60 Day Public Comment Response

A
1 60-Day Comment Response Document

Overview of Comments

2
3 Detailed Summary of Comments

Section

B

C

D

E

F

Commenter's Recommendation

CMS Response

Revised Requirements/Documents

Revised Burden Estimates

Column1
CMS received various comments from Part D sponsors,
PBMs and other associations. We received 8 comments
regarding the following reporting sections: Improving
Drug Utilization Review Controls, Coverage
Determinations and Redeterminations, Grievances, and
Medication Therapy Management.

Comment

4

DUR

5

Grievances

In the recently released 60 day Data Validation Audit N/A
comment period, the referenced Appendix B
Crosswalk for DUR Reporting under the CY2022 DV
(2021 Reporting Requirements) has a few sections
listed as N/A deleted however in the 2021 Record
File Layout it does not show as an N/A but rather a
different element than what was listed in 2020.
Please confirm is the N/A not required for the data
validation audit but remains required for the Part D
Reporting?
Appendix B, page 4, section REPORTING SECTION N/A
CRITERIA (for 2021 reported data), GRIEVANCES
(PART C) (for 2021 REPORTED DATA.),7.
For clarification the CY2021 Part D Reporting
Requirements Technical Specifications are not
required the distribution of the elements by category.
The language for this 2022 document makes mention
of categories. (Organization accurately calculates the
number of grievances by category for which it
provided timely notification of the decision, including
the following criteria)

Please note that the N/A or deletion applies to the data validation
check rather than the data elements themselves listed in the DUR
Record File Layout.

No

No

For Part C Grievances, RSC 7 in Appendix B and Appendix J has
been updated as per the Reporting Requirements to read as follows:

Yes

No

Appendix B: Data Validation Standards, page 24,
N/A
item 6a and page 25, item 10a:
There is a discrepancy between the CY2021 Part D
Reporting Requirements Technical Specifications
and the Attachment B: Data Validation Standards
Document specifically, for the Coverage
Determinations and Redeterminations Reporting. In
accordance with the Medicare Part D Plan Reporting
Requirements: Technical Specifications Document
Contract Year 2021 updated in January 2021, states
that for the coverage determination and
redetermination reports the data should be reported
based on the date the enrollee/enrollee’s
representative is notified in writing of the coverage
determination and redetermination decisions.
However, in the Attachment B: Data Validation
Standards states that the data should be reported
based on the date of decision that occurs during the
reporting period, regardless of when the request for
coverage determination was received. Please clarify
which is the correct date that the data should be
reported for the year 2021.

For CDR, RSC 6a, RSC 10 a, as well as RSC 7 a, have been
updated in Appendix B and J, as per Reporting Requirements to
read as follows:

Yes

No

"Organization accurately calculates the number of grievances for
which it provided timely notification of the decision, including the
following criteria:"
This language has also been updated in Exhibit 14, page 16 of the
DV Procedure Manual.

6

CD/RD

7

RSC 6a: Includes all coverage determinations (fully favorable,
partially favorable, and adverse), including exceptions, with a date of
decision that occurs during the reporting period. Date of the final
decision is based on the date the enrollee/enrollee’s representative is
notified in writing of the coverage determination decision.
RSC 7a: 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.
RSC 10 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.

A

B

C

D

E

F

Section

Comment

Commenter's Recommendation

CMS Response

Revised Requirements/Documents

Revised Burden Estimates

Yes

No

Yes

No

Yes

No

4

CD/RD

Will CMS update the Data Validation documents for N/A
Part D Coverage Determinations & Redeterminations
to reflect what it states in the 2021 Part D Reporting
Requirements, which is to report by notification date?
Or, should sponsors expect an update for the 2021
Reporting Requirements?

5

For CDR, RSC 6a, 7a, and 10a have been updated in Appendix B
and J, as per Reporting Requirements to read as follows:
RSC 6a: Includes all coverage determinations (fully favorable,
partially favorable, and adverse), including exceptions, with a date of
decision that occurs during the reporting period. Date of the final
decision is based on the date the enrollee/enrollee’s representative is
notified in writing of the coverage determination decision.
RSC 7a: 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.
RSC 10 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.

