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Appendix D. Drug Price Negotiation Program Complaint and Dispute Intake 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 will proposehas proposed in future rulemakingthe
Contract Year 2026 Medicare Advantage (MA) and Part D Proposed Rule to require Part D plan sponsors
to include in their 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 for Primary Manufacturers, dispensing
entities, beneficiaries and other interested parties to submit a complaint or dispute related to
effectuating the MFP. Completing this form either within the MTF DM module’s user interface, or via the
public-facing version (for non-MTF users) initiates the complaint and dispute process. This form will
need to be completed whenever an interested party needs to file a new complaint or dispute.
General information about CMS’ work related to the IRA is available at https://www.cms.gov/inflationreduction-act-and-medicare.
The relevant statute pertaining to this 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-andmanufacturer-effectuation-mfp-2026-2027.pdf

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General Instructions

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Overview

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CMS will establish a centralized intake system to receive complaints and disputes regarding MFP
effectuation. Complaints and disputes will be collected both through the MTF DM (for MTF users), and
via a publicly accessible web-based platform (for non-MTF users).
Complaints and disputes must be submitted to CMS no later than 120 calendar days from the date of the
subject of the complaint or dispute. Upon timely receipt of a reported issue, an initial triage will be
conducted to route the concern to the appropriate track.
The complaint and dispute process will be set up with two “tracks” within one overall system. The first
track is a dispute functionality within the MTF for qualifying disputes (see below description) from
Primary Manufacturers or dispensing entities regarding a technical aspect of the MTF process. The
second track is a complaint process that will intake complaints and will be available to thevia a public
portal to reach a broader audience, as well as in the MTF DM’s user interface for Primary Manufacturers
and dispensing entities, regardless of their degree of participation in any aspect of the MTF and will
encompass any issues that do not qualify as disputes under the definition set forth below.
•

•

Dispute: Identifiable challenge to a technical aspect of the MTF system and process (e.g., claims
included as potentially requiring an MFP refund).identification of duplicate claims processed
through the MTF system, misapplication of credits). A dispute will warrant CMS review and
issuance of a non-appealable finding and will be assessed based on available relevant factual
information.
Complaint: Any issue brought forward by an individual or entity that does not fall under the
above definition of dispute; this covers a wide range of concerns from a broad range of
interested parties. Complaints related to a lack of MFP availability may not always require a
specific resolution but will be reviewed by CMS and may trigger an investigation under CMS’
obligation to administer the Negotiation Program and to provide monitoring and oversight of
MFP availability.

Questions about CMS MTF Portal user access should be sent to [email protected]. For technical assistance
related to the submission of information in the MTF Portal, questions should be sent to [email protected].
Submission Method
MTF DM users will submit complaints and disputes via the MTF DM user interface. Instructions for MTF
users to gain access to the MTF DM will be available at [SYSTEM URL]. Non-MTF users, including
beneficiaries, and other interested parties, will submit complaints via an online form established by a
CMS contractor and available broadly to the public. Parties will have the ability to upload supporting
documents using the online form.
Additional Information

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Users of the complaint and dispute submission process within the platform will have the ability
to upload supporting documentation, which may expedite a resolution to the complaint and
dispute process. See Question 5 for examples of supporting documentation.
For purposes of this information collection request, all defined terms referenced in this ICR have
their meaning set forth in the final guidance.
Section 1: Identifying Information of the Submitter

Question 1: Contact Information.
Please provide the following contact information. You may be contacted if additional information is
needed as CMS reviews your submission.
Field
Q1A. Submitter
Type
I am a:

If Other for Q1A

Q1B. (If “c,” “d,” or
“f” selected in
Q1A). Select the
operating
structure that best
characterizes your
dispensing entity.

Response
Required – Select the option that best describes the submitter.
a. Primary Manufacturer
b. Secondary Manufacturer
c. Dispensing Entity chain home office (CHO), (i.e., an entity such as a chain
pharmacy, mass merchant, or supermarket that provides centralized
management and administrative services from corporate headquarters to
pharmacies or dispensing entities under common ownership)
d. Non-Chain Dispensing Entity (e.g., LTC, VA, Independent)
e. Third-party vendor acting on behalf of a Primary Manufacturer
f. Third-party vendor acting on behalf of a dispensing entity
g. Part D Plan Sponsor
h. Patient/Beneficiary
i. Caregiver
j. Healthcare Provider
k. Member of the General Public
l. Trade or Advocacy Association, or other Interested Organization
m. Other
Text field
Chain Pharmacy
Franchise Pharmacy
Independent Pharmacy
Specialty Pharmacy
Mail Order Pharmacy
Electronic or Online Pharmacy
Long-term Care Pharmacy
Indian/Tribal/Urban Indian (I/T/U) Pharmacy
Veterans Affairs Pharmacy
Other Governmental Pharmacy
Other
Text Field

If other for Q1B
Q1C. Contact
Text field
Name

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Q1D. Company
Name (if
applicable)
Q1E. Contact
Phone Number
Q1F. Contact
Email

Text field
Text field
Text field

Question 2: Selected Drug & Claim Information
Please provide the following information about the selected drug(s) related to your submission, if
known. This information provides useful context to support the potential investigation and resolution of
your submission. While you may not have information for all items in this section, please provide as
much information as possible.
Field
Response
Q2A. Selected Drug Name(s) related to this
submission.

