The health care providers and insurers specified in 105 CMR 240.003 shallprovide coverage for bone marrow transplantation, in accordance with 105 CMR 240.000, where the patient has been found to meet the eligibility criteria for a clinical trial satisfying the requirements of 105 CMR 240.006. The clinical trialshallbe conducted in accordance with a protocol approved by an institutional review board meeting the requirements for the protection of human subjects specified in 45 CFR Part 46. In addition, the clinical trial shall be conducted:

1. (A) at a licensed health facility which is located at the principal site of an academic medical center which participates in NCI sponsored or approved research in any cancer specialty area; or
2. (B) at a licensed health facility which has a formal affiliation agreement with an academic medical center to provide bone marrow transplantation as part of an NCI sponsored or approved research protocol.