Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 13.
HEALTH PLANNING AND RESOURCE DEVELOPMENT
Subchapter A. WAIVER OF VISA RECOMMENDATION FOR PHYSICIANS
25 TAC §§13.1 - 13.8
The Texas Department of Health (department) adopts new §§13.1
- 13.8, concerning the waiver of visa rules for physicians serving in health
professional shortage areas, who apply to the J-1 visa waiver program. Sections
13.1 - 13.8 are adopted with changes to the proposed text as published in
the March 14, 2003, issue of the
Texas Register
(28
TexReg 2216).
Federal law (8 USC §§1182(e) and 1184(l)) allows state departments
of health to recommend waivers of visa rules in certain cases involving physicians,
and this is known as the J-1 visa waiver program. These recommendations are
also addressed by Texas Education Code, §51.949, which is expected to
be repealed and recodified under the Health and Safety Code, §12.0127,
effective September 1, 2003. The Health and Safety Code, §12.031 and §12.032,
allows the Texas Board of Health (board) to set public health service fees
for administrative services by rule. The purpose of these rules is to establish
the criteria the department will use to make the recommendations and establish
the fee allowed by these laws. These rules will facilitate the service of
foreign physicians in underserved areas and therefore benefit public health.
The following comments were received concerning the proposed rules.
Comment: Concerning proposed §13.1(3), renumbered as §13.1(4),
one commenter suggested adding the words "graduate medical" in the following
sentence: "Removal of the requirement that a J-1 visa holder must return to
their country of origin for two years at the end of his/her graduate medical
training".
Response: The department agrees. The suggested change was made to the paragraph.
Comment: Concerning proposed §13.1(7), renumbered as §13.1(8),
one commenter suggested adding "psychiatry" to the definition.
Response: The issue of psychiatry and the qualified areas in which a psychiatrist
may be recommended is addressed in §13.2(3). No changes were made as
a result of this comment.
Comment: Concerning §13.2(1), one commenter suggested to add the wording
"fully served" to describe areas no longer available due to previous waiver
recommendations. Another commenter suggested defining fully served and eligible
areas more specifically.
Response: The term "fully served" was added to the definitions as §13.1(2)
and is also included in §13.2(1). The definition of an eligible area
is more specific for §13.2(1), (2), and (3).
Comment: Concerning §13.2(4), one commenter suggested removing the
term service area and including the terms HPSA or MUA.
Response: The department agrees. The changes were made as a result of this
comment.
Comment: Concerning §13.2(1), one commenter suggested listing the
criteria required to have an area to be designated as a Medically Underserved
Area.
Response: The designation criteria are a separate issue and these rules
are not the appropriate place to list them. No changes were made as a result
of this comment.
Comment: Concerning §13.2(2), a comment was received concerning the
rotation of pediatric subspecialist physicians at Driscoll Children's Hospital
in Corpus Christi, and their regional clinics in McAllen, Brownsville, Harlingen,
Victoria and Laredo.
Response: It is permissible for a visa waiver physician to split their
time between more than one location. However, each site must reside in a Health
Professional Shortage Area, or a Medically Underserved Area with a current
shortage of physicians. No changes were made as a result of this comment.
Comment: Concerning §13.2(2), a comment was received concerning the
designation of all freestanding, nonprofit children's hospitals as facility
Health Professional Shortage Areas.
Response: The designation eligibility includes Health Professional Shortage
Areas and Medically Underserved Areas with a current shortage of providers.
Facilities with Health Professional Shortage Area designation are not eligible.
No changes were made as a result of this comment.
Comment: Concerning §13.2(5), one commenter suggested adding the words
"Bureau of Citizenship and Immigration Services".
Response: The department agrees. The language "Bureau of Citizenship and
Immigrations Services" was added to §13.2(5). Also, the words "Bureau
of Citizenship and Immigrations Services" were added to §13.6 and §13.7,
and the words "Immigration and Naturalization Services" were deleted.
Comment: Concerning §13.3(b), one commenter suggested clarification
or removal of the term "acquaintance."
Response: The department agrees, and has deleted the words "or acquaintance".
Comment: Concerning §13.4(b), one commenter suggested being more specific
on the number of letters of support.
Response: The department agrees, and added the words "up to 6" for the
letters of support.
Comment: Concerning §13.5(a), one commenter suggested that the contract
include the wage and that a copy of the prevailing wage be included in the
visa waiver application.
Response: The department agrees. The changes were made as a result of this
comment.
Comment: Concerning §13.5(c)(1), (2), (3), (4) and (5), one commenter
suggested that the list of items to be included in the contract should be
more specific.
Response: The department agrees. The changes were made as a result of this
comment.
Comment: Concerning §13.6(a), two comments were received suggesting
that the 90 day notification to the Department of State and the Bureau of
Citizenship and Immigration Services rule be removed. Another commenter suggested
clarifying that the 90-day period begins upon receipt of the waiver.
Response: This is a Department of State rule and must be followed by state
health departments; therefore the 90-day notification is not removed. The
department agrees with the clarification that the 90 days begins upon receipt
of the waiver and added the word "receiving" in front of the word "waiver".
Comment: Concerning §13.6(b), one commenter suggested including the
language "in writing within ten days" to the section.
Response: The department agrees. The changes were made as a result of this
comment.
Comment: Concerning §13.6(c) (1), (2), and (3), one commenter suggested
that the section should be more specific regarding the department's verification
activities.
Response: The department agrees. The changes were made as a result of this
comment.
Comment: Concerning §13.8, one commenter suggested specific citation
of the federal laws that apply to this program and removal of the requirement
for letters of support for other waiver programs.
Response: The department agrees. The changes were made as a result of this
comment.
Change: There were minor changes made due to department staff comments,
which included changing upper case letters to lower case letters in several
sections.
The comments were from institutions and were in favor of the rules and
made recommendations. The commenters are two law offices, Pinchak & Associates,
P.C., and Pederson & Freedman, L.L.P.; one hospital, Driscoll Children's
Hospital, and department staff.
The new rules are adopted under Health and Safety Code, §12.032,
which allows the board to set fees by rule for public health services; 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.
§13.1.Definition of Terms.
The following words and terms when used in these sections, shall have
the following meaning.
(1)
Employer--A director of a health care facility where the
physician will practice.
(2)
Fully Served--An area with a population to provider ratio
of 3000:1 or more physicians per capita.
(3)
HPSA--Health Professional Shortage Area.
(4)
J-1 Visa Waiver--Removal of the requirement that a J-1
visa holder must return to their country of origin for two years at the end
of his/her graduate medical training. The waiver allows the J-1 visa holder
to remain in the United States if they agree to practice in an underserved
area.
(5)
MUA--Medically Underserved Area.
(6)
NHSC--National Health Service Corps.
(7)
Operational--Providing health care services to patients.
(8)
Primary Care Specialist--A physician who has a degree and
specialization in internal medicine, general practice, family practice, pediatrics,
or obstetrics/gynecology.
(9)
Provider--A physician requesting a J-1 visa waiver.
§13.2.J-1 Visa Waiver Rules.
The following apply to faculty and non-faculty waivers.
(1)
The Texas Department of Health (department) will consider
a recommendation for a J-1 visa waiver in the area or areas designated by
the Secretary of Health and Human Services as a HPSA or a MUA and are not
fully served by J-1, NHSC or other primary care physicians. The HPSA or MUA
must have a population to physician ratio of 3000:1 or fewer physicians per
capita.
(2)
Primary care specialists will be considered eligible to
apply to areas designated as Primary Care HPSAs or MUAs.
(3)
Psychiatrists will be considered eligible to apply to areas
designated as Mental Health HPSAs or MUAs.
(4)
The department will consider J-1 visa waivers for physicians
who are non-primary care specialists when additional documentation is submitted
supporting the need for the services of the specialist and the shortage of
that specialty in the HPSA or MUA.
(5)
The first 30 complete applications that meet federal and
state requirements will be considered for recommendation. The submission of
a complete waiver application to the department does not ensure that the department
will recommend a waiver to the United States Department of State and the Bureau
of Citizenship and Immigration Services.
(6)
The employer or the employer's representative must submit
the J-1 waiver request application to the department.
§13.3.Employer Rules.
(a)
The department will not accept requests from employers
who are physicians currently fulfilling their waiver obligation.
(b)
The department will not recommend a waiver for a relative
of the employer.
§13.4.Site Requirements.
(a)
The health care facility named as the site of service in
the application must be operational at the time of application.
(b)
A waiver request must include up to 6 letters of support
from community leaders, local physicians, hospital administrators, and/or
the local health department, where applicable.
§13.5.Contract.
(a)
The contract must include the wage to be paid over the
contract period. Documentation that the wage meets the prevailing wage for
the specialty for the area of practice must be included with the application
packet. An example of a "prevailing wage" can be found at the United States
Department of Labor web site at: http://www.workforcesecurity.doleta.gov/foreign/wages.asp.
(b)
The contract must state that the employer and the provider
agree that termination can be only for cause and not by mutual agreement.
(c)
The contract must contain the following information:
(1)
list of benefits, insurance to be provided to the provider;
(2)
field of practice of the provider;
(3)
practice site name, address and telephone number of the
health care facility where the provider will work;
(4)
hours of work;
(5)
amount of leave; and
(6)
statements that amendments shall adhere to state and federal
J-1 visa waiver requirements.
(d)
If applying under Education Code, §51.949, the applicant
must demonstrate compliance with its provisions.
§13.6.Verification.
(a)
The Department of State and the Bureau of Citizenship and
Immigration Services shall be notified if the physician fails to begin practicing
within 90 days of receiving waiver, or is found to not be practicing 40 hours
at the site approved for waiver.
(b)
The employer and/or the J-1 physician must notify the department
in writing within 10 days if the contract is breached or terminated.
(c)
The department will verify the following:
(1)
compliance with subsection (a) of this section; and
(2)
other information that supports the program goal of improving
access to health care in underserved areas.
§13.7.Application Fee.
The department shall collect a fee of $2000 from each applicant who
is granted a waiver of the two-year home residency requirement from the Bureau
of Citizenship and Immigration Services. The fee shall be submitted to the
department at the time of application. Part of the fees may be returned under
the following circumstances:
(1)
if the department recommends the waiver, and the Bureau
of Citizenship and Immigration Services denies it, $1500 will be returned
to the applicant; or
(2)
if the applicant withdrawals the application before a recommendation
is submitted by the department, $1700 will be returned to the applicant; or
(3)
if at the time the application is received by the department,
all 30 slots have been used for the fiscal year, $2000 will be returned to
the applicant.
§13.8.Other Federal or State Requirements.
All waiver request applications must meet federal laws 8 USC §1182
and §1184. All waiver request applications for faculty physicians must
meet applicable state laws (Texas Education Code, §51.949).
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 13, 2003.
TRD-200303573
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: March 14, 2003
For further information, please call: (512) 458-7236
Subchapter F. ADVISORY COMMITTEE
25 TAC §14.501
The Texas Department of Health (department) adopts an amendment
to §14.501, concerning the Indigent Health Care Advisory Committee (committee).
The section is adopted with one change to the proposed text as published in
the April 18, 2003, issue of the
Texas Register
(28
TexReg 3190).
The committee has provided advice to the Texas Board of Health (board)
and the department in the area of the Indigent Health Care Program. The committee
is established under the Health and Safety Code, §11.016, which allows
the board to establish advisory committees. The committee is subject to Government
Code, Chapter 2110, concerning state agency advisory committees.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). The department
has reviewed §14.501 and has determined that reasons for adopting the
section continue to exist; however, changes were necessary as described in
this preamble.
The department published a Notice of Intention to Review for §14.501
in the
Texas Register
on September 4, 1998
(23 TexReg 9077). No comments were received due to publication of this notice.
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 of the
committee, describe the 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 1999, the board established a rule relating to the Indigent Health Care
Advisory Committee. The rule states that the committee will automatically
be abolished on July 1, 2003. The board has now reviewed and evaluated the
committee and has determined that the committee should continue in existence
until July 1, 2007.
This section amends provisions relating to the operation of the committee.
Specifically, language is revised to: continue the committee until July 1,
2007; specify that the committee appoints its presiding and assistant presiding
officers; include additional requirements regarding statements by members;
and clarify the components that the committee must include in an annual report
to the board.
No public comments were received during the comment period for the rule.
However, the department has made the following minor change due to a staff
comment in order to provide consistency throughout the rule.
Change: Concerning §14.501(o)(2), the word "agency" was replaced with
the word "department".
The amendment is adopted under Health and Safety Code, §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;
and Government Code, §2110.005, which requires the department to adopt
rules stating the purpose and tasks of its advisory committees. The review
of this rule implements Government Code, §2001.039.
§14.501.Indigent Health Care Advisory Committee.
(a)
The committee. An advisory committee shall be appointed
under and governed by this section.
(1)
The name of the committee shall be the Indigent Health
Care Advisory Committee.
(2)
The committee is established under the Health and Safety
Code, §11.016, which allows the Board of Health (board) to establish
advisory committees.
(b)
Applicable law. The committee is subject to the Government
Code, Chapter 2110, concerning state agency advisory committees.
(c)
Purpose. The purpose of the committee is to provide advice
to the board in the area of the Indigent Health Care Program.
(d)
Tasks.
(1)
The committee shall advise the board concerning rules relating
to the Indigent Health Care Program.
(2)
The committee shall carry out any other tasks given to
the committee by the board.
(e)
Review and duration. By July 1, 2007, the board will initiate
and complete a review of the committee to determine whether the committee
should be continued, consolidated with another committee, or abolished. If
the committee is not continued or consolidated, the committee shall be abolished
on that date.
(f)
Composition. The committee shall be composed of 11 members
consisting of four consumer and seven other representatives appointed by the
board.
(g)
Terms of office. The term of office of each member shall
be six years. Members shall serve after expiration of their terms until a
replacement is appointed.
(1)
Members shall be appointed for staggered terms so that
the terms of a substantial equivalent number of members will expire on August
31st of each even- numbered year.
(2)
If a vacancy occurs, a person shall be appointed to serve
the unexpired portion of that term.
(h)
Officers. The committee shall select from its members the
presiding officer and an assistant presiding officer to begin serving on July
1 of each odd-numbered year.
(1)
Each officer shall serve until June 30th of each odd-numbered
year. Each officer may holdover until his or her replacement is elected.
(2)
The presiding officer shall preside at all committee meetings
at which he or she is in attendance, call meetings in accordance with this
section, appoint subcommittees of the committee as necessary, and cause proper
reports to be made to the board. The presiding officer may serve as an ex-officio
member of any subcommittee of the committee.
(3)
The assistant presiding officer shall perform the duties
of the presiding officer in case of the absence or disability of the presiding
officer. In case the office of presiding officer becomes vacant, the assistant
presiding officer will complete the unexpired portion of the term of the office
of presiding officer.
(4)
If the office of assistant presiding officer becomes vacant,
it may be filled by vote of the committee.
(5)
A member shall serve no more than two consecutive terms
as presiding officer and/or assistant presiding officer.
(6)
The committee may reference its officers by other terms,
such as chairperson and vice-chairperson.
(i)
Meetings. The committee shall meet only as necessary to
conduct committee business.
(1)
A meeting may be called by agreement of department staff
and either the presiding officer or at least three members of the committee.
(2)
Meeting arrangements shall be made by department staff.
Department staff shall contact committee members to determine availability
for a meeting date and place.
(3)
The committee is not a "governmental body" as defined in
the Open Meetings Act. However, in order to promote public participation,
each meeting of the committee shall be announced and conducted in accordance
with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception
that the provisions allowing executive sessions shall not apply.
(4)
Each member of the committee shall be informed of a committee
meeting at least five working days before the meeting.
(5)
A simple majority of the members of the committee shall
constitute a quorum for the purpose of transacting official business.
(6)
The committee is authorized to transact official business
only when in a legally constituted meeting with quorum present.
