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New Audit Protocols are Coming in 2021

By February 5, 2020Audits, CDAG, CPE, FA, ODAG, SNP-MOC

On December 6, 2019 CMS issued the HPMS Memo titled “Proposed Collection for New Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols – 60-Day Comment Period”.

CMS was busy in late 2019 issuing proposed changes to CMS Program Audit Protocols that will be utilized starting for the 2021 Audit Season. CMS will likely not finalize the 2021 CMS Program Audit Protocols until mid-year 2020.

If you have not reviewed these protocols BluePeak recommends that you review all sections and identify how the proposed changes will impact your organization and your vendors.  Plans should start working to identify subject matter experts and timelines to implement these changes, if approved.   Below we have given a high level of the proposed changes within each section.

  • This memo focuses on the substantial changes to the 2021 CMS Audit Protocols being proposed for 2021 implementation . This version would supersede the proposed changes for calendar year 2020 proposed on December 27, 2019.
  • Comments on the proposed 2021 CMS Audit Protocols are due to CMS by February 4, 2020

2021 CMS Audit Protocols Change Summary

Compliance Program Effectiveness (CPE)

  • Changed audit period from 52 to 26 weeks
  • Combined FTEAM, IA and IM universes into a new Universe-Compliance Oversight Activities (COA)
  • Removed the ECT Universe and instead will be requesting a listing of all employees that work in the delivery of the Program
  • Added a data integrity component
  • Removed the SIU Questionnaire
  • Revamped the Compliance Officer and FDR Oversight Questionnaires
  • Updated the Corporate Structure and Governance Presentation

Formulary Administration (FA)

  • Added Supplemental Documentation Submission and Request
  • FA Impact Analysis Summary (1IA) and the Enrollee Impact Analysis (2IA) has been formally defined
  • Added data integrity sessions for Universes 1-3 with 5 cases being selected for each universe
  • CMS has provided more clarity around specific criteria for case review including formulary-based rejections, messaging, opioid safety edit rejections, short cycle dispensing and prescriber rejections
  • Rejected Claims Formulary Administration (RCFA) universe extract timeframes have been adjusted to weekly cycles versus monthly

Coverage Determination, Appeals and Grievances (CDAG)

  • Universes have been consolidated with fields added to define processing timeframes (standard / expedited)
  • New universe to capture activities related to a Plan’s Drug Management Program (DMP) – Universe 7: Comprehensive Addiction and Recovery Act (CARA) At Risk Determination
  • The number of audit elements has increased from 3 to 4
  • Specific elements being tested by CMS are provided in greater detail
  • Increase in samples
    • Data Integrity – now 10 cases per universe instead of 5
    • Dismissed cases – now up to 10 cases instead of 5
    • Grievances cases – 20 cases proposed for both 2020 and 2021 instead of 10
    • Drug Management program administration cases – up to 15 cases can be selected

Organizational Determination, Appeals and Grievances (ODAG)

  • Clarified the new requirement for Part B drugs with adherence to shorter Part D timeframes for processing these requests and that extensions are NOT allowed
  • Significant universe updates:
  • Universes have been consolidated with fields added to define processing timeframes (standard /expedited)
    • Added new tables for Part B drugs and Dual Eligible Special Needs Plans determined to be an Applicable Integrated Plan
    • Removed the dismissal table and added “Dismissal” as an option for the request determination in applicable tables
    • Significant changes in column placement which will require plans to re-map where data is imported into templates
  • Changes in timeliness tests conducted for all but two universe tables

Special Needs Plan and Model of Care (SNP-MOC)

  • Added data integrity testing for Special Needs Plan Enrollees (SNPE) universe
  • Samples to be provided one hour prior to the webinar as done with other program areas
  • Added Timeliness testing IHRA and AHRA at the universe level
  • Changes to the required supplemental documentation
  • New root cause template for Care Coordination and HRA timeliness
  • Updated SNPE: Added, clarified and removed fields from the SNPE universe
  • CMS would not apply the SNPCC protocol if an accrediting organization has deemed a special needs plan compliant with CMS regulations and standards

Want to help ensure your Plan is ready for a 2021 Program Audit?  BluePeak Advisors can help!  We can perform operational assessments and/or mock audits of your Plan’s operations to detect areas requiring corrective action, help your Plan define and implement effective corrective actions where necessary, and assist your Plan with developing a prevention plan of ongoing monitoring and auditing to help minimize the ongoing risks of non-compliance.  Contact us today at (469) 319-1228 or

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