CMS-10912 CMS-10912.MTF_ICR_ MFPEffectuationPlanForm_clean

Appendix B: Drug Price Negotiation Program MTF DM Primary Manufacturer MFP Effectuation Plan Form

Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program (“the Negotiation Program”), codified in sections 1191 through 1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to negotiate a maximum fair price (“MFP”), defined at section 1191(c)(3) of the Act, for certain high expenditure, single source drugs covered under Medicare Part B and Part D (“selected drugs”). In accordance with section 1193(a) of the Act, any Primary Manufacturer of a selected drug that continues to participate in the Negotiation Program and reaches agreement upon an MFP for the selected drug must provide access to the MFP to MFP-eligible individuals, defined in section 1191(c)(2)(A) of the Act, and to pharmacies, mail order services, other dispensing entities, providers and suppliers with respect to such MFP-eligible individuals who are dispensed that selected drug during a price applicability period.

To facilitate the effectuation of the MFP, CMS will engage a Medicare Transaction Facilitator (MTF). The MTF system will be comprised of two modules: the MTF Data Module (MTF DM), and the MTF Payment Module (MTF PM). Primary Manufacturers participating in the Negotiation Program are required to participate in the MTF DM. Further, CMS has proposed in rulemaking to require Part D plan sponsors to include in their network pharmacy agreements provisions requiring dispensing entities to be enrolled in the MTF DM for purposes of data exchange. As discussed in section 40.4 of the Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 (“final guidance”), CMS will engage the MTF DM to facilitate the exchange of certain claim-level data elements and payment elements for selected drugs. The data exchange component of the MTF will involve both the transmission of certain claim-level data elements to the Primary Manufacturer and receipt of claim-level payment elements from the Primary Manufacturer.

This form is designed to collect the necessary information from Primary Manufacturers related to the MFP Effectuation Plan. The following questions collect information applicable to any mechanism a Primary Manufacturers chooses to effectuate the MFP. CMS understands that some information provided by a Primary Manufacturer may be proprietary. CMS reiterates that the MFP Effectuation Plans will not be shared publicly by the agency and a limited subset of the information will be provided to MTF DM participants, and possibly interested stakeholders via request, in the form of a redacted MFP Effectuation Plan. Specifically, CMS plans to make Section 1, Question 1; Section 2, in its entirety; and Section 3, in its entirety, available within the MTF DM, while Section 1, Question 2; and Sections 4 – 6, in their entirety, will be redacted and collected solely for CMS’ use to ensure effectuation of the MFP. CMS notes that Primary Manufacturers will respond to Section 1 in the MTF DM user interface during their enrollment process; thus, the response to Question 1 will be attached to sections 2 and 3 and made available to dispensing entities within the MTF DM when they enroll in the system.

General information about CMS’ work related to the IRA is available at https://www.cms.gov/inflation-reduction-act-and-medicare.

The relevant statute pertaining to this information collection request (ICR) can be found at this link: https://www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf

The relevant guidance pertaining to this ICR can be found at this link: https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf

General Instructions

Overview

Each Primary Manufacturer must complete Sections 1 through 6 of this form (listed below) detailing its plan for effectuating the MFP for the Primary Manufacturer’s selected drug(s). In the event a Primary Manufacturer holds more than one selected drug with agreed upon MFPs, this plan should cover all such selected drugs. If the Primary Manufacturer has an effectuation approach that is differentiated across selected drugs, the Primary Manufacturer should indicate such within the details of its Plan, noting which approach is attached to which drug where applicable. 

1. Primary Manufacturer’s Description of Participation in the MTF PM

2. Managing Relationships with Dispensing Entities

3. Information Requested of Primary Manufacturers Declining Use of the MTF PM

4. Primary Manufacturer’s Process for Effectuating the MFP

5. Primary Manufacturer Acknowledgements Regarding MFP Availability

6. Certification

Technical assistance for Primary Manufacturers will be made available. For technical assistance related to the submission of information in the MTF DM, questions should be sent to [email protected].

Questions about MTF DM user access should be sent to [email protected].

