Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 73.
LABORATORIES
25 TAC §73.21, §73.54
The Executive Commissioner of the Health and Human Services
Commission (commission), on behalf of the Department of State Health Services
(department), proposes amendments to §73.21, concerning newborn screening,
and §73.54, concerning fees for clinical testing and newborn screening.
BACKGROUND AND PURPOSE
The amendments are authorized by Health and Safety Code, §§12.031,
12.032, and 12.0122 that allow the department to charge fees to a person who
receives public health services from the department, and which are necessary
for the department to recover costs for performing laboratory services. The
Texas Legislature, 79th Regular Session, amended Health and Safety Code, §33.011,
mandating the expansion of newborn screening in Texas by November 1, 2006.
This mandate will require a change in technology and increased costs for testing.
The National Newborn Screening and Genetics Resource Center has also reviewed
the department's newborn screening program and recommended that all first
and second screens be linked. To facilitate this process the department proposes
an alternate design for the specimen collection kit. This proposed kit will
consist of two, bar-coded, quality controlled filter paper collection forms
that are easily separated such that when the first specimen is collected,
the remaining collection form and envelope will be given to the mother to
take to the first doctor's visit for the collection of the second newborn
screening blood specimen. The new fee for the two-screen specimen collection
kits will include the cost of both the first and second screens.
SECTION-BY-SECTION SUMMARY
The proposed amendments include editorial changes to existing rules; new
definitions; and a new fee. Section 73.21 contains new definitions for "screen",
"specimen collection form", "specimen collection kits", and "replacement specimen
collection forms". The definition for "test kit" was deleted, the references
to "test kit(s)" are replaced with "specimen collection kit(s)"; and the references
to "screening panel(s)" are replaced with "screen(s)". This section describes
the department's criteria for charging fees for specimen collection kits.
Section 73.54 includes a proposed new fee of $80 for a newborn screening specimen
collection kit designed to link the first and second screens as defined in §73.21.
The fee for a two-screen specimen collection kit is equal to the fee for two
single screen specimen collection kits.
FISCAL NOTE
Dr. Susan Neill, Director, Laboratory Services Section has determined that
for each year of the first five year period the sections are in effect, there
will be no fiscal implications to the state as a result of administering the
sections as proposed. There will be no effect on existing contracts with other
state agencies. Increased costs to local governments cannot be determined
at this time.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Dr. Neill has also determined that there are no anticipated costs to small
businesses or micro-businesses (other than to those that submit specimens
for testing) required to comply with the sections as proposed. This was determined
by interpretation of the rules that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with the sections. There are no anticipated economic costs to persons (other
than to those that submit specimens for testing) who are required to comply
with the sections as proposed. There is no anticipated negative impact on
local employment.
PUBLIC BENEFIT
In addition, Dr. Neill has also determined that for each year of the first
five years the sections are in effect, the public will benefit from adoption
of the sections. The public benefit anticipated as a result of enforcing or
administering the sections will be a more efficient way to link the first
and second newborn screens for each child born in Texas.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments do not restrict
or limit an owner's right to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be directed to Sherry S. Clay, Manager, Quality
Control Unit, Laboratory Services Section, 1100 West 49th Street, Austin,
Texas 78756-3199. Comments will be accepted for 30 days following the date
of publication of this proposal in the
Texas Register
.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The amended sections are proposed under 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 the Health and Safety Code,
Chapter 1001; Health and Safety Code, §33.004(b), which requires the
department to implement the newborn screening program in accordance with rules
adopted by the Executive Commissioner; §12.001, which provides the Executive
Commissioner the authority to adopt rules for the performance of every duty
imposed by law on the Executive Commissioner, department and commissioner; §12.031
and §12.032, which allow the Executive Commissioner to charge fees to
a person who receives public health services from the department; §12.034,
which requires the Executive Commissioner to establish collection procedures; §12.035,
which requires the department to deposit all money collected for fees and
charges under §12.032 and §12.033 in the state treasury to the credit
of the Department of State Health Services public health service fee fund;
and §12.0122, which allows the department to enter into a contract for
laboratory services.
The proposed amendments affect the Health and Safety Code, Chapters 12,
33, and 1001; and Government Code, Chapter 531.
§73.21.Newborn Screening.
(a)
Purpose. This section establishes procedures for the purchase
and submission of newborn screening
specimen collection
[
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings unless the context clearly
indicates otherwise.
(1) - (2)
(No change.)
(3)
Newborn Screening (NBS)--Newborn screening is a requirement
of the Health and Safety Code, Chapter 33.
Each screen consists of one
or more tests to identify a newborn who may be at risk of having phenylketonuria,
other heritable diseases, or hypothyroidism.
