California Health and Safety Code 111548.3 – (a) Notwithstanding any other law, a state regulatory board …
(a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board.
(b) The physician’s institutional review board or an accredited institutional review board shall biannually report the following information to the State Department of Public Health, the Medical Board of California, and the Osteopathic Medical Board of California:
Terms Used In California Health and Safety Code 111548.3
- department: means State Department of Health Services. See California Health and Safety Code 20
- Eligible patient: means a person who meets all of the following conditions:
California Health and Safety Code 111548.1
- Immediately life-threatening disease or condition: means a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months. See California Health and Safety Code 111548.1
- State: means the State of California, unless applied to the different parts of the United States. See California Health and Safety Code 23
- State regulatory board: means the Medical Board of California or the Osteopathic Medical Board of California. See California Health and Safety Code 111548.1
(1) The number of requests made for an investigational drug, biological product, or device.
(2) The status of the requests made.
(3) The duration of the treatment.
(4) The costs of the treatment paid by eligible patients.
(5) The success or failure of the investigational drug, biological product, or device in treating the immediately life-threatening disease or condition from which the patient suffers.
(6) Any adverse event for each investigational drug, biological product, or device.
(c) A state agency shall not alter any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an investigational drug, biological product, or device.
(d) A violation of this section shall not be subject to Chapter 8 (commencing with Section 111825).
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)