EMERGENCY RULES An agency may adopt a new or amended section or repeal an existing section on an emergency basis if it determines that such action is necessary for the public health, safety, or welfare of this state. The section may become effective immediately upon filing with the Texas Register, or on a stated date less than 20 days after filing and remaining in effect no more than 120 days. The emergency action is renewable once for no more than 60 additional days. Symbology in amended emergency sections. New language added to an existing section is indicated by the use of bold text. [Brackets] indicate deletion of existing material within a section. TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 98. HIV and STD Control Subchapter C. Texas HIV Medication Program General Provisions 25 TAC sec.98.101, sec.98.105 The Texas Department of Health (department) adopts on an emergency basis an amendment to sec.98.101, the repeal of sec.98.105, and new sec.98.105, concerning the Texas HIV Medication Program. The sections implement the provisions of the "Communicable Disease Prevention and Control Act," Health and Safety Code, Chapter 85.063, Subchapter C, concerning the Texas HIV Medication Program. The program assists hospital districts, local health departments, public or nonprofit hospitals and clinics, nonprofit community organizations, and HIV infected individuals in the purchase of medications approved by the board that have been shown to be effective in reducing hospitalizations due to HIV related conditions. Generally, the sections cover purpose, eligibility for participation, and medication coverage. The amendments expand the eligibility criteria for Zidovudine, Didanosine, Zalcitabine, SMZ-TMP, Fluconazole, and Itraconazole. The amendment, repeal, and new section are adopted on an emergency basis in order to expeditiously provide medications to HIV infected individuals. It is imperative to address this serious and imminent health condition by providing approved medications as soon as possible. The amendment and new section are adopted on an emergency basis under the Health and Safety Code, sec.85.063, which provides the Texas Board of Health with the authority to adopt rules concerning a Texas HIV Medication Program; Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the Commissioner of Health; and Texas Civil Statutes, Article 6252-13a, sec.5, which provide the Board with the authority to adopt rules on an emergency basis. This amendment effects Chapter 85 of the Health and Safety Code. sec.98.101. Purpose and Scope. (a) Purpose. These sections will implement the provisions of the Texas HIV Medication Program (program) as authorized by the Communicable Disease Prevention and Control Act, Health and Safety Code, sec.sec.85.061-85.066. The program shall assist hospital districts, local health departments, public or nonprofit hospitals and clinics, nonprofit community organizations, and HIV- infected individuals in obtaining medications that have been shown to be effective in reducing hospitalizations due to
    [indicated by the Food and Drug Administration for the treatment of] HIV-related conditions and approved by the Texas Board of Health for program coverage. (b) (No change.) sec.98.105. Drug specific eligibility criteria. A person is eligible for: (1) Zidovudine, Didanosine, and Zalcitabine if he or she is younger than 18 years of age and has a diagnosis of HIV infection; or has a positive HIV antibody test and is classified in Group III or IV according to the Centers of Disease Control (CDC) classification system, or pending available funding classified in Group I or II with a CD4 cell count of 500 or less; (2) Pentamidine for inhalation solution, sulfamethoxazole-trimethoprim (DS) tablets, and sulfamethoxazole-trimethoprim suspension if he or she is diagnosed with HIV infection and a CD4 cell count of 200 or less; or constitutional symptoms such as thrush or unexplained fever greater than 100 degrees F for greater than two weeks and children under the age of 13 with the following clinical indicators: (A) all children who have had a previous episode of Pneumocystis Carinii Pneumonia (PCP); (B) all children less than 13 years of age who meet the Center for Disease Control (CDC) definitions of HIV infection in children and who have CD4+ counts less than 400/mm3; (C) all children less than 15 months of age who have HIV isolated from blood, cerebrospinal fluid (CSF), or tissues; or P24 antigen detected in blood/plasma or CSF, regardless of CD4 count; (D) all children less than 15 months of age who are HIV-seropositive and have symptoms as defined by CDC class P2, regardless of CD4 count. Children will qualify in class P2a if they have one symptom and persistent hypergammaglobulinemia (two measurements, one month apart); (3) Erythropoietin if he or she soon would be or is currently transfusion dependent, has a hematocrit less than or equal to 25%, and has endogenous serum erythropoietin levels equal to or less than 500 mU/mL; (4) Immune Globulin Intravenous (Human) if he or she is diagnosed with HIV infection and is younger than 18 years of age; (5) Fluconazole if he or she has established cryptococcal meningitis or candida esophagitis and for prophylaxis after diagnosis. The total amount to be expended on this drug is up to $350,000, then pending available funding; (6) Acyclovir for the treatment of acute herpetic infections and chronic suppressive therapy for the treatment of recurrent disease. (7) IV Pentamidine for children 13 years of age or younger for the treatment of PCP and prophylaxis against PCP in HIV infected children; (8) Interferon-Alpha for the treatment of disseminated Kaposi's sarcoma in HIV infected persons with T-Cell counts over 500. The total amount to be expended on this drug is up to $122,600. The requesting physician must complete a form to be returned to the program which will allow the program to evaluate the benefits of providing this medication; (9) Amphotericin-B for the treatment of patients with progressive, and potentially fatal disseminated fungal infections. The total amount to be expended on this drug is up to $46,200. The requesting physician must complete a form to be returned to the program which will allow the program to evaluate the benefits of providing this medication; (10) Atovaquone for the oral treatment of acute mild to moderate Pneumocystis carinii Pneumonia (PCP) in patients who are intolerant to sulfamethoxazole- trimethoprim (SMZ-TMP); (11) Rifabutin for the prevention of disseminated mycobacterium avium complex disease in patients with a CD4 cell count of 100 or less. The total amount to be expended on this drug is up to $100,000, then pending available funding; and (12) Itraconazole for the treatment of Blastomycosis and Histoplasmosis. Issued in Austin, Texas, on March 31, 1994. TRD-9438445 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 31, 1994 Expiration date: July 30, 1994 For further information, please call: (512) 458-7500 25 TAC sec.98.105 The repeal is adopted on an emergency basis under the Health and Safety Code, sec.85.063, which provides the Texas Board of Health with the authority to adopt rules concerning a Texas HIV Medication Program; and Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the Commissioner of Health. This repeal effects Chapter 85 of the Health and Safety Code. sec.98.105. Drug Specific Eligibility Criteria. Issued in Austin, Texas, on March 31, 1994. TRD-9438446 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 31, 1994 Expiration date: July 30, 1994 For further information, please call: (512) 458-7500