Track Change - MFPEffecutationPlan Form

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. 117169), 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 will proposehas proposed in
future 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 claimlevel 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.

Style Definition: Unresolved Mention

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-2027and-manufacturer-effectuation-mfp-2026-2027.pdf

General Instructions
Overview
For each of its selected drug(s), the Primary Manufacturer must complete Sections 1 through 6,
which are specifically:
1) Primary Manufacturer MFP Effectuation Additional Points of Contact Information
2) Information Requested from All Primary Manufacturers
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)
2)
3)
4)

Primary Manufacturer’s Description of Participation in the MTF PM
Managing Relationships with Dispensing Entities
Information Requested of Primary Manufacturers Declining Use of the MTF PM
Assisting Dispensing Entities with Material Cashflow ConcernsPrimary 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.

Section 1: MFP Effectuation Additional Points of Contact Information
If the Primary Manufacturer would like to name representatives in addition to those established
during MTF DM account creation, then it may provide additional contact information below. For
example, these individuals may play a specific role in operationalizing the manufacturer’s MFP
Effectuation Plan but were not included previously as Negotiation or MTF Points of Contact, or MTF
DM system users during account creation. Using the format provided in Section 1 Q2, the
manufacturer may add multiple additional points of contact.Manufacturer’s Description of
Participation in the MTF PM

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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
Yes
to provide retrospective reimbursements to
No
dispensing entities.
If the response is “Yes”, then the Primary
Selecting ‘Yes’ indicates that the Primary
Manufacturer will move to Question 2 and
Manufacturer intends to use the MTF PM to
provide their financial information.
pass through MFP refunds as part of its
approach to MFP access for any of its MFPIf the response is “No”, then the Primary
eligible claims; selecting ‘Yes’ does not
Manufacturer will be reminded to describe their
preclude the Primary Manufacturer from also reimbursement mechanism in Section 3 of the
engaging in alternative arrangements to
downloadable PDF and is not required to
process MFP refunds without the MTF PM as
provide any financial information. The
described in Q11 – Q15 of this Form.
manufacturer will proceed directly to Section 2.

[Remainder of this page is intentionally blank.]

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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.
Q1. Election to Provide Additional Points of Contact
Field
Response Format
Q1. Manufacturer does not wish to establish any
Check box. If “checked, then none of
additional Points of Contact.
the fields below are available.

Q2. Enter Additional MFP Effectuation Point of Contact, if Applicable.
Ability to make multiple entries will be available in the submission form using the below format.
Q2A. Financial Institution Contact Information.
Field
Name
Title
Financial Institution’s Name
Financial Institution Contact Person’s Name
Address
Email Address
Phone Number
Point of Contact Role Description

Response Format
Text
Text
Text
Text
Text
Text
Text
Text

Section 2:Q2B. Bank Account and Federal Tax Identification Number Information.
Field
Routing Number
Bank Account Number

Formatted Table

Response Format
Text
Text

Formatted: Font: Not Bold
Formatted Table
Formatted: Font: Bold
Formatted: Ligatures: Standard + Contextual

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

Text
Text
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] Requested

from All

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 Text field (10,000responding to communications from dispensing entities regarding MFP
character limit)
effectuation. 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.
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
Q4A. Describe the Primary Manufacturer’s process for mitigating material
cashflow concerns for dispensing entities.
Q4B. Describe 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.

Response Format
Text field (15,000 character limit)
Text field (15,000character limit)

