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Overview of Comments
CMS received comments from Part D sponsors, PBMs, MTM vendors, and other organizations. We received over 65 comments from 17 organizations regarding revisions to the Standardized Format.
Detailed Summary of Comments
Standardized Format
Section
Comment
Commenter's Recommendation
CMS Response
Revised Requirements/Documents
Cover Letter
CMS received several
comments regarding
whether the cover letter
could be modified in the
case of delivery of the CMR
to someone other than the
beneficiary, such as
authorized representative
or other healthcare
provider.
One commenter recommended including an
option to capture when a CMR was
completed with someone other than the
beneficiary as is available in the current
standardized format. Yet another commenter
suggested the creation and distribution of a
separate representative-facing cover letter
again in occasions where the CMR is
completed on behalf of the beneficiary, i.e.
with the caregiver.
The current technical instructions explain that when the CMR is performed on
the behalf of a cognitively impaired beneficiary with someone other than the
beneficiary, such as the beneficiary’s legally authorized representative,
caregiver or prescriber, the MTM provider should discuss the delivery of
summary materials with the beneficiary’s representative to determine to whom
and where they should be sent. CMS expects the CMR summary will be
delivered to the beneficiary’s authorized representative, such as the health care
power of attorney, if known. When sending the CMR summary to the
beneficiary’s legally designated authorized representative, the inside address
should include the beneficiary’s name, c/o . The instructions also recommend that sponsors
include an explanatory note when the CMR is performed with an authorized
individual on the behalf of a cognitively impaired beneficiary. Once the revised
Standardized Format document is approved by the Office of Management and
Budget (OMB) through the Paperwork Reduction Act (PRA) process, CMS will
release updated technical instructions. The current instructions and frequently
asked questions (FAQ) documents are posted at:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/MTM.
No
Revised
Burden
Estimates
No
Cover Letter
The proposed template
Request that CMS consider reintroducing this Thank you for this suggestion. CMS has added the to the Cover Letter.
barcodes, document
reference numbers,
beneficiary identifiers, case
numbers or the document
title on the cover letter.
Yes
No
Cover Letter
Commenters asked
whether the hours of
operation are no longer
required as they were not
included in the proposed
standardized format.
Yes
No
Cover Letter
The proposed template
N/A
appears to indicate that
the plan name is no longer
required.
Several commenters
N/A
inquired whether TTY no
longer required as it was
not included in the
proposed standardized
format.
CMS added this detail to the Cover Letter.
Yes
No
CMS added this detail to the Cover Letter.
Yes
No
Cover Letter
Recommend including additional contact
CMS added this detail to the Cover Letter.
details, such as days and hours of operation,
or the option to direct beneficiaries to call a
department, rather than a specific person.
Cover Letter
We received several
comments regarding the
removal of the plan logo
from the first page of the
PML and MAP.
Cover Letter
We received several
comments about the
contact information on the
revised cover letter only
including the name of a
pharmacist.
Based on interviews with the pharmacists and sponsor/MTM representatives,
the logo was removed from the first page of the Action Plan and Medication List
to save space and improve readability. It remains as an optional insert on the
top left corner of the Cover Letter. More instructions will follow in the updated
technical guidance.
No
No
Recommendations included allowing MTM
provider contact information to be listed on
the cover letter and on each document,
similar to the current MAP and PML sections
and having the flexibility of including the
name and title of other authorized health
care professionals, who may complete a
CMR.
Grammar modification:
Recommendation: 1.Su Lista de
Current: Su Lista de
Medicamentos le ayudará a monitorear sus
Medicamentos le ayudará medicamentos y saber cuándo y cómo
a monitorear
tomarlos. Your list of medications will help
susmedicamentos y saber you monitor your medications and know
cuando y como tomarlos. when and how to take them (medications).
Your list of medications will
help you monitor your
medications and know
when and how to take
them (medications).
CMS updated the Cover Letter to allow signature of the MTM provider of the
CMR, which could be the pharmacist or other qualified provider. The MTM
provider information was removed from the PML and MAP in keeping with
measures to reduce the length of the standardized format.
Yes
No
Gracias por tu comentarios. Vamos agregar el espacio recomendado. Thank you
for your comments. We will add the recommended space and accents.
Yes
No
Medication List (PML)
Agree with many proposed
changes, disagreed with
renaming of the
Medication Action Plan
(MAP) to "Recommended
To-Do List". Many of the
interventions/recommend
ations on the MAP do not
require action by the
patient who receives the
comprehensive medication
review (CMR). This could
result in patient confusion.
The revised title for the Medication Action Plan (MAP), “Recommended To-Do
List,” tested better than "Medication Action Plan" when we tested potential
revisions with consumers in limited cognitive interviews in 2018. It did not
cause patient confusion. The participants generally understood that the MAP
included items they should complete and the revised title may have helped
communicate this. In addition, participants generally liked the revised title, with
several noting that it clearly indicated what the section was about. One
participant explained that he was familiar with the concept of to-do lists. A few
other participants suggested titles such as: “Reminders” or “Things you should
know” because some of the items on the list were things that she should not do
(e.g., eat grapefruit), rather than “to do” items.