(7)
The agenda for each committee meeting shall include an
item entitled public comment under which any person will be allowed to address
the committee on matters relating to committee business. The presiding officer
may establish procedures for public comment, including a time limit on each
comment.
(j)
Attendance. Members shall attend committee meetings as
scheduled. Members shall attend meetings of subcommittees to which the member
is assigned.
(1)
A member shall notify the presiding officer or appropriate
department staff if he or she is unable to attend a scheduled meeting.
(2)
It is grounds for removal from the committee if a member
cannot discharge the member's duties for a substantial part of the term for
which the member is appointed because of illness or disability, is absent
from more than half of the committee and subcommittee meetings during a calendar
year, or is absent from at least three consecutive committee meetings.
(3)
The validity of an action of the committee is not affected
by the fact that it is taken when a ground for removal of a member exists.
(k)
Staff. Staff support for the committee shall be provided
by the department.
(l)
Procedures. Roberts Rules of Order, Newly Revised, shall
be the basis of parliamentary decisions except where otherwise provided by
law or rule.
(1)
Any action taken by the committee must be approved by a
majority vote of the members present once quorum is established.
(2)
Each member shall have one vote.
(3)
A member may not authorize another individual to represent
the member by proxy.
(4)
The committee shall make decisions in the discharge of
its duties without discrimination based on any person's race, creed, gender,
religion, national origin, age, physical condition, or economic status.
(5)
Minutes of each committee meeting shall be taken by department
staff.
(A)
A draft of the minutes approved by the presiding officer
shall be provided to the board and each member of the committee within 30
days of each meeting.
(B)
After approval by the committee, the minutes shall be signed
by the presiding officer.
(m)
Subcommittees. The committee may establish subcommittees
as necessary to assist the committee in carrying out its duties.
(1)
The presiding officer shall appoint members of the committee
to serve on subcommittees and to act as subcommittee chairpersons. The presiding
officer may also appoint nonmembers of the committee to serve on subcommittees.
(2)
Subcommittees shall meet when called by the subcommittee
chairperson or when so directed by the committee.
(3)
A subcommittee chairperson shall make regular reports to
the advisory committee at each committee meeting or in interim written reports
as needed. The reports shall include an executive summary or minutes of each
subcommittee meeting.
(n)
Statement by members.
(1)
The board, the department, and the committee shall not
be bound in any way by any statement or action on the part of any committee
member except when a statement or action is in pursuit of specific instructions
from the board, department, or committee.
(2)
The committee and its members may not participate in legislative
activity in the name of the board, the department, or the committee except
with approval through the department's legislative process. Committee members
are not prohibited from representing themselves or other entities in the legislative
process.
(3)
A committee member should not accept or solicit any benefit
that might reasonably tend to influence the member in the discharge of the
member's official duties.
(4)
A committee member should not disclose confidential information
acquired through his or her committee membership.
(5)
A committee member should not knowingly solicit, accept,
or agree to accept any benefit for having exercised the member's official
powers or duties in favor of another person.
(6)
A committee member who has a personal or private interest
in a matter pending before the committee shall publicly disclose the fact
in a committee meeting and may not vote or otherwise participate in the matter.
The phrase "personal or private interest" means the committee member has a
direct pecuniary interest in the matter but does not include the committee
member's engagement in a profession, trade, or occupation when the member's
interest is the same as all others similarly engaged in the profession, trade,
or occupation.
(o)
Reports to board. The committee shall file an annual written
report with the board.
(1)
The report shall list the meeting dates of the committee
and any subcommittees, the attendance records of its members, a brief description
of actions taken by the committee, a description of how the committee has
accomplished the tasks given to the committee by the board, the status of
any rules which were recommended by the committee to the board, and anticipated
activities of the committee for the next year.
(2)
The report shall identify the costs related to the committee's
existence, including the cost of department staff time spent in support of
the committee's activities and the source of funds used to support the committee's
activities.
(3)
The report shall cover the meetings and activities in the
immediate preceding 12 months and shall be filed with the board each July.
It shall be signed by the presiding officer and appropriate department staff.
(p)
Reimbursement for expenses. In accordance with the requirements
set forth in the Government Code, Chapter 2110, a committee member may receive
reimbursement for the member's expenses incurred for each day the member engages
in official committee business if authorized by the General Appropriations
Act or budget execution process.
(1)
No compensatory per diem shall be paid to committee members
unless required by law.
(2)
A committee member who is an employee of a state agency,
other than the department, may not receive reimbursement for expenses from
the department.
(3)
A nonmember of the committee who is appointed to serve
on a subcommittee may not receive reimbursement for expenses from the department.
(4)
Each member who is to be reimbursed for expenses shall
submit to staff the member's receipts for expenses and any required official
forms no later than 14 days after each committee meeting.
(5)
Requests for reimbursement of expenses shall be made on
official state travel vouchers prepared by department staff.
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 13, 2003.
TRD-200303566
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: April 18, 2003
For further information, please call: (512) 458-7236
25 TAC §§27.1, 27.3, 27.5, 27.7, 27.9, 27.11, 27.13, 27.15
The Texas Department of Health (department) adopts new §§27.1,
27.3, 27.5, 27.7, 27.9, 27.11, 27.13 and 27.15, concerning case management
for children and pregnant women with changes to the proposed text as published
in the April 4, 2003, issue of the
Texas Register
(28 TexReg 2851).
Specifically, these new sections cover definitions; eligible recipients;
case management service provisions; service limitations; applicant and provider
qualifications; application process; case management provider review; and
monitoring processes.
The adopted new rules for Case Management for Children and Pregnant Women
will provide case management services to Medicaid eligible women of all ages
who have a high risk pregnancy and to children from birth to 21 years of age
with a health condition/health risk. Two programs, Medicaid Case Management
for High Risk Pregnant Women and High Risk Infants (TCM/PWI) and Texas Health
Steps Medical Case Management (THSteps MCM), will become one program due to
the adopted repeal of §§32.301 - 32.305, 32.307, 33.501 - 33.506,
and 37.81 - 37.86 of this title, and the adopted new Chapter 27. The new program
will provide a greater continuity of services for all eligible recipients
by allowing easier transition and coordination among services for family members.
The sections include changes made in response to comments, with the objective
of clarifying the requirements of the program. Particular concerns and suggestions
by stakeholders regarding issues such as the prior authorization requirement,
the cessation of the intake as a reimbursed contact for providers, and the
restrictions regarding solicitation of clients were raised during the public
comment period and are addressed in this preamble.
Many comments were positive, with commenters in favor of merging the two
programs. Several commenters felt the merged system would be beneficial for
both providers and clients.
The most common questions and comments concerned the issues of prior authorization,
the elimination of the intake as a reimbursable contact and the restrictions
against the solicitation of clients. Many commenters stated that the prior
authorization requirement will be too burdensome for providers and place a
barrier on services for clients. Several commenters stated that they believed
state resources are not sufficient to implement the new program. However,
in the interest of quality management, the assurance of non-duplication and
enrollment of only eligible clients, the department upheld the prior authorization
requirement.
Many commenters were concerned with eliminating the Targeted Case Management
for Pregnant Women and Infants intake as a reimbursed contact. These commenters
felt that the intake requires such a significant amount of time to complete
that without reimbursement, providers would have to cut services or lay off
staff. However, automatically reimbursing all intakes mean that a Targeted
Case Management for Pregnant Women and Infants provider who performed an intake
would always receive reimbursement--even if the recipient was ultimately determined
ineligible for the service. As a result, the intake has historically been
an over billed and misused contact.
Several comments indicated that changes to limit client solicitation would
inhibit the case managers from informing interested recipients about the program
and thus, eliminate client choice. However, the prohibitions will in fact
protect client choice and will not prohibit case managers from informing interested
recipients about the program. In most cases, it is the recipient that contacts
the case manager to learn more information about the program; therefore, there
should be no inhibition of case managers informing interested program participants.
The department is making the following minor changes due to staff comments
to clarify the intent and improve the accuracy of the sections.
Change: Concerning proposed §27.1(1), a semi-colon was added after
the term "facility operation" for proper format and style.
Change: Concerning proposed §27.1(2), "subchapter" was changed to
"chapter" to reflect the proper terminology.
Change: Concerning proposed §27.1(6), the words "Case Management Provider"
were changed to lower case for proper format and style.
Change: Concerning proposed §27.1(7), the word "Services" was changed
to lower case for proper format and style.
Change: Concerning proposed §27.1(9), the word "same" was added between
the terms "healthy" and "age" for clarity.
Change: Concerning proposed §27.1(12), a comma was inserted between
the words "Diagnosis" and "and" to reflect the proper punctuation in the program
name.
Change: Concerning proposed §27.1(13), the word "own" was changed
to "biological" and the statement "a person or persons acting as the family
of an individual; a foster family or identifiable support person or persons"
was changed to "a person or persons acting as an individual's family, foster
family or identifiable support person or persons" for clarity.
Change: Concerning proposed §27.1(15), the hyphen in "high-risk" was
deleted for consistency.
Change: Concerning proposed §27.1(18), a definition for the term "prior
authorization," was added, and the remaining definitions were renumbered accordingly.
Change: Concerning proposed §27.1(20), now renumbered as §27.1(21),
the words "the name of" were inserted between the term "In Texas" and "the
federal program" and the words ", is called Texas Health Steps" was deleted
for clarity.
Change: Concerning proposed §27.3, "subchapter" was changed to "chapter"
to reflect the proper title, and the hyphen in "high-risk" was deleted for
consistency.
Change: Concerning proposed §27.3, "birth through age 20" was added
for clarity.
Change: Concerning the title of proposed §27.5, the words "Service
Provisions" were added to the title so that it now reads, "Case Management
for Children and Pregnant Women Service Provisions" for clarity.
Change: Concerning proposed §27.5, the term "Case Management for Children
and Pregnant Women's" was changed to "Case Management for Children and Pregnant
Women" for proper format and style. The word "services" was added for clarity
and "over utilization," was changed to "over-utilization" in the first paragraph
of this section to reflect proper punctuation of this term.
Change: Concerning proposed §27.5(1)(A)(ii)(IV), the word "and" was
added after "confidentiality;" to ensure proper format and style.
Change: Concerning proposed §27.5(1)(B), the statement "during which
the" was added and the period and "The" deleted to combine the first and second
sentence for clarity and the term "post partum" was changed to "post-partum"
to reflect proper punctuation of this term.
Change: Concerning proposed §27.5(1)(B)(i), the word "the" was inserted
between the words "of" and "complete" for clarity.
Change: Concerning proposed §27.7(b), the word "a" was inserted between
the terms "for" and "billable", and "contact" was inserted following the word
"billable." The term "Case Management for Children and Pregnant Women services"
was deleted; the term "Comprehensive Visits and Follow up" was deleted and
replaced with "billable." All of these changes were made to ensure clarity.
Change: Concerning proposed §27.7(c), the words "a billable" was inserted
between "for" and "Case" to ensure clear and proper grammar.
Change: Concerning proposed §27.9(a)(3), the word "and" was deleted
at the end of this paragraph to ensure proper format and style.
Change: Concerning proposed §27.9(a)(4)(B), the period at the end
of this subparagraph was deleted and replaced with a semi-colon to ensure
proper format and style.
Change: Concerning proposed §27.9(c), the term "Federal Government"
was changed to lower case for proper format and style.
Change: Concerning the first line of proposed §27.11, the term "Case
Management Provider" was changed to lower case for proper format and style.
Change: Concerning proposed §27.11(3)(F), now renumbered as §27.11(3)(E),
the term "claims" was changed to "contacts" for accuracy and clarity.
Change: Concerning proposed §27.11(3)(G)(vi), now renumbered as §27.11(3)(F)(vi),
the period at the end of this clause was deleted and replaced with a semi-colon
to reflect proper format and style and punctuation.
Change: Concerning proposed §27.11(4), the statement "(relating to
applicant qualifications and case management provider requirements)" was deleted
for clarity.
Change: Concerning proposed §27.11(5), the word "TDH-" was changed
to "department-" for clarity.
Change: Concerning proposed §27.11(5)(F)(ii), the statement "involvement
in resolving case management problems" was moved to new §27.11(5)(F)(iii)
and the period at the end of this clause was deleted and replaced with a semi-colon
to reflect proper format and style.
Change: Concerning proposed §27.13(c), the term "subchapter" was deleted
and replaced with "chapter" to ensure accuracy.
Change: Concerning proposed §27.13, new subsection (f) was added for
clarity. That section reads, "Applications which do not meet department requirements
will be denied," and the remainder of the subsections were renumbered accordingly.
Change: Concerning proposed §27.15(b), the term "Case Management Providers"
were changed to lower case to ensure proper format and style.
The following comments were received concerning the rules. After each comment
are the department's responses and any resulting change(s).
Comment: Concerning the chapter as a whole, many commenters stated they
support the merger of TCM/PWI and THSteps MCM into one program.
Response: The department acknowledges the commenters' support. No changes
were made as the result of these comments.
Comment: Concerning the chapter as a whole, many commenters stated their
concern that the proposed rule changes would be harmful to children and pregnant
women by making it harder to get case management services.
Response: The department disagrees. The rules will not make it more difficult
for children and pregnant women to receive case management services. Rather,
the rules will assure appropriate enrollment of eligible clients and non-duplication
of services. No changes were made as a result of these comments.
Comment: Concerning the chapter as a whole, several commenters stated their
concern that the proposed rule changes would lead to an increase in state
spending because clients would not be able to access community organizations
and appropriate medical care.
Response: The department disagrees. The rules will assure appropriate enrollment
of eligible clients and non-duplication of services; they will not inhibit
eligible clients in accessing needed services. No changes were made as a result
of these comments.
Comment: Concerning the chapter as a whole, several commenters stated providers
should be able to choose which population group they wish to serve rather
than automatically having to provide services to both the TCM/PWI and THSteps
MCM population.
Response: The department disagrees. Providers can in fact "choose" to limit
the age ranges of clients served, although they must specify this in their
application. No changes were made as the result of these comments.
Comment: Concerning the chapter as a whole, several commenters stated small
case management providers will be more adversely affected by the proposed
rules than will larger case management providers.
Response: The department disagrees. There is little disparity in the way
the rules affect a small or a large case management provider. Any potential
loss to the provider resulting from the elimination of the intake as a reimbursed
service should be fairly minimal, regardless of provider size. No changes
were made as the result of these comments.
Comment: Concerning the chapter as a whole, several commenters suggested
withdrawing the proposed rules and continuing reimbursement for intake, replacing
prior authorization with client registry and continuing reimbursement for
first five visits without need for prior authorization.
Response: The department disagrees. The rules are being implemented to
address the quality concerns and duplication of services currently at issue
in the TCM/PWI and THSteps MCM services. No changes were made as the result
of these comments.
Comment: Concerning the chapter as a whole, one commenter stated that the
rules should be changed to include a statement that a qualified case manager
must complete all documentation of services.
Response: The department agrees that a qualified case manager must document
all billable contacts. As the rules require such documentation, no changes
were made as the result of these comments.
Comment: Concerning the chapter as a whole, one commenter wondered if the
program would allow independent contractors to serve as case managers.
Response: Currently, the program allows independently-enrolled case managers
to serve as case management providers. The adoption of these rules would not
result in any alteration of the ability of independent contractors to serve
as case managers. This issue is not addressed in the rules and is a decision
providers must make on their own. No change was made as a result of this comment.
Comment: Concerning the chapter as whole, one commenter asked if providers
would have to re-apply when the programs merged.
Response: Providers will not have to re-apply when the programs merge.
No change was made to the rules as a result of this comment.
Comment: Concerning the chapter as a whole, one commenter stated performing
provider numbers should be issued to all case managers.
Response: The department is currently pursuing such an implementation.
No change however was made to the rules as a result of this comment because
such an issue does not need to be addressed in these rules.
