Program Audits

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

ODAG_Protocol_508

Program Audits

OMB: 0938-1395

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2023-10-17 - Extension without change of a currently approved collection

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Part C Organization
Determinations, Appeals, and
Grievances (ODAG)
PROGRAM AUDIT PROTOCOL AND DATA
REQUEST

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

Table of Contents
Program Audit Protocol ............................................................................................................................. 3
Purpose ........................................................................................................................................................ 3
Audit Elements Tested................................................................................................................................ 3
Program Audit Data Request................................................................................................................... 15
Audit Engagement and Universe Submission Phase.............................................................................. 15
Universe Submissions ........................................................................................................................... 15
Universe Requests ................................................................................................................................. 16
Universe Table 1: Standard and Expedited Pre-service Organization Determinations (OD) Record
Layout ................................................................................................................................................. 16
Universe Table 2: Standard and Expedited Pre-service Reconsiderations (RECON) Record Layout 22
Universe Table 3: Payment Organization Determinations and Reconsiderations (PYMT_C) Record
Layout ................................................................................................................................................. 30
Universe Table 4: Part C Effectuations of Overturned Decisions by IRE, ALJ, or MAC (EFF_C)
Record Layout ..................................................................................................................................... 36
Universe Table 5: Part C Standard and Expedited Grievances (GRV_C) Record Layout ................. 39
Universe Table 6: Dual Special Needs Plan – Applicable Integrated Plan Reductions, Suspensions,
and Terminations (AIP) Record Layout.............................................................................................. 42
Audit Field Work Phase ........................................................................................................................... 47
Supporting Documentation Submissions ............................................................................................ 47
Root Cause Analysis Submissions ....................................................................................................... 50
Impact Analysis Submissions ............................................................................................................... 50

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v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

Program Audit Protocol
Purpose
To evaluate performance in the areas outlined in this Program Audit Protocol and Data Request
related to Part C Organization Determinations, Appeals and Grievances (ODAG). The Centers
for Medicare and Medicaid Services (CMS) performs its program audit activities in accordance
with the ODAG Program Audit Data Request and applying the compliance standards outlined in
this Program Audit Protocol and the Program Audit Process Overview document. At a minimum,
CMS will evaluate cases against the criteria listed below. CMS may review factors not
specifically addressed below if it is determined that there are other related ODAG requirements
not being met.
Audit Elements Tested
1. Timeliness
2. Processing of Coverage Requests
3. Classification of Requests

Page 3 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Not
Applicable

Compliance
Standard
Universe
Integrity
Testing

Data Request
Universe Table 1:
Standard and
Expedited PreService
Organization
Determinations
(OD)
Universe Table 2:
Standard and
Expedited PreService
Reconsiderations
(RECON)

Method of Evaluation
Select 10 cases from each universe,
Tables 1 through 6, for a total of 60 cases.

Criteria Effective
01/01/2021
42 CFR § 422.504(e)
42 CFR § 422.504(f)

Prior to field work, CMS will schedule a
webinar with the Sponsoring organization
to verify accuracy of data within the
universe submissions, and to confirm
effectuation of approved requests, for each
of the sampled cases.
Sample selections will be provided to the
Sponsoring organization approximately
one hour prior to the scheduled webinar.

Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)
Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)
Universe Table 5:
Part C Standard
and Expedited
Grievances
(GRV_C)
Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)

Page 4 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.1

1.2

1.3

1.4

Page 5 of 50

Data Request
Universe Table 1:
Standard and
Expedited PreService
Organization
Determinations
(OD)

Universe Table 1:
Standard and
Expedited PreService
Organization
Determinations
(OD)
Universe Table 1:
Standard and
Expedited PreService
Organization
Determinations
(OD)

Universe Table 1:
Standard and
Expedited PreService
Organization
Determinations
(OD)

Method of Evaluation
Conduct timeliness test at the universe
level on standard pre-service organization
determinations to determine whether the
Sponsoring organization provided
notification of the determination no later
than 14 calendar days after the date the
Sponsoring organization received the
request. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notification of the determination
no later than 28 calendar days after the
date the Sponsoring organization received
the request.
Conduct timeliness test at the universe
level on standard organization
determination requests for Part B drugs to
determine whether the Sponsoring
organization provided notification of the
determination no later than 72 hours after
receipt of the request.
Conduct timeliness test at the universe
level on expedited pre-service
organization determinations to determine
whether the Sponsoring organization
provided notification of the determination
no later than 72 hours after receipt of the
request. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notification of the determination
no later than 17 calendar days after receipt
of the request.
For Dual Eligible Special Needs Plans –
Applicable Integrated Plans (DSNP-AIP),
written notice of the denial must be
provided within 3 days of receipt of the
request. The additional 3 day allowance to
deliver the written notification after
providing oral notice does not apply.
Conduct timeliness test at the universe
level on expedited organization
determination requests for Part B drugs to
determine whether the Sponsoring
organization provided notification of the
determination no later than 24 hours after
the Sponsoring organization received the
request.

Criteria Effective
01/01/2021
42 CFR § 422.568(b)
42 CFR § 422.631(d)

42 CFR § 422.568(b)
42 CFR § 422.629(a)

42 CFR § 422.572(a)
42 CFR § 422.572(b)
42 CFR § 422.572(c)
42 CFR § 422.631(d)

42 CFR § 422.572(a)
42 CFR § 422.572(c)
42 CFR § 422.629(a)

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.5

1.6

Page 6 of 50

Data Request
Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Method of Evaluation
Conduct timeliness test at the universe
level on standard pre-service
reconsideration requests to determine
whether the Sponsoring organization
provided notification of its overturned
determination or forwarded its upheld
decision to the IRE no later than 30
calendar days after the date the
Sponsoring organization received the
request. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notification of the overturned
determination or forwarded its upheld
decision to the IRE no later than 44
calendar days after receipt of the request.
For DSNP-AIPs, the timeliness
assessment will ensure written notification
of the upheld reconsideration decision was
provided to the enrollee in addition to
being forwarded to the IRE no later than
30 calendar days or 44 days with
extension after receipt of the request.
Conduct timeliness test at the universe
level on standard reconsideration requests
for Part B drugs to determine whether the
Sponsoring organization provided
notification of its overturned
determination or forwarded its upheld
decision to the IRE no later than 7
calendar days after receipt of the request.

Criteria Effective
01/01/2021
42 CFR § 422.590(a)
42 CFR § 422.590(d)
42 CFR § 422.590(f)
42 CFR § 422.633(f)

42 CFR § 422.590(c)
42 CFR § 422.590(d)
42 CFR § 422.629(a)

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.7

1.8

Data Request
Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Method of Evaluation
Conduct timeliness test at the universe
level on expedited pre-service
reconsideration requests to determine
whether the Sponsoring organization
provided notification of its overturned
decision no later than 72 hours after
receipt of the request or forwarded its
upheld decision to the IRE no later than
24 hours after affirmation of the
determination or no later than 96 hours if
the Sponsoring organization failed to
provide the enrollee with the results of its
reconsideration within the required
timeframe. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notification of its overturned
decision no later than 17 calendar days
after receipt of the request or forwarded
its upheld decision to the IRE no later than
24 hours after the affirmation of the
determination or no later than 18 calendar
days if the Sponsoring organization failed
to provide the enrollee with the results of
its reconsideration within the required
timeframe.
For DSNP-AIPs, the timeliness test will
ensure written notification of the upheld
reconsideration decision was also
provided to the enrollee no later than 72
hours or 17 calendar days after receipt of
the request.
Conduct timeliness test at the universe
level on expedited reconsideration
requests for Part B drugs to determine
whether the Sponsoring organization
provided notification of its overturned
decision no later than 72 hours after
receipt of the request or forwarded its
upheld decision to the IRE no later than
24 hours after affirmation of the
determination or no later than 96 hours if
the Sponsoring organization failed to
provide the enrollee with the results of its
reconsideration within the required
timeframe.

