ODAGProtocol

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

ODAGProtocol

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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 ................................................................................................................................................. 17
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 ................................................................................................................................................. 29
Universe Table 4: Part C Effectuations of Overturned Decisions by IRE, ALJ, or MAC (EFF_C)
Record Layout ..................................................................................................................................... 34
Universe Table 5: Part C Standard and Expedited Grievances (GRV_C) Record Layout .................. 37
Universe Table 6: Dual Special Needs Plan – Applicable Integrated Plan Reductions, Suspensions,
and Terminations (AIP) Record Layout .............................................................................................. 41
Audit Field Work Phase ........................................................................................................................... 47
Supporting Documentation Submissions ............................................................................................ 47
Root Cause Analysis Submissions........................................................................................................ 49
Impact Analysis Submissions ............................................................................................................... 49

Page 2 of 49

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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 49

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

Method of Evaluation
Select 10 cases from each universe,
Tables 1 through 6, for a total of 60 cases.
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. Review all cases
selected for universe integrity testing. The
integrity of the universe will be questioned
if data points specific to the sample case(s)
are incomplete, do not match, or cannot be
verified by viewing the Sponsoring
organization’s systems and/or other
supporting documentation.

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

Sample selections will be provided to the
Sponsoring organization approximately
one hour prior to the scheduled webinar.

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 49

OMB Approval 0938-1395 (Expires 05/31/2024)

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

Timeliness

Timeliness

Timeliness

Page 5 of 49

Compliance
Standard
1.1

1.2

1.3

1.4

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)

OMB Approval 0938-1395 (Expires 05/31/2024)

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

Timeliness

Page 6 of 49

Compliance
Standard
1.5

1.6

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)

OMB Approval 0938-1395 (Expires 05/31/2024)

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 49

OMB Approval 0938-1395 (Expires 05/31/2024)

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

Audit
Element
Timeliness

Timeliness

Timeliness

Timeliness

Page 8 of 49

Compliance
Standard
1.9

1.10

1.11

1.12

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)
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)

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

OMB Approval 0938-1395 (Expires 05/31/2024)

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

Timeliness

Timeliness

Timeliness

Timeliness

Page 9 of 49

Compliance
Standard
1.13

1.14

1.15

1.16

1.17

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)

OMB Approval 0938-1395 (Expires 05/31/2024)

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 49

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 calendar 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)

OMB Approval 0938-1395 (Expires 05/31/2024)

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 49

Additionally, select 5 denial cases from
Table 6.
Ensure sample set represents various
medical services (e.g., ER services,
outpatient hospital, inpatient hospital,
urgent care, etc.).

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)
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.

OMB Approval 0938-1395 (Expires 05/31/2024)

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 49

OMB Approval 0938-1395 (Expires 05/31/2024)

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

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

Page 13 of 49

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)

OMB Approval 0938-1395 (Expires 05/31/2024)

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

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 § 422.578
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 49

OMB Approval 0938-1395 (Expires 05/31/2024)

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.
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.

Criteria Effective
01/01/2021
42 CFR § 422.564(a)
42 CFR § 422.564(e)
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. Sponsoring organizations may however enter the
time within universes instead of ‘None’ if the time is not required per the field description.

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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.

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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 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.
• 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

B

Enrollee Last Name

C

Enrollee ID

Page 17 of 49

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

50

Enter the last name of the
enrollee.

11

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 first name of the
enrollee.

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

Field Name

E

Plan Benefit Package
(PBP)

F

First Tier, Downstream,
and Related Entity

G

H

Contract ID

Authorization or Claim
Number

Date the request was
received

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
5

Description

3

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

70

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.

CHAR
40
Always
Required

CHAR
10
Always
Required

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

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 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.

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

Field Name
Time the request was
received

Field
Field
Type
Length
CHAR
8
Always
Required

Description
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.

J

Part B Drug
Request?