Comment: Concerning the chapter as a whole, one commenter stated that language
which requires the documentation of the client's continuing eligibility be
added.
Response: The department agrees. Proposed §27.1(4) was changed to
include the language "that continues to support eligibility of a" and "with
an eligible" was deleted to address the change.
Comment: Concerning the chapter as a whole, one commenter stated that language
be added to define how providers show documentation of justification of billing
for more than one client in a family.
Response: The department disagrees. Eligibility criteria for individual
clients is defined in the rule in §27.3. Each client within a family
must meet the eligibility criteria defined. No changes were made as a result
of this comment.
Comment: Concerning the chapter as a whole, one commenter asked that "should"
be replaced by "must" in every section of the rules referring to documentation.
Response: The department agrees. The word "should" was replaced by "must"
in §27.5(1)(A)(i) and (B) and the word "includes" was replaced by "must
include" in §27.5(1)(A)(ii)(V).
Comment: Concerning proposed §27.1(9) and §27.3, one commenter
asked that the term "at risk" be eliminated from eligibility criteria and
that eligibility language be changed to include "medically fragile children"
or "children with special health care needs."
Response: The department disagrees. The language, "with a health condition/health
risk," covers a broader population than the terms "medically fragile children,"
and "children with special health care needs," to ensure that more children
are potentially eligible for this service. No change was made as a result
of this comment.
Comment: Concerning proposed §27.5(2), many commenters stated that
the elimination of the intake as a reimbursable service will inhibit the case
manager/client relationship and serve as a barrier to service provision.
Response: The department disagrees. The elimination of the intake as a
reimbursable service will not inhibit the case manager/client relationship
or serve as a barrier to service provision. The information collected for
the purpose of the intake is needed to determine eligibility. Client/case
manager rapport may be further developed during the comprehensive visit. No
changes were made as a result of these comments.
Comment: Concerning proposed §27.5(2), some commenters stated that
the elimination of the intake as a reimbursable service will reduce the number
of participating providers.
Response: The department disagrees. No other component of the Texas Health
Steps Comprehensive Care Program (CCP) allows for the reimbursement of the
intake. By making this change through the combination of the programs, the
department will be in line with the rest of CCP. No changes were made as a
result of these comments.
Comment: Concerning proposed §27.5(2), some commenters stated that
the elimination of the intake as a reimbursable service will result in providers
potentially providing hours of intake services only to eventually discover
the recipient is ineligible for case management services which will result
in the provider performing significant amounts of services without pay.
Response: The department disagrees. The intake normally takes about five
to ten minutes to complete and can be completed by telephone. Thus, it should
not result in case managers providing hours of unpaid work if it is ultimately
determined that the client is ineligible for case management services. No
changes were made as a result of these comments.
Comment: Concerning proposed §27.7, many commenters stated that requiring
prior authorization of all services will greatly increase the amount of paperwork
they will be required to submit.
Response: The department disagrees. The paperwork that must be submitted
will be minimal. No changes were made as the result of these comments.
Comment: Concerning proposed §27.7, many commenters stated that requiring
prior authorization of all services will result in delayed and less frequent
service provision to clients.
Response: The department disagrees. Clients will be approved for contacts
based on their level of medical and psychosocial need. The prior authorization
process will not delay service provision; if an emergency request is submitted,
it must be processed quickly. Currently, medical case management is the only
CCP service that does not require prior authorization for all of its services.
With the adoption of these rules, case management procedures will be consistent
with that of the other CCP services. No changes were made as the result of
these comments.
Comment: Concerning proposed §27.7, many commenters stated the department
case management program lacks sufficient staff to implement the prior authorization
of services required by the proposed rules.
Response: The department disagrees. The staffing issue has been acknowledged
and was included in the cost estimate. No changes were made as the result
of these comments.
Comment: Concerning proposed §27.7, some commenters stated the department
should change the prior authorization system to pay for an initial contact
and then prior authorize the remaining contacts based on information on the
needs assessment and service plan.
Response: The department disagrees. Prior authorization of all services
is now a requirement, pursuant to these rules, in order to ensure only eligible
clients are enrolled in the Case Management for Children and Pregnant Women
program and receive program services. No changes were made as a result of
these comments.
Comment: Concerning proposed §27.7, some commenters stated that the
information included in the intake is insufficient for department staff to
appropriately determine client eligibility and service needs.
Response: The department disagrees. The intake will be revised to require
information regarding the medical and psychosocial needs of the client. The
intake contains enough information to determine client eligibility and the
amount of client contacts necessary to implement services. No changes were
made as the result of these comments.
Comment: Concerning proposed §27.7, some commenters felt that the
implementation of prior authorization through the adoption of the rules will
result in a client's inability to receive a monthly contact.
Response: The department disagrees. Clients will be approved for contacts
based on their level of medical and psychosocial need. If a client's needs
warrant a monthly contact, sufficient documentation should be submitted to
authorize these services. No changes were made as the result of these comments.
Comment: Concerning proposed §27.7, one commenter was curious about
the type of the department program staff that will be reviewing prior authorization
requests.
Response: Prior authorizations will be reviewed by case management program
specialists. No changes were made to the rules as a result of this comment.
Comment: Concerning proposed §27.7, one commenter wanted to know if
there would be a process available to appeal the denial of prior authorization
requests.
Response: Under state and federal law, any request for Medicaid services
that is denied may be appealed through the fair hearing process. This process
is currently in place and will continue to be available for appealing any
denial of Medicaid service. No changes were made to the rules as a result
of this comment.
Comment: Concerning proposed §27.9, several commenters stated the
new case manager qualifications are "unfair."
Response: The department disagrees. Applicants are now required to have
more years of experience, which will ensure better quality of service provision.
This should not affect our current case managers because current case managers
lacking the required experience can still participate as case managers. No
changes were made as the result of these comments.
Comment: Concerning proposed §27.9, several commenters stated case
managers currently providing services but lacking the new qualification requirements
of proposed §27.9, should be grandfathered in so that they can continue
to provide services.
Response: The department agrees. Section 27.9(b) has been amended to delete
the requirement that case managers approved as providers and providing services
before the implementation date of these rules can continue to provide case
management services only as long as that case manager does not leave the employ
of that agency. This requirement has been replaced by the words, "if the case
manager presents a certificate issued by the department attesting that the
case manager possesses experience providing services for an approved Targeted
Case Management for Pregnant Women and Infants or Texas Health Steps Medical
Case Management agency before the implementation date of these rules." The
statement "is eligible to" was changed to "may" and the statement "to provide"
was changed to "providing" for clarity.
Comment: Concerning §27.9(b), one commenter stated that case managers
with a temporary or provisional license should not be included in the clause
allowing previous case managers to continue to provide services.
Response: The department agrees. The term "licensure" was deleted from §27.9(b)
so that case managers currently providing either TCM/PWI or THSteps MCM services
must meet the licensure requirements of this chapter in order to continue
to be eligible case managers.
Comment: Concerning proposed §27.11(3)(C), one commenter stated the
requirement of a comprehensive resource directory was too difficult to produce.
Response: The department agrees. This requirement has been deleted since
referral directories are available from resources in local communities, and
the remainder of the paragraphs was renumbered accordingly.
Comment: Concerning proposed §27.11(3)(F), now renumbered as §27.11(3)(E),
one commenter asked if a provider could contract out the provider's accounts
receivable system.
Response: A provider may contract out their accounts receivable system,
but the provider is still responsible for the implementation of this component.
No changes were made to the rules as a result of this comment.
Comment: Concerning proposed §27.11(3)(G), now renumbered as §27.11(3)(F),
many commenters stated this section's prohibitions on client solicitation
will inhibit case managers from telling interested recipients about the program
and thus, eliminate client choice.
Response: The department disagrees. The prohibitions will not prohibit
case managers from informing interested recipients of the case management
program. In most cases, a recipient contacts the case manager to learn more
information about the program; therefore, there should be no such inhibition.
The client will continue to have choice of providers. No changes were made
as a result of these comments.
Comment: Concerning proposed §27.11(3)(G)(ii), now renumbered as §27.11(3)(F)(ii),
many commenters expressed dissatisfaction with certain rule language. In particular,
commenters felt that the terms "can reasonably be interpreted as intended
to market the provider's services" were both overbroad and vague.
Response: The department agrees. The statement "can reasonably be interpreted
as intended to market the provider's services" was changed to "impede client
choice" for clarity.
Comment: Concerning proposed §27.11(3)(G)(iii), now renumbered as §27.11(3)(F)(iii),
many commenters expressed dissatisfaction with certain rule language. In particular,
commenters felt that the terms "materially misleading materials" were both
overbroad and vague.
Response: The department agrees. The word "materially" was deleted from
"materially misleading materials" for clarity.
Comment: Concerning proposed §27.11(3)(G)(vi), now renumbered as §27.11(3)(F)(vi),
several commenters stated that prohibiting providers from entering into exclusive
relationships with referral sources is unfair.
Response: The department disagrees. Such prohibitions are consistent with
state and federal law; moreover, any provider currently engaging in such actions
should immediately cease this behavior. No changes were made as a result of
these comments.
Comment: Concerning proposed §27.13(g), now renumbered as §27.13(h),
one commenter asked about application approval guidelines.
Response: New criteria has been added to the rules to address this issue.
The rules have been amended accordingly. The new language may be found in
new §27.13(f) which states that applications which do not meet department
requirements will be denied. The rest of the subsections were renumbered accordingly.
Comment: Concerning proposed §27.13(g), now renumbered as §27.13(h),
one commenter asked about the rationale behind requiring rejected applicants
to wait six months before resubmitting a revised application for review.
Response: The rational for the six month wait period is to ensure case
management staff have adequate time to review all application documentation.
Often, when an application is submitted, additional documentation may be sent
by the applicant several months after filing the application. No change was
made as a result of this comment.
The following commenters were in favor of the merger of the two programs,
but had concerns or questions about the rules, which they generally did not
support: Community Outreach Referral, The Family Plan and Bona Healthy Start.
The following commenters had concerns, questions, and/or suggestions regarding
the rules, which they generally did not support: ReNas Family Services, Bexar
County Case Management Coalition, Rio Health Steps, Child Study Clinic, TLCare,
Catholic Charities, New Life Perinatal Health Care Services, Moving Ahead
Family Services, Catholic Charities, Empowerment Now, Guardian Angel, ACCESS,
Family Advocacy Case Management Services, Family Empowerment, Bienestar Case
Management for Children and Pregnant Women, and Medical Social Services.
The department adopts the repeal of §§32.301 - 32.305 and §32.307,
concerning case management for high risk pregnant women and high risk infants.
Specifically, these sections cover definitions; eligible individuals; case
management services; service limitations; provider qualifications and the
right to appeal. These sections are repealed as they were repeated in §§37.81
- 37.86. Sections 32.301 - 32.305 and §32.307 were not repealed when §§37.81
- 37.86 were adopted.
The department further adopts the repeal of Early and Periodic Screening,
Diagnosis, and Treatment, Subchapter J, Texas Health Steps Medical Case Management, §§33.501
- 33.506. Specifically, these sections cover definitions; eligible recipients;
THSteps Medical Case Management Services; service limitations; applicant and
provider qualifications; application, review and monitoring process. These
sections are being repealed in an effort to integrate services to the eligible
population for case management services: children with a health condition/health
risk birth to 21 years and/or high risk pregnant women of all ages.
The department at the same time adopts the repeal of §§37.81
- 37.86, concerning Medicaid case management for high risk pregnant women
and high risk infants. Specifically, these sections cover introduction; definitions;
case management services; provider qualifications; application and review
process; and documents adopted by reference.
The department provides health services to women and children in Texas
under the authority of the Health and Safety Code, Chapter 32; the State Appropriations
Act; and the Social Security Act, Title V. The Targeted Case Management Program
for High Risk Pregnant Women and High Risk Infants was established under the
authority of the Social Security Act, Title XIX, §1915(g), authorizing
states to provide case management as a distinct service to targeted populations,
through a waiver from the Health Care Financing Administration (HCFA). HCFA
is now known as the Center for Medicare and Medicaid Services (CMS). The Health
and Human Services Commission (HHSC) provides authority to the department
to propose rules to administer certain Medicaid program services in Texas.
The new sections are adopted under the Health and Safety Code, §12.001,
which provides the Board of Health (board) with the authority to adopt rules
to implement every duty imposed by law on the board, the department and the
commissioner of health; the Health and Safety Code, Chapter 32, which provides
the board with the authority to establish maternal and infant health improvement
services programs in the department to serve eligible recipients; the Human
Resources Code, Chapter 32, which enables the state to provide medical assistance;
and the Government Code, §531.021, which provides the Health and Human
Services Commission (HHSC) with the authority to propose rules to administer
the state's medical assistance program, and are submitted by the Texas Department
of Health under its agreement with HHSC to operate the EPSDT program, and
as authorized under §1.07 of the Acts of the 72nd Legislature, First
Called Session (1991), Chapter 15, as amended by the Acts of the 73rd Legislature,
Chapter 747, §2.
§27.1.Definition of Terms.
The following words and terms when used in this chapter shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Access--The ability of an eligible recipient to obtain
health and health-related services, as determined by factors such as: the
availability of THSteps services; service acceptability to the eligible child,
family, and/or pregnant woman; the location of health care facilities and
other resources; transportation; hours of facility operation; and length of
time available to see the healthcare provider.
(2)
Applicant--An agency, organization, or individual who submits
an application to the department to provide Case Management for Children and
Pregnant Women under this chapter and who meets the applicant qualifications
and requirements as stated in §27.9 and §27.11 of this title (relating
to Applicant Qualifications and Case Management Provider Requirements).
(3)
Application process--Submission of an application to provide
Case Management for Children and Pregnant Women and the department's ensuing
review and disposition of the application.
(4)
Billable contact--A documented Comprehensive Visit or Follow-up
contact that continues to support eligibility of a recipient, by an approved
case manager who provides an eligible case management service, as defined
in §27.5 of this title (relating to Case Management and Pregnant Women).
(5)
Board--The Texas Board of Health.
(6)
Case manager--An individual who provides Case Management
for Children and Pregnant Women services either independently or as an employee
of a case management provider.
(7)
Case management provider--An agency or individual approved
by the department to provide Case Management for Children and Pregnant Women
services and enrolled as a Medicaid provider.
(8)
Case Management for Children and Pregnant Women--The federal
enhancement service which assists eligible recipients in gaining access to
medically necessary medical, social, educational, and other services.
(9)
Children with a health condition/health risk--Children
who have or are at risk for a medical condition, illness, injury, or disability
that results in limitation of function, activities or social roles in comparison
with healthy same age peers in the general areas of physical, cognitive, emotional,
or social growth and development.
(10)
Continuity of care--The degree to which: the care of a
child is provided by the same medical home or primary care provider; the system
of care remains stable and services are consistent, unduplicated and uninterrupted.
(11)
Department--The Texas Department of Health.
(12)
EPSDT--Early and Periodic Screening, Diagnosis, and Treatment
program. All states participating in the Medicaid program must offer EPSDT
to children under age 21 who qualify for Medicaid. EPSDT provides medical
and dental services to Medicaid and Texas Health Steps clients under age 21
years. In Texas, EPSDT is known as Texas Health Steps (THSteps).
(13)
Family--A basic unit in society having at its nucleus:
one or more adults living together and cooperating in the care and rearing
of their biological or adopted children; a person or persons acting as an
individual's family, foster family or identifiable support person or persons.
(14)
Health and health-related services--Services which are
provided to meet the comprehensive (preventive, primary, tertiary and specialty)
health needs of the eligible recipient, including but not limited to, well
care and dental check ups, immunizations, acute care visits, pediatric specialty
consultations, physical therapy, occupational therapy, audiology, speech language
services, mental health professional services, pharmaceuticals, medical supplies,
prenatal care, family planning, adolescent preventive health, durable medical
equipment, nutritional supplements, prosthetics, eye glasses, and hearing
aids.
