The Texas Department of Health (department) adopts amendments to §§33.13-33.14, 33.61-33.63, 33.66, 33.112, 33.122-33.123, 33.125, 33.131-33.135; new §§33.15 and 33.140; and the repeal of §33.139, concerning the administration of Medicaid Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) services. Sections 33.13, 33.15, 33.61-33.62, 33.66, 33.122, 33.125, 33.132, 33.134-33.135 and 33.140 are adopted with changes to the proposed text as published in the April 4, 2003, issue of the Texas Register (28 TexReg 2857). Sections 33.14, 33.63, 33.112, 33.123, 33.131 and 33.133 are adopted without changes and will not be republished. In Texas, the EPSDT program is known as Texas Health Steps (THSteps).

Specifically, the final amendments cover program purpose; outreach, informing and support services; recipient rights; confidentiality of records; consent; freedom of choice; eligibility for services; periodicity; periodic check-up due date; exceptions to timely delivery of THSteps services; medical check-up services; medical diagnosis and treatment services; approved medical check-up providers; primary responsibilities of medical check-up providers; and claims. The final new sections concern definitions and management of allegations of Medicaid fraud and program abuse. The repeal covers replacement of hearing aids.

Specifically, the amendments are required to clarify program components that are administered by the department and delete obsolete terms; the new rules add sections regarding definitions and referrals for the investigation of fraud or program abuse. The repealed section eliminates the department's responsibility for replacing hearing aids.

The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning proposed §33.13(a), a comma was deleted after the term "Periodic," in order to reflect the correct punctuation in the EPSDT program title.

Change: Concerning proposed §33.15(5), the comma between "Steps" and "(THSteps)" was deleted to reflect proper punctuation.

Change: Concerning proposed §33.15(6), the word "and" that preceded "Head Start" was changed to "or" and the phrase "programs that are" was changed to "program that is" for proper grammar.

Change: Concerning proposed §33.15(13), the word, "The" was inserted before "Texas" to reflect the proper title of the Texas Department of Health.

Change: Concerning proposed §33.61(b), the text ", still" was deleted to ensure proper grammar.

Change: Concerning proposed §33.62(a), the word "and" was inserted between "20.012;" and "Government Code" to ensure all included legal cites were applicable to this section.

Change: Concerning proposed §33.66, a comma was inserted between "check-up" and "diagnosis," to reflect proper punctuation.

Change: Concerning proposed §33.122, the following language was inserted at the beginning of subsection (a), "Each THSteps recipient is eligible to receive a comprehensive medical check-up during," replacing the words "THSteps comprehensive medical check-up services are available at."

Change: Concerning proposed §33.125(1), the word "medical" was deleted to ensure this section was not exclusive to only medical check-ups.

Change: Concerning proposed §33.125(2), the word "or" was added at the end of this paragraph to reflect proper format and style.

Change: Concerning proposed §33.132, in the introductory paragraph, the colon following "limitations" was changed to a period to reflect proper format and style.

Change: Concerning proposed §33.132(2), the word "Clients" was changed to "Recipients" to assure uniformity and consistency within these rules.

Change: Concerning proposed §33.134(5)(B), the terms, "clinic, program, or facility" were deleted and replaced with "exempt entity" for clarification.

Change: Concerning proposed §33.135, a portion of subsection (a) was deleted and additional language was added to reflect the reference to 1 Texas Administrative Code, §354.1003, which contains the complete regulations concerning time limitations for the submission of claims and appeals. Subsections (b) and (c) were deleted because although legally correct, §33.135 did not contain the complete regulations regarding time limits for submitting claims and appeals.

Change: Concerning proposed §33.140, the section title "Management of Complaints" was deleted and replaced with "Referral for Investigation of Fraud or Program Abuse" to more accurately reflect the intent of this new section. Also, the words, "as defined in TDH policy" were deleted after the word "action" because the department policy has no effect on another agency's determination of the appropriate action.

The following comments were received concerning the rules during the comment period and the department's response(s) follow each comment:

Comment: Concerning proposed §33.62, one commenter suggested adding language which would identify those agencies THSteps contracts with that provide outreach, informing and transportation, pursuant to Health Insurance Portability and Accountability Act (HIPAA) guidelines which allow recipients the right to request the names of these contracted entities.

Response: The department disagrees. HIPAA and accompanying implementation standards (45 CFR Parts 160, 162 and 164) apply to all covered entities as that term is defined in HIPAA (45 CFR §160.103), including Medicaid. HIPAA requires covered health plans to provide a Notice of Privacy Practices (Notice) to all enrollees. Notices are required to be mailed to Medicaid recipients by Medicaid programs and Medicaid contracted HMOs. These notices advise recipients of certain rights, including the right to an accounting of how and to whom the covered entity uses and discloses the individual's health information. Because the notices adequately disclose these rights, the comment will not be added. No change was made as a result of the comment.

Comment: Concerning the rules in general, one commenter asked why the proposed rules deleted "EPSDT" and replaced it with "medical check-up." The commenter asked if there are implications for the language change.

Response: There was no replacement of "EPSDT" with the term "medical check-up." Rather, "EPSDT" was deleted and replaced with the term Texas Health Steps; "Screening," was deleted and replaced with the term "medical check-up." The department, following stakeholder input, adopted "Texas Health Steps" as the name that better described the program's goals and was more easily identified by recipients. Many recipients did not understand the terms "Early and Periodic Screening, Diagnosis, and Treatment or "EPSDT". Because "medical check-up" is a term more in line with every day language and better describes what is involved in early and periodic screening, diagnosis and treatment, the department chose to replace "screening," with the term, "medical check-up." The positive implications of the terminology changes will ensure clarification and comprehension of program goals; there should be no negative implications as a result of these changes. No change was made as a result of this comment.

Comment: Concerning proposed §33.62(a), one commenter suggested deleting the word "Public" because it was too vague. The commenter suggested this rule should be more specific in terms of the law to which it referred.

Response: The department agrees. The word "Public" has been deleted and replaced with the words "Federal and state" in the subsection for clarity.

Comment: Concerning proposed §33.62(b), one commenter suggested deleting language which indicated certain contracted agencies are "considered an extension of TDH" because while such entities are contracted to perform the services and are delegated to act on behalf of TDH, they do not become an extension of TDH nor are such entities entitled to rights and protections of the department. The commenter suggested revising the language in this section to better define the legal relationship between TDH and its contractor.

Response: The department agrees. "Agencies" has been deleted and replaced with "entities," or "contracted entities" throughout this subsection, as appropriate, in order to clarify the relationship. In addition, "in that such entities" was inserted between "operations" and "including" to better clarify the relationship.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed the sections and has determined that reasons for adopting the sections continue to exist; however, the revisions are needed to reflect the changes to program administration and the laws that pertain to them.

The department published a Notice of Intention to Review for §§33.13-33.14, 33.61-33.63, 33.66, 33.112, 33.122-33.123, 33.125, 33.131-33.135, and 33.139, in the Texas Register on May 12, 2000 (25 TexReg 4358). No comments were received.

The department received comments from one individual representing Community Health Choice, a health maintenance organization (HMO), who was generally in favor of the rules and made recommendations.

Subchapter A. GENERAL PROVISIONS

25 TAC §§33.13 - 33.15

The amendments and new section are adopted under the Human Resources Code, §32.021, which allows the department to establish rules governing the Medicaid program; the Health and Safety Code, §12.001, which provides the Texas 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 the Government Code, §531.021, which provides the Health and Human Services Commission with the authority to administer the state's medical assistance program and are submitted by the department under its agreement with the Health and Human Services Commission to operate the Early and Periodic Screening, Diagnosis, and Treatment program as authorized under Acts 1991, 72nd Legislature, First Called Session, Chapter 15, §1.07. The review of these rules implements Government Code, §2001.039.

§33.13.Purpose.

(a) The Texas Medicaid Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program is a Title XIX federally-mandated program of prevention, diagnosis, and treatment for Medicaid recipients under age 21 years. In Texas, EPSDT is known as the Texas Health Steps (THSteps) program. The Texas Department of Health administers the medical and dental check-ups and treatment components of this program.

(b) THSteps check-up services will be provided when requested by the recipient according to periodic eligibility for service. Other THSteps services will be provided when medical or dental necessity is established and federal financial participation is available.

(c) The rules in this subchapter implement the medical and dental check-up, dental treatment, and outreach and informing components of THSteps.

§33.15.Definitions.

The following words or terms, when used in Subchapters A, B, C, D, and E, shall have the following meanings unless the context clearly indicates otherwise:

(1) Accompanied - A parent, guardian or authorized adult who presents a recipient under age 15 at a THSteps medical or dental check-up, or treatment visit and continues to wait for the child while the check-up or treatment takes place. It is a requirement of §33.134(e) of this title (relating to Primary Responsibilities of Medical Check-up Providers) of Subchapter E that a recipient under the age of 15 be accompanied as a condition for reimbursement, unless services are provided by an exempt entity.

(2) Authorized adult - A person, including an adult related to the child, who is authorized by a child's parent or guardian to accompany that child to a THSteps medical or dental check-up or treatment visit.

(3) Board - The Texas Board of Health.

(4) EOB - Explanation of Benefits.

(5) EPSDT - Early and Periodic Screening, Diagnosis, and Treatment is a service of the Medicaid program. EPSDT provides medical and dental check-ups, diagnosis, and treatment to Medicaid eligible recipients younger than 21 years of age. EPSDT is known in Texas as Texas Health Steps (THSteps).

(6) Exempt entity - A child-care facility (as defined in the Human Resources Code §42.002(3)), school health clinic, or Head Start program that is exempt from the parental accompaniment requirement under §33.134(e) of this title of Subchapter E.

(7) FFP - Federal financial participation is the federal government's share of a state's expenditures under the Medicaid program.

(8) HHSC - The Health and Human Services Commission.

(9) Medicaid - The medical assistance program implemented by the State of Texas under the provisions of Title XIX of the Social Security Act, as amended, (42.U.S.C. §§1396-1396v).

