A.__A carrier may require that the care provided to an enrollee as a result of a referral under this subsection be pursuant to a treatment plan developed by the specialist and approved by the carrier in consultation with the enrollee and the enrollee's primary care physician in accordance with applicable quality assurance and utilization review standards of the carrier.

B.__A carrier is not required to provide a referral to a specialist that is not a participating provider unless the carrier does not have an appropriate specialist that is available and accessible to treat the enrollee's condition.

C.__If a carrier refers an enrollee to a nonparticipating specialist, the specialist must provide the services pursuant to the treatment plan at no additional cost to the enrollee beyond what the enrollee would otherwise pay for services rendered by such a specialist that is a participating provider.

5.__Standing referrals to specialists. A carrier shall have a procedure to allow enrollees who have a condition that requires ongoing care from a specialist to receive a standing referral to such a specialist for treatment of the condition.__If the carrier, or the enrollee's primary care physician, in consultation with the carrier's medical director, determines that a standing referral is appropriate, the carrier shall make a referral to a specialist.

§4312.__Access to clinical trials

1.__Qualified individual.__An enrollee is eligible for coverage for participation in an approved clinical trial if the enrollee meets the following conditions:

A.__The enrollee has a life-threatening or serious illness for which no standard treatment is effective;

B.__The enrollee is eligible to participate according to the clinical trial protocol with respect to treatment of such an illness;

C.__The enrollee's participation in the trial offers meaningful potential for a significant clinical benefit to the enrollee; and