CMS-10305 Coverage Determinations and Redeterminations (Part D) 20

Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (CMS-10305)

CY 2023 DV Appendix J_CDR_20221014_508

OMB: 0938-1115

Document [pdf]
Download: pdf | pdf
Coverage Determinations and
Redeterminations (Part D) 2022
Organization Name:
Contract Number:
Reporting Section:

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Coverage
Determinations
and
Redetermination
no data
s (Part D) 2022

Last Updated:

Date of Site Visit (on-site or virtual):
Name of Reviewer:
Name of Peer Reviewer:
Instructions:
1) In the "Data Sources and Review Results:" column, enter
the review results and/or data sources used for each
standard or sub-standard.
2) Enter "Y" if the requirements for the standard or substandard have been completely met. If any requirement for
the standard or sub-standard has not been met, enter "N". If
any standard or sub-standard does not apply, enter "N/A".
3) For standards 1c, 1d, 1e, 1g, 1h, and 2e, enter 'Findings'
as follows based on the five-point scale: Select "1" if plan
data has more than 20% error, select "2" if plan data has
between 15.1% - 20.0% error, select "3" if plan data has
between 10.1% - 15.0% error, select "4" if plan data has
between 5.1% - 10.0% error, select "5" if plan data has less
than or equal to a 5% error. Enter "N/A" if standard does
no data
not apply.
Standard/Sub-standard ID

Reporting
Section Criteria
ID

Standard/Sub-standard Description

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

1

No data

A review of source documents (e.g., programming code, spreadsheet formulas, analysis plans, saved data queries, file layouts,
process flows) indicates that all source documents accurately capture required data fields and are properly documented.

No data

Data Sources:

1.a

No data

Source documents are properly secured so that source documents can be retrieved at any time to validate the information
submitted to CMS via HPMS.

No data

Review Results:

1.b

No data

Source documents create all required data fields for reporting requirements.

No data

Review Results:

1.c

No data

Source documents are error-free (e.g., programming code and spreadsheet formulas have no messages or warnings indicating
errors, use correct fields, have appropriate data selection, etc.).

No data

Review Results:

1.d

No data

All data fields have meaningful, consistent labels (e.g., label field for patient ID as Patient ID, rather than Field1 and maintain
the same field name across data sets).

No data

Review Results:

1.e

No data

Data file locations are referenced correctly.

No data

Review Results:

1.f

No data

If used, macros are properly documented.

No data

Review Results:

1.g

No data

Source documents are clearly and adequately documented.

No data

Review Results:

1.h

No data

Titles and footnotes on reports and tables are accurate.

No data

Review Results:

1.i

No data

Version control of source documents is appropriately applied.

No data

Review Results:

2

No data

A review of source documents (e.g., programming code, spreadsheet formulas, analysis plans, saved data queries, file layouts,
process flows) and census or sample data, whichever is applicable, indicates that data elements for each reporting section are
accurately identified, processed, and calculated.

No data

Data Sources:

The appropriate date range(s) for the reporting period(s) is captured.

No data

Review Results:

No data

Review Results:

No data

Review Results:

2.a

RSC-1

Organization reports data based on the required reporting periods 1/1 through 3/31, 4/1 through 6/30, 7/1 through 9/30, and
10/1 through 12/31.
2.b

RSC-2

Data are assigned at the applicable level (e.g., plan benefit package or contract level).
Organization properly assigns data to the applicable CMS contract.

2.c

RSC-3

Appropriate deadlines are met for reporting data (e.g., quarterly).
Organization meets deadlines for reporting data to CMS by 2/27/2023.
[Note to reviewer: If the organization has, for any reason, re-submitted its data to CMS for this reporting section, the reviewer
should verify that the organization’s original data submissions met the CMS deadline in order to have a finding of “yes” for this
reporting section criterion. However, if the organization re-submits data for any reason and if the re-submission was completed
by 3/31 of the data validation year, the reviewer should use the organization’s corrected data submission for the review of this
reporting section.]

