2.__Approved clinical trial.__For the purposes of this section, an__"approved clinical trial" means a clinical research study or clinical investigation approved and funded by the National Institutes of Health or a cooperative group or center of the National Institutes of Health.

3.__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 the tests or measurements conducted primarily for the purpose of the clinical trial involved.

4.__Payment.__A carrier shall provide payment for routine patient costs, but is not required to pay for costs of items and services that are reasonably expected to be paid for by the sponsors of an approved clinical trial. In the case of covered items and services, the carrier shall pay participating providers at the agreed-upon rate and pay nonparticipating providers at the same rate the carrier would pay for comparable services performed by participating providers.

§4313.__Continuity of care

1.__Termination of provider.__If a contract between a carrier and a provider is terminated or benefits or coverage provided by a provider are terminated because of a change in the terms of provider participation in a health plan and an enrollee is undergoing a course of treatment from the provider at the time of termination, the carrier shall:

A.__Notify the enrollee on a timely basis of the termination; and

B.__Permit the enrollee to continue or be covered with respect to the course of treatment with the provider during a transitional period in accordance with subsections 2 and 3.

2.__Transitional period.__The transitional period must extend for at least 90 days from the date of notice to the enrollee of the provider's termination except in the following instances.