60-Day Comment Response

Commenters

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Common Theme

Prime West

Lumeris

BIO

BCBS MA

American Society of Hematology (ASH)

CVS Health

Ucare

Eli Lilly and Company

Humana

Capital Rx

American Lung Association

Medicare Rights Center

American Cancer Society Cancer Action Network (ACS CAN)

Cancer Support Community

MAPRx

AMCP

PCMA

PhRMA

UnitedHealth Group

Medical Card System

Viva Health

Independence Blue Cross

Alliance for Aging Research & Patient Access Network Foundation

Kaiser Permanente

The Leukemia & Lymphoma Society

National Health Council

Segal Co

PIRC

Haystack Project

Justice in Aging

Summary of Comment

Proposed Reponses

1

General

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A couple of commenters noted that CMS did not provide model materials for other required communications, including the notice to request additional information for an incomplete election request and the election request denial notice. The commenters requested that CMS clarify whether the agency will be providing model materials for these communications or if plans can leverage existing Part D model notices with modifications tailored to the Medicare Prescription Payment Plan. Another commenter requested that CMS provide a billing invoice template. A couple of commenters suggested that CMS provide an end-of-the-year notice for plan sponsors to issue to Medicare Prescription Payment Plan participants, providing information on how to “close out” payments for the current year and how to re-enroll for the following year. A commenter encouraged CMS to strengthen requirements for content standardization by plans. Another commenter asked CMS to create model language for Medicare Prescription Payment Plan information that plan sponsors are required to provide on their websites as well as within the Part D materials currently furnished to enrollees, including mailings of membership ID cards, explanation of benefits (EOB), Annual Notice of Change (ANOC), and Evidence of Coverage (EOC) documents.

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. 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. 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). If Part D sponsors choose to use the models, they must include all model language exactly as written unless otherwise specified, as stated in the updated instructions for the models included in this ICR package. If Part D sponsors choose to develop their own materials, they must ensure that required elements and information are included in their materials. CMS notes that the model EOC, ANOC, and EOB will be released in spring 2024 as part of the general issuance of CY 2025 Model Materials for the Part D program (CMS-10260; OMB 0938-1051).

2

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Many commenters recommended the inclusion of tools related to patient payment calculation in the model materials, such as a patient payment calculator, additional examples or real life scenarios illustrating the operations of the program. Several commenters also requested that the model materials provide clear direction to patients about where they can access additional information.

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.

3

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Several commenters requested that CMS finalize model documents as soon as possible, and no later than June 2024.

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.

4

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Several commenters encouraged CMS to ensure that all model materials are accessible for people with limited English proficiency as well as people with disabilities. A couple of commenters requested that CMS make model materials available in multiple languages and ensure they are culturally relevant for non-English speaking populations.

CMS agrees that Medicare Prescription Payment Plan materials must be accessible, appropriate, and easy to understand for all Medicare Part D enrollees. 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. These regulations apply to all required materials, including standardized and model materials, Part D sponsors use, tailor, or develop for the Medicare Prescription Payment Plan.

5

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Several commenters requested that CMS add an explanation of the document’s purpose and a brief overview of the Medicare Prescription Payment Plan to each of the model notices.

CMS thanks commenters for this suggestion. CMS has added an “Instructions” section to each document for plan sponsors and other stakeholders, which includes an explanation of the purpose of the document and notes the requirements fulfilled by using the document. CMS has also added a brief description of the Medicare Prescription Payment Plan to the appropriate model notices.

6

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Several commenters suggested that model documents clearly state that they originate from the beneficiary’s Part D sponsor, to help patients and consumers recognize official correspondence and reduce the risk of fraud. A couple of commenters also requested that CMS clarify whether any plan-specific information (such as plan logo, return address, plan name, or plan-specific disclaimers) are permitted on notices.

CMS thanks the commenters for their feedback. The “Instructions” section for each model notice states that plans may include plan-specific information and branding on all notices. The Likely to Benefit Notice may be plan-branded when the notice is provided by the Part D sponsor directly to the enrollee (such as in the prior to plan year outreach as described in section 30.2.2.1 of the draft part two guidance); however, when the notice is provided by the pharmacy directly to the enrollee (section 30.2.2.3), the pharmacy will provide the standardized notice without any plan-specific branding.

