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Data Validation Procedure Manual
Appendix B: Data Validation Standards
For Data Validation Occurring in 2022
Prepared by:
Centers for Medicare & Medicaid Services
Center for Medicare
Medicare Drug Benefit and C & D Data Group
Last Updated: September 2021
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Appendix B: Data Validation Standards
Table of Contents
1. OVERVIEW ............................................................................................................................................................................1
2. PART C DATA VALIDATION STANDARDS .........................................................................................................................2
GRIEVANCES (PART C) ........................................................................................................................................................2
ORGANIZATION DETERMINATIONS/RECONSIDERATIONS .............................................................................................5
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT ......................................................................................................9
3. PART D DATA VALIDATION STANDARDS .......................................................................................................................14
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS .........................................................................................14
GRIEVANCES (PART D) ......................................................................................................................................................19
COVERAGE DETERMINATIONS AND REDETERMINATIONS ..........................................................................................22
IMPROVING DRUG UTILIZATION REVIEW CONTROLS ...................................................................................................27
Appendix: Acronyms .........................................................................................................................................................34
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Appendix B: Data Validation Standards
1. OVERVIEW
The Data Validation Standards include general standards and reporting section criteria that the data validation
contractor must use to determine whether the organization’s data reported to CMS per the Part C/Part D Reporting
Requirements are accurate, valid, and reliable. Each reporting section’s Data Validation Standards include identical
instructions relating to the types of information that will be reviewed, a set of validation standards (identical for each
reporting section), and reporting section criteria that are based on the applicable Part C/Part D Reporting Requirements
and Technical Specifications.
The DV contractor must use these standards in conjunction with the Data Extraction and Sampling Instructions and the
Excel-version of the Findings Data Collection Form (FDCF) to upload into the Health Plan Management System Plan
Reporting Data Validation Module in order to evaluate the organization’s processes for producing and submitting the
reporting sections. It is strongly recommended that the DV contractor and report owner/data provider review the Data
Validation Standards documentation before and during the review of a reporting section to ensure that all applicable
data fields are extracted for each reporting section.
For the Part C reporting sections, the Medicare Part C Plan Reporting Requirements Document is used as the basis for
the data validation standards. For the Part D reporting sections, the Medicare Part D Plan Reporting Requirements
Document is used as the basis for the data validation standard.
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Appendix B: Data Validation Standards
2. PART C DATA VALIDATION STANDARDS
GRIEVANCES (PART C)
(for 2021 REPORTED DATA)
To determine compliance with the standards for Grievances (Part C), the data validation contractor will assess the
following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. 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).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data.
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements, and Technical
Specifications.
e. The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges
of data fields 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.
3
4
5
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately entered / uploaded into CMS systems and entries match corresponding source
documents. [Data Elements A – E]
b. All sources, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems
are archived.
Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).
Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster
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Appendix B: Data Validation Standards
GRIEVANCES (PART C)
(for 2021 REPORTED DATA)
6
7
recovery plan).
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.
If data collection and/or reporting for this reporting section is delegated to another entity: Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
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2
3
4
5
6
Organization reports data based on the periods of 1/1 through 3/31, 4/1 through 6/30, 7/1 through 9/30, and 10/1 through
12/31.
Organization properly assigns data to the applicable CMS contract.
Organization meets deadlines for reporting data to CMS by 2/7/2022.
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 each 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 resubmission 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.
Organization properly defines the term “Grievance” in accordance with 42 CFR §422.564 and the Parts C & D Enrollee
Grievances, Organization/Coverage Determinations and Appeals Manual. This includes applying all relevant guidance
properly when performing its calculations.
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
a. Number of total grievances in which timely notification was given (Data Element B) does not exceed number of
total grievances (Data Element A).
b. Number of expedited grievances in which timely notification was given (Data Element D) does not exceed number
of total grievances in which timely notification was given (Data Element B).
c. Number of expedited grievances (Data Element C) does not exceed total grievances (Data Element A).
d. Number of expedited grievances in which timely notification was given (Data Element D) does not exceed total
expedited grievances (Data Element C).
e. Number of dismissed grievances (Data Element E) are excluded from the total.
f. If the organization received a CMS outlier/data integrity notice, validate whether or not an internal
procedure change was warranted or resubmission through HPMS. (Data Elements A - E)
[Data Elements A – E]
Organization accurately calculates the total number of grievances, including the following criteria:
a. Includes all grievances that were completed (i.e., organization has notified member of its decision) during the
reporting period, regardless of when the grievance was received.
b. Includes all grievances reported by or on behalf of members who were previously eligible, regardless of whether
the member was eligible on the date that the grievance was reported to the organization.
c. If a grievance contains multiple issues filed under a single complainant, each issue is calculated as a separate
grievance.
d. If a member files a grievance and then files a subsequent grievance on the same issue prior to the organization’s
decision or the deadline for decision notification (whichever is earlier), then the issue is counted as one grievance.
e. If a member files a grievance and then files a subsequent grievance on the same issue after the organization’s
decision or deadline for decision notification (whichever is earlier), then the issue is counted as a separate
grievance.
f. Includes all methods of grievance receipt (e.g., telephone, letter, fax, and in-person).
g. Includes all grievances regardless of who filed the grievance (e.g., member or appointed representative)
h. Includes only grievances that are filed directly with the organization (e.g., excludes all complaints that are only
forwarded to the organization from the CMS Complaint Tracking Module (CTM) and not filed directly with the
organization). If a member files the same complaint both directly with the organization and via the CTM, the
organization includes only the grievance that was filed directly with the organization and excludes the identical
CTM complaint.
i. For MA-PD contracts: Includes only grievances that apply to the Part C benefit (If a clear distinction cannot be
made for an MA-PD, cases are reported as Part C grievances).
j. Excludes withdrawn grievances.
[Data Elements A – E]
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Appendix B: Data Validation Standards
GRIEVANCES (PART C)
(for 2021 REPORTED DATA)
7
Organization accurately calculates the number of grievances for which it provided timely notification of the decision,
including the following criteria:
a. Includes only grievances for which the member is notified of decision according to the following timelines:
i. For standard grievances: no later than 30 days after receipt of grievance.
ii. For standard grievances with an extension taken: no later than 44 days after receipt of grievance.
iii. For expedited grievances: no later than 24 hours after receipt of grievance.
[Data Element B]
4
Appendix B: Data Validation Standards
ORGANIZATION DETERMINATIONS / RECONSIDERATIONS
(for 2021 REPORTED DATA)
To determine compliance with the standards for Organization Determinations/Reconsiderations, the data validation contractor
will assess the following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
3
4
5
6
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. 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).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data (e.g., quarterly).
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and Technical
Specifications.
e. The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified;
ranges of data fields 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.
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately entered/uploaded into CMS systems and entries match corresponding source
documents. [Subsection #1, Data Elements A – G, Subsection #2, Data Elements I – L, Subsection #3, Data
Elements A – G, Subsection #4, Data Elements I – L, Subsection #5, Data Elements A – B, E – O]
b. All source, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems
are archived.
Organization implements policies and procedures for periodic data system updates (e.g., changes in
enrollment, provider/pharmacy status, and claims adjustments).
Organization implements policies and procedures for archiving and restoring data in each data system (e.g.,
disaster recovery plan).
If organization’s data systems underwent any changes during the reporting period (e.g., because of a merger,
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Appendix B: Data Validation Standards
ORGANIZATION DETERMINATIONS / RECONSIDERATIONS
(for 2021 REPORTED DATA)
7
acquisition, or upgrade): Organization provided documentation on the data system changes and, upon review, there were
no issues that adversely impacted data reported.
If data collection and/or reporting for this reporting section is delegated to another entity: Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream
contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
2
3
4
5
6
Organization reports data based on the periods of 1/1 through 3/31, 4/1 through 6/30, 7/1 through 9/30, and 10/1 through
12/31.
Organization properly assigns data to the applicable CMS contract.
Organization meets deadlines for reporting data to CMS by 02/28/2022.
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 each 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 resubmission 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.
Organization properly defines the term “Organization Determinations” in accordance with 42 C.F.R. Part 422, Subpart M,
and the Parts C & D Enrollee Grievances, Organization/Coverage Determinations and Appeals Manual. This includes
applying all relevant guidance properly when performing its calculations and categorizations.
Organization properly defines the term “Reconsideration” in accordance with 42 C.F.R. Part 422, Subpart M, and the
Parts C & D Enrollee Grievances, Organization/Coverage Determinations and Appeals Manual. This includes applying all
relevant guidance properly when performing its calculations and categorizations.