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Formatted: Font: Not Bold

Formatted: Font: Not Bold

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 use the MTF PM for the
selected drug(s) for which this form is being completed, or is using the MTF PM to pass through
payments related to this selected drug(s) 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 are encouraged to be as
specific as possible when describing their MFP Effectuation Plans, with policies and procedures to
address the needs of a diverse range of dispensing entities and dispensing entity types.
Responses contained in this section will be made available to dispensing entities and, possibly,
other interested stakeholders with no redactions.
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. 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). Address each of the following questions to describe the
Primary Manufacturer’s process for contacting, reimbursing, and responding to dispensing entities
to effectuate the MFP.
Field
Q5A. To the extent that any specific approaches are not included in the
Primary Manufacturer’s response to Q3, provide additional 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.
Q5B. Describe the Primary Manufacturer’s process for effectuating MFP
electronically to each applicable dispensing entity within the 14-day prompt
MFP payment window.
Q5C. Describe the Primary Manufacturer’s process for effectuating MFP via
paper check to each applicable dispensing entity within the 14-day prompt
MFP payment window.
Q5D. Describe any additional mechanisms the Primary Manufacturer
intends to implement to effectuate the MFP to each dispensing entity within
the 14-day prompt MFP payment window, if applicable.
Q5E. Describe the Primary Manufacturer’s process for responding to
dispensing entities if they express concern that MFP has not been made
available to them.

Response Format
Text field (15,000character limit)

Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)

Q5F. Describe the Primary Manufacturer’s process for ensuring the 14-day
prompt payment window is met for both its electronic and paper options.
Q5G. Describe the Primary Manufacturer’s process for generating and
timely sending a remittance either electronically or by paper using a
comprehensive, GAAP-compliant system.
Q5H. Describe the Primary Manufacturer’s approach for completing
internal auditing to ensure all transactions effectuate MFP.
Q5I. Describe the Primary Manufacturer’s method 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.
Q5J. The Primary Manufacturer confirms that its mechanism for MFP
reimbursement will use a GAAP-compliant system that can be audited.
Q5K. 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

Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Acknowledge
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 sectionssection 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.
Q6Q3. 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 Text field (10,000responding to communications from dispensing entities regarding MFP
character limit)
effectuation. The response should indicate the extent to which the Primary
Manufacturer’s approach includes 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.
Q4. CMS requires Primary Manufacturers to provide details on their processprocesses for
assessing the claims received by the Primary Manufacturer 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
Text field (15,000nonduplication of claims that are 340B eligible and not subject to MFP
character limit)
availability. The response should include, at a minimum, descriptions of
the following:
- Manufacturer’s valid and reliable process for identifying claims that
are 340B eligible claimsand the 340B ceiling is lower than the MFP.
- Process for effectuating the MFP for claims the Primary
Manufacturer has not definitivelyreasonably 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 any
duplicated discounts 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).

Q5Q7. 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
Text field (10,000claim-level payment elements to the MTF DM (e.g., daily, weekly, etc.), why character limit)
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.
Q6Q8. As described in the final guidance, the Primary Manufacturer is expected to include in its
MFP Effectuation Plan for making the MFP available 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
Field
1. The Primary Manufacturer generallyprimarily 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.

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

Formatted: List Paragraph, Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment:
Left + Aligned at: 0" + Indent at: 0.25"

OR
2. The Primary Manufacturer generally plans to usecontact
dispensing entities to obtain their actual acquisition cost to
calculate the MFP refund.

Formatted: List Paragraph, Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment:
Left + Aligned at: 0" + Indent at: 0.25"

OR
3. 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
4. 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.

Formatted: List Paragraph, Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment:
Left + Aligned at: 0" + Indent at: 0.25"

OR
5. The Primary Manufacturer does not intend to use
retrospective reimbursements to effectuate the MFP.

Formatted: List Paragraph, Numbered + Level: 1 +
Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment:
Left + Aligned at: 0" + Indent at: 0.25"

Q7Q9. Respond to the following question to provide additional details on the response to Question
8.
Field
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 Standard
Default Refund Amount.SDRA. Include a description of the
documentation the manufacturer intends to retain to support any MFP
refund calculations that do not use the Standard Default Refund
Amount.SDRA.

