60 Day Public Comment Response

60-Day Comment Response Document
CMS received various comments from Part D sponsors, PBMs and other associations. We
received 27 comments regarding the following reporting sections: Enrollment/Disenrollment,
Employer/Union-Sponsored Group Health Plan Sponsors, Medication Therapy Management,
Improving Drug Utilization Review Controls and Coverage Determinations and
Redeterminations. CMS also received two out of scope comments.

Detailed Summary of Comments

Section

Enrollment

Comment

The previous element D for enrollments
N/A
indicated, “the number of enrollment
requests denied due to the sponsor’s
determination of the applicant’s ineligibility
to elect the plan.” This version now states,
“the number of enrollment requests denied
due to the sponsor’s determination that
the applicant was not eligible for an
election period.” We would like clarification
if this means element D should only include
election period denials and no other upfront
denial reasons such as for outside the
service area and element F is for all other
denials.

Commenter's
Recommendation

CMS Response

The commenter is incorrect. There is no substantive change in the
criteria for this element from 2021 to 2022. Current Element D
states:

Revised
Revised
Requirements/D
Burden
ocuments
Estimates
No

No

No

No

Of the total reported in A, the number of enrollment requests
denied due to the sponsor’s determination of the applicant’s
ineligibility to elect the plan (i.e. individual not eligible for an
election period).
Proposed Element D:
Of the total reported in A, the number of enrollment requests
denied due to the sponsor’s determination that the applicant was
not eligible for an election period.
Element D should include denials based on lack of election period
eligibility only.
Element F should include the number of cases reported for
Element C which were eventually denied because the applicant or
his/her authorized representative/legal representative failed to
provide the information required to complete the enrollment
request within established timeframes.

Enrollment

The previous element K for enrollments
N/A
stated “the number of enrollment requests
effectuated by sales persons.” It now says,
“the number of enrollment requests
received from an applicant through an
agent broker.” We would like clarification
whether that means this should only
include applications received from 3rd party
brokers or if this also includes internal plan
sales agents.

As proposed, Element K should include enrollment requests
received from an applicant through an agent or broker, including
sales agents employed by the plan.

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

Enrollment

CY2021: Enrollment K: Of the total reported N/A
in A, the number of enrollment requests
effectuated by sales persons.
CY2022: Enrollment K: Of the total reported
in A, the number of enrollment requests
received from an applicant through an
agent broker.
Is “agent broker” the same as a sales
rep/person? We have an internal sales
team and external brokers. Are we only
reporting the brokers in this field? Or does
this include the sales team and brokers?

As proposed, Element K should include enrollment requests
received from an applicant through an agent or broker, including
sales agents employed by the plan.

No

No

Enrollment

We have agents that use our CRM system N/A
to submit the enrollments electronically.
Usually either on an iPad or Laptop. We
have always captured these as Electronic
since that is how we interpreted the
guidance. This is under I, "Of the total
reported in A, the number of electronic
enrollment requests received via an
electronic device or secure internet website
(if sponsor
offers this mechanism". Would this instead
fall under K "Of the total reported in A, the
number
of enrollment requests received from an
applicant through an agent broker"?

Elements I and K are not mutually exclusive. An enrollment request
can be counted in both elements if it meets the criteria for both
elements.

No

No

Enrollment

If the agent doesn’t submit the application N/A
via an electronic device but rather faxes in
an app, would that be captured as Paper
under G, "Of the total reported in A, the
number of paper enrollment requests
received" or under K, "Of the total reported
in A, the number of enrollment
requests received from an applicant
through an agent broker"?

An enrollment request that is reported as a paper, telephonic or
electronic enrollment request (Elements G, H or I, respectively)
should also be reported in Element K (enrollment requests
received from an applicant through an agent or broker) if the
enrollment request meets the criteria for Element K.

No

No

Section

Commenter's
Recommendation

Comment

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

MTM

For Data Element Z, 'Welcome Letter' is
listed as an option for the method of
delivery. Can you
please define 'Welcome Letter'? Is this
referring to the invitation/offer
communications sent to
members who meet our MTMP targeting
criteria?"

