CMS-10305 Improving Drug Utilization Review Controls (Part D) 2022

Improving Drug Utilization Review Controls
(Part D) 2022
Organization Name:
Contract Number:
Reporting Section:

no data

Improving
Drug
Utilization
Review
Controls (Part
D) 2022

Last Updated:

Date of Site Visit (on-site or virtual):
Name of Reviewer:
Name of Peer Reviewer:
Instructions:
1) In the "Data Sources and Review Results:" column, enter
the review results and/or data sources used for each
standard or sub-standard.
2) Enter "Y" if the requirements for the standard or substandard have been completely met. If any requirement
for the standard or sub-standard has not been met, enter
"N". If any standard or sub-standard does not apply, enter
"N/A".
3) For standards 1c, 1d, 1e, 1g, 1h, and 2e, enter 'Findings'
as follows based on the five-point scale: Select "1" if plan
data has more than 20% error, select "2" if plan data has
between 15.1% - 20.0% error, select "3" if plan data has
between 10.1% - 15.0% error, select "4" if plan data has
between 5.1% - 10.0% error, select "5" if plan data has less
than or equal to a 5% error. Enter "N/A" if standard does
not apply.
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Standard/Sub-standard ID

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Reporting
Section
Criteria ID

Standard/Sub-standard Description

Data Element

no data
Data Sources and Review Results:
Enter review results and/or data sources

1

No data

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

No data

Data sources:

1.a

No data

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

No data

Review Results:

1.b

No data

Source documents create all required data fields for reporting requirements.

No data

Review Results:

1.c

No data

Source documents are error-free (e.g., programming code and spreadsheet formulas have no messages or warnings
indicating errors).

No data

Review Results:

1.d

No data

All data fields have meaningful, consistent labels (e.g., label field for patient ID as Patient ID, rather than Field1 and maintain No data
the same field name across data sets).

Review Results:

1.e

No data

Data file locations are referenced correctly

No data

Review Results:

1.f

No data

If used, macros are properly documented.

No data

Review Results:

1.g

No data

Source documents are clearly and adequately documented.

No data

Review Results:

1.h

No data

Titles and footnotes on reports and tables are accurate.

No data

Review Results:

1.i

No data

Version control of source documents is appropriately applied.

No data

Review Results:

2

No data

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

No data

Data sources:

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

*

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.a

RSC-1

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

No data

Review Results:

RSC-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.
Data are assigned at the applicable level (e.g., plan benefit package or contract level).

No data

Review Results:

No data

Review Results:

No data

Review Results:

2.b

Standard/Sub-standard Description

Data Element

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

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

Organization properly assigns data to the applicable CMS contract and plan.
2.c

RSC-3

Appropriate deadlines are met for reporting data (e.g., quarterly).
Organization meets deadline for reporting annual data to CMS by 02/27/2023.

2.d

RSC-4

[Note to reviewer: If the organization has, for any reason, re- submitted its data to CMS for this reporting section, the
reviewer should verify that the organization’s original data submissions met the CMS deadline in order to have a finding of
“yes” for this reporting section criterion. However, if the organization re-submits data for any reason and if the resubmission was completed by 3/31 of the data validation year, the reviewer should use the organization’s corrected data
b i i f th
i
f thi
ti
ti ]
Terms used are properly defined per CMS regulations, guidance, Reporting Requirements, and Technical Specifications.
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 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 2022 care coordination safety edit formulary-level cumulative opioid MME
threshold submission report in HPMS.
d. For the hard MME edit,
i. Properly reports the opioid MME threshold, provider count, and pharmacy count criteria from the Reporting
Requirements submission matches the CY 2022 hard MME safety edit formulary-level cumulative opioid MME threshold
submission report in HPMS.
e. For the opioid naive days supply safety edit,

2.e

RSC-5

i. Properly reports that the opioid naïve days supply safety edit look-back period reported matches the CY 2022 look-back
The number of expected counts (e.g., number of members, claims, grievances, procedures) are verified; ranges of data fields No data
are verified; all calculations (e.g., derived data fields) are verified; missing data has been properly addressed; reporting
output matches corresponding source documents (e.g., programming code, saved queries, analysis plans); version control of
reported data elements is appropriately applied; QA checks/thresholds are applied to detect outlier or erroneous data prior
to data submission.

Data Sources:

RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
a: For the care coordination safety edit, the following is true:
2.e

RSC-5.ai

RSC-5.ai: The prescriber count criterion used and the pharmacy count criterion used must be reported (Data Elements A, B ≠ Data Elements A, B
blank).