Required – Check box list, with the ability to
select more than one.
Eliquis
Enbrel
Entresto
Farxiga
Fiasp; Fiasp FlexTouch; Fiasp PenFill;
NovoLog; NovoLog FlexPen; NovoLog PenFill
Imbruvica
Januvia
Jardiance
Stelara
Xarelto
[Selected drug list to be updated annually to
reflect current selected drugs]

Q2B. Applicable National Drug Code(s) (NDCs) (if
known); NDC-9s or NDC-11s accepted.
Q2C. Prescription Number(s)
Q2D. NDC-9 or NDC-11 (if known)
Q2E. Pharmacy/Dispensing Entity Name
Q2F. Pharmacy/Dispensing Entity Full Address (list
website address if mail order)
Q2G. Claim ID(s) or Transaction Control Number
(TCN)(s)
Q2H. Relevant Dates (including date of service,
date of claim, and/or date of prescription fill)

Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Date field (optional)

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Q2I. Please indicate the context for the relevant
dates provided by noting, for example, whether
this date is the date of service, the date of the
claim, the date of the prescription fill, etc.

Text field (optional)

Section 2: Description of Issue
Question 32: Issue Category.
Please select one of the following categories that best describes your submission:

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I amThis submission is reporting a technical issue pertaining to MTF system functionality or
processes, or a technical issue with the underlying data processed through the MTF. For
example, these issues may include concerns with MTF data calculations, contents of data files
transmitted by the MTF DM, application of MFP refund credits, or other technical concerns
directly related to the functions of the MTF system.
I amThis submission is reporting an issue related to nonduplication of the relationship between
the Medicare Drug Price Negotiation Program MFP and the 340B Programceiling price.
I amThis submission is reporting an issue related to MFP availabilityeffectuation; for example, a
Primary Manufacturer making the MFP available, and/or a dispensing entity’s receipt of an MFP
refund.
MyThis submission is about something else. If selected, please provide a brief description:
Text (100-character limit)
Question 3: Selected Drug & Claim Information
Please provide the following information about the selected drug(s) related to your submission, if
known. This information provides useful context to support the potential investigation and resolution of
your submission. While you may not have information for all items in this section, please provide as
much information as possible.
Field
Q3A. Selected Drug Name(s) related
to this submission.

Response
Required – Check box list, with the ability to select more than
one.
Eliquis (apixaban)
Enbrel (etanercept)
Entresto (valsartan / sacubitrilat)
Farxiga (dapagliflozin)
Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog
FlexPen; NovoLog PenFill (insulin aspart, human)
Imbruvica (ibrutinib)
Januvia (sitagliptin)
Jardiance (empagliflozin)
Stelara (ustekinumab)
Xarelto (rivaroxaban)
Non-drug specific technical issue

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Q3B. Applicable National Drug
Code(s) (NDCs) (if known); NDC-9s
or NDC-11s accepted.
Q3C. Prescription Number(s)
Q3D. Pharmacy/Dispensing Entity
Name
Q3E. Pharmacy/Dispensing Entity
Full Address (list website address if
mail order)
Q3F. Claim ID(s) or Transaction
Control Number (TCN)(s)
Q3G. MTF Internal Claim Number(s)
or Reference ID(s) on X12 835
Q3H. Relevant Dates (including date
of service, date of claim, and/or date
of prescription fill)
Q3I. Please indicate the context for
the relevant dates provided by
noting, for example, whether this
date is the date of service, the date
of the claim, the date of the
prescription fill, etc.

[Selected drug list to be updated annually to reflect current
selected drugs]
Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Text field (optional)
Date field (optional)

Text field (optional)

Question 4: Detailed Description of Issue
Please provide a detailed description of your complaint or dispute. Be as specific as possible, including
the full names and addresses of people and businesses involved. Include all relevant dollar amounts,
interactions, timeframes, and other pertinent details to aid in the potential investigation and resolution
of your submission.
Text (10,000-character limit)
Question 5: Supporting Documentation
Question 5A: Please upload any supporting documentation that aligns with the description provided in
Question 4is relevant to this submission to aid in the potential investigation and resolution of your
submission. Examples of possible supporting documentation may include but are not limited to:
Receipts, Explanation of Benefits statements (EOB), plan formulary and coverage documents, electronic
remittance advice or other remittance, wholesale acquisition cost (WAC) published in the pricing
compendia at date of dispensing, documentation of good faith attempts to make payment, bank
statements, proof of 340B status, acquisition cost documentation, agreements signed between the
dispensing entity and the Primary Manufacturer, proof of timely payment, documentation explaining