[
(4)
(No change.)
(5)
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."
[
(6)
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.
(7)
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. This term includes replacement specimen collection forms.
(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.
(8)
Replacement specimen collection
forms--consist of a single specimen collection kit for instances when a previously
purchased specimen collection form is lost, damaged or otherwise unavailable.
(c)
Specimen collection
[
(1)
The department will provide newborn screening
specimen
collection
[
(A)
The department will provide
specimen collection
[
(B)
If two screen specimen collections
kits are used by the department, the department will provide replacement specimen
collection forms at no cost to providers who purchase two screen specimen
collection kits. Providers who do not purchase two screen specimen collection
kits but need replacement specimen collection forms for the second screen
may be charged the single screen specimen collection kit fee described in §73.54(1)(H)
of this title (relating to Fee Schedule for Clinical Testing and Newborn Screening).
(C)
[
(2)
When a provider requests
specimen collection
[
(3)
The department will bill the requesting provider for
specimen collection
[
(4)
The department shall accept only its
approved specimen
collection
[
(5)
The provider shall ensure that the identifying and demographic
information provided with the
specimen collection
[
§73.54.Fee Schedule for Clinical Testing and Newborn Screening.
Fees for clinical testing and newborn screening shall not exceed the
following amounts.
(1)
Human specimens.
(A) - (G)
(No change.)
(H)
Newborn screening
.
[
(i)
Single screen specimen collection
kit--$40; and
(ii)
Two screen specimen collection
kit--$80.
(I) - (L)
(No change.)
(2) - (4)
(No change.)
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 July 6, 2006.
TRD-200603620
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 20, 2006
For further information, please call: (512) 458-7111 x6972
Subchapter J. DEPARTMENT OF STATE HEALTH SERVICES IMMUNIZATION SCHEDULE
25 TAC §97.221
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
proposes an amendment to §97.221, concerning the Department of State
Health Services Immunization Schedule, in accordance with the most recent
recommendations of the federal Center for Disease Control and Prevention's
Advisory Committee on Immunization Practices.
BACKGROUND AND PURPOSE
The amendment to §97.221 are proposed under Health and Safety Code, §81.023,
which requires the department to develop immunization requirements for children;
and, in accordance with the most recent recommendations of the Center for
Disease Control and Prevention's Advisory Committee on Immunization Practices.
The amendment to §97.221, Department of State Health Services Immunization
Schedule, will serve as an updated immunization guide to directors and school
nurses at child-care facilities, public or private primary and secondary schools,
and institutions of higher education for administering recommended and mandatory
age-appropriate vaccinations. Physicians and hospitals will also benefit from
the updated version of the Department of State Health Services Immunization
Schedule as a guide for determining age-appropriate vaccination of their patients.
The 2006 Advisory Committee on Immunization Practices, the American Academy
of Pediatrics (AAP), and the American Academy of Family Physicians approved
the recommendations and format of the childhood and adolescent immunization
schedule and catch-up schedule for January--December 2006. The department
will make the schedule available on the Immunization Branch's website at www.ImmunizeTexas.com.
SECTION-BY-SECTION SUMMARY
The department rule in 25 Texas Administrative Code, §97.63(2)(A),
references certain parts of the immunization schedule, and makes those vaccines
mandatory according to the stated schedule. Other references to the schedule
in department rule do not make the schedule mandatory, but are merely recommendations.
The substantive changes to the 2006 Department of State Health Services
Immunization Schedule are the following additional vaccines:
Meningococcal conjugate vaccine (MCV4) for all children ages 11-12 years,
as well as to unvaccinated adolescents at high school entry (age 15 years),
is now included in the 2006 Immunization Schedule; the previous 2005 Immunization
Schedule did not include this vaccine. A new tetanus toxoid, reduced diphtheria
toxoid, and acellular pertussis vaccine for adolescents (Tdap adolescent preparation)
has been added to the 2006 Schedule. Tdap is recommended for adolescents aged
11-12 years who have completed the recommended childhood diphtheria and tetanus
toxoids and pertussis/diphtheria and tetanus toxoids and acellular pertusis
(DTP/DTaP) vaccination series and have not received a tetanus and diphtheria
toxoids (Td) booster dose.
In addition, substantive changes to the following existing vaccine recommendations
were also made:
Hepatitis B vaccine birth dose is recommended for all newborns. In the
previous Immunization Schedule, the Hepatitis B vaccine was recommended at
1-2 months, but could be administered at birth.
Influenza vaccine is now recommended for children aged ≥6 months with
certain risk factors, which now specifically includes conditions that can
compromise respiratory function or handling of respiratory secretions or that
can increase the risk for aspiration. This was not previously included in
the 2005 recommendations.