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.
*

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.d

RSC-4

Standard/Sub-standard Description
Terms used are properly defined per CMS regulations, guidance, Reporting Requirements, and Technical Specifications.
Organization properly defines the term “Coverage Determinations” in accordance with 42 C.F.R. Part 423, Subpart M, and the
Parts C & D Enrollee Grievances, Organization/Coverage Determinations and Appeals Guidance. This includes applying all
relevant guidance properly when performing its calculations and categorizations.

Data Element
No data

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

Review Results:

Organization properly defines the term “Redetermination” in accordance with 42 C.F.R. Part 423, Subpart M, and the Parts C &
D Enrollee Grievances, Organization/Coverage Determinations and Appeals Guidance. This includes applying all relevant
guidance properly when performing its calculations and categorizations.
2.e

RSC-5.a

The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges of data fields
No data
are verified; all calculations (e.g., derived data fields) are verified; missing data has been properly addressed; reporting output
matches corresponding source documents (e.g., programming code, saved queries, analysis plans); version control of reported
data elements is appropriately applied; QA checks/thresholds are applied to detect outlier or erroneous data prior to data
submission.

Data Sources:

*

RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
[Note: Data Elements 1.A - 1.R relate to Coverage Determinations, Data Elements 2.A – 2.V relate to Redeterminations, and
Data Elements 3.A and 3.B.1 – 3.B.12 relate to Re-openings]
a: Number of coverage determination decisions by outcome (Data Elements (1.D + 1.E + 1.F) + (1.H + 1.I + 1.J) + (1.L + 1.M +
1.N) + (1.P + 1.Q + 1.R)) does not exceed the total number of processed coverage determinations that include exceptions (Data
Element 1.A).
2.e

RSC-5.a

No data

Data Elements
(1.D+1.E+1.F) +
(1.H+1.I+1.J) +
(1.L+1.M+1.N) +
(1.P+1.Q+1.R)

Review Results:

2.e

RSC-5.b

RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.

No data

Data Sources:

*

b: Number of exception decisions by outcome made in the reporting period (Data Elements (1.H + 1.I + 1.J) + (1.L + 1.M + 1.N) +
(1.P + 1.Q + 1.R)) does not exceed the total number of processed coverage determination decisions that include exceptions
(Data Element 1.A).
2.e

RSC-5.b

No data

Data Elements
(1.H+1.I+1.J) +
(1.L+1.M+1.N) +
(1.P+1.Q+1.R)

Review Results:

2.e

RSC-5.c

RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.

No data

Data Sources:

*

c: Number of redeterminations decisions by outcome (Data Elements (2.D + 2.E + 2.F) + (2.H + 2.I + 2.J) + (2.L + 2.M + 2.N) +(2.P
+ 2.Q + 2.R) +(2.T + 2.U+ 2V)) is equal to total number of processed redetermination decisions that include exception
redeterminations and at-risk redeterminations (Data Element 2.A).
2.e

RSC-5.c

No data

Data Elements (2.D + 2.E + Review Results:
2.F) + (2.H + 2.I + 2.J) + (2.L
+ 2.M + 2.N) +(2.P + 2.Q +
2.R)+ (2.T +2.U+ 2.V)

2.e

RSC-5.d

RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.

No data

Data Sources:

*

Data Element 3.A
No data

Review Results:
Data Sources:

*

Data Element 3.B.11

Review Results:

d: Total number of reopened (revised) decisions (Data Element 3.A) is equal to the number of records reported in data file.

2.e
2.e

RSC-5.d
RSC-5.e

No data
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
e: Verify that the date of each reopening disposition (Data Element 3.B.11) is in the reporting quarter.

2.e

RSC-5.e

No data

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-5.f

Standard/Sub-standard Description
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

No data

Data Sources:

*

Data Element 3.B.11
No data

Review Results:
Data Sources:

*

Data Element 3.B.11
No data

Review Results:
Data Sources:

*

Data Element 3.B.9
No data

Review Results:
Data Sources:

*

Data Elements 1.A−1.R,
2.A−2.V, 3.A−3.B.12

Review Results:

f: Verify that the date of disposition for each reopening (Data Element 3.B.11) is equal to or later than the date of original
disposition Data Element 3.B.5).

