60 Day Public Comment Response

60 day Comment Responses_5.10.24.pdf

Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, §423.514(a) (CMS-10185) - IRA

60 Day Public Comment Response

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2025 Part D Repor�ng Requirements - 60 day Comments and Responses
CMS received comments from 5 en��es including Part D sponsors, professional organiza�ons and trade
associa�ons. Comments were focused on two repor�ng sec�ons – Medica�on Therapy Management
and Medicare Prescrip�on Payment Plan.

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Repor�ng sec�on – Medica�on Therapy Management (MTM)

Comment: One organiza�on raised concern over the proposed removal of data element J, “Date met the
specified targe�ng criteria per CMS – Part D requirements in § 423.153(d)(2). Required if met the
specified targe�ng criteria per CMS – Part D requirements. (May be same as Date of MTM program
enrollment).” They stated the removal of data element J affects the MTM measure in the Star Ra�ngs,
specifically altering how the denominator is determined, and asked for clarifica�on.
Response: CMS will keep data element J in the MTM repor�ng sec�on and will reassess changes in the
future. The element is not used directly to calculate the MTM measure in the Star Ra�ngs but is part of
the data integrity checks which help confirm the accuracy of the plan-reported data.
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Repor�ng sec�on – Medicare Prescrip�on Payment Plan

Comment: Two commenters noted that a data collec�on deadline of the last Monday in February may be
too early to collect complete data on uncollected program balances through the end of the full plan year.
Because Part D sponsors will be sending December program bills in mid-January, program balances for
the month of December may s�ll be uncollected by the end of February. Addi�onally, due to the two
month grace period, some program balances for the months of October and November may also s�ll be
uncollected by the proposed repor�ng deadline. The commenters suggested that CMS establish a
repor�ng deadline of late April or early May to account for program payments made a�er the end of the
year, but during the program grace period for the plan year and allow for data produc�on �me prior to
repor�ng.
Response: CMS thanks the commenters for their sugges�on. CMS’ intent is to collect data on uncollected
balances through the end of the full plan year; we have updated the Medicare Part D Repor�ng
Requirements for Medicare Prescrip�on Payment Plan data elements to reflect a data collec�on deadline
of the last Monday in April.
Comment: One commenter urged CMS to use the informa�on collected from Part D plan sponsors to
monitor paterns of beneficiary behavior and develop stronger incen�ves for enrollees to make the
required monthly payments.
Response: CMS thanks the commenter for their feedback. As stated in sec�on 80.3 of Medicare
Prescrip�on Payment Plan: Final Part One Guidance on Select Topics, Implementa�on of Sec�on 1860D-2
of the Social Security Act for 2025, and Response to Relevant Comments, a Part D sponsor may preclude
an individual from op�ng into the Medicare Prescrip�on Payment Plan program in a subsequent year if
the individual owes an overdue balance to that Part D sponsor. In addi�on, as stated in sec�on 80.3,
preclusion is permited in plans that are offered by the same parent organiza�on and may extend
beyond the immediately subsequent plan year. If an individual pays off the outstanding balance during a
subsequent year, the enrollee is eligible to request to par�cipate in the program again. CMS intends to

use the collec�on of data as outlined in this Informa�on Collec�on Request to assess the opera�ons of
the Medicare Prescrip�on Payment Plan and ensure financial stability in the Medicare Part D program.
CMS may use this data to inform future program requirements.
Comment: Commenters suggested that CMS collect addi�onal data elements to ensure individuals likely
to benefit from the Medicare Prescrip�on Payment Plan are being made aware of the program by their
plan sponsors and op�ng into the program as appropriate, evaluate the effec�veness of different
mechanisms for enrolling beneficiaries in the program, and inform future outreach and educa�on
efforts. Suggested data elements included:
 Breakdown of total number of individuals a plan iden�fies as likely to benefit from the program
into individuals iden�fied a) by the Part D sponsor, prior to the plan year, b) by the Part D
sponsor, during the plan year, or c) following interac�on with the pharmacy at the point of sale
 Breakdown of total number of individuals who opted into the program, as well as total number
of individuals who were no�fied but chose not to opt in, by no�fica�on mechanism (at the
point-of-sale, by the plan sponsor prior to the plan year, and by the plan sponsor during to the
plan year)
 Mean and median annual and average monthly out-of-pocket costs of enrollees who elect to
par�cipate
 Mean and median annual and average monthly out-of-pocket costs of enrollees no�fied that
they were likely to benefit but who did not elect to par�cipate, including each mechanism of
no�fica�on (at the point-of-sale, by the plan sponsor prior to the plan year, and by the plan
sponsor during to the plan year)
 Number of enrollees who meet the annual out-of-pocket cap that were no�fied or not no�fied
that they were likely to benefit from the program and the distribu�on of such enrollees for each
month of the calendar year
 Number of beneficiaries who opted into the program who were not iden�fied as likely to benefit
 Breakdown of total number of beneficiaries who opted into the program by elec�on method
(elec�on request form sent with membership ID card, plan website, telephone, mail)
 Number of program par�cipants who missed payments
 Number of program par�cipants with a missed payment who paid a�er receiving first no�ce of a
late payment
 Number of program par�cipants with a missed payment who paid a�er receiving second no�ce
of a late payment
Response: CMS thanks the commenters for their sugges�ons. CMS has endeavored to strike a balance
between the burden on Part D plan sponsors in the first year of the program and collec�ng cri�cal data
elements that are necessary to assess the opera�ons of the Medicare Prescrip�on Payment Plan and
ensure financial stability in the Medicare Part D program. In response to public comment, CMS is adding
eleven addi�onal data elements to the Part D Repor�ng Requirements to support monitoring and
oversight of the Medicare Prescrip�on Payment Plan. These elements include:
• Total number of individuals iden�fied as likely to benefit from the Medicare Prescrip�on
Payment Plan during the repor�ng period on one or more of the following methods: prior plan
year criteria; during the plan year criteria; POS criteria (unique beneficiaries, including those
who did not elect to par�cipate in the Medicare Prescrip�on Payment Plan)
• Total number of individuals iden�fied as likely to benefit from the Medicare Prescrip�on
Payment Plan during the repor�ng period based on prior to plan year criteria (unique
beneficiaries, including those who did not elect to par�cipate in the Medicare Prescrip�on
Payment Plan)

