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

Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance

Table of Contents

10 ? Introduction........................................................................................................................................... 5 10.1 ? Glossary ......................................................................................................................................... 5 10.2 ? Applicability to Employer-Sponsored Benefits ............................................................................. 8 10.3 ? Claims Processing and Appeals for Medicare Cost Plans and Health Care Prepayment Plans (HCPPs) .................................................................................................................................................... 8 10.4 ? General Responsibilities of the Plan .............................................................................................. 9 10.4.1 ? Decision Making Timeframes................................................................................................. 9 10.4.2 ? Plan Communication to an Enrollee ..................................................................................... 10 10.4.3 ? Role of the Medical Director................................................................................................. 12 10.4.4 ? Delegation of Responsibilities .............................................................................................. 12 10.4.5 ? Outreach for Additional Information to Support Coverage Decisions ................................. 12

20 ? Representatives ................................................................................................................................... 13 20.1 ? Representatives Filing on Behalf of Enrollees............................................................................. 13 20.2 ? Appointment of Representative (AOR) Form or Equivalent Written Notice .............................. 14 20.2.1 ? Missing or Defective Representative Form........................................................................... 15 20.3 ? Authority of a Representative ...................................................................................................... 17

30 ? Grievances........................................................................................................................................... 17 30.1 ? Classification between Grievances, Inquiries, Coverage Requests, and Appeals........................ 17 30.1.1 ? Inquiries Related to Non-Part D and Excluded Drugs .......................................................... 19 30.2 ? Procedures for Handling a Grievance .......................................................................................... 20 30.3 ? Quality of Care Grievances.......................................................................................................... 22 30.3.1 ? Procedures for Handling a Quality of Care Grievance ......................................................... 23 30.4 ? Procedure for Handling Withdrawn Grievances .......................................................................... 23

40 ? Coverage Determinations, Organization Determinations (Initial Determinations) and At-Risk Determinations ............................................................................................................................................ 24

40.1 ? Part C Organization Determinations ............................................................................................ 24 40.2 ? Part D Coverage Determinations ................................................................................................. 25 40.3 ? Part D At-Risk Determinations .................................................................................................... 25

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40.4 ? Prior Authorization and Other Utilization Management Requirements....................................... 26 40.5 ? Part D Exceptions ........................................................................................................................ 27

40.5.1 ? Tiering Exceptions ................................................................................................................ 28 40.5.2 ? Formulary Exceptions ........................................................................................................... 28 40.5.3 ? Supporting Statements for Exception Requests .................................................................... 29 40.5.4 ? Adjudication Timeframes for Coverage Determinations Involving an Exception................ 31 40.5.5 ? Approval of an Exception Request ....................................................................................... 31 40.5.6 ? Approval of a Tiering Exception Request............................................................................. 33 40.6 ? Who May Request an Initial Determination ................................................................................ 33 40.7 ? Guidelines for Accepting Initial Determination Requests ........................................................... 34 40.8 ? How to Process Requests for Expedited Initial Determinations .................................................. 35 40.9 ? Who Must Review an Initial Determination ................................................................................ 38 40.10 ? Processing Timeframes .............................................................................................................. 38 40.11 ? Effect of Failure to Meet the Timeframe for an Initial Determination ...................................... 39 40.12 ? Notification Requirements for Initial Determinations ............................................................... 40 40.12.1 ? Part C Notification Requirements ....................................................................................... 40 40.12.2 ? Part D Notification Requirements....................................................................................... 44 40.12.3 ? Part D Coverage Determination Notices............................................................................. 46 40.13 ? Procedures for Handling Misclassified Initial Determinations .................................................. 48 40.14 ? Withdrawal of a Request for an Initial Determination............................................................... 48 50 ? Reconsiderations and Redeterminations (Level 1 Appeals) ............................................................... 49 50.1 ? Who May Request a Level 1 Appeal ........................................................................................... 50 50.1.1 ? Requirements for Provider Claim Appeals (Part C Only)..................................................... 51 50.2 ? Level 1 Appeal Requests.............................................................................................................. 52 50.2.1 ? Guidelines for Accepting Level 1 Appeal Requests ............................................................. 52 50.2.2 ? How to Process Requests for Expedited Level 1 Appeals .................................................... 53 50.3 ? Good Cause Exception for Late Filing ........................................................................................ 58 50.4 ? Withdrawal of Request for a Level 1 Appeal............................................................................... 59 50.5 ? Actions the Appealing Party Can Take During a Level 1 Appeal ............................................... 60 50.5.1 ? Opportunity to Submit Evidence........................................................................................... 60 50.5.2 ?Enrollee Request for Case File Content ................................................................................. 60 50.6 ? Who Must Conduct a Level 1 Appeal.......................................................................................... 60 50.7 ? Conducting a Level 1 Appeal....................................................................................................... 61