No
No
Medication List (PML)
N/A
No
No
No
No
Cover Letter
Medication List (PML)
The recommendation was to retain the logo
on the first pages of each document in the
standardized format for context on the
beneficiary's behalf. In addition, a request
was made for further instructions on the
inclusion of the logo on the Cover Letter.
Consider renaming the MAP to "My Plan" as
an enrollee friendly option and adding a "no
action needed" or "monitor" checkbox so
that the recommendation could still be
documented for the patient's benefit.
While CMS uses the term “physician,” it is
CMS does not use the term "physician" in the proposed Standardized Format
noted that beneficiaries could also have a
document, but rather used the term "prescriber".
nurse practitioner or a physician assistant as
their primary care provider. Accordingly,
CMS should replace “physician” with
“primary care providers and other
specialists” to better inform the scope of
providers that should receive this
information.
A couple of commenters
N/A
The current technical instructions note that for non-prescribed OTCs, enter
sought clarification on the
“self” or leave this field blank. The technical instructions will be updated and
desired selection for the
released after the document is approved and finalized.
prescriber field when an
over-the-counter
medication is recorded.
Medication List (PML)
Medication List (PML)
Medication List (PML)
Medication List (PML)
Medication List (PML)
Please confirm that the
“How I take it” portion of
the Medication List would
follow the same
expectations as the
“directions for use” section
found in the Personal
Medication List.
Some commenters pointed
out the listing of either the
brand or generic drug on
the medication list and that
inclusion of the brand
when the beneficiary is on
a generic medication may
lead to confusion.
N/A
The “How I Take it” field notes to < Insert regimen, (e.g., 1 tablet by mouth
daily), use of related devices, and supplemental instructions as appropriate >.
This includes the directions for use. The current Standardized Format field is
named “How I Use It”.
No
No
The recommendation was to require the
name of the actual medication being
dispensed as the true requirement. For
example, if atorvastatin 40 mg is dispensed,
the medication list must at least display
“Atorvastatin 40 mg.” If Lipitor 40 mg was
dispensed, the medication list must display
“Lipitor 40 mg.” Additionally, clarification
was sought that this would remain
unchanged from how the PML currently
functions.
We received several
We recommend CMS consider re-instating
comments on the “Other the “Other Information” box. This additional
Information” box which
section would allow CMR providers to
allowed a pharmacist, or
empower the beneficiaries with valuable
other provider, the space counseling points when needed and could be
to enter general
voluntarily populated at the discretion of the
information / instruction to CMR provider.
the patient. This field was
removed in the revised
standardized format but
was of value for including
additional patient centric
information that may not
have been captured
elsewhere.
We agreed with these comments and this is consistent with the current
technical instructions which note: For brand drugs and branded generics, list
both generic and brand names, such as “Generic Name (Brand Name)”. An
example is Furosemide (Lasix). For generic drugs, list the medication name as
“Generic Name” (e.g., Furosemide).
No
No
CMS will add back the "Other Information" box to the Medication List, and note
in the upcoming technical instructions that this field may be optional or
deleted.
Yes
No
We are also in support of
the separation of allergies
and side effects. We find
that beneficiaries
expressed interest in
adding information to the
PML on common drug
interactions (39.6%), side
effects (40.3%), and special
instructions (40.3%).
Furthermore, 34.8%
requested information
about alternative
medications in the same
class that could be
cheaper.”
We received comments
about the allergies box
being moved to the bottom
of the Medication List on
the proposed format.
CMS does not intend to revise the content of the Standardized Format, but
notes consistent with the current technical instructions and FAQ document,
Part D sponsors and MTM providers are encouraged to supplement the
Standardized Format with additional materials and information that may aid a
beneficiary. The instructions state that the enclosure notations or postscript of
the Cover Letter may be used to list or describe supplemental materials that will
be included in the package with the Format. The technical instructions will be
updated and released after the document is approved and finalized.
No
No
No
No
We realize there is limited space on the PML,
but guidance on specific supplemental
instructions should address making the
Medication List patient centered. With
respect to side effects, we recommend
incorporating sentinel side effects into the
Medication List under its own heading and
specific to each medication.
The recommendations were to rearrange the Based on interviews with beneficiaries, the allergies and side effects box was
form to include this information at the top of separated into two boxes and moved to the end.
the form for ease of access to providers and
because it is typically the first item discussed
and provides background information.
Medication List (PML)
Inclusion of bulleted
This commenter recommends an approach
information within the
that would allow for a non-bulleted
“What I should do” portion formatting of this content.
of “My To-Do List” has the
potential to create undue
burden in the technical
development of that
formatting.