Criteria Effective
01/01/2021
42 CFR § 422.590(e)
42 CFR § 422.590(f)
42 CFR § 422.590(g)
42 CFR § 422.633(f)
42 CFR § 422.634(a)

42 CFR § 422.590(e)
42 CFR § 422.590(g)
42 CFR § 422.629(a)

For DSNP-AIPs, the timeliness test will
ensure written notification of the upheld
reconsideration decision was also
provided to the enrollee no later than 72
hours after receipt of the request.

Page 7 of 50

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.9

1.10

1.11

1.12

Page 8 of 50

Data Request

Method of Evaluation

Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)

Conduct timeliness test at the universe
level on payment organization
determinations to determine whether the
Sponsoring organization paid or denied
claims from non-contracted providers and
enrollees no later than 60 calendar days
after receipt of the request.
Conduct timeliness test at the universe
level on payment reconsiderations to
determine whether the Sponsoring
organization paid overturned
reconsideration claims from noncontracted providers and enrollees or
forwarded its upheld decision to the IRE
no later than 60 calendar days after receipt
of the request.

Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)

Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)

For DSNP-AIPs, the timeliness
assessment will ensure whether the
Sponsoring organization paid overturned
reconsideration claims from noncontracted providers and enrollees or
forwarded its upheld decision to the IRE
no later than 30 calendar days after receipt
of the request.
Conduct timeliness test at the universe
level on standard pre-service IRE cases in
which the Sponsoring organization’s
determination was reversed in whole or in
part by the IRE to determine whether the
Sponsoring organization effectuated the
decision within 14 calendar days after
receipt of the notice reversing the
determination.
Conduct timeliness test at the universe
level on standard Part B drug request IRE
cases in which the Sponsoring
organization’s determination was reversed
in whole or in part by the IRE to
determine whether the Sponsoring
organization authorized or provided the
Part B drug under dispute within 72 hours
after receipt of the notice reversing the
determination.

Criteria Effective
01/01/2021
42 CFR § 422.568(c)
42 CFR § 422.520(a)

42 CFR § 422.590(b)
42 CFR § 422.618(a)
42 CFR § 422.633(f)

42 CFR § 422.618(b)
42 CFR § 422.634(d)

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.13

1.14

1.15

1.16

1.17

Page 9 of 50

Data Request
Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)
Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)

Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)
Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)
Universe Table 4:
Part C
Effectuations of
Overturned
Decisions by IRE,
ALJ, or MAC
(EFF_C)

Method of Evaluation
Conduct timeliness test at the universe
level on expedited pre-service IRE cases
in which the Sponsoring organization’s
determination was reversed in whole or in
part by the IRE to determine whether the
Sponsoring organization effectuated the
decision within 72 hours after receipt of
the notice reversing the determination.
Conduct timeliness test at the universe
level on expedited Part B drug request
IRE cases in which the Sponsoring
organization’s determination was reversed
in whole or in part by the IRE to
determine whether the Sponsoring
organization authorized or provided the
Part B drug under dispute within 24 hours
after receipt of the notice reversing the
determination.
Conduct timeliness test at the universe
level on payment decisions reversed in
whole or in part by the IRE to determine
whether the Sponsoring organization paid
for the service no later than 30 calendar
days after receipt of the notice reversing
the determination.
Conduct timeliness test at the universe
level on standard and expedited decisions
overturned by an ALJ or the MAC to
determine whether the Sponsoring
organization authorized or provided the
service under dispute no later than 60
calendar days after receipt of the notice of
determination reversal.
Conduct timeliness test at the universe
level on standard and expedited Part B
drug request decisions overturned by an
ALJ or the MAC to determine whether the
Sponsoring organization authorized or
provided the Part B drug under dispute no
later than 72 hours for standard requests
or 24 hours for expedited requests after
receipt of the notice of determination
reversal.

Criteria Effective
01/01/2021
42 CFR § 422.619(b)
42 CFR § 422.634(d)

42 CFR § 422.619(b)
42 CFR § 422.634(d)

42 CFR § 422.618(b)
42 CFR § 422.634(d)

42 CFR § 422.618(c)
42 CFR § 422.619(c)
42 CFR § 422.634(d)

42 CFR § 422.619(c)
42 CFR § 422.634(d)

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Timeliness

Compliance
Standard
1.18

1.19

Data Request
Universe Table 5:
Part C Standard
and Expedited
Grievances
(GRV_C)

Universe Table 5:
Part C Standard
and Expedited
Grievances
(GRV_C)

Timeliness

1.20

Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations
(AIP).

Timeliness

1.21

Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations
(AIP).

Page 10 of 50

Method of Evaluation
Conduct timeliness test at the universe
level on standard grievances to determine
whether the Sponsoring organization
notified the enrollee of its decision no
later than 30 days after receipt of the
grievance.
If the Sponsoring organization extended
the timeframe, determine whether the
Sponsoring organization notified the
enrollee of its decision no later than 44
days after receipt of the grievance.
Conduct timeliness test at the universe
level on expedited grievances to
determine whether the Sponsoring
organization responded to the enrollee’s
grievance no later than 24 hours after
receipt of the grievance.
Conduct timeliness test at the universe
level on adverse integrated organization
determinations to determine whether the
DSNP-AIP notified the enrollee of the
decision to terminate, suspend, or reduce
services no later than 10 days prior to the
action (that is, before the date on which a
termination, suspension, or reduction of
previously approved services becomes
effective).
Conduct timeliness test at the universe
level on standard integrated
reconsideration requests to determine
whether the Applicable Integrated Plan
provided written notice of its resolution to
enrollees no later than 30 calendar days
after the date the DSNP-AIP received the
request. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notice of the resolution no later
than 44 calendar days after receipt of the
request.

Criteria Effective
01/01/2021
42 CFR § 422.564(e)
42 CFR § 422.630(e)

42 CFR § 422.564(f)
42 CFR § 422.630(d)

42 CFR § 422.631(d)

42 CFR § 422.633(f)

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Timeliness

Compliance
Standard
1.22

Processing of
Coverage
Requests

2.1

Data Request

Method of Evaluation

Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)

Conduct timeliness test at the universe
level on expedited integrated
reconsideration requests to determine
whether the DSNP-AIP provided written
notice of its resolution to enrollees no
later than 72 hours after the date the
Applicable Integrated Plan received the
request. If the Sponsoring organization
extended the timeframe, determine
whether the Sponsoring organization
provided notice of the resolution no later
than 17 calendar days after receipt of the
request.
Select 30 denied requests from tables 1-3.
The number of cases per record layout
will vary.

Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)
Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)
Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)
Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)

Page 11 of 50

Additionally, select 5 denial cases from
Table 6.

Criteria Effective
01/01/2021
42 CFR § 422.633(f)

42 CFR § 422.568(d)
42 CFR § 422.568(e)
42 CFR § 422.561
42 CFR § 422.572(a)

Ensure sample set represents various
medical services (e.g., ER services,
outpatient hospital, inpatient hospital,
urgent care, etc.).