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why a retrospective refund was not paid, invoices from the dispensing entity, invoices for prospectively
purchased units of the selected drug, and financial data.
Materials must be submitted in English; any documents not originally in English must be accompanied by
an English translation with an attestation that the translation is complete and accurate, as well as the
name, address, and a brief statement of the qualifications of the person making the translation.
Document Upload
Allowed extensions: .csv, .doc, .docx, .jpg, .jpeg, .pdf, .png, .tif, .tiff, .txt, .xls, .xlsx.
Maximum size: 50MB per file.
File limit: 510
Question 5B. Explanation of Submitted Documentation.
Please provide a brief explanation of the supporting documentation uploaded with your submission.
Text (2,000-character limit)
Section 3: Privacy Statement
You Must Read and Agree to the Security & Privacy Agreement:
Privacy Notice and Terms of Use. By using this Drug Price Negotiation Program Complaint and Dispute
Form (the Form), you agree to the collection and use of information in accordance with this Privacy
Notice and Terms of Use, which includes a Privacy Act Statement required under the Privacy Act of 1974.
You must read and agree to the Privacy Notice and Terms of Use below. The Centers for Medicare &
Medicaid Services (CMS) ("us", "we", or "our") operates the complaints and disputes process and help
desk, including providing an avenue for a complaints form available online or by phone. Users will
submit the Form electronically to CMS, or may contact CMS by phone for assistance filing a complaint.
The information on this page tells you about our policies regarding the collection, use and disclosure of
the Personal Information we receive from users of this form. It also includes specifics about Personal
Information and other information that may be collected about you when you use the Form. Note that
the information transmitted in this form will be stored in a secure environment and only accessible by
authorized users. This Privacy Notice and Terms of Use cover activities as a part of the complaints and
disputes process. If you have any questions or concerns regarding your privacy related to this
submission, please contact [email protected].
Permission for information submitted By submitting the Form, you represent that you have permission
from all of the people whose information is on the form if you are submitting their information to CMS
on their behalf, and to receive any communications about their complaint or dispute, statuses, and
decisiondecisions from CMS and entities operating on its behalf or other federal and state agencies who
may be required to assist in researching and resolving your complaint or dispute.
CMS/HHS Vulnerability Disclosure Policy CMS is committed to ensuring the security of the American
public by protecting their information from unwarranted disclosure, available at:
https://www.cms.gov/vulnerability-disclosure-policy

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CMS.gov Privacy Policy Protecting your privacy is very important to us. This privacy policy describes
what information we collect, why we collect it, and what we do with it, available at
https://www.cms.gov/privacy
Medicare Drug Price Negotiation Program Privacy Act Statement – effective January 1, 2026
CMS is collecting this information as authorized by sections 11001 and 11002 of the Inflation Reduction
Act of 2022 (P.L. 117-169), in the course of the agency’s obligation to collect information necessary to
administer and monitor the Medicare Drug Price Negotiation Program. This law directs CMS to establish
a process to monitor compliance regarding the implementation of the Negotiation Program. We need
the information provided about you and the other individuals or entities you identify to process your
complaint or dispute and, when applicable, to otherwise support resolution of your complaint or dispute
in the course of our oversight and enforcement of Medicare Drug Price Negotiation Program’s
requirements. The information will be used to determine the validity of your complaint or dispute,
inform CMS’ investigation and resolution of the complaint or dispute, and to conduct ongoing
monitoring and oversight of the Negotiation Program. The contact information you provided will be
used to contact you if we need more information or documentation about your complaint or dispute,
and to notify you of the resolution, if appropriate. We will also use the information you provide as
necessary to enable us to fulfill a requirement of a Federal statute or regulation. Providing the
requested information is voluntary. In order to process your complaint or dispute, we may need to share
with persons or entities outside of CMS, selected information you provide, including to CMS contractors
engaged to perform a function related to, or in support of, complaints and disputes, in the Medicare
Drug Price Negotiation, and/or to parties relevant to your complaint or dispute and their authorized
representatives, including dispensing entities and manufacturers you identify as relevant to your
complaint or dispute.
Changes to this Privacy Notice and Terms of Use
This Privacy Notice and Terms of Use is effective as of January 1, 2026 and will remain in effect except
with respect to any changes in its provisions in the future, which will be effective immediately upon
posting on this page.
We reserve the right to update or change this Privacy Notice at any time, and you should check this page
periodically for updates. Your continued use of the Form after we post any modifications to the Privacy
Notice on this page will constitute your acknowledgment of the modifications and your consent to abide
and be bound by the modified Privacy Notice.
If we make any material changes to this Privacy Notice, we will notify you either through the email
address you have provided us, or by placing a prominent notice on our website.
[ ] Acknowledge and Agree
Section 4: Certification
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this submission
is complete and accurate, and that 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.

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Yes [ ]
No [ ]
Field
Name of the Person Responsible for the Submission
Signature
Date
[ ] Acknowledge and Agree

Response
Text
Text
MM/DD/YYYY