30-Day Comment Response

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Common Theme

CVS Health

Ucare

MAPRx

PCMA

PhRMA

UnitedHealth Group

Alliance for Aging Research & Patient Access Network Foundation

Kaiser Permanente

Teachers' Retirement Society of Kentucky

National Health Council

Anonymous

National Multiple Sclerosis Society

Health Partners

Devoted

Summary of Comment

Proposed Reponses

1

General

X

A commenter requested that the instructions for the model documents be revised to indicate that plans are not required to use model language exactly as written so long as the vital information is conveyed to beneficiaries.

CMS thanks the commenter for their feedback and notes that the instructions for the model documents (with the exception of the Likely to Benefit Notice, which is a standardized material that Part D sponsors are required to use verbatim), have been updated to clarify that these model materials and their content serve as an example of how to convey information on the Medicare Prescription Payment Plan to Part D enrollees and program participants. While Part D sponsors are not required to use the model materials and content verbatim, use of the model materials will satisfy the communications requirements included throughout Section 30.3 of the draft part two guidance.

2

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X

A couple of commenters requested that CMS finalize model documents as soon as possible.

CMS is making every effort to provide materials timely and believes the planned timelines provide Part D sponsors with sufficient lead time to implement necessary changes, prepare materials, and comply with the education and outreach requirements outlined in the draft part two guidance (scheduled to be finalized in summer 2024) ahead of the date on which they may begin marketing their plans for next year.

3

X

A commenter encouraged CMS to shorten and streamline model documents to ensure that model materials are clear, concise, and easy to understand.

CMS shares the commenters’ goal of making model materials clear, concise, and easy to understand. To this end, CMS considered feedback received from multiple rounds of research on CMS-developed program materials. The rounds of research included Medicare Part D enrollees from different socioeconomic and demographic backgrounds who would and would not benefit from the program, and CMS was responsive to feedback raised by participants when finalizing these materials.

4

X

A commenter requested that CMS provide plans with additional flexibility to tailor Medicare Prescription Payment Plan-related materials for specific plan designs that may be more generous than the standard Part D benefit.

CMS thanks the commenter for their feedback. As stated in section 30 of the draft part two guidance, Part D sponsors can choose to use the model materials to satisfy the requirements for communications with prospective and current program participants (with the exception of the Likely to Benefit Notice, which is a standardized material that Part D sponsors are required to use verbatim). CMS has included additional instructions to plan sponsors in the model materials to indicate where sponsors may tailor language for specific populations and plan types. If Part D sponsors choose to develop their own materials, they must ensure that required elements and information are included in their materials. Part D sponsors are strongly encouraged to provide interested Part D enrollees with additional information about the Medicare Prescription Payment Plan, including offering a review of what their estimated monthly payments under the program may be, to ensure that potential participants understand the financial implications of participation. Part D sponsors are also encouraged to provide support tailored to the potential participant’s unique situation and clearly communicate to enrollees when it appears that they are less likely to benefit from the program (e.g., enrollees with low to-moderate recurring OOP drug costs).

5

X

A commenter expressed concern that informing beneficiaries that they will not pay any interest or fees on the amounts they owe, even if their payment is late, could encourage default risk among participants.

CMS thanks the commenter for their feedback. Section 30.3 of the draft part two guidance requires Part D sponsors to provide Part D enrollees with promotional and educational materials on the Medicare Prescription Payment Plan. As outlined in Section 30.3, Part D sponsors must inform enrollees that the program is free to join and there are no fees or interest charged under the program. Part D sponsors are also required to educate enrollees on the importance of paying monthly bills, including the implications of not paying bills under the program. CMS believes it is important for enrollees to understand these aspects of the program before entering into this arrangement with their Part D sponsor.

6

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X

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A couple of commenters suggested that CMS test model documents with diverse user groups and requested that CMS implement a process to consistently incorporate stakeholder feedback (through regular engagement with patients, caregivers, patient organizations, SHIP counselors, and other stakeholders) and facilitate an annual process for revisions to the model documents through a public comment opportunity.