42 CFR § 422.590(d)
42 CFR § 422.631(d)

For each denial case, review case file
documentation for proper notification of
the denial decision.
If the enrollee identified a representative,
review case file to determine if
notification was sent to the enrollee’s
representative.
If a provider requested the coverage,
review case file to determine if
notification of decision was also sent to
provider.
Sample selections will be provided to the
Sponsoring organization approximately
one hour prior to the scheduled webinar.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.2

Data Request
Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)

Method of Evaluation
For the sampled cases review case file
documentation to ensure a physician or
other appropriate health care professional
with sufficient medical and other expertise
reviewed the determination.

Criteria Effective
01/01/2021
42 CFR § 422.566(d)
42 CFR § 422.590(g)
42 CFR § 422.629(k)

Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)
Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)

Processing of
Coverage
Requests

2.3

Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)
Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)

For each sampled denial case, review case
file documentation for clinical accuracy.

42 CFR § 422.101(a)
42 CFR § 422.101(b)
42 CFR § 422.100(c)

Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)
Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)

Page 12 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.4

Data Request
Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)

Method of Evaluation
For each sampled case, review case file
for documentation to ensure an extension
was appropriate.

Criteria Effective
01/01/2021
42 CFR § 422.568(b)
42 CFR § 422.572(b)
42 CFR § 422.590(e)
42 CFR § 422.631(d)

Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Processing of
Coverage
Requests

2.5

For each case sampled, review case file
documentation for proper downgrade from
an expedited determination request to a
standard determination and for proper
notification to the enrollee that explains
that the MA organization will process the
request using the 14-day timeframe for
standard determinations, informs the
enrollee of the right to file an expedited
grievance, informs the enrollee of the
right to resubmit a request for an
expedited determination with any
physician’s support, and provides
instructions about the grievance process
and timeframes.

42 CFR § 422.570(c)
42 CFR § 422.570(d)
42 CFR § 422.584(c)
42 CFR § 422.584(d)
42 CFR §422.631(d)
42 CFR §422.633(e)

Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)

Page 13 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.6

Processing of
Coverage
Requests

2.7

Classification
of Requests

3.1

Data Request
Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)
Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)
Universe Table 6:
Dual Special Needs
Plan – Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations (AIP)
Universe Table 1:
Standard and
expedited PreService
Organization
Determinations
(OD)
Universe Table 2:
Standard and
Expedited Preservice
Reconsiderations
(RECON)

Method of Evaluation
For each sampled case, review case file to
determine if the Sponsoring organization
applied step therapy only to new
administrations of Part B drugs using at
least a 365-day look back period.

Criteria Effective
01/01/2021
42 CFR § 422.136(a)

For each sampled case, review case file to
determine if the Applicable Integrated
Plan continued benefits to enrollees who
filed an appeal involving the termination,
suspension, or reduction of a previously
authorized service.

42 CFR §422.632

Select 10 dismissed requests from Tables
1-3.

42 CFR § 422.566
42 CFR § 422.578

Review case file documentation to
determine if the request was appropriately
dismissed or whether it should have been
treated as a coverage request or grievance.
Sample selections will be provided to the
Sponsoring organization approximately
one hour prior to the scheduled webinar.

42 CFR § 422.582
42 CFR § 422.584
42 CFR § 422.590
42 CFR § 423.564
42 CFR § 422.630

Universe Table 3:
Payment
Organization
Determinations and
Reconsiderations
(PYMT_C)

Page 14 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Audit
Element
Classification
of Requests

Compliance
Standard
3.2

Data Request
Universe Table 5:
Part C Standard
and Expedited
Grievances
(GRV_C)

Method of Evaluation
Select 20 grievance sample cases from
Table 5.

Criteria Effective
01/01/2021
42 CFR § 422.564(a)
42 CFR § 422.564(e)

Sample both verbal and written
grievances.
Target samples that appear to: relate to
quality of care; involve multiple issues
and do not appear in the organization
determination and reconsideration
universes; and appear to be misclassified
requests.

42 CFR § 422.564(f)
42 CFR § 422.564(g)
42 CFR § 422.561
42 CFR §422.630

Review case file documentation to
determine if proper notification (i.e.,
written or verbal) was provided. If the
Sponsoring organization extended the
deadline, review case file for
documentation stating how the delay is in
the interest of the enrollee. Also review
case file for written notification to the
enrollee of the reason(s) for the delay.
If the enrollee identified a representative,
review case file to determine if
notification was sent to the enrollee’s
representative.

Program Audit Data Request
Audit Engagement and Universe Submission Phase
Universe Submissions
Sponsoring organizations must submit universe tables 1 - 5, comprehensive of all contracts and
Plan Benefit Packages (PBP), identified in the audit engagement letter, in either Microsoft Excel
(.xlsx) file format with a header row or Text (.txt) file format without a header row. Sponsoring
organizations determined to be an Applicable Integrated Plan (AIP) must submit universe table 6
comprehensive of all contracts and/or PBPs offered as Dual Eligible Special Needs Plans only.
Descriptions and clarifications of what must be included in each submission and data field are
outlined in the individual universe record layouts below. Characters are required in all requested
fields, unless otherwise specified, and data must be limited to the request specified in each record
layout. Sponsoring organizations must provide accurate and timely universe submissions within
15 business days of the audit engagement letter date. Submissions that do not strictly adhere to
the record layout specifications will be rejected.

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Universe Requests
1. Universe Table 1: Standard and Expedited Pre-service Organization Determinations
(OD) Record Layout
2. Universe Table 2: Standard and Expedited Pre-service Reconsiderations (RECON)
Record Layout
3. Universe Table 3: Payment Organization Determinations and Reconsiderations
(PYMT_C) Record Layout
4. Universe Table 4: Part C Effectuations of Overturned Decisions by IRE, ALJ, or
MAC (EFF_C) Record Layout
5. Universe Table 5: Part C Standard and Expedited Grievances (GRV_C) Record
Layout
6. Universe Table 6: Dual Eligible Special Needs Plan – Applicable Integrated Plan
Reductions, Suspensions, and Terminations (AIP)
Universe
Record Layout
Table 1
Table 2
Table 3
Table 4
Table 5
Table 6

Scope of Universe Request*

Sponsoring organizations with MA/MAPD enrollment of –
• <50,000 enrollees: submit the 12-week period preceding, and including, the
date of the audit engagement letter.
• ≥50,000 but <250,000 enrollees: submit the 8-week period preceding, and
including, the date of the audit engagement letter.
• ≥250,000 but <500,000 enrollees: submit the 4-week period preceding, and
including, the date of the audit engagement letter.
• ≥500,000 enrollees: submit the 2-week period preceding, and including, the
date of the audit engagement letter.
* CMS reserves the right to expand the review period to ensure sufficient universe size.
Please use the guidance below for the following record layout:
Universe Table 1: Standard and Expedited Pre-service Organization Determinations (OD)
Record Layout
• Include all pre-service organization determination requests the Sponsoring organization
approved, denied or dismissed during the universe request period. The date of the
Sponsoring organization’s determination (Column ID P) must fall within the universe request
period.
• Include all pre-service requests for supplemental services that meet the criteria defined in 42
CFR § 422.100(c)(2).
• Include all pre-service organization determination requests for Part B drugs.
• If a pre-service organization determination includes more than one service, include all of the
request’s line items in a single row and enter the multiple line items as a single organization
determination request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single request in the same time zone. For example, if the Sponsoring
organization has systems in EST and CST, all data in a single line item must be in the same
time zone.
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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
•

Exclude all requests processed as reconsiderations, payments, reopenings, and withdrawals.
o Exclude all concurrent reviews for inpatient hospital services and inpatient SNF services,
and notifications of admissions.
o Exclude all requests for Value Added Items and Services.
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee ID

Contract ID

Plan Benefit
Package (PBP)

First Tier,
Downstream, and
Related Entity

Enrollee First
Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the
non-intelligent unique identifier that
replaced the HICN on Medicare cards as
a result of The Medicare Access and
CHIP Reauthorization Act (MACRA) of
2015. The MBI contains uppercase
alphabetic and numeric characters
throughout the 11-digit identifier and is
unique to each Medicare enrollee. This
number must be submitted excluding
hyphens or dashes.
Enter the contract number (e.g., H1234).