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A couple of commenters 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 thanks commenters for their feedback and interest in the program. CMS will conduct ongoing outreach to stakeholders during the first year of the program. CMS will monitor the program and consider any necessary changes to the model materials for future years; any revisions to the documents will go through the ICR process with opportunity for public comment.

8

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A couple of commenters requested that CMS provide additional flexibility to tailor Medicare Prescription Payment Plan-related materials for specific populations, such as enrollees in Employer Group Waiver Plans (EGWPs) and enrollees in Puerto Rico. One commenter requested that CMS permit plans that do not disenroll beneficiaries for failure to pay premiums to revise model language about losing coverage as a result of failing to pay premium.

CMS thanks the commenters 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). If Part D sponsors choose to use the models, they must include all model language exactly as written, except where specified. 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.

9

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Several commenters expressed support for CMS’ efforts to provide model materials and expressed their appreciation for the opportunity to provide feedback.

CMS thanks the commenters for their support.

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A commenter requested that CMS note in all model materials that the Medicare Prescription Plan is optional, free to join, and offered by all Part D plans.

CMS thanks the commenter for their suggestion and agrees that Part D sponsors should include language in their materials stating that the program is voluntary, doesn’t cost anything to join, and offered by all Medicare plans with Part D prescription coverage. This language is included in the Medicare Prescription Payment Plan Likely to Benefit Notice.

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A commenter requested that CMS ensure consistency in the naming conventions and references to model materials to ensure the correct model is provided to enrollees at the appropriate times.

CMS thanks the commenter for their feedback and will ensure consistency across references to these model materials in the ICR package and guidance documents. The official name of each model material is listed below. • Medicare Prescription Payment Plan Likely to Benefit Notice • Medicare Prescription Payment Plan Participation Request Form • Part D Sponsor Notice to Acknowledge Acceptance of Election into the Medicare Prescription Payment Plan • Part D Sponsor Notification of Voluntary Removal from the Medicare Prescription Payment Plan • Part D Sponsor Notice for Failure to Make Payments under Medicare Prescription Payment Plan • Part D Sponsor Notice for Failure to Make Payments under Medicare Prescription Payment Plan - Notification of Termination of Participation in the Medicare Prescription Payment Plan

12

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A commenter requested that CMS provide additional information in the model materials related to beneficiary protections, such as the grace period, good cause reinstatement, 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 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.

13

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A couple of commenters expressed support for the inclusion of information about other assistance programs for people with limited income in the model materials. Several commenters requested that CMS provide additional information related to financial assistance programs, including the expansion of the Low Income Subsidy in 2024, opportunities for retroactive coverage through LI-NET, and other significant benefits under Medicare Part D such as the elimination of copays for recommended vaccines and $35 monthly insulin cap. A couple of commenters also suggested that CMS consistently define the “other programs” available to lower costs.

CMS thanks the commenters for their support and agrees that raising awareness of other financial assistance programs, such as Medicare Extra Help, is paramount to ensuring that eligible Medicare beneficiaries are aware of and able to enroll in the program that best fits their needs. CMS also recognizes the importance of educating beneficiaries on the recent changes to the Part D benefit under the IRA, particularly those that increase affordability for beneficiaries. In section 30.1.5 of the draft part two guidance, CMS requires Part D sponsors to include on their websites general information about the LIS program, including information on the recent LIS expansion of eligibility and how to enroll in the program, with a note that LIS enrollment, for those who qualify, is likely to be more advantageous than participation in the Medicare Prescription Payment Plan. Additionally, CMS encourages Part D sponsors to include information on the new $2,000 OOP cap on Part D covered drugs in 2025. Part D sponsors are certainly encouraged to educate their beneficiaries on other important changes to the Part D benefit under the IRA, and CMS is undertaking efforts to strengthen beneficiaries’ awareness of the changes. CMS has reviewed the sections on other financial assistance on each of the model materials to ensure consistency across the documents.

14

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Several commenters encouraged CMS to ensure that model materials are clear, concise, and easy to understand. Commenters noted the importance of emphasizing that materials relate only to the Medicare Prescription Payment Plan, to limit possible beneficiary confusion about changes to their Part D plan coverage.

