Track Change - MFRPaymentElementsForm

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Appendix C: Medicare Drug Price Negotiation Program Primary Manufacturer Payment Elements 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 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 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.
The Primary Manufacturer Payment Elements ICR form will support CMS’ oversight and
administration of the Medicare Drug Price Negotiation Program and allow CMS to collect paymentrelated data elements via the MTF DM for each claim for a selected drug from Primary
Manufacturers indicating whether a refund was paid, and the amount of the refund paid to make
the MFP available, as applicable.
General Instructions
Overview
The Primary Manufacturer, inclusive of any of the Primary Manufacturer’s contracted parties, will be
required to transmit specified claim-level payment elements back to the MTF DM for every set of
claim-level data elements transmitted to the Primary Manufacturer by the MTF DM. The payment
elements must be transmitted back to the MTF DM within 14 calendar days of receipt of claim-level
data elements from the MTF DM and be accompanied by the corresponding information from the
MTF claim-level data elements outlined in section 40.4.1 of the final guidance.

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Submission Method
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The MTF DM will transmit an electronic file to Primary Manufacturers including claim-level
data elements and payment elements fields to be completed by the Primary Manufacturer.
A Primary Manufacturer, or its contracted parties, will populate the payment element fields
within the electronic file and transmit it back to CMS via Secure File Transfer Protocol.
Primary Manufacturer payment elements must be transmitted to the MTF DM on a
frequency determined by the Primary Manufacturer that is in compliance with the
requirement to transmit the payment elements within 14 calendar days of receipt of claimlevel data elements from the MTF DM. See section 40.4.2.1 of the final guidance (explaining
the circumstances in which the Primary Manufacturer will be considered to have
transmitted payment within the 14-day prompt MFP payment window).
CMS will provide Primary Manufacturers with additional technical instructions for gaining
access to the MTF DM, obtaining technical assistance, and transmitting payment elements
to the MTF DM before January 1, 2026 for initial price applicability year 2026, and before
January 1, 2027 for initial price applicability year 2027.

Additional Instructions
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The instructions in this section apply to all payment elements required to be submitted by
Primary Manufacturers of selected drugs within the payment elements.. For purposes of
this information collection request, all defined terms referenced in this ICR have their
meaning set forth in the final guidance.

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Questions about the final guidance should be sent to
[email protected]. Additional information regarding the Medicare
Drug Price Negotiation Program can be found on CMS’ website here.

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Each set of payment elements are in response to a specific set of data elements that are
derived from a drug claim. A Primary Manufacturer may batch multiple sets of payment
elements, including for different selected drugs if a Primary Manufacturer has more than
one selected drug, into a single file of payment elements to submit to the MTF DM.

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Response formats are indicated within each payment element description in this ICR.

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In situations where MFP refund payments are facilitated by the MTF PM, by transmitting the
claim-level payment elements to the MTF DM, the Primary Manufacturer authorizes the
electronic funds transfer of the MFP refund payments included in the payment elements
file. Upon receipt of the payment elements, the MTF PM will initiate the process to transmit
MFP refund payments to the dispensing entities identified in the claim-level payment
elements, in an amount not to exceed the MFP refund amount directed by the claim-level
payment elements for all applicable claims. MFP refund amounts transmitted to dispensing
entities may differ from the amount directed by the claim-level payment elements in
situations such as adjustment by the application of credits.

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The MTF PM’s transfer of the Primary Manufacturer’s authorized MFP refund payment to the
dispensing entity shall not in any way indicate or imply that CMS or its MTF Contractors
have evaluated or determined that the amount paid by the Primary Manufacturer is
sufficient to make the MFP available to the dispensing entity or has otherwise evaluated or
determined whether the transaction is consistent with applicable law.

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To transmit the payment elements to the MTF, the Primary Manufacturer must attest, to the
best of theirits knowledge, that the information being sent through the payment elements is
complete and accurate, and the payment elements were prepared in good faith and after
reasonable efforts. This attestation will be included in the workflow for transmission of the
payment elements within the MTF DM.

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The information contained in the payment elements is being provided in connection with
the Primary Manufacturer’s responsibility to ensure MFP is made accessible on MFPeligible claims of selected drugs of the Primary Manufacturer in accordance with section
1193(a)(3) of the Social Security Act and will be relied upon by the MTF in transmitting MFP
refund payments to dispensing entities.

Section 1: Manufacturer Claim-Level Payment Elements
Payment Element 1: MFP Refund Transmission Date and Time MTF PM Facilitation Indicator
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The Primary Manufacturer will use this payment element to indicate, for each MFP refund
payment, whether transmission of the MFP refund to the dispensing entity should be
facilitated through the MTF PM.
Primary Manufacturers who elected to participate in the MTF PM can choose to have their
MFP refunds facilitated through the MTF PM (by selecting “Y”) or not (by selecting “N”) with
each refund payment.
Primary Manufacturers who have not elected to participate in the MTF PM cannot have their
MFP refunds facilitated through the MTF PM and must select “N” for this field.
In situations where the MFP was accessed via prospective sale, this payment element will
contain “N”.

Field
MTF PM Indicator

Response Format
Y/N

Formatted Table

Payment Element 2: MFP Refund Transmission Date and Time
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The Primary Manufacturer will use this payment element to indicate when the MFP refund
was transmitted.
This payment element is only required from Primary Manufacturers when the MFP refund
payment to a dispensing entity is made outside of the MTF PM.
For MFP refunds paid via electronic payment, this payment element contains the date and
time when electronic payment was transmitted to the dispensing entity. For MFP refunds
paid via paper check, this payment element contains the date on which the paper check
was mailed to the dispensing entity.