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
70
Always
Required

Enter the first name of the enrollee.

Enter the PBP (e.g., 001).

Enter the name of the First Tier,
Downstream, and Related Entity (which
is any party that enters into a written
arrangement, acceptable to CMS, with
the Sponsoring organization to provide
administrative or health care services to
an enrollee under the Part C or D
program) that processed the request.
Enter None if the Sponsoring
organization processed the request.

Page 17 of 50

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
G

Field Name
Authorization or
Claim Number

Date the request
was received

Time the request
was received

Field
Field
Type
Length
CHAR
40
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter the associated authorization or
claim number for this request. If an
authorization or claim number is not
available, enter the internal tracking or
case number.
Enter None if there is no authorization,
claim or other tracking number available.
Enter the date the request was received.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
If a standard request was upgraded to
expedited, enter the date the request was
upgraded.
For all expedited requests and standard
Part B drug requests, enter the time the
request was received. Submit in
HH:MM:SS military time format (e.g.,
23:59:59).
If a standard request was upgraded to
expedited, enter the time the request was
upgraded.

Part B Drug
Request?

CHAR
1
Always
Required

Enter None for standard and dismissed
requests.
Enter:
• Y for Yes
• N for No
Sponsors must indicate ‘Y’ for any preservice request that includes a Part B
drug (primary or ancillary) or Part D
drug that is part of a Sponsor’s step
therapy requirement for a Part B drug.

Page 18 of 50

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
K

Field Name
AOR/Equivalent
notice Receipt
Date

AOR/Equivalent
notice Receipt
Time

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

Request
Determination

CHAR
9
Always
Required

Was the request
processed as
Standard or
Expedited?
Was a timeframe
extension taken?

CHAR
1
Always
Required

Date of
Determination

Page 19 of 50

CHAR
1
Always
Required
CHAR
10
Always
Required

Description
Enter the date the Appointment of
Representative (AOR) form or equivalent
written notice was received by the
Sponsoring organization. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for dismissed requests or if
no AOR or equivalent written notice was
received or required.
For all expedited requests and standard
Part B drug requests, enter the time the
Appointment of Representative (AOR)
form or equivalent written notice was
received by the Sponsoring organization.
Submit in HH:MM:SS format (e.g.,
23:59:59).
Enter None for standard requests,
dismissed requests or if no AOR or
equivalent written notice was received or
required.
Enter:
• Approved
• Denied
• Dismissed
Enter the manner by which the request
was processed:
• S for Standard
• E for Expedited
Enter:
• Y for Yes
• N for No
Enter the date of the determination.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01). For dismissed requests,
enter the date the Sponsor dismissed the
request.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
Q

Field Name
Time of
Determination

Date oral
notification
provided to
enrollee

Time oral
notification
provided to
enrollee

Date written
notification
provided to
enrollee

Time written
notification
provided to
enrollee

Field
Field
Type
Length
CHAR
8
Always
Required

CHAR
10
Always
Required

Description
For all expedited requests and standard
Part B drug requests, enter the time of the
determination. Submit in HH:MM:SS
military time format (e.g., 23:59:59).
Enter None for standard and dismissed
requests.
Enter the date oral notification was
provided to enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).

CHAR
8
Always
Required

Enter None if no oral notification was
provided.
For all expedited requests and standard
Part B drug requests, enter the time oral
notification was provided to enrollee.
Submit in HH:MM:SS military time
format (e.g., 23:59:59).

CHAR
10
Always
Required

Enter None for standard requests,
dismissed requests, or if no oral
notification was provided.
Enter the date written notification of
determination was provided to
enrollee. Do not enter the date a letter is
generated or printed. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).

CHAR
8
Always
Required

Enter None if no written notification was
provided.
For all expedited requests and standard
Part B drug requests, enter the time
written notification of determination was
provided to enrollee.
Do not enter the time a letter was
generated or printed. Submit in
HH:MM:SS military time format (e.g.,
23:59:59).
Enter None for standard requests,
dismissed requests, or if no written
notification was provided.

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

Column
ID
V

Field Name
Who made the
request?

Issue description
and type of service

Field
Field
Type
Length
CHAR
3
Always
Required

CHAR
2,000
Always
Required

Description
Enter who made the request:
• E for enrollee
• ER for enrollee’s representative
• CP for requests by a contract provider
• NCP for requests by a non-contract
provider
“Provider” includes physicians and
facilities.
Provide a description of the service or
item requested and why it was requested
(if known). For denials, also provide an
explanation of why the pre-service
request was denied.
For dismissed requests, provide the
reason for dismissal.

Was an expedited
request made but
processed as
standard?

CHAR
4
Always
Required

Was the request
denied for lack of
medical necessity?

CHAR
4
Always
Required

Page 21 of 50

For Part B drugs requests, include the JCode, National Drug Code (NDC), or
both.
Enter:
• Y for Yes if an expedited request was
received but downgraded to standard
• None for all other requests (e.g. the
request was received as expedited and
processed as expedited, the request
was received as standard)
Enter:
• Y for Yes
• N for No
None if the request was approved or
dismissed.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

Please use the guidance below for the following record layout:
Universe Table 2: Standard and Expedited Pre-service Reconsiderations (RECON) Record
Layout
• Include all pre-service reconsideration requests the Sponsoring organization approved,
denied, auto-forwarded to the IRE or dismissed during the universe request period. The date
of the Sponsoring organization’s determination (Column ID P) must fall within the universe
request period.
• Include all pre-service reconsideration requests for supplemental services that meet the criteria
defined at 42 CFR § 422.100(c)(2).

•
•

Include all pre-service reconsideration requests for Part B drugs.
If a pre-service reconsideration includes more than one service, include all of the request’s
line items in a single row and enter multiple line items as a single reconsideration request.
Enter any request denied in whole or in part as denied.
Enter all fields for a single request in the same time zone. For example, if the Sponsoring
organization has systems in EST and CST, all data in a single line item must be in a single
time zone.
Exclude all requests processed as organization determinations, payment requests, reopenings,
and withdrawals.
Exclude all requests for concurrent reviews for inpatient hospital and inpatient SNF services,
and notifications of admissions.
Exclude all requests for Value Added Items and Services.

•
•
•
•

Column Field Name
ID
A
Enrollee First Name

Enrollee Last Name

Page 22 of 50

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the
enrollee.

Enter the first name of the
enrollee.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
C
Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

Contract ID

Plan Benefit Package
(PBP)

First Tier, Downstream,
and Related Entity

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
70
Always
Required

Description
Enter the Medicare
Beneficiary Identifier (MBI)
of the enrollee. An MBI is the
non-intelligent unique
identifier that replaced the
HICN on Medicare cards as a
result of The Medicare
Access and CHIP
Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic
and numeric characters
throughout the 11-digit
identifier and is unique to
each Medicare enrollee. This
number must be submitted
excluding hyphens or dashes.
Enter the contract number
(e.g., H1234).
Enter the PBP (e.g., 001).