CMS considered feedback received from multiple rounds of research on CMS-developed program materials. The rounds of research included Medicare Part D enrollees from different socioeconomic and demographic backgrounds who would and would not benefit from the program, and CMS was responsive to feedback raised by participants when finalizing these materials. CMS also notes that beginning soon after the passage of the Inflation Reduction Act, CMS began conducting stakeholder outreach with a wide variety of groups representing beneficiaries, patient organizations, pharmacies, plans and others. CMS has continued conducting outreach since that time and plans to conduct ongoing outreach to stakeholders during the first year of the program. CMS will consider any necessary changes to the model materials for future years as a result of this stakeholder outreach; any revisions to the documents will go through the ICR process with opportunity for public comment.

7

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X

A couple of commenters suggested that CMS include a concise overview of the Medicare Prescription Payment Plan Program in all model documents and help orient beneficiaries to the purpose of each specific document.

CMS thanks the commenter for this suggestion. CMS has included a brief description of the Medicare Prescription Payment Plan in the appropriate model notices.

8

X

A commenter suggested that documents more clearly state that they originate from the beneficiary’s plan sponsor and that the information stems from a new offering from the Medicare program.

CMS thanks the commenters for their feedback. The instructions for plan sponsors included in each model notice state that plans may include plan-specific information and branding on all notices.

9

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X

A couple of commenters requested that CMS provide additional information in the model materials related to beneficiary protections, such as the grace period, the reinstatement process, appeals process, and prohibition on Part D plan disenrollment as a result of failure to pay Medicare Prescription Payment Plan balances.

CMS thanks the commenter for their feedback and agrees that enrollee protections are a critical part of the program. The Notice for Failure to Make Payments and the Notice for Failure to Make Payments – Notification of Termination both direct enrollees to contact their plan if they think they’ve received the notice in error and inform them of their right to appeal through the grievance process. The Notice of Voluntary Removal and Notice for Failure to Make Payments – Notification of Termination of Participation also direct enrollees to contact their plan to opt back into the program (once they’ve paid all outstanding balances, if applicable). Finally, CMS notes that the payment due date that plan sponsors are required to include in the Notice for Failure to Make Payments must reflect the full grace period.

10

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Several commenters encouraged CMS to ensure that all forms are accessible and usable by individuals living with various disabilities, including visual, auditory, and cognitive impairments. Specific suggestions for increased accessibility included additional white space to make the content more digestible, increased font size, a glossary defining terms, and the provision of translated materials, braille and large print notices. Additionally, commenters urged CMS to ensure that all forms use clear, plain language accessible to enrollees with varying levels of health literacy and be made available in multiple languages to accommodate the diverse Medicare population, including those with limited English proficiency.

CMS agrees that Medicare Prescription Payment Plan materials must be accessible and easy to understand for all Medicare Part D enrollees. All materials were written by CMS experts in plain language and health communication, with a strong focus on creating clear, readable materials that would be accessible for all audiences. Materials then went through multiple rounds of research focusing on the readability of the materials. Participants in the multiple rounds of research were comprised of Medicare Part D enrollees of varying socioeconomic and demographic backgrounds to ensure all beneficiaries with varying levels of health literacy can read the materials. Materials were revised multiple times between rounds of testing to ensure we addressed all points of confusion. All CMS materials are available in a variety of formats and languages as needed, and can be requested at any time: https://www.medicare.gov/about-us/accessibility-nondiscrimination-notice CMS has provided a Spanish translation of the Likely to Benefit Notice for public comment as part of this ICR package and will consider additional translations in the future. Additionally, CMS directs commenters to section 30.4 of the draft part two guidance, which states that Part D sponsors must meet existing Part D regulations for translating materials required under Part D at § 423.2267 and in the CY 2025 MA and Part D Final Rule. In addition, under § 423.2267(3), required model and standardized materials must be provided in a non-English language and an accessible format using auxiliary aids and services upon request or otherwise learning of the Part D enrollee’s primary language and/or need for an accessible format. These regulations apply to all required materials, including standardized and model materials, that Part D sponsors use, tailor, or develop for the Medicare Prescription Payment Plan.

