Beacon Compliance Hot Topics: August 2019


Medicare Parts C and D Program Audit Protocols and Data Requests

An HPMS memo titled “Proposed Collection for Updated Program Audit Protocol – 60 Day Comment Period” was issued on August 20, 2019. CMS is providing an opportunity for sponsor organizations and other stakeholders to comment on the proposed Medicare Parts C and D Program Audit and Timeliness Monitoring Data Requests and other supporting data collection documents. 


Medicare Part D plan sponsors and Medicare Advantage organizations are required to comply with all Medicare Parts C and D program requirements. CMS’ annual audit plan ensures that CMS evaluates sponsoring organizations’ compliance with these requirements. CMS program audits focus on high-risk areas that have the greatest potential for beneficiary harm. 

Currently, CMS utilizes the following 5 protocols to audit sponsoring organization performance: 

1. Part D Formulary and Benefit Administration (FA); 

2. Coverage Determinations, Appeals, and Grievances (CDAG); 

3. Organization Determinations, Appeals, and Grievances (ODAG); 

4. Special Needs Model of Care (SNP–MOC) (only administered on organizations who operate SNPs); and, 

5. Compliance Program Effectiveness (CPE). 

The data collected is detailed in each of these protocols. In addition, this collection request includes a pre-audit issue summary, three CPE questionnaires, one CPE organizational structure presentation template, one FA impact analysis template, two CDAG impact analysis templates, four ODAG impact analysis templates, and three SNP–MOC impact analysis templates. 


CMS’ proposed revisions for the Medicare Parts C and D Audit Protocols and Data Requests are as follows: 

1. Replaced use of the Secure File Transfer Protocol (SFTP) with CMS' Health Plan Management System (HPMS) 

2. Updated the Timeliness Test tables within the CDAG and ODAG protocols by replacing references to outdated sub regulatory guidance with regulatory references 

3. The following attachments/documents were removed:

  1. CPE Self-Assessment Questionnaire (Attachment 1-A)

  2. CDAG Supplemental Questionnaire (Attachment III-A)

  3. ODAG Supplemental Questionnaire (Attachment IV-A)

  4. MTM Audit Process Data Request (Attachment VI), Program Data Request and Impact Analysis template

4. Removed questions related to best practices and/or other questions no longer supported by Regulation from the following attachments:

a. CPE Compliance Officer Questionnaire (Attachment 1-B)

b. CPE FDR Oversight Questionnaire (Attachment 1-D)

c. CPE SIU FWA Questionnaire (Attachment 1-E) a. Also updated references from MBI MEDIC to I-MEDIC.

5. The following sections of the below mentioned documents have been removed:

a. CPE Table 1: First-Tier Entity Auditing and Monitoring Record Layout

a. Column C - FTE Contract Effective Date – Populate as ‘NR’

 b. CPE Table 2: Employees and Compliance Team (ECT) Record Layout

a. Column I - Medicare Compliance Department Employee,

b. Column J - Compliance Department Job Description,

c. Column K - Compliance Committee Member

d. Column L - Compliance Committee Member’s Role

 c. CDAG a. Table 9: Standard IRE Auto-forwarded CDR Record layout

b. Table 10: Expedited IRE Auto-forwarded CDR Record Layout

c. Table 16: Call Logs Part D Record Layout

 d. ODAG a. Table 14: Call Logs Part C (CLC) Record Layout

6. The following program area specific elements will be suspended from evaluation:

a. Formulary and Benefit Administration (FA) protocol - Website Review

b. Special Needs Plans – Model of Care (SNP-MOC) - Enrollment verification


7. Minor changes, such as additions, deletions, and revisions for clarification purposes were made in the following attachments:

a. CPE Audit Process Data Request (Attachment I) a. Added following language: If the audit review crosses calendar years, sponsoring organizations must provide the requested documentation that covers the entire audit period.

b. FA Audit Process Data Request (Attachment II)

a. Section II – Transition: Increased targeted sample of claims from 15 to 30 and claims will be selected for both protected and non-protected class drugs.

b. Replaced HICN with MBI.

c. CDAG Audit Process Data Request (Attachment III)

a. Table 7 – Compliance Standard is no later than 14 days (instead of 7).

b. If the organizations do not have responsive cases during the requested audit period, then upload an Excel to HPMS that includes a statement explaining that.

d. ODAG Audit Process Data Request (Attachment IV)

a. If the organizations do not have responsive cases during the requested audit period, then upload an Excel to HPMS that includes a statement explaining that.

b. Table 3 – Revised compliance standard: 95% in 30 days for clean claims and 60 days for unclean all other claims from non-contracted providers.

c. Section I – Timeliness Tests

i. Case sample selection decreased from 65 to 60 cases.

ii. Removed references to Dismissals

d. Section II – Appropriateness of Clinical Decision: Targeted case samples decreased from 40 to 35 and removed some compliance standards.

e. Section III - Increased the number of grievance samples from 10 to 20 cases.

f. Added specific exclusions from Tables 1-12.

e. SNP MOC Audit Process Data Request (Attachment V)

a. Copies of any pre-enrollment eligibility verification tools and P&Ps for C-SNPs & I-SNPs are no longer required.       

Recommended Action

1. Share documents with impacted operational areas.

2. Review changes and determine if any action is required to current organizational processes, inclusive of data collection and storage, and written policies and/or procedures.

3. Submit comments by October 15, 2019:

a. Electronically. You may send your comments electronically to Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

b. By regular mail. You may mail written comments to the following address: i. CMS, Office of Strategic Operations and Regulatory Affairs

c. Reference the document identifier or OMB Control number

i. Document identifier: CMS-10191

ii. OMB Control Number: 0938-1000