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 prescribing health care provider and has previously received approval for coverage of the relevant drug or drugs for the disease or condition by any group health plan or health insurance issuer. (6) Other circumstances, as determined by the Secretary. (c) Requirement of a clear process (1) In general The process required by subsection (a)— (A) shall provide the prescribing health care provider or beneficiary or designated third-party advocate an opportunity to present such provider’s clinical rationale and relevant medical information for the group health plan or health insurance issuer to evaluate such request for exception