N/A

In the February 2020 proposed rule (85 FR 9002), CMS proposed
to implement two sections of the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities (SUPPORT) Act which amended the
Part D MTM requirements. Section 6103 of the SUPPORT Act
requires Part D plans to provide all MTM targeted individuals with
information about the safe disposal of controlled substances,
including information on drug takeback programs, in-home
disposal, and cost-effective means for disposal. CMS proposed
requiring plans to include this information in a CMR, TMR, or other
follow-up service. The addition of other MTM correspondences or
services as a means of distribution of safe disposal information
was a result of public comments that indicated plan sponsors
wanted to provide this information sooner than a CMR or TMR.
MTM program welcome or enrollment letters and CMR offers were
suggested as additional ways the safe disposal information could
be disseminated. In CMS' final rule (86 FR 5899), “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), published on January 19, 2021, CMS finalized
§ 423.153(d)(1)(vii)(E) with modifications to allow plans to meet the
safe-disposal educational requirement through use of a CMR,
TMR, or other MTM correspondence or service, such as an MTM
welcome letter.

No

No

MTM

Our Medicare Advantage organization
N/A
seeks clarification from CMS regarding how
to populate Elements I and J of the
Medication Therapy Management Plan
Reporting. If a member is enrolled into
MTM due to plan-specific criteria (Some
sponsors also offer enrollment in the MTM
program to an expanded population of
beneficiaries who do not meet the targeting
criteria under §423.153(d)(2).): Would
Element I (Targeting criteria met) be
populated with “None” or is there a choice
of “N/A”? Would Element J (Date met the
specified targeting criteria per CMS – Part
D requirements in §423.153(d)(2)) be
populated with “N/A” or left blank?

Per the CY 2022 Part D Reporting Requirements Element I:
"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 beneficiary; Both; None)." The
options for Element J are Multiple chronic diseases/multiple Part D
drugs/cost threshold, Drug management program at-risk
beneficiary, Both, or None.

No

No

Please reference the field description column for Elements I and J
in the CY 2022 MTM Record Layout when it becomes available.

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

CD/RD

For Section V. Coverage Determinations
Redeterminations, and Reopenings, under
At-Risk Redeterminations, we ask CMS to
define in the reporting requirements and/or
technical specifications what would fall
under this At-Risk Redetermination
category. Clarification in the reporting
requirements and/or technical
specifications as to whether this would be a
combination of all redeterminations or only
exception redetermination requests would
be helpful for achieving the goal of
accurate and comparable reporting. Also, is
an “at-risk” redetermination based on the
drug, type of drug, protected drug class,
preauthorization criteria or some other
criteria?

Although we would suggest not
distinguishing between at-risk
versus non-at-risk
redeterminations, additional
background on the purpose
behind this reporting distinction
could be helpful as well.

Thank you for your suggestion. Clarification regarding At-Risk
Determinations will be clarified in the Reporting Requirements as
well as the Technical Specifications. Sponsors must also report
data relating to redeterminations of at-risk determinations made
under a plan sponsor’s drug management program pursuant to the
rules at 42 CFR §423.153(f), including the number of requests and
the disposition. At-risk redeterminations may involve decisions
about:
• Being identified as an at-risk beneficiary for prescription drug
misuse or abuse;
• Having a limitation, or the continuation of a limitation, on access
to coverage for frequently abused drugs (i.e., an enrollee specific
point-of-sale (POS) edit or the selection of a prescriber and/or
pharmacy for purposes of lock-in);
• Sharing information for subsequent Part D plan enrollments.

No

No

CD/RD

For the Redetermination section, please
N/A
provide guidance on how to report RD
DMR’s not related to an exception? For
example, which of the new reporting
sections would we report RD DMR’s related
to cost sharing appeals or SelfAdministered Drugs where the coverage
determination was denied for no proof of
payment and the member is now providing
documentation of payment?

Thank your for you inquiry. If the enrollee is appealing the initial
DMR denial and it is not an exception request, the DMR would be
reported under the total number of Redeterminations processed
(2A) as well as Dispositions- Redetermination (non exceptions).

No

No

EGWP

“We would like clarification on why CMS
N/A
removed the following paragraph from
section VI
“Employer/Union Sponsored Group Health
Plan Sponsors:
NOTE: This reporting requirement applies
only to individual PDPs and “800 series”
PDPs offered to employers. MA-PD plans
already report these data as part of the Part
C reporting requirements and are therefore
exempt from this Part D reporting section.
We would like to understand if this means
CMS expects MAPD plans to now follow
the Part D Reporting Requirements for this
specific section as of 2022 going forward.”