(15)
High risk pregnant women--Women who are pregnant and have
one or more high risk medical and/or personal/psychosocial condition(s) during
pregnancy.
(16)
Preventive services--Services that include health counseling
and education, immunizations, wellness care, nutritional supplementation,
family planning and screening aimed at avoiding illness and/or disability.
(17)
Primary services--Services that include care for minor
illnesses, injuries and abnormalities discovered through screenings.
(18)
Prior authorization--A condition for reimbursement, the
prior authorization process requires all providers of Case Management for
Children and Pregnant Women services to submit documentation of the requested
services for approval before such services may be authorized for payment.
(19)
State--The State of Texas.
(20)
Tertiary services--Services that include care for major
illnesses and injuries, and chronic or disabling conditions.
(21)
Texas Health Steps Program (THSteps)--In Texas, the name
of the federal program known as EPSDT, which is required of states participating
in the Medicaid program.
§27.3.Eligible Recipients.
Clients eligible for case management services under this chapter must
be either children birth through age 20 with a health condition/health risk
or high risk pregnant women who are:
(1)
Medicaid eligible in Texas;
(2)
in need of services to prevent illness(es) or medical condition(s),
to maintain function or slow further deterioration; and
(3)
desire case management.
§27.5.Case Management for Children and Pregnant Women Service Provisions.
Case Management for Children and Pregnant Women services, as defined
in §27.1 of this title (relating to Definitions), are services provided
to assist eligible recipients in gaining access to medically necessary medical,
social, educational and other services for which federal financial participation
is available in order to: encourage the use of cost-effective health and health-related
care; make referrals to appropriate community resources; discourage over-utilization
or duplication of services; and reduce morbidity and mortality. Case Management
for Children and Pregnant Women is not a "gatekeeper" function.
(1)
The following contacts are billable:
(A)
Comprehensive Visit--a face-to-face visit that includes
the development of:
(i)
Family Needs Assessment--a written evaluation of all issues
that impact the short and long term health and well being of the eligible
recipient and his/her family. Together, the case manager and family shall
assess the medical, social, educational and other medically necessary service
needs of the eligible recipient. Documentation of the Family Needs Assessment
must include, at a minimum:
(I)
the assessment of the medical, social/family, nutritional,
educational, vocational, developmental and health care transportation needs;
(II)
individualized assessment of the client; and
(III)
the case manager's dated signature.
(ii)
Service Plan--the written summary which:
(I)
documents the services to be accessed;
(II)
identifies the individual responsible for contacting the
appropriate health and human service providers;
(III)
designates the time frame within which the eligible recipient
should access services;
(IV)
may be sent to the medical provider or others as appropriate
in accordance with the limits of confidentiality; and
(V)
must include, at a minimum: the interventions and referrals
for addressing needs identified in the Family Needs Assessment; the time frame
for the client to access services; the client/parent/guardian's and case manager's
dated signatures.
(B)
Follow-up contact--a face-to-face or telephone contact
with the eligible recipient and his/her family during which the case manager
and the client/family review and reassess the client/family's needs, determine
what referrals and services specified in the Service Plan have been received
by the client/family, and develop appropriate modifications to the Service
Plan. The Follow-up contact includes the review of the referrals that have
occurred or are still needed to complete the Service Plan and meet the client/family's
needs. Follow-up contacts for children should occur as needed. Follow-up contacts
for pregnant women should occur as needed through the 59th day post-partum.
Documentation of the Follow-up contacts must include, at a minimum:
(i)
a review of the complete Service Plan;
(ii)
efforts to ascertain on an ongoing basis which needs specified
in the Service Plan have been addressed with appropriate referrals provided
and services accessed; and
(iii)
evidence of problem solving with client/parent/guardian
when needs are not addressed or referrals not accessed.
(2)
Case Management for Children and Pregnant Women services
will include a non-billable intake with each client/family. The intake will
include the collection of demographic information and determination of the
client's eligibility.
(3)
Only one billable contact per client shall be billed per
day.
§27.7.Service Limitations.
(a)
Case Management for Children and Pregnant Women services
are not reimbursable if they are duplicative of other billed, comprehensive
Medicaid case management services.
(b)
Following intake completion, the initial prior authorization
request for a billable contact must be supported by required documentation
and submitted to the department for review and disposition. The amount of
billable contacts that are prior authorized will be based on the client's
level of need, level of medical involvement and complicating psychosocial
factors.
(c)
Any additional requests for a billable Case Management
for Children and Pregnant Women services must also be prior authorized. Required
documentation must be submitted to the department for review and disposition
before any additional services may be prior authorized.
§27.9.Applicant Qualifications.
(a)
The minimum qualifications for a Case Management for Children
and Pregnant Women applicant are:
(1)
completion and approval of an application for Case Management
for Children and Pregnant Women as defined in §27.1 of this title (relating
to Definitions);
(2)
agreeing to comply with the department rules, policies
and procedures on Case Management for Children and Pregnant Women and the
applicable statutory provisions;
(3)
agreeing to comply with applicable state and federal laws
governing participation of providers in the Medicaid program;
(4)
employment of case managers with the following qualifications:
(A)
Registered nurse (with a diploma, an associate's, bachelor's
or advanced degree) or Social Worker (with bachelor's or advanced degree),
currently licensed by the respective Texas licensure board and whose license
is not temporary or provisional in nature; and
(B)
possessing two years of cumulative paid full-time work
experience or two years of supervised, full-time educational internship/practicum
experience in the past ten years with children, up to age 21, and/or pregnant
women. Experience must include assessing the psychosocial and health needs
of and making community referrals for these populations;
(5)
agreeing to comply with all licensure requirements of the
case manager(s) respective state licensure/examining boards including the
obligation to report all suspected child abuse/neglect; and
(6)
knowledge of and coordination with providers of health
and health-related services and other active community resources.
(b)
A case manager employed in an approved Targeted Case Management
for Pregnant Women and Infants or Texas Health Steps Medical Case Management
agency at the time of implementation of these rules but who does not meet
the educational and/or experience requirements outlined in subsection (a)(4)(A)
and (B) of this section, may continue providing case management services,
if the case manager presents a certificate issued by the department attesting
that the case manager possesses experience providing services for an approved
Targeted Case Management for Pregnant Women and Infants or Texas Health Steps
Medical Case Management agency before the implementation date of these rules.
(c)
An applicant under investigation or being sanctioned by
the department or any other State of Texas or federal governmental agency
will not be approved as a case management provider.
§27.11.Case Management Provider Requirements.
In order to remain a case management provider, an individual or agency
must:
(1)
comply with applicable state and federal laws and regulations
governing participation of providers in the Medicaid program;
(2)
maintain provider status with the department;
(3)
develop and maintain a system for Case Management for Children
and Pregnant Women services incorporating the following elements:
(A)
case Management for Children and Pregnant Women services
in locations convenient for the eligible recipient to facilitate face-to-face
contact;
(B)
provision of Case Management for Children and Pregnant
Women services in order to assist eligible recipients in accessing necessary
medical, social, educational, and other services;
(C)
an internal quality assurance plan that includes, but is
not limited to, chart reviews and staff observation;
(D)
a current list of opened and closed client records;
(E)
an accounts receivable system through which billed contacts
will be tracked and matched with paid claims and client records to assure
claims are billed and paid for correct dates of service, were billed with
appropriate procedure codes and are not duplicative of other claims for the
same client;
(F)
outreach activities that assure individualized referrals.
The following activities may impede client choice and therefore are prohibited:
(i)
door to door, telephone or other cold-call marketing or
solicitation of clients by providers;
(ii)
the distribution of materials to Case Management for Children
and Pregnant Women recipients that impede client choice;
(iii)
the distribution of any false or misleading materials
to Case Management for Children and Pregnant Women recipients;
(iv)
obtaining lists of Medicaid clients without a specific
referral;
(v)
offering incentives for enrollment into case management
services; and/or
(vi)
entering into exclusive referral relationships with referral
sources;
(4)
assure Case Management for Children and Pregnant Women
services will be provided by approved case managers who meet the qualifications
defined in §27.9 and §27.11 of this title;
(5)
assure that approved case managers:
(A)
have received department-approved education and training
regarding Case Management for Children and Pregnant Women;
(B)
have the opportunity to participate in appropriate Medicaid,
case management and THSteps workshops, seminars, and training;
(C)
assume responsibility for all Case Management for Children
and Pregnant Women services they provide to eligible recipients, including
services by their designated support staff;
(D)
participate in relevant motion or cost studies;
(E)
agree to permit the department or its designee access to
the Case Management for Children and Pregnant Women provider's records, and
permit direct observation of case management activities for the purpose of
determining the provider's suitability to continue participation as a Case
Management for Children and Pregnant Women provider; and
(F)
participate in local and/or regional case management systems/coalitions
in accordance with program policies to assure cooperation and coordination
with local health departments, the department's public health region(s), school
districts and other Medicaid-approved case management providers as evidenced
by:
(i)
participation in community coalition meetings in accordance
with program policy;
(ii)
collaboration in planning case management delivery systems;
and
(iii)
involvement in resolving case management problems;
(6)
share information, within the limits of confidentiality,
with the department and collaborating agencies to facilitate referral and
monitoring of eligible recipients; and
(7)
comply in a timely manner with all department data collection
and reporting requirements.
§27.13.Application Process.
(a)
Applications to become a Case Management for Children and
Pregnant Women provider may be obtained by contacting the department or by
accessing the department website.
(b)
Applicants must include copies of documentation of all
agency licenses, contracts and/or written agreements with their application.
(c)
Applications must be typed and accompanied by all required
supporting documentation set out in this chapter. An original must be sent
to the appropriate department regional office and one copy of the application
must be submitted to the department central office.
(d)
All applications shall be reviewed by the department staff.
The review process shall be completed within 20 working days following receipt
of an application.
(e)
Incomplete applications shall not be approved and shall
be returned to the applicant for completion.
(f)
Applications which do not meet department requirements
will be denied.
(g)
Applicants will be notified in writing of approval or non-approval
by the department. Applicants must still enroll as Medicaid providers through
Medicaid provider enrollment.
(h)
Applicants who have submitted complete applications and
who are not approved by the department to provide case management services
must wait, at a minimum, 6 months before resubmission of a new application.
§27.15.Case Management Provider Review and Monitoring Process.
(a)
Approved providers will be monitored on an as-needed basis
for compliance with rules and policies.
(b)
Case managers or case management providers who do not comply
with program requirements may be terminated, placed on probationary status,
referred to appropriate professional licensure entities for review, and/or
referred for fraud and abuse investigation as described in department policies
and procedures.
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 16, 2003.
TRD-200303690
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: September 1, 2003
Proposal publication date: April 4, 2003
For further information, please call: (512) 458-7236
Subchapter C. CASE MANAGEMENT FOR HIGH-RISK PREGNANT WOMEN AND HIGH-RISK INFANTS
25 TAC §§32.301 - 32.305, 32.307
The Texas Department of Health (department) adopts the repeal
of §§32.301 - 32.305 and §32.307, concerning case management
for high-risk pregnant women and high-risk infants. The repeal is adopted
without changes to the proposed repeal as published in the April 4, 2003,
issue of the
Texas Register
(28 TexReg 2855)
and, therefore, the repeal will not be republished.
Government Code, §2001.039, requires that each agency review and consider
for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed §§32.301
- 32.305 and §32.307 and determined that reasons for repealing these
sections exist; however, new rules are adopted in a new chapter as described
in this preamble.
The department published a Notice of Intention to Review the sections in
the
Texas Register
(24 TexReg 10378) on November
19, 1999. No comments have been received.
The repeal of §§32.301 - 32.305 and §32.307 will allow the
combination of the affected sections in new Chapter 27, entitled Case Management
for Children and Pregnant Women, of this title. Combining these sections in
this new chapter will ensure integration of services to the eligible population
for case management services: children with a health condition/health risk,
birth to 21 years, and/or high-risk pregnant women of all ages. Specifically,
the repealed sections cover definitions; eligible individuals; case management
services; service limitations; provider qualifications, and the right to appeal.
The purpose of the new chapter is to continue to make available medically
necessary Texas Health Steps ("THSteps") medical case management mandated
by the federal Early Periodic Screening, Diagnosis, and Treatment (EPSDT)
program and case management services for other eligible women and children.
No comments were received regarding the proposal to repeal this subchapter.
The department also adopts the repeal of Early and Periodic Screening,
Diagnosis, and Treatment, Subchapter J, Texas Health Steps Medical Case Management, §§33.501
- 33.506, under a separate publication. Specifically, these repealed sections
cover definitions; eligible recipients; THSteps Medical Case Management Services;
service limitations; applicant and provider qualifications, and application,
review and monitoring process. The sections will be integrated in new Chapter
27.
The department at the same time is adopting the repeal of §§37.81
- 37.86 of this title, concerning Medicaid case management for high risk pregnant
women and high risk infants, under a separate publication. Specifically, these
sections cover introduction; definitions; case management services; provider
qualifications; application and review process, and documents adopted by reference.
These sections will be integrated in the new Chapter 27 of this title.
The department also adopts new Chapter 27, Case Management for Children
and Pregnant Women, §§27.1, 27.3, 27.5, 27.7, 27.9, 27.11, 27.13
and 27.15, under a separate publication. The new sections combine case management
programs to meet the needs of pregnant women of all ages and children with
a health condition/health risk, birth to 21 years. Specifically, these new
sections cover definitions; eligible recipients; case management service provisions;
service limitations; applicant and provider qualifications; and application,
review and monitoring processes.
The adopted new rules for Case Management for Children and Pregnant Women
will provide case management services to Medicaid eligible women of all ages
who have a high risk pregnancy and to children from birth to 21 years of age
with a health condition/health risk. Two programs, Medicaid Case Management
for High Risk Pregnant Women and High Risk Infants and the Texas Health Steps
Medical Case Management were combined into one program in the new Chapter
27 upon the repeal of §§32.301 - 32.305, 32.307, 33.501 - 33.506
and 37.81 - 37.86. The new program will provide a greater continuity of services
for all eligible recipients.
The repeals are adopted under the Health and Safety Code, §12.001,
which provides the Board of Health (board) with the authority to adopt rules
to implement every duty imposed by law on the board, the department and the
commissioner of health; the Health and Safety Code, Chapter 32, which provides
the board with the authority to establish maternal and infant health improvement
services programs in the department to serve eligible recipients; the Human
Resources Code, Chapter 32, which enables the state to provide medical assistance;
and the Government Code, §531.021, which provides the Health and Human
Services Commission (HHSC) with the authority to propose rules to administer
the state's medical assistance program, and are submitted by the Texas Department
of Health under its agreement with HHSC to operate the EPSDT program, and
as authorized under §1.07 of the Acts of the 72nd Legislature, First
Called Session (1991), Chapter 15, as amended by the Acts of the 73rd Legislature,
Chapter 747, §2.
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 16, 2003.
TRD-200303688
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: September 1, 2003
Proposal publication date: April 4, 2003
For further information, please call: (512) 458-7236
Subchapter J. TEXAS HEALTH STEPS MEDICAL CASE MANAGEMENT
25 TAC §§33.501 - 33.506
The Texas Department of Health (department) adopts the repeal
of §§33.501 - 33.506, concerning the Texas Health Steps Medical
Case Management. The repeal is adopted without changes to the proposed repeal
as published in the April 4, 2003, issue of the
Texas Register
(28 TexReg 2869) and, therefore, the repeal will not
be republished.
Government Code, §2001.039, requires that each agency review and consider
for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed §§33.501
- 33.506 and determined that reasons for repealing these sections exist; however,
new rules are adopted in a new chapter as described in this preamble.
The department published a Notice of Intention to Review the sections in
the
Texas Register
(24 TexReg 11129) on December
10, 1999. No comments have been received.