Review Results:

2.e

RSC-5.aii

RSC-5.aii: The number of claims rejected due to the care coordination safety edit (Element C) should be greater than or equal Data Element C
to each of the following:
- the number of claim rejections overridden by the pharmacist at the pharmacy (Element D)
- the number of claim rejections overridden by the pharmacy within 24 hours of the initial claim rejection (Element E)
- The number of claim rejections overridden by the pharmacy due to an exemption (Element F); and
- the number of claim rejections overridden by the pharmacy as a result of prescriber consultation (Element G)

Review Results:

*

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-5.aiii

2.e

RSC-5.b

Standard/Sub-standard Description

Data Element

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

RSC-5.aiii: The number of unique beneficiaries with at least one claim rejected due to the care coordination safety edit
(Element H) should be greater than or equal each of the following:
- the number of unique beneficiaries with at least one claim rejection overridden by the pharmacy (Element I)
- The number of unique beneficiaries with at least one claim rejection overridden by the pharmacy within 24 hours of the
initial claim rejection (Element J)
- The number of unique beneficiaries with at least one claim rejection overridden by the pharmacy due to an exemption
(Element K)
- The number of unique beneficiaries with at least one claim rejection overridden by the pharmacy as a result of prescriber
consultation (Element L)

Data Element H

Review Results:

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

No data

Data Sources:

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

*

b: If the organization had a hard MME safety edit (Data Element M =Yes), the following is true:
2.e

RSC-5.bi

RSC-5.bi: The number of unique beneficiaries with at least one claim rejected due to the hard MME safety edit (Element R)
should be greater than or equal to each of the following:
- the number of unique beneficiaries with at least one claim rejection overriden by the pharmacy due to an exemption
(Element S);
- the number of beneficiairies who requested a coverage determination for the prescription(s) subject to the edit (Element
T);
- the number of unique beneficiaries that had a favorable (either full or partial) coverage determination for the
prescription(s) subject to the edit (Element U).

Data Element R

Review Results:

2.e

RSC-5.bii

RSC-5.bii: The cumulative MME threshold (Element N) must be reported (Data Element N ≠ blank)

Data Element N

Review Results:

2.e

RSC-5.c

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

No data

Data Sources:

*

c: If the organization does not have hard MME safety POS edits (Data Element M =No), Data Elements N, O, P Q, R, S, T, and U
should equal 0.
2.e

RSC-5.c

No data

Data Elements N, O, P Review Results:
Q, R, S, T, U

2.e

RSC-5.d

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

No data

Data Sources:

*

d: For the opioid naïve days supply safety edit, the following is true:
2.e

RSC-5.di

RSC-5.di: The look-back period used to identify an initial opioid prescription fill for the treatment of acute pain must be
reported (Data Element V ≠ blank).

Data Element V

Review Results:

2.e

RSC-5.dii

RSC-5.dii: The number of claims rejected due to the opioid naïve days supply edit (Element W) should be greater than or
equal to each of the following:

Data Element W

Review Results:

RSC-5.diii: The number of unique beneficiaries with at least one claim rejected due to the opioid naïve days supply edit
Data Element AA
(Element AA) should be greater than or equal to:
- the number of unique beneficiaries with at least one rejected claim overridden by the pharmacy due to an exemption
(Element BB);
-the number of unique beneficiaries with at least one rejected claim overridden by the pharmacy because the beneficiary
was not opioid naive (Element CC);
- the number of unique beneficiaries for whom up to a 7-day supply (covered by the plan) was dispensed by the pharmacy
(Element DD);
- the number of unique beneficiaries with an opioid naive days supply edit claim rejection who requested a coverage
determination for the prescription(s) subject to the edit (Element EE); and
- the number of unique beneficiaries with an opioid naive days supply edit claim rejection who had a favorable (either full or
partial) coverage determination for the prescription(s) subject to the edit (Element FF).
RSC-5: Organization accurately reports data by applying data integrity checks listed below and uploads it into HPMS.
No data

Review Results:

- the number of claim rejections overridden by the pharmacy due to an exemption (Element X);
- the number of rejected claims overridden by the pharmacy because the beneficiary was not opioid naive (Element Y); and
- the number of rejected claims for which up to a 7-day supply (covered by the plan) was dispensed by the pharmacy
(Element Z)
2.e

RSC-5.diii

2.e

RSC-5.e

Data Sources:

*

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-L, NU, and V-FF.
2.e

RSC-5.e

2.e

RSC-6

No data

Data Elements A-L, N- Review Results:
U, and V-FF

RSC-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:

No data

Data Sources:

*

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-6.a

Standard/Sub-standard Description
RSC-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:

Data Element

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

No data

Data Sources:

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

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.
2.e

RSC-6.ai

RSC-6.ai: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element C

Review Results:

2.e

RSC-6.ai

RSC-6.ai: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element H

Review Results:

2.e

RSC-6.aii

RSC-6.aii: The rejected opioid claim due to the care coordination safety edit is not associated with an early refill rejection
transaction.