The statement was removed for 2020 Part D reporting, it is not a
change for 2022. Please refer to the HPMS email sent on
11/24/20 that stated effective for 2020 reporting, all “800 series”
PDPs offered to employers are required to report data for this
reporting section.

No

No

Section

Commenter's
Recommendation

Comment

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

DUR

Regarding the updates for the DUR
N/A
reporting there are requests being made
that are not currently captured by Part D
Sponsors. For example, the proposal
includes capturing the number of claim
rejections overridden by the pharmacy due
to a beneficiary exemption. Today
pharmacies are just placing codes to
override claims and are not providing this
granular level of detail for a Part D Sponsor
to capture. It would require a large amount
of network recontracting to require our
pharmacies to provide this type of
information on their overrides, to the
amount of our entire network. This granular
level of override will be overly burdensome
to capture on a consistent basis as well
since pharmacies are not used to providing
detail to these overrides; rather they are
used to providing a singular code for
overrides. This could cause additional
rejections at the point of sale and
beneficiary dissatisfaction, as well as
potential for beneficiaries to go without their
medication due to a pharmacy not
submitting proper codes, etc. This
additional reporting requirement could be a
roadblock for beneficiaries and pharmacies
a like to provide needed medication.

Thank you for your comment. The NCPDP publishes
telecommunication standards which can capture the information in
the proposed elements. For more information, refer to the following
document: https://www.ncpdp.org/NCPDP/media/pdf/VersionDQuestions.pdf.

No

No

DUR

We ask CMS to add clarifying language to
the reporting requirements and/or technical
specifications on what is considered an
“exemption” for data elements F, S, and X.

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

If the reference to an excepted
beneficiary refers to the
beneficiary categories at
42CFR 423.100, we
recommend that CMS add a
link to the regulation, so that
plans, pharmacies, and others
can easily reference the most
up-to date list (since it has
changed and may continue to
do so). Alternatively, CMS
could, on an annual basis, add
the list to the specifications
from the regulation text.

Section

Comment

Commenter's
Recommendation

DUR

We ask CMS to add clarifying language to
the reporting requirements and/or technical
specifications on what is considered an
“exemption” for data elements F, S, and X.

If the reference to an excepted
beneficiary refers to the
beneficiary categories at
42CFR 423.100, we
recommend that CMS add a
link to the regulation, so that
plans, pharmacies, and others
can easily reference the most
up-to date list (since it has
changed and may continue to
do so). Alternatively, CMS
could, on an annual basis, add
the list to the specifications
from the regulation text.

DUR

DUR

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

For element U, would the favorable
N/A
coverage determination be a coverage
determination that fell within the same
quarter as the rejected claim edit? What
would happen if the rejected claim occurred
on the last day of quarter 1 and the
coverage determination was approved
during quarter 2?

Refer to the CY 2021 Technical Specifications, General, #8: If a
claim override, paid claim, coverage determination or appeal
request, or favorable coverage determination or appeal was
initiated after the current reporting period, but was the result of a
claim rejection during the calendar year and within the current
reporting period, it may be reported for the current reporting period.
It should not be reported again in the following reporting period.

No

No

For element U, are the favorable coverage N/A
determination and the rejected claim edit
linked at the National Drug Code (NDC)
level for the purposes of including in the
reporting?

As described in the CY 2021 Technical Specifications, Cumulative
hard MME edit/opioid naïve days supply safety edit, #2: The
coverage determination or appeal should be associated
with a cumulative opioid hard MME edit claim rejection. A favorable
determination may result in the original or a modified
(e.g., different daily dose, quantity, etc.) opioid prescription or a
different opioid being covered. We intend to update the Technical
Specifications accordingly for CY 2022.

No

No

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

DUR

Element E: The number of claim rejections N/A
overridden by the pharmacy within 24 hours
of the initial claim rejection
Question: Can CMS clarify the timeframe
for if/when a claim would become an "initial
claim rejection" again? For example, if a
claim was processed for a particular
member on January 1st, rejected for the
Care Coordination Safety Edit, and then
another claim was processed on April 1st
and also rejected for this edit, would they
be considered 2 separate "initial claim
rejections"? Or is CMS considering the
"initial claim rejection" to be counted once
per year, upon the first occurrence?

