Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 31.
NUTRITION SERVICES
25 TAC §31.1
The Texas Department of Health (department) adopts under
federal mandate an amendment to §31.1 concerning the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC). Section 31.1(c)
adopts by reference the WIC Policy and Procedure Manual.
The amendment to the WIC Policy and Procedure Manual covers United States
Department of Agriculture (USDA) regulations which were incorporated into
a policy that was approved by USDA. The department drafted an amendment to
certification policy CS: 03.5, Texas WIC Income Guidelines, submitted the
amendment for review by the Board of Health at its meeting on May 17, 2000,
and subsequently received USDA final approval. The amendment will allow the
department to announce and transmit to each local agency the changes in the
federal poverty income guidelines issued by the United States Department of
Health and Human Services by July 1, 2000, as required by USDA.
The amendment is adopted under federal mandate for the following reasons.
Under federal and state enabling legislation (the Child Nutrition Act of 1966,
42 USC §1786; and the Texas Omnibus Hunger Act of 1985, 69th Legislature,
Chapter 150, Title II), the WIC Program is 99% federally funded and governed
by federal regulations. Funds are made available to the department by a federal
grant. The federal statute (42 USC §1786), federal regulations (7 CFR
Part 246), and the federal grant (Federal-State Special Supplemental Nutrition
Program Agreement) authorize the USDA to make funds available to the department
to administer the WIC Program in the State of Texas, provided that the department
administers the program in accordance with the federal regulations.
The amendment is adopted under Health and Safety Code, §12.001(b)
which provides the Texas Board of Health (board) with authority to adopt rules
for the performance of every duty imposed by law upon the board, the department,
and the commissioner of health; the Texas Omnibus Hunger Act of 1985, 69th
Legislature, Chapter 150, Title II, Human Resources Code, Chapter 33; the
Child Nutrition Act of 1966, 42 USC §1786; and 7 CFR Part 246.
§31.1.Special Supplemental Food Program for Women, Infants and Children (WIC).
(a)
Federal regulations.
(1)
The department adopts by reference the United States Department
of Agriculture regulations on the Special Supplemental Food Program for Women,
Infants, and Children (WIC). These regulations are contained in the Federal
Register publication entitled "Special Supplemental Food Program for Women,
Infants, and Children" dated February 13, 1985, as amended October 4, 1993,
November 29, 1993, March 10, 1994, and March 11, 1994.
(2)
Copies of the regulations described in paragraph (1)
of this subsection are filed in the department's Bureau of Nutrition Services-Women,
Infants, and Children (WIC) Program, Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756, and are available for public inspection
during regular working hours.
(b)
WIC State Plan of Operations.
(1)
The department adopts by reference the publication titled
"WIC State Plan of Operations," as amended effective October 1, 1998. This
plan has been developed by the department's WIC Program and approved by the
United States Department of Agriculture.
(2)
Copies of the state plan are filed in the department's
Bureau of Nutrition Services-Women, Infants, and Children (WIC) Program, Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756, and are
available for public inspection during regular working hours.
(c)
WIC Policy and Procedure Manual
(1)
The department adopts by reference the publication titled
"WIC Policy and Procedure Manual," which the department developed, as amended
effective July 1, 2000. This policy and procedure manual has been developed
by the department's WIC Program and approved by the United States Department
of Agriculture.
(2)
Copies of the manual are filed in the department's
Bureau of Nutrition Services- Women, Infants, and Children (WIC) Program,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and
are available for public inspection during regular working hours.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 23, 2000.
TRD-200004411
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 1, 2000
For further information, please call: (512) 458-7236
Subchapter D. OSTEOPOROSIS ADVISORY COMMITTEE
25 TAC §61.61
The Texas Department of Health (department) adopts an amendment
to §61.61 concerning the Osteoporosis Advisory Committee (committee)
without changes to the proposed text as published in the April 14, 2000, issue
of the
Texas Register
(25 TexReg 3161), and
therefore the section will not be republished. The committee provides advice
to the Texas Board of Health (board) concerning the rules relating to educating
the public on the health benefits of the early detection, prevention, and
treatment of osteoporosis.
In 1993, the Texas Legislature passed Senate Bill 383 (now codified in
the Government Code, Chapter 2110), which requires that each state agency
adopt rules on advisory committees. The rules must state the purpose and tasks
of the committee, describe the manner in which the committee will report to
the agency, and establish a date on which the committee will be automatically
abolished unless the governing body of the agency affirmatively votes to continue
the committee's existence.
