia; and
(8)
biotinidase deficiency, upon the decision of the Commissioner
to include this disorder.
§37.54.Exemption from Screens.
A newborn may not be screened if the parent, managing conservator,
or guardian objects to the screens because the screens conflict with the religious
tenets or practices of the parent, managing conservator, or guardian.
§37.55.Responsibilities of Providers and Parent, Managing Conservator, or Guardian.
(a)
The nonphysician attending the delivery of a newborn or
any physician attending a newborn within the first 30 days of life has the
primary responsibility for causing the screens to be performed according to
these sections and ensuring that a satisfactory blood specimen is submitted
to the department or the department's designee on a properly completed specimen
collection form obtained from the department. When the baby is an inpatient
in the hospital, the hospital shall ensure that the appropriate screens are
done. When the baby is not in the hospital, the health care practitioner who
attends the newborn outside of the hospital shall be responsible for causing
the appropriate screens to be done.
(b)
A capillary blood specimen shall be collected by absorbing
the blood onto target circles on a filter paper collection device. Other body
fluids, or blood from the placenta, umbilical cord, or mother are not acceptable.
(c)
Blood specimens must air-dry on a flat surface for at least
four hours and must be mailed to the department within 24 hours after collection.
Directions for handling blood specimens must be followed to avoid cross-contamination.
(d)
The department will determine the method of collection
of the second screen. If the department determines the appropriate method
of collection is a two-part collection kit, the provider of the first screen
shall give the second specimen collection kit to the parent, managing conservator,
or guardian with instructions to take the kit to a health care provider for
collection of the newborn's second blood specimen at one to two weeks of age.
(e)
Providers shall ensure that the identifying and demographic
information sheet is complete and accurate when submitted to the department.
Identifying information shall include contact information for the newborn's
health care practitioner to ensure ability to contact the practitioner in
case of an abnormal screen.
§37.56.Blood Specimen Collection for Required Screens.
(a)
The blood specimen is to be obtained after 24 hours of
age and before 48 hours of age. If the newborn is discharged from the hospital
or birthing facility before the above criteria are met, the blood specimen
must be obtained immediately prior to discharge. A second blood specimen is
to be collected between one and two weeks of age by the newborn's health care
practitioner in accordance with §37.55 of this title (relating to Responsibilities
of Providers and Parent, Managing Conservator, or Guardian). If program data
demonstrate to the agency's satisfaction that the second screen is no longer
necessary as a method of detecting false negative results from the first screen,
the commissioner may discontinue the requirement for submission of the second
screen. The commissioner's decision shall be announced through means deemed
appropriate by the commissioner to notify health care practitioners, providers,
and other interested persons. Prior to the effective date of the announced
change, the agency's newborn screening educational information will be revised
to reflect the deletion of the second screen requirement.
(b)
A repeat blood specimen, which may or may not be the second
screen, shall be obtained as instructed by the Newborn Screening Program to
verify results or if the initial blood specimen was unsatisfactory.
(c)
Transfusions can cause invalid results. The first screen
should be collected prior to the first transfusion if possible. Transfused
newborns must be retested two to four weeks following transfusion.
§37.57.Screening Procedures To Be Used.
Analysis of the blood specimens for the required screens must be performed
by the department or the department designee. The department or the department
designee is responsible for identifying and implementing proper laboratory
procedures for the screens required in §37.53 of this title (relating
to Disorders for Which Screens Are Required).
(1)
The analysis of initial blood specimens and the analysis
of the follow-up blood specimens are included in these responsibilities.
(2)
The criteria for referring a newborn with an abnormal screen
are dependent upon the laboratory procedures employed by the department or
the department's designee in performing the analysis of the blood specimens.
Therefore, the department is responsible for identifying and implementing
the referral criteria based upon the laboratory procedures selected by the
department for the analysis.
(3)
Upon completion of the laboratory determination by the
department, laboratory results shall be mailed to the provider who submitted
the blood specimen. The department shall establish a written policy for communicating
the laboratory results.
§37.58.Follow-up and Record Keeping on Abnormal Screens.
(a)
The department shall maintain an active system of follow-up
for suspected cases of each disorder for which screens are required.
(b)
Health authorities, public health departments, public health
districts, and the department's health service regions may provide follow-up
and other needed assistance for individuals at risk from the disorders for
which screens are required as requested by the department.
