PRA - Crosswalk - Protocol 2012- 2013 changes v2--REDUCED

Crosswalk of Changes from 2012 to 2013 Medicare Part C and D Oversight and
Enforcement Group Audit Protocols

Compliance Program Effectiveness (CPE)
Area (Document)
Attachment III – Compliance Program
Data and Documentation Requests

Change
x
x
x

Attachment III-A –

x

Sample Case File Documentation
Requested
x

Changed formatting
Added references to Element Numbers to each data request –
corresponds in the order of the Compliance Program Guidelines for
easy use by the Sponsor
Questions 31, changed reference from 14 above to 15 above.

Added 2nd paragraph note to Sponsors: “With the exception of the
documents requested for Element I (Written Policies, Procedures
and Standards of Conduct), the documentation listed under each
sample request is provided as examples of what your organization
may provide as evidence of compliance for the respective element.”
Cross-identified related compliance elements to the sample
requested; streamlined the documentation request

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Attachment III- B – Key Contacts for
Compliance Program Operations

x

Newly created for purposes of identifying key people involved with
Compliance Program Operations and able to assist with explaining
the sample documentation. This list can also be used to identify the
appropriate personnel for interviews.

Attachment IV – Organizational
Structure and Governance PPT
Template

x

Updated to reflect new reporting requirements and information
needed for due diligence and reviewing documentation.

Interview Guides for CEO/Senior
Management, Board Member, and
Employee

x

Revised to provide suggestions on how to start a conversation with
the subject and inclusion of important questions to weave in.
Deleted Interview Questions for Compliance Officer. The SAQ will
be used as a checklist for ensuring all related evidence is collected
for each element and will serve as guide for the Compliance Officer
interview.

Attachment V - Self-Assessment
Questionnaire

x
x
x

x

x
x
x
x
Communication Strategy

x

Cross Reference Tool used for Compliance Officer Interview
Expanded to accommodate changes in sub-regulatory guidance
Reorganized questions and provided descriptions that correlate with
exact verbiage of “musts” and “should” of the Compliance Program
Guidelines
Questions refer to development of the program, implementation of
the requirements, and effectiveness measures
In 2012 = 133 questions
In 2013 = 80 questions
7 elements + FDR oversight (applicable elements)
Enhances communication between compliance program team lead
and operational area team leads during the audit.

2

Effectiveness Measures - Tracer
Methodology and Sample Results Grid

x

Methods of Evaluation (MOE)

x

x

x

*Sample Case Worksheets

x

*Auditors Manual

Process to look at how the Sponsor’s compliance program works as
a system
New Tracer Methodology with 7 sections: (a) Regulatory
Requirements and Policy Guidance, (b) What does an Effective
Compliance Program Look Like, (c) How to Evaluate Compliance
Program Effectiveness, (d) Selecting Samples (e) Evaluating the
Evidence (d) Completing the Sample Grid, (f) Sample Case
Examples
Revised to incorporate new sub-regulatory requirements and
measures to confirm implementation and effectiveness
7 elements + FDR oversight

Will need to be updated once the MOE and overall strategy is
approved by DAO and MOEG FO. It should only take approx. 2
weeks to complete revisions.

*Auditors Tool Kit

Part C Organization, Determinations, Appeals and Grievances (ODAG)
Area (Document)
Overall Changes

Change
x

Format was revised to incorporate multilevel list and bullets for
ease in referencing

x

Footer: contains proposed naming convention and included date the
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protocol was last updated
x

Removed references to overall pass/fail threshold. Added language
to explain that an individual sample case failure results in
documentation of a condition:
x

x

CMS will test each of the 30 cases. If CMS
requirements are not met, a sample case fails and a
condition (finding) is documented. If CMS
requirements are met, a sample case passes and no
conditions (findings) are documented.

Removed reference to Part C Access to Care
x

Audit TL and contractors stated not finding a lot of access to
care issue when testing in this area

x

In this element it was found that of the cases found they were
mis-classified grievances
x

These cases are removed from the sample’s element, but
reviewed in the grievance sample
x

x

Essentially sponsor is penalized twice

Review of CTMs rarely found access to care issues
x

CTM are monitored on a daily basis by RO
x

Reviewing during an audit, TL feel is double
work
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Purpose

x

removed reference to Part C Access to Care

Review Period

x

no longer based on size of plan
x

Requiring all plans to submit 3 months of data

x

Takes into account systematic issues that may arise in a
specific month that may cause a plan to fail.

x

Provides audit team with a better assessment of how the
sponsor operate

Note

x

added to stress the importance of submitting universes in
accordance with the instructions and to submit universes on time.

