1. (a) Experimental services means those drugs, equipment, procedures or services that are in a testing phase undergoing laboratory and/or animal studies prior to testing in humans.

2. (b) Investigational services means those drugs, equipment, procedures or services for which laboratory and animal studies have been completed and for which human studies are in progress but:

   1. (1) Testing is not complete; and
   2. (2) The efficacy and safety of such services in human subjects are not yet established; and
   3. (3) The service is not in wide usage.

3. (c) The determination that a service is experimental or investigational is based on:

   1. (1) Reference to relevant federal regulations, such as those contained in Title 42, Code of Federal Regulations, Chapter IV (Health Care Financing Administration) and Title 21, Code of Federal Regulations, Chapter I (Food and Drug Administration);
   2. (2) Consultation with provider organizations, academic and professional specialists pertinent to the specific service;
   3. (3) Reference to current medical literature.

Note: Authority cited: Sections 10725, 14105, 14105.44, and 14124.5, Welfare and Institutions Code. Reference: Sections 14059, 14105.44, 14124.5, 14132 and 14133.3, Welfare and Institutions Code.

History

1. New section filed 9-27-72; designated effective 11-1-72 (Register 72, No. 40). For history of prior section, see Register 71, No. 44.

2. Change without regulatory effect adding Note (Register 86, No. 49).

3. Amendment filed 12-18-87 as an emergency; operative 12-18-87 (Register 88, No. 1). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 4-18-88.

4. Certificate of Compliance including amendment of subsections (b) and (c) transmitted to OAL 4-14-88 and filed 5-16-88 (Register 88, No. 21).