BG C.S.H.B. 723 75(R)BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 723 By: Dukes 3-20-97 Committee Report (Substituted) BACKGROUND Hysterectomy is a controversial medical procedure that may eventually affect one out of every three women in this country. According to the Institute for Reproductive Health, only ten to twelve percent of the nearly 750,000 annual hysterectomies are performed for life threatening reasons. Hysterectomies are used as treatment or cure for endometriosis, fibroid tumors, ovarian cysts, adhesions, pelvic pain, menstrual pain, adenomyosis, benign ovarian tumors, infection, endometrial hyperplasia, menstrual disorders and pre-menstrual pain. Unfortunately, the lack of female reproductive organs is not benign. It can result in increased rates of heart disease, increased rates of osteoporosis and a variety of hormonal dysfunctions resulting in physical and behavioral changes including depression, fatigue, dry skin, joint pain, loss of memory, and sexual dysfunction. Support for a patient's consent and full understanding of the consequences of a hysterectomy have not yet resulted in specific disclosure and informed consent mandates. Hysterectomies, both vaginal and abdominal, are on the Texas Medical Disclosure Panel's "List A", which is the list of procedures requiring full written disclosure to the patient of the associated risks and benefits. Administratively attached to the Texas Department of Health, the Texas Medical Disclosure Panel's authority and responsibility to prepare a list of medical treatments and procedures that do and do not require disclosure of the risks and hazards involved derives from the 1977 Medical Liability and Insurance Improvement Act, Article 4590i, Subchapter F of Vernon's Texas Civil Statutes. PURPOSE HB 723 will require the Medical Disclosure Panel (Panel) to adopt a specific form with disclosures and warnings for hysterectomies. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subchapter F, Medical Liability and Improvement Act of Texas (Article 4590i, Vernon's Texas Civil Statutes), by adding Section 6.08, entitled "Informed Consent for Hysterectomies," as follows: Subsection (a) requires the Panel to develop written materials to provide information on the risks and hazards of a hysterectomy and on the availability of alternatives to a hysterectomy. Subsection (b) requires that the materials be available in English, Spanish, and any other language the Panel deems necessary and appropriate; and be easily understood by a lay person. Subsection (c) requires that the materials include: (1) a notice that benefits will not be withdrawn or withheld for failure to undergo a hysterectomy; (2) the name of the person providing and explaining the materials; (3) a statement expressing the understanding that hysterectomy is permanent and not reversible and that the patient will not be able to become pregnant or bear children if she undergoes the procedure; (4) a statement affirming the patient's right to seek a consultation from a second physician; (5) a description of the surgery and the disclosure that additional surgeries may be necessary; (6) blank spaces to list the procedures to be performed; (7) a statement that the available and medically appropriate alternatives were discussed and enumerated; (8) a description of the discomforts and risks that may accompany or follow the procedure; (9) a description of the risks, hazards and potential side effects of anesthesia; (10) blank space to indicate the approximate length of hospital stay and recovery time; (11) a statement of the physician's fees and any other related costs; and (12) a statement signed by the patient or her proxy that the materials about the nature and consequences of hysterectomy have been provided, explained, and understood. Subsection (d) requires the physician or health care provider to obtain consent under this section and also under Sec. 6.04, which provides for the warnings and disclosures of procedures for medical disclosures, as specified unless the hysterectomy is performed in a life threatening situation. Requires the physician to sign a written statement in the patient's medical records certifying the situation and the nature of the emergency if the obtaining of prior informed consent is not reasonably possible. Subsection (e) prohibits the Panel from prescribing materials under this section without approval of the Texas State Board of Medical Examiners. SECTION 2. Establishes the effective date of this Act to be September 1, 1997. Requires the Panel to prescribe the form and materials to be distributed not later than January 1, 1998. Establishes applicability to a hysterectomy performed at least 90 days after publication of their adoption. SECTION 3. Emergency clause. COMPARISON OF ORIGINAL TO SUBSTITUTE CSHB 723 omits all of the original bill's amendments to the Health and Safety Code, yet maintains the intent of HB 723 to ensure that a patient or her authorized proxy receive full medical disclosure, understand the associated risks, and give informed consent for a hysterectomy. In Section 1, CSHB 723 facilitates this purpose by adding a new section to the Medical Liability and Improvement Act of Texas, and detailing a mandate to the Medical Disclosure Panel. Section 2 in the substitute has been changed so as to establish the effective date, a time frame for the creation and distribution of required forms and materials, and to allow for adequate time and notice before this Act's applicability.