While the world is anything but predictable—especially in the age of COVID-19—the Centers for Medicare and Medicaid (CMS) isn’t being cryptic about the forthcoming changes to their audit protocols. But it takes regulatory compliance experts to sift through the minutiae to ensure that health plans keep current with evolving regulatory rules.

Here’s the problem. Health plans spend far too much time reacting to regulatory compliance, auditing and monitoring requirements by viewing them through the rearview mirror. Member issue management, built upon a real-time compliance platform, is essential if health plans want to ensure an audit-ready status at all times. Doesn’t that sound sublime?

Traditionally, health plans rely on compliance consultants to guide them through regulatory processes after audit and A&G notices strike. This results in large out-of-pocket expenses, operational disruption and enormous stress for compliance teams.

Fortunately, automated solutions exist to streamline processes and ensure health plans are consistently compliant with regulatory rules. By digitally transforming their regulatory compliance, auditing and monitoring processes, compliance teams can be fully liberated to know they can efficiently respond to any regulatory notice and submit compliant reports with the touch of a button.

For example, Inovaare’s team of regulatory compliance experts—with over 125 years of combined CMS compliance experience—ensures its clients are always in line with evolving regulatory requirements by proactively embedding rule changes into its automated compliance solutions. The 2021 CMS audit protocols change serve as a fantastic example.

2021 CMS Audit Protocols Change Overview

Below are some of the most significant changes slated for 2021:

Organizational Determination, Appeals and Grievances (ODAG)

  • New requirement for Part B drugs clarified regarding adherence to shorter Part D timeframes for processing requests; extensions are NOT allowed
  • Universes consolidated, with added fields, to define processing standard and expedited timeframes
    • New tables for Part B drugs added and Dual Eligible Special Needs Plans determined to be an Applicable Integrated Plan
    • Dismissal table replaced with “Dismissal” as an option for request determination in applicable tables
    • Column placement changes will require health plans to remap data placement within templates
  • Revised timeliness tests conducted for all but two universe tables

Coverage Determination, Appeals and Grievances (CDAG)

  • Universes consolidated, with added fields, to define processing standard and expedited timeframes
  • New universe to capture activities related to health plan’s drug management program (DMP) as required by Comprehensive Addiction and Recovery Act (CARA)
  • Audit elements increased from three to four
  • CMS targeting specific elements for testing tested; Inovaare can advise
  • Sample increases
    • Data integrity changed from five cases per universe to 10
    • Dismissed cases changed from five cases to 10
    • Grievances cases now proposed to change from 10 to 20 cases for 2020 and 2021
    • DMP administration now allows for up to 15 cases to be selected

Formulary Administration (FA)

  • Supplemental Documentation Submission and Request added
  • FA Impact Analysis Summary (1IA) and the Enrollee Impact Analysis (2IA) now formally defined
  • Data integrity sessions for Universes 1–3 added, with five cases selected for each universe
  • CMS provided clarity around case-review criteria, including formulary-based rejections, messaging, opioid safety edit rejections, short-cycle dispensing and prescriber rejections
  • Rejected Claims Formulary Administration (RCFA) universe extract timeframes revised from monthly to weekly cycles

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

  • Data integrity testing for Special Needs Plan Enrollees (SNPE) universe added
  • Timeliness testing IHRA and AHRA at universe level added
  • Required supplemental documentation revised
  • Root cause template for Care Coordination and HRA timeliness added
  • SNPE universe revisions included added, clarified and removed fields
  • SNPCC protocol wouldn’t be applied if accrediting organization deems a special needs plan compliant with CMS regulations and standards

Compliance Program Effectiveness (CPE)

  • Audit period revised from 52 to 26 weeks
  • FTEAM, IA and IM universes combined into a new Universe-Compliance Oversight Activities (COA)
  • ECT universe replaced with request for list of employees in program delivery
  • Data integrity component added
  • SIU questionnaire removed
  • Compliance Officer and FDR Oversight questionnaires revised
  • Corporate Structure and Governance Presentation updated

Inovaare knows the world of Medicare, Medicaid and commercial health plans from over 125 years of combined hands-on Regulatory Compliance department oversight. Our consultative approach guides health-plan compliance teams through everything needed to sustain a continuous audit-ready status and the Inovaare platform empowers them to submit CMS-compliant reports with the touch of a button.


Brenda Wade, Chief Compliance Officer

Inovaare Corporation