LEGISLATIVE BUDGET BOARD Austin, Texas FISCAL NOTE, 85TH LEGISLATIVE REGULAR SESSION April 28, 2017 TO: Honorable Four Price, Chair, House Committee on Public Health FROM: Ursula Parks, Director, Legislative Budget Board IN RE:HB661 by Parker (Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.), Committee Report 1st House, Substituted No significant fiscal implication to the State is anticipated. The bill would amend the Health and Safety Code to require the Executive Commissioner of the Health and Human Services Commission (HHSC) to adopt rules to designate medical conditions that are considered severe chronic diseases for the purposes of implementing the provisions of the bill, and to adopt a process for a patient to provide written informed consent to receive an investigational drug, biological product, or device. The bill would prohibit the Texas Medical Board (TMB) from revoking, failing to renew, suspending, or taking action against a physician's license based solely on the physician's recommendations to an eligible patient regarding access to an investigational drug, biological product, or device. The bill would also prohibit an agency from blocking an eligible patient's access to an investigational drug, biological product, or device. The bill would take effect immediately upon receiving a two-thirds majority vote by both houses. Otherwise, the bill would take effect September 1, 2017. The Employees Retirement System, Teacher Retirement System, HHSC, and TMB indicate that any costs associated with the bill could be absorbed within existing agency resources. Local Government Impact No significant fiscal implication to units of local government is anticipated. Source Agencies:323 Teacher Retirement System, 327 Employees Retirement System, 454 Department of Insurance, 503 Texas Medical Board, 529 Health and Human Services Commission LBB Staff: UP, KCA, EP, MDI, EK, TBo, TSI, KFa, CP LEGISLATIVE BUDGET BOARD Austin, Texas FISCAL NOTE, 85TH LEGISLATIVE REGULAR SESSION April 28, 2017 TO: Honorable Four Price, Chair, House Committee on Public Health FROM: Ursula Parks, Director, Legislative Budget Board IN RE:HB661 by Parker (Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.), Committee Report 1st House, Substituted TO: Honorable Four Price, Chair, House Committee on Public Health FROM: Ursula Parks, Director, Legislative Budget Board IN RE: HB661 by Parker (Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.), Committee Report 1st House, Substituted Honorable Four Price, Chair, House Committee on Public Health Honorable Four Price, Chair, House Committee on Public Health Ursula Parks, Director, Legislative Budget Board Ursula Parks, Director, Legislative Budget Board HB661 by Parker (Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.), Committee Report 1st House, Substituted HB661 by Parker (Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.), Committee Report 1st House, Substituted No significant fiscal implication to the State is anticipated. No significant fiscal implication to the State is anticipated. The bill would amend the Health and Safety Code to require the Executive Commissioner of the Health and Human Services Commission (HHSC) to adopt rules to designate medical conditions that are considered severe chronic diseases for the purposes of implementing the provisions of the bill, and to adopt a process for a patient to provide written informed consent to receive an investigational drug, biological product, or device. The bill would prohibit the Texas Medical Board (TMB) from revoking, failing to renew, suspending, or taking action against a physician's license based solely on the physician's recommendations to an eligible patient regarding access to an investigational drug, biological product, or device. The bill would also prohibit an agency from blocking an eligible patient's access to an investigational drug, biological product, or device. The bill would take effect immediately upon receiving a two-thirds majority vote by both houses. Otherwise, the bill would take effect September 1, 2017. The Employees Retirement System, Teacher Retirement System, HHSC, and TMB indicate that any costs associated with the bill could be absorbed within existing agency resources. Local Government Impact No significant fiscal implication to units of local government is anticipated. Source Agencies: 323 Teacher Retirement System, 327 Employees Retirement System, 454 Department of Insurance, 503 Texas Medical Board, 529 Health and Human Services Commission 323 Teacher Retirement System, 327 Employees Retirement System, 454 Department of Insurance, 503 Texas Medical Board, 529 Health and Human Services Commission LBB Staff: UP, KCA, EP, MDI, EK, TBo, TSI, KFa, CP UP, KCA, EP, MDI, EK, TBo, TSI, KFa, CP