(10) Parental Involvement - The encouragement and involvement in and management of the health care of children receiving services from an exempt entity as defined in paragraph (6) of this section. Parental involvement includes the exempt entity notifying the child's parent, guardian, or other authorized adult before each visit for a THSteps medical or dental check-up or treatment visit of the time and place of the child's appointment and encouraging the parent, guardian, or other authorized adult to attend. Notification shall be done by the means of communication determined by the exempt entity to be the most effective. Such communication must be documented and may include, but is not limited to, one or more of the following options: a home visit from an outreach worker, written or printed correspondence, or telephone contact.

(11) Recipient - An individual who has been determined eligible for Medicaid.

(12) R&S - A Remittance and Status report that provides information on pending, paid, denied, and adjusted claims.

(13) TDH - The Texas Department of Health.

(14) THSteps - Texas Health Steps (THSteps) is the Texas name for the federally-mandated Medicaid service known as EPSDT.

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 August 11, 2003.

TRD-200304953

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

Subchapter B. RECIPIENT RIGHTS

25 TAC §§33.61 - 33.63, 33.66

The amendments are adopted under the Human Resources Code, §32.021, which allows the department to establish rules governing the Medicaid program; the Health and Safety Code, §12.001, which provides the Texas 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 the Government Code, §531.021, which provides the Health and Human Services Commission with the authority to administer the state's medical assistance program and are submitted by the department under its agreement with the Health and Human Services Commission to operate the Early and Periodic Screening, Diagnosis, and Treatment program as authorized under Acts 1991, 72nd Legislature, First Called Session, Chapter 15, §1.07. The review of these rules implements Government Code, §2001.039.

§33.61.Recipient Rights.

(a) Acceptance of THSteps services is voluntary. Acceptance or refusal of THSteps services does not affect eligibility for or benefits of any other Medicaid service.

(b) A recipient who refuses THSteps services may subsequently request and be provided such services if still eligible for Medicaid and THSteps.

§33.62.Confidentiality of Records.

(a) Federal and state laws and Medicaid regulations prohibit the disclosure of information about Medicaid recipients without the recipient's consent, except for purposes directly connected with the administration of the program (see 42 U.S.C. §1396a(a)(7); 42 C.F.R. §§431.301-431.306; Human Resources Code §§12.003 and 21.012; and Government Code §552.101). Eligibility and other information for which the recipient gives consent may be provided to THSteps providers. Medicaid providers of THSteps services are not considered directly connected with the administration of the program. Consequently, THSteps providers are not entitled to confidential information, including lists of names and addresses of recipients, without the consent of the recipient.

(b) Contracted entities performing certain administrative functions are considered an extension of TDH in exercising its responsibility to ensure effective THSteps program operations in that such entities, including contractors for outreach, informing, and transportation services, may receive confidential information without an individual recipient's consent to the extent that it is necessary in the administration of the contract. Pursuant to 42 U.S.C. §1396a(a)(7), 42 C.F.R. §§431.301-431.306 and Human Resources Code §12.003, these contracted entities are bound by the same standards of confidentiality as TDH. They must provide effective safeguards to ensure confidentiality.

§33.66.Freedom of Choice.

(a) All THSteps recipients have the right to choose participating providers of THSteps medical and dental check-up, diagnosis, and treatment services.

(b) Selection assistance provided to the recipient must be free of worker preferences or prejudices.

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 August 11, 2003.

TRD-200304954

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

Subchapter C. ELIGIBILITY

25 TAC §33.112

The amendment is adopted under the Human Resources Code, §32.021, which allows the department to establish rules governing the Medicaid program; the Health and Safety Code, §12.001, which provides the Texas 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 the Government Code, §531.021, which provides the Health and Human Services Commission with the authority to administer the state's medical assistance program and are submitted by the department under its agreement with the Health and Human Services Commission to operate the Early and Periodic Screening, Diagnosis, and Treatment program as authorized under Acts 1991, 72nd Legislature, First Called Session, Chapter 15, §1.07. The review of the rule 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 August 11, 2003.

TRD-200304955

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

Subchapter D. PERIODICITY

25 TAC §§33.122, 33.123, 33.125

§33.122.Periodicity.

(a) Each THSteps recipient is eligible to receive a comprehensive medical check-up during each of the following time periods:

(1) newborn inpatient examination;

(14) six years through seven years;

(15) eight years through nine years;

(b) Periodic routine dental check-up services are available for eligible recipients one year of age and older once every six months, based on the date of the recipient's last dental check-up.

§33.125.Exceptions to Timely Delivery of THSteps Services.

Exceptions to standards for the timely delivery of THSteps services can be made if:

(1) the recipient or family loses eligibility. This means that the recipient or family does not have a valid Medicaid identification form or Medicaid verification letter for the date that a check-up or the first appointment for diagnosis and treatment is scheduled;

(2) the recipient or family could not be located despite a good faith effort to do so. This means that no personal contact could be made with an adult member of the recipient's family; or

(3) the recipient's failure to receive necessary services in a timely manner was due to an action or decision of the family or recipient rather than a failure of THSteps or its designee to offer and provide support services.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 11, 2003.

TRD-200304956

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

Subchapter E. MEDICAL SERVICES

25 TAC §§33.131 - 33.135, 33.140

§33.132.Medical Diagnosis and Treatment Services.

Payment will be considered for any service considered medically necessary and for which federal financial participation is available, subject to the following limitations.

(1) Service coverage is determined on an individual basis, requires prior approval for payment by HHSC or its designee, and is subject to periodic reassessment.

(2) Recipients must be under age 21 and eligible for Medicaid on the date of service.

(3) Payment for services will be made only to approved providers enrolled in the Texas Medicaid Program.

§33.134.Primary Responsibilities of Medical Check-up Providers.

The primary responsibilities of medical check-up providers are:

(1) to conduct medical check-ups according to policies and procedures established by TDH;

(2) to provide clinic surroundings which will establish a good relationship between clinic personnel, the recipient, and the recipient's family;

(3) to interpret medical check-up results to the recipient or the recipient's parent, conservator, or responsible adult, during the course of the medical check-up;

(4) to make referrals for needed follow-up diagnosis and treatment services; and

(5) to ensure a recipient under age 15 is accompanied by a parent, guardian or authorized adult at a THSteps medical check-up unless the services are provided by an exempt entity and if the exempt entity:

(A) obtains written consent to the services, which has not been revoked, from the child's parent or guardian within the one-year period prior to the date the services are provided; and

(B) encourages parental involvement in and management of the health care of the children receiving services from the exempt entity.

§33.135.Claims - Time Limits, Return, and Denial.

The THSteps Program has time limits for submitting claims. Time limits for filing claims and appeals shall be in accordance with the rules of the Health and Human Services Commission, 1 Texas Administrative Code, §354.1003.

§33.140.Referral for Investigation of Fraud or Program Abuse.

TDH will report all allegations of Medicaid fraud and other unlawful activities to the appropriate authority for review of the allegations and determination of the appropriate action. TDH will refer all complaints alleging quality of care issues to the appropriate licensing or regulatory authority.

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 August 11, 2003.

TRD-200304957

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

25 TAC §33.139

The repeal is adopted under the Human Resources Code, §32.021, which allows the department to establish rules governing the Medicaid program; the Health and Safety Code, §12.001, which provides the Texas 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 the Government Code, §531.021, which provides the Health and Human Services Commission with the authority to administer the state's medical assistance program and are submitted by the department under its agreement with the Health and Human Services Commission to operate the Early and Periodic Screening, Diagnosis, and Treatment program as authorized under Acts 1991, 72nd Legislature, First Called Session, Chapter 15, §1.07. 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 August 11, 2003.

TRD-200304958

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 4, 2003

For further information, please call: (512) 458-7236

Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

Subchapter P. SURVEILLANCE AND CONTROL OF BIRTH DEFECTS

25 TAC §§37.301 - 37.306

The Texas Department of Health (department) adopts amendments to §§37.301-37.306, concerning the surveillance and control of birth defects. Sections 37.301-37.306 are adopted without changes to the proposed text as published in the April 18, 2003, issue of the Texas Register (28 TexReg 3197) and will not be republished. The sections are amended to correlate with current state law and to add clarity to portions of the rules.

Government Code, §2001.039, requires that each state agency conduct a review of its rules every four years and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedures Act). Sections 37.301-37.306 have been reviewed and the department has determined that reasons for adopting the sections continue to exist, in that rules on this subject are needed.

The department published a Notice of Intention to Review for §§37.301-37.306, concerning Government Code, §2001.039, in the Texas Register on April 28, 2000 (25 TexReg 3799). The department received no comments due to the publication of the notice.

No comments were received on the proposal during the comment period.

The amendments are adopted under Texas Health and Safety Code, §87.021, which requires the Texas Board of Health (board) to adopt rules on the operation of the birth defects program; §87.022, which requires the board to adopt rules on how information will be collected and made available; §87.063, which requires the board to establish criteria to be used in deciding how research proposals will be approved; 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.

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 August 8, 2003.

TRD-200304916

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: April 18, 2003

For further information, please call: (512) 458-7236

Chapter 91. CANCER

Subchapter B. PROSTATE CANCER ADVISORY COMMITTEE

25 TAC §91.21

The Texas Department of Health (department) adopts the repeal of §91.21, concerning the Prostate Cancer Advisory Committee (committee), without changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4041) and will not be republished. The committee has provided advice to the Texas Board of Health (board) and the department on strategies for educating the public on the health benefits of the early detection, prevention, and treatment of prostate cancer.

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 2002, the board established a rule relating to the Prostate Cancer Advisory Committee. The rule states that the committee will automatically be abolished on September 1, 2003. The board has now reviewed and evaluated the committee and has determined that the committee should be abolished on that date. Issues relating to the type of advice previously provided by the committee may be better addressed through the establishment of ad hoc workgroups.

There were no comments received concerning the repeal during the 30-day comment period.

The repeal is adopted under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; the Government Code, Chapter 2110, which sets standards for the evaluation of advisory committees by the agencies for which they function; and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 8, 2003.