K

AOR/Equivalent notice
Receipt Date

L

M

Page 19 of 49

AOR/Equivalent notice
Receipt Time

Request
Determination

CHAR
1
Always
Required
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
9
Always
Required

Enter None for standard service
requests and dismissed requests.
Enter:
• Y for Yes
• N for No
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.
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 service
requests or if no AOR or
equivalent written notice was
received or required.
Enter:
• Approved
• Denied
• Dismissed
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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
N

O

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

P

Date of
Determination

Q

Time of
Determination

R

S

T

Field
Field
Type
Length
CHAR
1
Always
Required
CHAR
1
Always
Required
CHAR
10
Always
Required
CHAR
8
Always
Required

Date oral
CHAR
10
notification
Always
provided to enrollee Required

Time oral
CHAR
8
notification
Always
provided to enrollee Required

Date written
CHAR
10
notification
Always
provided to enrollee Required

Description
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 Sponsoring organization
dismissed the request.
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 service requests
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 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).
Enter None for standard service 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).
Enter None 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
U

Field Name
Time written notification
provided to enrollee

Field
Field
Type
Length
CHAR
8
Always
Required

V

Who made the request?

CHAR
3
Always
Required

W

2,000
Issue description and type CHAR
Always
of service
Required

X

Was an expedited request
made but processed as
standard?

Y

4
Was the request denied for CHAR
lack of medical necessity? Always
Required

Page 21 of 49

CHAR
4
Always
Required

Description
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 service
requests, dismissed requests, or if
no written notification was
provided.
Enter who made the request:
• E for enrollee
• ER for enrollee’s representative
or purported representative
• CP for requests by a contract
provider/facility
• NCP for requests by a noncontract provider/facility
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.
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.
OMB Approval 0938-1395 (Expires 05/31/2024)

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 ID Field Name
A

Enrollee First Name

B

Enrollee Last Name

C

Enrollee ID

Page 22 of 49

Field Type Field
Length
CHAR
50
Always
Required
CHAR
50
Always
Required
CHAR
11
Always
Required

Description
Enter the first name of the
enrollee.
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.
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Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column Field Name
ID
D
Contract ID
E

Plan Benefit Package
(PBP)

F

First Tier, Downstream,
and Related Entity

G

Authorization or Claim
Number

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
5

Description

3

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

70

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.

CHAR
40
Always
Required

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

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.

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

Field
Field
Type
Length
CHAR
10
Always
Required

Description
Enter the date the
reconsideration 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.

I

Time the request was
received

CHAR
8
Always
Required

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.
For all expedited requests,
enter the time the
reconsideration 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.
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.
Enter None for standard and
dismissed requests.

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

Field Name

K

AOR/Equivalent Notice
Receipt Date

L

Part B Drug Request?

AOR/Equivalent Notice
Receipt Time

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
1
10

CHAR
8
Always
Required

M

Request Determination

CHAR
9
Always
Required

N

Was the request processed CHAR
1
as Standard or Expedited? Always
Required

O

Was a timeframe
extension taken?

P

Date of Determination

CHAR
1
Always
Required
CHAR
10
Always
Required

Description
Enter:
• Y for Yes
• N for No
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.
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 standard 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.

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

R

S

T

U

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

CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
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 all expedited 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 standard requests,
dismissed requests, 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).
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.

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

W

X

Y

Field Name
Date reconsidered
determination effectuated
in the system

Time reconsidered
determination effectuated
in the system

Date forwarded to IRE

Time forwarded to IRE

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
10
Always
Required

Description
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.
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 enrollee 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 enrollee was
notified of the approved
reconsideration, if the request
was not forwarded to the IRE, or
for standard requests.

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

Field
Field
Type
Length
CHAR
3
Always
Required

AA

CHAR
2,000
Always
Required

Issue description and
type of service

AB

Was an expedited
request made but
processed as standard?

CHAR
4
Always
Required

AC

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

CHAR
1
Always
Required

Page 28 of 49

Description
Enter the person who made
the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• CP for requests by a
contract provider/facility
• NCP for requests by a noncontract provider/facility
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.
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, or the request
was dismissed).
Enter:
• Y for Yes
• N for No

OMB Approval 0938-1395 (Expires 05/31/2024)

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 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
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 N).
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
ID
A

Field Name

B

Enrollee Last Name

Page 29 of 49

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

50

Enter the last name of the
enrollee.

Enter the first name of the
enrollee.