Enter the name of the First
Tier, Downstream, and
Related Entity (which is any
party that enters into a written
arrangement, acceptable to
CMS, with the Sponsoring
organization to provide
administrative or health care
services to an enrollee under
the Part C or D program) that
processed the request.
Enter None if the Sponsoring
organization processed the
request.

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
G
Authorization or Claim
Number

Date the request was
received

Field
Field
Type
Length
CHAR
40
Always
Required

CHAR
10
Always
Required

Description
Enter the associated
authorization or claim
number for this request. If an
authorization or claim
number is not available, enter
the internal tracking or case
number.
Enter None if there is no
authorization, claim or other
tracking number available.
Enter the date the
reconsideration request was
received. If a standard request
was upgraded to expedited,
enter the date the request was
upgraded.
If the Sponsoring
organization obtained
information establishing good
cause after the 60-day filing
timeframe, enter the date the
Sponsoring organization
received the information
establishing good cause.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
I
Time the request was
received

Field
Field
Type
Length
CHAR
8
Always
Required

Description
For all expedited requests,
enter the time the
reconsideration request was
received. If a standard request
was upgraded to expedited,
enter the time the request was
upgraded.
If the Sponsoring
organization obtained
information establishing good
cause after the 60-day filing
timeframe, enter the time the
Sponsoring organization
received the information
establishing good cause.
Submit in HH:MM:SS
military time format (e.g.,
23:59:59).

Part B Drug Request?

CHAR
1
Always
Required

Enter None for standard and
dismissed requests.
Enter:
• Y for Yes
• N for No
Sponsors must indicate ‘Y’
for any pre-service request
that includes a Part B drug
(primary or ancillary) or Part
D drug that is part of a
Sponsor’s step therapy
requirement for a Part B drug.

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
K
AOR/Equivalent Notice
Receipt Date

AOR/Equivalent Notice
Receipt Time

Request Determination

Was the request
processed as Standard or
Expedited?

Was a timeframe
extension taken?

Page 26 of 50

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
9
Always
Required
CHAR
1
Always
Required
CHAR
1
Always
Required

Description
Enter the date the
Appointment of
Representative (AOR) form
or equivalent written notice
was received by the
Sponsoring organization.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None for dismissed
requests or if no AOR or
equivalent written notice was
received or required.
For all expedited requests,
enter the time the
Appointment of
Representative (AOR) form
or equivalent written notice
was received by the
Sponsoring organization.
Submit in HH:MM:SS format
(e.g., 23:59:59).
Enter None for dismissed
requests or if no AOR or
equivalent written notice was
received or required.
Enter:
• Approved
• Denied
Enter the manner by which
the request was processed:
• S for Standard
• E for Expedited
Enter:
• Y for Yes
• N for No

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
P
Date of Determination

Time of Determination

Date oral notification
provided to enrollee

Time oral notification
provided to enrollee

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter the date of the
determination. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
For dismissed requests enter
the date the Sponsor
dismissed the request.
For all expedited requests,
enter the time of the
determination. Submit in
HH:MM:SS military time
format (e.g., 23:59:59).
Enter None for standard and
dismissed requests.
Enter the date oral
notification was provided to
enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for dismissed
requests or if no oral
notification was provided.
For expedited requests,
including expedited Part B
drug requests, enter the time
oral notification was provided
to enrollee. Submit in
HH:MM:SS military time
format (e.g., 23:59:59).
Enter None for dismissed
requests or if no oral
notification was provided.

Page 27 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
T
Date written notification
provided to enrollee

Time written notification
provided to enrollee

Date reconsidered
determination effectuated
in the system

Time reconsidered
determination effectuated
in the system

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter the date written
notification was provided to
enrollee. Do not enter the date
a letter is generated or
printed. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written
notification was provided.
For all expedited requests,
enter the time written
notification was provided to
enrollee. Do not enter the
time a letter is generated or
printed. Submit in
HH:MM:SS military time
format (e.g., 23:59:59).
Enter None for standard
requests, dismissed requests,
or if no written notification
was provided.
Enter the date the
reconsidered determination
was effectuated in the system.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the
determination was denied or
dismissed.
For all expedited requests,
enter the time the
reconsidered determination
was effectuated in the system.
Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
Enter None for standard
cases, dismissed cases, or if
the request was denied.

Page 28 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
X
Date forwarded to IRE

Time forwarded to IRE

Who made the request?

Page 29 of 50

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

CHAR
3
Always
Required

Description
Enter the date the request was
forwarded to the IRE. Submit
in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if the beneficiary
was notified of the approved
reconsideration, or if the
request was not forwarded to
the IRE.
For all expedited requests,
enter the time the request was
forwarded to the IRE. Submit
in HH:MM:SS military time
format (e.g., 23:59:59).
Enter None if the beneficiary
was notified of the approved
reconsideration or if the
request was not forwarded to
the IRE.
Enter the person who made
the request:
• E for enrollee
• ER for enrollee’s
representative
• CP for requests by a
contract provider/facility
• NCP for requests by a noncontract provider/facility

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
AA
Issue description and
type of service

Field
Field
Type
Length
CHAR
2,000
Always
Required

Description
Provide a description of the
service or item requested and
why it was requested (if
known). For denials, also
provide an explanation of
why the pre-service request
was denied.
For dismissed requests,
provide the reason for
dismissal.

Was an expedited request
made but processed as
standard?

CHAR
4
Always
Required

Was the initial
organization
determination request
denied for lack of
medical necessity?

CHAR
1
Always
Required

For Part B drugs requests,
include the J-Code, National
Drug Code (NDC), or both.
Enter:
• Y for Yes if an expedited
request was received but
downgraded to standard
• None for all other cases
(e.g. the request was
received as expedited and
processed as expedited, the
request was received as
standard.)
• For dismissed requests,
populate based on how the
request was received.
Enter:
• Y for Yes
• N for No

Please use the guidance below for the following record layout:
Universe Table 3: Payment Organization Determinations and Reconsiderations (PYMT_C)
Record Layout
• Include all payment organization determinations and payment reconsiderations the
Sponsoring organization approved, denied or dismissed from non-contract providers,
enrollees, and non-contract pharmacies during the universe request period.
• Submit payment organization determinations (claims) based on the date the claim was paid
(Column O) or notification of the denial to the provider (if provider submitted the claim Column Q) or enrollee (if the enrollee submitted the claim – Column P). Submit payment

Page 30 of 50

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
reconsiderations based on the date the overturned reconsideration was paid or, for upheld
reconsiderations, submit based on the date the case was forwarded to the IRE. Submit
dismissed requests based on the date of the decision to dismiss (Column M).
Include all payment requests for Part B drugs if applicable.
Include all payment requests for supplemental services that meet the criteria defined at 42
CFR § 422.100(c)(2).
If a payment organization determination or reconsideration includes more than one service,
include all of the request’s line items in a single row and enter the multiple line items as a
single organization determination or reconsideration request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single case in the same time zone. For example, if the Sponsoring
organization has systems in EST and CST, all data in a single line item must be in a
single time zone.
Exclude all payment requests processed as:
o duplicate claims,
o payment adjustments,
o reopenings,
o withdrawals, and
o retrospective reviews.
Exclude all requests for Value Added Items and Services.
Exclude any payment requests that were denied due to:
o invalid billing codes,
o eligibility (i.e., enrollees who were not enrolled on the date of service, providers not
accepting assignment), or
o recoupment of payment, including pending determination of other primary insurance
such as automobile, worker’s compensation, etc.

•
•
•

•

•
•

Column Field Name
ID
A
Enrollee First Name

Enrollee Last Name

Page 31 of 50

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the
enrollee.

