peer-reviewed evidence, an adverse reaction or other physical or mental harm to the participant or beneficiary. (4) Any treatment otherwise required under the protocol has prevented, will prevent, or is likely to prevent a participant or beneficiary from achieving or maintaining reasonable and safe functional ability in performing occupational responsibilities or activities of daily living (as defined in section 441.505 of title 42, Code of Federal Regulations (or successor regulations)). (5) The participant or beneficiary is stable for his or her disease or condition on the prescription drug or drugs selected by the prescriber and has previously received approval for coverage of the relevant drug or drugs for the disease or condition by any public or private health plan. (6) Other circumstances, as determined by the Secretary. (c) Requirement of a clear process (1) In general The process required by subsection (a) shall— (A) provide the prescriber or participant or beneficiary an opportunity to present such prescriber’s clinical rationale and relevant medical information for the group health plan or health insurance issuer to evaluate such request for exception