Submission Method

Primary Manufacturers will submit the information for Sections 1 through 6 via the MTF DM, which can be accessed here: [SYSTEM URL]. Instructions for Primary Manufacturers to gain access to the MTF DM to submit data related to Sections 1 through 6 will be available prior to the deadline for submitting the MFP Effectuation Plan (i.e., September 1, 2025 for IPAY 2026, and September 1, 2026 for IPAY 2027). Primary Manufacturers will complete Section 1 electronically in the MTF DM interface and Sections 2 through 6 via a downloadable PDF document on which the Primary Manufacturer can input their responses to relevant questions and upload into the MTF system upon completion.

Explanation

• For purposes of this ICR, all defined terms referenced in this ICR have their meaning set forth in the final guidance.

• Response formats are indicated within each element description in this ICR. The character limits included in many of the ‘text’ fields represent maximums and are set to provide sufficient space for Primary Manufacturers to provide information; Primary Manufacturer may address these fields with shorter responses (i.e., using fewer characters than noted by the limit) at their discretion.

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Section 1: Primary Manufacturer’s Description of Participation in the MTF PM

Responses to Question 1 of this section will be made available to dispensing entities and, possibly, other interested stakeholders with no redactions. Any responses to Question 2, or its subparts, will be redacted in their entirety.

Q1. Respond to the following regarding the use of the MTF PM.

Field

Response Format

The Primary Manufacturer will use the MTF PM to provide retrospective reimbursements to dispensing entities. Selecting ‘Yes’ indicates that the Primary Manufacturer intends to use the MTF PM to pass through MFP refunds as part of its approach to MFP access for any of its MFP-eligible claims; selecting ‘Yes’ does not preclude the Primary Manufacturer from also engaging in alternative arrangements to process MFP refunds without the MTF PM as described in Q11 – Q15 of this Form.

Yes No If the response is “Yes”, then the Primary Manufacturer will move to Question 2 and provide their financial information. If the response is “No”, then the Primary Manufacturer will be reminded to describe their reimbursement mechanism in Section 3 of the downloadable PDF and is not required to provide any financial information. The manufacturer will proceed directly to Section 2.

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Q2. If the Primary Manufacturer responds “Yes” to Q1, provide the following financial information and account details to facilitate payment and applicable remittance advice consistent with the instructions set forth. Financial information and account details must be provided to facilitate payment. This information may also be necessary for making available an Electronic Remittance Advice (ERA) or remittance. This question will be for internal CMS use only and will not be made public.

Instructions

• Fill out the tables with the contact information for the financial institution that holds the funds that will be transmitted to dispensing entities in order to make the MFP available.

• The name entered for the financial institution must be the financial institution's legal business name.

• When providing the financial institution’s address, do not include P.O. Boxes.

• Account number should include applicable leading zeros.

Q2A. Financial Institution Contact Information.

Field	Response Format
Financial Institution’s Name	Text
Financial Institution Contact Person’s Name	Text
Address	Text
Email Address	Text
Phone Number	Text

Q2B. Bank Account and Federal Tax Identification Number Information.

Field	Response Format
Routing Number	Text
Bank Account Number	Text
Confirm Bank Account Number	Text
Registered Financial Account Type (Checking or Savings)	Text
Federal Tax Identification Number (TIN) (e.g., Employer Identification Number) (EIN))	Text

Q2C. Confirmation of Bank Account Information. To verify the banking information provided, please upload one of the following documents to your submission: either (1) a voided check for the account listed, which shows the account holder’s name, bank account number, and routing number—ensure that the check is clearly marked as “VOID” across the front; or, (2) a letter from the bank, printed on official bank letterhead, that confirms the account holder’s name, account number, and routing number—the letter must be signed by a representative of the bank and include their contact information for verification purposes.

[DOCUMENT UPLOAD]

Section 2: Managing Relationships with Dispensing Entities

Beginning in Section 2, these questions will be included in a downloadable, fillable PDF that is accessible on the CMS website during the enrollment process for Primary Manufacturers in the MTF DM. Primary Manufacturers must complete Sections 2 to 6 of their MFP Effectuation Plan by entering the required information in the fillable PDF and uploading the completed PDF to the MTF user interface as a means for submission.