(c)
The provider submitting the newborn screening specimen
shall assist the department with follow-up of individuals at risk for the
disorders listed in §37.53 of this title (relating to Disorders for Which
Newborn Screens are Required).
(d)
The department will identify pediatric specialists in the
state who are available to provide consultation to health care practitioners
regarding the diagnosis and management of newborns with abnormal screens.
When appropriate, Newborn Screening Program staff shall provide the health
care practitioner with the names of consultants in the health care practitioner's
geographic area. The program may provide information about the newborn and
the abnormal screen to the pediatric specialists who consult with the department.
(e)
Health care practitioners shall report to the department
all confirmed cases of the disorders for which required screens are performed
that have been detected by other mechanisms.
(f)
The department will collect epidemiologic data from information
in the specimen collection kits and other sources to derive incidence/prevalence
rates for the disorders for which screens are required. The data may enable
the department to identify high-risk population groups, with the ultimate
goal of preventing severe sequelae of the disorders.
(g)
The department may follow up with a confirmed case through
periodic data collection from the health care practitioner or parent, managing
conservator, or guardian.
(h)
The department shall maintain a registry of children born
in Texas who have been diagnosed as having one of the disorders for which
screens are required.
§37.59.Coordination with Children With Special Health Care Needs Program.
(a)
All newborns and other individuals under the age of 21
years who have an abnormal screen may be referred, if financially eligible,
to the department's Children With Special Health Care Needs (CSHCN) Program.
(b)
An individual who is determined to be eligible for CSHCN
services shall be given approved services through that program, including
special dietary formula, unless access to CSHCN health care benefits is restricted
according to §38.16 of this title (relating to Procedures to Address
CSHCN Services Program Budget Alignment). An individual who does not meet
CSHCN eligibility criteria shall be referred to the Newborn Screening Program
for a determination of eligibility for program benefits.
§37.60.Newborn Screening Benefits.
In cooperation with the individual's health care practitioner and within
the limits of funds appropriated by the legislature for this purpose, the
Newborn Screening Program shall provide dietary supplements, medications,
vitamins, confirmatory testing and follow-up care at no cost or reduced cost
to individuals approved for program benefits who have a disorder detected
through the program, and confirmed with appropriate diagnostic tests, that
have been interpreted by a physician recognized by the department as a specialist
in metabolic diseases. Dependent on available funding, program benefits will
be limited to specific populations of individuals diagnosed with an inheritable
disorder included in those screened by the department and whose income is
at or below 350% of the federal poverty income guideline. Dependent on available
funding, program benefits will be available to the following populations in
this order:
(1)
children 0-2;
(2)
children 3-5;
(3)
children 6-21;
(4)
pregnant women;
(5)
women of child bearing age; and
(6)
adults (female or male).
§37.61.Eligibility Requirements.
(a)
Except as otherwise provided for in these sections, to
be eligible to receive benefits from the Newborn Screening Program, an individual
must:
(1)
have a confirmed diagnosis of a disorder screened by the
program;
(2)
be a bona fide resident of the state;
(3)
have a family income that is within the financial guidelines
set by these sections;
(4)
if required, make financial participation payments in a
timely manner;
(5)
upon request from the program provide updated medical,
financial, and residency information and/or documentation; and
(6)
have a parent, managing conservator, or guardian agree
to abide by the requirements in these sections if the individual is a minor.
(b)
An individual is not eligible to receive benefits from
the program at no cost or reduced cost to the extent that the individual or
the parent, managing conservator, or other person with a legal obligation
to support the individual is eligible for some other benefit, such as Medicaid,
Children With Special Health Care Needs (CSHCN), Children's Health Insurance
Plan (CHIP) or private insurance, that would pay for all or part of the services.
§37.62.Application Process.
(a)
To be considered for newborn screening benefits, a complete
application for admission to the program must be filed annually with the program
by mailing to the following address: Newborn Screening Program, Health Screening
and Case Management Unit, Mail Code 1918, Department of State Health Services,
1100 West 49th Street, Austin, Texas 78756.
(b)
The application must be signed by one of the following
as appropriate:
(1)
an adult individual seeking services;
(2)
the parent, managing conservator, or guardian of a minor;
or
(3)
the guardian of an adult under a temporary, limited or
general guardianship.
(c)
An application signed with a mark must be attested to before
a notary public.