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
a. The total number of organization determinations (Subsection #1, Data Element A) is equal to sum of organization
determinations by outcome (Subsection #2, Data Elements A-L).
b. The total number of reconsiderations (Subsection#3, Data Element A) is equal to sum of reconsiderations by
outcome (Subsection #4, Data Elements A-L).
c. The total number of reopened decisions (Subsection #5, Data Element A) is equal to the number of records
reported in the data file with a disposition of reopened.
d. The date each case was reopened (Subsection #5, Data Element K) is after the date of its original disposition
(Subsection #5 Data Element F).
e. The date of disposition for each reopening (Subsection #5, Data Element N) is after the date of the original
disposition (Subsection #5, Data Element F).
f. The date of disposition for each reopening (Subsection #5, Data Element N) is after the date the case was
reopened (Subsection #5, Data Element K).
g. The date of disposition of each reopening (Subsection #5, Data Element N) is within the reporting quarter.
h. Verify that there is a valid value submitted for date of original disposition as MM/DD/YYYY format (Subsection #5,
Data Element F).
i. Verify that there is a valid value submitted for case level (Organization Determination or Reconsideration)
(Subsection #5, Data Element E).
j. Verify that there is a valid value submitted for reopening disposition (Fully Favorable; Partially Favorable; Adverse
or Pending) (Subsection #5, Data Element O).
k. If the organization received a CMS outlier/data integrity notice validate whether or not an internal procedure
change was warranted or resubmission through HPMS (Subsection #1, Data Elements A-G; Subsection #2, Data
Elements A-L; Subsection #3, Data Elements A-G; Subsection #4, Data Elements A-L; Subsection #5, Data
Elements A, E, F, G, N, and O).
Organization accurately calculates the total number of organization determinations, including the following criteria:
a. Includes all completed organization determinations (Part C only) for services requested by an
enrollee/representative, a provider on behalf of the enrollee, or a non-contract provider, and all organization
determinations for claims submitted by enrollee/representative or non-contract provider with a date of member
notification of the final decision that occurs during the reporting period, regardless of when the request for
organization determination was received.
b. Includes adjudicated claims with a date of adjudication that occurs during the reporting period.
c. Includes all claims submitted for payment including those that pass through the adjudication system that may
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Appendix B: Data Validation Standards
ORGANIZATION DETERMINATIONS / RECONSIDERATIONS
(for 2021 REPORTED DATA)
not require determination by the staff of the organization or its delegated entity.
Includes decisions made on behalf of the organization by a delegated entity.
Includes organization determinations that are filed directly with the organization or its delegated entities for
services requested by an enrollee/representative, or a provider on behalf of the enrollee, or non-contract provider,
and claims submitted either by an enrollee/representative or non-contract provider. If a member requests an
organization determination directly with the organization and files an identical complaint via the CTM, the
organization includes only the organization determination that was filed directly with the organization and
excludes the identical CTM complaint.
f. Includes all methods of organization determination request receipt (e.g., telephone, letter, fax, and in-person).
g. Includes all organization determinations for services requested by an enrollee/representative, or provider
on behalf of the enrollee, or non-contract provider, and claims submitted by either enrollee/representative
or non-contract provider.
h. Includes supplement benefits (i.e., non- Medicare covered item or service) provided as part of a plan’s
Medicare benefit package.
i. Excludes dismissals and withdrawals.
j. Excludes Independent Review Entity Decisions.
k. Excludes Quality Improvement Organization (QIO) reviews of a member’s request to continue Medicarecovered services (e.g., a SNF stay).
l. Excludes duplicate payment requests concerning the same service or item.
m. Excludes payment requests returned to an enrollee/representative or non-contract provider in which a
substantive decision (fully favorable, partially favorable or adverse) has not yet been made due to error (e.g.,
payment requests or forms that are incomplete, invalid or do not meet the requirements for a Medicare claim).
d.
e.
7
8
9
10
11
[Subsection #1, Data Elements A, D-G, and Subsection #2, Data Elements I-L]
Organization accurately calculates the number of organization determinations, including the following criteria:
a. Includes all service organization determinations requested by enrollee/representative, provider on behalf of
enrollee, or non-contract provider (Subsection #1, Data Elements D and F).
b. Includes all payment (claim) organization determinations submitted by enrollee/representative or non-contract
provider (Subsection #1, Data Elements E and G).
Organization accurately calculates the number of adverse (e.g., denial of entire request resulting in no coverage of
the item or service) organization determinations, including the criteria below. All non-adverse organization
determinations must be either partially or fully favorable organization determinations:
a. Includes all adverse service organization determinations requested by enrollee/representative, a provider on
behalf of the enrollee, or non-contract provider (Subsection #2, Data Elements I and J).
b. Includes all adverse payment (claim) organization determinations submitted by enrollee/representative or
non-contract provider that result in zero payment (Subsection #2 Data Elements K and L).
Organization accurately calculates “Withdrawn Organization Determination” according to the following criteria:
a. Includes an organization determination that is withdrawn upon the enrollee’s request, the enrollee
representative's request, or the enrollee provider's request but excludes appeals that the organization
forwards to the IRE for dismissal (Subsection #1, Data Element B).
Organization accurately calculates “Organization Determinations - Dismissals” according to the following criteria:
a. Includes dismissals that were processed in accordance with the Parts C & D Enrollee Grievances,
Organization/Coverage Determinations and Appeals Manual (Subsection #1, Data element C).
Organization accurately calculates the total number of reconsiderations, including the following criteria:
a. Includes all completed reconsiderations (Part C only) both for services requested by an
enrollee/representative, or provider on behalf of the enrollee, or non-contract provider, and claims submitted
either by enrollee/representative or non-contract provider with a date of member notification of the final
decision that occurs during the reporting period, regardless of when the request for reconsideration was
received.
b. Includes decisions made on behalf of the organization by a delegated entity.
c. Includes all methods of reconsideration request receipt (e.g., telephone, letter, fax, and in-person).
d. Includes all reconsiderations for services requested by an enrollee/representative, or provider on behalf of
the enrollee, or non-contract provider, and claims submitted either by enrollee/representative or non-contract
provider.
e. Includes reconsiderations that are filed directly with the organization or its delegated entities for services
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Appendix B: Data Validation Standards
ORGANIZATION DETERMINATIONS / RECONSIDERATIONS
(for 2021 REPORTED DATA)
f.
g.
h.
i.
j.
k.
12
13
14
15
16
requested by an enrollee/representative, or provider on behalf of the enrollee, or non-contract provider, and
claims submitted either by enrollee/representative or non-contract provider. If a member requests a
reconsideration directly with the organization and files an identical complaint via the CTM, the organization
includes only the reconsideration that was filed directly with the organization and excludes the identical CTM
complaint.
Includes supplemental benefits (i.e., non- Medicare covered item or service) provided as a part of a plan’s
Medicare benefit package.
Excludes dismissals and withdrawals.
Excludes Independent Review Entity Decisions.
Excludes QIO reviews of a member’s request to continue Medicare-covered services (e.g., a SNF stay).
Excludes duplicate payment requests concerning the same service or item.
Excludes payment requests returned to an enrollee/representative or non-contract provider in which a
substantive decision (Fully Favorable, Partially Favorable or Adverse) has not yet been made due to error
(e.g., payment requests or forms that are incomplete, invalid or do not meet the requirements for a Medicare
claim).
[Subsection #3 Data Elements A, D-G and Subsection #4 Data Elements I-L]
Organization accurately calculates the number of adverse (e.g., denial of entire request resulting in no coverage of
the item or service) reconsiderations, including the criteria below. All non-adverse organization reconsiderations
must be either partially or fully favorable organization determinations:
a. Includes all adverse service reconsideration determinations requested by enrollee/representative, or provider
on behalf of the enrollee, or non-contract provider (Subsection #4, Data Elements I and J).
b. Includes all adverse payment (claim) reconsideration determinations submitted by enrollee/representative or
non-contract provider that result in zero payment being made (Subsection #4, Data Elements K and L).
c. For instances when a reconsideration request for payment is submitted to an organization concerning an
item or service, and the organization has already made an adverse service reconsideration determination,
includes the reconsideration request for payment for the same item or service as another, separate, adverse
reconsideration determination (Subsection #4, Data Elements I-L).
Organization accurately calculates “Withdrawn Reconsiderations” according to the following criteria:
a. Includes a Reconsideration that is withdrawn upon the enrollee’s request, the enrollee representative’s
request, or the enrollee provider's request (Subsection #3, Data Element B).
