2003 LEGISLATIVE COMPENDIUM Medical Science

[ Genetics | Automated External Defibrillators | Returned Drugs | Regulation of Distressed Devices | Science Teaching ]

GENETICS

TMA worked to ensure no legislation in the 78th legislative session would preclude authentic medical scientific research. In concert with the geneticists in the state as well as the medical academic institutions, TMA provided revised language and definitions in House Bill 3521 and HB 1175, in particular "human cloning," "human embryo," and "somatic cell nuclear transfer" and sought to educate the members of the legislature regarding scientific research in genetics. The topic will be included in the TMA scientific symposia planned during the interim.

HB 3521, authored by Rep. Ken Paxton (R-McKinney), would have made it a felony to conduct destructive research on a human embryo with the exceptions of in vitro fertilization and accompanying transfer of a human embryo to a woman's body or a diagnostic procedure that may benefit a human embryo that is subjected to the procedure. Advocates for the bill viewed destructive research as part of the abortion issue. The bill was left pending.

HB 1175, authored by Rep. Phil King (R-Weatherford), would have banned human cloning and made it a felony to intentionally engage in human cloning. The bill also would have imposed a civil penalty of not less than $5 million or more than $10 million for each violation. Although the intent was to impact human cloning activities specifically, the bill's original language would have precluded much scientific research. The bill was left pending.

Senate Bill 1284, authored by Mario Gallegos (D-Houston), would have authorized the Texas Department of Health (TDH) to purchase tandem mass spectrometers for newborn genetic screening and to hire employees to use the machines. The March of Dimes was a major force behind the bill in an attempt to further its national initiative to have 10 specific screening tests performed on all newborns. However, in 2002 the TMA Council on Scientific Affairs had been in discussion with TDH and had outlined in writing concerns associated with implementing tandem mass spectrometry in the state at this time. Although sympathetic to the arguments to test for the additional illnesses, TMA's concerns about the clinical, operational, and financial issues of the existing newborn genetic screening program outweighed adding new tests. The bill was left pending.

AUTOMATED EXTERNAL DEFIBRILLATORS

HB 965 by Rep. Ken Mercer (R-San Antonio) would have required TDH, in consultation with the Texas Education Agency, to study the cost and feasibility of installing automated external defibrillators in public high school buildings. The bill required the estimation of the extent of improvement in the survival rate of those individuals experiencing sudden cardiac arrest while in a public high school, costs of personnel, maintenance, training, and other factors. TMA's Committee on Cardiovascular Diseases opposed the bill due to the significant cost for a very low potential savings of lives per year. The committee proposed that a better idea would be to require coaches, band directors, and other appropriate personnel to be trained in cardiopulmonary resuscitation (CPR). The American Heart Association project to train all high school sophomores in CPR in health class discovered that coaches often are not trained. The bill was left pending.

RETURNED DRUGS

HB 3486, authored by Rep. Diane Delisi (R-Temple), permits the return of certain unused drugs from a health care facility to a pharmacy and reimbursement for those returned drugs under the state's medical assistance program. No controlled substance may be returned. The unused drugs must be (1) approved by the federal Food and Drug Administration (FDA), (2) sealed in the original unopened tamper-evident packaging and either individually packaged or packaged in unit-dose packaging, (3) oral or parenteral medications in sealed single-dose containers approved by the FDA, (4) topical or inhalant drugs in sealed units-of-use containers approved by the FDA, (5) parenteral medications in sealed multiple-dose containers from which doses have not been withdrawn, and (6) not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer. The following drugs may not be returned: compounded, appears on inspection to be adulterated, requires refrigeration, or has less than 120 days until the expiration date or end of the shelf life.

The pharmacy may restock and redistribute these returned unused drugs and shall reimburse or credit the state Medicaid program for the returned drugs. The health care facility will be required to inform the Health and Human Services Commission (HHSC) of drugs returned to a pharmacy. A lengthy listing of prohibited acts are included in the bill, covering misbranding/adulteration, dissemination of any false advertisement, failure to maintain records or make required reports, counterfeiting trademarks/trade names/imprints, and more. HHSC is required to adopt rules governing the determination of the amount of reimbursement or credit for restocking drugs. A HIPAA-compliant electronic system for issuing credit for returned drugs will be provided. Only those drugs for which the credit exceeds the cost of the restocking fee by at least 100 percent are eligible for credit. Also, a task force will be established to develop the rules. The task force must include representatives of nursing facilities and pharmacies.

TMA supported the intent to have a realistic, reasonable process for cost-savings. The governor signed the bill on June 18 and it was effective immediately. HB 2292 (see above) also allows for reuse of returned drugs as described in HB 3486.

REGULATION OF DISTRESSED DEVICES

SB 1392, authored by Sen. Kyle Janek, MD, (R-Houston), would have created an exception to the existing law requiring medical device salvagers to restore distressed devices and equipment to full working order before offering them for resale and return to use. The pertinent regulations no longer would have applied to licensed equipment salvagers selling equipment to hospitals, whether public, private, or state-owned, or to hospitals selling to or trading equipment with other hospitals. Instead, the seller would have had to disclose the condition of the equipment/device to the buyer in concise, dated written statements containing the transferring entity's name, a description of the device's condition, and the following statement: "Prior to use, a distressed device that does not meet the manufacturer's specifications must be reconditioned." TMA's Council on Scientific Affairs' (CSA) initial concern regarding this deregulation was resolved with intensive research into the topic and discussions with the Texas Hospital Association. The bill was left pending.

SCIENCE TEACHING

HB 411 by Rep. Kent Grusendorf (R-Arlington) and Sen. Rodney Ellis (D-Houston) requires establishing master science teacher certifications for elementary, middle, and high school grade levels. The prescribed course of instruction is to be developed in consultation with science faculty members at institutions of higher education. Also included is a grant program to encourage teachers to become certified, funds for paying stipends to certified teachers who teach at high-need campuses, and provisions for providing training materials and other resources for teachers. Grade 8 was added to the grade levels at which students will be assessed in science. The option of implementing an after-school program or summer program to provide science education was also in the bill. The governor signed the bill on June 20, and it is effective Sept. 1.

Based on its sponsorship of the TMA Excellence in Science Teaching Awards Program, CSA supported this bill in theory as enhancing science teaching in Texas schools. The hesitancy regarding the fiscal note was resolved when it was noted that federal funds would be used for implementation.

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