CMS appreciates the commenters’ concerns regarding potential confusion between the new program and the Part D enrollee’s Part D prescription drug benefit plan and shares the commenters’ goal of making model materials clear, concise, and easy to understand. To this end, CMS performed multiple rounds of focus group testing with a representative sample of Medicare Part D enrollees to evaluate the materials and products newly developed for the Medicare Prescription Payment Plan. The updated model materials in this ICR package include revisions made in response to focus group feedback. Additionally, the model notices include language clarifying that the notice only applies to Medicare Prescription Payment Plan participation. For example, in the Part D Sponsor Notice for Failure to Make Payments under Medicare Prescription Payment Plan - Notification of Termination of Participation in the Medicare Prescription Payment Plan, we have included language stating, in bold, that the notice of removal only applies to program participation and not to Part D plan enrollment or drug coverage.

15

Likely to Benefit Notice

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Many commenters suggested edits to the Likely to Benefit notice to improve readability and plain language and provide additional information. These suggestions included further differentiating the bills for Part D premiums and Medicare Prescription Payment Plan balances, clarifying that the program covers only covered Part D drugs and is not available for medical services or Part B drugs, and explaining why someone who uses other health insurance or receives extra help with prescription drug costs might not benefit from the program.

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.

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Many commenters recommended that CMS add examples to the Likely to Benefit notice or provide a link/QR code to additional examples. Commenters also suggested that CMS use illustrations or visual aids to help enrollees understand the mechanics of the program, including how the monthly payment calculation works.

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.

17

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A couple of commenters recommended that CMS provide additional information in the Likely to Benefit notice on other changes increasing affordability in Part D, such as the $35 copay for covered insulins, the expansion of the Extra Help program, and the changes with patient financial responsibility for certain vaccines. A commenter also suggested that CMS provide additional information on what the Low Income Subsidy does and how a beneficiary can access it.

CMS thanks the commenters for their support and agrees that raising awareness of other financial assistance programs, such as Medicare Extra Help, is paramount to ensuring that eligible Medicare beneficiaries are aware of and able to enroll in the program that best fits their needs. CMS also recognizes the importance of educating beneficiaries on the recent changes to the Part D benefit under the IRA, particularly those that increase affordability for beneficiaries. In section 30.1.5 of the draft part two guidance, CMS requires Part D sponsors to include on their websites general information about the LIS program, including information on the recent LIS expansion of eligibility and how to enroll in the program, with a note that LIS enrollment, for those who qualify, is likely to be more advantageous than participation in the Medicare Prescription Payment Plan. Additionally, CMS encourages Part D sponsors to include information on the new $2,000 OOP cap on Part D covered drugs in 2025. Part D sponsors are certainly encouraged to educate their beneficiaries on other important changes to the Part D benefit under the IRA, and CMS is undertaking efforts to strengthen beneficiaries’ awareness of the changes. The model notices include a list of additional financial assistance programs, including Extra Help, with a description of the program and a link to learn more.

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Several commenters requested that CMS permit plan sponsors to customize the Likely to Benefit notice for specific enrollee populations, such as enrollees in EGWPs or D-SNPs with zero cost sharing.

CMS thanks the commenters for their feedback. The Likely to Benefit Notice is a standardized material that Part D sponsors are required to use verbatim when they have identified an enrollee as likely to benefit from the program. Part D sponsors must identify individuals likely to benefit based on pharmacy point-of-sale criteria outlined in section 60.2.3 of the final part one guidance or based on the prior to and during the plan year criteria outlined in section 30.2 of the draft part two guidance. While CMS recognizes that Part D enrollees with low cost sharing may be less likely to benefit from the Medicare Prescription Payment Plan, these enrollees must nonetheless be made aware of and given the option to participate in the program as required by statute. CMS reminds commenters that all Part D sponsors have a statutory obligation to broadly educate all Part D enrollees about the program and encourages sponsors to directly communicate with their Part D enrollees about this program to help them understand whether the Medicare Prescription Payment Plan program is a beneficial option for them given their unique situation.

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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. A commenter noted that many pharmacy systems with automated printing capabilities are restricted to printing a single page document, similar to the Medicare Know Your Rights model notice.

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.

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A commenter requested that CMS provide an explanation of the purpose of the Likely to Benefit Notice and instructions for how the notice should be utilized.

CMS thanks the commenter for their feedback and has added an “Instructions” section to each document, including the Likely to Benefit Notice, which includes an explanation of the purpose of the document and notes the requirements fulfilled by using the document. Section 30.2.1 of the draft part two guidance states that Part D sponsors are required to use the standardized Likely to Benefit Notice to satisfy their obligation to perform targeted outreach to Part D enrollees who are identified as likely to benefit prior to and during the plan year, including those identified through the pharmacy notification process. This outreach, when performed outside of the pharmacy POS notification process, may be done via mail or electronically (based on the Part D enrollee’s preferred and authorized communication methods). If the enrollee is identified through the pharmacy notification process, this outreach must be completed at the pharmacy POS.