Organization accurately calculates “Reconsiderations Dismissals” according to the following criteria:
a. Includes reconsiderations dismissals that were processed in accordance with the Parts C & D Enrollee
Grievances, Organization/Coverage Determinations and Appeals Manual (Subsection #3, Data Element
C).
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 (Subsection #5, Data Element A).
Organization accurately reports the following information for each reopened case.
a. Contract Number
b. Date of original disposition
c. Original disposition (Fully Favorable; Partially Favorable; or Adverse)
d. Case Level (Organization Determination or Reconsideration)
e. Date case was reopened
f. Reason (s) for reopening (Clerical Error, Other Error, New and Material Evidence, Fraud or Similar Fault, or
Other)
g. Date of reopening disposition (revised decision)
h. Reopening disposition (Fully Favorable; Partially Favorable; Adverse or Pending)
[Subsection #5, Data Elements B, E, F, G, K, L, N, and O]
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Appendix B: Data Validation Standards
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT
(for 2021 REPORTED DATA)
To determine compliance with the standards for Special Needs Plans (SNPs) Care Management, the data validation contractor
will assess the following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
3
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. 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).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data (e.g., quarterly).
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and Technical
Specifications.
e. The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges
of data fields 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.
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately entered / uploaded into CMS systems and entries match corresponding source
documents. [Data Elements A – H]
b. All source, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems
are archived.
4
Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).
5
Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster
recovery plan).
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Appendix B: Data Validation Standards
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT
(for 2021 REPORTED DATA)
6
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.
7
If data collection and/or reporting for this reporting section is delegated to another entity: Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
Organization reports data based on the required reporting period of 1/1 through 12/31.
2
Organization properly assigns data to the applicable CMS plan benefit package.
3
4
5
Organization meets deadline for reporting annual data to CMS by 2/28/2022.
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 submission 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 resubmission 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.
Organization properly defines the term Health Risk Assessment (HRA) as defined in 42 CFR § 422.101 (f). This includes
applying all relevant guidance properly when performing its HRA.
Organization accurately calculates the number of new members who are eligible for an initial health risk assessment (HRA),
including the following criteria:
a. Includes all new members who enrolled during the measurement year. Includes those members who have an
effective enrollment date that falls within the measurement year, and are continuously enrolled for at least 90
days during the measurement year. These members will be considered eligible for an initial HRA for the year in
which the effective enrollment date falls.
b. Includes members who have an effective enrollment date that falls within the measurement year, are
continuously enrolled for fewer than 90 days, and complete an initial HRA.
c. Includes members who have an effective enrollment date that falls in the previous measurement year, but a 90day deadline for initial HRA completion that falls in this measurement year, if no initial HRA was completed in the
previous measurement year.
d. Includes members who have enrolled in the plan after dis-enrolling from another plan (different sponsor or
organization).
e. Includes members who dis-enrolled from and re-enrolled into the same plan if an initial HRA was not performed
prior to dis-enrollment and calculates the member’s eligibility date starting from the date of re-enrollment.
f. Excludes continuously enrolled members with a documented initial HRA that occurred under the plan during the
previous year. These members, and their HRAs, should be counted as new in the previous year.
g. Excludes members who received an initial HRA but were subsequently deemed ineligible because they were
never enrolled in the plan.
h. Excludes members who disenroll from the plan prior to the effective enrollment date or within the first 90 days
after the effective enrollment date, if an initial HRA was not completed prior to disenrolling.
i. Excludes enrollees who receive an initial or reassessment HRA and remain continuously enrolled under a MAO
whose contract was part of a consolidation of merger under the same legal entity during the member’s
continuous enrollment, where the consolidated SNP is still under the same Model of Care (MOC) as the
enrollee’s previous SNP.
[Data Element A]
10
Appendix B: Data Validation Standards
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT
6
7
(for 2021 REPORTED DATA)
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
a. The number of initial HRAs performed on new enrollees (Data Element C) does not exceed the number of new
enrollees (Data Element A).
b. The number of annual re-assessments performed (Data Element F) does not exceed number of enrollees eligible
for annual HRA (Data Element B).
c. Number of initial HRAs refusals (Data Element D) does not exceed number of new enrollees (Data Element A).
d. Number of annual reassessment refusals (Data Element G) does not exceed the number of enrollees eligible for an
annual reassessment HRA (Data Element B).
e. Number of initial HRAs where SNP is unable to reach enrollees (Data Element E) does not exceed number of new
enrollees (Data Element A).
f. Number of annual reassessments where SNP is unable to reach enrollee (Data Element H) does not exceed
number of enrollees eligible for annual HRA (Data Element B).
g. If the organization received a CMS outlier/data integrity notice, validate whether or not an internal procedure
change was warranted or resubmission through HPMS. (Data Element A-H)
[Data Elements A-H]
Organization accurately calculates the number of members eligible for an annual health risk reassessment during the
reporting period, including the following criteria:
a. Includes members who remained continuously enrolled in the same plan for 365 days, starting from their initial
enrollment date if no initial HRA had been performed, or from the date of their previous HRA.
b. Includes members who received a reassessment during the measurement year within 365 days after their last
HRA.
c. Includes new enrollees who missed both the deadline to complete an initial HRA and the deadline to complete a
reassessment HRA, and are enrolled for all 365 days of the measurement year.
d. Includes new enrollees who missed an initial HRA, but completed a reassessment HRA by the 365-day deadline
(even if the enrollee was covered for fewer than 365 days).
e. Includes members who dis-enrolled from and re-enrolled into the same plan if an initial HRA was performed
within 90 days of re-enrollment and the member has continuously enrolled in the same plan for up to 365 days
since the initial HRA.
f. Includes members who dis-enrolled from and re-enrolled into the same plan if an initial HRA or reassessment
was not performed within 90 days of re-enrollment. The enrollee becomes eligible for a reassessment HRA the
day after the 90-day initial period expires.
g. Excludes enrollees for whom the initial HRA was completed within the current measurement year.
h. Excludes new enrollees who miss the deadline to complete an initial HRA, and have not yet completed their
reassessment HRA, but whose 365-day reassessment deadline is not until the following calendar year.
i. Excludes members who received a reassessment but were subsequently deemed ineligible because they were
never enrolled in the plan.
j. Excludes members who were not continuously enrolled in their same health plan for 365 days after their last HRA
and did not receive a reassessment HRA.
[Data Element B]
11
Appendix B: Data Validation Standards
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT
8
(for 2021 REPORTED DATA)
Organization accurately calculates the number of initial health risk assessments performed on new members, including the
following criteria:
a. Includes only initial HRAs performed on new members within 90 days before or after the effective date of
enrollment/re-enrollment.
b. The initial HRA is counted in the year that the effective date of enrollment occurred. For members who disenrolled from and re-enrolled into the same plan, excludes any HRAs (initial or reassessment) performed
during their previous enrollment unless the re-enrollment occurred the day after the disenrollment.
c. For members who dis-enrolled from and re-enrolled into the same plan, includes HRAs (initial or
reassessment) performed during their previous enrollment if the HRAs are not more than 365 days old.
d. Counts only one HRA for members who have multiple HRAs within 90 days before or after the effective date of
enrollment.
e. Excludes HRAs completed for members who were subsequently deemed ineligible because they were never
enrolled in the plan.
Note to reviewer: CMS has not identified a standard tool that SNPs must use to complete initial and annual health risk
assessments. The information will not be captured by designated CPT or ICD-10 Procedure codes. Reviewer should confirm
that the SNP maintained documentation for each reported assessment.
[Data Element C]
9
10
Organization accurately calculates the number of initial health risk assessments refusals, including the following criteria:
a. Includes only initial HRAs that were not performed within 90 days before or after the effective date of
enrollment/re-enrollment due to enrollee refusal.
b. Includes only initial HRA refusals for which the SNP has documentation of enrollee refusal.
[Data Element D]
Organization accurately calculates the number of initial health risk assessments not performed due to SNP not being able
to reach the enrollee, including the following criteria:
a. Includes only initial HRAs not performed for which the SNP has documentation showing that enrollee did not
respond to the SNP’s attempts to reach him/her. Documentation must show that the SNP made at least 3
phone calls and sent a follow-up letter in its attempts to reach the enrollee.
b. Includes only those initial HRAs not performed where the SNP made an attempt to reach the enrollee at least
within 90 days after the effective enrollment date.