TRD-200304879

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

Chapter 97. COMMUNICABLE DISEASES

Subchapter E. PROVISION OF ANTI-RABIES BIOLOGICALS

25 TAC §§97.121, 97.123 - 97.125

The Texas Department of Health (department) adopts amendments to §97.121 and §§97.123 - 97.125, concerning the provision of anti-rabies biologicals. Section 97.124 is adopted with changes to the proposed text as published in the April 18, 2003, issue of the Texas Register (28 TexReg 3200). Sections 97.121, 97.123, and 97.125 are adopted without changes and will not be republished. The sections are amended to correlate with current state law and to add clarity to portions of the rules.

Government Code, §2001.039, requires that each state agency conduct a review of its rules every four years and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001, (Administrative Procedures Act). Section 97.121 and §§97.123 - 97.125 have been reviewed and the department has determined that reasons for adopting the sections continue to exist in that rules on these subjects are needed.

The department published a Notice of Intention to Review for §97.121 and §§97.123 - 97.125 as required by Government Code, §2001.039, in the Texas Register on January 14, 2000 (25 TexReg 275). The department received no comments due to the publication of the notice.

No comments were received on the proposal during the comment period. However, the department has made the following minor change due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning §97.124, the word "distribution" was replaced with "biologicals" in the first sentence of the section.

The amendments are adopted under Texas Health and Safety Code, §12.033, which provides for fees for the distribution and administration of certain vaccines and sera; §826.025, which provides for vaccine and hyperimmune serum to be dispensed to persons at risk of being exposed to rabies; §826.011, which requires the Texas Board of Health (board) to adopt rules necessary to effectively administer Chapter 826; 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.

§97.124.Payment for Anti-Rabies Biologicals.

The department is specifically authorized by law to distribute anti-rabies biologicals and to receive reimbursement for the cost of the biologicals.

(1) Options for reimbursement will be in accordance with policies set by the Immunizations Division, Texas Department of Health, and are as follows:

(A) Payment at time of issue. Arrangements for payment must be complete at the time of issuance of the anti-rabies biologicals, including options for monthly payments and/or third party coverage, or payment in full at the time of receipt. The regional director is responsible for ensuring that payment arrangements are made.

(B) Inability to pay. The regional director will accept, in lieu of payment, a statement signed by the patient that the patient is unable to pay in whole or part the cost of the biologicals and has no third party or other alternate source to provide payment.

(2) Refusal to pay. The department shall have the right to seek reimbursement in the event of a refusal to pay by a patient, or by his or her third-party coverage or other legally obligated source. A county or district attorney or the Texas attorney general, upon request of a department, may initiate suit or other proceeding in the county of the recipient's residence against the recipient, the parent, guardian, or other person or persons legally responsible for the support of the recipient or against responsible third parties.

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 August 8, 2003.

TRD-200304889

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: April 18, 2003

For further information, please call: (512) 458-7236

Chapter 98. HIV AND STD PREVENTION

Subchapter C. TEXAS HIV MEDICATION PROGRAM

1. GENERAL PROVISIONS

The Texas Department of Health (department) adopts amendments to §§98.101 - 98.106, repeal of §§98.107 - 98.117, and new §§98.107 - 98.115, and §§98.117 - 98.119, concerning the Texas HIV Medication Program. The amendments to §§98.101, 98.102, and 98.106, new §§98.107, 98.109, 98.110, 98.112, 98.114, 98.115, 98.117, and 98.119 are adopted with changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4041), as a result of comments received during the 30-day comment period. The amendments to §§98.103 - 98.105, new §§98.108, 98.111, 98.113, and 98.118, and the repeal of §§98.107 - 98.117 are adopted without changes and will not be republished. Proposed new §98.116 has been withdrawn and was published in the May 23, 2003, issue of the Texas Register (28 TexReg 4041).

The amendments allow the department to implement cost containment measures, outlined in the rules, as needed to address a substantial budgetary shortfall in the program and to ensure that the department is able to continue delivering program services to individuals infected with the human immunodeficiency virus (HIV). Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to Government Code, Chapter 2001 (Administrative Procedure Act). Sections 98.101 - 98.117 have been reviewed, and the department has determined that the reasons for adopting the sections continue to exist; however, §§98.101 - 98.106 were amended; §§98.107 - 98.117 were repealed; and §§98.107 - 98.115 and §§98.117 - 98.119 are adopted as new rules.

The department published a Notice of Intention to Review for the sections, as required by Government Code, §2001.039, in the Texas Register on April 28, 2000 (25 TexReg 3801). No comments were received due to the publication of this notice.

The amendments cover: Purpose; Definitions; Medication Coverage; Nondiscrimination; Priority; General Eligibility Criteria. The repeal of §§98.107 - 98.117 allows for the adoption of the new sections in Texas Register format. The new sections cover: Medical Eligibility Criteria; Residency Eligibility Criteria; Financial Eligibility Criteria; Application Process; Confidentiality; Program Distribution of Medications; Participating Pharmacy; Prescription Fees; Fiscal Planning; Denial of Application or Termination of Client Benefits; Appeal Procedures; and Exceptions from Appeal Procedures.

The amendment to §98.101 reflects minor changes in wording regarding the purpose of the program. The amendment to §98.102 adds a definition for Eligible Metropolitan Area and deletes a definition for the HIV H.O.P.E. (Health Options to Promote Employment) Project. The amendment to §98.103 adds a provision that the program will not approve the dispensing of medication(s) in excess of a 30-day supply. The amendment to §98.104 includes a minor change for clarity. The amendment to §98.105 establishes the program's priority to serve eligible women and infants, and to children younger than 18 years of age. The amendment to §98.106 outlines the general eligibility criteria for participation in the program. New §98.107 establishes medical eligibility criteria for the program. New §98.108 establishes residency eligibility criteria for the program. New §98.109 establishes financial eligibility criteria for the program. New §98.110 establishes the process for applying to the program. New §98.111 establishes how the program will maintain confidentiality of individuals who apply and receive services from the program. New §98.112 establishes how the program will distribute medications. New §98.113 establishes that the program will only deliver services through pharmacies approved by the program. New §98.114 establishes that pharmacies participating in the program may collect a dispensing fee for each prescription dispensed and that the program will pay the dispensing fees for Medicaid clients. New §98.115 establishes temporary cost-containment measures, such as initiate medical criteria to meet at minimum the most recent Federal Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, discontinue using the formula for adjusting the clients' gross annual income, lower the financial eligibility criteria, and cease enrollment of new clients. New §98.117 establishes the criteria for denial of applications to the program and termination of client benefits. New §98.118 establishes appeal procedures when a person wishes to dispute the program's decision concerning either eligibility or funding. New §98.119 establishes that the department is not required to offer an opportunity to dispute the decision to deny or terminate client status when the department's actions result from the exhaustion of funds.

The department is making the following changes due to staff comments.

Change: Concerning §98.101, the program only provides prescription drugs and offers no other types of prescription assistance; therefore, the proposed rule language was changed to make clear that the program provides "prescription drugs" to low-income individuals with HIV disease.

Change: Concerning §98.102(6), the first word "A" in the definition was capitalized to be consistent with Texas Register format.

Change: Concerning §98.106(5), an applicant must submit a complete application to be considered for enrollment in the program. Proposed rule language did not clearly stipulate that the application for assistance must be complete; therefore, the final rule language has been amended to clarify this requirement.

Change: Concerning §98.107(a)(2), the word "medications(s)" was replaced with the word "medications" to correct a grammatical error.

Change: Concerning §98.110, the program must occasionally verify or collect additional information pertaining to the application or recertification process. Subsection (c) was added to the section to clarify that the applicant is expected to give informed consent to the department so that the program may contact an applicant, client, or medical provider to verify information contained in the application or to request additional supporting documentation pertaining to the application for enrollment or recertification purposes.

Change: Concerning §98.112, a comma was added after the word "Division".

Change: Concerning §98.115, the section pertains to fiscal planning and not program budget; therefore, the title of this section has been amended.

Change: Concerning §98.115(a)(1) - (2), the formula for determining the annual average cost to the program for providing prescription drugs to clients is derived from the aggregate client costs, and not the individual per client cost; therefore, the section has been amended to add clarity.

Change: Concerning §98.115(c)(1)(A) - (D), proposed language was amended to make the subsection stylistically consistent. The cost-containment measures described in this subsection have been re-prioritized.

Change: Concerning §98.115(c)(1)(A), the word "Initiate" was added to the first of sentence before the word "medical", and the word "must" was deleted and the word "to" was added before the word "meet" to correct the grammatical structure of the paragraph.

Change: Concerning proposed §98.115(c)(1)(E), renumbered as (C), clarifying language was added to improve comprehension of the paragraph. Specifically, the word "financial" has been added to describe the eligibility criteria being referred to, and a reference to §98.109(a)(4) of this title relating to Financial Eligibility Criteria has been added.

Change: Concerning §98.115(c)(2), the word "reverse" before "the cost-containment" has been replaced with the word "rescind" to correct the grammatically complex statement.

Change: Concerning §98.119, the change corrects a grammatically incorrect statement.

The following comments were received concerning the proposed sections during the public comment period. Following each comment is the department's response and change.

Comment: Concerning §98.106(4), one commenter felt the insertion of the word "only" seemed gratuitous and unnecessary since the program cannot provide medications not included on its formulary, and implied that someone applying for both formulary and non-formulary medications would somehow be declared ineligible.

Response: The department agrees. The word "only" was removed from §98.106(4).

Comment: Concerning §98.107(b), one commenter suggested that language allowing the Bureau Chief to make exceptions to the medical eligibility criteria should be moved to §98.115(c)(1)(A) for clarity. Another commenter felt that the rules as written appear to indicate that the Bureau Chief may waive medical criteria only if cost-containment measures have not been implemented, and suggested the wording be clarified to indicate the Bureau Chief has broader power to waive medical criteria in any case for every client, regardless of the implementation of cost-containment measures.

Response: The department disagrees. The Bureau Chief's ability to make exceptions to medical eligibility is clearly defined in §98.107(b). No change was made as a result of this comment.