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A couple of commenters suggested that CMS revise the Likely to Benefit notice to make the potential benefit of the program clearer to enrollees and better communicate the potential impact of not enrolling. Commenters suggested that CMS seek to balance the tone of the notice to avoid discouraging beneficiaries from learning more and enrolling; in particular, commenters noted that language focused on how beneficiaries can “manage” monthly drug costs and the emphasis on potential variation in monthly costs under the program could confuse beneficiaries and lead them to believe there is no benefit to a program from which they have been identified as “likely to benefit.”

CMS appreciates commenters’ concerns. Given that not all Part D enrollees are likely to benefit from the program and that the program creates a new financial relationship between the Part D enrollee and the Part D sponsor, CMS believes it is important to be very clear about the nature of the program and ensure enrollees understand that the Medicare Prescription Payment Plan will not save them money or lower their drug costs.

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A commenter expressed their support for the standardization of the Likely to Benefit Notice.

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Several commenters requested that CMS provide additional detail on how to sign up for the Medicare Prescription Plan and provide contact information for the enrollee to contact their plan in the Likely to Benefit notice.

CMS thanks the commenters for their feedback. Section 30.2.1 of the draft part two guidance states that Part D sponsors are required to use the standardized Likely to Benefit Notice to satisfy their obligation to perform targeted outreach to Part D enrollees who are identified as likely to benefit prior to and during the plan year, including those identified through the pharmacy notification process. If the enrollee is identified through the pharmacy notification process, this outreach must be completed at the pharmacy POS. When the notice is provided by the pharmacy directly to the enrollee (section 30.2.2.3), the pharmacy will provide the standardized notice without any plan-specific branding or contact information. When the notice is provided by the Part D sponsor directly to the enrollee (such as in the prior to plan year outreach described in section 30.2.2.1), the Part D sponsor may include the plan name and logo on the notice, including plan-specific contact information.

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A commenter requested that the Likely to Benefit notice’s alternative format disclaimer copy be consistent with the copy and the phone number provided in other CMS required materials. The commenter recommended that CMS direct enrollees to their plans’ Member Services phone number instead of 1-800-Medicare.

CMS thanks the commenter for their feedback. Because the Likely to Benefit Notice is a standardized notice that, in many cases, will be provided by the pharmacy to the enrollee at POS, the alternative format disclaimer is different from alternative format disclaimers used in other Part D materials and does not include plan-specific contact information because Part D sponsors are unable to modify the notice when it is distributed by the pharmacy. The disclaimer directs enrollees who need alternative formats to contact their plan and directs enrollees who need help contacting their plan to 1-800-Medicare.

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A commenter requested that the Likely to Benefit Notice expressly indicate the payment plan is optional and the program does not reduce costs in any way. The commenter urged CMS to avoid conflating the program with an enrollee’s chosen part D plan and recommended the document explain that the program does not replace or supplement Part D coverage.

CMS appreciates the commenter’s concerns and agrees that Part D sponsors should include language stating that the program is voluntary, free to join, and offered by all Medicare plans with Part D prescription coverage. This language is included in the Likely to Benefit Notice.

Participation Request Form

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Several commenters asked CMS to clarify the minimum elements that must be included for a plan to consider the Participation Request form complete. A couple of commenters requested that the form only require the last four digits of the Medicare Number. A couple of commenters requested to remove fields not required to enroll members into the program (if they are already provided by enrollees upon plan enrollment) or to add fields to streamline plan processing of enrollment requests, such as health plan ID number or billing information.

CMS thanks the commenters for their feedback and has added instructions to the notice indicating that Part D sponsors may consider a Participation Request Form complete if it has the enrollee’s name, Medicare number, and has been signed by the enrollee or their authorized representative as confirmation of intent to opt into the program. 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 “Medicare Prescription Payment Plan Likely to Benefit Notice,” which is a standardized material that Part D sponsors are required to use verbatim). If Part D sponsors choose to use the models, except where specified, they must include all model language exactly as written, as stated in the updated instructions for the models included in this ICR package. If Part D sponsors choose to develop their own materials, they must ensure that required elements and information are included in their materials.