The repeal of §§33.501 - 33.506 will allow the combination of
the affected sections in new Chapter 27, entitled Case Management for Children
and Pregnant Women, of this title. Combining these sections in a new chapter
will ensure integration of services to the eligible population for case management
services: children with a health condition/health risk, birth to 21 years,
and/or high-risk pregnant women of all ages. Specifically, the repealed sections
cover definitions; eligible recipients; THSteps Medical Case Management services,
services limitations, applicant and provider qualifications; and application,
review and monitoring processes. The purpose of the new chapter is to continue
to make available medically necessary Texas Health Steps ("THSteps") medical
case management mandated by the federal Early Periodic Screening, Diagnosis,
and Treatment (EPSDT) program and case management services for other eligible
women and children.
No comments were received regarding the proposal to repeal this subchapter.
The department also adopts the repeal of §§32.301 - 32.305 and §32.307
of this title, concerning case management for high-risk pregnant women and
high-risk infants, under a separate publication. Specifically, these sections
cover definitions; eligible individuals; case management services; service
limitations; provider qualifications and the right to appeal. These sections
are adopted for repeal as they were repeated in §§37.81 - 37.86.
Sections 32.301 - 32.305 and §32.307 were not repealed when §§37.81
- 37.86 were adopted. The sections are integrated in new Chapter 27.
The department at the same time is adopting the repeal of §§37.81
- 37.86 of this title, concerning Medicaid case management for high risk pregnant
women and high risk infants, under a separate publication. Specifically, these
sections cover introduction; definitions; case management services; provider
qualifications; application and review process, and documents adopted by reference.
These sections are integrated in the new Chapter 27 of this title.
The department also adopts new Chapter 27, Case Management for Children
and Pregnant Women, §§27.1, 27.3, 27.5, 27.7, 27.9, 27.11, 27.13
and 27.15, under a separate publication. The new sections combine case management
programs to meet the needs of pregnant women of all ages and children with
a health condition/health risk, birth to 21 years. Specifically, these new
sections cover definitions; eligible recipients; case management service provisions;
service limitations; applicant and provider qualifications; and application,
review and monitoring processes.
The adopted new rules for Case Management for Children and Pregnant Women
will provide case management services to Medicaid eligible women of all ages
who have a high risk pregnancy and to children from birth to 21 years of age
with a health condition/health risk. Two programs, Medicaid Case Management
for High Risk Pregnant Women and High Risk Infants and the Texas Health Steps
Medical Case Management were combined into one program in the new Chapter
27 upon the repeal of §§32.301 - 32.305, 32.307, 33.501 - 33.506,
and 37.81 - 37.86. The new program will provide a greater continuity of services
for all eligible recipients.
The repeals are adopted under the Health and Safety Code, §12.001,
which provides the Board of Health (board) with the authority to adopt rules
to implement every duty imposed by law on the board, the department and the
commissioner of health; and under the Health and Safety Code, Chapter 32,
which provides the board with the authority to establish maternal and infant
health improvement services programs in the department to serve eligible recipients;
the Human Resources Code, Chapter 32, which enables the state to provide medical
assistance; and the Government Code, §531.021, which provides the Health
and Human Services Commission (HHSC) with the authority to propose rules to
administer the state's medical assistance program and are submitted by the
Texas Department of Health under its agreement with HHSC to operate the EPSDT
program, and as authorized under §1.07 of the Acts of the 72nd Legislature,
First Called Session (1991), Chapter 15, as amended by the Acts of the 73rd
Legislature, Chapter 747, §2.
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 16, 2003.
TRD-200303687
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: September 1, 2003
Proposal publication date: April 4, 2003
For further information, please call: (512) 458-7236
Subchapter E. MEDICAID CASE MANAGEMENT SERVICES FOR HIGH RISK PREGNANT WOMEN AND HIGH RISK INFANTS
25 TAC §§37.81 - 37.86
The Texas Department of Health (department) adopts the repeal
of §§37.81 - 37.86, concerning case management for high-risk pregnant
women and high-risk infants. The repeal is adopted without changes to the
proposed repeal as published in the April 4, 2003, issue of the
Texas Register
(28 TexReg 2871) and, therefore, the repeal will not
be republished.
Government Code, §2001.039, requires that each agency review and consider
for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed §§37.81
- 37.86 and determined that reasons for repealing these sections exist; however,
new rules are adopted in a new chapter as described in this preamble.
The department published a Notice of Intention to Review the sections in
the
Texas Register
(25 TexReg 602) on January
28, 2000. No comments have been received.
The repeal of §§37.81 - 37.86 will allow the combination of the
affected sections in new Chapter 27, entitled Case Management for Children
and Pregnant Women, of this title. Combining these sections in this new chapter
will ensure integration of services to the eligible population for case management
services: children with a health condition/health risk, birth to 21 years,
and/or high-risk pregnant women of all ages. Specifically, the repealed sections
cover introductions, definitions, case management services, provider qualifications,
application and review process, and documents adopted by reference. The purpose
of the new chapter is to continue to make available medically necessary Texas
Health Steps ("THSteps") medical case management mandated by the federal Early
Periodic Screening, Diagnosis, and Treatment (EPSDT) program and case management
services for other eligible women and children.
No comments were received regarding the proposal to repeal this subchapter.
The department also adopts repeal of §§32.301 - 32.305 and §32.307,
of this title, concerning case management for high-risk pregnant women and
high-risk infants, under a separate publication. Specifically, these sections
cover definitions; eligible individuals; case management services; service
limitations; provider qualifications, and the right to appeal. These sections
are adopted for repeal as they were repeated in Chapter 37, §§37.81
- 37.86. Sections 32.301 - 32.305 and §32.307 were not repealed when §§37.81
- 37.86 were adopted. The repeal is also necessary in order to combine the
affected sections in a new chapter entitled Chapter 27, Case Management for
Children and Pregnant Women.
The department at the same time is adopting the repeal of Early and Periodic
Screening, Diagnosis and Treatment, Subchapter J, THSteps Medical Case Management
Services, §§33.501 - 33.506, under a separate publication. The repeal
is necessary in order to combine these sections in new Chapter 27, Case Management
for Children and Pregnant Women. Specifically, these sections cover definitions;
eligible recipients; THSteps Medical Case Management services; service limitations;
applicant and provider qualifications, and application, review and monitoring
processes.
The department also adopts new Chapter 27, Case Management for Children
and Pregnant Women, §§27.1, 27.3, 27.5, 27.7, 27.9, 27.11, 27.13
and 27.15, under a separate publication. The new sections combine case management
programs to meet the needs of pregnant women of all ages and children with
a health condition/health risk, birth to 21 years. Specifically, these new
sections cover definitions; eligible recipients; case management service provisions;
service limitations; applicant and provider qualifications; and application,
review and monitoring processes.
The adopted new rules for Case Management for Children and Pregnant Women
will provide case management services to Medicaid eligible women of all ages
who have a high risk pregnancy and to children from birth to 21 years of age
with a health condition/health risk. Two programs, Medicaid Case Management
for High Risk Pregnant Women and High Risk Infants and the Texas Health Steps
Medical Case Management were combined into one program in the new Chapter
27 upon the repeal of §§32.301 - 32.305, 32.307, 33.501 - 33.506,
and 37.81 - 37.86. The new program will provide a greater continuity of services
for all eligible recipients.
The repeals are adopted under the Health and Safety Code, §12.001,
which provides the Board of Health (board) with the authority to adopt rules
to implement every duty imposed by law on the board, the department and the
commissioner of health; the Health and Safety Code, Chapter 32, which provides
the board with the authority to establish maternal and infant health improvement
services programs in the department to serve eligible recipients; the Human
Resources Code, Chapter 32, which enables the state to provide medical assistance;
and the Government Code, §531.021, which provides the Health and Human
Services Commission (HHSC) with the authority to propose rules to administer
the state's medical assistance program, and are submitted by the Texas Department
of Health under its agreement with HHSC to operate the EPSDT program, and
as authorized under §1.07 of the Acts of the 72nd Legislature, First
Called Session (1991), Chapter 15, as amended by the Acts of the 73rd Legislature,
Chapter 747, §2.
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 16, 2003.
TRD-200303689
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: September 1, 2003
Proposal publication date: April 4, 2003
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts amendments to §§181.1-181.11,
181.13 - 181.14, 181.21, 181.23 - 181.26, 181.28 - 181.32, and 181.41 - 181.47;
repeal of §§181.22, 181.27, 181.48 - 181.49; and new §§181.22
and 181.27, concerning administrative procedures, issuance of vital records
events and statistical information, and the Central Adoption Registry of the
Bureau of Vital Statistics. Sections 181.1, 181.26, and 181.44 are adopted
with changes to the proposed text as published in the January 31, 2003, issue
of the
Texas Register
(28 TexReg 889). The
amendments to §181.2 - 181.11, 181.13 - 181.14, 181.21, 181.23 - 181.25,
181.28 -181.32, 181.41 - 181.43, 181.45 - 181.47, repeal of §§181.22,
181.27, and 181.48 -181.49, and new §§181.22 and 181.27 are adopted
without changes and will not be republished.
Specifically, the amendments cover the following: Subchapter A clarifies
key vital statistics words and terms; provides instructions and requirements
for the preservation, transportation, and final disposition of dead bodies;
set requirements regarding access, confidentiality and filing of supplemental
birth certificates, fetal death certificates, and requests for personal data;
and defines the form and content of birth, death, and fetal death certificates.
Subchapter B provides instructions, sets requirements, and fees for issuance
of certified copies, and registration of birth and death records; defines
who can prescribe the form and context of the marriage application form; sets
minimum requirements for adoption reporting and index access; and establishes
notification, maintenance, and preservation requirements for out-of-business
child-placing agencies' records. Subchapter C establishes rules for notifying
adoptive parents about the Central/Voluntary Adoption Registry; defines the
duties, responsibilities and fees associated with the voluntary adoption registries;
and provides guidelines pertaining to the confidentiality, notification and
the release of information. The repeals cover Confidentiality of Records Maintained
by Each Registry and Fee Requirement for the Central Adoption Registry. The
new sections cover Fees Charged for Vital Records Services and Memorandum
of Understanding with the Texas Funeral Service Commission.
The Government Code, §2001.039, requires state agencies to review
and consider for readoption each rule adopted by that agency, pursuant to
the Government Code, Chapter 2001 (Administrative Procedures Act). Sections §§181.1
- 181.11, 181.13 - 181.14, 181.21 - 181.32 and 181.41 - 181.49 have been reviewed,
and the department has determined that the rules should continue to exist;
however, changes were necessary.
A Notice of Intention to Review for §§181.1 - 181.11, 181.13
- 181.14; 181.21 - 181.32; and 181.41 - 181.49 was published in the November
17, 2000, issue of the
Texas Register
(25
TexReg 11528). No comments were received as a result of the publication of
this notice.
The following comments were received concerning the proposed rules. Following
each comment is the department's response and any resulting changes.
Comment: Concerning §181.1(5), the definition of "certified copy,"
a commenter stated that the phrase "seal of the State of Texas" should be
changed to "state seal." The term "state seal" is used by the legislature,
the secretary of state, and to the best of the commenter's knowledge, all
other state agencies. If the bureau wishes to be specific about the precise
design of the state seal, then the commenter suggested a reference to Title
I, Texas Administrative Code, §72.50(1), which is the standard design
for the state seal.
Response: The department agrees with the commenter, and has corrected the
wording in this paragraph.
Comment: Concerning §181.7(a), (b), and (2), a commenter stated that
when a stillbirth or fetal death occurs at the gestation of 20 completed weeks
or more, the certificate filed should continue to be referred to as a Certificate
of Stillbirth. Furthermore, Texas should consider giving the mother of a stillborn
baby a "Certificate of Birth Resulting in Stillbirth."
Response: After consulting with the department's Office of General Council,
it was determined that no changes be made as a result of the comment based
on the following reasons: There was no live birth, hence no birth certificate
should be issued; and issuing a certificate of stillbirth would still require
a certificate of fetal death to be issued for the same event.
The comments received were neither for nor against the rules in their entirety;
however, the commenters were individuals and raised questions and offered
suggestions for changes.
The department has made the following editorial changes due to staff comments
to correct punctuation.
Change: Concerning §181.26(d)(5), a semicolon was added after the
word "card".
Change: Concerning §181.44(a), a comma was added after the word "(CAR)".
Subchapter A. MISCELLANEOUS PROVISIONS
25 TAC §§181.1 - 181.11, 181.13, 181.14
The amendments are adopted under authority of the Health and
Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; 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, department and the Commissioner of Health. The review
of these rules implements Government Code, §2001.039.
§181.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Applicant--A person who requests a service pertaining to
a record of birth or death, verification of marriage or divorce, or release
of personal data. (Also, see definition for properly qualified applicant).
(2)
Birth records--Records governing births filed pursuant
to the Texas Vital Statistics Act, the Health and Safety Code, Title 3.
(3)
Bureau of Vital Statistics (Bureau)--The office within
the Texas Department of Health charged with the implementation of the Texas
Vital Statistics Act.
(4)
Certification--A certified statement, form, or letter,
of the facts stated on the form or document as filed in the Bureau of Vital
Statistics, certified by the state registrar or duly appointed designee, over
the respective signature and may bear the seal of the Bureau of Vital Statistics.
(5)
Certified copy--An abstract or photocopy of the original
record issued as filed with the Bureau of Vital Statistics, and issued on
a designated form or security paper which shall bear the "state seal", the
Texas Department of Health-Bureau of Vital Statistics or the seal of their
office, and the facsimile signature of the State Registrar or the local registration
official.
(6)
Dead body--A lifeless human body or such parts of the human
body or the bones thereof from the state of which it may be reasonably concluded
that death occurred.
(7)
Disinterment--To exhume, unbury, or take out of the grave.
(8)
Death records--Records governing deaths and fetal deaths
filed pursuant to the Texas Vital Statistics Act.
(9)
Department--The Texas Department of Health.
(10)
Embalming--The act of disinfecting or preserving a human
dead body, entire or in part, by the use of chemical substances, fluids, or
gases in the body; or by the introduction of the same into the body by vascular
or hypodermic injection; or by direct application into the organs or cavities;
or by any other method intended to disinfect or preserve a dead body or restore
body tissues and structures.
(11)
Fetal death (stillbirth)--Death prior to the complete
expulsion or extraction from its mother of a product of conception, irrespective
of the duration of pregnancy; the death is indicated by the fact that after
such separation, the fetus does not breathe or show any other evidence of
life such as beating of the heart, pulsation of the umbilical cord, or definite
movement of voluntary muscles.
(12)
Genealogist--An individual who traces the descent of persons
or families. He or she may be an individual family member or a person hired
by the family to trace a family tree or do family research.
(13)
Identification of applicant--Each applicant must present
a current form of government issued photo identification along with his or
her application. If the applicant is unable to present a current form of photo
identification, two valid supporting forms of identification may be presented,
one of which bears the applicant's signature.
(14)
Immediate family member--The registrant, a member of his
or her immediate family either by blood, marriage or adoption, his or her
guardian, or his or her legal agent or representative.
(15)
Indexes--An index to or listing of birth records, death
records, applications for marriage licenses, and reports of divorce or annulment
of marriage.
(A)
Consolidated indexes--These indexes are vital records consisting
of more than one event year. Consolidated indexes may be prepared for any
vital event at the discretion of the State Registrar in the form prescribed.
(B)
General birth and death indexes--These indexes are maintained
or established by the bureau of vital statistics or a local registration official
which shall be prepared by event year, in alphabetical order by surname of
the registrant, followed by any given names or initials, the date of the event,
the county of occurrence, the state or local file number, the name of the
father, the maiden name of the mother, and sex of the registrant.
(C)
Summary birth and death index--These indexes are maintained
or established by the Bureau of Vital Statistics or a local registration official
which shall be prepared by event year, in alphabetical order by surname of
the registrant, followed by any given names or initials, the date of the event,
the county of occurrence, and sex of the registrant.