Comment: Concerning §98.109(a)(2), three commenters asserted that the proposed rules did not clearly state that exceptions would be allowed for inadequate private insurance prescription coverage and that Medicare supplements were not specifically addressed. The commenters wanted to ensure that the rules treat all underinsured individuals in the same manner, regardless of whether their health care is provided in part by the government or by a private insurer. One of the commenters also stated that the methodology of projecting future expenditures would need to also take into account increases in the cost of medications for more accurate forecasting.

Response: The department agrees. The wording in §98.109(a)(1) - (3) has been strengthened to allow the program to provide prescription drugs to clients who receive less than full coverage for prescription medications regardless of whether clients participate in federal, state or private insurance programs.

Comment: Concerning §98.109(a)(4), three commenters felt that clarification was needed to ensure that currently enrolled clients would not be negatively impacted by the implementation of the new financial eligibility criteria that bases eligibility on annual gross income rather than on adjusted annual gross income. One commenter recommended retaining the income adjustment as a criterion for eligibility and then placing the adjustment on hold when funding levels preclude its utilization.

Response: The department agrees. The adjustment to a client's annual gross income has been retained. The suspension of the income adjustment has been added to the cost-containment measures described in §98.115(c)(1). New language in §98.115(d) ensures that cost-containment measures, if and when implemented, will apply to clients enrolling in the program after the cost-containment measure is implemented.

Comment: One commenter expressed confusion over the use of the terms "minors" versus "emancipated minors" in §98.109(b)(2) and §98.102(9), and felt clarification was necessary.

Response: The department agrees and has changed §98.109(b)(2) and added new §98.109(b)(3) to distinguish the difference of determining the financial eligibility criteria of a minor and that applied to an emancipated minor. Section 98.102(9) was not revised.

Comment: Concerning §98.114, one commenter was concerned that the section implied that client fees could consist of both prescription co-payments and a monthly premium for services received. A second commenter stated that it was unclear whether "dispensing fees" for Medicaid clients also included the co-payments that are being proposed by Medicaid.

Response: The department agrees. Concerning §98.114, the word "copayment" has been changed to "dispensing fee". Concerning §98.116, the rules proposing the department collect client fees have been deleted.

Comment: Concerning §98.115(a), one commenter would like to see the monthly analysis of program costs made available on a regular basis via the program web site.

Response: The department agrees. The department will consider posting expenditure and utilization data on the program web site. No change was made as a result of this comment.

Comment: Concerning §98.115(c)(1)(B), two commenters noted that the implementation of a cost-containment measure that would halt admission of clients from Title I Eligible Metopolitan Areas (EMAs) appears to violate the Ryan White Care Act and does not treat all clients equally. One commenter specified that the provision also violated the U.S. Department of Health and Human Services policy, the Equal Protection Clause of the Fourteenth Amendment, and the Health Resources and Services Administration's Department of Social Services Program Policy Guidance Number 5, which specifies that AIDS Drug Assistance Program (ADAP) treatments must be equally and consistently applied across the state.

Response: The department agrees that the proposed rules would not provide equal opportunity to all persons choosing to enroll in the program. Concerning §98.115(c)(1)(B), the proposed cost containment strategy to cease enrollment to clients living in Title I EMAs has been deleted. Cost containment strategies, if implemented, will be applied equitably to all clients.

Comment: Concerning proposed §98.115(c)(1)(D), two commenters questioned the viability of implementing client fees for service. It was recommended that the implementation of sliding scale fees be eliminated because the revenue the fees would generate would not cover the department's administrative expense of collecting the fees.

Response: The department agrees. The language in §98.115(c)(1)(D) was deleted and §98.116 has been withdrawn.

Comment: Concerning §98.116(c) and (d), one commenter thought the wording was unclear as to whether both sections were describing the same client fees. The commenter also stated that the word "monthly" needed to be added to describe the fees, otherwise the fees could be construed as outrageously high co-payments per prescription for this population.

Response: The department agrees. The language in §98.115(c)(1)(D) was deleted and §98.116 has been withdrawn.

Comment: Concerning the repeal of §98.117, one commenter felt the provision for making complaints needed to be reinstated in the rules, either in this section or elsewhere in the rules governing the Bureau.

Response: The department disagrees. Public complaints are processed in accordance with established department policy. No change was made as a result of this comment.

Comment: Concerning §98.117(a)(1)(B), three commenters stated that clarification was needed to assure that current clients would not be terminated from the program if they do not meet the revised financial eligibility criteria proposed in new §98.109. It was recommended that a clear statement of intention regarding the continuing eligibility (or "grandfathering") of current clients be incorporated into the proposed rules.

Response: The department agrees. New language in §98.115(d) ensures that cost-containment measures, if and when implemented, will apply to clients enrolling in the program after the cost-containment measure is implemented. Section 98.117(a)(1)(B) was not revised.

Comment: Concerning §98.117(a)(2)(C), two commenters expressed concern that clients who cease to receive services for a time-period exceeding three months due to physician scheduled treatment interruptions (STIs), also known as "drug holidays", could be subject to termination from the program. One commenter suggested the following rewording as follows: "the client has not requested or used services during any period of three consecutive months, and the program has established that the client's failure to access services during the period was not the result of reliance on the advice or suggestion of a medical provider."

Response: The department agrees. Section 98.117(a)(2)(C) has been changed from three consecutive months to six consecutive months.

Comment: Concerning §98.118(b), one commenter thought that the review panel for appeals regarding denial or termination of service should include an additional person or persons who have not been directly involved in the previous decision-making process.

Response: The department disagrees. The Chief of the Bureau of Communicable Disease Prevention and Control, is an external member of the review panel who is not involved in the daily operations of the Bureau of HIV and STD Prevention and, therefore, is an objective reviewer. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter stated that the program should require annual recertifications of all clients. Third party client certifications from clinics and other service providers should not be accepted as proof of recertification, as those organizations may misrepresent their client's eligibility status in order to gain program approval.

Response: The department agrees. Section 98.109(c) has been added to allow the program to annually verify the financial status of an enrolled client to determine if the client is continuing to meet the financial eligibility criteria of the program.

Comment: Concerning the rules in general, one commenter expressed confusion regarding the need for rule changes since the Texas Legislature has appropriated additional funding.

Response: The department disagrees. The program did not receive its full requested amount of funding for fiscal years 2004 - 2005. Funding shortfalls are still projected for fiscal years 2004 - 2005, necessitating rule changes to maintain fiscal responsibility for the program. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter felt that drug prices should be negotiated with the manufacturers in order to secure lower drug prices for the program rather than implementing eligibility changes.

Response: The department disagrees. The program is part of a National Task Force that has been negotiating additional drug discounts from major manufacturers of HIV drugs. The aggregate amount of these discounts fall far short of the amount needed to cover the projected budget shortfalls for fiscal years 2004 - 2005. No change was made as a result of this comment.

Comment: Concerning the rules in general, several commenters stated that they believed the implementation of medical criteria for determining eligibility of new and returning clients was the most acceptable and/or least damaging option of the cost-containment measures proposed.

Response: The department agrees. The implementation of additional medical eligibility criteria is the first cost-containment strategy that will be implemented if needed. No change was made as a result of this comment.

Comment: Concerning the rules in general, two commenters thought that any proposed cost-sharing fees passed on to clients should be capped.

Response: The department agrees. The cost-containment strategy of implementing client fees has been deleted from §98.115(c)(1)(D) and §98.116 has been withdrawn.

Comment: Concerning the rules in general, one commenter believed that if Priority Two and Three medications were removed from the program formulary, it would be preferable to have Priority Three removed first, with Priority Two removed only if absolutely necessary to continue services.

Response: The department agrees; however, removing any currently approved medication from the program was not proposed. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter expressed favor of eliminating the spend-down for income adjustment before restricting income eligibility any further than 200% of Federal Poverty Level (FPL).

Response: The department agrees. Suspending the adjustment for annual gross income has been added to the cost-containment strategies listed in §98.115(c).

Comment: Concerning the rules in general, one commenter requested that the program facilitate a process that would allow local agencies to purchase supplemental HIV medications at a reduced cost.

Response: The department agrees. The department is currently analyzing the feasibility of assisting local agencies in securing HIV medications at the same cost that the department pays. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter stated that in order to encourage Texans enrolled in the program to maintain health insurance coverage, the out-of-pocket expenses the client pays to maintain health insurance should be subtracted from the client's annual gross income.

Response: The department disagrees. The program is not a provider of health insurance but a provider of medications. The annualized cost of a person's medications is used to adjust the person's annual income for eligibility purposes. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter felt that priority should be given to the clients most in need medically rather than financially as determined by their viral load and T-cell counts. The commenter stated the neediest clients would not necessarily also be the poorest clients.

Response: The department agrees. Concerning §98.115(c)(1)(A), language has been added to require that applicants, applying to the program after the cost-containment strategy has been implemented, meet "at minimum" the most recent Federal Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents.

Comment: Concerning the rules in general, one commenter stated that the Medical Certification Form (MCF) should be changed in order to allow a patient's medical provider to establish medical eligibility rather than having someone representing the department doing it.

Response: The department disagrees. Both federal and state governments mandate eligibility criteria be developed by the state agency managing the AIDS Drug Assistance Program (ADAP). No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter opined that by providing priority access to participation to eligible women and infants the program is performing a disservice to the persons living with HIV/AIDS in the West Texas planning area, 90% of which are male.

Response: The department disagrees. The overwhelming majority of program clients are male. They represent 78% of the total enrolled clients. Women make up only 22% of the total clients. As for children, less than 1% of the program's clients are under the age of 19. No change was made as a result of this comment.

Comment: Concerning the rules in general, several commenters expressed their disapproval that funds for international AIDS relief efforts were being increased at the same time domestic policies were preventing clients in need from accessing needed medications and medical services within our own country.

Response: The department does not agree or disagree with the comment. The department is not involved in international AIDS relief. No change was made as a result of this comment.

Comment: Concerning the rules in general, two commenters mentioned that a portion of the Texas Lottery profits should be diverted to the program to help cover expenses.

Response: The department does not agree or disagree with the comment. The department is not involved in the allocation of Texas Lottery profits. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter asserted that the money donated to the department should be used to assist with purchasing of HIV medication.

