Response to Comments Document

Response to Public Comments Received – CMS-10453 (OMB 0938-1228)

CMS received 11 comments regarding the Medicare Advantage and Prescription Drug Programs: Part C and Part D Explanation of
Benefits information collection request (ICR), which was posted in the Federal Register on June 6, 2023 for a 60-day public comment
period (88 FR 37066). This document provides summaries of the comments received and CMS’ responses.
Section/Subject
Part D, Medicare
Prescription Payment
Plan (MPPP)

1

Comment
Several commenters provided input on the
inclusion of MPPP language in the EOB.
Some commenters recommended that
CMS not include any information about
the MPPP on EOBs since EOBs are only
required following months in which the
Part D benefit is used and are therefore
not a dependable mechanism for
conveying monthly information required
for MPPP participants. Commenters noted
that including MPPP information on EOBs
could confuse enrollees and would be
contrary to CMS’ efforts to maintain
streamlined EOB processes and minimize
duplicative administrative work.

CMS Response
We agree with the commenters that enrollee-specific financial
information related to the MPPP should not be included on the EOB.
Under 42 CFR 423.128(e), EOBs must include claims information in
relation to how the enrollee moves through the phases of the Part D
benefit, including information about incurred costs, and reflecting the
enrollee’s position as of that month in relation to the annual deductible,
initial coverage limit, and out-of-pocket threshold. As such, CMS
believes the EOB must continue to reflect what the enrollee, the Part D
plan, and others would have paid toward that month’s claims under
their plan benefit versus what an enrollee who participates in MPPP
actually paid. Pursuant to MPPP Part 1 Draft Guidance,1 the latter
information will be provided to such enrollees in a monthly billing
statement and therefore would be duplicative if reflected in the EOB, as
the commenters suggest. Additionally, the statute and CMS regulations
require that the EOB be provided following months in which the Part D
benefit is used, making it an insufficient method for conveying monthly
MPPP invoice information. Considering the aforementioned, we intend
to include only high-level references to the MPPP on EOBs to clarify that
amounts shown in the EOB may differ from what an MPPP participant
paid and how enrollees can learn more about the MPPP payments and
program. See the PRA attachments for the proposed text.

CMS’ “Maximum Monthly Cap on Cost-Sharing Payments Under Prescription Drug Plans: Draft Part One Guidance on Select Topics, Implementation of Section
1860D-2 of the Social Security Act for 2025, and Solicitation of Comments” was published August 21, 2023 and is available at
https://www.cms.gov/files/document/medicare-prescription-payment-plan-part-1-guidance.pdf

Section/Subject
Part D, MPPP

Comment
Two commenters recommended waiting
until CMS releases final MPPP guidance to
incorporate MPPP information into the
CY2026 EOB model or later.

Part D, MPPP

Multiple commenters recommended that
CMS use the EOB to inform Part D
enrollees about the MPPP, including
through examples or scenarios that
illustrate how the program can alleviate
high prescription drug cost burdens. Some
commenters recommended that the EOB
include an enrollee’s history of MPPP
payments, future costs owed, and
information as to whether an enrollee has
met their out-of-pocket cap.

Part D, MPPP

One commenter noted that because the
statute requires disenrollment from MPPP
for non-payment of amounts billed, this
would coincide with existing premium
billing processes and should be
incorporated therein.
One commenter recommended that CMS
conduct robust education and outreach to
inform enrollees about MPPP.

