; and (2) where the participant or beneficiary or prescribing health care provider’s request for an exception to the medication step therapy protocols satisfies the criteria and requirements of subsection (b), cover the requested drug in accordance with the terms established by the health plan or coverage for patient cost-sharing rates or amounts at the time of the participant’s or beneficiary’s enrollment in the health plan or health insurance coverage. (b) Circumstances for exception approval The circumstances requiring an exception to a medication step therapy protocol, pursuant to a request under subsection (a), are any of the following: (1) Any treatments otherwise required under the protocol, or treatments in the same pharmacological class or having the same mechanism of action, have been ineffective in the treatment of the disease or condition of the participant or beneficiary, when prescribed consistent with clinical indications, clinical guidelines, or other peer-reviewed evidence. (2) Delay of effective treatment would lead to severe or irreversible consequences, and the treatment otherwise required under the protocol is reasonably expected to be ineffective based upon the documented physical or mental characteristics of the participant or beneficiary and the known characteristics of such treatment. (3) Any treatments otherwise required under the protocol are contraindicated for the participant or beneficiary or have caused, or are likely to cause, based on clinical, peer-reviewed evidence, an adverse reaction or other physical 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