I. Effectuation Timeliness - 1. Select
Universe and submit to CMS

x

Clarifying language about what should be included in the universe

x

inserted additional element for review- DAP provided feedback that
IRE,ALJ, MAC overturns are included in this review

x

on 2/12/13-deleted first sentence “The plan expected to provide
accurate and timely universe submissions,” as this is stated in
previous note

I. Effectuation Timeliness – Note

x

2/12/13- corrected note to state “favorable” rather than
“unfavorable” determinations

I. Effectuation Timeliness – 4.1 Apply
Compliance Standard

x

Deleted appropriate as there is no clear guidance about what should
be included in an approval letter. Guidance is only clearly provided
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for denial letters and the appropriateness of the notification letter is
reviewed in ODAG CDM.
II. Appropriateness of Clinical Decision
Making - 1. Select universe and
submit to CMS

x

Included clarifying language to ensure ALJ/MAC decisions are
included in the sample

x

Note

x

Inserted Reconsiderations overturned by the IRE, ALJ, or MAC.
Per SME feedback, this parallels ET review above and CDAG
review
Clarifying language

II. Appropriateness of Clinical Decision
Making – 2. Select 30 cases

x

Change sample selection to include IRE/ALJ/MAC cases

II. Appropriateness of Clinical Decision
Making – 3 Obtain Evidence

x
x

II. Appropriateness of Clinical Decision
Making – 4.1.6 – Initial Organization
Determination

x

II. Appropriateness of Clinical Decision
Making – 4.2.4 Reconsideration

x

added language to clarify what is being reviewed for compliance
1st bullet: Clarified original request is needed to assess how the
sponsor processed reconsideration from initial request
added additional compliance standard “If the plan made as adverse
decision or did not meet the decision making timeframe, did the
plan auto-forward to the IRE properly and within required
timeframe.” Insert, reflects compliance standards for
reconsiderations and further clarifies the purpose for testing this
element
deleted and notification requirements as notification is reviewed in
ET, not CDM

II. Appropriateness of Clinical Decision
Making – 4.2.6 added

x

made an adverse decision or” as this clarifies type of decision

III. Grievances, 1. Select Universe and
submit to CMS

x

added a note under select universe and submit to CMS

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III. Grievances - 3. Obtain Evidence,
3.1

x

Inserted additional clarification for what is needed in review of
quality of care cases

III. Grievances – 4. Apply Compliance
Standard, 4.1

x

language added to clarify that this area is to determine if plan is
properly categorizing and process grievances. If misclassified as a
grievance did the plan route it to the proper unit untimely?

IV. Dismissals – 1. Select Universe and
submit to CMS

x

added language to clarify what is needed in the universe

x

inserted (non-contracted providers only) after WOL to clarify
which provider type

IV. Dismissals - 2. Select 20 Cases

x

Reduced sample size as sponsors’ universes typically yields low
amount of dismissals

IV. Dismissals - 4, Apply Compliance
Standard

x

removed last bullet under 4.1.2 as it is redundant
removed last bullet under 4.2.2 as it is redundant

x

Formatted compliance standards to ensure sponsor is aware of what
is required for each type of dismissal

Part D Coverage Determinations, Appeals and Grievances (CDAG)
Area (Document)
Attachment II - Audit Process of
Universe Request

Change
x

Removed references to overall pass/fail threshold. Added language
to explain that an individual sample case failure results in
documentation of a condition:
x CMS will test each of the 30 cases. If CMS
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requirements are not met, a sample case fails
and a condition (finding) is documented. If
CMS requirements are met, a sample case
passes and no conditions (findings) are
documented.
Purpose

I. Effectuation Timeliness Coverage
Determinations and Appeals (CDA)

II. Appropriateness of Clinical
Decision-Making & Compliance with

x

Updated review period to reflect “Three (3) month period
preceding the date of the audit engagement letter (Month, Day,
Year) CMS reserves the right to expand the review period to ensure
a sufficient universe size.”

