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 an enrollee who has 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 that illness;

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

D.__The enrollee's referring physician has concluded that the enrollee's participation in such a trial is appropriate based upon the satisfaction of the conditions in paragraphs A, B and C.

2.__Coverage.__A carrier may not deny an enrollee participation in an approved clinical trial or deny, limit or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in the clinical trial.__For the purposes of this subsection, "routine patient costs" do not include the costs of