Yes, based on the example you describe, these would be different
initial claim rejections. We will consider additional clarification in
the Technical Specifications.

No

No

DUR

Element J: The number of unique
N/A
beneficiaries with at least one claim
rejection overridden by the pharmacy within
24 hours of the initial claim rejection
Question: In the example above, should the
beneficiary be counted only if the January
1st claim (first incidence) was overridden
by the pharmacy within 24 hours? Or
should the April 1st claim also be reviewed
and taken into account?

For Element J, report the beneficiary the first time they meet the
conditions. We will consider clarifying in Technical Specifications.
With regard to additional claims after a care coordination override,
refer to A18-19 in the Frequently Asked Questions (FAQs) about
Formulary-Level Opioid Point-of-Sale (POS) Safety Edits. We
expect sponsors to implement reasonable logic to remove the
likelihood of redundant or duplicative coordination edits from
triggering multiple times and necessitating repeated pharmacistprescriber consultations (e.g., after they receive the prescriber
attestation via a coverage determination request or confirmation
from the pharmacy that the prescriber was consulted). We
encourage the use of 90 MME message-only alerts similar to
sponsors’ care coordination edit parameters once the care
coordination edit has been resolved; that is, has been overridden
at the POS or no longer triggers as the result of a coverage
determination or appeal.

No

No

Section

DUR

Comment

Commenter's
Recommendation

CMS Response

Element K: The number of unique
beneficiaries with at least one claim
rejection overridden by the pharmacy due
to an exemption.
Element L: Of the total not in element K, the
number of unique beneficiaries with at least
one claim rejection overridden by the
pharmacy as a result of prescriber
consultation.

Healthfirst recommends that
CMS not include elements K or
L. CMS does not require
dispensing pharmacists to
include special documentation
for these overrides and only
one Result of Service Code
may be entered per reject
reason. Pharmacists may be
overriding Opioid Care
Coordination edits “with
prescriber approval,” rather
than using specific exemption
overrides. For these reasons
we question the value in
collecting the volume of claims
overridden by the pharmacy for
a specific reason, given that
pharmacists may not be using
specific exemption overrides
for this edit.

Thank you for your comment. The NCPDP publishes
telecommunication standards which can capture the information in
the proposed elements. For more information, refer to the following
document: https://www.ncpdp.org/NCPDP/media/pdf/VersionDQuestions.pdf.

Revised
Revised
Requirements/D
Burden
ocuments
Estimates
No

No

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

DUR

Element X: The number of rejected claims
overridden by the pharmacy due to an
exemption.
Element Y: The number of rejected claims
overridden by the pharmacy because the
beneficiary was not
opioid naïve.
Element BB: The number of unique
beneficiaries with at least one rejected
claim overridden by the pharmacy due to
an exemption.
Element CC: The number of unique
beneficiaries with at least one rejected
claim overridden by the pharmacy because
the beneficiary was not opioid-naive.

Healthfirst recommends that
CMS combine elements X and
Y into a single element: The
number of rejected claims
overridden by the pharmacy.
We also recommend the CMS
combine elements BB and CC
into a single element: The
number of unique beneficiaries
with at least one rejected claim
overridden by the pharmacy.
Hard rejects, like the opioid
naïve safety edit, may only be
overridden by a pharmacist
using a Submission
Clarification Code (SCC).
“Beneficiary is not opioid
naïve” overrides cannot be
distinguished from exemption
overrides, as SCC values to
clarify the reason for an opioid
naïve edit override do not exist.
For this reason, we
recommend CMS combine
elements X and Y and
elements BB and CC.

Thank you for your comment. The NCPDP publishes
telecommunication standards which can capture the information in
the proposed elements. For more information, refer to the following
document: https://www.ncpdp.org/NCPDP/media/pdf/VersionDQuestions.pdf.

No

No

DUR

Element G states:
N/A
Of the total not in element F, the number of
claim rejections overridden by the
pharmacy as a result of prescriber
consultation.
We will be including the following override
in the element G count:
• Prescriber consulted, dispensed, with
prescriber approval
Is this the correct override to include in the
Element G count?
Are there any other overrides that should
be included in the element G count and
what overrides
are they?