2.e
2.e

RSC-5.f
RSC-5.g

No data
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
g: Verify that the date of each reopening disposition (Data Element 3.B.11) is equal to or later than the date the case was
reopened (Data Element 3.B.9).

2.e
2.e

RSC-5.g
RSC-5.h

No data
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
h: Verify that the date each case was reopened (Data Element 3.B.9) is after the date of original disposition (Data Element
3.B.5).

2.e
2.e

RSC-5.h
RSC-5.i

No data
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
i: If the organization received a CMS outlier/data integrity notice, validate whether or not an internal procedure change was
warranted or resubmission through HPMS.

2.e

RSC-5.i

No data

2.e

RSC-6.a

RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:

Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

a: Includes all coverage determinations (fully favorable, partially favorable, and adverse), including exceptions, with a date of
decision that occurs during the reporting period. Date of the final decision is based on the date the enrollee/enrollee’s
representative is notified in writing of the coverage determination decision.
2.e
2.e

RSC-6.a
RSC-6.b

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
b: Includes hard morphine milligram equivalent dose (MME) edit coverage determinations.

2.e
2.e

RSC-6.b
RSC-6.c

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
c: Includes opioid naïve days supply edit coverage determinations.

2.e
2.e

RSC-6.c
RSC-6.d

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
d: Includes hospice-related coverage determinations.

2.e
2.e

RSC-6.d
RSC-6.e

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
e: Includes all methods of receipt (e.g., telephone, letter, fax, and in-person).

2.e

RSC-6.e

No data

Data Element 1.A

Review Results:

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-6.f

Standard/Sub-standard Description

Data Element

RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

f: Includes all coverage determinations (including exceptions) regardless of who filed the request (e.g., member, appointed
representative, or prescribing physician).
2.e
2.e

RSC-6.f
RSC-6.g

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
g: Includes coverage determinations (including exceptions) from delegated entities.
[Note: Delegated entities are contractors to Part D sponsors]

2.e
2.e

RSC-6.g
RSC-6.h

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
h: Includes both standard and expedited coverage determinations (including exceptions).

2.e
2.e

RSC-6.h
RSC-6.i

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
i: Excludes requests for coverage determinations (including exceptions) that are withdrawn or dismissed.

2.e
2.e

RSC-6.i
RSC-6.j

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
j: Includes each distinct dispute (i.e., multiple drugs) contained in one coverage determination request as a separate coverage
determination request.

2.e
2.e

RSC-6.j
RSC-6.k

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
k: Includes adverse coverage determination cases that were forwarded to the IRE because the organization made an untimely
decision.

2.e
2.e

RSC-6.k
RSC-6.l

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
l: Includes all coverage determination decisions that relate to Part B versus Part D coverage (drugs covered under Part B are
considered adverse decisions under Part D).

2.e
2.e

RSC-6.l
RSC-6.m

i. Point of Sale (POS) claims adjudications (e.g., a rejected claim for a drug indicating a B vs. D prior authorization (PA) is
required) are not included unless the plan subsequently processed a coverage determination.
No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
m: Includes Direct Member Reimbursements (DMRs) part of the total number of exceptions if the plan processed the request
under the tiering or formulary exceptions process. Verify that all DMRs regardless of request disposition type that were
processed under the tiering or formulary exception process should be included in the count of the total number of coverage
determination decisions made in the reporting period.

2.e

RSC-6.m

No data

2.e

RSC-6.n

RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:

Data Elements 1.G, 1.K, 1.O Review Results:
Data Sources:

n: Excludes coverage determinations (including exceptions) regarding drugs assigned to an excluded drug category.

2.e

RSC-6.n

No data

Data Element 1.A

Review Results:

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-6.o

Standard/Sub-standard Description

Data Element

RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

Data Sources:

*

Review Results:
Data Sources:

*

Review Results:
Data Sources:

*

o: Excludes members who have Utilization Management (UM) requirements waived based on an exception decision made in a
previous plan year or reporting period.
2.e
2.e

RSC-6.o
RSC-6.p

No data
Data Element 1.A
RSC-6: Organization accurately calculates the number of coverage determinations (Part D only) decisions made in the reporting No data
period, including the following criteria:
p: Confirm that a coverage determination was denied for lack of medical necessity based on review by a physician or other
appropriate health care professional.