Responses to questions in this section will be made available to dispensing entities and, possibly, other interested stakeholders with no redactions.

Q3. Respond to the following question related to establishing communications with dispensing entities.

Field

Response Format

Describe the Primary Manufacturer’s process for contacting, receiving, and responding to communications from dispensing entities regarding MFP effectuation. If applicable, the response should describe any proactive outreach to dispensing entities related to the Primary Manufacturer’s MFP Effectuation Plan and its related policies and procedures, plans for disseminating or publishing key information, and the approach the Primary Manufacturer intends to establish for intaking and responding to communications initiated by dispensing entities as the program continues. For Primary Manufacturers electing to forgo use of the MTF PM, this response should provide details describing the Primary Manufacturer’s process for contacting and working with dispensing entities to integrate and assist them in receiving MFP refunds through the manufacturer’s identified methods, including an approach for receiving and responding to communications related to the availability of MFP to dispensing entities.

Text field (10,000-character limit)

The Primary Manufacturer will be provided a list of dispensing entities that have self-identified as having material cashflow concerns at the start of a price applicability period with respect to a selected drug as a result of potential delays created by reliance on retrospective MFP refunds within the 14-day prompt MFP payment window.

Q4. Respond to the following question regarding interaction with dispensing entities that have indicated they have material cashflow concerns.

Field

Response Format

Describe the Primary Manufacturer’s process for mitigating material cashflow concerns for dispensing entities. Include, as applicable, a description of any qualifying criteria for dispensing entities to participate in the Primary Manufacturer’s process to assist dispensing entities with material cashflow concerns, including but not limited to the dispensing entities that have self-identified as having such concerns.

Text field (15,000 -character limit)

Section 3: Information Requested of Primary Manufacturers Declining Use of the MTF PM

This section is to be completed only for selected drugs for which the Primary Manufacturer has fully declined use of the MTF PM. If the Primary Manufacturer has elected to broadly use the MTF PM for its selected drug(s) for which this form is being completed, or has elected to use the MTF PM to pass through payments to some dispensing entities while using alternative arrangements that do not rely on the MTF PM to pay others, the Primary Manufacturer may proceed to Section 4 without completing this section.

Primary Manufacturers that elect to completely forgo the use of the MTF PM are encouraged to be as specific as possible when describing their MFP Effectuation Plans in the questions below, with policies and procedures to address the needs of a diverse range of dispensing entities and dispensing entity types. As discussed in section 90.2.1 of the final guidance, if a Primary Manufacturer declines to use the MTF PM, then it is required to provide, at a minimum, a functionally equivalent electronic reimbursement mechanism to that offered by the MTF PM and will be responsible for ensuring that paper checks are provided as a reimbursement mechanism for dispensing entities that do not wish to be reimbursed electronically. Further, the Primary Manufacturer will maintain responsibility for transmitting claims-level payment elements to CMS for payments processed outside the MTF DM (please reference Table 3 and Table 5 in sections 40.4.3.1, and 40.4.4.2 of the final guidance, describing required payment elements). CMS may request supporting documentation for fields that require an acknowledgement from a Primary Manufacturer consistent with the requirements set forth in the final guidance.

Responses contained in this section will be made available to dispensing entities and, possibly, other interested stakeholders with no redactions to ensure their awareness of the approach to MFP Effectuation by Primary Manufacturers forgoing the MTF PM.

Q5. Describe the Primary Manufacturer’s processes for effectuating MFP with both an electronic and paper check method without using the MTF PM to pass through any MFP refunds by addressing each of the following questions.

