BILL ANALYSIS
C.S.H.B. 988
By: Maxey
2-21-95
Committee Report (Substituted)
BACKGROUND
One of the barriers to an individual getting tested for the human
immunodeficiency virus (HIV) is the fear that test results will be
divulged to another party such as an insurance company or an
employer. Technology has been developed that allows an individual
to collect a blood sample and send it to a laboratory for HIV
testing. Seven to ten days later, a person would call a toll-free
800 number, give the operator a code number, receive anonymous
counseling, get the test results, and be referred to a service
provider (in the caller's local area) for follow-up services, if
required.
PURPOSE
The committee substitute for H.B. 988 establishes Subchapter J of
Chapter 85 in the Health and Safety Code, which would allow a
manufacturer to market and sell a home collection kit in Texas for
HIV testing. The bill sets guidelines governing testing,
confidentiality of results, reporting of results, counseling,
marketing, and labeling in Texas. H.B. 988, as substituted, also
contains some prohibitions that mirror current law in regard to
confidentiality and compliance with the federal Food and Drug Act.
RULEMAKING AUTHORITY
It is the committee's opinion that this bill does not expressly
delegate any additional rulemaking authority to a state officer,
institution, or agency.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends the Health and Safety Code by adding SUBCHAPTER
J. HOME COLLECTION KITS FOR HIV INFECTION TESTING, as follows:
Section 85.251 establishes the definitions used for this
subchapter.
Section 85.252 prohibits the marketing, distribution, or sale
of a product that does not comply with the Texas Food, Drug, and
Cosmetic Act, Chapter 431, Health and Safety Code.
Section 85.253 prohibits the sale or use of an HIV test that
gives immediate results to the individual using it, unless the
kit complies with the Texas Food, Drug, and Cosmetic Act.
Physicians and other persons authorized to give such a test
are exempted from this
section. Subsection (c) prohibits anyone from requiring an
individual to be tested, as
provided by Section 81.102, Health and Safety Code.
Section 85.254 sets out the services that shall be available
with any kit marketed including (1) laboratory testing, (2)
reporting of results, (3) verification of positive tests, (4)
counseling, and (5) information relating to the storage of test
results.
Section 85.255 requires any lab authorized to conduct the
actual clinical testing to be in compliance with the federal
Clinical Laboratory Improvement Amendments of
1988.
Section 85.256 allows a service provider (i.e. the party
selling the kit) to give test results to an individual over
the telephone. This type of notification was previously prohibited by Section 81.109 of the Health and Safety Code.
Section 85.257 states that (a) pre-test counseling and (b)
post-test counseling must be
provided and shall (c) conform with current protocols for
counseling and (d) be made
available in English and Spanish, at a minimum. Pre-test
counseling may be provided over
the telephone or through written information. Subsection (e)
prohibits a service
provider from soliciting the purchase of other products or
services and from referring an
individual to a company, or subsidiary, that has a financial
relationship with the original
service provider.
Section 85.258 states that any kit distributed must (a) comply
with the labeling requirements of the Texas Food, Drug, and
Cosmetic Act, (b) explain who will have access to the results,
and (c) must be available in English and Spanish, at a minimum.
Section 85.259 stipulates that a home collection kit for HIV
testing is a "device," as
defined in the Texas Food, Drug, and Cosmetic Act and
establishes that violations of this
act will be subject to the penalties outlined in Chapter 431,
Health and Safety Code.
Section 85.260 requires that (a) test results be confidential
as already provided in current law, Section 81.103 of the Health
and Safety Code, and (b) establishes that any penalty under
Section 81.103 shall apply to offenses under this section.
Section 85.261 prohibits the use of caller-ID technology by
the service provider to obtain the identity of any caller.
Section 85.262 states that the service provider shall report
results under current rules and
as provided in Subchapter C, Chapter 81 of the Health and
Safety Code.
SECTION 2. This section (a) encourages the manufacturer of any kit
to make kits available to non-profit organizations at reduced cost
for HIV testing and counseling programs. Section 2 (b) states that
the use of home collection kits for HIV infection shall not affect
the availability of TDH anonymous testing sites.
SECTION 3. Emergency clause.
COMPARISON OF ORIGINAL TO SUBSTITUTE
The committee substitute removes all rule-making authority given to
the Texas Department of Health in the original bill. It was
determined that the protections, authorities, and penalties
established in H.B. 988 as originally filed already existed in the
Texas Food, Drug, and Cosmetic Act, Chapter 431, Health and Safety
Code. The committee substitute incorporates references to Chapter
431 and federal law, where they apply to provisions of this bill.
The substitute adds the requirement that service providers make
available, upon request, information describing how test results
will be stored and under what circumstances the information may be
communicated to others. The substitute requires the Act to go into
effect upon passage instead of September 1, 1995. The substitute
also removes the stipulation included in the original bill that
home collection kits not be sold in Texas before January 1, 1996.
The substitute adds the statement that this bill is not intended to
affect the accessibility of anonymous testing programs established
by TDH.
SUMMARY OF COMMITTEE ACTION
H.B. 988 was considered in a public hearing on February 21, 1995.
Testifying on the bill were Dr. Carolyn Parker, representing Texas
AIDS Network, and Dr. Charles Bell, representing the Texas
Department of Health. A complete committee substitute was laid out
and adopted. A motion to report H.B. 988 as substituted to the full
House with the recommendation that it do pass carried with a vote
of 7 Ayes, 0 Nays, 0 PNV, and 2 Absent.