(16)
Interment--Burial or the act of placing in a grave.
(17)
Legal representative (personal representative or agent)--An
attorney in fact, a funeral director, or any other person designated by affidavit,
contract, or court order acting on behalf and for the benefit of the registrant
or his or her immediate family. In order to determine the need for protection
for personal property rights when the legal representative is acting on behalf
and for the benefit of the registrant or the registrant's immediate family
or other entity having a direct and tangible interest in the record, the state
registrar, local registrar, or county clerk shall require a designation document
or an attested statement to that effect.
(18)
Live birth--The complete expulsion or extraction from
its mother of a product of conception, irrespective of the duration of pregnancy,
which, after such separation, breathes or shows any other evidence of life
such as beating of the heart, pulsation of the umbilical cord, or definite
movement of voluntary muscles, whether or not the umbilical cord has been
cut or the placenta is attached; each product of such a birth is considered
live born.
(19)
Local registration official--A county clerk or person
authorized by the Vital Statistics Act to maintain a duplicate system of records
for each birth, death, or fetal death that occurs in the person's jurisdiction.
(20)
Non-institutional Birth--A birth occurring outside a hospital
or birthing center licensed by the Texas Department of Health.
(21)
Person in charge of interment--Any person who places or
causes to be placed a fetus, dead body or the ashes, after cremation, in a
grave, vault, urn, or other receptacle, or otherwise disposes thereof.
(22)
Properly qualified applicant (qualified applicant)--The
registrant, or immediate family member either by blood, marriage or adoption,
his or her guardian, or his or her legal agent or representative. Local, state
and federal law enforcement or governmental agencies and other persons may
be designated as properly qualified applicants by demonstrating a direct and
tangible interest in the record when the information in the record is necessary
to implement a statutory provision or to protect a personal legal property
right. A properly qualified applicant may also be a person who has submitted
an application for a request to release personal information and has been
approved as outlined in §181.11 of this title (relating to Requests for
Personal Data).
(23)
Registrant--The individual named on the certificate of
birth, death, or fetal death; application for marriage license; or report
of divorce or annulment of marriage.
(24)
Research copy--A plain paper noncertified reproduction
of the complete original document or a portion of the original document.
(25)
Search--The act of examining the files and/or indexes
maintained by the Bureau of Vital Statistics for a specific record or information.
(26)
Signature--The name of a person written with his or her
own hand; or by an electronic process approved by the State Registrar.
(27)
State Registrar--The Chief, Bureau of Vital Statistics,
Texas Department of Health.
(28)
Supplemental Birth Certificate--A new birth certificate
prepared and filed by the Bureau, which is based upon a paternity determination,
or adoption. This new birth certificate replaces the original certificate
of birth.
(29)
Birth Verification--A noncertified statement only of the
registrant's name, date of birth, and place of birth as it appears on the
birth index filed with the Bureau of Vital Statistics.
(30)
Death Verification--A noncertified statement only of the
registrant's name, date of death, and place of death as it appears on the
death index filed with the Bureau of Vital Statistics.
(31)
Fetal Death Verification--A noncertified statement only
of the registrant's name, date of delivery, and place of delivery as it appears
on the fetal death index filed with the Bureau of Vital Statistics.
(32)
Marriage Verification--A noncertified statement only of
the registrant's name, date of marriage, and place of marriage as it appears
on the application for marriage license index filed with the Bureau of Vital
Statistics.
(33)
Report of Divorce or Annulment of Marriage Verification--A
noncertified statement only of the registrant's name, date of divorce, and
place of divorce as it appears on the report of divorce or annulment of marriage
index as it appears on the birth index filed with the Bureau of Vital Statistics.
(34)
Vital statistics--The registration, preparation, transcription,
collection, compilation, distribution and preservation of data pertaining
to births, adoptions, paternity determinations, deaths, fetal deaths, suits
affecting parent child relationship, court of continuing jurisdiction, marital
status, and such other data as deemed necessary by the department.
(35)
Vital Statistics Act--The Health and Safety Code, Title
3.
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 13, 2003.
TRD-200303600
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §§181.21 - 181.32
The amendments and new rules are adopted under authority of
the Health and Safety Code, §191.003, which provides the Board of Health
with authority to adopt necessary rules for collecting, recording, transcribing,
compiling, and preserving vital statistics; 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, department and the Commissioner of Health. The
review of these rules implements Government Code, §2001.039.
§181.26.Filing of Birth Certificates for Infants Born Outside of a Licensed Institution.
(a)
All certificates of birth shall be filed as required by
the Health and Safety Code, §192.001.
(1)
Births occurring in a licensed institution shall be filed
as required by the Health and Safety Code, §192.003. Licensed institutions
include hospitals and birthing centers licensed by the department.
(2)
Births occurring outside licensed institutions shall be
filed as described in this section.
(b)
The signature on the certificate of the registered, certified,
or documented health care provider shall serve as prima facie evidence of
the essential elements of proof required in subsection (c) of this section.
The local registrar may accept certificates by mail when the signature of
the registered, certified, or documented health care provider is on file with
that registrar's office.
(c)
The essential elements to register a noninstitutional birth
are:
(1)
proof of pregnancy in the following order of preference:
(A)
an affidavit from a licensed, registered, or certified
health care provider who is qualified to determine pregnancy as part of the
scope of his/her license or registration, or certification; or
(B)
an affidavit from one person, other than the parents, having
knowledge of the pregnancy/birth.
(2)
that there was an infant born alive;
(3)
proof of the mother's presence in the registration district
on the date of the birth if the birth occurred outside the locale of the mother's
primary place of residence. Such proof shall consist of an affidavit from
a person having knowledge of the mother's presence in the registration district
in which the birth occurred on the date of the birth. If the birth occurred
in the mother's primary place of residence, proof shall be presented in the
following order of preference:
(A)
a utility, telephone, or other bill which includes the
mother's name and address;
(B)
a rent receipt or agreement which includes the mother's
name and address, and the printed name, address, and signature of the mother's
landlord;
(C)
a driver's license, or state issued identification card,
which includes the mother's current residence on the face of the license/card;
(D)
an envelope addressed to the mother at her place of residence,
and postmarked prior to the date of the birth; or
(E)
an affidavit attesting to the mother's place of residence
from a person, other than the father, who was either living with the mother
at the time of the alleged birth, or has other knowledge of the mother's residency;
and
(4)
the infant's birth occurred on the date stated.
(d)
A birth as described in subsection (c) of this section
shall only be filed upon personal presentation of the following evidence by
the individual responsible for the preparation and registering of the certificate.
An identifying document, with photograph, shall be presented in the following
order of preference:
(1)
a passport or certificate of naturalization;
(2)
a military service or military dependent identification
card;
(3)
a United States government identification card, or national
identification card issued by another country;
(4)
a current driver's license or other state identification
card;
(5)
an alien registration receipt card; or
(6)
an employee or student identification card, with photograph.
(e)
At the discretion of the local registrar, the requirements
contained in this section may be supplemented with any additional requirements
which may be needed to verify the circumstances of the birth. Such additional
requirements may include, but are not limited to, one or more of the following:
(1)
an unannounced visit to the mother's residence or the place
of the alleged birth by a public health nurse, other health professional,
registrar staff, or other person including city, county, state, or federal
law enforcement officer, prior to registering the alleged birth. This paragraph
does not permit nor give authority to enter these premises unless permission
is obtained from the occupant at the time of the visit;
(2)
multiple forms of identifying documents, with or without
photographs, when the documents described in this section are unavailable;
(3)
personal appearance of both parents, either together or
separately; or
(4)
personal appearance of the infant whose birth certificate
the parents are attempting to file.
(f)
If the required or supplemental evidence described in this
section is not available and the registrar is otherwise unable to verify the
circumstances of the birth, the birth may only be filed upon order of a court
of competent jurisdiction.
(g)
A certificate of birth concerning a child who is between
one and four years of age may only be filed by the state registrar. The state
registrar shall require the same proof and documentation as previously mentioned
in this section and, in addition, an affidavit of the parents and the attendant,
if any, as to why the certificate was not timely filed. If the proof and documentation
are not available, the certificate may only be filed as prescribed by the
Health and Safety Code, §192.027.
(h)
Each local registrar shall notify the state registrar's
office of any suspicious documents or records submitted or filed with his/her
office.
(i)
Blank birth certificate forms shall only be issued to licensed
institutions, certified nurse midwives, documented midwives, and individuals
by the local registrar or the state registrar in reasonable amounts. No blank
birth certificate forms shall be distributed by mail to any one other than
a registered, certified, or documented health care provider.
(j)
Each local registrar shall maintain a record of the number
of blank birth certificate forms and their control number issued to each individual.
The local registrar shall submit a copy of this record to the state registrar
on a monthly basis.
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 13, 2003.
TRD-200303601
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §181.22, §181.27
The repeals are adopted under authority of the Health and
Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; 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, department and the Commissioner of Health. The review
of these rules implements Government Code, §2001.039.
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 13, 2003.
TRD-200303602
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §§181.41 - 181.47
The amendments are adopted under authority of the Health and
Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; 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, department and the Commissioner of Health. The review
of these rules implements Government Code, §2001.039.
§181.44.Inquiry through the Central Index.
(a)
The bureau charges a fee of $5.00 to determine if a child-placing
agency that operates its own registry was involved in a specified adoption.
The person may send the inquiry, along with the appropriate fee and proof
of age and identity to the Central Adoption Registry (CAR), P.O. Box 140123,
Austin, Texas 78714-0123 or may inquire in person at the Bureau of Vital Statistics,
1100 West 49th Street, Austin, Texas.
(b)
Proof of age and identity is a copy of the requestor's
driver's license or other photo identification and a copy of the birth certificate,
if the requestor's name has changed due to marriage. If the name has been
legally changed through a court order, a certified copy of the order shall
accompany the request.
(c)
The department shall provide the child-placing agency's
name, address, telephone number, and E-mail address, if appropriate, if that
agency operates its own registry to which a person may apply. If the CAR finds
inconclusive information to determine which agency handled the adoption, the
person is entitled to apply only to the CAR.
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 13, 2003.
TRD-200303603
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §181.48, §181.49
The repeals are adopted under authority of the Health and
Safety Code, §191.003, which provides the Board of Health with authority
to adopt necessary rules for collecting, recording, transcribing, compiling,
and preserving vital statistics; 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, department and the Commissioner of Health. The review
of these rules implements Government Code, §2001.039.
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 13, 2003.
TRD-200303604
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
The Texas Department of Health (department) adopts amendments to §§229.81,
229.82, 229.84, 229.85, 229.87 - 229.91, the repeal of §§229.83
and 229.86, and new §§229.83 and 229.86, concerning the production,
processing, and distribution of bottled and vended drinking water. The amended §§229.81,
229.85 and 229.88, and new §229.86 are adopted with changes to the proposed
text as published in the January 31, 2003, issue of the
Texas Register
(28 TexReg 901). Repeals §§229.83 and 229.86,
amendments §§229.82, 229.84, 229.87, and 229.89 - 229.91, and new §229.83
are adopted without changes, and will not be republished.
An amendment to §229.81 adds definitions for clarification of the
regulation. Duplicative language was deleted in §229.82. New §229.83
inserts the reference to the Texas Commission on Environmental Quality regulations
on water hauling. An amendment to §229.84 updates the section title name.
An amendment to §229.85 updates examples for labeling and advertising.
New §229.86 reorganizes the section for clarity and adds a requirement
for submission of sample results to the department. An amendment to §229.87
updates the reference to the Texas Commission on Environmental Quality. An
amendment to §229.88 clarifies oversight of bottling and vending operations
by a certified individual. An amendment to §229.89 adds a timeline for
completing the bottled and vended water certificate examination within a limited
time frame. An amendment to §229.90 updates the section title for clarification.
Amendments to §229.91 update references to the department's hearing procedures
and correct spellings to be consistent within the regulation.
Government Code, §2001.039, requires each state agency to review and
consider for readoption each rule adopted by that agency. The current rules
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however the rules need revisions as described
in the preamble. Sections 229.83 and 229.86 are repealed, and new sections
are adopted.
The department published a Notice of Intention to Review for §§229.81
- 229.91 in the
Texas Register
on March 22,
2002, (27 TexReg 2265). No comments were received as a result of the publication
of this notice. Over 300 stakeholders were subsequently notified by mail that
these rules were under review. Comments were submitted as a result of this
mailing and were taken into consideration when drafting the proposed rules.
The following comments were received by the department during the official
comment period concerning the proposed sections. Following each comment is
the department's response and any resulting change.
Comment: Concerning §229.81(c)(14)(B), several commenters stated that
deleting the word "unit" in the definition of "vended water" changes the meaning
to include all sorts of waters.
Response: The department disagrees with these comments. The department
feels the terms "unit" and "servings" are redundant, therefore "unit" was
deleted in the proposed rules. No change was made as a result of these comments.
Comment: Concerning Section §229.81(c)(16), several commenters stated
that definition of "water dispensing device" expands bureaucracy and is too
vague. One commenter added, "What is your purpose?"
Response: The department disagrees with these comments. This definition
was only added to provide some clarity on requirements for vending machines
and bottled water stores. Under the current rules, requirements for both vending
machines and bottled water stores were combined in §229.86. This section
can be confusing because some of the requirements only apply to vending machines,
not the store facilities. Since not all the requirements applied to vended
water stores, the term "water dispensing device" was created, and §229.86
was divided into §§229.86(a) and 229.86(b) to provide better differentiation
on requirements between the two types of facilities. No additional regulatory
requirements were added on bottled water stores or vending machines due to
the addition of this definition. No change was made as a result of these comments.
Comment: Concerning §229.83, several commenters recommended the removal
of the wording that places jurisdiction of water hauled for bottled water
from the Texas Commission on Environmental Quality's (TCEQ) jurisdiction as
the department has sole jurisdiction over the production of food products
including bottled water. The commenters also asserted that bulk hauled water
is not drinking water and that deletion of this rule will not adversely impact
health or safety.
Response: The department disagrees with these comments. The TCEQ regulates
drinking water from its source to the point of the plant or dispensing device.
As all water used in bottled and vended water must be from an approved source,
the water at the point of source must be treated and therefore already meets
the TCEQ's requirements for drinking water. While it is true that the department
regulates food and beverages and their ingredients from the point of production
through to the consumer, there is already a TCEQ regulation in place for hauling
drinking water. The department feels there is no reason to create an additional
or conflicting regulation. This department rule complements and does not conflict
with the TCEQ rules. The deletion of this wording would remove any regulation
of the tankers transporting water destined for bottled and vended water facilities.
The department feels this could cause confusion and would have an impact on
health and safety. The department does agree that there is confusion on the
definition of "drinking water." A definition of "drinking water" has been
added in §229.81(c)(6).
Comment: Concerning §229.83, several commenters stated that microbiological
standards stated in §229.84 allow for flexibility on disinfection methods
for transport. These commenters also stated that §229.83 is in direct
conflict with federal regulations governing disinfection byproducts in bottled
water and deletion would remove the requirement to test for disinfection byproducts
in the source water.
Response: The department disagrees with these comments. Section 229.84
states, "Bottled and vended water production including transporting... shall
be conducted under such conditions and controls as are necessary to minimize
the potential for microbiological contamination... These conditions and controls
shall include the following. (1) bottled and vended water shall be subject
to effective germicidal treatment...". The commenters are requesting the removal
of the treatment for the hauling of the water prior to plant production. Section
229.84 does allow for flexibility; however, this flexibility does not allow
for no treatment and, as stated in the comment, would conflict with rules
already in place for the transportation of drinking water. TCEQ regulation
30 TAC §290.42(b)(1) already requires disinfection of water at the source
in order to obtain source approval. The reference to TCEQ water hauling regulations
ensures disinfection residual through transportation. As the disinfection
begins at the source, the requirement for testing disinfection byproducts
of source water would not be eliminated by removing this section. There are
methods during the processing of bottled and vended water to reduce the chlorine
to an acceptable level in the finished product. Therefore, this rule is not
in direct conflict with federal regulations. No changes were made as a result
of these comments.
