CMS 2015 Program Audit Protocol In this Webinar attendees discussed and learnt about the changes which impact their audit(s). During this Webinar, we discussed: 1. CMS 2015 Program Audit Protocol changes 2. The importance of a correct universe 3. “Monitoring” is not good enough 4. Beneficiary Investigation Analysis (BIA)

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Q&A Session
June 30th
, 2015 Webinar
CMS 2015 Program Audit Protocol
Do your protocols meet CMS Standard

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Audience Question:
Q: can I get a copy of the slides?
A: We will be sending a copy of the presentation to all the attendees
Q: can I get a copy of the slides?
A: We will be sending a copy of the presentation to all the attendees
Q: Hello - is there a PowerPoint for this presentation
A: We will be sharing the presentation with all the attendees
Q: Who exactly is the target audience for this presentation?
We are a cardiology practice.... sounds like this is not for us
A: The Targeted Audience is mainly for entities that will be audited by CMS either because
they are a sponsor meaning a Medicare Advantage (“MA”) and prescription drug benefit
(“Part D”) plant or have been delegated the responsibility for Appeals and Grievances by
a Medicare Advantage (“MA”) and prescription drug benefit (“Part D”) plan.
Q: What is a tracer as it relates to compliance?
A: A Tracer is the new approach for testing Compliance Program Effectiveness. CMS will
use five sample issues that will be “traced” through the sponsor’s compliance program
to assess program effectiveness.
Q: What is the CMS audit cycle?
A: The CMS Audit cycle is the rotation in which Medicare Advantage (“MA”) and
prescription drug benefit (“Part D”) plans are audited on a routine basis. The Last cycle
was from 2010 through 2014. 2015 is the beginning of a new cycle meaning that all
sponsors, even those audited in the previous cycle will be considered for audit selection.
Q: Will you be making the slides available to attendees?
A: We will be sharing the presentation with all the attendees
Q: Is the process different for Pace programs?
A: No the process is very much the same

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Q: what is the definition of the term "universe?"
A: a “universe” in association to a CMS audit is a listing of all the cases that apply to a
particular audit. For example a CDAG Universe would list all the cases that a plan
received for Part C Organization Determinations during the audit period being reviewed
at that time. It will include several date elements so that CMS can properly Audit that
case for accuracy and compliance.
Q: What are the Timeline submissions for BIA's?
A: the BIA are due within 5 business days after receipt of the audit engagement letter.
CMS will compare it to their data. Sponsors will have a maximum of three attempts to
provide the Pre-Audit Summary and BIA complete and accurate documentation must be
received no later than the universe submission due date
Q: What is ODAG/ CDAG?
A: These are the acronyms used by CMS to describe
1. ODAG = Part D Coverage Determinations, Appeals, and Grievances
2. CDAG = Part C Organization Determinations, Appeals, and Grievances
Q: Will the trend of increasing detail required continue in the following years or will the
standards set and timeline be consistent?
A: It is very likely that as the program is fine-tuned the elements that are being requested
in the BIA’s or Universes will be modified. I do believe that the standards are going to
be consistent over the current audit cycle.
Q: During the presentation you mentioned the Pre Audit Issue summary was for disclosed
and self-identified or undisclosed what is the difference?
A: A disclosed issue is one that has been reported to CMS prior to the date of the audit
start notice. A self-identified issue is one that has been discovered by the sponsor but
notification was not made to CMS.
Q: What issues should be reported in the Pre-Audit Issue summary? What time frame of
issues is being requested?
A: Sponsors will be asked to provide a list of all previously disclosed and self-identified
issues of non-compliance, from January 1, 2015 through the date of the audit start
notice