Data Element C

Review Results:

2.e

RSC-6.aii

RSC-6.aii: The rejected opioid claim due to the care coordination safety edit is not associated with an early refill rejection
transaction.

Data Element H

Review Results:

2.e

RSC-6.aiii

RSC-6.aiii: Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, date of service (DOS) and formulary-level opioid MME POS edit.

Data Element C

Review Results:

2.e

RSC-6.aiii

RSC-6.aiii: Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, date of service (DOS) and formulary-level opioid MME POS edit.

Data Element H

Review Results:

2.e

RSC-6.aiv

RSC-6.aiv: Properly counts the number of unique beneficiaries by contract that triggered the care coordination safety edit
and, if applicable, a provider and/or pharmacy criterion.

Data Element C

Review Results:

2.e

RSC-6.aiv

RSC-6.aiv: Properly counts the number of unique beneficiaries by contract that triggered the care coordination safety edit
and, if applicable, a provider and/or pharmacy criterion.

Data Element H

Review Results:

2.e

RSC-6.b

RSC-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:

No data

Data Sources:

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.
2.e

RSC-6.bi

RSC-6.bi: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element Q

Review Results:

2.e

RSC-6.bi

RSC-6.bi: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element R

Review Results:

2.e

RSC-6.bii

RSC-6.bii: The rejected opioid claim due to the hard MME safety edit is not associated with an early refill rejection
transaction.

Data Element Q

Review Results:

2.e

RSC-6.bii

RSC-6.bii: The rejected opioid claim due to the hard MME safety edit is not associated with an early refill rejection
transaction.

Data Element R

Review Results:

2.e

RSC-6.biii

RSC-6.biii: Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, DOS and formulary-level opioid MME POS edit.

Data Element Q

Review Results:

2.e

RSC-6.biii

RSC-6.biii: Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, DOS and formulary-level opioid MME POS edit.

Data Elements R

Review Results:

2.e

RSC-6.biv

RSC-6.biv: Properly counts the number of unique beneficiaries by contract that triggered the established hard MME safety
edit threshold and if applicable, a provider and/or pharmacy criterion.

Data Element Q

Review Results:

2.e

RSC-6.biv

RSC-6.biv: Properly counts the number of unique beneficiaries by contract that triggered the established hard MME safety
edit threshold and if applicable, a provider and/or pharmacy criterion.

Data Element R

Review Results:

*

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-6.c

Standard/Sub-standard Description
RSC-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:

Data Element

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

No data

Data Sources:

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

c: Properly identifies and counts the number of POS rejects triggered and unique beneficiaries related to the opioid naïve
days supply safety edit.

2.e

RSC-6.ci

RSC-6.ci: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element W

Review Results:

2.e

RSC-6.ci

RSC-6.ci: Includes pharmacy transactions for Part D opioid drugs with a fill date (not batch date) that falls within the
reporting period.

Data Element AA

Review Results:

2.e

RSC-6.cii

RSC-6.cii: The rejected opioid claim due to opioid naïve days supply safety edit is not associated with an early refill rejection
transaction.

Data Element W

Review Results:

2.e

RSC-6.cii

RSC-6.cii: The rejected opioid claim due to opioid naïve days supply safety edit is not associated with an early refill rejection
transaction.

Data Element AA

Review Results:

2.e

RSC-6.ciii

RSC-6.ciii:Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, and DOS.

Data Element W

Review Results:

2.e

RSC-6.ciii

RSC-6.ciii:Rejected opioid claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and
dosage form), quantity, and DOS.

Data Element AA

Review Results:

2.e

RSC-6.civ

RSC-6.civ: Properly counts the number of unique beneficiaries by contract that triggered the opioid naïve days supply safety
edit.

Data Element W

Review Results:

2.e

RSC-6.civ

RSC-6.civ: Properly counts the number of unique beneficiaries by contract that triggered the opioid naïve days supply safety
edit.

