30 Day Public Comment Response

2025 Part D Reporting Requirements - 30 Day Comments and Responses:

CMS received comments from 12 entities including Part D sponsors, professional organizations and trade associations. Comments were related to two reporting sections – 1. Coverage Determinations/Redeterminations (including At–Risk Redeterminations under a Drug Management Program), and Reopenings and 2. Medicare Prescription Payment Plan.

• Reporting section – Coverage Determinations, Redeterminations (including At–Risk Redeterminations under a Drug Management Program), and Reopenings

Comment: A commenter sought clarification on whether plans should report the data based upon the date the enrollee/enrollee’s representative is notified that the decision was not made in a timely manner and is being forwarded to the Independent Review Entity (IRE) for review. The commenter requested CMS clarify that the data should be reported based on the date the enrollee was notified that the request was auto-forwarded to the IRE.

Response: CMS thanks the commenter for their feedback. Untimely coverage determinations and redeterminations are considered adverse decisions; therefore, the plan must report as an adverse decision under the appropriate data element. The plan should report the data based upon the date the enrollee/enrollee’s representative is notified that the decision was not made timely and is being forwarded to the IRE for review.  This response aligns with each section of the Technical Specifications that state, “Requests for coverage determinations and redeterminations, including exceptions, are reported based on the date the enrollee/enrollee’s representative is notified in writing of the coverage determination decision or redetermination decision”.  While the plan has not notified the enrollee or enrollee’s representative in writing of an approval or denial, the plan has provided written notification of why the case is being forwarded to the IRE. 

• Reporting section - Medicare Prescription Payment Plan

Comment: A commenter requested clarification on whether CMS will be including technical specifications for reporting on the new program and if so, whether Part D sponsors will be given an opportunity to comment on those requirements.

Response: CMS will be providing technical specifications for Medicare Prescription Payment Plan reporting as part of the Medicare Part D Reporting Requirements Technical Specifications Document for Contract Year 2025. Interested parties may share any questions or comments on the Medicare Prescription Payment Plan reporting requirements with CMS by emailing [email protected].

Comment: A couple of commenters expressed support for the changes CMS made to the Medicare Prescription Payment Plan reporting requirements following the 60-day comment period, particularly the inclusion of new measures to better delineate the efficiency of the “likely to benefit” identification process, measures to better track election request processing, and measures related to unsettled balances.

Response: CMS thanks the commenters for their support.

Comment: Several commenters requested clarification on definitions of specific data elements and the reporting period parameters.

Response: CMS thanks the commenters for their careful review of the Medicare Prescription Payment Plan reporting requirements. The Technical Specifications document, to be released later this year, will further define data elements, help ensure a common understanding of the data to be reported, and assist sponsors in preparing and submitting datasets.

Comment: A couple of commenters expressed concern that instructing plans to report “The total number of individuals identified as likely to benefit from the Medicare Prescription Payment Plan during the reporting period based on one or more of the following methods” in Element A appeared to give plan sponsors a choice of which methods to report, leading to inconsistent reporting, and suggested that CMS clarify the intent of the data element.

Response: CMS thanks the commenters for their careful review of the Medicare Prescription Payment Plan reporting requirements. CMS has revised Element A to clarify that plan sponsors should report the total number of individuals identified as likely to benefit from the Medicare Prescription Payment Plan during the reporting period through any of the following methods: prior to plan year criteria, during the plan year criteria, and point of sale (POS) criteria. Additional definitions will be provided in the technical specifications document to be released later this year.

Comment: A commenter recommended that CMS revise Element G to state “Of the total reported in element F, the number of election requests that were complete at the time of initial receipt.” The commenter expressed concern that the current description (“requests that were accepted during the reporting period”) could create confusion by requiring the reporting of requests received at the end of December in one contract year but not processed and accepted until January of the following contract year.

Response: CMS thanks the commenter for their feedback and declines to make this change. CMS will provide additional guidance in the Technical Specifications document defining “accepted” election requests.

Comment: One commenter recommended that CMS revise Element J by replacing the phrase “enrollment request” with the phrase “election request,” consistent with CMS guidance that beneficiaries do not ‘enroll’ in the Medicare Prescription Payment Plan but rather ‘elect’ the program.

Response: CMS thanks the commenter for their feedback and has revised Element J.