Response Format
Text field (15,000character limit)

Q8
Q10. Describe the Primary Manufacturer’s procedures for collecting and maintaining
documentation related to all aspects of MFP effectuation.
Field
Response Format
Describe your policies and procedures for collecting, maintaining, and
Text field (15,000producing documentation related to MFP effectuation that may be
character limit)
required during the course of CMS’ monitoring and oversight activities. as
described in final guidance. The response should include, at a minimum,
descriptions of the types of supporting documentation the Primary
Manufacturer anticipates maintaining to support use of the justification
codes provided in Table 5 of the final guidance or in any subsequent
technical instruction provided from CMS, procedures for maintaining
documentation in an organized manner such that documents can be
produced and shared with CMS upon request, and the process the
Primary Manufacturer will use to respond to CMS document requests
and provide the requested documents in a timely manner.
Q9 – Q13Q11 – Q15 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
Q9Q11. Does the Primary Manufacturer have in place, or expect with a high
Yes
degree of likelihood that it will establish, alternative arrangements for
No
providing access to the MFP outside of the MTF PM? If no, skip to Q13.
Q10Q12. If the Primary Manufacturer answered ‘Yes’ to Question 911,
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 (i.e., NPIs of applicable dispensers),, 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.

Text field [No
character limit]
AND
File Upload for
Applicable NPI List,
if needed.

If the Primary Manufacturer entershas 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.
If the Primary Manufacture has, or plans to have, alternative arrangements
with a large number of dispensing entities, the manufacturer may upload a
list of applicable NPIs to facilitate easier information submission. If
multiple arrangements are in place, the uploaded file must clearly
delineate which NPIs align to which arrangement.
Q11Q13. If the Primary Manufacturer answered ‘Yes’ to question 911, does
the Primary Manufacturer have contracts for these arrangements in place?
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

Formatted Table

Q12Q14. If the Primary Manufacturer answered ‘Yes’ to question 11 but
Text field
‘No’ to Question 1113, 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).
Q13Q15. 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 Q10-Q12 – Q14 for the new
arrangement.

Checkbox for
“Acknowledged” to
advance to next
question.

Primary Manufacturer must check [Acknowledged] to advance to next
question.
Q14 – Q18
Q16 – Q20 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
Q14Q16. There are no Secondary Manufacturers with respect to the
selected drug covered by this MFP Effectuation Plan.

Q15Q17. 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 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.

Response Format
Checkbox.
If selected, Questions
15 – 1817 – 20 do not
need to be addressed.
Text field (15,000character limit)

Q16Q18. Describe how secure data transmission will occur between
the Primary Manufacturer and Secondary Manufacturers, including
descriptions of the Primary Manufacturer’s policies and procedures for
complete and timely data transmissions, the types of data included in
such transmissions, and policies related to ensuring data integrity and
security during such transmissions.

Text field (15,000character limit)

Q17Q19. Describe how the Secondary Manufacturer(s) will be
incorporated into the Primary Manufacturer’s review of incoming
claims-level data elements, including the timeframe for contacting the
Secondary Manufacturer after receiving claims data (if necessary for the
MFP to be made available).
Q18Q20. Describe any document retention requirements the Primary
Manufacturer is placing on any Secondary Manufacturers to support
MFP effectuation. Describe the Primary Manufacturer’s approach to
retention of any documentation maintained by the Secondary
Manufacturer regarding MFP effectuation.
Q19. Respond to the following regarding the use of the MTF PM.

Text field (15,000character limit)

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 Q9 – Q13 of this Form.

Text field (15,000character limit)

Yes
No
If the response is
“Yes”, then the
Primary
Manufacturer will
skip Section 3 and
proceed to Section 4.

Q20. If the Primary Manufacturer responds “Yes” to Q19, 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.
Instructions
•
•
•
•
•

Fill out the tables with the contact information for the financial institution that holds the
funds that will be transmitted in order to make the MFP available to dispensing entities.
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.
The account must bear the legal business name of the financial institution.
Account number should include applicable leading zeros.

Formatted Table

Q20A. Financial Institution Contact Information.
Field
Financial Institution’s Name
Contact Person’s Name
Address
Email Address
Phone Number

Response Format
Text
Text
Text
Text
Text

Q20B. Bank Account Information.
Field
Routing Number
Depositor Account Number
Registered Financial Account Type

Response Format
Text
Text
Text

Q20C. 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 3: Information Requested of Primary Manufacturers Declining Use of the MTF PM
Q21. 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. 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. 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 which will be used for
monitoring and oversight of refunds and reimbursements. Address each of the following questions
to describe the Primary Manufacturer’s process for contacting, reimbursing, and responding to
dispensing entities to effectuate the MFP.
Field
Q21A. To the extent that any specific approaches are not included in the
Primary Manufacturer’s response to Q3, provide additional 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.