x

Added the following note about the proper use of naming
conventions

x

“Note: The sponsor is expected to present their supporting
documentation during the audit and upload it to the secure site
using the designated naming convention within the timeframe
specified by the reviewers. If the sponsor fails to submit the
supporting documentation using the designated naming convention
and within the timeframe specified by the reviewers, CMS will
document this as an observation in the sponsor’s program audit
report.”
Added language to emphasis overturns by the IRE, ALJ and MAC
during the review period must be included in the universe

x
x

Removed reference to review periods dependent of the size of the
Plan Sponsor

x

Removed reference to finding threshold

x

Removed reference to finding threshold
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CDA Processing Requirements
III. Grievances

x

Removed reference to finding threshold

Attachment II-A Universe Template Effectuation Timelines Tab

x

A field was added in column 12 for the Plan Sponsor to indicate if
the prescriber is in-network or out-of-network

Attachment II-A Universe Template CDM & CDA Comp tab

x

A field was added in column 12 for the Plan Sponsor to indicate if
the prescriber is in-network or out-of-network

Formulary Benefit Administration (FA)
Area (Document)
Attachment I – Audit Process and
Universe Request

Change
x

Removed references to overall pass/fail threshold. Added language
to explain that an individual sample case failure results in
documentation of a condition:
ƒ

CMS will test each of the 30 cases. If CMS
requirements are not met, a sample case fails and a
condition (finding) is documented. If CMS
requirements are met, a sample case passes and no
conditions (findings) are documented.

x

Reformatted document so that outline is consistent throughout.

x

Page 1 –
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i. Added statement “The rejected claims universes submitted
should not be filtered by the sponsor and no attempts to reprocess
claims prior to the audit should occur.” In 2012 a few sponsors
have done one or both of these.
ii. Removed universe reference to # of weeks and left as 30 or 60
days.
iii. Clarified rejected claims with “dates of service”. Same
clarification done in transition.
x

Modified FA sample to 30 cases (instead of 20) to be consistent
with transition.

x

Website review –
i. Moved website attestation ahead of P&T committee since many
sponsors do not see this at the end of the document
ii. At MDBG’s request added review of sponsor posted formulary
and PA criteria compared to CMS approved formulary. This review
would be completed after the audit engagement letter is sent and
prior to start of audit.

x

P&T Committee
i. Propose making P&T element three sections:
x
x
x

membership universe – complete for all sponsors;
membership COI - complete for all sponsors;
minutes universe/UM controls would be completed
if:
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x

when issues identified during the formulary
administration or transition portions of the
audit warrant additional P&T audit steps; OR

x

when concerns are raised during the
Compliance team review* of Element IV of
the MA/Part D Compliance Program
Requirements. Element IV is:
Establishment and implementation of
effective lines of communication, ensuring
confidentiality, between the compliance
officer, members of the compliance
committee, the organization's employees,
managers and governing body, and the
organization's first tier, downstream, and
related entities. Such lines of communication
must be accessible to all and allow compliance
issues to be reported including a method for
anonymous and confidential good faith
reporting of potential compliance issues as
they are identified. 422.503(b)(4)(vi)(D) and
423.504(b)(4)(vi)(D)

*new for 2013 – FA TL will be involved or present during
Compliance Committee and/or Auditing/Monitoring of FDRs
discussions.
Attachment 1A – Universe Template

x
x

Added tab for Transition Rejected Claims Universe
From FA and Transition tabs deleted two columns related to
NCPDP 5.1 transactions (Place of Service; Patient
Locations (For 5.1 Claims Only)).
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Attachment 1B – Description of
Documentation Required Sample Case
File Minimum Documentation
Required

x

Added P&T Committee Membership Tab

x

Added language under purpose to clarify that this is
documentation that will be requested during the live sample
review during audit. One of the contractors noted that some
plans were taking original wording to mean that they should
prepare samples ahead of time.
Updated contract years.
Clarified “route” to “route of administration”

x
x

Outbound Enrollment Verification (OEV)
Area (Document)

Change
x

Attachment X - Audit Process and
Universe Request

x

Apply Compliance Standard To Each Case: Apply the following
test to each of the 30 cases. OEV calls will be reviewed to
determine the following:
i.

Verify through the review of supporting
documentation that the first two call attempts were
made within 10 days of the effective enrollment date.

ii.

Verify through the review of supporting
documentation that all three call attempts were made
within 15 days of the effective enrollment date.

iii.

In instances where the sponsor did not successfully
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reach the beneficiary on the first or second attempt,
verify that the sponsor sent a fully compliant
enrollment verification letter after the second attempt
and completed a third call attempt within 15 days of
the effective enrollment date.
iv.

Verify that the sponsor appropriately handled the
beneficiary request (e.g. cancellation).

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