60 Day Public Comment Response

60-Day Comment Response Document
Overview of Comments
CMS received comments from four Part D sponsors regarding the following sections from the Data Validation Procedure Manual: Data Validation Requirement and DV Review Findings
Detailed Summary of Comments
Section

Comment

Commenter's Recommendation

DV Procedure
Manual, 1.1
Data Validation
Requirement

Two commenters disagree with the proposal to move the end date
of the data validation review period from June 30 to June 15
because more time is needed to complete all tasks and review
before submission.

DV Procedure
Manual, 5.3.1
DV Review
Findings

Two commenters request CMS not eliminate the ability currently for Request to revert to the current
a sponsor and DVC to review draft DV findings prior to submission. DV manual language permitting
Such reviews allow issues to be resolved in the early stages of DV, this review process.
e.g. additional documentation if DVC findings are inconsistent with
SO-submitted documentation.

CMS Response

Request to maintain current data CMS's changes to streamline the data validation
validation time period April 1 process will support a shortened review period.
June 30
Additionally, the earlier deadline in June will allow
sponsors time to request an appeal, should there
be disputes or unresolved issues with their DV
results. For these reasons, CMS will continue to
propose the June 15th deadline.
CMS will allow SOs to review preliminary findings,
but review of findings should be limited to
technical corrections for factual accuracy. The DV
audit must be conducted independently by the
DVC. Therefore, DVCs should not make and SOs
should not suggest changes to findings based on
new data not submitted timely to DVCs or request
changes that are not supported by evidence. If
organizations are not satisfied with the findings,
SOs may follow the appeal process outlined in the
DV Manual.

Revised
Requirements/
Documents
No

Revised
Burden
Estimates
No

Yes

No