Data Element AA

Review Results:

2.e

RSC-7

RSC-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:

No data

Data Sources:

*

2.e

RSC-7.a

RSC-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:

No data

Data Sources:

*

a: Properly identifies and counts the number of pharmacist-overridden care coordination safety edit POS rejected claims.
2.e

RSC-7.ai

RSC-7.ai: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element D

Review Results:

2.e

RSC-7.ai

RSC-7.ai: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element H

Review Results:

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-7.ai

RSC-7.ai: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element I

Review Results:

2.e

RSC-7.b

RSC-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:

No data

Data Sources:

Standard/Sub-standard Description

Data Element

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

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

*

b: Properly identifies and counts the number of unique beneficiaries per contract 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.

2.e

RSC-7.bi

RSC-7.bi: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element D

Review Results:

2.e

RSC-7.bi

RSC-7.bi: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element H

Review Results:

2.e

RSC-7.bi

RSC-7.bi: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element I

Review Results:

2.e

RSC-8

RSC-8: The organization accurately identifies claims leading to a coverage determination request and correctly uploads the
count into HPMS including the following criteria:

No data

Data Sources:

*

2.e

RSC-8.a

RSC-8: The organization accurately identifies claims leading to a coverage determination request and correctly uploads the
count into HPMS including the following criteria:

No data

Data Sources:

*

Data Element T

Review Results:

a: From the data set (RSC6b) of POS rejects related to the hard MME safety edits,

2.e

RSC-8.ai

RSC-8.ai: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-8.aii

RSC-8.aii: Includes all methods of coverage determination receipt (e.g., telephone, letter, fax, in-person).

Data Element T

Review Results:

2.e

RSC-8.aiii

RSC-8.aiii: Includes all coverage determination requests.

Data Element T

Review Results:

2.e

RSC-8.b

RSC-8: The organization accurately identifies claims leading to a coverage determination request and correctly uploads the
count into HPMS including the following criteria:

No data

Data Sources:

2.e

RSC-8.bi

RSC-8.bi: Rejected claims are counted at the unique contract, beneficiary, prescriber, pharmacy, drug (strength and dosage
form), quantity, date of service (DOS) and formulary-level cumulative opioid MME POS edit. For example, if multiple
transactions are submitted and rejected by the sponsor for the same formulary-level cumulative opioid MME POS edit from
the same pharmacy for the same beneficiary, prescription (drug, quantity and prescriber) and DOS, this would count as one
rejected claim. However, if a beneficiary attempted to fill the same prescription at 3 different pharmacies, either on the
same day or on different days, and the prescription was rejected each time for the same formulary-level cumulative opioid
MME POS edit, this would count as 3 rejected claims. The same claim and beneficiary should be reported in multiple
reporting sections of the opioid safety edits, if a claim triggers multiple safety edits at POS.

Data Element EE

Review Results:

2.e

RSC-8.bii

RSC-8.bii: Includes all methods of coverage determination request receipt (e.g., telephone, letter, fax, in-person).

Data Element EE

Review Results:

2.e

RSC-8.biii

RSC-8.biii: Includes all coverage determination requests subject to the opioid naïve edit.

Data Element EE

Review Results:

2.e

RSC-9

RSC-9: The organization accurately identifies the number of unique beneficiaries with at least one POS claim rejection related No data
to a hard MME safety edit and/or opioid naïve days supply safety edit who had a favorable (either full or partial) coverage
determination for the prescription(s) subject to the edit. Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

Data Sources:

*

2.e

RSC-9.a

RSC-9: The organization accurately identifies the number of unique beneficiaries with at least one POS claim rejection related No data
to a hard MME safety edit and/or opioid naïve days supply safety edit who had a favorable (either full or partial) coverage
determination for the prescription(s) subject to the edit. Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

Data Sources:

*

2.e

RSC-9.ai

2.e

RSC-9.b

2.e

RSC-9.bi

RSC-9.bi: The beneficiary’s opioid claim is also included in Data Element AA.

Data Element FF

Review Results:

2.e

RSC-10

RSC-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 was overridden due to an exemption
(Elements S, BB), because the beneficiary was not opioid naïve (Element CC), or for whom up to a 7-day supply (covered by
the plan) was dispensed by the pharmacy (Element DD). Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

No data

Data Sources:

*

2.e

RSC-10.a

RSC-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 was overridden due to an exemption
(Elements S, BB), because the beneficiary was not opioid naïve (Element CC), or for whom up to a 7-day supply (covered by
the plan) was dispensed by the pharmacy (Element DD). Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

No data

Data Sources:

*

Standard/Sub-standard Description

Data Element

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

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

*

b: From the data set (RSC6c) of POS rejects related to the opioid naïve days supply safety edits,

a: From the subset of POS rejects (RSC 6b) related to the hard MME safety POS edits,
RSC-9.ai: The beneficiary’s opioid claim is also included in Data Element R.