8

CD/RD

In our review of the 2022 Medicare Part C and D
N/A
Reporting Requirements Data Validation Procedure
Manual, Appendix B we found a discrepancy on page
24. To improve consistency, we ask for CMS to
update sections 6 and 7, Coverage Determinations,
to match the section E Notes 2. Coverage
Determinations and Exceptions, bullet 3, on p. 19 of
the 2021 Medicare Part D Plan Reporting
Requirements: Technical Specifications.

For CDR, RSC 6a, 7a, as well as 10a have been updated in
Appendix B and J, as per Reporting Requirements to read as
follows:
RSC 6a: Includes all coverage determinations (fully favorable,
partially favorable, and adverse), including exceptions, with a date of
decision that occurs during the reporting period. Date of the final
decision is based on the date the enrollee/enrollee’s representative is
notified in writing of the coverage determination decision.
RSC 7a: 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.
RSC 10 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.

9

CD/RD

In our review of the Medicare Part C and D Reporting N/A
Requirements Data Validation Procedure Manual,
Appendix B we found a discrepancy on p. 25. To
improve consistency, we ask for CMS to update
section 10.ato match section E.3. on p. 20,
Redeterminations of the 2021 Medicare Part D Plan
Reporting Requirements: Technical Specifications.

For CDR, RSC 6a, 7a, as well as 10a have been updated in
Appendix B and J, as per Reporting Requirements to read as
follows:
RSC 6a: Includes all coverage determinations (fully favorable,
partially favorable, and adverse), including exceptions, with a date of
decision that occurs during the reporting period. Date of the final
decision is based on the date the enrollee/enrollee’s representative is
notified in writing of the coverage determination decision.
RSC 7a: 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.
RSC 10 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.

10

A

B

C

D

E

F

Section

Comment

Commenter's Recommendation

CMS Response

Revised Requirements/Documents

Revised Burden Estimates

Yes

No

No

No

4

DUR

We would request that CMS add additional language N/A
to element CC to emphasize that the request for
coverage determination or appeal be directly linked to
element Z. We would propose the following language
be added to the Appendix J RSC-8.biii “RSC-8 biii:
Includes all coverage determination or appeals
requests subject to the opioid naïve edit specific to
same drug and date”.

5

RSC-8 biii has been updated in Appendix J and Appendix B as
follows:
"Includes all coverage determination or appeal requests subject to
the opioid naïve edit."
As Note #5 in DUR Technical Specifications addresses rejected
claims and the specifications include aspects beyond drug and date,
such as quantity, strength and dosage form; we took out the part
about being "specific to same drug and date".

11

MTM

12

The CY 2021 Part D Reporting Requirements lay out the link
between Data Elements Z and CC.

UHC asks CMS to confirm the process to populate
the data for Elements I, J and K, (Appendix B: Data
Validation Standards, 3. Part D Data Validation
Standards, Medication Therapy Management (MTM)
Programs) in the scenario below. We understand that
Element K will not be validated in the 2022 Data
Validation audit. Element I. Date of MTM program
enrollment.
Element J. Date met the specified targeting criteria
per CMS – Part D requirements in § 423.153(d)(2).
Required if met the specified targeting criteria per
CMS – Part D requirements (May be same as date
of MTM program enrollment).
Element K. Targeting criteria met. Required if met
the specified targeting criteria per CMS – Part D
requirements in § 423.153(d)(2) (Multiple chronic
diseases/multiple Part D drugs/cost threshold, (Drug
management program at-risk beneficiary1, Both)).

Member meets Medication Therapy
Management (MTM) program targeting
criteria on 1/5/22 based on having multiple
chronic diseases/multiple Part D drugs/cost
threshold. Later in the year, on 4/5/22, the
member is identified as a Drug Management
Program At Risk Beneficiary (DMP-ARB).
Given the member meets two reporting
categories, please confirm the reporting for
this member should be as follows:
• Element I = 1/5/22 (date member met MTM
program criteria)
• Element J = 4/5/22 (date the member meets
both MTM program and DMP-ARB criteria)
• Element K = “Both”

This question is outside of the scope of this PRA.
This PRA is for the 2022 DV of CY 2021 reporting data, not CY 2022
reporting data. Please reference the CY 2021 Medicare Part D
Reporting Requirements which is located at
https://www.cms.gov/files/document/cy2021-part-d-reportingrequirements-120920.pdf.
Specifically refer to the Section II. Medication Therapy Management
Programs and footnotes 1 and 2 that identify where items are not
applicable for January 1 – December 31, 2021 reporting period.