In 1996, the board established a rule relating to the Osteoporosis Advisory
Committee. The rule states that the committee will automatically be abolished
on September 1, 2000. The board has now reviewed and evaluated the committee
and has determined that the committee should continue in existence until September
1, 2004.
This section amends provisions relating to the operation of the committee.
Specifically, language is revised to reference the Health and Safety Code,
§11.016 and the Government Code; to continue the committee until September
1, 2004; to change the composition; to clarify that members holdover until
their replacement is appointed; to state that the presiding and assistant
presiding officers shall be appointed by the chairman of the board for a term
of two years; to allow a temporary vacancy in the office of assistant presiding
officer to be filled by vote of the committee until appointment by the chairman
of the board occurs; to clarify that the committee is prohibited from holding
an executive session (closed meeting) for any reason; to clarify that the
committee and its members may not participate in legislative activity in the
name of the board, the department, or the committee except with certain approval;
to require the committee's annual report in September rather than January;
and to reference reimbursement for a committee member's expenses if authorized
by the General Appropriations Act or budget execution process. Other minor
language changes were made for clarification. These changes will clarify procedures
for the committee and emphasize the advisory nature of the committee.
No comments were received on the proposal during the comment period.
The amendment is adopted under the Health and Safety Code, §90.003
which allows the appointment of an osteoporosis task force; Health and Safety
Code, §11.016, which allows the board to establish advisory committees;
the Government Code, Chapter 2110, which sets standards for the evaluation
of advisory committees by the agencies for which they function; and the Health
and Safety Code, §12.001, which provides the board with authority to
adopt rules for the performance of every duty imposed by law upon the board,
the department, and commissioner of health.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 26, 2000.
TRD-200004448
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 16, 2000
Proposal publication date: March 10, 2000
For further information, please call: (512) 458-7236
25 TAC §159.1
The Texas Department of Health (department) adopts new §159.1
concerning reimbursement for tertiary medical services and stabilization services.
Section 159.1 is adopted with changes to the proposed text as published in
the March 10, 2000, issue of the
Texas Register
(25 TexReg 1956).
House Bill 1398, passed in 1999 by the Texas Legislature, added Chapter
46 to the Health and Safety Code, which establishes a method by which the
department may allocate funds to certain facilities for unreimbursed tertiary
medical services and unreimbursed stabilization services provided to persons
who reside outside the service area of the county, public hospital, or hospital
district that is responsible for indigent health care under the Health and
Safety Code, Chapter 61, in the area in which the eligible facility is located.
Chapter 46 established the tertiary care account in the state treasury, from
which funds are appropriated to the department for the purposes of this chapter.
Health and Safety Code, Chapter 46, requires the Board of Health (board)
to adopt rules governing the collection of information relating to unreimbursed
tertiary medical services or stabilization services. The final rule specifies
the information eligible facilities are required to provide to the department
in order to receive funding under this chapter. The rule establishes a process
for allocation of funds when the total costs certified are greater than the
amount available in the tertiary care account and a process by which eligible
facilities may apply for reimbursement under extraordinary emergencies.
The following written comments were received from the public:
Comment: Concerning proposed §159.1(b)(5), a comment was received
that the definition of "tertiary medical services" should reflect the statutory
definition.
Response: The department agrees and this change was made in renumbered
§159.1(b)(7).
Comment: A comment was received that requested the addition of definitions
for "cost of tertiary care services" and "cost of stabilization services."
Response: The department agrees and added these definitions as §159.1(b)(1)
and (2), but changed the term "cost of tertiary care services" to "cost of
tertiary medical services" to reflect terminology used elsewhere in the rule.
Adding these definitions meant the subsequent definitions were renumbered.
Comment: Concerning proposed §159.1(d)(3), a comment was received
that asked to eliminate the requirement that the chairman of the facility's
board of directors sign the application for funds.
Response: The department disagrees that this requirement is a costly administrative
burden to facilities because the signature is required only once a year and
the board is ultimately responsible for the facility's financial operations.
No change was made.
Comment: Concerning proposed §159.1(f), a comment was received that
the rule should include statutory language concerning the percentage of available
funds to be allocated for stabilization services.
Response: The department agrees and has added new paragraph (3) to §159.1(f).