#REF!

X

A commenter recommended the inclusion of supplementary educational tools, such as interactive and customizable cost calculators, additional examples or real-life scenarios illustrating the operations of the program.

CMS encourages sponsors to provide additional information, tools, and resources to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them. As stated in section 30.1.5 of the draft part two guidance, Part D sponsors are required to provide examples of how the program calculation works with easy-to-understand explanations; sponsors may utilize a calculator tool to help fulfill this requirement. CMS encourages Part D sponsors to use the example calculations included in the final part one guidance or in the technical memoranda available here: https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements/medicare-prescription-payment-plan. Additionally, Part D sponsors are encouraged to use CMS-provided resources as outlined in section 40 of the draft part two guidance.

X

A commenter expressed concern that the inclusion of more flexible and customizable sections for sponsors in the revised documents could potentially make it harder for beneficiaries to compare plans consistently if there is not uniform language. The commenter suggested that CMS provide guidelines outlining permissible and impermissible content for the customizable sections or create a bank of uniform language that plans can select from.

CMS thanks the commenter for their feedback. Though Part D sponsors are not required to use the model materials and content verbatim, Section 30.3 of the draft part two guidance outlines communications requirements for each document. If a Part D sponsor chooses not to use a model material, they must meet the content requirements included throughout Section 30.3 for the alternate notices they develop. CMS is aiming to balance Part D sponsor operational burden with the need to provide consistent language on the program to Part D enrollees and believes that requiring specific, standardized educational and communications materials and language at every touch point may be overly burdensome.

X

X

One commenter noted that CMS did not provide a model denial notice for the Medicare Prescription Payment Plan and requested that CMS confirm if a denial model notice will be included in future Part D guidance. Another commenter encouraged CMS to develop a standardized form for plans to send to beneficiaries at the end of the calendar year with information about how to make their final payment for the current year and enrollment for the following year.

CMS will not be providing model materials for CY2025 beyond those included in this ICR package. CMS encourages sponsors to leverage CMS-provided language when developing other necessary communications for CY2025 and will monitor the need for additional model materials in future years. As the Medicare Prescription Payment Plan is an arrangement between the Part D sponsor and the enrollee, the Part D sponsor is ultimately responsible for ensuring the enrollee receives accurate and appropriate communications related to their participation in the program.

#REF!

X

A commenter requested that CMS include “charitable foundations” in each form that lists other programs that may help lower a beneficiary’s costs.

CMS thanks the commenter for their feedback. The Likely to Benefit Notice notes that the Medicare Prescription Payment Plan may not be the best choice for beneficiaries if they get help paying for drugs from other organizations, which would include charitable foundations.

#REF!

Likely to Benefit Notice

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X

A couple of commenters requested that CMS condense the Likely to Benefit Notice to a single page or provide a one-page version for pharmacies to use.

CMS thanks commenters for their feedback. While a one-page notice may reduce burden for pharmacies, CMS believes that the information included in the Likely to Benefit Notice is necessary to provide enrollees with a clear overview of the program and actionable next steps when they receive the notice at the pharmacy.

16

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X

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X

X

Several commenters suggested edits to the materials to improve readability and plain language and provide additional information, including clarification that only covered Part D drugs are included in the program, clarification that enrollees may opt into the program at any time during the plan year, language that more clearly explains the impact of not enrolling, language explaining that nonpayment will result in termination from the program, the date that participation becomes effective, example calculations, and explanations of why someone who relies on other forms of prescription drug assistance might not benefit.

CMS thanks the commenters for their careful review of the Likely to Benefit Notice and has made revisions to improve readability and plain language throughout the document, while keeping the document concise. Sponsors are encouraged to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them.

18

X

A commenter requested that CMS confirm that the language access and accessibility requirements outlined in section 30.4 in the delivery of the Likely to Benefit Notice apply only to communications made by Part D sponsors, and not to those made by pharmacies.