Field	Response Format
Q5A. Describe the Primary Manufacturer’s comprehensive process for effectuating MFP to each applicable dispensing entity within the 14-day prompt MFP payment window. If the approach includes issuing MFP refund payments, this response should describe the process for processing such refund payments both via electronic transfers and paper checks.	Text field (20,000-character limit)
Q5B. Describe the Primary Manufacturer’s method or methods of reconciling over- or under-payments arising from situations such as adjusted or updated claim information (e.g., 340B, reversals, revisions, etc.) using a comprehensive, GAAP-compliant system.	Text field (10,000-character limit)
Q5C. The Primary Manufacturer has developed a process or processes for generating and timely sending a remittance either electronically or by paper using a comprehensive, auditable, GAAP-compliant system aligned with either processing MFP refund payments and/or any other applicable approach to MFP effectuation.	Acknowledge
Q5D. The Primary Manufacturer has developed an approach for completing internal auditing to ensure all transactions effectuate MFP.	Acknowledge
Q5E. The Primary Manufacturer confirms that it will submit claim-level payment elements to the MTF DM in accordance with the final guidance, including the specific payment elements discussed in sections 40.4.3 and 40.4.4, as required for purposes of administering the Negotiation Program consistent with section 1193(a)(5) of the Act.	Acknowledge

Section 4: MFP Effectuation

The following questions collect information that is applicable to any mechanism a Primary Manufacturer chooses to use to effectuate MFP. These questions relate to the Primary Manufacturer’s responsibilities set forth in section 40.4 (and its associated subsections) and section 90.2.1 of CMS’ final guidance.

Any responses to the questions in this section will be for CMS use only and will not be made public.

Q6. CMS requires Primary Manufacturers to provide details on their processes for assessing the claims received from the MTF DM for eligibility for the exception in section 1193(d)(1) of the Act, as described in section 40.4.5 of the final guidance.

Field

Response Format

Describe the Primary Manufacturer’s process for effectuating nonduplication of claims that are 340B eligible and not subject to MFP availability. The response should include, at a minimum, descriptions of the following: Manufacturer’s valid and reliable process identifying claims that are 340B eligible and the 340B ceiling is lower than the MFP. Process for effectuating the MFP for claims the Primary Manufacturer has not reasonably determined to be 340B eligible. Approach to collection, review, and storage of documentation to support 340B nonduplication. Approach to monitoring the Primary Manufacturer’s 340B nonduplication process over time to support reconciling as new data becomes available. Approach to using the MTF credit/debit ledger system for reconciliation of any 340B duplicate discounts (note: applicable only for claims for which MFP refund is made using the MTF PM). Approach for reconciling any 340B duplicate discounts for claims that were not processed through the MTF PM (if applicable).

Text field (15,000-character limit)

Q7. As described in the final guidance, Primary Manufacturers are required to transmit their claim-level payment elements within 14 days of receiving claim-level data elements from the MTF DM. Describe the Primary Manufacturer’s planned frequency of submission of the report of payment-related data below.

Field

Response Format

Describe the frequency that the Primary Manufacturer plans to transmit claim-level payment elements to the MTF DM (e.g., daily, weekly, etc.), why the Primary Manufacturer intends to adopt that frequency, and, if applicable, how any batched or consolidated reporting from the Primary Manufacturer will accomplish the data transmission to the MTF DM within each claim’s 14-day prompt MFP payment window.

Text field (5,000-character limit)

Q8. As described in the final guidance, the Primary Manufacturer is expected to include in its MFP Effectuation Plan whether it will use the dispensing entity’s actual acquisition cost or a reasonable proxy for such a cost, such as the Standard Default Refund Amount (SDRA) using wholesale acquisition cost (WAC), when providing retrospective reimbursements. Describe the Primary Manufacturer’s general plan for calculating the MFP refund amount if using a retrospective reimbursement model. If the Primary Manufacturer does not intend to use retrospective reimbursements, then it should select option 5 and provide its detailed MFP Effectuation Plan in response to Question 5 above.

Field

Response Format

The Primary Manufacturer primarily plans to use the Standard Default Refund Amount (SDRA) set forth in the final guidance to calculate and make the retrospective MFP refund payments to a dispensing entity. OR The Primary Manufacturer generally plans to contact dispensing entities to obtain their actual acquisition cost to calculate the MFP refund. OR The Primary Manufacturer generally plans to use a proxy for acquisition cost other than WAC to calculate and make the retrospective MFP refund payments to a dispensing entity. OR The Primary Manufacturer does not intend to use one of the methods listed above as its primary approach and instead intends to use a variety of approaches (e.g., using the SDRA for some dispensing entities while using actual acquisition costs for others) to calculate MFP refunds. OR The Primary Manufacturer does not intend to use retrospective reimbursements to effectuate the MFP.