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Several commenters requested that CMS remove the question on the Participation Request form asking whether the beneficiary receives assistance in paying for their prescription drugs through programs like Extra Help or a State Pharmaceutical Assistance Program. Commenters noted that this question is not necessary to process the request to participate in the Medicare Prescription Payment Plan and CMS has not provided sufficient explanation or instructions for why this information is being collected on the model form.

CMS thanks the commenters for their feedback and has replaced this question on the participation request form with a statement reminding individuals that the program might not be the best choice for them if they get help paying for their drugs, and suggesting they call their plan for additional information.

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Several commenters suggested that CMS provide a brief overview of the program on the election request form to ensure enrollees understand what they are signing up for.

CMS thanks the commenters for their suggestion and has added a description of the program to the participation request form.

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Several commenters requested that CMS align fields for an authorized representative on the participation request form with current MA-PD/PDP enrollment forms or otherwise clarify the signature panel to indicate that either a Part D enrollee or that enrollee’s legal representative may complete and sign the request to participate.

CMS thanks the commenters for their feedback and has revised the participation request form to note that the authorized representative fields should be completed only if the person making the request is not the enrollee.

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Several commenters suggested that CMS add language to the participation request form directing enrollees to Medicare.gov or 1-800-MEDICARE as a resource for additional information on the program or provide plan contact information for enrollees who may need assistance completing the election request form.

CMS thanks the commenters for their feedback and has added language directing enrollees to call their plan if they have questions or need assistance completing the participation request form.

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Several commenters asked CMS to clarify the means by which election request forms may be submitted and to provide information on mechanisms besides the paper election form to opt into the program.

CMS thanks the commenters for their feedback and has added instructions to plan sponsors to insert their instructions for submitting the Participation Request form online, over the phone, or by mail.

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Many commenters suggested that CMS include information on the election request form on the timeline for plan sponsors to respond to election requests or reasons a plan sponsor might have for denying a request.

CMS thanks the commenters for their suggestion and declines to include this information in the model Participation Request form, in order to keep model materials concise and easy to understand. The Participation Request form provides enrollees with plan contact information for questions and additional assistance (“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>”).

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Several commenters requested that CMS provide guidelines for plan sponsors on what may be included in their terms and conditions.

CMS thanks the commenters for their suggestion and 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.

Election Approval Notice

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Many commenters suggested edits to the Election Approval notice to improve readability and plain language.

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.

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A couple of commenters recommended that CMS provide additional information in the Election Approval notice on other changes increasing affordability in Part D, such as the $35 copay for covered insulins, the expansion of the Extra Help program, and the changes with patient financial responsibility for certain vaccines.

CMS thanks the commenters for their support and agrees that raising awareness of other financial assistance programs, such as Medicare Extra Help, is paramount to ensuring that eligible Medicare beneficiaries are aware of and able to enroll in the program that best fits their needs. CMS also recognizes the importance of educating beneficiaries on the recent changes to the Part D benefit under the IRA, particularly those that increase affordability for beneficiaries. In section 30.1.5 of the draft part two guidance, CMS requires Part D sponsors to include on their websites general information about the LIS program, including information on the recent LIS expansion of eligibility and how to enroll in the program, with a note that LIS enrollment, for those who qualify, is likely to be more advantageous than participation in the Medicare Prescription Payment Plan. Additionally, CMS encourages Part D sponsors to include information on the new $2,000 OOP cap on Part D covered drugs in 2025. Part D sponsors are certainly encouraged to educate their beneficiaries on other important changes to the Part D benefit under the IRA, and CMS is undertaking efforts to strengthen beneficiaries’ awareness of the changes.

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A commenter expressed concern that the description of monthly bills in the Election Approval Notice noting that payments may change every month and enrollees might not know what their bill will be ahead of time will create confusion or cause enrollees concern that they may receive surprise medical bills.

CMS appreciates the commenter’s concern. Given that not all Part D enrollees are likely to benefit from the program and that the program creates a new financial relationship between the Part D enrollee and the Part D sponsor, CMS believes it is important to ensure that Part D enrollees understand the nuances of the program, including the possibility that bills may change month-to-month depending on the prescriptions the enrollee fills.

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Several commenters suggested that CMS provide more clarity under the header “Can I leave the Medicare Prescription Payment Plan?” in the Election Approval Notice about amounts that must still be paid upon termination from the program. Commenters requested that CMS emphasize enrollees are not required to pay the remaining balance immediately upon disenrollment.