CMS thanks the commenter for their question. Part D sponsors are responsible for meeting translation requirements outlined in section 30.4 of the draft part two guidance and notes that CMS does not specifically obligate pharmacies to provide translated materials to Part D enrollees. The Part D sponsor must ensure compliance with the language access and accessibility requirements at § 423.2267, as outlined in section 30.4 of the draft part two guidance. CMS is providing a Spanish translation of the “Medicare Prescription Payment Plan Likely to Benefit Notice” to support sponsors in meeting their requirements. Pharmacies are encouraged to make available the CMS-developed Spanish-language version of the notice, in lieu of the English-language version, to their patients upon request.

19

X

A commenter requested that CMS confirm whether the pharmacy Likely to Benefit Notice can include a bar-code, for internal pharmacy notice tracking purposes.

CMS thanks the commenter for their question and confirms that it is permissible for pharmacies to include a barcode on the Likely to Benefit notice for internal tracking purposes.

Participation Request Form

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A commenter suggested that Part D sponsors should be required to collect any missing information and confirm enrollees' understanding of the program's terms and conditions, particularly when enrollees submit election requests in non-standard formats.

CMS thanks the commenter for their feedback. As outlined in Section 70.3.3 of the final part one guidance, if a Part D sponsor receives an election request that does not have all the necessary elements required to consider it complete, the sponsor must contact the individual to request the additional documentation necessary to process the request within 10 calendar days of receipt of the incomplete election request.

X

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X

X

X

Several commenters suggested edits to the materials to improve readability and plain language and provide additional information, including language outlining timing by when prospective participants should hear from the plan or when they should contact plan to inquire about enrollment status, estimates of monthly payments under the MPPP, and additional tools and resources (e.g., decision aids, an interactive online platform, and a monthly cost calculator) to help beneficiaries understand how the program affects their specific situation.

CMS thanks the commenters for their careful review of the Participation Request Form and has made revisions to improve readability and plain language throughout the document, while keeping the document concise. Sponsors are encouraged to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them.

X

A commenter requested that CMS allow plans to include a QR code that links members to their online request form.

CMS thanks the commenter for their suggestion. The Participation Request Form includes a line for plans to insert their instructions for submitting the participation request online, over the phone, or by mail. This would include the provision of a QR code linking to the online request form.

X

X

A commenter requested that plans be allowed to include terms and conditions on the same page as the form to reduce paper usage, or given the flexibility to refer consumers to a plan’s website or call center for information on terms and conditions. Another commenter recommended that CMS provide guidelines for plans regarding the terms and conditions that plans can place at the end of the Participation Request Form.

CMS thanks the commenters for their suggestions and notes that the Participation Request Form includes an instruction to plans to insert their terms and conditions on the back of the Participation Request Form or to attach them separately. CMS declines to provide additional guidelines on terms and conditions for Part D plan sponsors. CMS will monitor program implementation in 2025 and evaluate whether additional guidelines are necessary in future years.

X

A commenter requested to add an optional field to collect internal beneficiary identification numbers to streamline plan processing of enrollment requests.

CMS thanks the commenter for their suggestion and has noted in the instructions for the Participation Request Form that plans may add a field for plan-specific beneficiary identification numbers.

X

A commenter asked CMS to clarify whether plans will have the option to incorporate this information into one overall Enrollment Election form to reduce burden on beneficiaries and plans.

CMS thanks the commenter for their question. CMS created a separate election form for the Medicare Prescription Payment Plan because a Medicare Part D enrollee must be enrolled in a Part D plan in order to participate, and the enrollee may opt into the Medicare Prescription Payment Plan at any point in the plan year, not just at the time of their enrollment with a plan. Additionally, while this program is open to all Part D enrollees, Part D enrollees incurring high out of pocket costs earlier in the plan year are generally more likely to benefit. Therefore, CMS believes that separate and distinct processes for plan enrollment and Medicare Prescription Payment Plan election will reduce confusion and help target the program to enrollees most likely to benefit. Plan sponsors are required to provide a Medicare Prescription Payment Plan Participation Request form as part of their membership ID hard copy mailing or in a separate mailing after an individual signs up for a Part D plan, and when the plan sponsor identifies the enrollee as likely to benefit from the program prior to or during the plan year.