Enter the first name of the
enrollee.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
C
Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

Contract ID

Plan Benefit Package (PBP)

First Tier, Downstream, and
Related Entity

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
70
Always
Required

Enter the name of the First
Tier, Downstream, and
Related Entity (which is any
party that enters into a written
arrangement, acceptable to
CMS, with the Sponsoring
organization to provide
administrative or health care
services to an enrollee under
the Part C or D program) that
processed the request.
Enter None if the Sponsoring
organization processed the
request.

Page 32 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
G
Authorization or Claim
Number

Date the request was received

AOR/Equivalent notice
Receipt Date

Field
Field
Type
Length
CHAR
40
Always
Required

CHAR
10
Always
Required

Description
Enter the associated
authorization or claim number
for this request. If an
authorization or claim number
is not available, enter the
internal tracking or case
number.
Enter None if there is no
authorization, claim or other
tracking number available.
Enter the date the payment
request was received. If the
Sponsoring organization
obtained information
establishing good cause after
the 60-day filing timeframe,
enter the date the Sponsoring
organization received the
information establishing good
cause.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter the date the
Appointment of
Representative (AOR) form
or equivalent written notice
was received by the
Sponsoring organization.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None for dismissed
requests or if no AOR or
equivalent written notice was
received or required.

Page 33 of 50

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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
J
Waiver of Liability (WOL)
Receipt Date

Field
Field
Type
Length
CHAR
10
Always
Required

Was it a clean claim?

CHAR
4
Always
Required

Was the request processed as
an OD or Recon?

CHAR
5
Always
Required

Request Determination

CHAR
9
Always
Required

Date of Determination

CHAR
10
Always
Required

Description
Enter the date the WOL form
was received for noncontracted provider payment
appeals. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for ODs, enrollee
submitted requests, or if a
WOL was never received.
Enter:
• Y for clean claim
• N for unclean claim
• None for payment
reconsiderations
Enter the manner by which
the request was processed:
• OD
• Recon
Enter:
• Approved
• Denied
• Dismissed
Enter the date of the
determination. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01). This is the date
the determination was entered
in the system and may be the
same as the date claim was
paid.
For dismissed requests, enter
the date the Sponsor
dismissed the request.

Page 34 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
O
Date claim/reconsideration
was paid

Date written notification
provided to enrollee

Date written notification
provided to provider

Date forwarded to IRE

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

Description
Enter the date the
claim/reconsideration was
paid. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if payment was
not provided, if the request
was denied, or if the request
was dismissed.
Enter the date written
notification was provided to
enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written
notification was provided.
Enter the date written
notification was provided to
provider. Do not enter the
date a letter is generated or
printed. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written
notification was provided or if
the enrollee submitted the
request.
Enter the date the
reconsideration request was
forwarded to the IRE. Submit
in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None for organization
determination requests, or if
the reconsideration request
was approved, dismissed, or
not forwarded to the IRE.

Page 35 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
S
Who made the request?

Issue description and type of
service

Field
Field
Type
Length
CHAR
3
Always
Required

CHAR
2,000
Always
Required

Description
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative
• NCP for requests by a noncontract provider
NCP includes non-contract
pharmacies.
Provide a description of the
service or item requested and
why it was requested (if
known). For denials, also
provide an explanation of
why the payment organization
determination or payment
reconsideration request was
denied.
For dismissed requests, please
provide the reason for
dismissal.

Was the initial organization
determination request denied
for lack of medical necessity?

CHAR
4
Always
Required

For Part B drugs requests,
include the J-Code, National
Drug Code (NDC), or both.
Enter:
• Y for Yes
• N for No
• None if the request was
approved or dismissed.

Please use the guidance below for the following record layout:
Universe Table 4: Part C Effectuations of Overturned Decisions by IRE, ALJ, or MAC
(EFF_C) Record Layout
• Include all reconsiderations fully or partially overturned by the IRE, ALJ, or MAC requiring
an effectuation as pre-service or post-service (payment) that were received from the IRE,
ALJ, or MAC during the universe request period. The date of the Sponsoring organization’s
receipt of the overturn decision (Column ID J) must fall within the universe request period.
• Exclude any cases that were dismissed or upheld by the IRE, ALJ, or MAC.

Page 36 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee ID

Contract ID

Plan Benefit
Package (PBP)

First Tier,
Downstream, and
Related Entity

Enrollee First
Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
70
Always
Required

Enter the first name of the enrollee.

Enter the PBP (e.g., 001).

Page 37 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
G

Field Name
Authorization or
Claim Number

Type of
reconsideration
case

Field
Field
Type
Length
CHAR
40
Always
Required

CHAR
9
Always
Required

Review Entity

CHAR
3
Always
Required

Date the
overturned
decision was
received
Time the
overturned
decision was
received

CHAR
10
Always
Required

Date overturned
decision or
payment
effectuated in the
system

CHAR
8
Always
Required

CHAR
10
Always
Required

For post-service cases, enter Payment.
Enter the entity that overturned the
decision:
• IRE
• ALJ
• MAC
Enter the date the overturned decision
was received. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
For expedited requests and Part B drug
requests, enter the time the overturned
decision was received. Submit in
HH:MM:SS military time format (e.g.,
23:59:59).
Enter None for Standard (pre-service)
and Payment reconsideration cases.
Enter the date overturned decision
effectuated in the system. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the overturned decision
was not effectuated.

Page 38 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
M

Field Name
Time overturned
decision or
payment
effectuated in the
system

Field
Field
Type
Length
CHAR
8
Always
Required

Description
For expedited requests and Part B drug
requests, enter the time the overturned
decision was effectuated in the system.
Submit in HH:MM:SS military time
format (e.g., 23:59:59).
Enter None for Standard (pre-service)
and Payment reconsideration cases, or if
the overturned decision was not
effectuated.

Please use the guidance below for the following record layout:
Universe Table 5: Part C Standard and Expedited Grievances (GRV_C) Record Layout
• Include all grievances the Sponsoring organization responded to during the universe request
period. The date of the Sponsoring organization’s notification (Column ID Q or S) must fall
within the universe request period.
• Exclude all grievances that were withdrawn and dismissed during the universe request
period.
• Exclude complaints filed only within the Complaints Tracking Module (CTM) in HPMS. If a
complaint was processed both within the CTM and was also received as a grievance, exclude
the CTM complaint but include the grievance as processed by the Sponsoring organization.
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee ID

Enrollee First
Name

Page 39 of 50

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

Enter the first name of the enrollee.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
D

Field Name

Plan Benefit
Package (PBP)

First Tier,
Downstream, and
Related Entity

Contract ID

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
5

Description

Enter the PBP (e.g., 001).

Date the grievance
was received

Time the
grievance was
received

CHAR
10
Always
Required
CHAR
8
Always
Required

AOR/Equivalent
notice Receipt
Date

CHAR
10
Always
Required

Enter the contract number (e.g., H1234).

Enter None if the Sponsoring
organization processed the grievance.
Enter the date the grievance was
received. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter the time the grievance was
received. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None for standard cases.
Enter the date the Appointment of
Representative (AOR) form or
equivalent written notice was received
by the Sponsoring organization. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no AOR or equivalent
written notice was received or required.

Page 40 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID

Field Name

Field
Type

Field
Length

AOR/Equivalent
notice Receipt
Time

CHAR
8
Always
Required

How was the
grievance
received?

CHAR
7
Always
Required

Was the grievance
processed as
Standard or
Expedited?
Category of the
issue

CHAR
1
Always
Required

Grievance
Description

Was this
processed as a
quality of care
grievance?
Was a timeframe
extension taken?

