CMS-10717 Independent Validation Audit Work Plan

Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols (CMS-10717)

Indep_Validation_508

Program Audits

OMB: 0938-1395

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Independent Validation Audit Work Plan

Sponsoring Organization Information
Name of Sponsoring Organization
Enter sponsoring organization name
Contract Numbers
Enter contract number/s
Total Enrollment
Enter total enrollment number for all corresponding contracts listed above

Independent Auditor Information
Independent Auditor
Enter IA name
Summary of Previous Work for Sponsoring Organization
Enter summary of previous work performed for the sponsoring organization’s Medicare line of
business. Enter NA if not applicable.
Validation Audit Team
List of all auditors (i.e., at least two per program area) with sufficient subject matter expertise,
including those with clinical expertise as necessary:
• FA and/or CDAG clinical auditor (e.g., pharmacist) with expertise in the formulary
administration, transition, and processing of coverage request requirements.
• CDAG, ODAG, and/or MMP-SARAG clinical auditor (e.g., physician) with expertise in
processing of coverage requests requirements.
• MMP-SARAG clinical auditor (e.g., social worker) with expertise in evaluating the level
of care and social supports necessary for the provision of long-term services and
supports for the dual-eligible population.

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SNP-CCQIPE and/or MMP-CCQIPE clinical auditor (e.g., nurse) with expertise in
care coordination and quality improvement program effectiveness requirements,
including model of care processes, health risk assessments, interdisciplinary care
teams, care coordination, and care planning.

☐ Checked box indicates individual resumes are attached to work plan.
Name
Enter name. Example:
John Doe, RPh

Program Area/s

Auditor Type

Enter program area/s.
Auditors with
appropriate expertise
may be assigned to
more than one
program area.
Example:

Enter auditor type (e.g.,
Physician, Nurse,
Pharmacist, or Nonclinician). Example:
Pharmacist

FA and CDAG

Validation Audit
Scope
List of all conditions of non-compliance (or remaining conditions for revalidation) found
during the initial program audit, universe record layouts, and scope of universe requests.
Condition Number

Enter condition
number (as listed in
final report).

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Universe Record Layout

Scope of
Universe
Request Start
Date

Scope of
Universe
Request End
Date

Enter universe record layout.
Example:

Select scope of
universe
request start
date. In
general, this
“clean period”
must align with
the projected
completion
date provided
in the accepted
CAP.

Select scope of
universe
request end
date. In
general, the
duration must
be maintained
(i.e., based on
sponsoring
organization’s
enrollment)
consistent with
the initial audit
of the specific
program area.
For CPE and

Table 1: Rejected Claims
Formulary Administration
(RCFA)

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SNP-CCQIPE,
the scope may
vary based on
the audit
approach to
testing the
condition.

Methodology
Description of evaluation approach focused on compliance outcomes to determine remediation
of each condition.
Program Area: Enter program area. Example: Part D Formulary and Benefit Administration
(FA)
Element:

Enter program area element. Example: Formulary Administration

Condition:

Enter condition number and condition (as stated in final report).

Cause:

Enter cause (as stated in final report).

Method of Evaluation:
Enter description of validation approach, which must address the original root cause found and
consider all impact analyses submitted during the program audit, including but not limited to:
•
•

•

•

•

Universe integrity testing with a minimum of five sample cases to ensure the accuracy
and completeness of universe/s, as applicable.
Number of samples to be selected for review from specific universe record layout/s,
which must be appropriate to test the non-compliance. For timeliness and IRE autoforward conditions, evaluation must be conducted at the universe level. For all other
conditions, a minimum of 10 cases must be targeted for selection.
Sampling criteria to target and identify applicable cases in the universe/s. Specify all
parameters and preparatory steps taken prior to sample selection (e.g., call types, drug
types, number of days supply, formulary comparison to identify negative cross-year
changes and use of prior year PDE data for continuing enrollee transition issues, all
possible rejections associated with the issue not limited to those in the impact analyses).
Alternative evaluation approach if 10-sample minimum is not achieved to assess
remediation of a condition (e.g., expanded scope of universe request, use of test claims,
CAP review, policies and procedures review). (Note: For FA, use of test claims must
always be considered as an alternative approach.)
Process for requesting and evaluating impact analyses if non-compliance is identified to
understand the root cause and extent of the issue.

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Timeline
Schedule of validation audit activities and other key milestones.
Activity
Enter activity, including necessary details. Examples:

Start Date

End Date

Kick-off

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Work Plan – allow two to three weeks for CMS review
and approval of final work plan

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Data Request

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Universe Submission

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Universe Integrity Testing

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Sample Selection

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Validation Audit/Fieldwork

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Report Submission

Select activity
start date.

Select activity
end date. If
milestone, use
start date.

Audit Report Template
At a minimum, the report template includes:
• Independent auditing firm’s identifying information;
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•
•

Objective, scope, and methodology of the validation audit;
Summary of results (i.e., outcome of transactions or sample cases tested for each
condition), less any opinion about any individual audit condition’s classification or
correction;
Description of criteria, cause, and effect of any non-compliance, as well as new issues
of non-compliance (i.e., new conditions not previously cited in the initial audit report)
found during the validation audit, including references to failed case samples, impact
analyses, universe record layouts, and other information that support the noncompliance.

☐ Checked box indicates report template is attached to work plan.

PRA Disclosure Statement According to the Paperwork Reduction Act of 1995, no persons are required to respond to a
collection of information unless it displays a valid OMB control number. The valid OMB control number for this information
collection is 10938-NEW (Expires: TBD). The CMS control number is CMS-10717. The time required to complete this
information collection is estimated to average 701 hours per response, including the time to review instructions, search existing
data resources, gather the data needed, and complete and review the information collection. If you have comments concerning
the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard,
Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. Please do not send applications,
claims, payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office.
Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB
control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding
where to submit your documents, please contact 1-800-MEDICARE.

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File Typeapplication/pdf
File TitleIndependent Validation Audit Work Plan
SubjectWork Plan
AuthorDate/version#
File Modified2020-05-11
File Created2020-05-08

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