[Data Element E]
11
Organization accurately calculates the number of annual health risk reassessments performed on members eligible for a
reassessment, including the following criteria:
a. Includes annual HRA reassessments that were completed within 365 days of the member becoming eligible
for a reassessment.
b. Includes annual HRA reassessments within 365 days of the member's initial date of enrollment if the member
did not receive an initial HRA within 90 days before or after the effective date of enrollment.
c. Includes only HRAs that were performed between 1/1 and 12/31 of the measurement year.
d. Counts only one HRA for members who have multiple reassessments within 365 days of becoming eligible for
a reassessment.
e. Excludes HRAs completed for members who were subsequently deemed ineligible because they were never
enrolled in the plan.
Note to reviewer: CMS has not identified a standard tool that SNPs must use to complete initial and annual health risk
assessments. The information will not be captured by designated CPT or ICD-10 Procedure codes. Reviewer should confirm
that the SNP maintained documentation for each reported assessment.
[Data Element F]
12
Appendix B: Data Validation Standards
SPECIAL NEEDS PLANS (SNP) CARE MANAGEMENT
12
(for 2021 REPORTED DATA)
Organization accurately calculates the number of annual health risk reassessments not performed on members eligible for
a reassessment due to enrollee refusal.
a. Only includes annual reassessments not performed due to enrollee refusal.
b. Includes only annual reassessments refusals for which the SNP has documentation of enrollee refusal.
[Data Element G]
13
Organization accurately calculates the number of annual health risk reassessments not performed on members eligible for
a reassessment due to SNP not being able to reach enrollee.
a. Only includes annual reassessments not performed for which the SNP has documentation showing that the
enrollee did not respond to the plan’s attempts to reach him/her. Documentation must show that the SNP
made at least 3 phone calls and sent a follow-up letter in its attempts to reach the enrollee.
[Data Element H]
13
Appendix B: Data Validation Standards
3. PART D DATA VALIDATION STANDARDS
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
(for 2021 Reported Data)
Note to reviewer: If the Part D sponsor has no MTM members, then it is not required to report this data and data validation is not
required for this reporting section.
To determine compliance with the standards for Medication Therapy Management (MTM) Programs, the data validation
contractor will assess the following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
3
4
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. 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).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
A review of source documents (e.g., programming code, spreadsheet formulas, analysis plans, saved data queries, file
layouts, process flows) and census data, whichever is applicable, indicates that data elements for each reporting section are
accurately identified, processed, and calculated.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data (e.g., quarterly).
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and
Technical Specifications.
e. The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges of
data fields 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.
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately uploaded into CMS systems and entries match corresponding source
documents. [Data Elements A – J, L – Z]
b. All source, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems
are archived.
Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).
14
Appendix B: Data Validation Standards
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
(for 2021 Reported Data)
5
6
7
Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster
recovery plan).
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.
If data collection and/or reporting for this reporting section is delegated to another entity; Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
2
3
4
Organization reports data based on the required reporting period of 1/1 through 12/31.
Organization properly assigns data to the applicable CMS contract.
Organization meets deadline for reporting annual data to CMS by 2/28/2022.
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 submission 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
resubmission 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
Organization properly defines the MTM program services per CMS definitions, such as Comprehensive Medication Review
(CMR) with written summary and Targeted Medication Review (TMR) in accordance with the annual MTM Program
Guidance and Submission memo posted on the CMS MTM web page. This includes applying all relevant guidance
properly when performing its calculations and categorizations.
15
Appendix B: Data Validation Standards
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
(for 2021 Reported Data)
5
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS:
a. Date of MTM program enrollment (Data Element I) is within the reporting period (between 1/1/2021 and
12/31/2021).
b. One record is entered for each unique beneficiary i.e., only one record exists for a unique MBI number (Data
Element B).
c. Only reports beneficiaries enrolled in the contract during the reporting period, i.e., MBI (Data Element B) maps to
a beneficiary enrolled at any point during the reporting year for the given Contract Number (Data Element A).
d. CMR received date (Data Element R) is within the beneficiary's MTM enrollment period.
e. If the beneficiary was identified as cognitively impaired at time of CMS offer or delivery (Data Element G = Yes),
the beneficiary should have been offered a CMR (Data Element N = Yes).
f. If the beneficiary was offered or received a CMR (Data Element N = Yes or Data Element Q = Yes), the contract
should report if beneficiary was cognitively impaired at time of CMR offer or delivery (Data Element G ≠ missing).
g. If the beneficiary was offered or received a CMR (Data Element N = Yes or Data Element Q = Yes), the contract
should report if beneficiary was in a long-term care facility at time of CMR offer or delivery (Data Element H≠
missing).
h. If the beneficiary met the specified targeting criteria per CMS-Part D Requirements in § 423.153(d)(2). (Data
Element F = Yes), then the contract should report the date the beneficiary met the specified targeting criteria
(Data Element J ≠ missing).
i. If the beneficiary did not meet the specified targeting criteria per CMS-Part D Requirements in § 423.153(d)(2).
(Data Element F = No), then the field for ‘date meets the specified targeting criteria’ (Data Element J) should be
missing.
j. If a contract reports beneficiaries that were not eligible according to CMS-Part D Requirements in § 423.153(d)(2).
(Data Element F = No), then Contract's MTM program submission information should indicate that contract uses
expanded eligibility (Targeting Criteria for Eligibility in the MTMP ≠ Only enrollees who meet the specified
targeting criteria per CMS requirements).
k. If the beneficiary opted out (Data Element L ≠ missing) then contract should provide an opt-out reason (Data
Element M should not be missing).
l. If the beneficiary did not opt-out (Data Element L = missing), the field for opt-out reason should be missing (Data
Element M = missing).
m. Date of MTM program opt-out (Data Element L) should not be before the date of MTM program enrollment (Data
Element I).
n. Date of (initial) CMR offer (Data Element O) should either be between the beneficiary’s MTM enrollment date (Data
Element I) and 12/31/2021 or the beneficiary’s opt out date (Data Element L).
o. If a CMR was offered (Data Element N = Yes), there is also a reported offer date (Data Element O ≠ missing).
p. If a CMR was not offered (Data Element N = No), there is no reported offer date (Data Element O = missing).
q. If a CMR was received (Data Element Q = Yes), there is a reported date of initial CMR (Data Element R ≠ missing).
r. If a CMR was received (Data Element Q = Yes), there is a reported delivery date(s) (Data Element S ≠ missing).
s. If a CMR was not received (Data Element Q = No), there are no reported delivery date(s) (Data Element S =
missing) unless the CMR summary was returned via mail, then the reported delivery date should be the date that
the written summary was sent (Data Element S ≠ missing).
t. If records indicate that beneficiary received CMR (Data Element Q = Yes), then indicator for CMR offered (Data
element N ≠ No).
u. CMR offer date (Data Element O) is before the CMR received date (Data Element R).
v. If a CMR was offered (Data Element N), there is a reported recipient of initial offer (Data Element P ≠ missing).
w. If a CMR was received (Data Element Q = Yes), there is a reported method of delivery (Data Element T ≠ missing).
x. If a CMR was not received (Data Element Q = No), there is no reported method of CMR delivery (Data Element T
= missing).
16
Appendix B: Data Validation Standards
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
(for 2021 Reported Data)
5
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS:
y. If a CMR was received (Data Element Q = Yes), there is a reported provider who performed the CMR (Data
Element U ≠ missing).
z. If a CMR was not received (Data Element Q = No), there is no reported provider who performed the CMR (Data
Element U = missing).
aa. If a CMR was received (Data Element Q = Yes), there is reported recipient of CMR (Data Element V ≠ missing).
bb. If a CMR was not received (Data Element Q = No), there is no reported recipient of CMR (Data Element V =
missing).
cc. Properly identifies and includes members' date of first TMR (Data Element X) if the number of targeted
medication reviews (Data Element W) >0.
dd. If the organization received a CMS outlier/data integrity notice validate whether or not an internal procedure
change was warranted or resubmission through HPMS (Data Elements A-J, L-Z).