Part D, MPPP

CMS Response
We thank the commenters for this input. Though the 2025 EOB will not
be final until after the 2025 MPPP final guidance is issued, Paperwork
Reduction Act timelines required us to request stakeholder feedback
prior to the final MPPP guidance being released. We believe that
including MPPP information in EOBs beginning in 2025, instead of
waiting until 2026, will provide the most clarity for enrollees regarding
how amounts reflected on EOBs may differ from what enrollees paid at
point of sale. We refer the commenters to the previous response and
the PRA attachments for more detail about the high-level information
we're proposing to add to the 2025 EOB.
The purpose of the Part D EOB is to communicate to enrollees when
their Part D benefits are used and how those benefits align with the
enrollee’s annual deductible, initial coverage limit, and out-of-pocket
threshold. EOBs are not billing statements, are retrospective, and are
required following months in which the Part D benefit is used. Including
information about the MPPP, such as the process for opting in and
examples of payment structures, is likely to detract from the important
information the EOB is intended to provide and could confuse enrollees.
It would also be duplicative as this type of information about the MPPP
will be provided in multiple other enrollee materials, some of which are
discussed in the MPPP Draft Part 1 Guidance. We refer the commenters
to the previous responses and the PRA attachments for more detail
about the high-level information we're proposing to add to the 2025
EOB.
This comment is out of scope. We refer the commenter to the MPPP
Draft Part 1 Guidance, which was released on August 21, 2023.

This comment is out of scope. We refer the commenter to the MPPP
Draft Part 1 Guidance, which was released on August 21, 2023.

Section/Subject
Part D, MPPP

Part D, General
support
Part D, Timing

Comment
One commenter recommended that CMS
conduct focus group testing regarding
whether the term “maximum monthly
cap” resonates with consumers or
whether a different term should be used in
enrollee educational materials.
One commenter expressed strong support
for the Part C and Part D EOBs.
One commenter urged CMS to issue a final
model as soon as possible and no later
than September 2023.

Part D, Delivery

One commenter requested that CMS
expand the opportunity for electronic
delivery of the EOB to include electronic
delivery without prior authorization.

Part D, Languages

One commenter requested approval to
remove information regarding language
translations from the EOB cover page.

Part D, Format

Two commenters requested that CMS
offer plans the option to include or
remove the decimal points and cents
(”.00”) in chart amounts to alleviate
formatting burden.

CMS Response
This comment is out of scope. We refer the commenter to the MPPP
Draft Part 1 Guidance, which was released on August 21, 2023.

We thank this commenter for the feedback.
We appreciate that plans need these model documents with sufficient
time to update their systems. However, we cannot finalize the 2025 EOB
until we finalize 2025 policies that may affect the content of the EOB.
The final version of the 2025 Part C and Part D EOBs will be published in
spring 2024.
We disagree with the commenter’s suggestion to permit electronic
delivery of EOBs without approval by the enrollee, and note that doing
so would require a change to the regulations at § 423.2267(d)(2) and
create an inconsistency between the policy for electronic delivery of the
EOB and the policy for electronic delivery of other required materials
containing individualized information.
We disagree with the commenter’s suggestion to eliminate text
regarding translating the EOB into other languages. Under §
423.2267(a)(3), plans are required to provide EOBs in any non-English
language upon receiving a request or when otherwise learning of the
enrollee's need for materials in a non-English language. Further, under
regulations implementing Section 1557 of the Affordable Care Act,
specifically 45 CFR § 92.101, Part D sponsors must take reasonable steps
to ensure meaningful program access for individuals with limited
English proficiency.
We have incorporated this change.

Section/Subject
Part D, Format

Part D, Format

Part D, Format

Part D, Format

Comment
Two commenters requested that CMS give
plans the option to print the EOB in
landscape or portrait orientation to
alleviate formatting burden.
One commenter requested clarification as
to the placement of the footer and
whether the information in the footer
must be on every page of the EOB.
One commenter requested that CMS allow
plans to spread text boxes and columns
across the page to save space.
One commenter requested that CMS
provide a large print sample of the EOB.

Part D, Definitions

One commenter recommended adding a
definitions page or section.

Part D, Terminology

One commenter recommended that the
terms “stage” and “phase” not be used
interchangeably, and that “phase” be used
in all instances.
One commenter requested that Out-ofPocket Costs and Total Drug Costs be
capitalized and requested general
consistency between exhibits and
instructions.
One commenter recommended that EOB
changes be mostly based on statutory
changes and that the term Total Drug
Costs be removed throughout the
document.

Part D, Terminology

Part D, Terminology

CMS Response
We have incorporated this change.