The new section is adopted under the Health and Safety Code,
Chapter 46, as added by Acts 1999, 76th Legislature, Chapter 1377 (House Bill
1398), Article 2, which provides the board with the authority to adopt rules
concerning tertiary medical care; and §12.001 which provides the board
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
§159.1.Reimbursement to Tertiary Care Facilities and Level IV Trauma Facilities.
(a)
Introduction. The Texas Department of Health (department)
shall, on an annual basis, allocate available funds to eligible facilities
to compensate the facilities for the costs of unreimbursed tertiary medical
services and unreimbursed stabilization services.
(b)
Definitions. The following words and terms, when used in
this chapter, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)
Cost of tertiary medical services - The cost of a tertiary
medical service provided by a tertiary care facility is the average amount
payable under Medicare reimbursement policies for that service.
(2)
Cost of stabilization services - The cost of a stabilization
service provided by a tertiary care facility or level IV trauma facility is
the average amount payable under Medicare reimbursement policies for that
service.
(3)
Emergency reserve - Five percent of the total amount
of funds in the Tertiary Care Account to be used only for reimbursement of
unreimbursed tertiary medical services or unreimbursed stabilization services
resulting from an extraordinary emergency.
(4)
Stabilization services - Services provided by a tertiary
care facility or a designated level IV trauma center that are necessary to
assure, within reasonable medical probability, that no material deterioration
of a patient's medical condition is likely to result from or occur during
the transfer of the patient to a tertiary care facility.
(5)
Tertiary Care Account - An account in the state treasury.
(6)
Tertiary care facility - A primary teaching hospital
of a medical school or a designated level I, II or III trauma center.
(7)
Tertiary medical services - Includes, but is not limited
to services provided by state-designated trauma center services, burn center
treatment, neonatology level III unit services, pediatric surgery, trauma
surgery, neurosurgery, cardiothoracic and vascular surgery, organ transplant,
services provided for a life-threatening dermatologic illness, services provided
to a person with a high-risk pregnancy or cancer, and radiation oncology.
(8)
Unreimbursed stabilization services - Stabilization
services for which a tertiary care facility or a designated level IV trauma
center has not received full payment from any public or private source.
(9)
Unreimbursed tertiary medical services - Tertiary
medical services for which a tertiary care facility has not received full
payment from any public or private source.
(c)
Eligibility for funds.
(1)
The department shall allocate available funds for unreimbursed
tertiary medical services to tertiary care facilities who submit the required
information on a timely basis.
(2)
The department shall allocate available funds for
unreimbursed stabilization services to tertiary care facilities and designated
level IV trauma centers who submit the required information on a timely basis.
(3)
A facility must have operated as a tertiary care facility
or level IV trauma facility during the previous calendar year in order to
claim costs of unreimbursed services.
(d)
Application for funds.
(1)
On an annual basis, the department, in writing, will inform
each tertiary care facility and level IV trauma facility of the following:
(A)
that it may apply for funds to compensate it for the costs
of unreimbursed tertiary medical services (tertiary care facilities only)
and unreimbursed stabilization services (tertiary care facilities and level
IV trauma facilities) provided to persons who reside outside the service area
of the county, public hospital, or hospital district that is responsible for
indigent health care under the Health and Safety Code, Chapter 61, in the
area in which the tertiary care facility or level IV trauma facility is located;
(B)
the estimated, total amount of funding available at the
end of the reporting period;
(C)
the number of facilities eligible to apply for funds;
(D)
the information required to be submitted to the department
in order to apply for the funds;
(E)
the date by which the information must be submitted to
the department; and
(F)
the date by which the department expects to certify amounts
to the state comptroller of public accounts.
(2)
By the date established by the department, each
tertiary care facility or level IV trauma facility must submit the following
information on a form provided by the department:
(A)
name of the facility;
(B)
location including mailing address, city and county;
(C)
total costs of unreimbursed tertiary medical services (tertiary
care facilities only) provided during the reporting period to persons who
reside outside the service area of the county, public hospital, or hospital
district that is responsible for indigent health care under the Health and
Safety Code, Chapter 61, in the area in which the tertiary care facility is
located; and
(D)
total costs of unreimbursed stabilization services (tertiary
care facilities and level IV trauma facilities) provided during the reporting
period to persons who reside outside the service area of the county, public
hospital, or hospital district that is responsible for indigent health care
under the Health and Safety Code, Chapter 61, in the area in which the tertiary
care facility or level IV trauma facility is located.
