The Centers for Medicare & Medicaid Services (CMS) launched a new cycle of program audits in February 2022. Multiple Medicare Advantage Prescription Drug Plans (MAPDs) have already received notification of their selection. CMS anticipates a total of 25 plan organizations to be audited in this cycle. Plan sponsors that have gone through program audits previously are well advised to review the new features in this year’s audit protocols (CMS 10717; OMB 0938 NEW) and incorporate them into practice.

CMS recognizes the time necessitated by the changes and estimates a one-time labor-related transition burden of 340 hours associated with reprogramming data extracts, developing new processes for quality assurance testing, general business owner testing, compliance review, etc. In addition, CMS estimates a total burden of 501 hours on average for the sponsor organization to participate in the audit. On average, this is how the total hours break down:

  • 200 hours for administrative and systemic work to assemble the requested information
  • 60 hours to review the information for completeness
  • 30 minutes to submit the information to CMS
  • 160 hours for the actual administration of the audit
  • 40 hours to respond to audit documentation requests
  • 40 hours to review and respond to the draft audit report
  • 10 minutes to complete the optional post-audit survey.

The total burden equals 500 hours and 40 minutes, rounded up to 501 hours.

The good and bad news regarding the changes promulgated for the 2022 program audit are: data submission is streamlined (good news) but programming revision and re-configuration of data fields are needed (bad news).

Here are highlights of the 2022 Program Audit protocols changes:

  1. Data Integrity — Universes for Formulary Administration (FA) will be tested for data integrity. All samples selected for testing will be reviewed (instead of 4 out of 5, if no discrepancies are identified). The same applies to CDAG, ODAG, CPE and SNPCC.
  2. Universe Consolidation — The number of universes required for each audit area has been reduced through attrition or consolidation, but with additional fields to define processing timeframes. For example, there is only one table for rejected claims for transition instead of two (Table 2 RCT). For CPE, FTEAM, IA and IM, universes are combined into Table 1 Compliance Oversight Activities (COA) and ECT is removed. Notably, seven tables are required for CDAG (down from 15) and six for ODAG (down from 13). This reduction entails significant changes to the fields in the tables and plan sponsors must remap data extraction to comply.
  3. New Elements — On the other hand, new audit elements have been added. Table 7 Comprehensive Addiction and Recovery Act (CARA) At-Risk Determination is added to review activities related to plan sponsor’s Drug Management Program (DMP), which became mandatory in CY2022 and was codified in CMS-4190-F2. Table 6 Applicable Integrated Plan Reductions, Suspensions and Terminations (AIP) for ODAG is to review if a previously approved service is being reduced, suspended or terminated by the D SNP. At the same time, the Special Needs Plans Enrollees field descriptions have been redefined.
  4. Model templates — CMS has provided standard templates for the Attendance log, a Supplemental Questionnaire for FA and Root Cause Analysis.
  5. Other technical changes — The protocol has standardized “Yes” to “Y”, “No” to “N” and “NA” to “None” in CD (Coverage Determinations) record layout. Medicare Beneficiary Identifier (MBI) has been replaced with Enrollee ID.

CMS provided support to plan sponsors through training sessions in August 2021, crosswalk of changes that occurred after the 30-day comment period and audit protocols. Even with all the help available, it does require a major effort to review all the final changes and be ready before July 6 is over.

Getting universe tables properly formatted is merely the point of entry. Inovaare has a Universe Management Suite comprised of three modules — Universe Scrubber, Universe Generator and Universe Aggregator — helping health plans to simplify complex audit-preparation processes and ensure properly formatted CMS universe tables. The validation software within the Universe Management Suite completes the table analysis process by flagging issues related to turnaround times, outliers and inclusion/exclusion criteria, which proves to CMS that the health plan is properly managing its regulatory compliance responsibilities.

The Universe Management Suite was developed under the guidance of a team with over 125 years of combined regulatory compliance experience, and in partnership with several health plans who have been successfully using it for mock audits. We can save you hours in preparing transition to the new audit universes and practice for the program audit.

For more details, please contact us at or 408-850-2235