Response to Comment

Responses to Comments Received on the Revised CMS-10788
Federal Register 60-Day Notice (89 FR 6118)
Table of Contents
A.

Introduction ...................................................................................................................... 1

B.
Comments on the 2023 Drug Data Collection (RxDC) Reporting Instructions and
Templates ................................................................................................................................... 1
A. Introduction
We received four comments on specific issues regarding the notice of the revised Prescription
Drug Data Collection (RxDC) PRA package published in the Federal Register on January 31,
2024 (89 FR 6118). The 60-day comment period closed on April 1, 2024.
The PRA package contains the RxDC Reporting Forms that issuers must file with CMS each
year by June 1 and the accompanying Reporting Instructions. The PRA package modifies the
RxDC Reporting Instructions that were previously approved by OMB under OMB Control
Number 0938-1407.
The comments addressed clarification of the instructions and conveyed concerns about data
quality, reporting burden, and the submission deadline. The summary below sets forth each
comment and our response.
B. Comments on the 2023 Prescription Drug Data Collection (RxDC) Reporting
Instructions and Templates
1. All four comments requested that the Departments obtain OMB approval and publish
finalized changes to the reporting instructions at least six to 12 months in advance of the
reporting deadline. Commenters expressed concern about the ability of the reporting entities
to accurately implement the changes, given that this data collection involves data sharing
and coordination among multiple entities. One comment suggested that in the alternative,
the Departments should grant good faith reporting relief and/or defer enforcement of the
June 1, 2024 deadline. Two comments additionally recommended that the Departments
begin holding webinars with stakeholders five to seven days after publishing the proposed
changes to the instructions.
Response
The Departments appreciate concerns expressed by the commenters and acknowledge the
challenges faced by the reporting entities and the potential impact of the current timeline on
the quality of the reported data. The Departments will continue to strive to finalize changes
to the instructions significantly in advance of the reporting deadline. As the program
matures, the Departments also anticipate that the need for clarifications and for substantive
changes will diminish. In addition, the Departments agree with the recommendation to host
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webinars shortly after release of the proposed changes to the instructions, and will seek to
do so, subject to resource availability.
2. Three comments requested that the Departments continue to suspend enforcement of the
aggregation restriction for another year (until June 2025), as it requires extensive
coordination across multiple reporting entities and their clients within a constrained
timeframe. Two comments similarly requested that the Departments defer enforcement of
the requirement to report pharmacy benefits enrollment on the D6 template for a year,
expressing concerns with the ability to implement this timely, and seeking clarification
regarding enrollment methodology.
Response
The Departments note that the aggregation restriction is a requirement in the regulations as
well as the initial reporting instructions, and its suspension was specific to the initial
reporting years. In addition, given the difficulties encountered by the Departments in
analyzing plans’ and issuers’ data spread across multiple reporting entities, both consistent
aggregation (that will be achieved under the aggregation restriction) and the addition of Rx
enrollment to D6 are critical to the Departments’ ability and efforts to continue to allow
multiple reporting entities to submit the data of plans and issuers. However, the
Departments recognize that implementation will present stakeholders with logistical
challenges that may result in reporting entities being able to submit only partially accurate,
complete, or consistent data with respect to these two requirements by the June 1, 2024
deadline. The Departments' approach in implementation of this requirement will focus on
assisting those reporting entities who are working diligently and in good faith to comply
with this requirement when reporting data in 2024 and toward achieving full compliance.
The Departments also clarified in the instructions that member months on D6 should be
calculated as described in the definition for life-years.
3. Three comments related that issuers continue to experience difficulty obtaining complete
and accurate employer vs. member premium and other information from group health plans.
Two comments requested that the instructions clarify that employer group health plans that
fail to provide this information to their reporting entities must submit the data directly to the
Departments. One comment recommended an enforcement safe harbor for reporting entities
that are unable to obtain the necessary information from plan sponsors despite a good faith
effort, while another comment supported the exclusion of plans that did not provide the
necessary information from calculation of average monthly premium in section 6.1 of the