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

DUR

Element S states:
N/A
Of the total reported in element R, the
number of unique beneficiaries with at least
one claim
rejection overridden by the pharmacy due
to an exemption.
We will be including the following overrides
in the element S count:
• Prescriber consulted, dispensed, palliative
care
• Prescriber consulted, dispensed, cancer
treatment
• Pharmacist consulted other source,
dispensed, palliative care
• Pharmacist consulted other source,
dispensed, cancer treatment
Is this a complete list of the overrides to
include in the Element S count?
If it is not, which other overrides should be
included?
Should any of the above overrides not be
included?

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

DUR

Element X states:
N/A
The number of rejected claims overridden
by the pharmacy due to an exemption.
We will be including the following overrides
in the element X count:
• Prescriber consulted, dispensed, palliative
care
• Prescriber consulted, dispensed, cancer
treatment
• Pharmacist consulted other source,
dispensed, palliative care
• Pharmacist consulted other source,
dispensed, cancer treatment
Is this a complete list of the overrides to
include in the Element X count?
If it is not, which other overrides should be
included?
Should any of the above overrides not be
included?

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

Section

Comment

Commenter's
Recommendation

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

DUR

Element Y states:
N/A
The number of rejected claims overridden
by the pharmacy because the beneficiary
was not
opioid naïve.
We will be including the following overrides
in the element Y count:
• Prescriber consulted, dispensed, patient
is not opioid naive
• Pharmacist consulted other source,
dispensed, patient is not opioid naive
Is this a complete list of the overrides to
include in the Element Y count?
If it is not, which other overrides should be
included?
Should any of the above overrides not be
included?

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for the
definitions of an exemption or exclusion:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization

No

No

DUR

Element Z states:
N/A
Of the total not in elements X or Y, the
number of rejected claims for which up to a
7 day
supply (covered by the plan) was
dispensed by the pharmacy.
We will be including the following in the
element Z count:
• Claims which were paid without a
pharmacy override or a favorable or
partially favorable coverage determination
for up to a 7 day supply
Is this a complete list of what should be
included in the Element Z count?
If it is not, which other claims should be
included?

Yes, based on the examples you describe, these would be reported
in Element Z.

No

No

DUR

Element F, K, S, and X - The number of
N/A
claim rejections overridden by the
pharmacy due to
an exemption
o What is classified as an exemption?
Element T - Of the total reported in element N/A
R and not in element S, the number of
unique beneficiaries who requested a
coverage determination for the
prescription(s) subject to the edit.
o So CMS wants us exclude CD for claims
that were overridden at POS?

We will consider clarifying in the Technical Specifications. In the
meantime, refer to the current opioid safety edit guidance for more
information about exemptions:
https://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/RxUtilization
Yes, based on the example you describe, CDs for claims
overridden at POS would be excluded for Element T.

No

No

No

No

DUR

Section

DUR

DV
PPM

Commenter's
Recommendation

Comment

Element EE – The number of unique
beneficiaries with an opioid naïve days
supply edit claim rejection who requested a
coverage determination for the
prescription(s) subject to the edit.
o For this element we do not need to
exclude members with a POS override or
got a paid claim due to reduced supply?
Will the Part D excluded drugs be excluded
from the DV count as in the past?
We recognize this as an important first step
in the process of standard pharmacy
performance metrics being applied across
the industry. We appreciate CMS hearing
the issues raised bypass comments in the
Part D space and for willingly taking the
first step in situational awareness around
the discrepancies in the application of
performance measures by plans/PBMs to
pharmacies within the various PBM
networks.

CMS Response

Revised
Revised
Requirements/D
Burden
ocuments
Estimates

N/A

Beneficiaries with a POS override or who received a paid claim
due to a reduced supply would be excluded for Element EE.

No

No

N/A

This comment is out of scope of this PRA collection.

No

No

The measure developer or
This comment is out of scope of this PRA collection.
entity responsible for
development of the measure;
 How the measure was
validated and tested;
 If the plan/PBM is using the
measure in accordance with
published measure
specifications
which have been validated and
tested;
 If the plan/PBM is using the
measure according to licensing
agreements with measure
stewards;
 Adjustments or modifications
to measure steward
specifications;
 Source of data used to
calculate the measure;
 The minimum number of
patients required in the
denominator to reliably
calculate the
measure;
 The platform, e.g., EQuIPP,
and measurement period used
in calculating the measure.
 Thresholds for incentives or
other cut points related to

No

No