Based on interviews with beneficiaries, participants liked the revised Action
Plan, and thought the checkboxes could help patients recognize the document
as a To-Do List and make it “more actionable.” We received limited feedback
from plans and MTM providers that the checkboxes may be difficult to
program, while others did not think the checkboxes and graphics would present
technical issues.
No
No
Medication List (PML)
Please specify the desired
content of the “My To-Do
List” when no items are
identified by the CMR
provider.
N/A
As noted in the current technical instructions, there may be CMRs that do not
identify issues of current drug therapy or beneficiary-specific action items. The
Format allows plan sponsors to enter other statements into a new MAP as
appropriate for the beneficiary, such as reinforcing compliance, maintaining
beneficiary’s actions, and acknowledging beneficiary success in his/her
medication therapy. Beneficiaries will best understand a consistent deliverable
after their CMRs, including the medication action plan, even if there are no new
beneficiary-specific action steps. The technical instructions will be updated and
released after the document is approved and finalized.
No
No
Medication List (PML)
Grammar modification:
Current: Como lo tomo |
Por que lo tomo How to
take them (medications) |
Why I am taking them
(medications).
Several commenters asked
about the inclusion of
blank lines or rows at the
end of the medication list,
this would allow
beneficiaries to add in
medications for tracking
post- CMR. If they were to
be included, how many
would CMS recommend?
Recommendation: Cómo lo tomo | Por qué
lo tomo How to take them (medications) |
Why I am taking them (medications).
Gracias por tu comentarios. Actualizamos el documento. Thank you for your
comments. We updated the document.
Yes
No
N/A
This is a good suggestion which we will include in the updated technical
instructions. We recommend the addition of a minimum of three blank rows
within the completed medication list.
No
No
Medication List (PML)
Medication List (PML)
Commenter supports the N/A
removal of the strength
from the medication
directions. However as this
change is not specifically
identified in the proposal,
we ask for confirmation
that the intent is to remove
this requirement. From 1
tablet (20mg) by mouth
daily to 1 tablet by mouth
daily.
Thank you for your support. Yes, that was our intent. Several participants
during cognitive interviews indicated that including the total dose in the “How I
use it” field is confusing. Several participants noted that the strength of the
medication is listed both in the medication field and the “How I use it” field.
They indicated that this could be confusing when a patient is supposed to take
two tablets of a particular medication – e.g., two pills that are 800 mg each, or
1600 mg total. If patients read “800 mg” on their pill bottle, then reads “1600
mg” in the “How I use it” field, the participants felt they might be confused
about how much to take, which could contribute to a dangerous situation
where someone is taking the wrong dose. They therefore suggested removing
this information from the “How I use it” field to avoid causing confusion.
No
No
Medication List (PML)
N/A
We agree with this comment. More information will be in the technical
instructions including an explanation that the Allergies box could be deleted if
there is no relevant information to include, or the MTM provider may populate
the box with no known drug allergies to indicate this was discussed.
No
No
Auto-populate the “allergies” section. The
allergies section should be auto-populated
with “no known drug allergies,” rather than
left blank, to ensure that this question is
addressed during the provision of the CMR.
Medication List (PML)
Require information on quantity, dose,
dosage form, route of administration, and
frequency. This would ensure clear
communication of instructions captured
during the review. Inclusivity for all relevant
providers.
Standardized CMR format Increase number of medications that fit per
inflexible for end user use. page by patient preference. Ability to send
Options to transmit CMR the medication list on one page vs. multiple
pages or both.
via email or securely
through a eMR
We agree and this is consistent with the current technical instructions.
No
No
Readability is an important consideration for the Medicare Part D enrollee
population. The current technical instructions document, which will be updated
and released by CMS upon OMB approval of the revised Standardized Format,
currently note that a 14-point font size is required except where another font
size is specified in the instructions. Therefore, it may not be feasible to increase
the number of medications per page on the Medication List.
No
No
Side Effects
A major concern among
CMS should provide clarification on what is
commenters was obtaining to be included in the side effects section.
clarification on what
information should be
used to populate the side
effects box and what
sources, if any, were
required for obtaining that
information. Causes for
concern were that
populating with all the side
effects for each drug the
member was on had the
potential to overwhelm the
beneficiary with too much
information, significantly
increase the length of the
document length, and
increased on burden of
preparing and printing
such a document.
The side effects field should be used to indicate the adverse drug reactions
experienced by the beneficiary that are not true allergies. More information will
be released in the updated technical instructions once the format is approved
and finalized.
No
No
Side Effects
CMS received multiple
comments on the
separation of the side
effects and allergies boxes
in the revised standardized
format and the possible
confusion this may cause
beneficiaries if too many
were listed or if perhaps
the box was left blank.