2.e
2.e

RSC-6.p
RSC-7.a

No data
RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

Data Element 1.A
No data

a: Includes all decisions made (fully favorable, partially favorable, and adverse) with a date of decision that occurs during the
reporting period. Date of the final decision is based on the date the enrollee/enrollee’s representative is notified in writing of
the exception decision.
2.e

RSC-7.a

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.b

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

*

b: Includes all methods of receipt (e.g., telephone, letter, fax, in person).

2.e

RSC-7.b

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.c

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

*

c: Includes exception requests that were forwarded to the Independent Review Entity (IRE) because the organization failed to
make a timely decision.
2.e

RSC-7.c

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.d

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

*

d: Includes requests for exceptions from delegated entities.

2.e

RSC-7.d

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.e

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

*

e: Includes both standard and expedited exceptions.

2.e

RSC-7.e

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.f

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

*

f: Excludes requests for exemptions that are withdrawn or dismissed.

2.e

RSC-7.f

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.g

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

g: Excludes requests for exceptions regarding drugs assigned to an excluded drug category.

Data Sources:

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

Standard/Sub-standard Description

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

2.e

RSC-7.g

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-7.h

RSC-7: Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the
reporting period, including the following criteria:

No data

Data Sources:

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

*

h: Excludes members who have utilization management requirements waived based on an exception decision made in a
previous plan year or reporting period.
2.e

RSC-7.h

No data

Data Elements 1.G, 1.K, 1.O Review Results:

2.e

RSC-8.a

RSC-8: Organization accurately calculates the number of coverage determinations decisions made by final decision, including
the following criteria:

No data

Data Sources:

*

Data Element 1.D
Data Element 1.E
Data Element 1.F
No data

Review Results:
Review Results:
Review Results:
Data Sources:

*

Data Element 1.D
Data Element 1.E
Data Element 1.F
No data

Review Results:
Review Results:
Review Results:
Data Sources:

*

No data
Data Element 1.B
No data
Data Element 1.C
RSC-9: Organization accurately calculates the number of coverage determinations that were withdrawn or dismissed, including No data
the following criteria:

Review Results:
Review Results:
Data Sources:

*

Data Element 1.B
Data Element 1.C
No data

Review Results:
Review Results:
Data Sources:

*

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

a: Properly categorizes the number of coverage determinations (excluding exceptions) by final decision: fully favorable, partially
favorable, or adverse. Verify that all cases included in the count for the total number of processed coverage determinations
made in the reporting period are identified as one of the accepted disposition types.
2.e
2.e
2.e
2.e

RSC-8.a
RSC-8.a
RSC-8.a
RSC-8.b

No data
No data
No data
RSC-8: Organization accurately calculates the number of coverage determination decisions made by final decision, including the
following criteria:
b: Includes untimely coverage determination decisions, regardless if they were auto-forwarded to the IRE.

2.e
2.e
2.e
2.e

RSC-8.b
RSC-8.b
RSC-8.b
RSC-9.a

No data
No data
No data
RSC-9: Organization accurately calculates the number of coverage determinations that were withdrawn or dismissed, including
the following criteria:
a: Includes all withdrawals and dismissals on requests for coverage determinations (including exceptions). This includes
expedited coverage determinations and exceptions that were withdrawn or dismissed for any reason.

2.e
2.e
2.e

RSC-9.a
RSC-9.a
RSC-9.b

b: Includes dismissals that are made where the procedural requirements for a valid request are not met within the stipulated
timeframe. The plan should issue a dismissal only when the required documentation was not received within a reasonable
amount of time.
2.e
2.e
2.e

RSC-9.b
RSC-9.b
RSC-10.a

No data
No data
RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:
a: Includes all redetermination final decisions for Part D drugs with a date of final decision that occurs during the reporting
period. Date of the final decision is based on the date the enrollee/enrollee’s representative is notified in writing of the
redetermination decision.

2.e

RSC-10.a

No data

2.e

RSC-10.b

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

b: Includes all redetermination decisions, including fully favorable, partially favorable, and adverse decisions.