6
Organization accurately identifies data on MTM program participation and uploads it into HPMS, including the following
criteria:
a. Properly identifies and includes members who either met the specified targeting criteria per CMS Part D
requirements in § 423.153(d)(2) or other expanded plan-specific targeting criteria at any time during the
reporting period (Data Elements B, C, D, E, F, G, H, I, J).
b. Includes the ingredient cost, dispensing fee, sales tax, and the vaccine administration fee (if applicable) when
determining if the total annual cost of a member’s covered Part D drugs is likely to equal or exceed the specified
annual cost threshold for MTM program eligibility (Data Element F).
c. Includes continuing MTM program members as well as members who were newly identified and auto-enrolled in
the MTM program at any time during the reporting period (Data Elements B, C, D, E, F, G, H, I, J).
d. Includes and reports each targeted member, reported once per contract year per contract file, based on the
member's most current MBI (Data Elements B, C, D, E, F, G, H, I, J).
e. Excludes members deceased prior to their MTM eligibility date (Data Elements B, C, D, E, F, G, H, I, J).
f. Includes members who receive MTM services based on plan-specific MTM criteria defined by the plan (Data
Elements B, C, D, E, F, G, H, I, J).
g. Properly identifies and includes members’ date of MTM program enrollment (i.e., date they were automatically
enrolled) that occurs within the reporting period (Data Element I).
h. For those members who met the specified targeting criteria per CMS Part D requirements in § 423.153(d)(2),
properly identifies the date the member met the specified targeting criteria (Data Element J).
i. Includes members who moved between contracts in each corresponding file uploaded to HPMS. Dates of
enrollment, disenrollment elements, and other elements (e.g., TMR/CMR data) are specific to the activity that
occurred for the member within each contract (Data Elements B, C, D, E, F, G, H, I, J).
j. Counts each member who disenrolls from and re-enrolls in the same contract once (Data Elements B, C, D, E, F,
G, H, I, J).
7
Organization accurately identifies MTM eligible members who are cognitively impaired at the time of CMR offer or delivery
of CMR and uploads it into HPMS, including the following criteria:
a.
Properly identifies and includes whether each member was cognitively impaired and reports this status as of the
date of the CMR offer or delivery of CMR (Data Element G).
8
Organization accurately identifies data on members who opted-out of enrollment in the MTM program and uploads it into
HPMS, including the following criteria:
a.
Properly identifies and includes members’ date of MTM program opt-out that occurs within the reporting period, but
prior to 12/31 (Data Element L).
b.
Properly identifies and includes the reason participant opted-out of the MTM program for every applicable member
with an opt-out date completed (death, disenrollment, request by member, other reason) (Data Element M).
c.
Excludes members who refuse or decline individual services without opting-out (disenrolling) from the MTM
program (Data Elements L, M).
d.
Excludes members who disenroll from and re-enroll in the same contract regardless of the duration of the gap of
MTM program enrollment (Data Elements L, M).
17
Appendix B: Data Validation Standards
MEDICATION THERAPY MANAGEMENT (MTM) PROGRAMS
(for 2021 Reported Data)
9.
Organization accurately identifies data on CMR offers and uploads it into HPMS, including the following criteria:
a.
Properly identifies and includes MTM program members who were offered a CMR per CMS Part D requirements
in § 423.153(d)(2) during the reporting period (Data Element N).
b.
Properly identifies and includes members' date of initial offer of a CMR that occurs within the reporting period
(Data Element O).
10
Organization accurately identifies data on CMR dates and uploads it into HPMS, including the following criteria:
a.
Properly identifies and includes the date the member received the initial CMR, if applicable. The date occurs within
the reporting period, is completed for every member with a “Y” entered for Field Name “Received annual CMR with
written summary in CMS standardized format,” and if more than one comprehensive medication review occurred,
includes the date of the first CMR (Data Element R).
b.
Properly identifies and includes the method of delivery for the initial CMR received by the member; if more than one
CMR is received, the method of delivery for only the initial CMR is reported. The method of delivery must be
reported as one of the following: Face-to-Face, Telephone, Telehealth Consultation, or Other (Data Element T).
c.
Properly identifies and includes the qualified provider who performed the initial CMR; if more than one CMR is
received, the qualified provider for only the initial CMR is reported. The qualified provider must be reported as one
of the following: Physician; Registered Nurse; Licensed Practical Nurse; Nurse Practitioner; Physician’s Assistant;
Local Pharmacist; LTC Consultant Pharmacist; Plan Sponsor Pharmacist; Plan Benefit Manager (PBM)
Pharmacist; MTM Vendor Local Pharmacist; MTM Vendor In-house Pharmacist; Hospital Pharmacist; Pharmacist –
Other; Supervised Pharmacy Intern; or Other). Required if received annual CMR (Data Element U).
d.
Properly identifies the recipient of the annual CMR; if more than one CMR is received; only the recipient of the
initial CMR is reported. The recipient of the CMR interaction must be reported, not the recipient of the CMR
documentation. The recipient must be reported as one of the following: Beneficiary, Beneficiary’s Prescriber,
Caregiver, or Other Authorized Individual (Data Element V).
11
Organization accurately identifies data on MTM medication therapy problem recommendations and uploads it into HPMS,
including the following criteria:
a. Properly identifies and includes all targeted medication reviews within the reporting period for each applicable
member (Data Element W).
b. Properly identifies and includes the number of medication therapy problem recommendations made to the
beneficiary’s prescriber(s) as a result of MTM services within the reporting period for each applicable member,
regardless of the success or result of the recommendations, and counts these recommendations based on the
number of unique recommendations made to prescribers (e.g., the number is not equal to the total number of
prescribers that received medication therapy problem recommendations from the organization). Organization
counts each individual medication therapy problem identified per prescriber recommendation (e.g., if the
organization sent a prescriber a fax identifying 3 medication therapy problems for a member, this is reported as 3
recommendations) (Data Element Y).
c. Properly identifies and includes the number of medication therapy problem resolutions resulting from
recommendations made to beneficiary’s prescriber(s) as a result of MTM program services within the reporting
period for each applicable member. For reporting purposes, a resolution is defined as a change or variation from
the beneficiary’s previous medication therapy. Examples include, but are not limited to, Initiate medication,
Change medication (such as product in different therapeutic class, dose, dosage form, quantity, or interval),
Discontinue or substitute medication (such as discontinue medication, generic substitution, or formulary
substitution), and Medication compliance/adherence (Data Element Z).
Note to reviewer: If the resolution was observed in the calendar year after the current reporting period, but was the result of
an MTM recommendation made within the current reporting period, the resolution may be reported for the current reporting
period. However, this resolution cannot be reported again in the following reporting period.
18
Appendix B: Data Validation Standards
GRIEVANCES (Part D)
(for 2021 Reported Data)
To determine compliance with the standards for Grievances (Part D), the data validation contractor will assess the
following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
3
4
5
6
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. 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).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data (e.g., quarterly).
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and Technical
Specifications.
e. The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges
of data fields 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.
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately uploaded into CMS systems and entries match corresponding source
documents. [Data Elements A – E]
b. All source, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems
are archived.
Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).
Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster
recovery plan).
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
19
Appendix B: Data Validation Standards
GRIEVANCES (Part D)
(for 2021 Reported Data)
7
no issues that adversely impacted data reported.
If data collection and/or reporting for this reporting section is delegated to another entity; Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
2
3
4
5
6
Organization reports data based on the periods of 1/1 through 3/31, 4/1 through 6/30, 7/1 through 9/30, and 10/1 through
12/31.
Organization properly assigns data to the applicable CMS contract.
Organization meets deadline for reporting data to CMS by 2/7/2022.
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 each 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 resubmission 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.
Organization properly defines the term “Grievance” in accordance with 42 CFR §422.564 and the Parts C & D Enrollee
Grievances, Organization/Coverage Determinations and Appeals Manual. This includes applying all relevant guidance
properly when performing its calculations.
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS:
a. Number of total grievances in which timely notification was given (Data Element B) does not exceed number of
total grievances (Data Element A).
b. Number of expedited grievances in which timely notification was given (Data Element D) does not exceed number
of total grievances in which timely notification was given (Data Element B).
c. Number of expedited grievances (Data Element C) does not exceed total grievances (Data Element A).
d. Number of expedited grievances in which timely notification was given (Data Element D) does not exceed total
expedited grievances (Data Element C).
e. Number of dismissed grievances (Data Element E) are excluded from the total.
f. If the organization received a CMS outlier/data integrity notice, validate whether or not an internal procedure
change was warranted or resubmission through HPMS.