Plans are required to include a small footer on every page regarding
how enrollees can call the plan if they have questions. Enrollees shared
during EOB user testing that they found this footer information helpful.
Hours of operation are not required footer content.
These are model documents, and plans are permitted to spread text
boxes and text columns across the page to eliminate empty space. We
have clarified this in the Part D EOB instructions.
We thank the commenter for the suggestion and take it into
consideration for future updates. While CMS does not provide large
print versions of all required Part D materials, under § 423.2267(a)(3),
plans must provide accessible formats upon receiving such a request or
when otherwise learning of an enrollee's need for an accessible format.
We thank the commenter for this suggestion. During the EOB redesign
process and user testing, CMS determined that including definitions
beneath the corresponding charts was the most helpful for enrollees.
The EOB instructions and models contain no use of the word “phase.”
We will continue to refer to stages throughout the EOB.

We have capitalized Out-of-Pocket Costs and Total Drug Costs
throughout the instructions and models.

We will not remove the term Total Drug Costs because it refers to gross
covered prescription drug costs, as defined at section 1860D-15(b)(3) of
the Act.

Section/Subject
Part D, Cover Page,
Return Address
Part D, Chart 1, Tier
Number
Part D, Chart 1, Price
Change

Part D, Chart 1, Lower
Cost Alternative Drug

Comment
One commenter recommended adding a
return-to-sender address placeholder.
One commenter suggested adding tier
numbers to Chart 1 because it may help
enrollees understand their costs.
One commenter recommended that CMS
remove the Price Change column because
the information may be confusing to
enrollees.
One commenter recommended that CMS
clarify what happens when the current
drug is already the lowest cost drug.

Part D, Chart 2

One commenter recommended that CMS
explain the types of financial assistance
that Part D enrollees may receive and
whether the assistance counts toward
TrOOP.

Part D, Chart 2 and
throughout

One commenter requested that CMS
reference Extra Help in a bullet separate
from other payment examples, because
Extra Help is a component of the Medicare
Part D program, unlike the other
examples.
One commenter suggested that CMS
clarify that Chart 3 identifies the stage an
enrollee was in at the end of a reporting
month.
One commenter requested that CMS
clarify that enrollees may have cost

Part D, Chart 3

Part D, Chart 3

CMS Response
In the return mailing address field, plans should use the return address
that meets the plan’s business needs.
We thank the commenter for this comment and will consider it for
future years.
Under 42 CFR 423.128(e)(4), EOBs must include any cumulative
percentage increase in the negotiated price since the first claim of the
current benefit year. For this reason, we do not intend to remove the
“Price Change” term or column.
We thank the commenter for this suggestion. We have clarified the
instructions to include that if no lower-cost therapeutically equivalent
drug is available, plans may enter: “No lower-cost alternative drug is
available.”
We thank the commenter for this suggestion. The EOB provides the
information required under 42 CFR § 423.128(e), which specifies that it
must be provided in a manner that can be easily understood by Part D
enrollees. The EOB clearly indicates in the charts and text boxes the
enrollee’s out-of-pocket costs (TrOOP), and explanations for terminology
written in a beneficiary-friendly manner. CMS does not expect to
release final guidance related to the Part D redesign until Spring 2024.
In the interest of conserving space, we will not reference Extra Help as a
separate bullet.

Thank you for this feedback. We have clarified text in Chart 3 to say:
“This chart helps you understand what stage you were in at the end of
[insert name of month and full year] and when you’ll move to the next
stage.”
We thank the commenter for this comment. Chart 1A identifies drugs
excluded from Part D that are covered under an enhanced benefit.

Section/Subject

Part D, Chart 3

Part D, Chart 3

Part D, Chart 3

Part D, Chart 3

Part D, Chart 4

Part D, Chart 3

Comment
sharing for drugs that are covered under
an enhanced benefit.
One commenter requested that CMS
clarify that the deductible does not apply
to the preventative tetanus vaccines, or
not reference tetanus at all.
One commenter requested that CMS allow
plans with no enrollee cost sharing to
suppress the coverage phase details
section, regardless of the low-income cost
sharing level.
One commenter requested that CMS
provide examples for a plan that does not
have a deductible and a plan that has a
brand-only or tier-level deductible.
One commenter requested that CMS
clarify that the annual deductible is not
applicable to low-income subsidy (LIS)
enrollees.
One commenter recommended that, in an
effort to conserve paper, CMS allow plans
to suppress Chart 4 when there are no
drug updates for the member.
One commenter requested that CMS
provide additional clarification on drug
payment stages for LIS enrollees, given the
differences in their coverage and cost
sharing compared to non-LIS enrollees.
Examples 6 and 7 in Exhibit C should be
updated to clarify which costs would be
paid by the LIS enrollee directly and which

