BILL ANALYSIS

C.S.H.B. 2294

By: Gattis

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

Every year, individuals die of diseases that go undiagnosed, despite the best efforts of medical professionals. Unfortunately, there is currently no way of knowing how many medical cases go unresolved because records are not kept. Last year, the National Institutes of Health (NIH) launched the federally funded undiagnosed diseases program, which reviews a very small number of undiagnosed cases for research at NIH. While diagnosis is a goal of the program's scientists, advancement of medicine is a major driver. This new program only underscores the need to provide research tools to medical professionals in the study of disease.

C.S.H.B. 2294 requires the Department of State Health Services to maintain an undiagnosed disease registry for undiagnosed diseases that result in death or other cases the executive commissioner of the Health and Human Services Commission by rule requires to be included in the registry. The bill provides for the retention of records and relevant information in the event of an undiagnosed disease that results in death and permits the retention of tissue samples.

RULEMAKING AUTHORITY

It is the committee's opinion that rulemaking authority is expressly granted to the executive commissioner of the Health and Human Services Commission in SECTIONS 1 and 2 of this bill.

ANALYSIS

Section 531.0055, Government Code, as amended by Chapter 198 (H.B. 2292), Acts of the 78th Legislature, Regular Session, 2003, expressly grants to the executive commissioner of the Health and Human Services Commission all rulemaking authority for the operation of and provision of services by the health and human services agencies. Similarly, Sections 1.16-1.29, Chapter 198 (H.B. 2292), Acts of the 78th Legislature, Regular Session, 2003, provide for the transfer of a power, duty, function, program, or activity from a health and human services agency abolished by that act to the corresponding legacy agency. To the extent practicable, this bill analysis is written to reflect any transfer of rulemaking authority and to update references as necessary to an agency's authority with respect to a particular health and human services program.

C.S.H.B. 2294 amends the Health and Safety Code to require the Department of State Health Services (DSHS) to maintain an undiagnosed disease registry for undiagnosed diseases that result in death or other cases the executive commissioner of the Health and Human Services Commission by rule requires to be included in the registry. The bill sets forth a short title for the provisions relating to the undiagnosed disease registry providing that those provisions may be cited as the Undiagnosed Diseased Reporting Act. The bill makes its provisions applicable to records of cases of undiagnosed diseases that result in death on or after January 1, 2010. The bill requires the undiagnosed disease registry to be a central data bank of accurate, precise, and current information that medical authorities agree serves as an invaluable tool in the early recognition, prevention, cure, and control of undiagnosed diseases.

C.S.H.B. 2294 requires the undiagnosed disease registry to include a record of the cases of undiagnosed diseases that result in death in the State of Texas and information concerning undiagnosed disease cases DSHS considers necessary and appropriate for the recognition, prevention, cure, or control of undiagnosed diseases. The bill authorizes the undiagnosed disease registry to include cases of undiagnosed diseases that do not result in death. The bill requires DSHS to store samples of tissues corresponding to individual registry records that may be of future benefit to medical professionals. The bill authorizes the executive commissioner, to implement the bill's provisions, to adopt rules; execute contracts; receive data; compile and publish statistical studies; comply with requirements as necessary to obtain federal funds; receive and use gifts made for the purpose of the bill; and limit undiagnosed disease reporting activities to specified geographic areas of Texas to ensure optimal use of funds available for obtaining the data.

C.S.H.B. 2294 requires DSHS to submit an annual report to the legislature on the information obtained under the bill's provisions. The bill authorizes DSHS, in cooperation with other undiagnosed disease reporting organizations and research organizations, to publish reports DSHS determines are necessary or desirable to carry out the purpose of the bill. The bill requires each clinical laboratory, health care facility, and physician, in order to ensure an accurate and continuing source of data concerning undiagnosed disease, to furnish to DSHS or its representative data upon request that the executive commissioner considers necessary and appropriate and that is derived from each medical record pertaining to a case of an undiagnosed disease that is in the custody or under control of the clinical laboratory, health care facility, or physician. The bill prohibits DSHS from requesting data that is more than three years old unless DSHS is investigating a possible undiagnosed disease cluster.

C.S.H.B. 2294 requires a clinical laboratory, health care facility, or physician to furnish the requested data in a reasonable format prescribed by DSHS and within six months of the patient's death or treatment for an undiagnosed disease unless a different period is prescribed by the United States Department of Health and Human Services. The bill requires such data to include patient identification, symptoms, tests conducted, and any other information DSHS requires. The bill authorizes DSHS to access medical records that would identify cases of undiagnosed diseases, establish characteristics or treatment of undiagnosed diseases, or determine the medical status of any identified patient from a health care facility or clinical laboratory providing screening or therapeutic services to a patient related to an undiagnosed disease or a physician providing treatment to a patient with an undiagnosed disease.

C.S.H.B. 2294 requires the executive commissioner to adopt procedures that ensure adequate notice is given to a clinical laboratory, health care facility, or physician before DSHS accesses the required data. The bill authorizes the data required to be furnished to be shared with undiagnosed disease registries of clinical laboratories or health care facilities subject to the confidentiality provisions in the bill. The bill requires each clinical laboratory, health care facility, and physician to furnish to DSHS or its representative any available tissue samples on request that the executive commissioner considers necessary.

C.S.H.B. 2294 provides for confidentiality of reports, records, and information obtained under provisions of the bill. The bill authorizes the release of medical or epidemiological information for statistical purposes in a manner that prevents identification of individuals, clinical laboratories, health care facilities, or physicians; with the consent of each person identified in the information; or to promote undiagnosed disease research, including release of information to other undiagnosed disease registries and appropriate state and federal agencies under rules adopted by the executive commissioner to ensure confidentiality as required by state and federal laws. The bill prohibits a state employee from testifying in a civil, criminal, special or other proceeding as to the existence or contents of records, reports, or information concerning an individual whose medical records have been used in submitting required data to the registry unless the individual consents in advance.

C.S.H.B. 2294 establishes that the data furnished to an undiagnosed disease registry or an undiagnosed disease researcher is for the confidential use of the undiagnosed disease registry or the undiagnosed disease researcher, as applicable, and is subject to the bill's provisions on confidentiality. The bill establishes procedures for immunity from liability. The bill establishes that an individual is not required to submit to any medical examination or supervision or to examination or supervision by the executive commissioner or the executive commissioner's representatives.

C.S.H.B. 2294 requires the executive commissioner to adopt rules and procedures to establish the registry not later than December 1, 2009. The bill requires DSHS to establish the undiagnosed disease registry not later than January 1, 2010. The bill establishes that a clinical laboratory, health care facility, or physician is not required to report the required data to the registry until January 1, 2010. The bill defines "clinical laboratory," "executive commissioner," "health care facility," and "physician."

EFFECTIVE DATE

September 1, 2009.

COMPARISON OF ORIGINAL AND SUBSTITUTE

C.S.H.B. 2294 omits provisions included in the original requiring a clinical laboratory, health care facility, or physician that knowingly or in bad faith fails to furnish data or tissue samples on request of the executive commissioner of the Health and Human Services Commission, as required by the bill, to reimburse the Department of State Health Services (DSHS) for the costs of assessing and reporting the data or collecting the samples; requiring the reimbursed costs to be reasonable; authorizing DSHS to assess a late fee on an overdue account; and authorizing the affected laboratory, facility, or physician to request DSHS conduct a hearing to determine the appropriateness of the reimbursement.