The current approved Standardized Format combined allergies or side effects in
one box and instructed users to insert the beneficiary’s allergies and adverse
drug reactions including the medications and their effects. The technical
instructions noted that if the MTM provider is able to distinguish between
allergy and adverse event, the MTM provider may label true allergies with the
text “allergy” after the medication. The revised Format separates these fields
based on cognitive interviews conducted in 2018 with consumers and
stakeholders. It was noted that using the same box for information about
medications the beneficiary should and should not be taking was confusing.
More information will be in the updated technical instructions, available after
the standardized format is approved and finalized, including an explanation that
one or both of these boxes could be deleted if there is no relevant information
to include, or the MTM provider may populate the box with no known drug
allergies to indicate this was discussed. In addition, if the provider identifies an
action step during the review associated with an adverse reaction experienced
by the beneficiary, the To-Do list would be an appropriate place to include
those recommendations.
No
No
Medication List (PML)
N/A
Suggestions on the side effects box included
recombining with the allergy box, removing
it and placing side effects beside the
appropriate drug in the medication list, and
moving side effects to the recommended-todo list.
Side Effects
“Side effects to watch for” Proposing changing the title to “Side effect We received many comments on the separation of the allergies and side effects
could create confusion.
history” or “Adverse reactions” if intention is box from one into two and what should be included. The side effects field
to separate prior intolerances from allergies. should be used to indicate the adverse drug reactions experienced by the
beneficiary that are not true allergies. Based on comments, we will rename this
field: Side Effects I Have Had. More instructions will follow in the updated
technical guidance once the standardized format is approved and finalized
Yes
No
Layout
Having the first page be
It would be better if all pages were portrait
portrait layout and the rest layout to make it easier for the member to
use and read.
landscape makes this an
awkward document to
staple and have the
member take to their
physician.
Thank you for your comment. The Medication List was revised to landscape
based on interviews with beneficiaries and stakeholder feedback to decrease
the length of the document. We believe that beneficiaries may detach the
Medication List and take with them to appointments. Also, we recognize the
technical and layout concerns raised. Therefore, we will keep the order of
documents in the currently approved Standardized Format: Cover Letter
(portrait), To-Do List (portrait), and Medication List (Landscape).
Yes
No
Layout
We are concerned with the Recommend consideration be given to
change of the list to a
mandatory Standardized Format elements
landscape format. If the
but not format.
document is meant to be
printed, then switching
from portrait to landscape
makes double sided
printing more complex and
requires the reader to flip
and turn the document,
decreasing usability. The
rigidity of the Standardized
Format has limited
adaptability to different
formats (e.g. print and
electronic).
See comment above. Based on the layout comments, we changed the order of
the items in the document. The Standardized Format is a beneficiary-focused
output, and plans must share the unaltered version with the patient by means
of a printed copy or the current PDF format may also be transmitted to the
patient through secure means.
Yes
No
Layout
Supportive of this format N/A
change and the printing
burden should be
significantly reduced as a
direct result of this change.
Thank you for your support.
No
No
CMS does not have guidance on the maximum length of the Recommended to do list as long as pertinent information discussed during the beneficiary's CMR
is included.
No
No
Action
N/A
plan/Recommended ToDo List
Is there a limit of how much can be entered
in the Recommended to-do list area?
Action
Moving “My follow-up
N/A
plan/Recommended To- plan” and “Questions I
want to ask” to the end of
Do List
the document and
removing “What I did and
when I did it”. Although
the MAP has been a
valuable source of
information, our research
found about 50% of the
beneficiaries do not utilize
fill-in sections at all. Thus,
minimizing sections with
lower use may help save
space, reduce
beneficiaries’ burden, and
improve portability.
Action
N/A
plan/Recommended ToDo List
Thank you for your comment. The "My Follow-up plan" and "Questions I want
to ask" sections have been combined into a "My notes and questions" section at
the end of the document. The "What I did" and "When I did it" have been
combined into the "What should I do" section with added checkboxes. These
changes were made based on beneficiary interviews that allowed for increased
readability/accessibility, encourage engagement, and reduce burden.
Suggest considering to make the column
Thank you for your suggestion. We intend to keep the columns equal width
“What we talked about:” narrower to allow based on review of mock-ups and limited cognitive testing on the revised
for more horizontal space for the “What I
Format
should do:” section. This will allow more
space for the actions to be documented and
will prevent the document from becoming
unnecessarily lengthy.
No
No
No
Action
One commenter requested N/A
plan/Recommended To- clarification as to whether
completion of the boxes in
Do List
the “What should I do”
section required.
Yes, the "What I should do" fields in the Action Plan should include the
checkboxes and list the relevant recommendation(s), action item(s), or
reinforcing statement(s) for that topic for the beneficiary.
No
No
Action
In the Supporting
N/A
plan/Recommended To- Statement Section A1.
Need and Legal Basis, the
Do List
last sentence says
“Components of the CMR
summary in Standardized
Format should include a
cover letter, personalized
medication list, and action
plan if applicable.” Does
this mean that the action
plan could be optional? Or
if there is no
recommended To Do, are
we still expected to include
a generic
recommendation?