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50.7.1 ? Processing Timeframes ......................................................................................................... 61 50.7.2 ? Effect of Failure to Meet the Timeframe for Level 1 Appeals.............................................. 62 50.8 ? Service or Benefit Received Prior to Notice of Decision ............................................................ 63 50.9 ? Dismissals (Part C Only) ............................................................................................................. 64 50.10 ? Notification Requirements for Level 1 Appeal Decisions ......................................................... 65 50.10.1 - Part C Notification Requirements........................................................................................ 65 50.10.2 - Part D Notification Requirements........................................................................................ 65 50.11 ? Procedure for Handling Misclassified Appeals.......................................................................... 67 50.12 ? Timeframes and Responsibilities for Forwarding Case Files to the Independent Review Entity ................................................................................................................................................................ 68 50.12.1 ? Forwarding Case Files ? Plan Responsibilities ................................................................... 68 50.12.2 ? Forwarding Case Files - Timeframes .................................................................................. 69 50.12.3 ? Preparing the Case File for the Independent Review Entity ............................................... 69 50.12.4 ? Including Evidence of Coverage and Formulary in Case Files........................................... 70 60 ? Reconsiderations by the Independent Review Entity (Level 2 Appeal) ............................................. 71 60.1 ? Who May Request a Level 2 Appeal ........................................................................................... 71 60.2 ? How to Request a Level 2 Appeal (Part D Only)......................................................................... 71 60.3 ? Processing Timeframes ................................................................................................................ 72 60.4 ? Good Cause Extension (Part D Only) .......................................................................................... 72 60.5 ? IRE Notification and Retention Requirements ............................................................................ 72 60.6 ? Withdrawal of Request for a Level 2 Appeal............................................................................... 73 60.7 ? Effect of a Reconsideration Determination.................................................................................. 73 60.8 ? Reconsideration of Late Enrollment Penalty Determinations...................................................... 73 60.8.1 ? Summary of the LEP Reconsideration Process..................................................................... 75 60.8.2 ? Part D Plan Responsibilities under the LEP Reconsideration Process.................................. 75 60.8.3 ? Requests for Information ...................................................................................................... 77 60.8.4 ? Reasons for Requesting LEP Reconsideration and Presentation of Evidence ...................... 77 60.8.5 ? IRE LEP Processing Timeframes.......................................................................................... 78 60.8.6 ? Withdrawal of an LEP Reconsideration Request.................................................................. 79 60.8.7 ? Dismissal of an LEP Reconsideration Request ..................................................................... 79 70 ? Key Aspects of Administrative Law Judge (ALJ)/Attorney Adjudicator, Council, and Judicial Review ........................................................................................................................................................ 80 70.1 ? Parties to a Hearing ...................................................................................................................... 80 70.2 ? Amount in Controversy................................................................................................................ 80

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70.3 ? Filing Requests for Review.......................................................................................................... 81 70.4 ? Review Procedures....................................................................................................................... 84