(3)
The form must be signed by the chief operating
officer and the chairman of the facility's board of directors.
(4)
The form must be notarized.
(5)
A form postmarked after the due date will not be considered
for allocation of funds.
(6)
If a facility receives partial reimbursement from
another source for its tertiary medical services or stabilization services
provided to persons who reside outside the service area of the county, public
hospital, or hospital district that is responsible for indigent health care
under the Health and Safety Code, Chapter 61, in the area in which the tertiary
care facility or level IV trauma facility is located, the facility may request
compensation for the portion of the costs not covered by the partial reimbursement.
(7)
By signing the application form, a facility that is
reimbursed in full by a private or public source for tertiary medical services
or stabilization services after the services have been reported to the department,
agrees to promptly reimburse the State of Texas for such funds paid to the
facility under this section.
(e)
Reporting period. A facility's annual application for funds
shall apply to costs incurred during the preceding state fiscal year, beginning
with State Fiscal Year 2000 (September 1, 1999 to August 31, 2000).
(f)
Allocation of funds.
(1)
If the total cost of unreimbursed tertiary medical services
certified for all eligible facilities exceeds the amount available in the
Tertiary Care Account, the department shall allocate funds based on percentages
computed by dividing the costs of each facility's unreimbursed tertiary medical
services by the total cost of all facilities' unreimbursed tertiary medical
services.
(2)
If the total cost of unreimbursed stabilization services
certified for all eligible facilities exceeds the amount available in the
Tertiary Care Account, the department shall allocate funds based on percentages
computed by dividing the costs of each facility's unreimbursed stabilization
services by the total cost of all facilities' unreimbursed stabilization services.
(3)
The department may allocate not more than four percent
of available funds to eligible facilities for the cost of unreimbursed stabilization
services.
(g)
Certification to comptroller. Once the department has determined
the amount of reimbursement allotted for each eligible facility, the department
will certify those amounts to the state comptroller of public accounts for
processing of payments.
(h)
Emergency reserve.
(1)
The department may allocate funds to tertiary care facilities
or level IV trauma centers to compensate the facilities for the costs of unreimbursed
tertiary medical services or unreimbursed stabilization services resulting
from an extraordinary emergency.
(2)
An extraordinary emergency shall be certified by the
department:
(A)
if the governor issues an executive order or a proclamation
under Government Code, Chapter 418, pertaining to emergency management;
(B)
if a disaster is declared by the president of the United
States under the Robert T. Stafford Disaster Relief and Emergency Assistance
Act (42 U.S.C. §5121 et seq.); or
(C)
for another similiar disaster the department finds has
resulted in an extraordinary cost to a tertiary care facility or level IV
trauma facility.
(3)
A facility which incurs costs as a result of
an extraordinary emergency may apply to the department at any time; however,
reimbursement may be provided only for costs incurred during the emergency.
(4)
The facility must submit, in writing, the following
information:
(A)
name of the facility;
(B)
location including mailing address, city and county;
(C)
total costs of unreimbursed tertiary medical services (tertiary
care facilities only) resulting from an extraordinary emergency;
(D)
total costs of unreimbursed stabilization services (tertiary
care facilities and level IV trauma facilities) resulting from an extraordinary
emergency; and
(E)
a description of the extraordinary emergency.
(5)
The written statement must be signed by the chief
operating officer and the chairman of the facility's board of directors.
(6)
The department will review requests for emergency
funds and certify costs to the state comptroller of public accounts until
the emergency reserve is exhausted.
(i)
Audits. The department may conduct random, on-site audits
of documentation used by the facilities to calculate their reported costs
for unreimbursed services.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 26, 2000.
TRD-200004438
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 16, 2000
Proposal publication date: March 10, 2000
For further information, please call: (512) 458-7236
Subchapter Y. REGULATIONS TO SET STANDARDS FOR THE FORMULATION, SALE AND DISTRIBUTION OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE FROM NATURAL EPHIDRA ALKALOIDS AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN DRUG PRODUCTS CONTAINING EPHEDRINE
Chapter 61.
CHRONIC DISEASES
Chapter 159.
TERTIARY MEDICAL CARE
Chapter 229.
FOOD AND DRUG