Response: The department disagrees. The program does not receive public donations to support the activities of the program. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter suggested that the department continue dialogue with HIV planning bodies and Title I EMAs before attempting to redirect a portion of State and/or Ryan White client service dollars into the program.

Response: The department agrees. Dialogue with Texas Title I EMAs and the department is continuing. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter requested that the program focus their energy on continuing to work with state AIDS directors to negotiate reasonable prices for HIV medications as a long-term solution.

Response: The department agrees. The Bureau of HIV and STD Prevention is involved with the National ADAP Task Force in an effort to negotiate lower drug costs with drug manufacturers. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter warned the program not to rely on manufacturers' compassionate care programs for continuing assistance.

Response: The department disagrees. During the National ADAP Task Force negotiations with eight major drug manufacturers (Roche, Gilead, Merck, Glaxo-Smith-Kline, Bristol Myers Squibb, Pfizer, and Abbott), top management from all eight companies offered more assistance from their patient assistance programs and also offered to streamline their application processes to help with the current national ADAP financial crisis. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter proposed a statewide workgroup be created to recommend a variation on cost-containment measures rather than sticking to the ones mentioned in the proposed rule changes.

Response: The department disagrees. A thirty day written comment period, two public hearings, and 19 town-hall meetings were conducted throughout the state to collect public comments on the proposed rules. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter hoped that the program would give at least three months advance notice to clients prior to implementing cost containment measures, in order to allow clients time to secure alternate resources.

Response: The department agrees. The department has convened a statewide work group to assist in developing procedures for implementing proposed cost-containment measures. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter expressed concern that the department has a legal and ethical obligation to ensure that program clients are not terminated from the program as a result of changes to the eligibility criteria. The commenter said the proposed rule changes indicate that such terminations could occur, which would violate the right to due process guaranteed under the Fourteenth Amendment of the U.S. Constitution, as well as the estoppel doctrine, a legal principle adopted by Texas courts.

Response: The department disagrees. The subsection in §98.115(d) has been added to clarify that if and when a cost-containment measure(s) is implemented, the measure will be applied to clients enrolling in the program after the date the measure was implemented. Clients currently enrolled in the program will not be affected by the implementation of a cost-containment measure.

Comment: Concerning the rules in general, numerous commenters expressed concern that clients denied services will become sick and require hospitalization in public hospitals and indigent care facilities, thus increasing the amount spent on healthcare for each person.

Response: The department disagrees. Clients denied services will have to identify other resources in the community (Pharmaceutical Patient Assistance Programs, Hospital Districts, additional Ryan White Funding) already within their communities to assist in accessing medications. No change was made as a result of this comment.

Comment: Concerning the rules in general, numerous commenters expressed concern that the clients who are "disqualified" from receiving services would shift the public health burden to local communities who lack funding to support such a volume of services.

Response: The department disagrees. While the burden of ineligible clients may be shifted to local communities, the overwhelming majority of the program's clients reside in Ryan White Title I EMAs. These EMAs receive direct federal funding to provide HIV-related services for clients including medication assistance. No change was made as a result of this comment.

Comment: Concerning the rules in general, numerous commenters expressed concern that lapses in medication therapy coverage while attempting to obtain services from alternate resources would jeopardize patient health, leading to drug-resistant strains of HIV, increased viral loads that would serve to increase the transmission of HIV to others, and a higher mortality rate due to lack of treatment.

Response: The department disagrees. Increased viral loads do not lead to the transmission of HIV to others. Unsafe sexual practices and/or intravenous drug use with contaminated needles are the behaviors that lead to HIV transmission. Clients denied services from the program should identify resources within their community to assist them with accessing needed medications. No change was made as a result of this comment.

Comment: Concerning the rules in general, numerous commenters expressed concern that the working poor would be hardest hit by the proposal; their inability to receive additional services would cause them to become too sick to work and lose their jobs, making them eligible for additional public assistance while shrinking the taxpayer base.

Response: The department agrees. The department has reconsidered the financial eligibility criteria and has decided to continue providing for an adjustment to a client's annual gross income; therefore, §98.109(b) has been amended to allow for the annual gross income adjustment.

Comment: Concerning the rules in general, numerous commenters expressed concern that the proposal discourages people recovering from illness to actively seek reemployment, for fear of losing their eligibility to access medications.

Response: The department disagrees. The rules are designed to serve persons most in need of assistance while staying within the budget. No change was made as a result of this comment.

Commenters in favor of the rules were: None.

The comments received during the comment period were overwhelmingly opposed to any and all of the proposed rule changes. Although a few of the commenters expressed their understanding regarding the financial issues facing the department, none of the 1,016 comments received could be interpreted as actually favorable towards the proposed rules. Two client advocacy organizations expressed concerns over the specific wording of the various sections and submitted suggestions for alternate language concerning specific provisions in the rules. Commenters opposed to the rules were: the Texas AIDS Network, and the Lambda Legal Defense and Education Fund National Headquarters.

Commenters neither for nor against the rules were: None.

25 TAC §§98.101 - 98.115, 98.117 - 98.119

The amendments and new sections are adopted under the Health and Safety Code, §85.063, which provides the Texas Board of Health (board) with the authority to adopt rules necessary to establish eligibility guidelines to ensure the most appropriate distribution of funds; §85.016, which provides the board with the authority to adopt rules necessary to implement Subchapters A - F of Chapter 85, Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus Infection; and §12.001, which provides the board with the authority to adopt rules for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

§98.101.Purpose.

This subchapter establishes procedures and eligibility guidelines for the Texas HIV Medication Program (program) as required in the Health and Safety Code, §85.063. The program, established under the authority of the Health and Safety Code, Chapter 85, Subchapter C, HIV Medication Program, provides prescription drugs to low-income individuals with HIV disease. Hospital districts, local health departments, public or nonprofit hospitals and clinics, and nonprofit community organizations may request assistance from the program with obtaining public health pricing for medications to treat individuals with HIV disease.

§98.102.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) AIDS--Acquired immune deficiency syndrome as defined by the Centers for Disease Control and Prevention.

(2) Board--The Texas Board of Health.

(3) Client--An individual who, under these sections, is determined by a program to be eligible for services.

(4) Commissioner--The commissioner of health.

(5) Department--The Texas Department of Health.

(6) Eligible Metropolitan Area--A metropolitan area that is eligible to receive direct federal funding as defined in 42 U.S.C. 300ff-17.

(7) HIV--Human immunodeficiency virus infection as defined by the Centers for Disease Control and Prevention.

(8) Legally responsible person--A parent, managing conservator, or other person that is legally responsible for the support of a minor, a ward, or himself/herself.

(9) Minor--A person who has not reached his or her 18th birthday and who has not been emancipated by a court or who is not married or recognized as an adult by the State of Texas.

(10) Program--The Texas HIV Medication Program established under the Health and Safety Code, Chapter 85, Subchapter C.

(11) Services--Activities determined by the department as appropriate to carry out the intent of, Health and Safety Code, Chapter 85, Subchapter C.

(12) Texas resident--An individual who physically resides within the geographic boundaries of the state.

§98.106.General Eligibility Criteria.

A person is eligible to participate in the program if the person applying to the program:

(1) meets the medical eligibility criteria in §98.107 of this title (relating to Medical Eligibility Criteria);

(2) meets the residency eligibility criteria in §98.108 of this title (relating to Residency Eligibility Criteria);

(3) meets the financial eligibility criteria in §98.109 of this title (relating to Financial Eligibility Criteria);

(4) requests assistance in obtaining medications provided under the program; and

(5) submits a complete application for assistance as described in §98.110 of this title (relating to Application Process).

§98.107.Medical Eligibility Criteria.

(a) A person is medically eligible to participate in the program if the person applying to the program:

(1) provides evidence that the applicant has a diagnosis from a licensed physician of HIV disease; and

(2) is under the care of a physician licensed to practice in Texas who prescribes the medications.

(b) Exceptions to the Medical Eligibility Criteria can be made at the discretion of the Chief of the Bureau of HIV and STD Prevention.

§98.109.Financial Eligibility Criteria.

(a) A person is financially eligible for the program if he or she:

(1) is not covered for approved program medication(s) under the Texas Medicaid Program, or has exhausted Medicaid pharmacy benefits for the given month;

(2) does not qualify for assistance or receives less than full coverage for approved program medication(s) under any State compensation program or under any other state or federal health benefits program;

(3) is not covered under an insurance policy or is otherwise underinsured for prescription drugs; and

(4) has an annual gross income (minus the adjustments described in subsection (b) of this section) that does not exceed 200% of the most recently published federal poverty income guidelines.

(b) Formula for adjusting annual gross income.

(1) An applicant's annual gross income (if single), or the combined annual gross income of the applicant and his or her spouse, minus the program's cost of the prescribed medication(s).

(2) For a minor child, the (combined) annual gross income of the child's parent(s), minus the program's cost of the prescribed medication(s). Only the income of the parent(s) living in the same household as the child at the time of application or recertification will be used to determine financial eligibility.

(3) For an emancipated minor, financial eligibility is determined as set forth in paragraph (1) of this subsection.

(c) The department shall annually verify the financial status of an enrolled client to determine if the client is continuing to meet the financial eligibility criteria of the program.

§98.110.Application Process.

(a) To request an application packet, call toll-free 1-800-255-1090 or write to: Texas Department of Health, Bureau of HIV and STD Prevention, Texas HIV Medication Program, 1100 West 49th Street, Austin, Texas 78756-3199. The program's client application for assistance is also available online at the following URL: http://www.tdh.state.tx.us/hivstd/meds/document.htm.

(b) Submit completed applications along with certification forms to: Texas Department of Health, Bureau of HIV and STD Prevention, Texas HIV Medication Program, 1100 West 49th Street, Austin, Texas 78756-3199.

(c) The applicant is expected to give informed consent to the department so that the program may contact an applicant, client, or medical provider to verify information contained in the application or to request additional supporting documentation pertaining to the application for enrollment or recertification purposes.

§98.112.Program Distribution of Medications.