[Data Elements A – E]
Organization accurately calculates and uploads into HPMS the total number of grievances, including the following criteria:
a. Includes all grievances that were completed (i.e., organization has notified member of its decision) during the
reporting period, regardless of when the grievance was received.
b. If a grievance contains multiple issues filed by a single complainant, each issue is calculated as a separate
grievance.
c. If a member files a grievance and then files a subsequent grievance on the same issue prior to the organization’s
decision or deadline for decision notification (whichever is earlier), then the issue is counted as one grievance.
d. If a member files a grievance and then files a subsequent grievance on the same issue after the organization’s
decision or deadline for decision notification (whichever is earlier), then the issue is counted as a separate
grievance.
e. Includes all methods of grievance receipt (e.g., telephone, letter, fax, and in-person).
f. Includes all grievances regardless of who filed the grievance (e.g., member or appointed representative).
g. Excludes complaints received only by 1-800 Medicare or recorded only in the CMS Complaint Tracking Module
(CTM); however, complaints filed separately as grievances with the organization are included.
h. Excludes withdrawn Part D grievances.
i. For MA-PD contracts: Includes only grievances that apply to the Part D benefit and were processed through the
Part D grievance process. If a clear distinction cannot be made for an MA-PD, cases are calculated as Part C
grievances.
j. Counts grievances for the contract to which the member belongs at the time the grievance was filed, even if the
beneficiary enrolled in a new contract before the grievance is resolved (e.g., if a grievance is resolved within the
reporting period for a member that has disenrolled from a plan and enrolled in a new plan, then the member’s
previous plan is still responsible for investigating, resolving, and reporting the grievance).
[Data Elements A – E]
20
Appendix B: Data Validation Standards
GRIEVANCES (Part D)
(for 2021 Reported Data)
7
Organization accurately calculates the number of grievances which the Part D sponsor provided timely notification of
the decision, including the following criteria:
a. Includes only grievances for which the member is notified of decision according to the following timelines:
i. For standard grievances: no later than 30 days after receipt of grievance.
ii. For standard grievances with an extension taken: no later than 44 days after receipt of grievance.
iii. For expedited grievances: no later than 24 hours after receipt of grievance.
[Data Element B]
21
Appendix B: Data Validation Standards
COVERAGE DETERMINATIONS AND REDETERMINATIONS
(for 2021 Reported Data)
To determine compliance with the standards for Coverage Determinations and Exceptions, the data validation contractor
will assess the following information:
• Written response to OAI Sections 3 and 4, and
• Data file created for submission to CMS and copy of HPMS
documentation requested per OAI Sections 5 and 6
screen shots of data entered
• Outlier/data integrity notification(s)- See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• Results of interviews with organization staff
• Census and/or sample data
VALIDATION STANDARDS
1
2
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.
Criteria for Validating Source Documents:
a. Source documents are properly secured so that source documents can be retrieved at any time to validate the
information submitted to CMS via CMS systems.
b. Source documents create all required data fields for reporting requirements.
c. 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.).
d. All data fields have meaningful, consistent labels (e.g., label field for patient ID as Patient ID, rather than Field 1
and maintain the same field name across data sets).
e. Data file locations are referenced correctly.
f. If used, macros are properly documented.
g. Source documents are clearly and adequately documented.
h. Titles and footnotes on reports and tables are accurate.
i. Version control of source documents is appropriately applied.
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a. The appropriate date range(s) for the reporting period(s) is captured.
b. Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c. Appropriate deadlines are met for reporting data (e.g., quarterly).
d. Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and Technical
Specifications.
The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges of
data fields 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.
3
Organization implements policies and procedures for data submission, including the following:
a. Data elements are accurately uploaded into CMS systems and entries match corresponding source
documents. [Data Elements 1.A – 1.R, 2.A – 2.F, 3.A, 3.B.1-3.B.12]
All source, intermediate, and final stage data sets and other outputs relied upon to enter data into CMS systems are
archived.
22
Appendix B: Data Validation Standards
COVERAGE DETERMINATIONS AND REDETERMINATIONS
4
5
6
7
(for 2021 Reported Data)
Organization implements policies and procedures for periodic data system updates (e.g., changes in enrollment,
provider/pharmacy status, and claims adjustments).
Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster
recovery plan).
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.
If data collection and/or reporting for this reporting section is delegated to another entity; Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
2
3
4
Organization reports data based on the periods of 1/1 through 3/31, 4/1 through 6/30, 7/1 through 9/30, and 10/1 through
12/31.
Organization properly assigns data to the applicable CMS contract.
Organization meets deadlines for reporting data to CMS by 2/28/2022.
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 each 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 resubmission 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.
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.
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.
5
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS:
a. Number of coverage determinations 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).
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).
c. Number of redeterminations by outcome (Data Elements 2.D + 2.E + 2.F) is equal to total number of
redeterminations (Data Element 2.A).
d. Total number of reopened (revised) decisions (Data Element 3.A) is equal to the number of records reported in
data file.
e. Verify that the date of each reopening disposition (Data Element 3.B.11) is in the reporting quarter.
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).
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).
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).
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.
23
Appendix B: Data Validation Standards
COVERAGE DETERMINATIONS AND REDETERMINATIONS
(for 2021 Reported Data)
6
7
Data Elements [1.A−1.R, 2.A−2.F, 3.A−3.B.9]1
Organization accurately calculates the number of coverage determination (Part D only) decisions made in the reporting
period, including the following criteria:
a. Includes all coverage determinations (fully favorable, partially favorable, and adverse), including exceptions,2 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.
b. Includes hard morphine milligram equivalent dose (MME) edit coverage determinations.
c. Includes opioid naïve days supply edit coverage determinations.
d. Includes hospice-related coverage determinations.
e. Includes all methods of receipt (e.g., telephone, letter, fax, and in-person).
f. Includes all coverage determinations (including exceptions) regardless of who filed the request (e.g., member,
appointed representative, or prescribing physician).
g. Includes coverage determinations (including exceptions) from delegated entities.3
h. Includes both standard and expedited coverage determinations (including exceptions).
i. Excludes requests for coverage determinations (including exceptions) that are withdrawn or dismissed.
j. Includes each distinct dispute (i.e., multiple drugs) contained in one coverage determination request as a separate
coverage determination request.
k. Includes adverse coverage determination cases that were forwarded to the Independent Review Entity (IRE)
because the organization made an untimely decision.
l. Includes all coverage determination decisions that relate to Part B versus Part D coverage (drugs covered under
Part B are considered as adverse decisions under Part D).
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.
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.
n. Excludes coverage determinations (including exceptions) regarding drugs assigned to an excluded drug category.
o. Excludes members who have Utilization Management (UM) requirements waived based on an exception decision
made in a previous plan year or reporting period.
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.
[Data Elements 1.A, 1.G, 1.K, 1.O]
Organization accurately calculates the total number of UM, Formulary, and Tier exceptions decisions made in the reporting
period, including the following criteria:
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.
b. Includes all methods of receipt (e.g., telephone, letter, fax, in-person).
c. Includes exception requests that were forwarded to the IRE because the organization failed to make a timely
decision.
d. Includes requests for exceptions from delegated entities.
e. Includes both standard and expedited exceptions.
f. Excludes requests for exceptions that are withdrawn or dismissed.
1
Note that Data Elements 1.A – 1.R relate to Coverage Determinations, Data Elements 2.A – 2.F relate to Redeterminations, and Data Elements 3.A
and 3.B.1 – 3.B.12 relate to Re-openings.
2 Exception requests include tiering exceptions, formulary exceptions, and UM exceptions, such as prior authorization, step therapy, quantity limits,
etc.
3 Delegated entities are contractors to Part D sponsors.
24
Appendix B: Data Validation Standards
COVERAGE DETERMINATIONS AND REDETERMINATIONS
g.
h.
8
9
10
(for 2021 Reported Data)
Excludes requests for exceptions regarding drugs assigned to an excluded drug category.
Excludes members who have utilization management requirements waived based on an exception decision made in
a previous plan year or reporting period.
[Data Element 1.G, 1.K, 1.O]
Organization accurately calculates the number of coverage determinations decisions made by final decision, including the
following criteria:
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.
b. Includes untimely coverage determinations decisions, regardless if they were auto-forwarded to the IRE.
[Data Elements 1.D, 1.E, 1.F]
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.
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.
[Data Elements 1.B, 1.C]
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.
b. Includes all redetermination decisions, including fully favorable, partially favorable, and adverse decisions.
c. Includes redetermination requests that were forwarded to the IRE because the organization failed to make a
timely decision.
d. Includes both standard and expedited redeterminations.
e. Includes beneficiary-specific Point of Sale (POS) edit, prescriber or pharmacy coverage limitation appeals (at-risk
determination appeals) made under a drug management program redeterminations.
f. Includes all methods of receipt (e.g., telephone, letter, fax, in-person).
g. Includes all redeterminations regardless of who filed the request (e.g., member, appointed representative, or
prescribing physician).
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.
i. Includes all redetermination decisions that relate to Part B versus Part D coverage (drugs covered under Part B are
considered as 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.
j. Includes each distinct dispute contained in one redetermination request (i.e., multiple drugs) as a
separate redetermination request.
k. Excludes dismissals and withdrawals.
l. Excludes IRE decisions.
m. Excludes redeterminations regarding excluded drugs.
n. Limits reporting to just the redetermination level.