Hepatitis A vaccine is now universally recommended for all children at
age 1 year (12-23 months). The previous recommendation was for children located
only in certain high-risk areas.
The catch-up schedule for persons aged 7-18 years has been changed for
Td. Now, Tdap may be substituted for any dose in a primary catch-up series
or as a booster if age appropriate for Tdap. A 5-year interval from the last
Td dose is encouraged when Tdap is used as a booster dose.
FISCAL NOTE
Casey S. Blass, Section Director, Disease Prevention and Intervention Section,
has determined that for each year of the first five years that the section
will be in effect, if future funds are appropriated at current levels, there
will be no additional fiscal implications to state or local government as
a result of enforcing and administering the section as proposed since funds
needed to implement the rule were appropriated.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Mr. Blass has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the section as proposed. This
was determined by interpretation of the rules that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with the section. There are no anticipated economic costs to persons who are
required to comply with the section as proposed. There is no anticipated negative
impact on local employment.
PUBLIC BENEFIT
In addition, Mr. Blass has also determined that for each year of the first
five years the section is in effect, the public will benefit from adoption
of the section. The public benefit anticipated as a result of enforcing and
administering the section as proposed will be to update the immunization schedule
that will serve as an updated immunization guide to directors and school nurses
at child-care facilities, public or private primary and secondary schools,
and institutions of higher education for administering recommended and mandatory
age-appropriate vaccinations. Physicians and hospitals will also benefit from
the updated version of the Department of State Health Services Immunization
Schedule as a guide for determining age-appropriate vaccination of their patients.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendment does not restrict
or limit an owner's right to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Tim Hawkins, Disease Prevention
and Intervention Section, Department of State Health Services, 1100 West 49th
Street, Austin, Texas 78756, (512) 458-7111, extension 3394, or (800) 252-9152.
Comments will be accepted for 30 days following publication of this proposal
in the
Texas Register
.
LEGAL CERTIFICATION
The Department of State Health Services General Council, Cathy Campbell,
certifies that the proposed rule has been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The amendment is proposed under Health and Safety Code, §81.023, which
requires the department to develop immunization requirements for children;
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 amendment affects Health and Safety Code, §81.023; Texas Education
Code, §38.001 and §51.933; and Human Resource Code, §42.043.
§97.221.Department of State Health Services Immunization Schedule.
This schedule [
Figure: 25 TAC §97.221 (.pdf)
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 July 6, 2006.
TRD-200603628
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 20, 2006
For further information, please call: (512) 458-7111 x6972
Subchapter B. PERSONAL EMERGENCY RESPONSE SYSTEM PROVIDERS
test
] kits provided by the Department of State Health Services (department).
Each newborn must
have two screening panels performed.
] Additional
screens
[
screening panels
] may be necessary under certain circumstances.
(5)
Test kit--The department-designed
collection device, demographic information form and envelope used to submit
a newborn's blood specimens for screening by the department.]
Test
] kits.
test
] kits upon written request from a provider
of newborn screening. A separate
specimen collection form
[
test kit
] is required for each
screen
[
screening panel
].
test
] kits for Medicaid-eligible or charity care newborns at no cost
to the provider.
(B)
] The department will provide
specimen collection
[
test
] kits for all other newborns at
a fee described in §73.54(1)(H) of this title [
(relating to Fee
Schedule for Clinical Testing and Newborn Screening)
].
test
] kits, the provider must identify the number estimated to be needed
for Medicaid-eligible newborns, charity care newborns and other newborns.
The provider's estimate shall be based on the provider's newborn screening
services provided in the most recent fiscal or calendar year if the provider
has previously provided these services. A provider shall provide further information
upon request of the department to verify the appropriateness of the number
of
specimen collection
[
test
] kits provided at no cost.
A provider may use the no-cost
specimen collection
[
test
]
kit only for a Medicaid-eligible or charity care newborn.
test
] kits when the
specimen collection
[
test
] kits are sent to the provider. Payment is due within
120 days from the provider's receipt of the
specimen collection
[
test
] kits.
test
] kits for submission of specimens.
test
]
kit is complete and accurate when submitted to the department.
test kit, including
screening panel--$40.
] (Fees are based on the newborn screening
specimen collection
[
test
] kits described in §73.21
of this title (relating to Newborn Screening), which includes the
cost
of screening).
[
costs of the screening panel.)
]
Chapter 97.
COMMUNICABLE DISEASES
is effective January 1, 2006, and
] indicates
the recommended ages for routine administration of childhood vaccines.
Chapter 140.
HEALTH PROFESSIONS REGULATION