CMS thanks the commenters for their feedback and notes that the Notice to Acknowledge Acceptance of Election states that enrollees who choose the leave the Medicare Prescription Payment Plan must pay any outstanding balances but can choose to pay their balance all at once or be billed monthly.

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Several commenters requested that CMS provide additional information in the Election Approval Notice related to beneficiary protections, such as the grace period, good cause reinstatement, opportunities to opt back into the program following termination or plan switching, and how to re-elect the program in a subsequent plan year.

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.

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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 that expectation.

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.

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Several commenters requested that CMS include other mechanisms besides a phone call for participants to opt out of the program in the Election Approval notice.

CMS thanks the commenters for their feedback and has added instructions to plan sponsors allowing them to add their preferred contact mechanisms for participants opting out of the program.

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A commenter requested that CMS use consistent links for Social Security Administration resources related to the Extra Help program.

CMS thanks the commenter for their feedback and has confirmed consistency for the Social Security Administration resources provided across all of the model materials.

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Several commenters requested that CMS provide clarity on plan sponsors’ ability to make changes to the Election Approval notice, including the ability to add copy directing members online or to call the Member Help Team to find their EOC, and the ability to make the Rx ID, Rx Group, Rx Bin, and Rx PCN optional fields.

CMS thanks the commenters for their feedback and has provided additional instructions to plan sponsors in the model notice indicating where they may make changes to the notice. The updated instructions state that the Rx ID, Rx Group, Rx Bin, and Rx PCN fields are all optional for sponsors to include.

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A commenter suggested that CMS provide an illustration or visual aid in the Election Approval notice to help enrollees understand the mechanics of monthly payments.

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.

Voluntary Termination Notice

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A commenter suggested edits to the Voluntary Termination notice to improve readability and plain language.

CMS thanks the commenter for their careful review of the Notification of Voluntary Removal and has made revisions to improve readability and plain language throughout the document.

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A commenter expressed concern that referring to the program as a “payment option” in the Voluntary Termination notice could confuse beneficiaries who think of “payment options” as payment through the mail or credit/debit card.

CMS appreciates the commenter’s concerns regarding potential confusion around the new program and shares the commenter’s goal of making model materials clear, concise, and easy to understand. To this end, CMS performed multiple rounds of focus group testing with a representative sample of Medicare Part D enrollees to evaluate the materials and products newly developed for the Medicare Prescription Payment Plan. The language in the model materials reflects the feedback received during consumer testing.

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Some commenters requested that CMS add language to the Voluntary Termination notice making clear that voluntary termination does not require an enrollee to pay an immediate lump sum in full; other commenters requested CMS emphasize the need for payment of any outstanding balance under the Medicare Prescription Payment Plan even when participation is ended voluntarily. A commenter suggested that CMS remove specific unpaid amounts from the “How Do I Pay My Balance” section and refer enrollees to monthly invoices for information on unpaid amounts.

CMS thanks the commenters for their feedback and has revised the language related to payment of outstanding balances. The Notification of Voluntary Removal states “You’ll continue to be billed monthly, or you can choose to pay the amount you owe all at once. You’ll never pay any interest or fees on the amount you owe. Contact <plan name> if you have questions about paying your balance.”

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Commenters requested to differentiate voluntary termination as a result of plan switching from voluntary termination as a result of no longer wanting to participate in the program in the Voluntary Termination notice. Commenters asked CMS to specify that there may still be payments owed to their former plan and enrollees must re-elect the program under their new plan.

CMS thanks the commenters for their suggestion and has revised the Notification of Voluntary Removal to provide plan sponsors with the option to tailor the notice based on the reason for voluntary termination. This will reduce potential enrollee confusion. The notice also states that unpaid balances will continue to be paid monthly, unless the enrollee chooses to pay the amount they owe all at once, and provides information about how the enrollee may elect into the Medicare Prescription Payment Plan in the future under a new Part D plan.

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Several commenters requested that CMS provide clarity on plan sponsors’ ability to make changes to the Voluntary Termination notice, including the ability to add other payment methods, add an address or mailing instructions for payments by mail, remove the sections "How do I pay my balance?" and "What happens if I don’t pay my balance?" if the member does not owe a balance , and make the Rx ID, Rx Group, Rx Bin, and Rx PCN optional fields.