25
Appendix B: Data Validation Standards
COVERAGE DETERMINATIONS AND REDETERMINATIONS
(for 2021 Reported Data)
11
12
13
14
[Data Element 2.A]
Organization accurately calculates the number of redeterminations by final decision, including the following criteria:
a. Properly categorizes the total number of redeterminations by final decision: 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).
b. Excludes redetermination decisions made by the IRE.
[Data Elements 2.D−2.F]
Organization accurately calculates the number of requests for redeterminations that were withdrawn or dismissed,
including the following criteria:
a. Includes all withdrawals and dismissals on requests for redeterminations.
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.
c. Each number calculated for requests for redeterminations that were withdrawn (Data Element 2.B) and requests
for redeterminations that were dismissed (Data Element 2.C) is a subset of the number of redeterminations
decisions made (Data Element 2.A).
[Data Element 2.B and 2.C]
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.
[Data Element 3.A]
Organization accurately reports the following information for each reopened case.
a. Contract Number
b. Plan ID
c. Case ID
d. Case level (Coverage Determination or Redetermination)
e. Date of original disposition
f. Original disposition (Fully Favorable; Partially Favorable; or Adverse)
g. Was case processed under expedited timeframe (Y/N)
h. Case type (Pre-Service; Payment)
i. Date case was reopened
j. Reason(s) for reopening (Clerical Error, Other Error, New and Material Evidence, Fraud or Similar Fault, or Other)
k. Date of reopening disposition (revised decision)
l. Reopening disposition (Fully Favorable; Partially Favorable; Adverse; or Pending).
[Data Elements 3.B.1−3.B.12]
26
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
Note to reviewer: Access to the CY 2021 cumulative opioid MME POS edits and the attestation opioid naïve days supply edit submissions
is in HPMS. Consider implementation dates of all CMS approved changes to the organization’s drug utilization management program
policies and procedures.
To determine compliance with the standards for Improving Drug Utilization Review Controls, the data validation contractor will assess the
following information:
• Written response to OAI Sections 3 and 4 and documentation
• Data file created for submission to CMS and copy of HPMS
requested per OAI Sections 5 and 6
screenshots of data entered
• Outlier/data integrity notification(s) – See OAI 4.3.3 for
• Other relevant information provided by organization
instructions on how to retrieve notices
• CY 2021 Care Coordination Safety Edit, Hard Formulary
• Results of interview with organization staff
Morphine Milligram Equivalent (MME) Safety Edit, and Opioid
Naïve days Supply Safety Edit submission report in HPMS
• Census and/or sample data
VALIDATION STANDARDS
1
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.
Criteria for Validating Source Documents:
a.
Source documents and output are properly secured so that source documents can be retrieved at any time to validate
the information submitted to CMS via HPMS.
b.
Source documents create all required data fields for reporting requirements.
c.
Source documents are error-free (e.g., programming code and spreadsheet formulas have no messages or warnings
indicating errors).
d.
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).
e.
Data file locations are referenced correctly.
f.
If used, macros are properly documented.
g.
Source documents are clearly and adequately documented.
h.
Titles and footnotes on reports and tables are accurate.
i.
Version control of source documents is appropriately applied.
2
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.
Criteria for Validating Reporting Section Criteria (Refer to reporting section criteria section below):
a.
The appropriate date range(s) for the reporting period(s) is captured.
b.
Data are assigned at the applicable level (e.g., plan benefit package or contract level).
c.
Appropriate deadlines are met for reporting data (e.g., quarterly).
d.
Terms used are properly defined per CMS regulations, guidance, Reporting Requirements and Technical
Specifications.
e.
The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges of data
fields 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.
27
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
3
Organization implements appropriate policies and procedures for data submission, including the following:
a.
Data elements are accurately uploaded into the HPMS tool and entries match corresponding source
documents. [Data Elements A-EE]
b.
All source, intermediate, and final stage data sets relied upon to enter data into CMS systems are archived.
4
Organization implements appropriate policies and procedures for periodic data system updates (e.g., changes in
enrollment, provider/pharmacy status, and claims adjustments).
5
Organization implements appropriate policies and procedures for archiving and restoring data in each data system (e.g., disaster
recovery plan).
6
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.
7
If data collection and/or reporting for this data reporting section is delegated to another entity: Organization regularly monitors
the quality and timeliness of the data collected and/or reported by the delegated entity or first tier/downstream contractor.
REPORTING SECTION CRITERIA (for 2021 reported data)
1
2
Organization reports data based on the required reporting period of 1/1 through 3/31, 1/1 through 6/30, 1/1 through 9/30, 1/1
through 12/31.
Organization properly assigns data to the applicable CMS contract and plan.
3
Organization meets deadline for reporting annual data to CMS by 2/28/2022.
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 submission 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.
4
Organization complies with drug utilization management (DUM) requirements of 42 C.F.R §423.153 et seq. to prevent
overutilization of opioids as well as other DUM requirements according to guidelines specified by CMS. This includes but is not
limited to:
a. Applying all relevant guidance to properly establish and implement a care coordination formulary-level cumulative opioid
morphine milligram equivalent (MME) threshold point of sale (POS) edit, an opioid naïve days supply POS edit, and if
applicable, a hard formulary-level cumulative opioid MME threshold POS edit.
b. Organization provides documentation that its care coordination safety POS edit, an opioid naïve days supply POS edit, and
if applicable, a hard formulary-level cumulative opioid MME threshold POS edit were properly tested and validated prior to
its implementation date.
c. For the care coordination safety edit,
i. Properly reports the opioid MME threshold, provider count, and pharmacy count criteria from the Reporting
Requirements submission matches the CY 2021 care coordination safety edit formulary-level cumulative
opioid MME threshold submission report in HPMS.
d. For the hard MME edit,
i. Properly reports opioid MME threshold, provider count, and pharmacy count criteria from the Reporting
Requirements submission matches the CY 2021 hard MME safety edit formulary-level cumulative opioid MME
threshold submission report in HPMS.
e. For the opioid naïve days supply safety edit,
i. Properly reports that the opioid naïve days supply safety edit look-back period reported matches the CY 2021
look-back period submission report in HPMS.
28
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
5
Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
a. For the care coordination safety edit, the following is true:
i.
The prescriber count criterion used and the pharmacy count criterion used must be reported (Data
Elements A, B ≠ blank).
ii.
The number of claims rejected due to the care coordination safety edits (Element C) should be greater than or
equal to the number of claim rejections overridden by the pharmacist at the pharmacy (Element D) and the
number of claim rejections overridden by the pharmacist at the pharmacy that also had an opioid claim
successfully processed at POS (Element E).
iii.
The number of unique beneficiaries with at least one claim rejected due to the care coordination safety edit
(Element F) should be greater than or equal to the number of unique beneficiaries with at least one claim
rejection overridden by the pharmacist at the pharmacy (Element G) and the number of unique beneficiaries
with at least one rejection overridden by the pharmacist at the pharmacy that also had an opioid claim
successfully processed at POS. (Element H)
b.
If the organization had a hard MME safety edit (Data Element I =Yes), the following is true:
i.
The number of claims rejected due to the hard MME safety edit (Element M) should be greater than or equal to
the number of claim rejections successfully processed at POS other than through a favorable coverage
determination or appeal, such as pharmacist communication and/or plan override (Elements N) and the number
of claim rejections successfully processed at POS through a favorable coverage determination or appeal
(Element O).
ii.
The number of unique beneficiaries with at least one claim rejected due to the hard MME safety edit (Element P)
should be greater than or equal to:
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS through any process (Element Q);
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS other than through a favorable coverage determination or appeal, such as
pharmacist communication and/or plan override (Element R);
•
the number of unique beneficiaries with a claim rejection that had a coverage determination or
appeal request for an opioid prescription subject to the edit (Element S);
•
the number of unique beneficiaries with a claim rejection and with a coverage determination or
appeal request for an opioid drug subject to the edit that had a favorable (either full or partial)
coverage determination or appeal (Element T); and
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS through a favorable coverage determination or appeal (Element U).
iii.
The cumulative MME threshold (Element J) must be reported (Data Element J ≠ blank).
c.
If the organization does not have hard MME safety POS edits (Data Element I=No), Data Elements J, K, L, M, N, O, P Q,
R, S, T and U should equal 0.
29
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
5
d.
For the opioid naïve days supply safety edit, the following is true:
i.