(a) The department will contract with a pharmaceutical wholesaler for purchase of drugs. The Texas Department of Health, Pharmacy Division, will distribute drugs to pharmacies participating in the program and a mail order pharmaceutical distributor for the dispensing of drugs directly to clients who reside outside areas covered by participating pharmacies.

(b) Program funds must be used as payor of last resort and coordinated with other local, state, and federal funds, including Medicaid.

§98.114.Prescription Fees.

A dispensing fee may be collected by a participating pharmacy for each prescription dispensed in accordance with the existing Memorandum of Agreement with the department. Medicaid clients will have their dispensing fees paid for by the program.

§98.115.Fiscal Planning.

(a) To ensure the program's expenditures do not exceed the program's budget, the department will analyze program expenditures as follows.

(1) Determine the annual average client cost using program expenditures from the previous 12 months. The annual average client cost is calculated by dividing the total amount of funds expended during a 12-month period into the total number of clients served during the same 12-month period.

(2) Project the number of clients that may be served during the next 12-month period using current budget figures. The projected number of clients that may be served is calculated by dividing the program's total available dollars by the annual average client cost derived from paragraph (1) of this subsection.

(b) The department will perform an analysis of program expenditures every month using the methodology in subsection (a) of this section to determine if funds are sufficient to meet projected expenditures.

(c) To insure that expenditures do not exceed the program's budget, the department may implement the following temporary cost-containment measures as necessary.

(1) Cost-containment measures may be implemented in the following order.

(A) Initiate medical criteria to meet at minimum the most recent Federal Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents. Present medical criteria is a CD4 +T-cell count at or below 350 cells per cubic millimeter and/or an HIV viral load greater than 30,000 copies per milliliter when using the branched DNA test or more than 55,000 copies per milliliter when using the RT-PCR test.

(B) Discontinue using the formula for adjusting the clients' gross annual income described in §98.109(b) of this title (relating to Financial Eligibility Criteria.)

(C) Lower the financial eligibility criteria described in §98.109(a)(4) of this title to a level that is not lower than 125% of federal poverty level.

(D) Cease enrollment of new clients.

(2) As funds become available, the department will rescind the cost-containment measures in the reverse order of which they were implemented.

(d) Cost-containment measures, if implemented, will be applied to clients enrolling after the cost-containment measure(s) is implemented.

§98.117.Denial of Application or Termination of Client Benefits.

(a) Individuals already receiving services will have their application denied or services terminated only for one or more of the following reasons.

(1) Services will be denied or terminated if:

(A) the person is not a resident of the state as required in §98.108 of this title (relating to Residency Eligibility Criteria);

(B) the annual gross income does not meet the criteria set in §98.109 of this title (relating to Financial Eligibility Criteria);

(C) the person does not provide evidence to meet the criteria set in §98.107 of this title (relating to Medical Eligibility Criteria); or

(D) the client notifies the program in writing that he/she no longer wants to receive services.

(2) Services may be terminated if:

(A) the applicant or client submits an application form or any document required in support of the application which contains a misstatement of fact which is material to determining program eligibility;

(B) the client submits false claims to a participating pharmacy;

(D) program funds are exhausted.

(b) Denial, modification, suspension, or termination of services to a client will be governed by the procedures required by §98.118 of this title (relating to Appeal Procedures), and §98.119 of this title (relating to Exceptions from Appeal Procedures).

§98.119.Exceptions from Appeal Procedures.

The department is not required to offer an opportunity to dispute the decision to deny or terminate client status if the department's actions result from the exhaustion of funds appropriated to the department for purposes authorized under Health and Safety Code, Chapter 85, Subchapter C, Texas HIV Medication Program.

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 August 8, 2003.

TRD-200304926

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

25 TAC §§98.107 - 98.117

The repeals are adopted under the Health and Safety Code, §85.063, which provides the Texas Board of Health (board) with the authority to adopt rules necessary to establish eligibility guidelines to ensure the most appropriate distribution of funds; §85.016, which provides the board with the authority to adopt rules necessary to implement Subchapters A - F of Chapter 85, Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus Infection; and §12.001, which provides the board with the authority to adopt rules for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 8, 2003.

TRD-200304928

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

Chapter 130. CODE ENFORCEMENT REGISTRY

25 TAC §§130.1 - 130.18, 130.20

The Texas Department of Health (department) adopts amendments to §§130.1 - 130.18, and 130.20, concerning the registration of code enforcement officers. Sections 130.3 and 130.20 are adopted with changes to the proposed text as published in the April 18, 2003, issue of the Texas Register (28 TexReg 3201). Sections 130.1 - 130.2 and 130.4 - 130.18 are adopted without changes and, therefore, the sections will not be republished.

Government Code, §2001.039, requires that each state agency conduct a review of its rules every four years and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 130.1-130.18 and 130.20 have been reviewed and the department has determined that the reasons for adopting the sections continue to exist.

A Notice of Intent to Review for the sections, regarding Government Code, §2001.039, agency review of rules, was published in the February 12, 1999, issue of the Texas Register (24 TexReg 1003). No comments were received due to the publication of this notice.

The amendments update references to the Act as codified in Texas Occupations Code, Chapter 1952; update references to other codified laws; clarify existing language; and remove obsolete language. Minor amendments to wording in several sections for which no substantive change is indicated allow the sections to be published in their entirety. Amendments to §130.20 expand the list of activities approved for continuing education to include initial certification in related disciplines.

Three comments were received from individuals and were generally in favor of the rules. However, the commenters had questions and/or offered suggestions. Following each comment is the department's response and any resulting change(s).

Comment: One commenter requested that §130.12 be amended to allow registrants to renew once every two years instead of annually. Response: The department disagrees. The requirement for annual renewal is established in statute at Occupations Code, §1952.05. No change was made as a result of the comment.

Comment: Concerning §130.20, one commenter expressed support for the continuing education requirement included in the rules as proposed.

Response: The department considered the comment. No change was made as a result of the comment.

Comment: One commenter requested that the requirement for continuing education at §130.20 be changed to require six hours every four years.

Response: The department disagrees. The current annual requirement for six hours of continuing education, including at least one hour of legal/legislative updates, was developed in cooperation with all stakeholders, and has been successfully implemented in the last two years. The proposed change would lower the standard required for annual renewal to only 1.5 hours annually. No change was made as a result of the comment.

Comment: One commenter requested that the National Certified Pool Operators certification course be added to the list of initial certifications accepted under §130.20(q).

Response: The department agrees and has added a new paragraph to §130.20(q)(5).

The following changes were due to department staff comments.

Change: Concerning §130.20(b), a closing parenthesis was added after the word "Renewal".

Change: Concerning §130.3, standard language was added relating to the operation of the advisory committee to include the continuance of the committee until September 1, 2007; language was revised concerning the election of officers; additional requirements were included regarding statements by members; and clarification of the components that the committee must include in an annual report to the Board of Health (board).

The amendments are adopted under the Occupations Code, Chapter 1952; Government Code, §2110.005, which requires the department to adopt rules stating the purpose and tasks of its advisory committees; and the Health and Safety Code, §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, the department, and the commissioner of health. The review of these rules implements Government Code, §2001.039.

§130.3.Code Enforcement Officers' Advisory Committee.

(a) The committee. An advisory committee shall be appointed under and governed by this section.

(1) The name of the advisory committee shall be the Code Enforcement Officers' Advisory Committee (committee).

(2) The committee is established under the Health and Safety Code, §11.016 which allows the Texas 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 rules regarding code enforcement officers.

(d) Tasks.

(1) The committee shall advise the board concerning rules relating to registered code enforcement officers.

(2) The committee shall advise the department concerning the registration of code enforcement officers.

(3) The committee shall carry out any other tasks given to the committee by the board.

(e) Review and duration. By September 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 seven members appointed by the board. The composition of the committee shall include:

(1) three registered code enforcement officers;

(2) one structural engineer or licensed architect;

(3) two consumers, one of which must be a certified building official; and

(4) one person involved in the education and training of code enforcement officers.

(g) Terms of office. The term of office of each member shall be six years. Members shall serve after expiration of their term 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 December 31st of each odd-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 elect from its members a presiding officer and an assistant presiding officer to begin serving on September 1 of each odd-numbered year.

(1) Each officer shall serve until the next regular election of officers.

(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 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 Texas Department of Health (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 sitting 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 preceding 12 months and shall be filed with the board each September. 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.

§130.20.Continuing Education.

(a) Each registered code enforcement officer and code enforcement officer in training must meet the renewal requirements set out in this section.

(b) Code enforcement officers in training who apply to upgrade prior to the department's issuance of notice regarding the expiration of their registration as required by §130.12(c)(1) of this title (relating to Code Enforcement Registration Renewal) are not required to submit continuing education hours in order to upgrade.

(c) Each registered code enforcement officer and code enforcement officer in training must obtain and show proof of not less than six continuing education hours as set forth in this section within the twelve months preceding renewal of their registration, at least one hour of which must be in legal/legislative issues as provided in subsection (j)(12) of this section.

(d) Only continuing education activities conducted in accordance with this section shall be considered approved by the department and may be represented to the public as acceptable for registration renewal for registered code enforcement officers in Texas.

(e) Department approved continuing education activities for license renewal include the following:

(1) conferences;

(2) home-study training modules (including professional journals requiring successful completion of a test document);

(3) lectures;

(4) panel discussions;

(5) seminars;

(6) accredited college or university courses;

(7) video or film presentations with live instruction;

(8) field demonstrations;

(9) teleconferences; or

(10) other activities approved by the department.

(f) Only the following continuing education activities shall serve as a basis for registration renewal:

(1) approved by the department or its designee in accordance with this section; or

(2) approved by another professional regulatory agency in the State of Texas as acceptable continuing education for license renewal; and

(3) covering one or more of the curriculum areas listed in subsection (j) of this section.