Per the technical instructions, the format includes the cover letter, the action
plan and the medication list. There may be CMRs that do not identify issues of
current medication therapy or beneficiary-specific action items. The Format
allows plan sponsors to enter other statements into a new MAP as appropriate
for the beneficiary, such as reinforcing compliance, maintaining beneficiary’s
actions, and acknowledging beneficiary success in his/her medication therapy.
Beneficiaries will best understand a consistent deliverable after their CMRs,
including the medication action plan, even if there are no new beneficiaryspecific action steps.
No
No
Action
In the ‘My To-Do List’
plan/Recommended To- section, the proposed
Do List
standardized format shows
four topic boxes on the
page. We request
clarification on whether
there is a minimum and/or
maximum requirement on
the number of topic boxes
to include in the ‘My To-Do
List’ section.
No
No
Action
The ‘What I should do:’ box We request that CMS allow a minimum of
Correct, providers may populate with one or more action items for each topic
plan/Recommended To- for each topic appears to one and a maximum of two action items per even though two were shown in the Format. We will provide this clarification in
the updated technical instructions.
have a requirement for
topic.
Do List
each topic to include two
bullet points/check boxes.
However, it is unclear on
whether we can insert
more than two check boxes
in this section. While we
agree with the template as
is, since it currently shows
two action items, we don’t
want to be required to
populate both for every
topic as it is not always
applicable or necessary
No
No
Safe Disposal
Yes
No
It is very hard to include
real-time drug take-back
programs for each
individual member’s
location. Researching for
local take back programs
will add time to the CMR
documentation process
and take time away from
outreach to additional
targeted members.
We ask that CMS only require a minimum of
one topic box be completed, the safe
disposal topic that is preset, and allow plans
to add additional topic boxes beyond the
four included in the template so that plans
have maximum flexibility to meet the needs
of their members.
We believe a better approach would be to
provide general safe disposal information so
that the information can be standardized and
apply to a larger population rather than
include detailed locations for take back.
Consistent with the current technical instructions, the MTM provider has
flexibility to determine the most important activities to include on the Action
Plan summary for the beneficiary based on the beneficiary’s concerns, the
therapeutic need, and the beneficiary’s ability to understand and complete the
recommended activities. There may be CMRs that do not identify issues of
current drug therapy or beneficiary-specific action items. The Format allows
plan sponsors to enter other statements into a new MAP as appropriate for the
beneficiary, such as reinforcing compliance, maintaining beneficiary’s actions,
and acknowledging beneficiary success in his/her medication therapy.
Beneficiaries will best understand a consistent deliverable after their CMRs,
including the medication action plan, even if there are no new beneficiaryspecific action steps. Therefore, rows may be added or deleted as appropriate.
CMS issued a final rule (86 FR 5864), “Medicare and Medicaid Programs;
Contract Year 2022 Policy and Technical Changes to the Medicare Advantage
Program, Medicare Prescription Drug Benefit Program, Medicaid Program,
Medicare Cost Program, and Programs of All-inclusive Care for the Elderly”
(CMS 4190-F2), on January 19, 2021 that implements changes to the MTM
program beginning January 1, 2022. Pursuant to 42 CFR § 423.153(d)(1)(vii)(E),
beginning January 1, 2022, Part D sponsors must provide to all MTM enrollees,
at least annually, as part of the CMR, a TMR, or other MTM correspondence or
service, information about safe disposal of prescription drugs that are
controlled substances, drug take back programs, in-home disposal and costeffective means to safely dispose of such drugs. Under 42 CFR §
423.153(d)(1)(vii)(F), such enrollees must be provided all information required
at 42 CFR § 422.111(j). It was our intent to include the safe disposal information
as the first item in the Medication Action Plan if safe disposal information was
discussed during the CMR. However, based on this feedback, and other
comments to this solicitation, the proposed document will be revised to include
one My Notes & Questions" section at the end of the document, as well as the
safe disposal information if discussed during the CMR, to better make use of
space. CMS will include information in the updated technical instructions.
Safe Disposal
What I should do: Does CMS
require the MTM provider
to complete this section or,
can the provider leave it
blank for the beneficiary to
complete?
Safe Disposal
Understanding that this is a
statutory requirement and
given the number of
federal government
websites related to the
safe disposal of
prescription drugs, it is
imperative for CMS to
provide specifications
about what information
plans must provide.
We received several
comments about the safe
disposal topic listed on the
revised format as the first
recommended to-do.
Concerns raised were
things such as this is often
not the most pressing
matter for the beneficiary,
it may be irrelevant to the
conversation had with the
MTM provider, and finally
if it was a requirement.
