Current through Register Vol. 48, No. 14, April 8, 2022
Experimental services are not covered. A service is not experimental 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
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.
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 demonstrated 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 services.
The following factors shall be considered
when evaluating the weight of peer-reviewed articles or the opinions of
1. The mortality rate and
survival rate of the service as compared to the rates for alternative
types, severity, and frequency of complications associated with the services as
compared with the complications associated with alternative non-experimental
3. The frequency with
which the service has been performed in the past.
4. Whether there is sufficient historical
information regarding the service to provide reliable data regarding risks and
5. The reputation and
experience of the authors and/or specialists and their record in related
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.