CHAR
1,800
Always
Required
CHAR
1
Always
Required

Date oral
notification
provided to
enrollee

CHAR
50
Always
Required

CHAR
1
Always
Required
CHAR
10
Always
Required

Description
For expedited grievances, enter the time
the Appointment of Representative
(AOR) form or equivalent written notice
was received by the Sponsoring
organization. Submit in HH:MM:SS
format (e.g., 23:59:59).
Enter None for standard grievances,
dismissed grievances, or if an AOR or
equivalent written notice was not
received or required.
Enter the method of receipt of the
grievance:
• Oral
• Written
Enter how the grievance was processed:
• S for Standard
• E for Expedited
Enter the category of the grievance as
assigned by the Sponsoring organization.
Enter based on the Sponsoring
organization’s internal labeling system.
Enter a description of the grievance.

Enter:
• Y for Yes
• N for No
Enter:
• Y for Yes
• N for No
Enter the date oral notification was
provided to the enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no oral notification was
provided.

Page 41 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
R

Field Name
Time oral
notification
provided to
enrollee

Date written
notification
provided to
enrollee

Time written
notification
provided to
enrollee

Field
Field
Type
Length
CHAR
8
Always
Required

Description
Enter the time oral notification was
provided to the enrollee. Submit in
HH:MM:SS military time format (e.g.,
23:59:59).

CHAR
10
Always
Required

Enter None for standard grievances, or
if no oral notification was provided.
Enter the date written notification was
provided to enrollee. Do not enter the
date a letter is generated or printed.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).

CHAR
8
Always
Required

Enter None if a written notification was
not provided.
Enter the time written notification was
provided to enrollee. Submit in
HH:MM:SS military time format (e.g.,
23:59:59).
Enter None for standard cases, or if
written notification was not provided.

Universe Table 6: Dual Special Needs Plan – Applicable Integrated Plan Reductions,
Suspensions, and Terminations (AIP) Record Layout
• Include all integrated organization determination cases where a previously approved service
is being reduced, suspended, or terminated by the DSNP-AIP. The date of the DSNP-AIP
Integrated Denial Notification (Column ID G) must fall within the universe request period.
• Populate this Table with requests involving Medicare-coverable benefits only.
• Exclude all pre-service cases.
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee First
Name

Page 42 of 50

Field
Type
CHAR
Always
Required

Field
Length
50

Description

CHAR
Always
Required

Enter the last name of the enrollee.

Enter the first name of the enrollee.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
C

Field Name

Contract ID

Enrollee ID

Field
Type
CHAR
Always
Required

CHAR
Always
Required
Plan Benefit
CHAR
Package (PBP)
Always
Required
First Tier,
CHAR
Downstream, and Always
Related Entity
Required

Authorization or
Claim Number

Date DSNP-AIP
notified enrollee
of its decision to
reduce,
terminate, or
suspend services.

Page 43 of 50

CHAR
Always
Required

Field
Length
11

Description

Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the nonintelligent unique identifier that replaced
the HICN on Medicare cards as a result of
The Medicare Access and CHIP
Reauthorization Act (MACRA) of 2015.
The MBI contains uppercase alphabetic
and numeric characters throughout the 11digit identifier and is unique to each
Medicare enrollee. This number must be
submitted excluding hyphens or dashes.
Enter the contract number (e.g., H1234).

Enter the PBP (e.g., 001).

Enter the name of the First Tier,
Downstream, and Related Entity (which is
any party that enters into a written
arrangement, acceptable to CMS, with the
Sponsoring organization to provide
administrative or health care services to
an enrollee under the Part C or D
program) that processed the request.

Enter None if the Sponsoring organization
processed the request.
Enter the associated authorization or
claim number for this request. If an
authorization or claim number is not
available, enter the internal tracking or
case number.
Enter None if there is no authorization,
claim or other tracking number available.
Enter the date the DSNP-AIP notified the
enrollee of the reduction, suspension, or
termination. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
I

Field Name
Effective date of
reduction,
suspension, or
termination of
services.
Was the decision
appealed?

Who made the
request?

Field
Type
CHAR
Always
Required

Field
Length
10

CHAR
Always
Required

Description
Indicate the intended date of action (that
is, the date on which reduction,
suspension, or termination became
effective). Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter:
• Y for Yes
• N for No
If ‘N’ is entered, populate all remaining
fields with None.
Enter who made the plan level appeal:
• E for enrollee
• ER for enrollee’s representative
• CP for requests by a contract provider
• NCP for requests by a non-contract
provider
“Provider” includes physicians and
facilities.

Date the appeal
was received

AOR/Equivalent
notice receipt
date

CHAR
Always
Required

Enter None if the decision was not
appealed as indicated by N in column ID
J.
Enter the date the request was received.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the decision was not
appealed as indicated by N in column ID
J.
Enter the date the Appointment of
Representative (AOR) form or equivalent
written notice was received by the
Sponsoring organization. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for dismissed requests, if no
AOR or equivalent written notice was
received or required, or if the decision
was not appealed as indicated by N in
column ID J.

Page 44 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
N

Field Name
Was the appeal
processed as
Standard or
Expedited?

Field
Type
CHAR
Always
Required

Field
Length
4

Was appeal made CHAR
under the
Always
expedited
Required
timeframe but
processed by the
plan under the
standard
timeframe?

Was a timeframe
extension taken?

CHAR
Always
Required

If an extension
CHAR
was taken, did
Always
the DSNP-AIP
Required
notify the
enrollee of the
reason(s) for the
delay and of their
right to file an
expedited
grievance?

Page 45 of 50

Description
Enter the manner by which the appeal was
processed:
• S for Standard
• E for Expedited
Enter None if the decision was not
appealed as indicated by N in column ID
J.
Yes (Y)/No (N) indicator of whether the
request was received as expedited but was
downgraded and processed under the
standard timeframe (e.g., based on the
DSNP-AIP deciding that the expedited
plan level appeal was unnecessary).
Enter None if the request was received as
a standard request or if the decision was
not appealed as indicated by N in column
ID J.
Yes (Y)/No (N) indicator of whether the
DSNP-AIP extended the timeframe to
make the appeal decision.
Enter None if the decision was not
appealed as indicated by N in column ID
J.
Yes (Y)/No (N) indicator of whether the
DSNP-AIP notified the enrollee of the
delay.
Enter None if no extension was taken or if
the decision was not appealed as indicated
by N in column ID J.

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
R

Field Name
Did the enrollee
request
continuation of
benefits?

Field
Type
CHAR
Always
Required

Field
Length
4

Were the benefits CHAR
under appeal
Always
provided to the
Required
enrollee during
the plan level
appeal process?

Request
Disposition

Date of DSNPAIP decision

Date oral
notification
provided to
enrollee

CHAR
Always
Required

Description
Yes (Y)/No (N) indicator of whether the
enrollee requested continuation of
benefits.
Enter None if someone other than the
enrollee requested continuation of
benefits or if the decision was not
appealed as indicated by N in column ID
J.
Yes (Y)/No (N) indicator of whether the
benefits under appeal were provided to
the enrollee during the reconsideration
process.
Enter None if no request for continuation
of benefits was made or if the decision
was not appealed as indicated by N in
column ID J.
Enter:
• Approved
• Denied
• Dismissed
Enter None if the decision was not
appealed as indicated by N in column ID
J.
Date of the DSNP-AIP decision. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the decision was not
appealed as indicated by N in column ID
J.
Date oral notification provided to
enrollee. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if no oral notification
provided or if the decision was not
appealed as indicated by N in column ID
J.