CMS thanks the commenters for their feedback and has provided additional instructions to plan sponsors in the model notice indicating where they may make changes to the notice. The Rx ID, Rx Group, Rx Bin, and Rx PCN fields are all optional for sponsors to include.

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A commenter recommended that CMS clarify whether, in situations where a beneficiary makes a mid-year plan change within the same parent organization, the parent organization has the ability to automatically transfer the beneficiary’s Medicare Prescription Payment Plan election to their new plan, and to address this circumstance in the Voluntary Termination notice.

CMS thanks the commenter for the question. As discussed in section 70.4 of the Medicare Prescription Payment Plan: Final Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments, when a Part D enrollee disenrolls from a Part D plan, such as when switching plans during the coverage year or for a subsequent coverage year, their participation in the Medicare Prescription Payment Plan, as administered by the Part D sponsor losing the enrollee, effectively ends. This is the case even when the first plan and second plan are administered by the same Part D sponsor. The Part D sponsor of the new plan may not automatically sign up the individual for the Medicare Prescription Payment Plan under the individual’s new plan. The Part D enrollee may choose to elect into the program with the new Part D plan, regardless of any balance owed to the Part D plan sponsor of the prior plan.

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A commenter noted that the variable “Date” is missing from the Voluntary Termination notice.

CMS thanks the commenter for their feedback. The variable “Date” has been added to the model notice.

Initial Notice of Failure to Pay

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Many commenters suggested edits to the Initial Notice of Failure to Pay to improve readability and plain language and provide additional information. These suggestions included further differentiating the bills for Part D premiums and Medicare Prescription Payment Plan balances, clarifying that the notice is not referring to missed payment or possible termination from the enrollee’s Part D plan, and clarifying that responsibility for out-of-pocket costs after termination from the program will be limited to the enrollee’s remaining share of out-of-pocket costs up to the $2,000 threshold.

CMS thanks the commenter for their careful review of the Initial Notice of Failure to Pay and has made revisions to improve readability and plain language throughout the document.

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A couple of commenters expressed concern that using language in the Initial Notice of Failure to Pay such as “urgent” is too harsh and suggested revisions to soften the messaging; other commenters encouraged CMS to emphasize the urgency of past due payments.

CMS appreciates the commenters’ concerns. Part D sponsors may insert a title for the notice; the suggested title provided by CMS has been revised to “Reminder: Pay your Medicare

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Some commenters expressed concern that the sentence in the Initial Notice of Failure to Pay stating “like any other debt, you’re required to pay the amount you owe” could be too harsh or confusing, since the next sentence says that enrollees will keep their drug coverage as long as they pay their premium.

CMS appreciates the commenters’ concerns and has updated the language for additional clarity. (“You’re required to pay the amount you owe. You won’t pay any interest or fees on the amount you owe, even if your payment is late. If you’re removed from the Medicare Prescription Payment Plan, you’ll still be enrolled in <plan name>.”)

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A commenter recommended that plans state the actual date of the deadline for payment in the Initial Notice of Failure to Pay.

CMS thanks the commenter for their suggestion and notes that the first paragraph of the Notice for Failure to Make Payments includes a field for the plan sponsor to insert the payment due date. ( “To stay in the Medicare Prescription Payment Plan, you must pay <insert the full amount or a partial amount(s) should the plan choose to allow enrollees to pay the balance over separate payments> by <insert date for the end of the grace period (i.e., the date that is two calendar months from the first day of the month for which the balance is unpaid or the first day of the month following the date on which the payment is requested, whichever is later)>.”)

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A couple of commenters requested that CMS remove the language in the Initial Notice of Failure to Pay indicating that a Medicare Prescription Payment Plan payment can be redirected to the enrollee’s premium. Commenters noted that the management of the program may be delegated to a plan’s PBM and the PBM/vendor would have to coordinate with the plan to apply a Program’s payment to premiums, introducing further complexities and potential for error.

CMS thanks the commenters for their feedback and has removed this language from the Notice for Failure to Make Payments. As stated in section 40.1 of the final part one guidance, Part D sponsors are required to prioritize payments towards Part D plan premiums to avoid a Part D enrollee losing their Part D coverage when it is unclear whether a payment received from a participant is intended by the participant to cover their outstanding Part D plan premium or Medicare Prescription Payment Plan balance.

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Several commenters requested that CMS include additional information in the Initial Notice of Failure to Pay about the process of reinstatement, or how an enrollee can re-elect the program after being terminated.