Safe Disposal
Safe Disposal
No
No
Clarify which “federal government safe
See January 2021 final rule (86 FR 5864) for the safe disposal requirements at
disposal website information” is supposed to 42 CFR § 423.153(d)(1)(vii)(E). Under 42 CFR § 423.153(d)(1)(vii)(F), such
be included in the Recommended To-Do List. enrollees must be provided all information required at 42 CFR § 422.111(j).
No
No
Recommendations included may more
urgent To-Do's that were raised during the
CMR come before the safe disposal
information; can it be a general statement
rather than a To-Do; removing it from the
Recommended To-Do List and instead
including it on the medication list, perhaps at
the bottom or in place of the side effects to
watch for.
Thank you for your comment. It was our intent to include the safe disposal
information as the first item in the Medication Action Plan if safe disposal
information was discussed during the CMR. However, based on this feedback,
and other comments to this solicitation, the proposed document will be revised
to include one "My Notes & Questions" section at the end of the document, as
well as the safe disposal information if discussed during the CMR, to better
make use of space. CMS will include information in the updated technical
instructions.
Yes
No
No, it should only be included in the Standardized Format summary if discussed
during the CMR.
No
No
It is our understanding that N/A
the SUPPORT Act is
requiring the mailing of
safe disposal information
of prescriptions that are
controlled substances to all
MTM program enrollees.
Since not all MTM program
enrollees receive a CMR, if
the safe disposal
information is provided in
a different manner, is it still
required to be included in
the post-CMR standard
format mailing?
It was our intent to include the safe disposal information as the first item in the
Medication Action Plan if safe disposal information was discussed during the
CMR. However, based on other comments to this solicitation, the proposed
document will be revised to include one "My Notes & Questions" section at the
end of the document, as well as the safe disposal information if discussed
during the CMR, to better make use of space. CMS will include information in
the updated technical instructions.
Safe Disposal
It has been demonstrated There needs to be explicit guidance on which See January final rule (86 FR 5864) for the safe disposal requirements at 42 CFR
that discussions about
federal website and/or printed information § 423.153(d)(1)(vii)(E). Under 42 CFR § 423.153(d)(1)(vii)(F), such enrollees
proper medication
should be provided to beneficiaries.
must be provided all information required at 42 CFR § 422.111(j).
handling and disposal are
generally well-received and
are positively correlated
with understanding the
risks that come with
keeping unused
medications at home.
Providing beneficiaries
with high-quality resources
on medication disposal
allows them to be used
later.
No
No
Safe Disposal
Of note, the added
N/A
language in the revised
version on medication
disposal is sensible for
beneficiaries who live at
home and manage their
own medications but is not
relevant to skilled nursing
facilities where
medications are
administered. We believe
that MTM has the potential
for high acceptance by
Medicare beneficiaries in
long-term care, but in
order to achieve this
potential, operational
hurdles such as the SF need
to be addressed.
No
No
See January 2021 final rule (86 FR 5864) for the safe disposal requirements at
42 CFR § 423.153(d)(1)(vii)(E). Under 42 CFR § 423.153(d)(1)(vii)(F), such
enrollees must be provided all information required at 42 CFR § 422.111(j). The
requirements do not distinguish between beneficiary setting; however, the
information could be tailored to the individual as needed.
Safe Disposal
Commenter supports
providing safe drug
disposal information to
MTM enrollees, with the
following
recommendations to
ensure consistent
messaging across MA-PD
plans and with existing U.S.
government messaging on
safe disposal of drugs.
Additionally, CMS has
indicated that providing
safe disposal information
in the Comprehensive
Medication Review (CMR)
written summary in
standardized format will
not by itself meet the CMS
requirement because MTM
members who do not
complete a CMR or decline
the CMR would not receive
the standardized format
that would contain the safe
disposal information.
To avoid plans sending incorrect or
See January 2021 final rule (86 FR 5864) for the safe disposal requirements at
inadequate safe disposal information in the 42 CFR § 423.153(d)(1)(vii)(E). Under 42 CFR § 423.153(d)(1)(vii)(F), such
MTM standardized format written summary, enrollees must be provided all information required at 42 CFR § 422.111(j).
commenter recommends that CMS provide
template language on safe disposal in the
MTM standardized format document ‘My ToDo-List’ section that would apply universally
to all MTM members. Commenter
recommends that CMS provide template
language on safe disposal to include with our
MTM member offer letter that would be sent
to all eligible MTM members, regardless of
whether or not they complete a CMR.
Sending the safe disposal information at the
outset of a member’s enrollment eligibility
would ensure that the member receives the
information as early as possible.
No
No
My Notes and
Questions
CMS received multiple
comments on the "My
notes & Questions" pages
included at both the end of
the PML and the MAP.
Questions and concerns
were as follows: Could they
be combined into one page
at the end of the document
to eliminate waste, as one
page seemed sufficient?
Were they only for the
beneficiary or could the
MTM provider populate
these fields in place of the
"Other Information" box?