Check box. Select the option that reflects the Primary Manufacturer’s plan.

Q9. Respond to the following question to provide additional details on the response to Question 8.

Field	Response Format
Describe the Primary Manufacturer’s methodology for determining the amounts it will reimburse dispensing entities when the Primary Manufacturer is not calculating an MFP refund using the SDRA. Include a description of the documentation the manufacturer intends to retain to support any MFP refund calculations that do not use the SDRA.	Text field (10,000-character limit)

Q10. The Primary Manufacturer has developed procedures for collecting and maintaining documentation related to all aspects of MFP effectuation.

Field

Response Format

The Primary Manufacturer has developed policies and procedures for collecting, maintaining, and producing documentation related to MFP effectuation that may be required during the course of CMS’ monitoring and oversight activities as described in final guidance. In addition, CMS may request a copy of the Primary Manufacturer’s policies and procedures in addition to other relevant documentation for the particular CMS inquiry.

Acknowledge

Q11 – Q14 The questions below collect necessary information to document alternative purchasing or reimbursement arrangements, such as prospective purchasing, that a Primary Manufacturer and dispensing entity may have entered into outside of the MTF PM. Even if the Primary Manufacturer has opted to use the MTF PM to facilitate making MFP refunds to dispensing entities, Primary Manufacturers and dispensing entities may enter into alternative arrangements to effectuate the MFP. This information is necessary to provide oversight and monitoring of alternative arrangements and to avoid duplicate reimbursement claims in the MTF PM. CMS recognizes the responses captured in this section are subject to change over time. In accordance with the requirements outlined in section 90.2.1 of the final guidance, Primary Manufacturers must timely update their MFP Effectuation Plan should there be any changes in their alternative arrangements for MFP effectuation.

Field	Response Format
Q11. Does the Primary Manufacturer have in place, or expect with a high degree of likelihood that it will establish, alternative arrangements for providing access to the MFP outside of the MTF PM? If no, skip to Q13.	Yes No
Q12. If the Primary Manufacturer answered ‘Yes’ to Question 11, describe the nature of these alternative arrangements, including any planned arrangements that may not already be established. Include information such as who the arrangements are, or are planned to be, with, when the arrangements take effect, and the duration of the arrangements. If the Primary Manufacturer has multiple such arrangements planned or in place, detail each arrangement separately, including indicating the dispensing entities engaged in each arrangement. If the Primary Manufacturer has entered into, or expects with a high degree of likelihood that it will enter into, any arrangements with one or more third-party contractors to make MFP refund payments, please provide information regarding such arrangement(s), including whether the Primary Manufacturer has contracts in place for such arrangement(s), a description of the services performed under such arrangement(s), the contractor name(s), the term of the arrangement(s), and how the arrangement(s) with the contractor(s) would meet the requirements of the final guidance.	Text field [No character limit]
Q13. If the Primary Manufacturer answered ‘Yes’ to question 11, does the Primary Manufacturer have contracts for these arrangements in place? If no, please explain whether contracts will be put in place and indicate whether they will be in place prior to the start of the applicable initial price applicability year (i.e., Jan. 1, 2026 or Jan. 1, 2027). NOTE: CMS may request copies of these contracts, including, without limitation, in response to complaints from dispensers regarding lack of MFP availability, or as part of routine audits or investigations related to MFP availability. In addition, if the NPIs of affected dispensing entities are not contained within the contracts, then CMS may request documentation to support any instances of a Primary Manufacturer declining to pay a claim for a specific NPI based upon an alternative arrangement.	Yes No Text Field, if ‘No’, [10,000 character limit]
Q14. Please note the Primary Manufacturer must provide notice of any update to its alternative arrangements (including if the Primary Manufacturer has selected “No” to Question 11 in this submission) to CMS within 90 days of the arrangement. Such notice must include any updates to the NPI(s) of the dispensing entity(ies) affected by the change and the effective date(s) of the update. As it pertains to new arrangements, such notice must include the details collected in Q12 – Q14 for the new arrangement. Primary Manufacturer must check [Acknowledged] to advance to next question.	Checkbox for “Acknowledged” to advance to next question.