Comment: A couple of commenters suggested that CMS collect additional data elements to evaluate the effectiveness of different mechanisms for enrolling beneficiaries in the program and increase oversight of program viability. Suggested data elements included:

• Number of beneficiaries who opted into the program upon a plan enrollment

• Breakdown of total number of beneficiaries who opted into the program by election method (election request form sent with membership ID card, plan website, telephone, mail)

• Number of program participants who missed payments

• Number of program participants with a missed payment who paid after receiving first notice of a late payment

• Number of program participants with a missed payment who paid after receiving second notice of a late payment

• Number of program participants with higher average balances

Response: CMS thanks the commenters for their suggestions. CMS has endeavored to minimize burden for Part D plan sponsors in the first year of the program by limiting data collection to those critical data elements that are necessary to assess the operations of the Medicare Prescription Payment Plan and ensure financial stability in the Medicare Part D program. CMS may consider revised or additional reporting requirements for future years.

Comment: A couple of commenters suggested that CMS collect additional data elements to determine whether the $600 single prescription threshold is appropriate for identifying 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 suggestions. CMS has endeavored to minimize burden for Part D plan sponsors in the first year of the program by limiting data collection to those critical data elements that are necessary to assess the operations of the Medicare Prescription Payment Plan and ensure financial stability in the Medicare Part D program. CMS may consider revised or additional reporting requirements for future years.

Comment: Two commenters encouraged CMS to consider collecting demographic information of those electing and opting against electing into the Medicare Prescription Payment Plan, including income level, geographic location, 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 suggestion. CMS is committed to advancing health equity by addressing the health disparities that underlie our health system and recognizes the importance of collecting data that assesses whether programs like the Medicare Prescription Payment Plan are aligning with the needs of communities and individuals. CMS will collect beneficiary-level data on participation in the Medicare Prescription Payment Plan through the Medicare Advantage Prescription Drug (MARx) System (OMB control number 0938-1468).

Comment: One commenter urged CMS to use the information collected from Part D plan sponsors to monitor patterns of beneficiary behavior and develop stronger incentives for enrollees to make the required monthly payments.

Response: CMS thanks the commenter for their feedback. As stated in section 80.3 of 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, a Part D sponsor may preclude an individual from opting into the Medicare Prescription Payment Plan program in a subsequent year if the individual owes an overdue balance to that Part D sponsor. In addition, as stated in section 80.3, preclusion is permitted in plans that are offered by the same parent organization 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 participate in the program again. CMS intends to use the collection of data as outlined in this Information Collection Request to assess the operations of the Medicare Prescription Payment Plan and ensure financial stability in the Medicare Part D program. CMS may use this data to inform future program requirements.

Comment: A commenter asked CMS to confirm that Medicare Prescription Payment Plan data reporting is due in April and not February. Another commenter noted that a December 31 cut off date for Medicare Prescription Payment Plan reporting risks losing collection activities that plans may need to pursue into the next plan year, and asked whether CMS intends to collect data for events that have occurred as of 12/31/2025, or to cover results for Medicare Prescription Payment Plan claims/payments due through 12/31/2025 even if the billing and collection period are past 12/31/2025. The commenter suggested that data on unsettled balances under the program should be included in Direct and Indirect Remuneration (DIR) reporting instead of the Part D Reporting Requirements, because the June DIR reporting deadline may better align with the Medicare Prescription Payment Plan billing and collection period, and because payments under the Medicare Prescription Payment Plan are likely within the scope of the One-Third financial audit process rather than the Part D Data Validation audit.

Response: CMS thanks the commenters for their feedback. CMS’ intent is to collect data on uncollected balances for Medicare Prescription Payment Plan claims due through the end of the plan year (12/31), even if the billing and collection period extends beyond that date. Consequently, the Medicare Prescription Payment Plan data elements in the Medicare Part D Reporting Requirements are not due until the last Monday in April. CMS also notes that in 2025, CMS will not be requiring plan sponsors to undergo data validation for Medicare Prescription Payment Plan data. CMS may consider data validation requirements in future years. As unsettled balances under the program are not a form of DIR, CMS believes that data on unsettled balances is best reported through the Part D Reporting Requirements and not the Summary and Detailed DIR Reports.

Comment: A commenter recommended that CMS make data reported by Part D plan sponsors publicly available to inform broader outreach and education efforts. The commenter also requested that CMS provide oversight of plans to ensure they do not seek to pass the administrative burden of data reporting onto patients via access restrictions or higher premiums.

Response: CMS thanks the commenter for their suggestion and looks forward to working with stakeholders to support outreach and education related to the Medicare Prescription Payment Plan program. Our main objective in collecting data for CY 2025 is to assess the operations of the Medicare Prescription Payment Plan and ensure financial stability in the Medicare Part D program. CMS will evaluate data submissions once we review them and consider opportunities for increased data transparency. We also note that plans submit bids to cover benefit and operational costs for a payment year, and plan sponsors have a strong incentive to keep bids as low as possible.