(d)
A complete application for newborn screening benefits shall
consist of the following:
(1)
a properly completed and signed application form;
(2)
a statement from the individual or, if the individual is
a minor, from the individual's parent, managing conservator, or guardian that
the individual is a bona fide resident of the state and if requested by the
Newborn Screening Program, documentation of residency status, and proof of
income as established in the Newborn Screening Program policy; and
(3)
information on any other benefit to which the applicant,
recipient, or person with a legal obligation to support the applicant or recipient
may be entitled.
(e)
An application shall be deemed incomplete for any one of
the following reasons:
(1)
failure to provide all information requested in the application
form;
(2)
lack of supporting documents;
(3)
failure to provide documentary evidence requested by the
program, including documentation to verify residency or financial data; or
(4)
lack of, or improper signatures.
(f)
An application will be reviewed and will be:
(1)
denied if eligibility requirements are not met;
(2)
returned, if incomplete, with the deficiencies noted to
the individual or if the individual is a minor or a ward, to the individual's
parent(s), managing conservator(s), or guardian as is appropriate, for completion
and resubmission; or
(3)
approved if all criteria are met.
(g)
An individual's eligibility date shall be considered to
be the date on which the program determines that the application is substantially
complete.
§37.63.Denial of Application; Modification, Suspension, Termination of Program Benefits.
(a)
An individual applying for or receiving benefits from the
Newborn Screening Program may have his/her application denied or his/her benefits
modified, suspended, or terminated for any of the following reasons.
(1)
Benefits may be denied, modified, suspended, or terminated
if:
(A)
the individual does not have a confirmed diagnosis of a
disorder for which program benefits are available;
(B)
the individual is not a bona fide resident of the state;
(C)
the individual fails or refuses to provide the periodic
information regarding residency and financial status when requested by the
program.
(2)
Benefits may be denied, modified, suspended, or terminated
if:
(A)
the individual submits an application form or any document
required in support of the application or continued participation in the program
which contains an intentional misstatement of fact which is material to the
program's determination that the individual is eligible for program benefits;
or
(B)
program funds are curtailed.
(b)
An individual applying for or receiving benefits from the
Newborn Screening Program may not appeal or request an administrative hearing
concerning adjustments made by the program in poverty income guidelines to
conform to federal poverty income guidelines or adjustments in the type and
amount of program benefits available when such adjustments are necessary to
conform to budgetary limitations.
(1)
An individual applying for program benefits will be notified
in writing if their application has been denied. The notification will outline
the reasons for denial.
(2)
An individual receiving newborn screening benefits will
be notified if the benefits are to be modified, suspended, or terminated.
Notification will be by certified mail to the most recent address known to
the program.
(3)
Within 30 days after receiving notice as specified in paragraph
(2) of this subsection, the individual, or if the individual is a minor, the
individual's parent, managing conservator, or guardian, may appeal the program's
decision to deny, suspend, modify, or terminate the services to the department
and request an administrative hearing before the department. Appeals and request
for hearings must be in writing and sent to the following address by certified
mail: Newborn Screening Program, Health Screening and Case Management Unit,
Mail Code 1918, Department of State Health Services, 1100 West 49th Street,
Austin, Texas 78756. Failure to respond will be deemed a waiver of the appeal
and of the opportunity for a hearing.
(4)
Appeals and administrative hearings will be conducted in
accordance with the department's fair hearing rules, §§1.51-1.55
of this title (relating to Fair Hearing Procedures).
§37.64.Advisory Bodies and Task Forces.
The commissioner may appoint both technical and lay advisory committees
to assist in the administration of the Newborn Screening Program. The commissioner
may also convene special task forces to assist the program and advisory committees
with technical expertise or to address special emotional, social, educational,
financial, or other problems which arise in families having a family member
with a confirmed diagnosis of phenylketonuria, other heritable disease, or
hypothyroidism.
§37.65.Confidentiality of Information.
(a)
All information required to be submitted by these sections
may be verified by the department with or without notice to any individual
applying for or receiving newborn screening benefits, or to the providers
of program benefits. Except as necessary for timely and effective referral
for diagnostic services or to ensure appropriate management for individuals
with confirmed diagnoses, the information received by the program in the administration
of the program is confidential to the extent authorized by law.
(b)
Information may be disclosed in summary, statistical, or
other forms, which do not identify particular individuals.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on June 26, 2006.
TRD-200603436
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 6, 2006
For further information, please call: (512) 458-7111 x6972