Response Format
Text field (15,000character limit)

Q21B. Describe the Primary Manufacturer’s process for effectuating MFP
electronically to each applicable dispensing entity within the 14-day prompt
MFP payment window.
Q21C. Describe the Primary Manufacturer’s process for effectuating MFP
via paper check to each applicable dispensing entity within the 14-day
prompt MFP payment window.
Q21D. Describe any additional mechanisms the Primary Manufacturer
intends to implement to effectuate the MFP to each dispensing entity within
the 14-day prompt MFP payment window, if applicable.
Q21E. Describe the Primary Manufacturer’s process for responding if
dispensing entities express concern that MFP has not been made available
to them.
Q21F. Describe the Primary Manufacturer’s process for ensuring the 14-day
prompt payment window is met for both its electronic and paper options.
Q21G. Describe the Primary Manufacturer’s process for generating and
timely sending a remittance either electronically or by paper using a
comprehensive, GAAP-compliant system.
Q21H. Describe the Primary Manufacturer’s approach for completing
internal auditing to ensure all transactions effectuate MFP in compliance
with the final guidance and Negotiation Program requirements.
Q21I. Describe the Primary Manufacturer’s method 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.
Q21J. The Primary Manufacturer confirms that its mechanism for MFP
reimbursement will use a GAAP-compliant system that can be audited.
Q21K. The Primary Manufacturer confirms that it will submit verification of
reimbursement to the MTF via the report of claim-level payment elements
discussed in sections 40.4.3 and 40.4.4 of the final guidance, as required for
purposes of administering and monitoring compliance with the Negotiation
Program consistent with section 1193(a)(5) of the Act

Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Text field (15,000character limit)
Yes
No
Yes
No

Section 4: Assisting Dispensing Entities with Material Cashflow Concerns
Q22. Respond to the following question regarding interaction with dispensing entities that have
indicated they have material cashflow concerns.
Field
Q22A. The Primary Manufacturer acknowledges that it has, or 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.
Q22B. Describe the Primary Manufacturer’s process for mitigating such
material cashflow concerns for dispensing entities.
Q22C. Describe the qualifying criteria for dispensing entities to participate
in the Primary Manufacturer’s process to assist dispensing entities with

Response Format
Checkbox for
“Acknowledged”
to advance to B &
C.
Text field (15,000 character limit)
Text field (15,000character limit)

such material cashflow concerns, including but not limited to the
dispensing entities that have self-identified.
Formatted: Font: Not Bold

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
Q23Q21. 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.
Q24.Q22. 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.
Q25Q23. 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 previousnewly-submitted MFP Effectuation
Plan.

Response Format
Checkbox for
“Acknowledged”
to advance to next
question.

Checkbox for
“Acknowledged”
to advance to next
question.

Formatted: Font: Not Bold

Checkbox for
“Acknowledged”
to advance to next
question.

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.
Q26Q24. If the Primary Manufacturer is submitting an updated MFP
Provide ability to
Effectuation Plan consistent with Question 2523, then upload the summary upload
of changes and, upon request, new copies of agreements here.
documents.

Formatted: Font: 11 pt

Section 6: Certification
This Section collects necessary information to confirm the accuracy and completeness of the
Primary Manufacturer’s submission. This information is necessary to execute a legally binding
submission.
Q27Responses in this section will not be made public.
Q25. Signature of CEO/Authorized Representative Legally Authorized to Bind the Primary
Manufacturer
Field
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 through the MTF DM and MTF PM, and to inform
CMS’ monitoring and oversight efforts as described in section 90.2.1 of
the final guidance. , in accordance with sections 1193(a) and 1196(b) of
the Social Security Act.

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