Data Element U

RSC-9: The organization accurately identifies the number of unique beneficiaries with at least one POS claim rejection related No data
to a hard MME safety edit and/or opioid naïve days supply safety edit who had a favorable (either full or partial) coverage
determination for the prescription(s) subject to the edit. Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

Review Results:
Data Sources:

*

b: From the subset of POS rejects (RSC 6c) related to the opioid naïve days supply safety POS edits,

a: From the subset of POS rejects (RSC 6b) related to the hard MME safety POS edits,

2.e

RSC-10.ai

RSC-10.ai:The beneficiary’s opioid claim is also included in Data Element R.

Data Element S

Review Results:

2.e

RSC-10.b

RSC-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 was overridden due to an exemption
(Elements S, BB), because the beneficiary was not opioid naïve (Element CC), or for whom up to a 7-day supply (covered by
the plan) was dispensed by the pharmacy (Element DD). Correctly uploads the count, if the data set of POS rejects includes
the complete reporting period, into HPMS including the following criteria:

No data

Data Sources:

b: From the subset of POS rejects (RSC 6c) related to the opioid naïve days supply safety POS edits,

*

Standard/Sub-standard ID

Reporting
Section
Criteria ID

2.e

RSC-10.bi

RSC-10.bi:The beneficiary’s opioid claim is also included in Data Element AA.

Data Element BB

Review Results:

2.e

RSC-10.bi

RSC-10.bi:The beneficiary’s opioid claim is also included in Data Element AA.

Data Element CC

Review Results:

RSC-10.bi

Standard/Sub-standard Description

Data Element

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

RSC-10.bi:The beneficiary’s opioid claim is also included in Data Element AA.

Data Element DD

Review Results:

3

No data

Organization implements policies and procedures for data submission, including the following:

No data

Data Sources:

3.a

No data

Data elements are accurately uploaded into the HPMS tool and entries match corresponding source documents.

Data Element Zero
Enrollment

Review Results:

3.a

No data

No data

Data Element A

Review Results:

3.a

No data

No data

Data Element B

Review Results:

3.a

No data

No data

Data Element C

Review Results:

3.a

No data

No data

Data Element D

Review Results:

3.a

No data

No data

Data Element E

Review Results:

3.a

No data

No data

Data Element F

Review Results:

3.a

No data

No data

Data Element G

Review Results:

3.a

No data

No data

Data Element H

Review Results:

3.a

No data

No data

Data Element I

Review Results:

3.a

No data

No data

Data Element J

Review Results:

3.a

No data

No data

Data Element K

Review Results:

3.a

No data

No data

Data Element L

Review Results:

3.a

No data

No data

Data Element M

Review Results:

3.a

No data

No data

Data Element N

Review Results:

3.a

No data

No data

Data Element O

Review Results:

3.a

No data

No data

Data Element P

Review Results:

3.a

No data

No data

Data Element Q

Review Results:

3.a

No data

No data

Data Element R

Review Results:

3.a

No data

No data

Data Element S

Review Results:

3.a

No data

No data

Data Element T

Review Results:

3.a

No data

No data

Data Element U

Review Results:

3.a

No data

No data

Data Element V

Review Results:

3.a

No data

No data

Data Element W

Review Results:

3.a

No data

No data

Data Element X

Review Results:

3.a

No data

No data

Data Element Y

Review Results:

3.a

No data

No data

Data Element Z

Review Results:

3.a

No data

No data

Data Element AA

Review Results:

3.a

No data

No data

Data Element BB

Review Results:

3.a

No data

No data

Data Element CC

Review Results:

3.a

No data

No data

Data Element DD

Review Results:

3.a

No data

No data

Data Element EE

Review Results:

3.a

No data

No data

Data Element FF

Review Results:

3.b

No data

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

Review Results:

4

No data

Organization implements appropriate policies and procedures for periodic data system updates (e.g., changes in enrollment, No data
provider/pharmacy status, and claims adjustments).

Review Results:

5

No data

Organization implements policies and procedures for archiving and restoring data in each data system (e.g., disaster recovery No data
plan).

Review Results:

6

No data

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

No data

Review Results:

7

No data

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

Review Results:

2.e

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

*