CMS Response
Because excluded drugs are not included in Chart 3, we decline to add
such language.
We thank the reader for this suggestion. We specify on the EOB that the
deductible doesn’t apply to most adult Part D vaccines, which includes
the preventative tetanus vaccine. We note that the tetanus vaccine,
when administered because of an injury or wound, is covered under
Part B and is, therefore, not a Part D vaccine.
This section can be suppressed for full benefit dual-eligible enrollees
who are either institutionalized or receiving home and communitybased waiver services (low-income cost sharing (LICS) level 3), but
because LICS levels have not changed for 2025, the information should
not otherwise be suppressed.
We refer the commenter to Part D Model Materials EOB Exhibit C,
which includes examples of Chart 3 for plans with no deductible, as well
as plans with a brand name/tier-level only deductible.
We have incorporated this change.

We thank the commenter for this comment. Considering the
requirements at 42 CFR § 423.128(e)(5), we will not suppress Chart 4,
including when there are no drug updates for enrollees. The
information on Chart 4 does not need to be presented on a separate
sheet of paper.
We thank the commenter for this comment. We include separate
examples of Chart 3 for LIS and non-LIS enrollees. The notes under the
chart explain the various parts of the chart and benefit stages. We
specify in Charts 1 and 2 that Extra Help counts toward TrOOP. The
purpose of the examples of Chart 3 in Exhibit C is to display how a
completed EOB might look, and the numbers contained within the
examples, while realistic, are fictional. The EOC provides information

Section/Subject

Part D, Instructions
and Exhibit F

Part C, MSA and PPO
Monthly

Part C

Part C, Monthly HMO
and PPO

Comment
costs would be covered on their behalf by
the low-income cost share subsidy (LICS).
One commenter suggested that language
regarding the LIS rider should be removed
when EOBs are sent to non-LIS enrollees,
to minimize the risk of enrollee confusion.
A commenter recommended CMS include,
for clarity to enrollees, a section in the
Part C EOB for plans to include denial
reasons when there is no member liability.
The commenter also expressed concern
with a CMS Program Audit.
A commenter recommended that CMS
integrate the information in the FAQ
document into the EOB instructions.

A commenter inquired about a portion of
the Part C EOB which states that an
enrollee can make an appeal if a claim is
approved and the enrollee disagrees with
the amount they were charged. The
commenter asked whether or not this type
of dispute qualifies as an appeal, or if it is
considered to be a grievance. The
commenter pointed out that an enrollee
would not receive an integrated denial
notice (IDN) in such a case, because the
claim was approved.

CMS Response
regarding how an enrollee moves through the Part D benefit stages, and
we do not duplicate this information in the EOB.
We thank the commenter for this comment. Under the current
instructions, the LIS Rider language is only included for LIS enrollees.

We thank the commenter for this feedback; however, at this time, we
will not be adding a new section for denial reasons that is solely
designated for denials that have no corresponding member liability.
Issues that pertain to CMS Program Audits are outside the scope of this
ICR and should be sent to [email protected] for
response.
In order to ensure that the instructions in the EOB remain as concise as
possible, CMS will not be adding to the instructions at this time.
However, we appreciate this feedback and will consider ways to include
clarifying information in future updates to the EOB templates in a way
that is practical for users.
If an enrollee believes they were charged an incorrect cost-sharing
amount for an approved item or service as reflected on the EOB, the
plan should process the request as an organization determination. If
the plan determines the cost-sharing amount was correct, it must issue
an IDN which would provide the enrollee information about how to file
an appeal. For more information about organization determinations and
appeals, see the Parts C & D Enrollee Grievances,
Organization/Coverage Determinations, and Appeals Guidance available
on cms.gov.