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

Field Name

D

Contract ID

E

Plan Benefit Package
(PBP)

F

First Tier,
Downstream, and
Related Entity

G

Enrollee ID

Authorization or Claim
Number

Field
Field
Type
Length
CHAR
11
Always
Required

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

CHAR
40
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.
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.

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Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
H

I

J

Field Name
Date the request was
received

AOR/Equivalent notice
Receipt Date

Waiver of Liability
(WOL) Receipt Date

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

CHAR
10
Always
Required

K

Was it a clean claim?

L

Was the request processed CHAR
5
as an OD or Recon?
Always
Required

Page 31 of 49

CHAR
4
Always
Required

Description
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.
Enter the date the WOL form was
received for non- contracted
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

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

Field Name

N

Date of Determination

O

P

Q

Request Determination

Field
Field
Type
Length
CHAR
9
Always
Required
CHAR
10
Always
Required

Date claim/reconsideration CHAR
10
Always
was paid
Required

Date written notification
provided to enrollee

Date written notification
provided to provider

CHAR
10
Always
Required

CHAR
10
Always
Required

Description
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 Sponsoring organization
dismissed the request.
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.

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

Field
Field
Type
Length
CHAR
10
Always
Required

Description
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.

S

Who made the request?

CHAR
3
Always
Required

Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• NCP for requests by a noncontract
provider/pharmacy

T

Issue description and type of
service

CHAR
2,000
Always
Required

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.

U

Page 33 of 49

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

CHAR
4
Always
Required

For dismissed requests, please
provide the reason for
dismissal.
Enter:
• Y for Yes
• N for No
• None if the request was
approved or dismissed.

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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 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.
Column
ID
A

Field Name

B

Enrollee Last Name

C

Enrollee ID

D

Contract ID

E

Plan Benefit Package
(PBP)

Page 34 of 49

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

50

Enter the last name of the enrollee.

11

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

Enter the first name of the
enrollee.

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

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

G

H

Field Name
First Tier, Downstream,
and Related Entity

Authorization or Claim
Number

Type of reconsideration
case

Field
Field
Type
Length
CHAR
70
Always
Required

CHAR
40
Always
Required

CHAR
9
Always
Required

Description
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 type of
reconsideration case
submitted to IRE/ALJ/MAC:
• Standard
• Expedited
• Payment
For pre-service cases, enter
Standard or Expedited.

I

Page 35 of 49

Review Entity

CHAR
3
Always
Required

For post-service cases, enter
Payment.
Enter the entity that
overturned the decision:
• IRE
• ALJ
• MAC

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

Field Name

K

Time the overturned
decision was received

Date the overturned
decision was
received

L

Part B Drug Request?

M

Date overturned decision
or payment effectuated in
the system

N

Time overturned decision
or payment effectuated in
the system

Field
Field
Type
Length
CHAR
10
Always
Required
CHAR
8
Always
Required

CHAR
1
Always
Required
CHAR
10
Always
Required

CHAR
8
Always
Required

Description
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 (preservice) and Payment
reconsideration cases.
Enter:
• Y for Yes
• N for No
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.
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
service requests and payment
reconsideration cases, or if the
overturned decision was not
effectuated.

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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 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.
• Grievances with multiple issues must be entered as a single line item, unless the Sponsoring
organization issued separate notifications.
• 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.
• Sponsoring organizations determined to be an applicable integrated plan as defined by 42 CFR
§ 422.561 should populate the universe with grievances related to Medicare coverage only.
Column
ID
A

Field Name

B

Enrollee Last Name

C

Enrollee ID

D

Contract ID

Page 37 of 49

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

50

Enter the last name of the enrollee.

11

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

Enter the first name of the
enrollee.

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

Field Name

F

First Tier, Downstream,
and Related Entity

Plan Benefit Package
(PBP)

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
3

Description

70

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 grievance.

G

Date the grievance was
received

CHAR
10
Always
Required

H

Time the grievance was
received

CHAR
8
Always
Required

I

AOR/Equivalent notice
Receipt Date

CHAR
10
Always
Required

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

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.

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Part C Organization Determinations, Appeals, and Grievances (ODAG)
Column
ID
J

Field Name
AOR/Equivalent notice
Receipt Time

Field
Field
Length
Type
CHAR
8
Always
Required

K

How was the grievance
received?