(g) Continuing education activities must meet the following criteria if they are to be acceptable for continuing education credit:

(1) the activity must cover one or more of the curriculum areas listed in subsection (j) of this section;

(2) the activity must be conducted by an organization which is:

(A) an accredited college or university;

(B) a governmental agency, including local, state or federal agencies;

(D) a commercial education business;

(3) the activity must have a record keeping procedure which includes a register of who took the course and the number of continuing education units earned;

(4) the organization must implement procedures for verifying participant's attendance;

(5) the activity must be at least 50 minutes in length of actual instruction time. Round table discussions and more than one speaker for the total of 50 minutes per activity is permissible. No credit will be given for time used for other non-relevant activities; and

(6) the activity must be conducted in compliance with all applicable federal and state laws, including the Americans with Disabilities Act (ADA) requirements for access to activities.

(h) Organizations shall send, e-mail, or fax notification of upcoming continuing education to the department at least 15 days prior to the event which includes the:

(1) date(s) of the continuing education activity;

(2) time of the continuing education activity ;

(3) location of the continuing education activity;

(4) title of the activity; and

(5) name of the instructor(s).

(i) Commercial education businesses, in addition to the items listed in subsection (h) of this section, shall submit a request for approval on department forms; and shall not represent any course as approved until such approval is granted by the department in writing.

(j) The curriculum of an approved activity must include one or more of the following subjects:

(1) zoning and zoning ordinance enforcements;

(2) sign regulations;

(3) home occupations;

(4) housing codes and ordinances;

(5) building abatement;

(6) nuisance violations;

(7) abandoned vehicles;

(8) junk vehicles;

(9) health ordinances;

(10) basic processes of law related to code enforcement;

(11) professional, supervisory or management training related to the profession of code enforcement; or

(12) legislative or legal updates related to the profession of code enforcement.

(k) Documentation of continuing education activity shall be maintained by the organization for three years, including:

(1) a roster which shall include the following:

(A) name, address, phone number, code enforcement officer or code enforcement officer in training registration number, social security number (used to coordinate continuing education activity information with the department's records), and signature of the registrant; and

(B) number of continuing education hours earned by each individual;

(2) copy of notification and description of method transmitted to the department as required by subsection (h) of this section; and

(3) copies of all program materials sufficient to demonstrate compliance with this section.

(l) At the conclusion of the activity the organization shall distribute to those registered code enforcement officers and code enforcement officers in training who have successfully completed the activity a certificate of completion which shall include the name of the registrant; the name of the organization providing the training, the title of the activity; the date and location of the activity, and the continuing education hours earned. The certificate shall state "Approved in accordance with 25 Texas Administrative Code, §130.20 for code enforcement officer/code enforcement officer in training registration renewal in Texas." It shall include a breakdown of the hours earned on each topic listed under subsection (j) of this section.

(m) Each registered code enforcement officer and code enforcement officer in training shall collect and keep certificates of completion of approved courses. These certificates of completion will be used to document the attendance of a registered code enforcement officer or code enforcement officer in training at approved courses. The department will conduct random audits for compliance with this requirement.

(n) Failure to comply with the annual continuing education hour requirements for the registered code enforcement officer or code enforcement officer in training registration issued by the department will:

(1) result in suspension of a code enforcement officer or code enforcement officer in training registration until the necessary credits for continuing education are successfully completed; and

(2) require the registered code enforcement officer or code enforcement officer in training to make new application for registration as a code enforcement officer or code enforcement officer in training, if the registered code enforcement officer or code enforcement officer in training does not renew within one year after the original registration expired.

(o) The department may fail to accept any or all courses for registration renewal if an organization fails to file a timely notice of upcoming continuing education, fails to retain documentation related to the activity as required by this section, or fails to comply with any other requirements that are a basis for approval or that are a part of this subchapter.

(p) A registered code enforcement officer or code enforcement officer in training registration may file a written request for an extension of time for compliance with any deadline in this subsection. Such request for extension, not to exceed 30 days, shall be granted by the department if the registered code enforcement officer or code enforcement officer in training files appropriate documentation to show good cause for failure to comply timely with the requirements of this subsection. Good cause includes, but is not limited to, extended illness, extended medical disability, or other extraordinary hardship which is beyond the control of the person seeking the extension.

(q) Initial certification in the 12 months preceding renewal will be accepted as proof of the continuing education required by subsection (c) of this section if the certification is listed as follows.

(1) International Code Council (ICC):

(A) residential building inspector;

(B) residential electrical inspector;

(D) residential plumbing inspector;

(E) commercial building inspector;

(F) commercial electrical inspector;

(G) commercial mechanical inspector;

(H) commercial plumbing inspector;

(I) fire inspector I;

(J) fire inspector II;

(K) residential combination inspector;

(L) commercial combination inspector;

(M) certified building official;

(N) accessibility inspector;

(O) zoning inspector;

(P) property maintenance and housing inspector; or

(Q) housing code official; or

(2) International Association of Plumbing and Mechanical Officials (IAPMO):

(A) voluntary plumbing inspector; or

(B) voluntary mechanical inspector; or

(3) National Fire Protection Association (NFPA):

(A) certified fire protection specialist;

(B) fire inspector I;

(D) certified building inspector;

(E) certified residential electrical inspector; or

(F) certified master electrical inspector; or

(4) International Association of Electrical Inspectors (IAEI):

(A) building 1 & 2 family dwelling;

(B) building general;

(D) electrical general;

(E) fire protection general;

(F) fire protection plan review;

(G) mechanical 1 & 2 family dwelling;

(H) mechanical general;

(I) plumbing 1 & 2 family dwelling; or

(J) plumbing general or;

(5) National Swimming Pool Foundation (NSPF) certified pool-spa operator.

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 August 11, 2003.

TRD-200304984

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 31, 2003

Proposal publication date: April 18, 2003

For further information, please call: (512) 458-7236

Chapter 145. NURSING FACILITIES AND RELATED INSTITUTIONS

Subchapter H. LONG-TERM CARE SERVICES FOR THE ELDERLY

25 TAC §145.121

The Texas Department of Health (department) adopts the repeal of §145.121, concerning a memorandum of understanding between the department and the Texas Department on Aging, the Texas Department of Human Services, and the Texas Mental Health and Mental Retardation for long term care services for the elderly without changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4045) and 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). The department has reviewed §145.121 and has determined that reasons for adopting the section no longer exist.

The department published a Notice of Intention to Review for §145.121 in the Texas Register on February 12, 1999 (24 TexReg 1003). No comments were received due to publication of this notice.

The department adopts the repeal of §145.121 because there is no statutory requirement for the department to adopt a rule pertaining to a memorandum of understanding between the department and the Texas Department on Aging, the Texas Department of Human Services, and the Texas Mental Health and Mental Retardation for long term care services for the elderly.

No comments were received on the proposal during the comment period.

The repeal is adopted under the Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with authority to adopt rules to implement every duty imposed by law on the board, the department and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 8, 2003.

TRD-200304882

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

Chapter 221. MEAT SAFETY ASSURANCE

Subchapter B. MEAT AND POULTRY INSPECTION

25 TAC §221.15

The Texas Department of Health (department) adopts an amendment to §221.15, concerning meat and poultry inspection. Section 221.15 is adopted without changes to the proposed text as published in the March 14, 2003, issue of the Texas Register (28 TexReg 2240) and, therefore, the section will not be republished. The amendment clarifies how inedible by-products are to be handled and the requirements for field slaughter and processing of exotic wild game animals.

Under the proposed changes, inedible by-products are no longer required to be placed in containers marked with the word "INEDIBLE" if they will not be removed from the premises. However, the handling of inedible by-products must be in a manner that does not result in insanitary conditions or attract insects, vermin, or other pests. If inedible by-products are to be removed from the premises for disposal or rendering, they must be adequately denatured to preclude their use in human food and placed in containers conspicuously marked "INEDIBLE."

The Health and Safety Code, Chapter 433, requires inspection of each livestock animal before it is allowed to enter a processing establishment. Farm or ranch raised domestic livestock are examined while at rest and in motion before entering the slaughter department of a processing establishment. Due to their wild nature, exotic livestock raised under free-range natural wildlife conditions cannot always be presented for ante-mortem inspection. Trapping and holding or transporting these animals is not practical. Under field conditions, there may not be an opportunity to observe the animals in rest, in motion, and from both sides.

Current harvesting practice includes harvesting the animals with the aid of a helicopter. The game are located in the brush and chased out into an opening where they are killed by a single shot to the head or neck. It is not beneficial to the inspection process to observe animals that are fleeing. It is beneficial to examine the freshly killed animal to ensure that the body condition is that of a healthy animal and to determine that the animal was indeed killed by being shot.

Historical data from more than ten years of harvesting exotic wild game and the nature of the species indicate that exotic wild game available for slaughter in their natural environment are very low risk for disease. Exotic wild game has been harvested under inspection from Texas ranches since 1989 and none of the game has ever been condemned for health reasons or disease conditions observed during ante-mortem inspection.

When exotic game animals are harvested in their natural environment, unhealthy animals are not expected to be presented or available for harvesting. By nature, as a matter of survival, animals that are unhealthy will not show signs of illness or give indication that they are weaker than the rest of the herd. Predators generally select weak animals as an easy target. Those animals that are injured or ill enough to be symptomatic generally hide themselves until they recover or die.

There were no comments received during the 30-day comment period.

The amendment is adopted under the Health and Safety Code, Chapter 433, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 433; 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, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 8, 2003.

TRD-200304886

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: March 14, 2003

For further information, please call: (512) 458-7236

Chapter 229. FOOD AND DRUG

Subchapter H. SEAFOOD HACCP

25 TAC §§229.121 - 229.129

The Texas Department of Health (department) adopts amendments to §§229.121 - 229.129, concerning seafood Hazard Analysis Critical Control Point (HACCP). Section 229.124 is adopted with changes to the proposed text as published in the April 18, 2003, issue of the Texas Register (28 TexReg 3204). Sections 229.121 - 229.123 and §§229.125 - 229.129 are adopted without changes to the proposed text and, therefore, the sections will not be republished.

Amendments to §229.121 and §229.122 add references to §§229.211 - 229.222 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food). An amendment to §229.123 updates a mailing address for the U.S. Food and Drug Administration. An amendment to §129.124 updates verbiage for consistency within the sections. An amendment to §229.125 inserts language for clarification. Amendments to §229.126 and §229.127 move one section to a more appropriate location. Amendments to §229.128 and §229.129 update verbiage for consistency within the sections.