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Total number of individuals iden�fied as likely to benefit from the Medicare Prescrip�on
Payment Plan during the repor�ng period based on during the plan year criteria (unique
beneficiaries, including those who did not elect to par�cipate in the Medicare Prescrip�on
Payment Plan)
Among individuals iden�fied as likely to benefit based on prior to plan year, during the plan year
or point of sale criteria, the total number of those individuals who submited an elec�on request
to par�cipate in the Medicare Prescrip�on Payment Plan during the repor�ng period
The total number of Medicare Prescrip�on Payment Plan elec�on requests received during the
repor�ng period.
Of the total number of Medicare Prescrip�on Payment Plan elec�on requests received during
the repor�ng period, the number of elec�on requests that were accepted during the repor�ng
period.
Of the total number of Medicare Prescrip�on Payment Plan elec�on requests received during
the repor�ng period, the number of elec�on requests that were not complete at the �me of
ini�al receipt and for which the sponsor was required to request addi�onal informa�on from
the applicant (or his/her representa�ve)
Of the total number of elec�on requests that were not complete at the �me of ini�al receipt
and for which the sponsor was required to request addi�onal informa�on from the applicant,
the number of elec�on requests received that are incomplete upon ini�al receipt and
completed within established �meframes.
Of the total number of elec�on requests that were not complete at the �me of ini�al receipt
and for which the sponsor was required to request addi�onal informa�on from the applicant,
the number of elec�on requests denied due to the applicant or his/her authorized legal
representa�ve not providing the informa�on required to complete the enrollment request
within established �meframes.
Of the total number of Medicare Prescrip�on Payment Plan elec�on requests received during
the repor�ng period, the number of elec�on requests that were denied during the repor�ng
period.
The collected Medicare Prescrip�on Payment Plan amounts from the repor�ng period.

CMS may consider revised or addi�onal repor�ng requirements for future years.
Comment: One commenter suggested that CMS collect addi�onal data elements to determine whether
the $600 single prescrip�on threshold is appropriate for iden�fying individuals likely to benefit prior to
the plan year, during the plan year, and at point of sale.
Response: CMS thanks the commenter for their sugges�ons. CMS has endeavored to minimize burden
for Part D plan sponsors in the first year of the program by limi�ng data collec�on to those cri�cal data
elements that are necessary to assess the opera�ons of the Medicare Prescrip�on Payment Plan and
ensure financial stability in the Medicare Part D program. CMS may consider revised or addi�onal
repor�ng requirements for future years.
Comment: Commenters encouraged CMS to consider collec�ng demographic informa�on of those
elec�ng and op�ng against elec�ng into the Medicare Prescrip�on Payment Plan, including income
level, geographic loca�on, age, race/ethnicity, and sex, to ensure that the program is being
implemented in a manner that is fair and equitable to all Medicare beneficiaries.

Response: CMS thanks the commenters for their sugges�on. CMS is commited to advancing health
equity by addressing the health dispari�es that underlie our health system and recognizes the
importance of collec�ng data that assesses whether programs like the Medicare Prescrip�on Payment
Plan are aligning with the needs of communi�es and individuals. CMS has proposed to collect
beneficiary-level data on par�cipa�on in the Medicare Prescrip�on Payment Plan through the Medicare
Advantage Prescrip�on Drug (MARx) System; these data elements are available for public comment
through the Office of Management and Budget’s Informa�on Collec�on Request (ICR) process un�l May
8, 2024.
Comment: One commenter recommended that CMS make data reported by Part D plan sponsors
publicly available to inform broader outreach and educa�on efforts. The commenter also requested that
CMS provide oversight of plans to ensure they do not seek to pass the administra�ve burden of data
repor�ng onto pa�ents via access restric�ons or higher premiums.
Response: CMS thanks the commenter for their sugges�on and looks forward to working with
stakeholders to support outreach and educa�on related to the Medicare Prescrip�on Payment Plan
program. Our main objec�ve in collec�ng data for CY 2025 is to assess the opera�ons of the Medicare
Prescrip�on Payment Plan and ensure financial stability in the Medicare Part D program. CMS will
evaluate data submissions once we review them and consider opportuni�es for increased data
transparency. We also note that plans submit bids to cover benefit and opera�onal costs for a payment
year, and plan sponsors have a strong incen�ve to keep bids as low as possible.


File Typeapplication/pdf
AuthorEmma Strauss
File Modified2024-05-10
File Created2024-05-10

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