Recommendations included removing one
page entirely, clarify if this section were
solely for the patient's use, re-introduce the
"other information" box.
Yes
No
This is a good suggestion to further streamline the document and number of
pages. The proposed document will be revised to include one My Notes &
Questions" section at the end of the document, as well as the safe disposal
information if applicable to the CMR summary, to better make use of space.
CMS will add back the "Other Information" box to the Medication List, and note
in the technical instructions that this field may be optional or deleted.
Formatting
Several commenters
Allow plans flexibility to determine the
inquired about the new
specific graphic icons they use to reduce
icons, fonts, and other
implementation burden
technical guidance.
Questions were raised
about whether the icons
were required and if so did
they have to be the exact
same ones, would they be
provided in advance, and
when could they expect
detailed instructions that
addressed these issues
along with other technical
matters.
Formatting
N/A
Formatting
Formatting
Formatting
Once the revised Standardized Format document is approved by the Office of
Management and Budget (OMB) through the Paperwork Reduction Act (PRA)
process, CMS will release updated technical instructions. Specifics such as font
size, table borders, etc., will be laid out in the technical guidance. CMS will
provide image files for the icons. Plans will be required to adhere to these
guidelines as the format is standardized.
No
No
Ability to select a font, some may need larger We disagree. It is a Standardized Format. The font sizes will be specified in the
font some don’t need a large font & want the technical instructions document as currently done.
medication list on one page, this should be
based on patient preference and not
predetermined .
Can we expect a comment N/A
Once the revised Standardized Format document is approved by the Office of
period surrounding the
Management and Budget (OMB) through the Paperwork Reduction Act (PRA)
instructions?
process, CMS will release updated technical instructions. There will not be a
comment period on technical guidance.
One commenter requested N/A
Yes, it is a Standardized Format.
clarification as to whether
plans required to utilize the
exact same icons that are
on the template.
No
No
No
No
No
No
To assist members with
Allow to include symbols in the Medication
poor literacy in
List section for those members.
understanding the
condition for which they're
taking the medication
(example: a symbol of a
heart to remind them that
the drug is for a cardiac
condition), as well as the
time of the day they should
be taking it (example: a
symbol of a sun or moon).
No
No
Updated technical instructions will be released. Symbols or text may be
included in the boxes and fields.
Formatting
One commented asked
N/A
that CMS include a style
guide that can be utilized
to generate the
standardized format
including, but not limited
to: font type, font size,
header and footer sizing
and margins. This style
guide should also include a
template file in Word or
OpenOffice format and an
FAQ document, similar to
that provided with the
previous Standardized
Format.
Requests clarity on the
N/A
style guide that CMS
proposes be utilized to
generate the standardized
format including, but not
limited to: font type, font
size, header and footer
sizing and margins. We ask
that CMS provide a
template file in Word or
OpenOffice format to
support this style guide.
Updated technical instructions will be released similar to the documents
previously released.
No
No
Once the revised Standardized Format document is approved by the Office of
Management and Budget (OMB) through the Paperwork Reduction Act (PRA)
process, CMS will release updated technical instructions.
No
No
Formatting
Will CMS allow doubleN/A
sided printing for the letter
and the accompanying
Medication and To Do
Lists?
Consistent with the current technical instructions, the Standardized Format
summary may be printed singled-sided or double-sided.
No
No
General
One commenter requested N/A
clarification on the page
numbering in this section
as page one lists “Page 2 of
2” and page two notes
“Page 2 of 3.”
Thank you for pointing this out. The page numbering has been corrected in the
document.
Yes
No
General
The footer on the cover
N/A
letter appears incomplete
“Attn: PRA Reports
Clearance Officer, 7500
Security Boulevard,
Baltimore, Maryland 21244", seems to be missing the
rest of the zip code. It does
not match how the Spanish
version reads "212441850".
Thank you for pointing this out. The footer has been corrected in the
document.
Yes
No
Formatting
General
General
General
General
A CMR rate of 87% of
N/A
targeted beneficiaries is a
high reach estimation.
Several members
throughout the program
year and across multiple
program years have either
not responded to multiple
passive and active
invitation attempts or are
very hesitant to do
anything via telephone due
to fear of scams.
Depending on how many N/A
members are determined
to be “At Risk,” this can
affect final MTM eligibility
counts and thus affect the
CMR rate potentially
making rates go down due
to higher denominator
(targeted enrollees) for the
calculation. Are the star
ratings cut points going to
be adjusted to take this
into account?
The CMR acceptance rate has been updated based on more recent data and is
now estimated to be 71.8% in 2022.
Yes
Yes
This comment is out of scope for the standardized format changes.
No
No
No
No
No
No
In addition, while ARBs are N/A
This comment is out of scope for the standardized format changes.
a very necessary
population to target, they
may be more
resistant/hesitant to a
discussion about
medications and may
consistently decline the
discussion.