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The Primary Manufacturer will use this payment element to indicate when the MFP refund
was transmitted.
The payment element should be omitted if the claim was prospectively purchased or a
refund was not sent.

Field
MFP Refund Transmission Date and
Time

Response Format
MM/DD/YYYY; hh:mm:ss

Payment Element 23: Method for Determining MFP Refund Amount
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The Primary Manufacturer will include a mandatory payment element, “Method for
Determining MFP Refund Amount”,” to be populated with one of several pre-identified
justification codes from Table 1 to indicate whether the MFP refund payment was at the
Standard Default Refund Amount, a different amount, or the reason an MFP refund payment
was not provided.
The Primary Manufacturer must report the code that most accurately describes the method
for determining the MFP Refund Amount consistent with applicable regulations, guidance,
and technical instructioninstructions.
Codes should be based on the final disposition of a refund.
Primary Manufacturers should use Code 2 for refunds calculated using a methodology
different than the Standard Default Refund Amount. Code 7 should be used when the
refund amount transmitted was adjusted by a credit amount on manufacturer-maintained
credit ledger.
Codes and values presented in Table 1 below are preliminary and may be updated by CMS
over time in technical instructions.

Field
Method for Determining MFP Refund
Amount

Response Format
Numeric

Table 1
Code Value
1
Standard Default Refund Amount Transmitted
2
Amount Other than Standard Default Refund Amount
Transmitted
3
No Refund Transmitted – Prospective MFP Access
4
No Refund Transmitted – Section 1193(d)(1) Exception
5
No Refund Transmitted – Payment Transmission Attempted but
Unsuccessful
6
No Refund Transmitted – Other
7
Refund Transmitted Consistent with Alternative Reconciliation

Payment Element 3: National Provider Identifier (NPI) of the Entity Receiving the MFP Refund or
Prospective Sale
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The Primary Manufacturer will use this payment element to document the recipient of the
MFP refund or prospective sale by including the NPI of the entity receiving the MFP refund or
prospective sale. This data element should be completed even if the MFP refund amount is
zero.
In situations where MFP refund payments are facilitated by the MTF, this payment element
will only contain the NPI of the entity receiving the MFP refund.

Field
Response Format
NPI of the Entity Receiving the MFP Refund Numeric (nnnnnnnnnn)
or Prospective Sale

Formatted Table

Payment Element 4: Quantity of Selected Drug
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The Primary Manufacturer will use this payment element to indicate the number of units of
the selected drug included in the MFP refund paid. This data element should be completed
even if the MFP refund amount is a zero. -dollar amount.
In cases where the payment elements represent a claim that was adjusted or reversed, the
Primary Manufacturer will indicate the new number of units of the selected drug included in
the adjusted MFP refund paid or reversed as a positive value.
Quantity should be reported in the same unit of measure used in the claim-level data
elements received from the MTF.

Field
Quantity of Selected Drug

Response Format
Numeric

Payment Element 5: Amount of Payment Transmitted as the MFP Refund
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Field

The Primary Manufacturer will use this payment element to provide the amount of payment
transmitted as the MFP refund. Monetary amounts must be reported in United States
dollars (USD) and include two decimal places (i.e., dollars and cents).
This payment element should be omitted (i.e., left blank) if the claim was prospectively
purchased or a refund was not transmitted.
In situations where MFP refund payments are facilitated by the MTF PM, this payment
element will contain the amount to be transmitted as the MFP refund by the MTF PM, before
the application of any applicable credits. This amount may be an initial MFP refund
payment amount, or an adjusted amount if the claim is being re-processed following a
previous submission.
In situations where MFP refund payments are facilitated by the MTF PM, if reflecting an
adjusted refund amount, this field should reflect the intended total refund amount for the
claim (e.g., previously paid refund was $100 and intended refund is $80, this field should
contain $80). The MTF will calculate credits based on previously paid refunds and update
the ledger or calculate the difference between the previously paid refund and the updated
refund amount and request this difference from the Primary Manufacturer’s bank.
Response Format

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Amount of Payment Transmitted as the
MFP Refund

$

Payment Element 6: MFP Refund Adjustment
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The Primary Manufacturer will use this payment element to indicate if the refund payment
adjusts a previously paid refund (i.e., the claim was included in a previous submission of
payment elements, and is being included again due to the manufacturer’s determination
that an adjustment to the previous MFP refund amount is needed). For this payment
element, the Primary Manufacturer will provide one of the codes provided in Table 2.
This payment element will be used to understand whether to match the refund payment to a
previously paid refund payment and calculate a credit or debit.

Field
MFP Refund Adjustment

Response Format
Y/N
Table 2

Code
Yes
No

Value
Indicates the MFP refund payment adjusts a
previously paid refund to a new payment
amount
Indicates the MFP refund payment is not
adjusting a previously paid refund

Attestation Statement
The information included in the payment elements transmitted in this submission is, to the best of
this Primary Manufacturer’s knowledge, complete and accurate, and was prepared in good faith
and after reasonable efforts. I understand the information contained in this submission is being
provided to and will be relied upon by CMS for administering the Negotiation Program, including to
facilitate and monitorsupport effectuation of the MFP, in accordance with sections 1193(a) and
1196(b) of the Social Security Act. The Primary Manufacturer agrees to transmit corrected payment
elements should any error be identified within the submission. I also understand that any
misrepresentations may give rise to liability, including under the False Claims Act, and/or may
result in other enforcement action such as serving as the basis for civil monetary penalties and
assessments.
[ ] Acknowledge and Agree

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