Page 46 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
W

Field Name
Date written
notification
provided to
enrollee/provider

Field
Type
CHAR
Always
Required

Date
reconsidered
determination
effectuated in the
DSNP-AIP
system

CHAR
Always
Required

Date forwarded
to IRE if denied
or untimely

CHAR
Always
Required

If request denied,
date services
were terminated,
reduced,
suspended

CHAR
Always
Required

Field
Length
10

Description
Date written notification provided to
enrollee, or if applicable the non-contract
provider. Do not enter the date when a
letter is generated or printed within the
DSNP-AIP’s organization. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written notification was
provided or if the decision was not
appealed as indicated by N in column ID
J.
Date reconsidered determination
effectuated in the DSNP-AIP 's system.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for denials and or if the
decision was not appealed as indicated by
N in column ID J.
Date the AIP forwarded request to the
IRE if request for Medicare service was
denied or processed untimely. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if approved or not forwarded
to IRE or if the decision was not appealed
as indicated by N in column ID J.
Enter the date the services were
terminated, reduced, suspended. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the decision was not
appealed as indicated by N in column ID
J.

Audit Field Work Phase
Supporting Documentation Submissions
Each case will be evaluated to determine whether the Sponsoring organization is compliant with
its Part C contract requirements. To facilitate this review, the Sponsoring organization must have
access to, and the ability to save and upload screenshots of, supporting documentation and data
Page 47 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
relevant for a particular case, including, but not limited to:
• Original pre-service or payment (i.e., claim or reimbursement request) or reconsideration
request.
o If request was received via fax/mail/email, copy of original request including date/time
stamp of receipt.
o If request was received via phone, copy of Customer Service Representative (CSR) notes
and/or documentation of call including date/time stamp of call and call details.
o If a request was received via a chat feature that is available on the sponsoring
organization’s website, copy of the transcript.
o If request was received from a representative or NCP (payment reconsiderations), copy of
the AOR or equivalent written notice/WOL received.
• Letters, emails or documentation confirming the sponsoring organization’s receipt of the
request:
o If request was received via fax/mail/email, copy of original request.
o If request was received via phone, copy of CSR notes and/or documentation of call.
• Description of the service/benefit requested from the provider/physician or the enrollee.
• Notices, letters, call logs or other documentation showing the Sponsoring organization
requested additional information (if applicable) from the requesting provider/physician,
including type of communication. If the request was made via phone call, copy of the call log
detailing what was communicated to the physician/provider.
• All supplemental information submitted by the requesting provider/physician or enrollee.
o If information was received via fax/mail/email, copy of original request.
o If information was received via phone, copy of CSR notes and/or documentation of call.
• Documentation of case review steps including name and title of final reviewer; clinical
criteria that supports rationale for denial; any reference to CMS guidance, Federal
Regulations, clinical criteria, peer reviewed literature (where allowed), and Sponsoring
organization documents (e.g., EOC); or any other documentation used when considering the
request.
• Documentation of effectuation including approval in organization
determinations/reconsiderations systems and evidence of effectuation in Sponsoring
organization’s claims adjudication system.
• Documentation showing approval notification to the enrollee and/or their representative and
physician/provider, as applicable.
o Copy of the written decision letter;
o If oral notification was given, copy of CSR notes and/or documentation of call.
• Records indicating that payments were made/issued such as EFT records.
• Documentation showing denial notification to the enrollee and/or their representative and
provider/physician, if applicable:
o Copy of written decision letter;
o If oral notification was given, copy of CSR notes and/or documentation of call.
• Documentation showing reconsideration denial notification to the enrollee and/or their
representative and provider/physician, if applicable:
o Copy of written decision letter;
o If oral notification was given, copy of CSR notes and/or documentation of call.
• If applicable, all documentation to support the Sponsoring organization’s decision to process
an expedited request under the standard timeframe, including any pertinent medical
Page 48 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)

•

•
•
•
•
•
•

•

•
•

•

documentation, and any associated notices provided to the enrollee and the requesting
provider/physician.
If applicable, providing timely notification of dismissed requests to enrollees or another
party, and informing enrollees and other parties about the right to request IRE review of the
dismissed request since Sponsoring organizations will no longer automatically forward such
reconsideration cases to the IRE for review.
ANOC/EOC to support application of Step Therapy to Part B drugs
For reconsiderations, all documentation outlined for both the original determination and the
reconsideration.
If reconsidered case was untimely, include the following:
o Documentation showing the Sponsoring organization auto-forwarded the request to the
IRE.
Copy of overturn notice from IRE/ALJ/MAC.
Copy of effectuation notice sent to IRE.
Initial Complaint and any other supplemental documentation explaining the issue:
o If complaint was received via fax/mail/email, copy of original complaint including
date/time stamp of receipt;
o If complaint was received via phone, copy of CSR notes and/or documentation of call
including date/time of call and call details.
Where applicable, copy of all notices, letters, call logs, or other documentation showing
when the Sponsoring organization acknowledged receipt of the grievance to the enrollee,
and/or requested additional information from the enrollee and/or their representative,
including the date and time of the acknowledgement. If the request was made via phone call,
copy of the CSR notes and/or documentation of call, as well as what was communicated to
the enrollee.
Documentation of all supplemental information submitted by enrollee and/or their
representative:
o If information was received via fax/mail/email, copy of documentation provided
including date/time stamp of receipt;
o If information was received via phone, copy of CSR notes and/or documentation of call
including date/time of call and call details.
Documentation showing the steps the Sponsoring organization took to resolve the issue and a
description of the final resolution. Documentation showing the steps the Sponsoring
organization took to resolve the issue may include, but is not limited to, appropriate
correspondence with other departments within the organization; referral to the Sponsoring
organization’s fraud, waste, and abuse department; and outreach to providers.
Documentation showing the Sponsoring organization’s investigation, follow-up steps, and
description of the final grievance outcome. Include all notices, letters, and enrollee
communications.
Documentation showing resolution notification to the enrollee and/or their representative:
o Copy of the written decision letter sent and documentation of date/time letter was printed
and mailed.
o If oral notification was given, copy of CSR notes and/or documentation of call including
date/time stamp.
Documentation that supports a Sponsoring organizations record layout population (e.g.
mailroom policies).

Page 49 of 50

v.05-2020

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Sponsoring organizations are expected to submit supporting documentation within two business
days of the request.
Root Cause Analysis Submissions
Sponsoring organizations may be required to provide a root cause analysis using the Root Cause
Template provided by CMS. Sponsoring organizations have two business days from the date of
the request to respond.
Impact Analysis Submissions
When non-compliance with contract requirements is identified on audit, Sponsoring
organizations must submit each requested impact analysis, comprehensive of all contracts and
Plan Benefit Packages (PBP) identified in the audit engagement letter, in either Microsoft Excel
(.xlsx) file format with a header row or Text (.txt) file format without a header row using one of
the universe record layouts above, as specified by CMS. The Sponsoring organization must
include all requests impacted by the issue of non-compliance during the impact analysis request
period. Sponsoring organizations must provide accurate and timely impact analysis submissions
within 10 business days of the request. Submissions that do not strictly adhere to the record
layout specifications will be rejected.
Verification of Information Collected: CMS may conduct integrity tests to validate the
accuracy of all universes, impact analyses, and other related documentation submitted in
furtherance of the audit. If data integrity issues are noted, Sponsoring organizations may be
required to resubmit their data.

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 Type	application/pdf
File Title	ODAG Protocols and Data Request
Subject	ODAG Protocols and Data Request
Author	CMS
File Modified	2020-05-18
File Created	2020-05-15