Comment: Concerning §229.84(2) and (3), several commenters recommended
a change to this section allowing water to be filled in lines used for other
beverages. The comments include the addition of a requirement for a Clean
in Place (CIP) system or the equivalent to sanitize the lines prior to use
for bottled water. The commenters assert with this change that firms prepare
and follow a Hazard Analysis Critical Control Point Plan (HACCP).
Response: The department disagrees with these comments. The current rules
do not require HACCP for bottled water facilities. To require such a system
to be put in place at this time would require extensive start-up and training
expenses for bottled water facilities. Since the requirement for dedicated
lines has been the regulation in Texas for the past 15 years, industry in
Texas is in general compliance at this time. No changes were made as a result
of these comments.
Comment: Concerning §229.85(b), a commenter stated, "It should be
specified that this subsection (b) applies to bottled water only since vending
machine owners do not necessarily have control over the bottles being provided
for use at the machine."
Response: The department disagrees with this comment. Labeling is only
required for food in packaged form. Since vending machines do not sell water
already in packaged form, there is no requirement for labeling, therefore
this section does not apply. No change was made as a result of this comment.
Comment: Concerning §229.85(b), several commenters request the deletion
of the source labeling requirement. These commenters assert this is in violation
of the Federal Food, Drug and Cosmetic Act (FFDCA) 403A, and the Commerce
Clause of the U.S Constitution and, as such, is preempted.
Response: The department disagrees with these comments. Federal preemption
requirements described in FFDCA 403A do not apply to geographic source labeling.
Section 403(A)(1) of the FFDCA preempts the states and locals on the name
of the food if it has a "standard of identity." FFDCA 403(A)(1) only preempts
the names of these waters and what they stand for. That is what a "standard
of identity" means. As long as the "standards of identity" for the various
types of waters are in conformance (i.e. "Deionized Water," "Distilled Water,"
"Purified Water," etc.), states are permitted to have other types of labeling
requirements for these waters, including source labeling. Requiring manufacturers
to label the source of the product has nothing to do with a "standard of identity."
The Commerce Clause of the U.S. Constitution does not apply in the matter
of source labeling. Source labeling is required only for manufacturers of
bottled water in the State of Texas. Manufacturers of bottled water in other
states do not have to comply with these requirements. No change was made as
a result of these comments.
Comment: Concerning §229.86(b)(3), two commenters did not agree that
vending machines should be equipped with self-closing, tight-fitting doors.
A commenter understood why this could be required for outdoor machines, but
not for the machines kept indoors. The commenter suggested that a sneeze guard
should be adequate indoors. Another commenter stated that machines with dispensing
nozzles that are inaccessible when the machine in not dispensing water should
be allowed.
Response: The department partially agrees with these comments. First, the
purpose of this section of the regulation is to protect the dispenser from
environmental contamination. Even if a vending machine is placed indoors,
it may be in an area with high traffic or where it is exposed to handling
or cross drafts. Therefore, the department believes the reason for the protective
door requirement remains. The department does not believe a sneeze guard meets
this requirement. Second, the department considers vending machines that have
a design such that the dispensing nozzle is protected by a mechanism that
isolates the dispenser by an internal door when not in use, to be in compliance
with this portion of the regulation. No change was made as result of these
comments.
Comment: Concerning §229.86(c)(2), a commenter recommended that if
the water used in the vending machine is from an approved source per state
and local government agencies, why should the language, "...and if required
by the department, shall also be analyzed for other physical, chemical, or
microbiological parameters..." be added.
Response: The department disagrees with this comment. The department recognizes
that approved sources are required to maintain certain physical, chemical,
or microbiological test results. The department includes this language in
the regulation to allow the department to do testing in cases where water
from a particular facility is believed to be contaminated. In the case of
vended water, this language does not require any additional routine testing
other than the monthly bacteriology testing. No change was made as a result
of this comment.
Comment: Concerning §229.86(c)(2)(A), a commenter recommended that
the "testing lab or agency should be responsible for reporting POSITIVE TEST
results to Austin rather than the vendor."
Response: The department disagrees with this comment. The vendor is responsible
for testing the water and ensuring it is safe to distribute to the public.
The department feels it is the vendor's responsibility to notify the department
if water from their facility tests positive. In addition, the department does
not have statutory authority to require private laboratories to submit sample
results. No change was made as result of this comment.
Comment: Concerning §229.86(c)(2)(A), a commenter suggested that positive
tests results be e-mailed in place of faxing.
Response: The department agrees with this comment. An option for e-mailing
the positive test results has been added to this section.
Comment: Concerning §229.86(c)(2)(B), several commenters requested
deletion of this section.
Response: The department disagrees with these comments. The department
was approached during the rulemaking process to reduce the sampling interval
on water dispensing devices. The department does not have enough data to determine
the public health impact of this request. This section was added with the
intent of requiring vendors to submit all sample results for the period of
one year from the date of the rule implementation to obtain the needed data.
After one year, the requirement to submit negative sample results to the department
will be removed. No change was made as a result of these comments.
Comment: Concerning §229.86(c)(2)(B), a commenter suggests that a
single, complete file of results be e-mailed within five business days of
the end of each month.
Response: The department agrees with this comment. The section has been
changed to allow negative sample results for one month to be sent in bulk
within ten calendar days of the last day of the month. In addition, an option
was added for e-mailing the test results.
Comment: Concerning §229.86(c)(5)(A), a commenter suggested that if
the water sample is positive for coliforms, the machine should be disinfected
and then a second sample taken. Also, the commenter recommended changing the
verbiage "...one sample per day during a four consecutive-day period..." to
three days later after disinfecting based on the assumption that the vending
machine is using a reverse osmosis membrane in the purifying process. If the
water is not processed by reverse osmosis, then the original rule would apply.
The commenter stated, "Where can E-coli come from in these machines?" Another
commenter recommended a single retest within 24 hours of notification of a
positive coliform, without shutting the machine down. Should the retest be
positive, the machine must be shut down, the "entire" machine sanitized, then
a sample of the vended water and the source water be submitted. Both samples
must be coliform negative in order to allow the machine to return to operation.
Another commenter stated, "The four consecutive-day requirement is difficult
to achieve without significant and unnecessary down time. For example, if
we are notified of a positive sample on a Wednesday, in order to meet the
four consecutive-day requirement, we would have to wait to begin repeat sampling
until the following Monday." The commenter suggested that the repeat sampling
should be completed on the same day.
Response: The department agrees with these comments. Regarding §229.86(c)(5)(A)
- (C), subparagraphs (A) and (B) were amended, and subparagraph (C) was added
to reflect the wording recommended by the Association of Food and Drug Officials
model regulation for vended water.
Comment: Concerning §229.86(c)(5)(B), one commenter suggested eliminating
this section or changing it to state, "GO GET ANOTHER SAMPLE as long as it
is in the time frame required, i.e. monthly." Another commenter recommended
deleting this section. The commenter stated, "A repeat test from water vending
machines that have initially tested positive for coliform bacteria is an appropriate
monitor of sample collection techniques."
Response: The department agrees with these comments. Regarding §229.86(c)(5)(A)
- (C), subparagraphs (A) and (B) were amended, and subparagraph (C) was added
to reflect the wording recommended by the Association of Food and Drug Officials
model regulation for vended water.
Comment: Concerning §229.86(c)(2), several comments were received
regarding bacteriological sampling of each water dispensing device. The commenters
stated that this is very costly, and if the source of the water is the same
for each dispensing device, why have to test each device?
Response: The department agrees with these comments in that the wording
in the definition for a water dispensing device is not clear. The definition
has been changed in §229.81(c)(17) to specify a water dispensing device
as each unit that filters and disinfects the water for dispensing. The department
did not intend for the definition to include each faucet in the case of a
vended water store. However, each vending machine is a separate water dispensing
device.
Comment: Concerning §229.88(a) and (b), a commenter recommended clarifying
this section. The commenter stated that "§229.88(a) seems to require
a vended water operator to hold a certificate...; however, (b) appears to
allow an operator to run a system as long as he/she is being guided by someone
who holds a certificate..."
Response: The department disagrees with this comment. The rule actually
states the opposite. Section 229.88(a) requires that a bottled water facility
have full-time supervision by a certified bottled water operator. The record
keeping and sampling requirement for bottled water are more involved than
vending. Section 229.88(b) requires that vending operations have a certified
bottled and vended water operator guide the operation and be available whenever
there are problems. No change was made as a result of this comment.
Comment: Concerning §§229.88 - 229.89, several commenters requested
the expansion of this section to include acceptance of the International Bottled
Water Association's (IBWA) Certified Plant Operator Program. The commenters
also requested that the department standardize its program to follow the IBWA's
certifying program.
Response: The department disagrees with these comments. The Texas Health
and Safety Code, Chapter 441, Regulation of Bottled and Vended Drinking Water
requires the department to provide for the testing of the applicant and issue
a certificate of competency. It does not give the department the authority
to allow for third party testing or reciprocity of third party certifications.
No change was made as a result of these comments.
Comment: Concerning §§229.88 - 229.89, a commenter requested
a change in the section to include two separate tests, one for water vending
operators and a second for bottled water operators.
Response: The department disagrees with the comment at this time. However,
we are studying the issue for future consideration. No change was made as
a result of this comment.
Comment: Concerning the legend for the proposed rules, one commenter stated,
"A new legend hidden in the text before paragraph §229.83 is a violation
of order, common sense, standard procedure, and usual purpose. Why publish
proposed changes if they are going to be camouflaged?"
Response: The department disagrees with this comment. A department copy
of the proposed rules was forwarded to the commenter which included a legend
to determine the underlining of new rule text, brackets for rule text being
deleted, and (No change.) for rule text not being changed. The legend is department
format which is almost identical to the
Texas Register's
weekly publication of rules that explains and utilizes the underlining,
brackets, and (No change.) language at the beginning of proposed rules. No
change was made as a result of this comment.
The commenters were: Culligan Store Solutions, Danone Waters of North America,
Glacier Water, International Bottled Water Association, National Automatic
Merchandising Association. In addition, numerous individuals commented. All
commenters were not against the rules in their entirety, however, expressed
concerns, asked questions, and suggested recommendations for change as discussed
in the summary of comments.
The department is making the following changes due to staff comments.
Change: Concerning §229.88, a period was added at the end of the first
sentence of the rule text.
Change: Concerning §229.85(b), a statement was added to clarify that
water processed by deionization, distillation, or reverse osmosis that renders
the water "purified" as defined by §229.81(c)(11) are not required to
declare the source of the water.
Subchapter F. PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER USE
25 TAC §§229.81 - 229.91
The amendments and new rules are adopted under the Health
and Safety Code, §431.241, which provides the department with the authority
to adopt necessary regulations pursuant to the enforcement of Chapter 431;
and §12.001, which provides the Texas Board of Health (board) with the
authority to adopt rules for the performance of every duty imposed by law
on the board, department, and the commissioner of health. The review of these
rules implements Government Code, §2001.039.
§229.81.General Provisions.
(a)
Purpose. These sections establish definitions and standards
for the processing and bottling of drinking and vended water. The sections
also will supplement §§229.181-229.184 of this title (relating to
Licensure of Manufacturers of Food and Wholesale Distributors of Food - Including
Good Manufacturing Practices) and federal regulations in Title 21, Code of
Federal Regulations, Part 165 concerning standards of quality, and Part 129
concerning processing and bottling of bottled drinking water.
(b)
Requirements for specific standardized beverages. The department
adopts by reference Title 21 Code of Federal Regulations, §165.110 concerning
the identity, nomenclature, other label statements and label declarations
for both bottled and vended water, except as modified by the Texas Board of
Health in §229.85(b) of this title (relating to Labeling and Advertising).
(c)
Definitions. The following words and terms, when used in
this chapter, shall pertain to both bottled and vended water and shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Approved source (when used in reference to a plant's product
water or operations water)--A source of water and the water therefrom, whether
it be from a spring, artesian well, drilled well, municipal water supply,
or any other source, that has been inspected and the water sampled, analyzed,
and found to be of a safe and sanitary quality according to applicable laws
and regulations of State and local government agencies having jurisdiction.
The presence in the plant of current certificates or notifications of approval
from the government agency or agencies having jurisdiction constitutes approval
of the source and the water supply.
(2)
Artesian water--Water from a well tapping a confined aquifer
in which the water level stands at some height above the top of the aquifer
is "artesian water" or "artesian well water."
(3)
Bottled water--Water that is intended for human consumption
and that is sealed in bottled or other containers with no added ingredients
except that it may optionally contain safe and suitable antimicrobial agents.
(4)
Department--Texas Department of Health.
(5)
Distilled water--Water which has been produced by a process
of distillation and meets the definition of purified water in the United States
Pharmacopeia, 23rd revision, January 1, 1995, which the department adopts
by reference. (Copies may be obtained from the United States Pharmacopial
Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852).
(6)
Drinking water--All water from the point of the approved
source intended for the purpose of human consumption or which may be used
in the preparation of foods or beverages.
(7)
Fluoridated water--Water containing added fluoride.
(8)
Ground water--Water from a subsurface saturated zone that
is under a pressure equal to or greater than atmospheric pressure.
(9)
Mineral water--Water containing not less than 250 parts
per million (ppm) total dissolved solids (TDS), coming from a source tapped
at one or more bore holes or springs, originating from a geologically or physically
protected underground water source.
(10)
Person--Includes individual, partnership, corporation,
or association.
(11)
Purified water--Water that has been produced by distillation,
deionization, reverse osmosis, or other suitable processes and that meets
the definition of "purified water" in the United States Pharmacopoeia, 23rd
revision, January 1, 1995, which the department adopts by reference. (Copies
may be obtained from the United States Pharmacopial Convention, Inc., 12601
Twinbrook Parkway, Rockville, MD 20852).
(12)
Sparkling bottled water--Water that after treatment and
possible replacement of carbon dioxide, contains the same amount of carbon
dioxide that it had at emergence from the source.
(13)
Spring water--Water derived from an underground formation
from which water flows naturally to the surface of the earth.
(14)
Sterile water or sterilized water--Water that meets requirements
under "Sterility Tests" in the United States Pharmacopeia, 23rd revision,
January 1, 1995, which the department adopts by reference. (Copies may be
obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook
Parkway, Rockville, MD 20852).
(15)
Vended water--Vended water is:
(A)
water dispensed from any vending machine; or
(B)
servings of water dispensed in bulk by any operator or
consumer from any water dispensing device.
(16)
Vending machine--Any self-service device which upon insertion
of a coin, coins, or token, or upon receipt of payment by other means, dispenses
servings of water in bulk, without the necessity of refilling the machine
between each operation.
(17)
Water dispensing device--Any water unit that dispenses
water in bulk without the necessity of refilling the machine between operations.
This term includes stores that are manned by an operator at all times in which
consumers bring containers to be filled by the operator, facilities that are
not manned by an operator and where consumers dispense their own water, and
vending machines. A water dispensing device may have several dispensing faucets
in the case of a store. However, each vending machine is considered a separate
water dispensing device.
(18)
Well water--Water taken from a hole bored, drilled, or
otherwise constructed in the ground which taps the water of an aquifer.
(d)
Other requirements for specific standardized beverages.
(1)
Artesian water may be collected with the assistance of
external force to enhance the natural underground pressure. On request, a
bottler or vendor shall demonstrate to the department that the water level
stands at some height above the top of the aquifer.