N/A
For data validation audit purposes, will CMS Correct, “Recommended To-Do List” is the beneficiary friendly terminology on
still refer to the new “Recommended To-Do the form and is synonymous with the Medication Action Plan.
List” as the MAP (Medication Action Plan)?
General
Implementation of these N/A
proposed changes to the
Standardized Format will
require the allocation of
considerable time and cost
resources by plan sponsors
and vendors. It is
important that CMS
recognize this and provide
plan sponsors with details
on the exact specifications
and requirements of the
new Standardized Format
and ensure that the final
specifications provide
plans and vendors with
sufficient time to
implement them.
Yes, we recognize that these changes to the Standardized Format if finalized will
require time for sponsors to implement. The technical instructions will be
updated and released after the document is approved and finalized.
No
No
General
Standardized CMR format
inflexible for end user use.
Options to transmit CMR
via email or securely
through a eMR
An option to send the CMR via secure email,
if the business has a platform to support it.
An option to upload the CMR via secure
method to an eMR, if the business has a
platform to support it.
No
No
Cover Letter
The summaries must
comply with the
requirements specified by
CMS and thus flexibility in
the presentation or
delivery format of this
material is limited, stifling
innovative approaches that
Part D plans may wish to
implement in order to
more clearly and efficiently
communicate this
information to their
enrollees.
Recommended approaches that could be
used by plans include more streamlined
paper forms, emails, patient portals, text
messaging, mobile applications (apps) and
other digital, electronic technologies.
Additionally, the lack of flexibility prevents
enrollees from being able to specify their
preferred communication method, which
may limit the usefulness of this information
and result in the CMR service not providing
the desired results.
No, the Standardized Format is a beneficiary-focused output, and plans must
share the unaltered version with the patient. The current PDF format may also
be transmitted to the patient through secure means. CMS encourages Part D
plans and MTM providers to develop a mechanism to auto-populate the
Standardized Format as needed. We also permit the use of HL7 FHIR standards
so the documents can be integrated into EMRs and other health information
technologies (HITs).
CMS reminds sponsors that the CMR summary in the Standardized Format may
be delivered through mail or other means, including electronic means, as long
as it complies with the Format.
No
No
General
The “Prepared on” date on Please clarify which date belongs in the field.
the Medication List and ToDo List may be different
from the date that the
beneficiary interacted with
the MTM provider (i.e.
“CMR date”).
This is the date the Medication List and To-Do are prepared and per the
technical instructions may be different from the date the beneficiary interacted
with the MTM provider. The format, FAQs and technical instructions will all be
updated once the PRA package is finalized by OMB.
No
No
General
Medication List-Sources of N/A
Information: The new
format does not address
how to document where
we received the
information about the
medication list. I.e.:
pharmacy claims, member
caregiver, prescriber.
The revisions to the PML were made for simplicity and readability, based on
interviews with beneficiaries, these changes tested well and mostly
appreciated. Once the format is approved and finalized, more information will
be released in the updated technical instructions.
No
No
General
One commenter requested
clarification from CMS as to
when we can expect the
final templates to be
released.
We find these revisions do
not address three
deficiencies of the current
SF: its lack of true
portability, its difficulty to
use as a living document,
and its inapplicability to
the long-term care setting.
We again strongly feel and
have noted that
transforming the
Standardized Format into
interoperable elements
meaningful to beneficiaries
would help address
integration, portability and
improve goal attainment of
increased medication
effectiveness and safety.
We believe that an
electronic version of the SF
would be more convenient
for patients and providers
to update. In fact, were the
SF permitted to exist with
greater leeway, and in
more of an electronic
manner, providers may
The current standard form
has an instructions
document as well as an
FAQ that provides
clarification on how the
form should be completed
for several components.
Recommend CMS provide
these again to the Health
Plans with the new
template.
N/A
The final Standardized Format documents will be released after OMB approval
through the PRA process.
No
No
N/A
CMS reminds sponsors that the CMR summary in the Standardized Format may
be delivered through mail or other means, including electronic means, as long
as it complies with the Format. Also, alternative formats may be used in
addition to the required Standardized Format. CMS also reminds
sponsors/MTM providers that the requirement to offer MTM services and
CMRs to targeted beneficiaries in LTC settings is a statutory requirement.
No
No
No
No
General
General
If there are no plans to provide separate
Thank you for your comment, we will provide updated technical instructions
documents like the ones that currently exist, with release of the final version.
recommend for CMS to make the
instructions within the template more
explicit to provide additional clarity to the
Health Plans on expectations and intent.
General
N/A
Include the “Prepared for” and “Prepared
On” identifiers in the header rather than
inserting that content into the body of the
document. This will create a consistent
format from page to page.
Thank you for this suggestion. The formatting has been updated for
consistency.
Yes
No
| File Type | application/pdf |
| Author | MDBG-DCOP 41816 |
| File Modified | 2021-04-15 |
| File Created | 2021-04-15 |