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Q: If after failing to submit a Universe correctly 3 times will the ICAR for this still require 72
hours to be resolved?
A: No they will not require proof of correction within 72 hours, as typical ICARs currently
require. However, CMS will include these areas in their validation exercises and
sponsors will be expected to be able to produce a correct universe for that effort. In
addition, an IDS condition will be created and the sponsors will be cited for it based on
the inaccurate data provided.
Q: The number of Universes for the audit was mentioned. How many have been added to
the audit process?
A: CMS deconstructed the previous 3 ODAG and 3 CDAG universes to 13 and 15 templates
respectively, and made a number of modifications to the data elements required
Q: You mentioned that failing to provide accurate BIA has a range of consequences, what
are they?
A: If a sponsor fails to provide accurate data for the Pre-Audit Issue Summary and every
associated BIA by the universe submission deadline (regardless of the
number of attempts), the sponsor will not receive credit for any disclosed or self-
identified issue during the course of the audit.
CMS will consider self-identified issues that are reported to CMS per the engagement
letter instructions and corrected prior to receipt of the audit engagement letter to be
observations, therefore if not given credit for disclosing the issue and a case is found
during the audit that relates to the uncorrected disclosed issue, CMS will cite the
applicable condition(s) of non-compliance (Observation, CAR or ICAR depending on the
severity of the issue) and include the findings in the audit report
Q: So what is the purpose of the BIA?
A: CMS expects the sponsor to identify how many beneficiaries were adversely impacted
by the noncompliance. the sponsors must describe the methodology used to identify all
of the beneficiaries impacted by the noncompliance and in detail describe what was
done to remedy the issues. The instructions have also been updated to require sponsors
to identify all beneficiaries impacted dating back to the start of the plan year (January
1).

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Q: What is an “ICAR”?
A: “Immediate Corrective Action Required (ICAR)” - An ICAR is the result of noncompliance
with specific requirements that has the potential to cause significant beneficiary harm.
Immediate Corrective Actions identified during the program audit require a sponsor to
correct the identified conditions within 72 hours of notification. Once the sponsoring
organization attests to correcting the various issues, CMS may engage in validation
activities to confirm that correction has occurred.
Q: If you have a finding on a previous audit and remediated the issue at the time, however
the issue is identified again during the current audit, what is CMS's protocol, will it
escalate the corrective action or go directly to disciplinary action?
A: This becomes a matter where CMS will base its actions on the severity of the issue
identified. It will be referred to the Division of Compliance
Enforcement. If substantial and/or repeated non-compliance with the terms
of its contract with CMS a sponsor may receive actions in the form of a Civil Money
Penalty, Intermediate Sanction, or Termination (technically a contract action).
Q: Are there specific restrictions on the consulting or audit firm that can be used to do the
corrective action and validation?
A: Not in regards to consulting firm or auditor you select. The only requirement is that the
audit firm must be independent with no conflicts of interest and a firm hired to develop
or implement the corrective action cannot also conduct the validation audit.
Q: Have there been plans that have been able to affectively prove that the issue does not
cross over to the other products, or how do you gather the data effectively to make the
comparison?
A: Yes there have been plans that have been able to successfully validate that issues
identified in one product or plan did or did not affect the beneficiaries of another plan
that is under the sponsor’s product offerings. It is a matter of being able to run the
queries in the different data bases and merge the information together. I believe the
difficult part is developing those queries to identify the specific issue that was identified.
Q: If you had to focus on one thing in particular to start now in preparation for a future
audit, what would it be?
A: From an Audit prospective I would start with ensuring that the Universe I have to
provide are accurate and meet the requirements. Having issues with the Universe pulls
or the BIA is a bad start to the audit. You need to have these items developed and ready
to go. That is why I along with others recommend that you have these completed on a

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monthly or at least on a quarterly basis to ensure you are ready when you receive the
Notice of selection for audit.
But in reality I think that even before the audit is upon you it is crucial to have your
organization familiar with the materials provided by CMS. The HPMS memorandums,
Best Practice From Audits, and the regulations. CMS has released four memoranda
summarizing the common compliance issues found during its program audits and has
stated that the agency continues to find many of the same “Common Conditions or
Findings” during its yearly program audits. For 2015, CMS will escalate the
consequence of finding a condition from one or more of these memos, and substantial
failures may result in additional enforcement actions due to these “aggravating
circumstances.”
Thank you for your participation in our Webinar, and thank you to our sponsor.

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About Inovaare
Inovaare provides a software platform “CQMS TracX” to automate Compliance, Quality management
and Operation processes for the healthcare industry with a particular focus on Regulatory compliance.
Inovaare Corporation. All rights reserved. 2015
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