X

A commenter expressed concern that the Participation Request Form does not explain that nonpayment of bills will result in termination of Medicare Prescription Payment Plan participation.

CMS thanks the commenter for their feedback. This information is included in other materials, including the Notice of Election Approval.

X

A commenter requested that CMS add a placeholder for the plan’s phone number in the section for the plan’s information in the event a beneficiary may need assistance while filling out the form (currently, the form only includes plan name, address, fax number, and email).

CMS thanks the commenter for their request. The Participation Request Form includes the following language in the section “How to submit this form”: “If you have questions or need help completing this form, call us at [phone number], [days and hours of operation]. TTY users can call [TTY number].

Election Approval Notice

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X

A couple of commenters suggested edits to the Election Approval notice to improve readability and plain language and provide additional information, such as detailed examples that illustrate the billing process and the consequences of non-payment.

CMS thanks the commenters for their careful review of the Notice to Acknowledge Acceptance of Election and has made revisions to improve readability and plain language throughout the document. CMS encourages sponsors to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them. As stated in section 30.1.5 of the draft part two guidance, Part D sponsors are required to provide examples of how the program calculation works with easy-to-understand explanations; sponsors may utilize a calculator tool to help fulfill this requirement. CMS encourages Part D sponsors to use the example calculations included in the final part one guidance or in the technical memoranda available here: https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements/medicare-prescription-payment-plan. Part D sponsors are also encouraged to use CMS-provided resources as outlined in section 40 of the draft part two guidance.

X

X

A couple of commenters requested that CMS add language clarifying that enrollees cannot rejoin the program if they have a past due balance. Another commenter requested that CMS add language stating that a beneficiary can be reinstated in the program if they repay any owed amounts to their plan.

CMS thanks the commenters for their feedback. The Notice of Voluntary Removal and Notice for Failure to Make Payments – Notification of Termination of Participation direct enrollees to contact their plan to opt back into the program (once they’ve paid all outstanding balances, if applicable).

X

X

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Several commenters asked CMS to clarify whether program participation will automatically renew beyond the plan year for which the beneficiary opts in. Commenters recommended that if participation is limited to the current plan year, CMS insert language into the Election Approval notice clearly stating the duration of program participation.

CMS thanks the commenters for their feedback. Automatic re-election into the Medicare Prescription Payment Plan will be addressed in future guidance; CMS will consider whether updates to the model materials are necessary at that time.

X

A commenter requested that CMS provide additional information in the Election Approval Notice related to beneficiary protections, such as the grace period and the prohibition on requiring beneficiaries to pay the remaining balance immediately upon disenrollment.

CMS thanks the commenters for their feedback and agrees that enrollee protections are a critical part of the program. The Notice for Failure to Make Payments and the Notice for Failure to Make Payments – Notification of Termination both direct enrollees to contact their plan if they think they’ve received the notice in error and also informs them of their right to appeal through the grievance process. CMS also notes that the payment due date that plan sponsors must include in the Notice for Failure to Make Payments must reflect the full grace period.

Voluntary Termination Notice

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Several commenters suggested edits to the Notification of Voluntary Termination to improve readability and plain language and provide additional information, such as detailed examples and scenarios to help beneficiaries understand their rights and responsibilities upon voluntary termination and variable language addressing termination due to death of a member.

CMS thanks the commenters for their careful review of the Notification of Voluntary Termaination and has made revisions to improve readability and plain language throughout the document, while keeping the document concise. Sponsors are encouraged to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them.

Initial Notice of Failure to Pay

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X

X

Several commenters suggested edits to the Notice of Failure to Pay to improve readability and plain language and provide additional information, such as detailed examples that illustrate the payment process and consequences of non-payment.