CMS thanks the commenters for their feedback. 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).

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A few commenters asked CMS to clarify in the Initial Notice of Failure to Pay whether an overdue amount can be paid monthly; if the balance has to be paid by a specific due date, the language in the notice on how to pay a bill is confusing. A commenter also asked CMS to clarify whether monthly payments can be made after December of the plan year.

CMS thanks the commenters for their feedback and has removed the language indicating that an overdue amount can be billed monthly. As stated in section 80.2.2 of the final part one guidance, the two-month grace period must carry over into the next calendar year if non-payment occurs at the end of a prior calendar year.

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A commenter suggested that CMS provide a brief overview of the program in the Initial Notice of Failure to Pay.

CMS thanks the commenter for their feedback and has added a one sentence overview of the Medicare Prescription Payment Plan to the first paragraph of the notice as a reminder for enrollees.

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A commenter noted that the variable “Date” is missing from the Initial Notice of Failure to Pay.

CMS thanks the commenter for their feedback. The variable “Date” has been added to the model notice.

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Several commenters requested that CMS provide clarity on plan sponsors’ ability to make changes to the Initial Notice of Failure to Pay, including the ability to add other payment methods, add an address or mailing instructions for payments by mail, add copy directing members online or to the plan’s Member Help Team to find their Evidence of Coverage, and make the Rx ID, Rx Group, Rx Bin, and Rx PCN optional fields.

CMS thanks the commenters for their feedback and has provided additional instructions to plan sponsors in the model notice indicating where they may make changes to the notice, including tailoring payment methods and including a mailing address for payments made through the mail. The Rx ID, Rx Group, Rx Bin, and Rx PCN fields are all optional for sponsors to include.

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A commenter requested that CMS permit plan sponsors to provide a customized list of other financial assistance options to include plan-specific programs in the Initial Notice of Failure to Pay.

CMS thanks the commenter for their suggestion and has noted in the instructions to plan sponsors that plan sponsors may include their plan-specific assistance programs, if applicable, to the list of resources in the section “Are there programs that can help lower my costs?”

Removal for Failure to Pay

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Many commenters requested that CMS include additional information in the Notice of Removal for Failure to Pay about how an individual can re-enroll in the program after termination.

CMS thanks the commenters for their feedback and has added language to the section “Can I use this payment option in the future?” directing enrollees to contact their plan for more information on reinstatement after paying back any outstanding balances.

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A commenter requested that CMS state more clearly in the Notice of Removal for Failure to Pay that enrollees terminated from the Medicare Prescription Payment Plan are not being disenrolled from their Part D plan.

CMS thanks the commenter for their concern. The Notice for Failure to Make Payments under Medicare Prescription Payment Plan - Notification of Termination of Participation states, in bold text, “This letter only applies to your participation in the Medicare Prescription Payment Plan. Your Medicare drug coverage and other Medicare benefits won’t be affected, and you’ll continue to be enrolled in <plan name> for your drug coverage.”

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Several commenters suggested edits to the Notice of Removal for Failure to Pay to improve readability and plain language and provide additional information. These suggestions included clarifying that responsibility for out-of-pocket costs after termination from the program will be limited to the enrollee’s remaining share of out-of-pocket costs up to the $2,000 threshold.

CMS thanks the commenter for their careful review of the Notice for Failure to Make Payments under Medicare Prescription Payment Plan - Notification of Termination of Participation and has made revisions to improve readability and plain language throughout the document.

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Several commenters requested that CMS provide clarity on plan sponsors’ ability to make changes to the Notice of Removal for Failure to Pay, including the ability to add other payment methods, add an address or mailing instructions for payments by mail, add copy directing members online or to the plan’s Member Help Team to find their Evidence of Coverage, and make the Rx ID, Rx Group, Rx Bin, and Rx PCN optional fields.

CMS thanks the commenters for their feedback and has provided additional instructions to plan sponsors in the model notice indicating where they may make changes to the notice, including tailoring payment methods and including a mailing address for payments made through the mail. The Rx ID, Rx Group, Rx Bin, and Rx PCN fields are all optional for sponsors to include.

Out of Scope

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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, year-over-year enrollment in the program, election request processing, providing a real-time opt-in mechanism, setting the likely to benefit threshold, notification of individuals identified as likely to benefit, and processes for submitting termination data to CMS.

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