70.4.1 ? Decision-Making Timeframes .............................................................................................. 84 70.4.2 ? Part D Plan Sponsor, CMS, or IRE Requesting ALJ Hearing Participation (Part D Only) .. 84 70.4.3 ? Submitting Evidence at the Third Level of Review.............................................................. 85 80 ? Reopening and Revising Determinations and Decisions .................................................................... 86 80.1 ? Guidelines for Reopening ............................................................................................................ 87 80.2 ? Reopenings Separate and Distinct from Appeals......................................................................... 88 80.3 ? Timeframes for Reopening .......................................................................................................... 89 80.3.1 ? Timeframes for Initiating a Reopening ................................................................................. 89 80.3.2 ? Timeframes for Processing a Reopening .............................................................................. 90 80.4 ? Reopening Based on Clerical Error ............................................................................................. 90 80.5 ? Good Cause for Reopening .......................................................................................................... 91 80.5.1 ? New and Material Evidence .................................................................................................. 91 80.6 ? Notification Requirements for Reopenings.................................................................................. 92 90 ? Effectuation......................................................................................................................................... 92 90.1 ? Independent Review Entity Monitoring of Effectuation Requirements....................................... 93 90.2 ? Effectuation Requirements for Former Plans............................................................................... 94 100 ? Provider Notices in Hospital, SNF, HHA, and CORF Settings (Part C Only) ................................. 94 100.1 ? Hospital Settings ? Important Message from Medicare and Detailed Notice............................ 94 100.1.1 MA Plan Responsibilities Following BFCC-QIO Notification of Appeal ............................ 95 100.2 ? Skilled Nursing Facility (SNF), Home Health (HH), and Comprehensive Outpatient Rehabilitation Services (CORF) Settings ............................................................................................... 95 100.2.1 ? MA Plan Responsibilities Following BFCC-QIO Notification of Appeal.......................... 96 100.3 ? Part A Medicare Outpatient Observation Notice (MOON) ....................................................... 97 110 ? Part C Data ........................................................................................................................................ 97 Appendices.................................................................................................................................................. 98 Appendix 1 ? Medicare Managed Care (Part C) Appeals Process Overview......................................... 98 Appendix 2 ? Medicare Prescription Drug (Part D) Appeals Process Overview ................................... 99 Appendix 3 ? Resources ....................................................................................................................... 100

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10 ? Introduction

This guidance covers the appeal provisions set forth at 42 CFR Part 422 Subpart M and 42 CFR Part 423 Subparts M and U. It addresses grievances, coverage/organization determinations, and appeals for beneficiaries enrolled in a plan provided by a Medicare Advantage (MA) organization, a Medicare cost plan, health care prepayment plan (HCPP), or a stand-alone Part D plan.

Additional information related to Part C and Part D grievances, coverage/organization determinations, and appeals may be found on the following Appeals and Grievances guidance webpages:





10.1 ? Glossary

For purposes of this guidance, the following terminology will be used as described in the corresponding instances:

Refers to Part C Only

Medicare Advantage (MA) plan, Medicare Advantage

Organization (MAO), Medicare cost plan or health care prepayment plan (HCPP)

Refers to Part D Only

Part D plan sponsor or plan sponsor

When Refers to Both Parts C & D

Plan

Request for Organization Determination

Request for Coverage Determination

Coverage Request

Organization Determination

Coverage Determination

Initial Determination

Reconsideration*

Redetermination

Level 1 Appeal

*This term is also used to refer to the IRE level of appeal (level 2 appeal) under both Part C and Part D.

Note: The term "coverage decision" will be used throughout this guidance in circumstances where the term applies to both an initial determination and a level 1 appeal decision.

Unless otherwise stated in this guidance, the following definitions apply:

Appeal: As defined at 42 CFR ?422.561 and ?423.560, the procedures that deal with the review of adverse initial determinations made by the plan on health care services or benefits under Part

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