A health insuring corporation that provides basic health care services shall establish or use an internal technology assessment process for assessing whether a drug, device, protocol, procedure, or other therapy is proven to be safe and efficacious for a particular indication or condition when compared to alternative therapies, or whether it remains experimental or investigational. The health insuring corporation's internal technology assessment process shall meet all of the following criteria:
(A) Decisions are made by medical professionals, including physicians.
(B) The process includes a review of relevant medical evidence, including the following, if available:
(1) Peer-reviewed medical and scientific literature on the subject;
(2) Published opinions, actions, and other relevant documents of independent, external research organizations such as the national institute of health, the national cancer institute, the United States food and drug administration, the health care finance administration, and the agency for health care policy and research;
(3) Published opinions of medical experts or affected specialty societies.
(C) General coverage decisions, made pursuant to this process, that exclude drugs, devices, protocols, procedures, or other therapies on the basis that they are not safe or efficacious and remain experimental or investigational, are reviewed and updated as new scientific evidence becomes available.
(D) A description of the health insuring corporation's internal technology assessment process is made available to participating providers and enrollees, upon request.
(E) A copy of the health insuring corporation's specific coverage protocols and procedures is made available to participating providers and enrollees upon the request of an enrollee who has been denied coverage for a drug, device, protocol, procedure, or other therapy on the basis that it has been assessed as not being safe or efficacious for a particular indication or condition. Specific coverage protocols and procedures shall include a description of the evidence upon which the protocol or procedure is based, and shall contain the date the protocol or procedure was adopted.
(F) A drug or device that has received full market approval by the United States food and drug administration for treatment of a particular indication or condition cannot, for purposes of this assessment process, be considered experimental or investigational for that indication or condition.
Effective Date: 10-01-1998 .