Government Code, §2001.039, requires each state agency to conduct a review of its rules every four years and consider for readoption each rule adopted by that agency. Sections 229.121 - 229.129 have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however the rules needed revisions as described in this preamble.

The department published a Notice of Intention to Review for §§229.121 - 229.129 in the Texas Register on March 2, 2001 (26 TexReg 1876). No comments were received as a result of the publication of this notice.

No comments were received on the proposal during the comment period.

The department is making the following change due to staff comments.

Change: Concerning §229.124, a "semicolon" replaced the "period" at the end of subsection (c)(2).

The amendments 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, the department, and the commissioner of health. The review of these rules implements Government Code, §2001.039.

§229.124.Corrective Actions.

(a) Whenever a deviation from a critical limit occurs, a processor shall take corrective action either by:

(1) following a corrective action plan that is appropriate for the particular deviation; or

(2) following the procedures in subsection (c) of this section.

(b) Processors may develop written corrective action plans, which become part of their HACCP plan in accordance with §229.123(c)(5) of this title (relating to Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) Plan), by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

(1) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(2) the cause of the deviation is corrected.

(c) When a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall:

(1) segregate and hold the affected product, at least until the requirements of paragraphs (2) and (3) of this subsection are met;

(2) perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience in the affected product to perform such a review;

(3) take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(4) take corrective action, when necessary, to correct the cause of the deviation;

(5) perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with §229.127 of this title (relating to Training), to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(d) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with §229.125(a)(3)(B) of this title (relating to Verification) and the record keeping requirements of §229.126 of this title (relating to Records).

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 August 8, 2003.

TRD-200304887

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: April 18, 2003

For further information, please call: (512) 458-7236

Subchapter O. LICENSING OF WHOLESALE DISTRIBUTORS OF DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §229.255

The Texas Department of Health (department) adopts the repeal of §229.255, concerning the Wholesale Drug Distributors Advisory Committee (committee), without changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4049) and will not be republished. The committee has provided advice to the Texas Board of Health (board) and the department in the area of licensing of wholesale drug distributors.

In 2002, the board established a rule relating to the Wholesale Drug Distributors Advisory Committee. The rule states that the committee will automatically be abolished on September 1, 2003, and the board has determined that the committee should be abolished on that date. Issues relating to the type of advice previously provided by the committee are better addressed through the establishment of ad hoc workgroups.

A comment was received from a representative of the Healthcare Distribution Management Association and was not in favor of abolishing the committee.

Comment: The commenter requested that the committee be continued stating that the committee serves an important function in the determination and development of regulatory strategies designed to ensure the safe distribution of pharmaceutical and health care products in Texas. The commenter is concerned that ad hoc workgroups would not be specifically familiar with drug distribution and not directly affected by rules.

Response: The department disagrees. The department believes that the ability to create ad hoc workgroups with membership specific to the issue will allow the department to better meet the needs of the public. The current committee last met in 2001. No change was made as a result of the comment.

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 August 8, 2003.

TRD-200304880

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

Subchapter X. LICENSURE OF DEVICE DISTRIBUTORS AND MANUFACTURERS

25 TAC §229.444

The Texas Department of Health (department) adopts an amendment to §229.444, concerning the Device Distributors and Manufacturers Advisory Committee (committee). The section is adopted without changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4049), and the section will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department in the area of licensure of device distributors and manufacturers. The committee is established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; and the Health and Safety Code, §431.275, which requires the establishment of the committee. 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 §229.444 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 §229.444 in the Texas Register on September 28, 2001 (26 TexReg 7581). No comments were received due to publication of this notice.

In 1999, the board established a rule relating to the Device Distributors and Manufacturers Advisory Committee. The rule states that the committee will automatically be abolished on September 1, 2003. The board has now reviewed and evaluated the committee and has determined that the committee should continue in existence until September 1, 2007.

This section amends provisions relating to the operation of the committee. Specifically, language is revised to: continue the committee until September 1, 2007; 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.

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; Health and Safety Code, §431.275, which requires the establishment of the committee; 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.

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 August 8, 2003.

TRD-200304883

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 28, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 458-7236

Chapter 265. GENERAL SANITATION

Subchapter K. REGISTRATION OF SANITARIANS

The Texas Department of Health (department) adopts amendments to §§265.141-265.149, 265.151-265.158, new §265.159, and the repeal of §265.150, concerning the registration of sanitarians. The amendments to §§265.142, 265.144, 265.147, 265.149, and new §265.159 are adopted with changes to the proposed text as published in the April 18, 2003, issue of the Texas Register (28 TexReg 3206). The amendments to §§265.141, 265.143, 265.145 - 265.146, 165.148, 265.151 - 265.158, and the repeal of §265.150 are adopted without changes and, therefore, the sections will not be republished.

Government Code, §2001.039 requires that each state agency conduct a review of its rules every four years and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 265.141-265.149 and 265.151-265.158 have been reviewed and the department has determined that the reasons for adopting the sections continue to exist. Section 265.150 has been reviewed and the department has determined that the reason for adopting the section no longer exists, and the section has been repealed.

A Notice of Intent to Review in regards to Government Code, §2001.039, agency review of rules was published in the March 14, 2003, issue of the Texas Register (27 TexReg 2638). No comments were received due to the publication of this notice.

The amendments update references to the Act as codified in the Texas Occupations Code, Chapter 1953 (the Act); update references to other codified laws; clarify existing language; and remove obsolete language. Minor amendments to wording in several sections for which no substantive change is indicated are also being adopted to allow the sections to be published in their entirety.

Amendments to §§265.142 and 265.145 and the repeal of §265.150 eliminate an obsolete and unworkable requirement for preceptorship for persons not required by the Act.

Amendments to §265.143 (related to Fees) and new §265.159 (related to Exemption from Renewal and Continuing Education for Retired Professional Sanitarians) provide a voluntary status for retired professional sanitarians.

Comments were received from the Registered Sanitarian Advisory Committee and five individuals. The comments received were generally favorable of the rules as proposed; however, many of the commenters had questions or specific concerns, and/or offered suggestions for changes.

Comment: One commenter requested that "bioterrorism training" be included in §265.142 as a part of the definition of "environmental health or consumer health and sanitation".

Response: The department agrees and has amended §265.142(12) to include "bioterrism".

Comment: Three commenters stated that they supported the exemption for retired sanitarians provided by new §265.159.

Response: The department appreciated the comments. No change was necessary as a result of the comments.

Comment: One commenter requested that §265.143 be modified so that no fee is assessed for the retired sanitarian exemption. .

Response: The department disagrees. The proposed fee will offset the costs to the department associated with verifying the sanitarian's eligibility for the exemption; issuing the exemption certificate; and maintaining a record of the exemption. No change was made as a result of this comment.

Comment: One commenter requested that §265.143 be modified so that a $25 fee every two years is assessed for the retired sanitarian exemption, in place of the proposed one-time $150 fee.

Response: The department disagrees. The proposed one-time fee will offset the costs to the department associated with a one-time application for the exemption, after which the rules as proposed exempt the retired sanitarian from submitting further renewal forms or fees. Requiring the department to bill and process the smaller fee every two years would impose additional costs on the department which would not be offset by the proposed change in fees. No change was made as a result of this comment.

Comment: One commenter requested that §265.159 be modified to permit a retired sanitarian to use the title "Emeritus" or "RS-E".

Response: The department disagrees. The rules as proposed clearly distinguish a retired sanitarian from a sanitarian currently working in the field. Additionally, the title "RS-E" might be misleading to the public. No change was made as a result of this comment.

Comment: One commenter proposed that an RS be permitted to return to active practice by submitting proof of the total number of continuing education hours he or she would have needed to earn for each year on exempt status.

Response: The department disagrees. The rules as proposed do not permit a retired sanitarian to return to active practice unless he or she meets the then current requirements for registration, including number of hours of science completed and passing the examination. No change was made as a result of this comment.

Comment: One commenter requested that sanitarians who have retired from active practice and are faculty members at universities or institutions of higher learning be permitted to hold a "Retired" or "Emeritus" status under §265.159.

Response: The department disagrees. The rules as proposed already permit faculty members who are not employed in the fields of environmental or consumer health to apply for the exemption. However, if an individual is employed in a field where holding an RS conveys information regarding that individual's qualifications in that field (e.g. teaching environmental health at a community college) the exemption for a "Retired Professional Sanitarian" would not be appropriate. No change was made as a result of the comment.

Comment: One commenter requested that the number of years of registration as a Professional Sanitarian required for an individual to be eligible for retired sanitarian status be increased from five to ten years.

Response: The department agrees and has amended §265.159(a) and (f)(2) accordingly.

The following changes were made due to comments by department staff.

Change: Minor editorial changes for punctuation and Texas Register format were made to §§265.142, 265.147, 265.149 and 265.159.

Change: New language was added at §265.159(d) to ensure that a registrant with a pending complaint would need to remain currently registered until the complaint was resolved before being approved for the exemption for retired sanitarians.

25 TAC §§265.141 - 265.149, 265.151 - 265.159

The amendments and new section are adopted under the Occupations Code, Chapter 1953; and the Health and Safety Code, §12.001, which provides the Board of Health (board) with 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.

§265.142.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings.

(1) Act--Occupations Code, Chapter 1953, concerning the registration of sanitarians.

(2) Administrator--The department employee designated as the administrator of registration activities authorized by the Act.

(3) Advanced mathematics--A mathematics course equivalent to or beyond calculus that was taken at an accredited college or university.

(4) Applicant--A person who applies for registration under the Act.

(5) Applied science--The application of general principles from environmental science, agricultural science, public health, epidemiology, food science, medical science, and sanitary engineering to solve problems.

(6) Basic Science--Science such as anatomy, bacteriology, biochemistry, biology, chemistry, geology, microbiology, pathology, physiology and physics.

(7) Board--The Texas Board of Health.

(8) Consumer health--The application of scientific knowledge to recognize, evaluate, and control hazards associated with the distribution of contaminated, adulterated, unsafe, and misbranded foods, drugs, medical devices, cosmetics, toys or consumer products.