BILL ANALYSIS H.B. 988 By: Maxey (Gallegos) Health and Human Services 4-6-95 Senate Committee Report (Amended) BACKGROUND The fear of the divulgence of human immunodeficiency virus (HIV) test results to an insurance agency or employer creates a barrier to HIV testing for some persons. Technology has been developed that allows a person to collect a blood sample and send it to a laboratory for HIV testing. Seven to 10 days later, a person would call a toll-free number, give the operator a code number, receive anonymous counseling, get the test results, and be referred to a service provider for follow-up services, if required. PURPOSE As proposed, H.B. 988 sets forth regulations regarding home collection kits for human immunodeficiency virus infection testing and provides penalties. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not grant any additional rulemaking authority to a state officer, institution, or agency. SECTION BY SECTION ANALYSIS SECTION 1. Amends Chapter 85, Health and Safety Code, by adding Subchapter J, as follows: SUBCHAPTER J. HOME COLLECTION KITS FOR HIV INFECTION TESTING Sec. 85.251. DEFINITIONS. Defines "home collection kit" and "service provider." Sec. 85.252. PROHIBITIONS RELATING TO HOME COLLECTION KIT. (a) Prohibits a person from marketing, distributing, or selling a home collection kit for human immunodeficiency virus infection testing (kit) in this state, unless the kit complies with Chapter 431. Sec. 85.253. PROHIBITIONS RELATING TO HOME TESTING. (a) Prohibits a person from marketing, distributing, or selling a product for public use to test a specimen collected from the human body (specimen) for human immunodeficiency virus (HIV) infection, unless the kit complies with Chapter 431. (b) Provides that this section does not apply to a product marketed, distributed, or sold only to physicians or other persons authorized by law to test a specimen for HIV infection. (c) Prohibits a person from requiring an individual to be tested for HIV infection under Section 81.102. Sec. 85.254. PACKAGE OF SERVICES. Requires a kit to be sold as part of a package of certain services. Sec. 85.255. QUALIFIED FACILITY. Requires a facility that tests a specimen collected with a kit to comply with the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a). Sec. 85.256. ORAL REPORTING. Requires a service provider to report test results from a kit orally to the individual tested. Sec. 85.257. COUNSELING; COUNSELING PROTOCOLS. (a) Requires a service provider to provide pretesting counseling to an individual who is considering using a kit, and authorizes the counseling to be provided orally by telephone or through written information included with the kit. (b) Requires the service provider, at the time the test results are reported to the individual tested, to provide counseling and appropriate referral for care and treatment. (c) Requires counseling to conform with counseling protocols adopted by the Texas Board of Health (board). Requires the protocols to be consistent with Sections 81.109 and 85.081. (d) Requires counseling under this section to be provided in English and Spanish. Authorizes the board to require a service provider to provide counseling in another language if the board finds that the service provider is marketing kits in a community where a significant portion of the population speaks a language other than English or Spanish. (e) Prohibits a service provider, in providing counseling, from soliciting the purchase of additional services or products, or from referring the individual being counseled to certain entities. Sec. 85.258. LABELING. (a) Requires a kit to meet the requirements of Chapter 431. (b) Requires the labelling to explain which persons and entities will have access to the test results. (c) Requires a kit labeled in Spanish to be available. Authorizes the board to require a service provider to label a kit in another language upon finding that the provider markets kits in a community where a significant portion of the population speaks a language other than English or Spanish. Sec. 85.259. ENFORCEMENT. Calls a kit a "device" according to the definition of "device" under Section 431.002, and subjects a kit and any violation of Section 85.258 to the provisions for enforcement under Chapter 431. Sec. 85.260. CONFIDENTIALITY. (a) Makes confidential any statement that an identifiable individual has or has not been tested with a kit. (b) Provides that a person commits an offense, punishable as an offense under Section 81.103, if the person violates this section. Sec. 85.261. CERTAIN TECHNOLOGY PROHIBITED. Prohibits a service provider from using technology that permits the provider to identify an individual to whom test results or counseling is provided, or to identify the telephone number from which that individual is calling. Sec. 85.262. REPORTS. Requires a service provider to report test results from a kit in the manner provided by Chapter 81B. SECTION 2. (a) Declares that the legislature encourages manufacturers of kits to make the kits available, at reduced cost, to appropriate nonprofit organizations for use in HIV testing and counseling programs. (b) Declares that the legislature intends that the use of kits shall not affect the accessibility of anonymous testing programs established by the Texas Department of Health. SECTION 3. Emergency clause. Effective date: upon passage.