(2)
For bottled water or drinking water, fluoride may be optionally
added within the limitations established in 21 Code of Federal Regulations
(CFR) Part 165.110(b)(4)(ii). Bottled water may be used as an ingredient in
beverages (e.g., diluted juices, flavored bottled waters). It does not include
those food ingredients that are declared in ingredient labeling as "water,"
"carbonated water," "disinfected water," "filtered water," "seltzer water,"
"soda water," "sparkling water," and "tonic water." The processing and bottling
of bottled water shall comply with applicable regulations in 21 CFR, Part
129.
(3)
For fluoridated water, the total fluoride content levels
cannot exceed levels contained in 21 CFR 165.110(b)(4)(ii).
(4)
Ground water must not be under the direct influence of
surface water as defined in 40 CFR 141.2.
(5)
Mineral water shall be distinguished from other types of
water by its constant level and relative proportions of minerals and trace
elements at the point of emergence from the source, due account being taken
of the cycles of natural fluctuations. No minerals may be added to this water.
(6)
Water processed by demineralization that meets the purified
water definition may alternatively be called "demineralized water." Alternatively,
water that has been processed by deionization may be called "deionized water,"
and water processed by distillation may be called "distilled water," and water
that has been processed by reverse osmosis may be called "reverse osmosis
water." Also, if the water has been processed by either of the previously
listed methods the water may be called "(blank) drinking water," with the
blank being filled in with one of the defined terms describing the method
of processing.
(7)
Spring water shall be collected only at the spring or through
a bore hole tapping the underground formation feeding the spring. There shall
be a natural force causing the water to flow to the surface through a natural
orifice. The location of the spring shall be identified. Spring water collected
with the use of an external force shall be from the same underground stratum
as the spring, as shown be a measurable hydraulic connection using a hydrogeologically
valid method between the bore hole and the natural spring, and shall have
all the physical properties, before treatment, and be of the same composition
and quality, as the water that flows naturally to the surface of the earth.
If spring water is collected with the use of an external force, water must
continue to flow naturally to the surface of the earth through the spring's
natural orifice.
§229.85.Labeling and Advertising.
(a)
Claims of medicinal and health-giving properties shall
not be placed on labels and references shall not be made to bacterial purity
or to laboratory examinations which may have been made by department laboratories.
(b)
The label must state the source of all artesian water,
spring water, mineral water, well water, or drinking water sold. Source refers
to the point of origin. Examples: Singing Hollow Spring Water from Buck Hollow,
Arkansas; drinking water obtained from Austin municipal water supply, Austin,
Texas; well water from Bandera, Texas. Except that water processed by distillation,
deionization, reverse osmosis, or other suitable process that alters the water's
physical properties enabling it to meet the definition of purified as defined
in §229.81(c)(11) of this title (relating to General Provisions) is not
required to state the source. This exception only applies if all the water
used in the finished product is processed to meet the definition of purified.
(c)
Other label statements.
(1)
If the Total Dissolved Solids (TDS) content of Mineral
water is below 500 ppm, or if it is greater than 1,500 ppm, the statement
"low mineral content" or the statement "high mineral content," respectively,
shall appear on the principal display panel following the statement of identity
in type size at least one-half the size of the statement of identity but in
no case less that one-sixteenth of an inch. If the TDS of mineral water is
between 500 and 1,500 ppm, no additional statement need appear.
(2)
When the label or labeling of a bottled water product states
or implies (e.g., through label statements or vignettes with reference to
infants) that the bottled water is for use in feeding infants, and the product
is not commercially sterile, the product label shall bear conspicuously and
on the principal display panel the statement "Not sterile. Use as directed
by physician or by labeling directions for use of infant formula."
§229.86.Processing of Vended Water.
(a)
Water dispensing device requirements are as follows.
(1)
Any device from which any operator or consumer dispenses
servings of water in bulk shall comply with Title 21, Code of Federal Regulations
(CFR), §129.40, Equipment and Procedures, and §165.110, Requirements
for Specific Standardized Beverages. Except §129.40, the provision pertaining
to the cleaning, sanitizing, filling, and capping or sealing of containers
shall not apply to containers furnished by the consumer.
(2)
Water dispensing devices shall:
(A)
be designed and constructed to permit thorough cleaning,
sanitization, and maintenance of all exterior and interior surfaces and component
parts;
(B)
have all parts and surfaces that come into contact with
the water constructed of corrosion-resistant, and nonabsorbent material acceptable
to the department and capable of withstanding repeated cleaning and sanitizing
treatment;
(C)
be designed so all treatment of the water by distillation,
ion-exchange, filtration, ultraviolet light, reverse osmosis, mineral addition,
or any other acceptable process is done in an effective manner;
(D)
have an effective system of collection and handling of
drip, spillage, and overflow of water;
(E)
have a backflow prevention device approved by the department
or local authority for all connections with the water supply;
(F)
disinfect water by ultraviolet light or other method approved
by the department immediately prior to delivery into the customer's container;
(G)
comply with the American Water Works Association (AWWA)
specifications for granular activated carbon if used in the treatment of potable
water (AWWA B604-74);
(H)
be maintained in a clean and sanitary condition; and
(I)
be free from dirt and vermin.
(b)
Vending machines, in addition to requirements in subsection
(a) of this section, shall:
(1)
have a recessed or guarded corrosion-resistant dispensing
spout;
(2)
be equipped with monitoring devices designed to shut down
operation of the machine when the disinfection unit fails to function;
(3)
be equipped with a self-closing, tight-fitting door on
the vending compartment;
(4)
be located in an area that can be maintained in clean condition
and in a manner that avoids insect and rodent harborage; and
(5)
display in a position clearly visible to customers, the
following information:
(A)
the name and address of the operator;
(B)
a statement to the effect that the water is obtained from
an approved source; and
(C)
a local or toll-free telephone number that may be called
for further information, service, or complaints.
(c)
Service, sampling and records shall meet the following
requirements.
(1)
All parts and surfaces of the water dispensing device shall
be maintained in clean condition by the vended water operator. The dispensing
chamber and dispensing nozzle shall be cleaned and sanitized each time the
device is serviced; whereas, all surfaces in contact with the vended water
shall be maintained as a deposit free, visibly clean system. A record of cleaning
and maintenance operations shall be kept by the operator for each water dispensing
device for a period of two years and be available for inspection upon request.
(2)
The vended water from each water dispensing device shall
have a bacteriological analysis conducted a minimum of once every month and
if required by the department, shall also be analyzed for other physical,
chemical, or microbiological parameters.
(A)
Sample results reported as coliform positive or unsuitable
for analysis shall be submitted by facsimile to the department within 24 hours
of receipt of the sample results from a laboratory acceptable to the department.
The person shall submit the results to the Manufactured Foods Division by
facsimile at (512) 719-0263, or by e-mail at Feedback.MFD@tdh.state.tx.us.
(B)
Sample results reported as coliform negative shall be submitted
to the department within ten calendar days of the last day of each month in
which the sample(s) were taken. The person shall send the results to the department
via mail to the following address: Manufactured Foods Division, Bottled and
Vended Water Program, 1100 West 49th Street, Austin, Texas 78756, or via e-mail
to Feedback.MFD@tdh.state.tx.us.
(C)
The person operating a water dispensing device shall maintain
the original of all sample results for a period of two years. The analyses
shall be performed by a laboratory acceptable to the department to perform
drinking water analyses, and a copy of the analysis shall be available for
review and copying during inspections.
(3)
Each person operating a water dispensing device shall maintain
a written maintenance program. The written maintenance program shall include
written servicing instructions for the operator; technical manuals for the
machine and water treatment appurtenances involved; and records of service.
The written maintenance program shall be available for inspection by the department.
(4)
The vended water operator shall clean and perform servicing
of the water vending machine a minimum of once per month.
(A)
More frequent cleaning and servicing may be required to
maintain sanitation or as required by the manufacturer of the equipment.
(B)
Sampling results of positive coliform or unsuitable for
analysis are indications that servicing of machine may be required at a higher
frequency than once per month as detailed in paragraph (5) of this subsection.
(5)
Methods of testing for maximum contaminant levels (MCLs)
for microbiological contaminants in water dispensed from water dispensing
devices shall be performed as follows:
(A)
if any sample collected from a water dispensing device
is determined to be unsatisfactory for any reason (i.e. coliform positive
or unsuitable for analysis), the operator shall notify the department in accordance
with paragraph (2)(A) of this subsection; and
(B)
the water dispensing device shall be cleaned, sanitized
and resampled immediately. Until the sample results are known the machine
shall remain out of service; and
(C)
if after being cleaned and sanitized, the vended water
is determined to be unsatisfactory, the machine shall remain out of service
until the source of the contamination has been located and corrected and a
negative sample obtained. The negative sample result shall be maintained in
accordance with paragraph (2)(C) of this subsection.
§229.88.Certificates of Competency.
A person may not furnish bottled or vended water to the public or for
distribution to the public unless the bottled or vended water operator holds
a certificate of competency under this chapter.
(1)
A person may not furnish bottled water to the public or
for distribution to the public unless the processing, bottling, and distribution
of the bottled water is performed by or under the full-time supervision of
a bottled and vended water operator who holds a certificate of competency
under this chapter.
(2)
A person may not furnish vended water to the public or
for distribution to the public unless the processing, bottling, and distribution
of the vended water is performed by or under the guidance and control of a
bottled and vended water operator who holds a certificate of competency under
this chapter.
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 13, 2003.
TRD-200303571
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §229.83, §229.86
The repeals are adopted under the Health and Safety Code, §431.241,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 431; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for the
performance of every duty imposed by law on the board, department, and the
commissioner of health. The review of these rules implements Government Code, §2001.039.
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 13, 2003.
TRD-200303572
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
Subchapter A. HAZARD COMMUNICATION
25 TAC §§295.1 - 295.9, 295.11 - 295.13
The Texas Department of Health (department) adopts amendments
to §§295.1-295.9 and 295.11-295.13, concerning the requirements
for public employers (tax base-supported employers and agencies created by
state law) to take actions to protect their employees from hazardous chemicals.
Section 295.12 is adopted with changes to the proposed text as published in
the March 14, 2003, issue of the
Texas Register
(28
TexReg 2242). Sections 295.1-295.9, 295.11, and 295.13 are adopted without
changes and, therefore, the sections will not be republished.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 295.1-295.9
and 295.11-295.13 have been reviewed and the department has determined that
reasons for adopting the sections continue to exist.
A notice of intention to review rules was published for §§295.1-295.9
and 295.11-295.13 in the January 24, 2003, issue of the
Texas Register
(28 TexReg 761) for the state agency review of rules
in accordance with Government Code, §2001.039. No comments were received
by the department on these sections.
The sections ensure that public employers will have access to new compliance
assistance documents that have been developed by the department and more timely
access to hazardous chemical information contained in material safety data
sheets. In addition, the sections clarify responsibilities of employers under
the Health and Safety Code, Chapter 502, and clarify how the department will
enforce the Chapter.
The amendment to §295.1 eliminates an outdated effective date established
in the previous rule. The amendments to §295.2 add one new definition,
delete one definition, and amend five others to clarify the intent of the
rules. The amendments to §295.3 reflect a change in the Division name
and provide the program's toll free telephone number. The amendments to §295.4
clarify that a model workplace chemical form is now available to employers
from the department. The amendment to §295.5 reduces the amount of time
that a hazardous chemical manufacturer or distributor will have to provide
a material safety data sheet (MSDS) to an employer after receipt of the employer's
written request for this document. The amendments to §295.6 specify the
federal citation for the standard that manufacturers and distributors of hazardous
chemicals must meet in providing container labels and clarify that employers
are responsible for re-labeling a hazardous chemical container when the label
is missing. The amendments to §295.7 notify employers of the availability
of a model written hazard communication program from the department and clarify
that this model is a recommended format. The amendments to §295.8 clarify
that an employer's refusal to allow an inspection is a violation of both the
Health and Safety Code, Chapter 502, and the rules. The amendments to §295.9
reflect the change in the Division name. The amendments to §295.11 clarify
that an employer's written response to the department's written notice of
proposed administrative penalties must conform to at least one of the options
listed in the written notice. The amendments to §295.11 also clarify
that a hazardous chemical manufacturer's or distributor's failure to provide
an MSDS within three business days of an employer's written request is an
example of a severe violation of Chapter 502. The amendments to §295.12
notify employers of the availability of the department's electronic and Spanish
versions of the workplace notice. The amendments to §295.13 clarify that
nurses, as well as physicians, may obtain trade secret information for a hazardous
chemical when that information is needed for medical treatment during an emergency.
No comments were received on the proposal during the comment period; however,
the department is making the following minor change due to staff comments
to clarify the intent and improve the accuracy of the section.
Change: Concerning §295.12(a), the wording of the workplace notice
was inadvertently omitted in the proposed amendments. The department is providing
an updated version of the workplace notice that provides the new program mailing
address.
The amendments are adopted under the Health and Safety Code, §502.019,
which provides the Texas Board of Health (board) with the authority to adopt
necessary rules to administer and enforce Chapter 502; 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. The review of these rules implements Government Code, §2001.039.
§295.12.Employee Notice; Rights of Employees.
(a)
Employers covered by the Act must post and maintain workplace
notices specified in this section. The wording of the required workplace notice
may be changed by the commissioner as needed.
Figure: 25 TAC §295.12(a) (.pdf format)
(b)
The workplace notice shall measure at least 8-1/2 by 11
inches and be typed, typeset, or mechanically produced with lettering that
is clearly legible. The letters shall not be smaller than 12 characters per
inch. The words "NOTICE TO EMPLOYEES" shall be in bold capital letters at
least 1/2 inch high. Other words spelled in capital letters in the sample
notice shall be reproduced in capital letters.
(c)
A current version of the workplace notice shall be clearly
posted and unobstructed at all locations in the workplace where notices are
normally posted, and at least one location in each workplace.
(d)
An employer may add information to the workplace notice
as long as the wording required by this section is included. Employers may
add the name and telephone number of the employer's safety or environmental
health officer to the bottom of the workplace notice in order to facilitate
communication within the workplace.
(e)
To assist employers in providing the workplace notice information,
the department shall make original copies of the workplace notice available
for photocopying by employers. The department shall also make an electronic
version of the workplace notice available to employers. A Spanish translation
of the workplace notice is available from the department.
(f)
Employees have guaranteed rights to accessing the workplace
chemical list and MSDSs and to receive training under the Act.
(g)
Employees have a guaranteed right to receive appropriate
personal protective equipment (PPE) from their employer. Employers shall provide
appropriate PPE to employees who may be exposed to hazardous chemicals in
their workplace. The employer shall provide training to employees regarding
how to maintain and store PPE appropriately to ensure that contamination does
not occur.
(h)
An employee shall not be disciplined, harassed, or discriminated
against by an employer for filing complaints, assisting inspectors of the
department, participating in proceedings related to the Act, or exercising
any rights under the Act.
(i)
Employees cannot waive their rights under the Act. A request
or requirement for such a waiver by an employer violates the Act.
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 13, 2003.
TRD-200303578
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 3, 2003
Proposal publication date: March 14, 2003
For further information, please call: (512) 458-7236
Chapter 1301.
HEALTH CARE INFORMATION
Subchapter A. COLLECTION AND RELEASE OF HOSPITAL DISCHARGE DATA
Chapter 14.
COUNTY INDIGENT HEALTH CARE PROGRAM
Chapter 27.
CASE MANAGEMENT FOR CHILDREN AND PREGNANT WOMEN
Chapter 32.
CASE MANAGEMENT
Chapter 33.
EARLY AND PERIODIC SCREENING, DIAGNOSIS, AND TREATMENT
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Chapter 181.
VITAL STATISTICS
Subchapter B. VITAL RECORDS
Subchapter C. CENTRAL ADOPTION REGISTRY
Chapter 229.
FOOD AND DRUG
Subchapter F. PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER
Chapter 295.
OCCUPATIONAL HEALTH
Part 16.
TEXAS HEALTH CARE INFORMATION COUNCIL