CMS Issues New Proposed Protocols for Medicare Part C and D Program Audits and Part C Timeliness Monitoring Project.  Proposed Changes Would Take Effect in 2021 Audit Year.

By Alexander Henrichs
Thu, Dec, 12, 2019

CMS issued Medicare Part C and Part D Program Audit and industry-wide Part C Timeliness Monitoring Project (TMP) Protocols. The 60-day comment period is now open and will close on February 4, 2020.

These protocols are neither final nor approved. While there are quite a few proposed changes to the current program audit protocols, note that the 2020 audit year will still use the same protocols as in 2019. The proposed protocols would take effect starting in 2021.

The protocols cover 5 areas of program audits:  CPE, FA, CDAG, ODAG, and Special Needs Plan – Care Coordination (SNPCC).

Here is an overview of the major changes and important considerations we have identified:

Program Audit

Overall Process

  • Independent Validation Audit Work Plan Template
    1. This would be a new template but the information is largely the same. It contains the elements that are expected to be included within the IVA work plan. This template doesn’t indicate if IVA work plans need to be in this exact format, but it reads that way.
  • Proposed Protocol Expiration
    1. No expiration dates listed at this time.
  • Root Cause Template
    1. Similar information required, but appears to be in Word format rather than Excel (and could change).

Compliance Program Effectiveness (CPE)

  • Compliance Oversight Activities (COA)
    1. This is the only record layout/universe included in the protocols and would apply to all auditing and monitoring activities. The timeframe has changed to a ‘26-week period preceding and including the date of the audit engagement letter.’ CMS notes that it could expand this, if needed, to obtain a universe of sufficient size.
  • Questionnaires
    1. The Compliance Officer and FDR Oversight questionnaires have some updated and new questions included. Missing, however, is the FWA Oversight Interview. There is a note that “interviews with … individuals responsible for SIU/FWA … oversight [will take place], as applicable,” but there is no mention of the FWA Oversight questionnaire.
  • Tracers
    1. Six tracers will still be included in this review; however, all six will come from one universe, instead of three as specified in the current protocols.
  • PDC
    1. CMS still plans to audit ‘Prevention, Detection, Correction’ elements. There appear to be typos s in the Program Audit Protocol table starting on page 3. (Prevention is listed twice, and the correction isn’t included; this will likely be updated.)

Formulary Administration (FA)

  • Formulary and Benefit Administration Supplemental Questionnaire
    1. Includes five questions that appear designed to help CMS during their sample selections.
  • Universes
    1. The tables and layouts remain mostly unchanged.
  • Impact Analysis Requests
    1. The layouts for two separate tables are included within the protocols: Impact Analysis Summary (IAS) and Enrollee Impact Analysis Request (ENR-IA). Different methodologies are noted for FA and Transition related issues.

Part D Coverage Determinations, Appeals and Grievances (CDAG)

  • Universes
    1. As foreshadowed in the draft protocols of 2018 that never made it past the comment period, there will be a significant reduction in the number of universes in the CDAG element. CMS had combined standard and expedited determinations of like requests into the same universe, removed the call log universe (no longer collected in 2019 and 2020), and added Table 7: Comprehensive Additional and Recovery Act (CARA) At Risk Determination (AR).
    2. Review Period
      1. There is a new line in the review period for plans with greater than 500,000 members; only two weeks of data will be required. Everything else remains the same, except the changed the term ‘months’ to ‘weeks’ (two months in the current protocols is referred to as eight weeks in the new).
  • Samples
    1. Universes Data Integrity Testing: This changes from five samples per universe to 10 samples per universe. The total number of samples for the CDAG element declines from 75 to 70 due to the overall decrease in required universes.
    2. Grievances: CMS will now select 20 grievances from the combined grievances universe, a significant increase from the10 grievancesfrom the standard and expedited universes as specified in the current protocol. This increase may be linked to CMS’ decision to remove 10 call log samples.

Part C Organization Determinations, Appeals, and Grievances (ODAG)

  • Universes
    1. As in the CDAG protocols, there has been a decrease in the overall number of universes CMS requires. The agency has combined standard and expedited determinations of like requests into the same universe, combined the IRE/ALJ/MAC effectuations into one universe, and is no longer requiring the call log universe (removed from current protocol requirement in 2019).
    2. There are two new universes in this protocol: Table 6: Standard and Expedited Pre-Service Part B Drug Organization Determinations and Reconsiderations (Part B Drugs) and Table 7: Dual Special Needs Plan – Applicable Integrated Plan Reconsiderations (AIP).
      1. The requests from Table 6 were previously being collected in the OD universes, but are now given a separate table.
      2. Table 7 is being collected to determine if benefits were continued for enrollees who filed an appeal on their benefit changes.
    3. Review Period
      1. There is a new line in the review period for plans with greater than 500,000 members: only two weeks of data will be required. Everything else remains the same, except CMS has changed ‘months’ to ‘weeks’ (i.e., two months in the current protocols is referred to as eight weeks in the new).
    •  Samples
      1. Universes Data Integrity Testing: This changes from five samples per universeto 10 sample per universe, for a total of 70. This will be a slight increase in overall data integrity samples (the current protocol calls for 65).
      2. Processing of Coverage Requests: 30 denials total from Tables 1, 2, 3 and 6, with an additional five from table
        1. Contrary to the current protocols, CMS does not mention reviewing approved requests for this element in the new protocol. The current protocol calls for the review of 10 approvals,
      3. Dismissals: a total of 15 combined from Tables 1, 2, 3, 5, and 7.  There are no changes to the overall quantity; however, the new protocols do not specify how many will be pre-service, payment or grievance dismissals.
      4. Grievances: As with CDAG, CMS will now select 20 grievances from the combined grievances universe. Current protocols call for 10 grievances from the standard and expedited universes. The reasoning behind this increase is likely tied to the removal of the 10 call log samples.

Special Needs Plans Care Coordination (SNPCC)

  • Enrollment Verification & PPME
    1. There is no PPME universe requirement in the new protocols and there is no suggestion that this will be evaluated elsewhere. Enrollment verification is not listed as a singular review and is not included as one of the compliance standards that the samples will be reviewed against. However, it is possible that these might be evaluated during specific sample reviews.
  • Timeliness Tests
    1. Initial health risk assessment (IHRA) and annual health risk assessment (AHRA) will now undergo a timeliness test. CMS notes that it will request an impact analysis (IA) for enrollees who fall outside of the expected completion timeframe.
      1. CMS also notes that it might conduct integrity tests to verify IAs.

Given the large number of changes we have identified in the 2021 protocols, we encourage your organization to dig deeper into those applicable to your operations. The comment period for these proposals is open through February 4, 2020 and will likely be the one time to voice your concerns to CMS regarding any difficulties you envision the prospective changes will present.

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