CHAR
7
Always
Required

L

Was the grievance
processed as Standard or
Expedited?

CHAR
1
Always
Required

M

Category of the issue

CHAR
50
Always
Required

N

Grievance Description

O

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

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

P
Q

Date oral notification
provided to enrollee

1,800
1
1
10

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 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.

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

S

T

U

Page 40 of 49

Field Name
Time oral notification
provided to enrollee

Date written notification
provided to enrollee

Time written notification
provided to enrollee

Who made the request?

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).

CHAR
2
Always
Required

Enter None for standard cases, or
if written notification was not
provided.
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or purported
representative

OMB Approval 0938-1395 (Expires 05/31/2024)

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 6: Dual Special Needs Plan – Applicable Integrated Plan Reductions,
Suspensions, and Terminations (AIP) Record Layout
• The AIP record layout must be submitted by all Sponsoring organizations determined to be
an applicable integrated plan as defined by 42 CFR § 422.561 and have been notified by
CMS of their status.
• Include all integrated organization determination cases where a previously approved service
is being reduced, suspended, or terminated by the DSNP-AIP. The date the DSNP-AIP
notified the enrollee must fall within the universe request period (Column ID H).
• Populate this Table with requests involving Medicare-coverable benefits only.
• Exclude all pre-service cases.
Column
ID
A

Field Name

Field
Field
Type
Length
CHAR
50
Always
Required

Description

B

Enrollee Last Name

CHAR
50
Always
Required

Enter the last name of the enrollee.

C

Enrollee ID

CHAR
11
Always
Required

D

Contract ID

E

Plan Benefit Package
(PBP)

CHAR
5
Always
Required
CHAR
3
Always
Required

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).

Page 41 of 49

Enrollee First Name

Enter the first name of the
enrollee.

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

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

G

Field Name
First Tier, Downstream,
and Related Entity

Authorization or Claim
Number

Field
Field
Type
Length
CHAR
70
Always
Required

CHAR
40
Always
Required

H

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

CHAR
10
Always
Required

I

Effective date of
reduction, suspension, or
termination of
services

CHAR
10
Always
Required

J

Was the decision
appealed?

CHAR
1
Always
Required

Description
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).
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.

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

L

M

N

Field Name
Who made the request?

Date the appeal was
received

AOR/Equivalent notice
receipt date

Field
Field
Type
Length
CHAR
4
Always
Required

CHAR
10
Always
Required

CHAR
10
Always
Required

4
Was the appeal processed CHAR
as Standard or Expedited? Always
Required

Description
Enter who made the plan level
appeal:
• E for enrollee
• ER for enrollee’s representative
or purported representative
• CP for requests by a contract
provider/facility
• NCP for requests by a
non-contract
provider/facility
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.
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.

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

P

Q

R

Field Name
Was appeal made under
the expedited timeframe
but processed by the plan
under the standard
timeframe?

Was a timeframe
extension taken?

Did the enrollee request
continuation of benefits?

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

Field
Field
Type
Length
CHAR
4
Always
Required

CHAR
4
Always
Required

CHAR
4
Always
Required

CHAR
4
Always
Required

Description
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 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.

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

T

Field Name
Request Disposition

Date of DSNP- AIP
decision

Field
Field
Type
Length
CHAR
9
Always
Required

CHAR
10
Always
Required

Description
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.

U

V

Date oral notification
provided to enrollee

Date written notification
provided to
enrollee/provider

10
CHAR
Always
Required

CHAR
10
Always
Required

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.
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.

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

X

Y

Field Name
Date reconsidered
determination effectuated
in the DSNP-AIP
system

Date forwarded to IRE if
denied or untimely

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

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

CHAR
10
Always
Required

Description
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 reconsideration
was approved or if the decision
was not appealed as indicated by
N in column ID J.

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

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
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.
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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 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.

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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).

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.

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 0938-1395 (Expires
05/31/2024). This is a mandatory information collection. 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. ****CMS Disclosure**** 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 [email protected].

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File Typeapplication/pdf
File TitlePart C Organization Determinations Appeals and Grievances Program Audit Protocol and Data Request
SubjectODAG Protocols and Data Request
AuthorCMS
File Modified2023-09-28
File Created2023-04-07

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