2.e

RSC-10.b

No data

2.e

RSC-10.c

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:
c: Includes redetermination requests that were forwarded to the IRE because the organization failed to make a timely decision.

Data Sources:

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

Standard/Sub-standard Description

2.e

RSC-10.c

No data

2.e

RSC-10.d

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S

Review Results:

Data Sources:

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

*

d: Includes both standard and expedited redeterminations.

2.e

RSC-10.d

No data

2.e

RSC-10.e

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

e: Includes At-risk determination appeals (beneficiary-specific Point of Sale (POS) edit, prescriber or pharmacy coverage
limitation appeals, sharing information for subsequent Part D enrollments) made under a drug management program
redeterminations.
2.e

RSC-10.e

No data

2.e

RSC-10.f

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

f: Includes all methods of receipt (e.g., telephone, letter, fax, in-person).

2.e

RSC-10.f

No data

2.e

RSC-10.g

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

g: Includes all redeterminations regardless of who filed the request (e.g., member, appointed representative, or prescribing
physician).

2.e

RSC-10.g

No data

2.e

RSC-10.h

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

h: Includes Direct Member Reimbursements (DMRs) part of the total number of redeterminations if the plan processed the
request under the tiering or formulary exceptions process.

2.e

RSC-10.h

No data

2.e

RSC-10.i

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

i: Includes all redetermination decisions that relate to Part B versus Part D coverage (drugs covered under Part B are considered
adverse decisions under Part D).
a. 	
Point of Sale (POS) claims adjudications (e.g., a rejected claim for a drug indicating a B vs. D PA is required) are not included
unless the plan subsequently processed a redetermination.
2.e

RSC-10.i

No data

2.e

RSC-10.j

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

j: Includes each distinct dispute contained in one redetermination request (i.e., multiple drugs), as a separate redetermination
request.

2.e

RSC-10.j

No data

2.e

RSC-10.k

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

k: Excludes dismissals and withdrawals.

2.e

RSC-10.k

No data

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-10.l

Standard/Sub-standard Description
RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

No data

Data Sources:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Data Elements 2.A, 2.G,
2.K, 2.O, 2.S
No data

Review Results:

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.
*

l: Excludes IRE decisions.

2.e

RSC-10.l

No data

2.e

RSC-10.m

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

m: Excludes redeterminations regarding excluded drugs.

2.e

RSC-10.m

No data

2.e

RSC-10.n

RSC-10: Organization accurately calculates the total number of redeterminations (Part D only), including the following criteria:

Data Sources:

*

n: Limits reporting to just the redetermination level.

2.e

RSC-10.n

No data

2.e

RSC-11.a

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

Data Sources:

*

a. Includes all decisions made (fully favorable, partially favorable, and adverse) with a date of decision that occurs during the
reporting period. Date of the final decision is based on the date the enrollee/enrollee’s representative is notified in writing of
the exception redetermination decision.
2.e

RSC-11.a

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-11.b

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

No data

Data Sources:

*

b.Includes all methods of receipt (e.g., telephone, letter, fax, in-person).

2.e

RSC-11.b

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-11.c

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

No data

Data Sources:

*

c. Includes exception redetermination requests that were forwarded to the IRE because the organization failed to make a
timely decision.
2.e

RSC-11.c

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-11.d

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

No data

Data Sources:

*

d. Includes requests for exception redeterminations from delegated entities.

2.e

RSC-11.d

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-11.e

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

No data

Data Sources:

e.Includes both standard and expedited exception redeterminations.

2.e

RSC-11.e

No data

Data Elements 2.G, 2.K, 2.O Review Results:

*

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-11.f

Standard/Sub-standard Description
RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

Data Element
No data

Data Sources and Review Results:
Enter review results and/or data
sources
Data Sources:

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.
*

f. Excludes requests for exception redeterminations that are withdrawn or dismissed.

2.e

RSC-11.f

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-11.g

RSC-11: Organization accurately calculates the total number of UM, Formulary, and Tier exception redetermination decisions
made in the reporting period, including the following criteria:

No data

Data Sources:

*

g. Excludes requests for exception redeterminations regarding drugs assigned to an excluded drug category.