proposed instructions. One comment noted that the simplified approach of dividing the total
annual premium by 12 could lead to misleading numbers in circumstances involving partialyear data.
Response
The Departments recognize the difficulty faced by issuers in complying with statutory
requirements to report data which may not be in their immediate possession and which they
may not be able to access despite appropriate contractual arrangements and good faith
efforts. The Departments note that section 6.1 directs issuers to exclude plans that did not
provide the necessary information from the calculation of average monthly premium in the
issuer’s D1. The Departments further note that section 3.8 of the proposed instructions
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already stated that if an issuer or vendor does not submit P2 and D1 (or other required files)
on a plan’s behalf, then the plan must submit P2 and D1 directly to CMS. However, the
Departments added the same clarification to the description of average monthly premium in
section 6.1 of the instructions. The Departments also confirm that division of total premium
by 12 in section 6.1 is deliberate as it will enable the Departments to obtain accurate and
consistent annualized data in all circumstances.
4. Two comments recommended making the Form 5500 Plan Number optional because it is
not received or stored by third-party administrator reporting entities and issuers.
Response
The Departments revised the instructions to clarify that reporting entities that do not obtain
this information from the plan may leave this field blank.
5. Three comments requested clarification regarding the carve-out description field in D2. Two
comments questioned whether “Medical only” is an appropriate carve-out category. One
comment recommended removing references to “the majority of the plan’s other benefits” to
relieve reporting entities from the need to analyze services provided to a plan by other
service providers.
Response
The proposed instructions added details to the description of carved-out benefits in response
to questions about how to report such benefits and how to identify the relevant coverage
arrangements, as well as to improve the Department’s ability to differentiate between
subsets of data submitted by multiple reporting entities. The Departments revised the
instructions to clarify that the reporting entity does not need to analyze services provided to
a plan by other service providers, and that “Medical only” is used to indicate that a different
reporting entity will submit data regarding the plan’s pharmacy benefit.
6. Two comments recommended enabling reporting entities to use actual dates for prior plan
year beginning and end dates for termed plans in P2, instead of the workaround dates that
were designated in the proposed instructions to prevent the system from rejecting
submissions containing plan year end dates in the year prior to the reference year. One of
these comments additionally suggested using an indicator or null values as an alternative,
and expressed concern about the burden of the additional required reporting.
Response
The proposed instructions added clarification regarding prior plan year beginning and end
dates for termed plans in response to questions about the data collection system’s limitations
in being able to accept such dates. The Departments revised instructions to clarify that
inclusion of such plans in P2 remains optional and that null values can be used in lieu of the
workaround 01/01/2023 and 01/02/2023 dates.
7. One comment requested clarification regarding whether inclusion of non-drug items such as
medical devices that are not used in tandem with drugs is appropriate in the medical benefit
drugs category on D2.

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Response
No changes were made to the instructions based on this comment. The Departments note
that the referenced provision in section 8.1 of the proposed instructions refers to
pharmaceutical supplies, medical devices, nutritional supplements, and OTCs in the
appropriate spending category in D2 if the products are covered under a plan’s medical
benefit (emphasis added). Therefore, medical devices unrelated to medical benefit drugs
should not be reported in the medical benefit drug category on D2. The clarification in the
proposed instructions was intended to clarify that all such items that are covered under the
medical benefit should be reported in the relevant category on D2 (hospital, primary care,
specialty care, or other), while some items may also need to be reported in the medical
benefit drugs category as appropriate. The Departments welcome suggestions for how to
further improve the clarity.
8. One comment inquired whether the Departments intend to update the CMS crosswalk and
data validations technical documents annually or only as needed.
Response
The Departments anticipate that the CMS crosswalk is likely to require annual updates, for
example, to include new drugs. The Departments expect to update data validations only as
needed, for example, to reflect new or modified data elements, or if new validations are
determined to be necessary for any required data elements that experience poor compliance
with the instructions.

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