Section R9-22-203. Experimental Services

A.      Experimental services are not covered. A service is not experi- mental if:

1.        It is generally and widely accepted as a standard of care in the practice of medicine in the United States and is a safe and effective treatment for the condition for which it is intended or used.

2.        The service does not meet the standard in subsection (A)(1), but the service has been demonstrated to be safe and effective for the condition for which it is intended or used based on the weight of the evidence in peer- reviewed articles in medical journals published in the United States.

3.        The service does not meet the standard in subsection (A)(2) because the condition for which the service is intended or used is rare, but the service has been demon- strated to be safe and effective for the condition for which it is intended or used based on the weight of opinions from specialists who provide the service or related ser- vices.

B.       The following factors shall be considered when evaluating the weight of peer-reviewed articles or the opinions of specialists:

1.        The mortality rate and survival rate of the service as com- pared to the rates for alternative non-experimental ser- vices.

2.        The types, severity, and frequency of complications asso- ciated with the services as compared with the complica- tions associated with alternative non-experimental services.

3.        The frequency with which the service has been performed in the past.

4.        Whether there is sufficient historical information regard- ing the service to provide reliable data regarding risks and benefits.

5.        The reputation and experience of the authors and/or spe- cialists and their record in related areas.

6.        The extent to which medical science in the area develops rapidly and the probability that more definite data will be available in the foreseeable future.

7.        Whether the peer reviewed article describes a random controlled trial or an anecdotal clinical case study.

Historical Note

Adopted as an emergency effective May 20, 1982 pursu- ant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82- 3). Former Section R9-22-203 adopted as an emergency now adopted and amended as a permanent rule effective August 30, 1982 (Supp. 82-4). Amended effective Octo-

ber 1, 1985 (Supp. 85-5). Amended effective October 1,

1987; amended effective December 22, 1987 (Supp. 87-

4). Amended effective May 30, 1989 (Supp. 89-2).

Amended effective April 13, 1990 (Supp. 90-2).

Amended effective September 29, 1992 (Supp. 92-3). Amended under an exemption from the provisions of the Administrative Procedure Act effective March 22, 1993; received in the Office of the Secretary of State March 24, 1993 (Supp. 93-1). Amended effective December 13, 1993 (Supp. 93-4). Section repealed effective September 22, 1997 (Supp. 97-3). New Section made by exempt

rulemaking at 16 A.A.R. 1638, effective October 1, 2010 (Supp. 10-3). Section amended by final rulemaking at 20

A.A.R. 1956, effective September 6, 2014 (Supp. 14-3).