CMS thanks the commenters for their careful review of the Notice for Failure to Make Payments and has made revisions to improve readability and plain language throughout the document, while keeping the document concise. Sponsors are encouraged to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand

X

A commenter expressed concern that explaining failure to pay a Medicare Prescription Payment Plan bill will not terminate the participant’s enrollment in their Part D plan may encourage nonpayment.

CMS thanks the commenter for their feedback. Section 30.3 of the draft part two guidance requires Part D sponsors to provide Part D enrollees with promotional and educational materials on the Medicare Prescription Payment Plan. As outlined in Section 30.3, Part D sponsors must inform enrollees that termination due to nonpayment only applies to participation in the Medicare Prescription Payment Plan and that the enrollee’s Part D drug coverage will not be impacted. CMS believes it is important for enrollees to understand how the Medicare Prescription Payment Plan interacts with their Part D coverage in advance of entering into this arrangement with their Part D sponsor.

X

A commenter suggested that materials make clear that beneficiaries may re-elect into the Medicare Prescription Payment Plan provided they repay any outstanding balances.

CMS thanks the commenter for their feedback. The Notice for Failure to Make Payments – Notification of Termination of Participation directs enrollees to contact their plan to opt back into the program (once they’ve paid all outstanding balances).

X

A commenter recommended that CMS require the Part D plan to include their latest monthly billing statement—including information such as total drug costs, dates the prescription(s) were filled, at what pharmacy, patient OOP portion, portion paid by plan, amount remaining in annual $2,000 OOP max—with the provision of this notice so participants have a clear understanding of their costs and responsibilities.

CMS thanks the commenter for their recommendation. As outlined in section 30.3 of the draft part two guidance, the Notice for Failure to Make Payments – Notification of Termination of Participation must include pertinent dates and key pieces of information, including the date the missed monthly payment was due, the amount the individual must pay to remain in the program, and the date by when payment must be received.

Notice of Involuntary Termination

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X

X

Several commenters suggested edits to the Notice for Failure to Make Payments – Notification of Termination of Participation to improve readability and plain language and provide additional information, such as detailed examples that illustrate the steps beneficiaries need to take if they are terminated from the program.

CMS thanks the commenters for their careful review of the Notice for Failure to Make Payments – Notification of Termination of Participation and has made revisions to improve readability and plain language throughout the document, while keeping the document concise. Sponsors are encouraged to provide additional information, tools, and visualizations to best serve their Part D enrollees and ensure they properly understand the program and how it may benefit them.

X

X

A couple of commenters expressed concern that explaining that failure to pay a Medicare Prescription Payment Plan bill will not terminate the participant’s enrollment in their Part D plan may encourage nonpayment. Another commenter suggested that materials make clear that beneficiaries may re-elect into the Medicare Prescription Payment Plan provided they repay any outstanding balances.

CMS thanks the commenters for their feedback. Section 30.3 of the draft part two guidance requires Part D sponsors to provide Part D enrollees with promotional and educational materials on the Medicare Prescription Payment Plan. As outlined in Section 30.3, Part D sponsors must inform enrollees that termination due to nonpayment only applies to participation in the Medicare Prescription Payment Plan and that the enrollee’s Part D drug coverage will not be impacted. CMS believes it is important for enrollees to understand how the Medicare Prescription Payment Plan interacts with their Part D coverage in advance of entering into this arrangement with their Part D sponsor. The Notice for Failure to Make Payments and the Notice for Failure to Make Payments – Notification of Termination of Participation both direct enrollees to contact their plan to opt back into the program (once they’ve paid all outstanding balances, if applicable).

Out of Scope

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X

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X

CMS received a number of comments that are out of scope for this ICR package, including comments related to other CMS outreach and educational efforts, point-of-sale enrollment, the election request process, safeguards against inadvertent disenrollment, use of a member’s preferred contact method for distribution of notices, requirements for Part D sponsors to offer a dedicated helpline for completing paper forms, the requirement to include the election request form in membership ID card mailings, and inclusion of enrollees with no Part D cost sharing.

N/A