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 25 TAC sec.98.104, sec.98.105 The Texas Department of Health (department) adopts on an emergency basis amendments to sec.98.104 and 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 eligibility for participation and medication coverage. The amendments expand the coverage of the program to include Dapsone for eligible participants and amends the eligibility criteria for Didanosine, Zalcitabine, SMZ-TMP, Fluconazole, and Itraconazole; and Zidovudine to include pregnant women. The amendments 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. These emergency actions are proposed for permanent adoption in this issue of the Texas Register. The amendments are adopted 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; and Texas Civil Statutes, Article 6252-13a, sec.5, which provides The Board with the authority to adopt rules on an emergency basis. sec.98.104. Medication Coverage.
    The following medications will be provided to each eligible participant. (1) Zidovudine capsules must be provided in increments of 100 not to exceed 400 capsules per month. Zidovudine syrup must be provided in eight ounce bottles. IV Zidovudine must be provided intrapartum in 10mg/ml-2 ml vials. (2)-(15) (No change.) (16) Dapsone must be provided in increments of 100 not to exceed 100 tablets per month. 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] Category B or C
        according to the Centers for Disease Control 1993 Revised
          Classification System for HIV Infection; [,] or,
            pending available funding,
              is classified in [Group I or II with a CD4 cell count of 500 or less;] Category A2 or A3 according to the Centers for Disease Control 1993 Revised Classification System for HIV Infection; (2) Zidovudine if she has a positive HIV antibody test and is a female in the second trimester or later of pregnancy, regardless of classification according to the Centers for Disease Control 1993 Revised Classification System for HIV Infection; or, is the biological newborn infant of a female with a diagnosis of HIV infection; (3) Pentamidine for inhalation solution, sulfamethoxazole- trimethoprim (DS) tablets, dapsone,
                and sulfamethoxazole-trimethoprim suspension if he or she is diagnosed with HIV infection and has a CD4 cell count of 200 or less; or constitutional symptoms such as thrush or unexplained fever greater than 100 degrees Fahrenheit 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 Centers 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) Didanosine if he or she has advanced HIV infection and is intolerant of zidovudine therapy of who have demonstrated significant clinical or immunological deterioration during zidovudine therapy.] (4)-(5) (No change.) (6) Fluconazole if he or she has [an] established cryptococcal [infection] 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
                    ; (7) (No change.) [(8) Zalcitabine in combination with zidovudine is indicated for the treatment of adult patients with advanced HIV infection (CD4 cell count less than or equal to 300) who have demonstrated significant clinical or immunologic deterioration;] (8)
                      [(9)] IV Pentamidine for children 13 years of age or younger for the treatment of PCP and prophylaxis against PCP in HIV infected children; (9)
                        [(10)] Interferon-Alpha for the treatment of disseminated Kaposi's sarcoma in HIV infected persons with T-cell counts over 200. 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; (10)
                            [(11)] 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; (11)
                                [(12)] Atovaquone for the oral treatment of acute mild to moderate Pneumocystis carinii Pneumonia (PCP) in patients who are intolerant to trimethoprim-sulfamethoxazole (TMP-SMZ); (12)
                                  [(13)] 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
                                    [.] (13)
                                      [(14)] Itraconazole for the treatment of Blastomycosis and Histoplasmosis. Issued in Austin, Texas, on June 28, 1994. TRD-9443143 Susan K. Steeg General Counsel, Office of the General Counsel Texas Department of Health Effective date: June 28, 1994 Expiration date: October 27, 1994 For further information, please call: (512) 458-7500