Section 438.406 - Handling of grievances and appeals(a)General requirements. In handling grievances and appeals, each MCO, PIHP, and PAHP must give enrollees any reasonable assistance in completing forms and taking other procedural steps related to a grievance or appeal. This includes, but is not limited to, auxiliary aids and services upon request, such as providing interpreter services and toll-free numbers that have adequate TTY/TTD and interpreter capability.(b)Special requirements. An MCO's, PIHP's or PAHP's process for handling enrollee grievances and appeals of adverse benefit determinations must:(1) Acknowledge receipt of each grievance and appeal.(2) Ensure that the individuals who make decisions on grievances and appeals are individuals- (i) Who were neither involved in any previous level of review or decision-making nor a subordinate of any such individual.(ii) Who, if deciding any of the following, are individuals who have the appropriate clinical expertise, as determined by the State, in treating the enrollee's condition or disease.(A) An appeal of a denial that is based on lack of medical necessity.(B) A grievance regarding denial of expedited resolution of an appeal.(C) A grievance or appeal that involves clinical issues.(iii) Who take into account all comments, documents, records, and other information submitted by the enrollee or their representative without regard to whether such information was submitted or considered in the initial adverse benefit determination.(3) Provide that oral inquiries seeking to appeal an adverse benefit determination are treated as appeals.(4) Provide the enrollee a reasonable opportunity, in person and in writing, to present evidence and testimony and make legal and factual arguments. The MCO, PIHP, or PAHP must inform the enrollee of the limited time available for this sufficiently in advance of the resolution timeframe for appeals as specified in § 438.408(b) and (c) in the case of expedited resolution.(5) Provide the enrollee and his or her representative the enrollee's case file, including medical records, other documents and records, and any new or additional evidence considered, relied upon, or generated by the MCO, PIHP or PAHP (or at the direction of the MCO, PIHP or PAHP) in connection with the appeal of the adverse benefit determination. This information must be provided free of charge and sufficiently in advance of the resolution timeframe for appeals as specified in § 438.408(b) and (c) .(6) Include, as parties to the appeal- (i) The enrollee and his or her representative; or(ii) The legal representative of a deceased enrollee's estate. 81 FR 27853 , May 6, 2016, as amended at 85 FR 72842 , Nov. 13, 2020 81 FR 27852 , 5/6/2016; 85 FR 72842 , 12/14/2020