The look-back period used to identify an initial opioid prescription fill for the treatment of acute pain (Element V)
must be reported (Data Elements V ≠ blank).
ii.
The number of claims rejected due to the opioid naïve days supply edit (Element W) should be greater than or
equal to the number of claim rejections successfully processed at POS other than through a favorable coverage
determination or appeal, such as pharmacist communication and/or plan override (Element X) and the number of
claim rejections successfully processed at POS through a favorable coverage determination or appeal (Element
Y).
iii.
The number of unique beneficiaries with at least one claim rejected due to the opioid naïve days supply edit
(Element Z) should be greater than or equal to:
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS through any process (Element AA);
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS other than through a favorable coverage determination or appeal, such as
pharmacist communication and/or plan override (Element BB);
•
the number of unique beneficiaries with a claim rejection that had a coverage determination or
appeal request for an opioid prescription subject to the edit (Element CC);
•
the number of unique beneficiaries with a claim rejection and with a coverage determination or
appeal request for an opioid prescription subject to the edit that had a favorable (either full or partial)
coverage determination or appeal (Element DD); and
•
the number of unique beneficiaries with a claim rejection that had an opioid claim successfully
processed at POS through a favorable coverage determination or appeal (Element EE).
e.
If the organization received an outlier/data integrity notice for the Improving Drug Utilization Review Controls section
validate whether or not an internal procedure change was warranted or resubmission through HPMS. Data Elements: A-H,
J-U, and V-EE.
[Data Elements A-EE]
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Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
6
Organization can accurately identify and create a Part D data set of POS claim rejects related to its care coordination safety edit,
hard MME safety edit, and/or opioid naïve days supply safety edit and correctly calculate and report counts to CMS via HPMS,
including the following criteria:
a.
Properly identifies and counts the number of POS rejects triggered and unique beneficiaries related to the care
coordination safety edit and if applicable, a provider and pharmacy criterion.
i.
Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.
ii.
The rejected opioid claim due to the care coordination safety edit is not associated with an early refill rejection
transaction.
iii.
Rejected opioid claims are counted at the unique plan, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, date of service (DOS) and formulary-level opioid MME POS edit.
iv.
Properly counts the number of unique beneficiaries by plan that triggered the care coordination safety edit and if
applicable, a provider and/or pharmacy criterion.
b.
Properly identifies and counts the number of POS rejects triggered and unique beneficiaries related to the established
hard MME safety edit threshold and if applicable, a provider and pharmacy criterion.
i.
Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.
ii.
The rejected opioid claim due to the hard MME safety edit is not associated with an early refill rejection
transaction.
iii.
Rejected opioid claims are counted at the unique plan, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity date of service (DOS) and formulary-level opioid MME POS edit.
iv.
Properly counts the number of unique beneficiaries by plan that triggered the established hard MME safety edit
threshold and if applicable, a provider and/or pharmacy criterion.
c.
Properly identifies and counts the number of POS rejects triggered and unique beneficiaries related to the opioid naïve
days supply safety edit.
i.
Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.
ii.
The rejected opioid claim due to opioid naïve days supply safety edit is not associated with an early refill rejection
transaction.
iii.
Rejected opioid claims are counted at the unique plan, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), and quantity date of service (DOS).
iv.
Properly counts the number of unique beneficiaries by plan that triggered the opioid naïve days supply safety
edit.
[Data Elements C, F, M, P, W, Z]
31
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
7
From the data set of POS rejects (RSC 6a) related to the care coordination safety edit the organization accurately identifies and
counts the number of overridden rejected claims and correctly uploads the counts into HPMS, including the following criteria:
a.
Properly identifies and counts the number of pharmacist overridden care coordination safety edit POS rejected claims.
i.
If a prescription drug claim contains multiple POS rejections, each rejection is considered as a separate
pharmacy transaction and included in the data set.
b.
Properly identifies and counts the number of unique beneficiaries per plan with at least one claim rejection due to its care
coordination safety POS edit and a pharmacist overridden care coordination safety POS edit rejected claim.
i.
If a prescription drug claim contains multiple POS rejections, each rejection is considered as a separate
pharmacy transaction and included in the data set.
[Data Elements D, G]
8
The organization accurately identifies claims leading to a coverage determination or appeal request and correctly uploads the
count into HPMS including the following criteria:
a.
From the data set (RSC6b) of POS rejects related to the hard MME safety edits,
i.
If a prescription drug claim contains multiple POS rejections, each rejection is considered as a separate
pharmacy transaction.
ii.
Includes all methods of coverage determination or appeal receipt (e.g., telephone, letter, fax, in-person).
iii.
Includes all coverage determination or appeal requests.
b.
From the data set (RSC6c) of POS rejects related to the opioid naïve days supply safety edits,
i.
If a prescription drug claim contains multiple POS rejections, each rejection is considered as a separate
pharmacy transaction.
ii.
Includes all methods of coverage determination or appeal receipt (e.g., telephone, letter, fax, in-person).
iii.
Includes all coverage determination or appeal requests subject to the opioid naïve edit.
[Data Elements S, CC]
32
Appendix B: Data Validation Standards
IMPROVING DRUG UTILIZATION REVIEW CONTROLS
(2021 Reported Data)
9
10
The organization accurately identifies the number of unique beneficiaries with at least one POS claim rejection related to a hard
MME safety edit and/or opioid naïve days supply safety edit that also had a claim successfully processed at POS through a
favorable coverage determination or plan override. Correctly uploads the count, if the data set of POS rejects includes the
complete reporting period, into HPMS including the following criteria:
a.
From the subset of POS rejects (RSC 6b) related to the hard MME safety POS edits,
i.
The beneficiary’s opioid claim is also included in data element P. [Data Element T]
b.
From the subset of POS rejects (RSC 6c) related to the opioid naïve days supply safety POS edits,
i.
The beneficiary’s opioid claim is also included in data element Z. [Data Element DD]
The organization accurately identifies the number of unique beneficiaries with at least one POS claim rejection related to a hard
MME safety edit and/or opioid naïve days supply safety edit that also had a claim successfully processed at POS other than
through a favorable coverage determination or appeal such as pharmacist communication and/or plan override. Correctly
uploads the count, if the data set of POS rejects includes the complete reporting period, into HPMS including the following
criteria:
a.
From the subset of POS rejects (RSC 6b) related to the hard MME safety POS edits,
i.
The beneficiary’s opioid claim is also included in data element P.
[Data Element R]
b.
From the subset of POS rejects (RSC 6c) related to the opioid naïve days supply safety POS edits,
i.
The beneficiary’s opioid claim is also included in data element Z.
[Data Element BB]
33
APPENDIX: ACRONYMS
Acronym
ASO
CABG
CFR
CMR
CMS
CPT
CTM
DBA
DME
DOS
DUM
DVT
FFS
HAC
HEDIS
HPMS
ICD-9
ICD-10
IRE
LIS
LTC
MA
MAO
MA-PD
MME
MTM
OAI
OP
PA
PBM
PBP
PDP
POA
POS
QA
QIO
RPPO
Rx
SNF
SNP
SSI
TBD
TMR
UM
Description
Administrative Services Only
Coronary Artery Bypass Surgery
Code of Federal Regulations
Comprehensive Medication Review
Centers for Medicare & Medicaid Services
Current Procedural Terminology
Complaint Tracking Module
Doing Business As
Durable Medical Equipment
Date of Service
Drug Utilization Management
Deep Vein Thrombosis
Fee for Service
Hospital Acquired Condition
Healthcare Effectiveness Data and Information Set
Health Plan Management System
International Classification of Diseases, 9th Revision
International Classification of Diseases, 10th Revision
Independent Review Entity
Low Income Subsidy
Long-Term Care
Medicare Advantage
Medicare Advantage Organization
Medicare Advantage Prescription Drug Plan
Morphine Equivalent Dose
Medication Therapy Management
Organizational Assessment Instrument
Outpatient
Prior Authorization
Pharmacy Benefit Management
Plan Benefit Package
Prescription Drug Plan
Present on Admission
Point of Sale
Quality Assurance
Quality Improvement Organization
Regional Preferred Provider Organization
Prescription
Skilled Nursing Facility
Special Needs Plan
Surgical Site Infections
To Be Determined
Targeted Medication Review
Utilization Management
34
| File Type | application/pdf |
| File Title | Medicare Part C and Part D Reporting Requirements Data Validation Procedure Manual Appendix B: Data Validation Standards |
| Subject | Data Validation Procedure Manual |
| Author | Centers for Medicare and Medicaid Services |
| File Modified | 2021-09-27 |
| File Created | 2021-09-27 |