CMS part C and D

30-Day Comment Period Underway for Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols

By Jen Sousa, Vice President

CMS issued proposed Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols on December 6, 2019 and allowed a 60-day period for public comments. CMS received 42 public submissions, which included 662 comments, which were then broken down to 329 unique comments. Overall, most of the changes were not significant, they are worth reviewing to ensure full understanding of the changes and the impact to your organization. The 95-page document responding to the comments received is a lot to sort through, so we are highlighting key changes by area. This does not include a summary of each change or clarification, MCS is happy to discuss specific changes to expedite the organizations implementation of the revisions.

Compliance Program Effectiveness (CPE)

  • Protocol to be renamed as “Medicare Part C and Part D Compliance Program Effectiveness (CPE) Program Audit Protocol and Data Request.”
  • CMS clarified that onsite CPE audits will continue.
  • CMS removed the “Corporate Compliance/Medicare Compliance/FWA Plan (or similar document in effect at any time during the audit review period)” document from the Supplemental Documentation Requests.
  • CMS updated the method of evaluation for compliance standard 4.1 to clarify the categories from which auditors will pull tracer case samples, when available.
  • CMS clarifies that the 26-week period for the Compliance Oversight Activities (COA) record layout is intended to reflect activities that are in progress within this timeframe. CMS does not expect Sponsoring organizations to have completed all audit activities within the 26-week period.
  • Sponsoring organizations will no longer have to generate a complete listing of all employees. CMS will select 20 samples from the week one and week two (as applicable) audit attendance logs as well as individuals and entities involved in the tracer case summary reviews, supporting documentation and/or supplemental documentation.
  • There is one CPE universe (COA). CMS revised the wording in the Activity Type field of the COA record layout to remove the reference to investigating noncompliance and investigating FWA and simplified the activities into three categories: auditing, monitoring and investigations.
  • CMS has updated the COA record layout to include a Description of Deficiencies field, but a field for the descriptions of the CAP is not needed.
  • CMS will use the Compliance Officer Questionnaire to capture additional information pertaining to the way in which organizations ensure incoming requests (call center calls) are handled correctly.



  • The changes to the FA audit protocols mostly clarify terms used in the protocols or clarify record layout instructions.
  • CMS removed the RCT-P record layout from the data request and made corresponding numbering edits to the remaining record layouts. CMS will test mid-year new enrollee transition using the RCFA universe and will continue to use the NE record layout to test negative cross year formulary changes that impact transition.



  • The changes to the CDAG audit protocols mostly clarify terms used in the protocols or clarify record layout instructions.
  • CMS clarified the CDER record layout instructions to indicate that each exception request must be listed as its own line item in the submitted universe when a drug has multiple exception types (ex. PA and QL in the same request.) For the PYMT_D record layout, if a request for multiple drugs is made at the same time, enter each drug in a separate row.



  • CMS clarified that there is no specific number of cases that will be selected from each applicable record layout for the Processing of Coverage Requests review. CMS updated the method of evaluation for compliance standard 2.1 to clarify this point.
  • CMS clarifies it will select a total sample of 10 dismissed requests, distributed across the applicable universes, for review.
  • In light of the numerous comments received, CMS removed the Part B Drugs record layout from its data request and incorporated its data request for pre-service Part B drug organization determination and reconsideration requests into the OD and RECON record layouts, respectively. They modified the description of existing fields in the OD and RECON record layouts to account for this merger and added a new field.
  • CMS updated the instructions for the PYMT_C record layout to include pharmacy claims



  • In response to public comment, CMS will provide the 30 care coordination samples the Thursday prior to the start of audit field work. The prior proposed protocols indicated one hour before the start of audit field work.
  • CMS will limit the IHRA timeliness calculation to enrollees that have been enrolled with effective dates within 12 months of the audit engagement letter.
  • CMS updated the SNPE record layout inclusion criteria limiting it to all current SNP enrollees as of the date of the audit engagement letter. CMS is able to complete its analysis of subsets within the data using data points already included in the SNPE record layout.
  • CMS has decided to collect and consider mitigating factors, such as outreach attempts and refusals for untimely cases, separately in the HRAT-IA record layout.
  • CMS removed questions 3, 7, 9, 10, 11, and 14 from the SNPCC Supplemental Questionnaire due to overlap with data that is available in the Sponsoring organizations’ MOC(s).

The 30-day notice for the proposed Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols (CMS-10717; OMB control number: 10938-NEW) is published at: Comments must be received by July 6, 2020. The supporting statement and related forms for the proposed collection summarized in this notice are available at: under CMS Form Number CMS-10717.

Upon OMB approval, CMS will make the aforementioned protocols and supporting data collection instruments available on the program audit website located at:  

Although the new protocols will not go into effect until 2021, the most important advice that we can give you is to develop and test your universes NOW – don’t wait for CMS to announce an audit to start! Need help developing and/or testing your universes? Give MCS a call! We have a team of dedicated experts that are ready to help.

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