Parts C & D Enrollee Grievances, Organization/Coverage ...

1 I Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Effective January 1, 2020 Table of Contents 10 Introduction .. 6 Glossary .. 6 Applicability to Employer-Sponsored Benefits .. 9 Claims Processing and Appeals for Medicare Cost Plans and Health Care Prepayment Plans (HCPPs) .. 9 General Responsibilities of the plan .. 10 Medical Exigency Standard .. 10 Role of the Medical 10 Delegation of Responsibilities .. 11 plan Communication to an Enrollee .. 11 Adjudication 12 Calculation of Days for Assessing plan 12 When a Request is Considered Received by the plan .

2 13 When Notification is Considered Delivered by the plan .. 13 Outreach for Additional Information to Support Coverage Decisions .. 14 20 Representatives .. 15 Representatives Filing on Behalf of Enrollees .. 15 Appointment of Representative (AOR) Form or Equivalent Written Notice .. 16 Missing or Defective Representative Form .. 17 Authority of a Representative .. 18 30 18 Classification between Grievances, Inquiries, Coverage Requests, and Appeals .. 19 Inquiries Related to Non-Part D and Excluded Drugs (Part D Only) .. 21 Procedures for Handling a Grievance.

3 22 Notification Requirements for Grievances .. 23 Quality of Care Grievances .. 24 Procedures for Handling a Quality of Care Grievance .. 24 Procedure for Handling Withdrawn Grievances .. 25 ii 40 Coverage Determinations, Organization Determinations (Initial Determinations) and At-Risk Determinations .. 25 Part C Organization Determinations .. 25 Part D Coverage Determinations .. 26 Part D At-Risk Determinations .. 27 Prior Authorization and Other Utilization Management Requirements .. 28 Part D Exceptions .. 29 Tiering Exceptions.

4 29 Formulary Exceptions .. 30 Supporting Statements for Exception Requests .. 30 Adjudication Timeframes for Coverage Determinations Involving an Exception .. 32 Approval of an Exception Request .. 33 Approval of a Tiering Exception Request .. 34 Who May Request an Initial Determination .. 35 Guidelines for Accepting Initial Determination Requests .. 36 How to Process Requests for Expedited Initial Determinations .. 37 Who Must Review an Initial Determination .. 40 Processing Timeframes .. 40 Effect of Failure to Meet the Timeframe for an Initial Determination.

5 42 Notification Requirements for Initial Determinations .. 43 Part C Notification Requirements .. 43 Part D Notification Requirements .. 46 Part D Coverage Determination Notices .. 48 Procedures for Handling Misclassified Initial Determinations .. 51 Withdrawal of a Request for an Initial Determination .. 51 50 Reconsiderations and Redeterminations (Level 1 Appeals) .. 52 Who May Request a Level 1 Appeal .. 53 Requirements for Provider Claim Appeals (Part C Only).. 54 Level 1 Appeal 55 Guidelines for Accepting Level 1 Appeal Requests.

6 55 How to Process Requests for Expedited Level 1 Appeals .. 56 Good Cause Exception for Late Filing .. 62 Withdrawal of Request for a Level 1 63 iii Actions the Appealing Party Can Take During a Level 1 Appeal .. 63 Opportunity to Submit Evidence .. 63 Enrollee Request for Case File Content .. 64 Who Must Conduct a Level 1 Appeal .. 64 Conducting a Level 1 Appeal .. 65 Processing Timeframes .. 65 Effect of Failure to Meet the Timeframe for Level 1 Appeals .. 66 Service or Benefit Received Prior to Notice of Decision.

7 67 Dismissals (Part C Only) .. 68 Notification Requirements for Level 1 Appeal Decisions .. 69 - Part C Notification Requirements .. 69 - Part D Notification 70 Procedure for Handling Misclassified 72 Timeframes and Responsibilities for Forwarding Case Files to the Independent Review Entity .. 72 Forwarding Case Files plan Responsibilities .. 72 Forwarding Case Files - Timeframes .. 73 Preparing the Case File for the Independent Review Entity .. 73 Including Evidence of Coverage and Formulary in Case Files .. 75 60 Reconsiderations by the Independent Review Entity (Level 2 Appeal).

8 75 Who May Request a Level 2 Appeal .. 75 How to Request a Level 2 Appeal (Part D Only).. 76 Processing Timeframes .. 76 Good Cause Extension (Part D Only) .. 77 IRE Notification and Retention Requirements .. 77 Withdrawal of Request for a Level 2 Appeal (Part D Only) .. 77 Effect of a Level 2 Appeal Determination .. 78 Reconsideration of Late Enrollment Penalty Determinations .. 78 Summary of the LEP Reconsideration Process .. 79 Part D plan Responsibilities under the LEP Reconsideration Process .. 80 Requests for Information.

9 81 Reasons for Requesting LEP Reconsideration and Presentation of Evidence .. 82 IRE LEP Processing 83 iv Withdrawal of an LEP Reconsideration Request .. 83 Dismissal of an LEP Reconsideration Request .. 84 70 Key Aspects of Administrative Law Judge (ALJ)/Attorney Adjudicator, Council, and Judicial Review .. 85 Parties to a Hearing .. 85 Amount in Controversy .. 85 Filing Requests for Review .. 86 Review Procedures .. 89 Decision-Making Timeframes .. 89 Part D plan Sponsor, CMS, or IRE Requesting ALJ Hearing Participation (Part D Only).

10 90 Submitting Evidence at the Third Level of Review .. 91 80 Reopening and Revising Determinations and Decisions .. 91 Guidelines for Reopening .. 92 Reopenings Separate and Distinct from Appeals .. 93 Timeframes for Reopening .. 94 Timeframes for Initiating a Reopening .. 94 Timeframes for Processing a Reopening .. 95 Reopening Based on Clerical Error .. 95 Good Cause for Reopening .. 96 New and Material Evidence .. 97 Notification Requirements for Reopenings .. 97 90 Effectuation .. 98 Independent Review Entity Monitoring of Effectuation Requirements.