2.e

RSC-11.g

No data

Data Elements 2.G, 2.K, 2.O Review Results:

2.e

RSC-12.a

RSC-12: Organization accurately calculates the number of redeterminations by final decision, including the following criteria:

No data

Data Sources:

*

a: Properly categorizes the total number of redeterminations by final decision, including the following criteria: fully favorable
(e.g., fully favorable decision reversing the original coverage determination), partially favorable (e.g., denial with a “part” that
has been approved), and adverse (e.g., the original coverage determination decision was upheld).
2.e

RSC-12.a

No data

Data Elements 2.D─2.F

Review Results:

2.e

RSC-12.b

RSC-12: Organization accurately calculates the number of redeterminations by final decision, including the following criteria:

No data

Data Sources:

*

b: Excludes redetermination decisions made by the IRE.

2.e

RSC-12.b

No data

Data Elements 2.D─2.F

Review Results:

2.e

RSC-13.a

RSC-13: Organization accurately calculates the number of redeterminations that were withdrawn or dismissed, including the
following criteria:

No data

Data Sources:

*

Data Element 2.B
Data Element 2.C
No data

Review Results:
Review Results:
Data Sources:

*

Data Element 2.C
No data

Review Results:
Data Sources:

*

Data Element 3.A
No data

Review Results:
Data Sources:

*

Data Element 3.B.1
No data

Review Results:
Data Sources:

*

a: Includes all withdrawals and dismissals on requests for redeterminations.

2.e
2.e
2.e

RSC-13.a
RSC-13.a
RSC-13.b

No data
No data
RSC-13: Organization accurately calculates the number of redeterminations that were withdrawn or dismissed, including the
following criteria:
b: Includes dismissals that are made when the procedural requirements for a valid request are not met within the stipulated
timeframe. The plan should issue a dismissal only when the required documentation has not been received within a reasonable
amount of time.

2.e
2.e

RSC-13.b
RSC-14.a

No data
RSC-14: Organization accurately calculates the total number of reopened decisions according to the following criteria:
a: Includes a remedial action taken to change a final determination or decision even though the determination or decision was
correct based on the evidence of record.

2.e
2.e

RSC-14.a
RSC-15.a

No data
RSC-15: Organization accurately reports the following information for each reopened case.
a: Contract Number

2.e
2.e

RSC-15.a
RSC-15.b

No data
RSC-15: Organization accurately reports the following information for each reopened case.
b: Plan ID

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e
2.e

RSC-15.b
RSC-15.c

Standard/Sub-standard Description
No data
RSC-15: Organization accurately reports the following information for each reopened case.

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

Data Element 3.B.2
No data

Review Results:
Data Sources:

*

Data Element 3.B.3
No data

Review Results:
Data Sources:

*

Data Element 3.B.4
No data

Review Results:
Data Sources:

*

Data Element 3.B.5
No data

Review Results:
Data Sources:

*

Data Element 3.B.6
No data

Review Results:
Data Sources:

*

Data Element 3.B.7
No data

Review Results:
Data Sources:

*

Data Element 3.B.8
No data

Review Results:
Data Sources:

*

Data Element 3.B.9
No data

Review Results:
Data Sources:

*

Data Element 3.B.10
No data

Review Results:
Data Sources:

*

Data Element 3.B.11

Review Results:

c: Case ID

2.e
2.e

RSC-15.c
RSC-15.d

No data
RSC-14: Organization accurately reports the following information for each reopened case.
d: Case level (Coverage Determination or Redetermination)

2.e
2.e

RSC-15.d
RSC-15.e

No data
RSC-15: Organization accurately reports the following information for each reopened case.
e: Date of original disposition

2.e
2.e

RSC-15.e
RSC-15.f

No data
RSC-15: Organization accurately reports the following information for each reopened case.
f: Original disposition (Fully Favorable; Partially Favorable; or Adverse)

2.e
2.e

RSC-15.f
RSC-15.g

No data
RSC-15: Organization accurately reports the following information for each reopened case.
g: Was case processed under expedited timeframe (Y/N)