Q15 – Q16 The questions below collect information regarding MFP effectuation for a selected drug with Secondary Manufacturers. This information is necessary to provide oversight and monitoring to ensure access to the MFP is provided consistent with requirements of section 1193 of the Act. Describe policies and procedures for interacting with Secondary Manufacturers below. CMS reiterates that CMS will not enroll Secondary Manufacturers into the MTF DM. However, in their use of the MTF DM, a Primary Manufacturer may assign a user role to a representative from a Secondary Manufacture to establish access to the MTF DM for Secondary Manufacturers should the Primary Manufacturer deem such access necessary. In these cases, a Secondary Manufacturer can act as an authorized user to participate in the Primary Manufacturer’s MTF DM account.

Field	Response Format
Q15. There are no Secondary Manufacturers with respect to the selected drug covered by this MFP Effectuation Plan.	Checkbox. If selected, Question 16 does not need to be addressed.
Q16. Describe the Primary Manufacturer’s approach to engaging with any Secondary Manufacturers in connection with the Primary Manufacturer’s obligation to effectuate the MFP. The response should include, at a minimum, a description of the operational needs and processes established or expected to be established (e.g., secure data transmission, applicable policies and procedures, claims and data review protocols, document retention protocols) for complete and timely MFP effectuation, and a description of how the Primary Manufacturer will monitor the activities of the Secondary Manufacturer and ensure the Secondary Manufacturer’s activities in coordination with the Primary Manufacturer are sufficient to satisfy the requirement to provide access to the MFP.	Text field (20,000-character limit)

Section 5: Primary Manufacturer Acknowledgements Regarding MFP Availability

This Section collects necessary information related to the Primary Manufacturer’s responsibility to ensure MFP availability as well as to obtain official acknowledgment of key requirements of the statute governing the program.

Responses in this section will be for CMS use only and will not be made public.

Field	Response Format
Q17. The Primary Manufacturer understands that it must comply with all applicable requirements for the Negotiation Program set forth in statute and in all applicable guidance and regulations. Those requirements include but are not limited to, providing access to the MFP to dispensing entities, receiving claim-level data directly from the MTF DM for all NDCs of the selected drug, and abiding by all relevant privacy laws, regulations, and agreements when handling both the claim-level data and dispensing entities bank account information.	Checkbox for “Acknowledged”
Q18. The Primary Manufacturer understands that it is solely responsible for making MFP available under section 1193(a)(3). The Primary Manufacturer is not absolved of this obligation due to any actions or omissions by a Secondary Manufacturer that result in the failure to effectuate the MFP; the Primary Manufacturer is responsible for ensuring any Secondary Manufacturer complies with any applicable requirements set forth between the parties relating to MFP effectuation.	Checkbox for “Acknowledged”
Q19. Per section 90.2.1 of the final guidance, the Primary Manufacturer acknowledges that any future changes to this MFP Effectuation Plan must be submitted to CMS via an updated MFP Effectuation Plan as soon as practicable, signed by the Authorized Signatory, with a summary of changes listed as an attachment to its newly-submitted MFP Effectuation Plan. Additionally, upon request, the Primary Manufacturer must submit copies of any new agreements that memorialize any substantive changes to alternative arrangements with dispensing entities within 90 days of the change.	Checkbox for “Acknowledged”
Q20. If the Primary Manufacturer is submitting an updated MFP Effectuation Plan consistent with Question 23, then upload the summary of changes and, upon request, new copies of agreements here.	Provide ability to upload documents.

Section 6: Certification

This Section collects necessary information to confirm the accuracy and completeness of the Primary Manufacturer’s submission.

Responses in this section will not be made public.

Q21. Signature of Representative Legally Authorized to Bind the Primary Manufacturer

Field

Response Format

I hereby certify, to the best of my knowledge, that the information being sent to CMS in this submission is complete and accurate, and the submission was prepared in good faith and after reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content. I understand the information contained in this submission will be used by CMS for administering the Negotiation Program, including to support MFP effectuation, in accordance with sections 1193(a) and 1196(b) of the Social Security Act.

E-signature capability with system time stamp to record date.