2.e
2.e

RSC-15.g
RSC-15.h

No data
RSC-15: Organization accurately reports the following information for each reopened case.
h: Case type (Pre-Service; Payment)

2.e
2.e

RSC-15.h
RSC-15.i

No data
RSC-15: Organization accurately reports the following information for each reopened case.
i: Date case was reopened

2.e
2.e

RSC-15.i
RSC-15.j

No data
RSC-15: Organization accurately reports the following information for each reopened case.
j: Reason (s) for reopening (Clerical Error, Other Error, New and Material Evidence, Fraud or Similar Fault, or Other)

2.e
2.e

RSC-15.j
RSC-15.k

No data
RSC-15: Organization accurately reports the following information for each reopened case.
k: Date of reopening disposition (revised decision)

2.e

RSC-15.k

No data

Standard/Sub-standard ID

Reporting
Section Criteria
ID

2.e

RSC-15.l

Standard/Sub-standard Description
RSC-15: Organization accurately reports the following information for each reopened case.

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.

No data

Data Sources:

*

*

l: Reopening disposition (Fully Favorable; Partially Favorable; Adverse, or Pending)

2.e
3

RSC-15.l
No data

No data
Organization implements policies and procedures for data submission, including the following:

Data Element 3.B.12
No data

Review Results:
Data Sources:

3.a

No data

Data elements are accurately uploaded into CMS systems and entries match corresponding source documents.

Data Element 1.A

Review Results:

3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a
3.a

No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data

No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data
No data

Data Element 1.B
Data Element 1.C
Data Element 1.D
Data Element 1.E
Data Element 1.F
Data Element 1.G
Data Element 1.H
Data Element 1.I
Data Element 1.J
Data Element 1.K
Data Element 1.L
Data Element 1.M
Data Element 1.N
Data Element 1.O
Data Element 1.P
Data Element 1.Q
Data Element 1.R
Data Element 2.A
Data Element 2.B
Data Element 2.C
Data Element 2.D
Data Element 2.E
Data Element 2.F
Data Element 2.G
Data Element 2.H
Data Element 2.I
Data Element 2.J
Data Element 2.K
Data Element 2.L
Data Element 2.M
Data Element 2.N
Data Element 2.O
Data Element 2.P
Data Element 2.Q
Data Element 2.R
Data Element 2.S
Data Element 2.T
Data Element 2.U
Data Element 2.V
Data Element 3.A
Data Element 3.B.1
Data Element 3.B.2
Data Element 3.B.3
Data Element 3.B.4
Data Element 3.B.5
Data Element 3.B.6
Data Element 3.B.7
Data Element 3.B.8
Data Element 3.B.9

Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:
Review Results:

Standard/Sub-standard ID

Reporting
Section Criteria
ID

Standard/Sub-standard Description

Data Element

Data Sources and Review Results:
Enter review results and/or data
sources

3.a
3.a
3.a
3.b

No data
No data
No data
No data

No data
No data
No data
All source, intermediate, and final stage data sets and other outputs relied upon to enter data into HPMS are archived.

Data Element 3.B.10
Data Element 3.B.11
Data Element 3.B.12
No data

Review Results:
Review Results:
Review Results:
Review Results:

4

No data

Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).

No data

Review Results:

5

No data

Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster recovery
plan).

No data

Review Results:

6

No data

If organization’s data systems underwent any changes during the reporting period (e.g., because of a merger, acquisition, or
upgrade): Organization provided documentation on the data system changes and, upon review, there were no issues that
adversely impacted data reported.

No data

Review Results:

7

No data

If data collection and/or reporting for this reporting section is delegated to another entity; Organization regularly monitors the No data
quality and timeliness of the data collected and/or reported by the delegated entity or first tier/ downstream contractor.

Review Results:

Enter 'Findings' using the applicable choice in the
appropriate cells. Cells marked with an '*' should
not be edited.


File Typeapplication/pdf
File TitleMedicare Part C and Part Reporting Requirements Data Validation Procedure Manual Appendix J_FDCF_CDR
SubjectData Validation Procedure Manual
AuthorCenters for Medicare and Medicaid Services
File Modified2022-10-14
File Created2022-10-14

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