Redline Negotiation Program Drug Selection for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Infla

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Negotiation Program Drug Selection for Initial Price Applicability Year 2028
20XX
under Sections 11001 and 11002 of the Inflation Reduction Act
Information Collection Request (ICR) Forms (CMS-10844, OMB
0938-1443)
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, codified in sections 1191 through 1198 of the Social Security
Act (“the Act”).
This Negotiation Program Drug Selection for Initial Price Applicability Year 202820XX under
Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR)
includes threetwo parts: Part 1 (Small Biotech Exception ICR Form), Part 2 (Biosimilar Delay
ICR Form),) and Part 32 (Identification and Selection of Renegotiation-Eligible Drugs ICR
Form).
Terms used in this ICR have the meaning set forth in the Medicare Drug Price Negotiation
Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for
Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price
(MFP) in 2026, 2027, and 2028 (expected to be issued in Fall 2025 concurrently with this ICR;
referenced hereinafter as the “final guidance”).
If a term included in this ICR Form is also included and defined in 42 CFR 429.20, the term’s
definition in this form is the same as in the final rule. Definitions included in this form are
intended for purposes related to this form and the Medicare Drug Price Negotiation Program
only.
PART 1
Small Biotech Exception ICR Form
In accordance with section 1192(d)(2) of the Act, the term “negotiation-eligible drug” excludes,
with respect to initial price applicability years 2026, 2027, and 2028, a qualifying single source
drug that meets the requirements for the exception for small biotech drugs (the “Small Biotech
Exception” or “SBE”).
CMS needs to collect information to accurately identify, at the request of a manufacturer
(“Submitting Manufacturer”), whether a given qualifying single source drug qualifies for the
SBE. Only the entity that currently holds the New Drug Application(s) (NDA)(s) or Biologics
License Applications(s) (BLA)(s) for the qualifying single source drug may be the Submitting
Manufacturer for this ICR.
For initial price applicability year 2028, section 1192(d) of the Act requires CMS to evaluate
whether a qualifying single source drug qualifies for the SBE based on Total Expenditures under
Part D or Part B. CMS will make separate determinations with respect to the Part D criteria
pursuant to section 1192(d)(2)(A)(i) of the Act (the “Part D Track”) and the Part B criteria
pursuant to section 1192(d)(2)(A)(ii) of the Act (the “Part B Track”). For initial price

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applicability year 2028, the term “negotiation-eligible drug” will exclude any qualifying single
source drug that meets either the Part D or Part B criteria to qualify for the SBE.
For the purposes of the SBE, in accordance with section 30.2.1 of the final guidance, CMS needs
to collect information to accurately identify the “Part D 2021 Manufacturer” and/or the “Part B
2021 Manufacturer”, as applicable. The Part D 2021 Manufacturer is the entity that had the
Medicare Coverage Gap Discount Program (CGDP) Agreement under section 1860D-14A of the
Act in effect for the qualifying single source drug on December 31, 2021. The Part B 2021
Manufacturer is the entity that held the NDA(s) / BLA(s) for the qualifying single source drug on
December 31, 2021. In addition, the aggregation rule at section 1192(d)(2)(B)(i) of the Act
requires that CMS treat as a single manufacturer all corporations or partnerships, sole
proprietorships, and other entities that, on December 31, 2021, were treated as a single employer
(i.e., part of the same controlled group) under subsection (a) or (b) of section 52 of the Internal
Revenue Code of 1986 (IRC) with the Part D 2021 Manufacturer or Part B 2021 Manufacturer.
The controlled group of the Part D 2021 Manufacturer comprises all entities that, as of December
31, 2021, were treated as a single employer with the Part D 2021 Manufacturer and had a CGDP
Agreement in effect on December 31, 2021. CMS also collects information regarding the unique
identifier assigned by CMS (P Number) and labeler code(s) for these entities. The controlled
group of the Part B 2021 Manufacturer comprises all entities that, as of December 31, 2021,
were treated as a single employer with the Part B 2021 Manufacturer. CMS also collects
information regarding the NDA(s) and/or BLA(s) for qualifying single source drugs held by the
Part B 2021 Manufacturer and the Part B 2021 Manufacturer’s controlled group on December
31, 2021. Additionally, the limitation at section 1192(d)(2)(B)(ii) of the Act states that a
qualifying single source drug is not eligible for an SBE if the Submitting Manufacturer of such
drug is acquired after 2021 by another entity that does not meet the definition of a specified
manufacturer under section 1860D–14C(g)(4)(C)(ii) of the Act.1 The earliest effective date for
this limitation is January 1, 2025 for acquisitions prior to January 1, 2025, or January 1, 2026, for
acquisitions occurring during 2025.
Note: This ICR only collects information relevant to a manufacturer’s request for the SBE for
initial price applicability year 2028. A Submitting Manufacturer seeking to be considered for the
SBE for initial price applicability year 2028 must submit a request for an SBE for initial price
applicability year 2028 regardless of whether the manufacturer submitted a request for a prior
initial price applicability year. A determination by CMS that a given qualifying single source
drug qualifies for an SBE for initial price applicability year 2027 does not mean that this drug
will continue to qualify for an SBE for initial price applicability year 2028.
A determination by CMS that a given qualifying single source drug qualifies for the SBE for
initial price applicability year 2028 does not determine if the drug will qualify for the temporary
1

See section 50.1 of the Medicare Part D Manufacturer Discount Program Final Guidance, dated December 20,
2024, available https://www.cms.gov/files/document/revised-manufacturer-discount-programfinalguidance122024.pdf, and, see also, the November 17, 2023 HPMS memorandum titled, “Medicare Part D
Manufacturer Discount Program: Methodology for Identifying Specified Manufacturers and Specified Small
Manufacturers”, available at https://www.cms.gov/files/document/manufacturer-discount-program-specified-andspecified-small-manufacturer-methodology.pdf, for more information.

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floor for a small biotech drug that is selected for initial price applicability years 2029 or 2030 as
described in section 1194(d) of the Act. CMS will provide information about section 1194(d) of
the Act in future rulemaking.

Instructions:
• A Submitting Manufacturer must complete and submit the information requested on this
form in order for the drug to be considered for an SBE for initial price applicability year
2028. For a qualifying single source drug to be considered under the Part D Track, a
Submitting Manufacturer should complete Section A, Section B, and Section D; to be
considered under the Part B Track, a Submitting Manufacturer should complete Section A,
Section C, and Section D; to be considered under both the Part D Track and Part B Track, a
Submitting Manufacturer should complete Section A, Section B, Section C, and Section D.
• A separate form must be submitted for each qualifying single source drug for which the
Submitting Manufacturer seeks the SBE. The definition of a qualifying single source drug is
described in section 30 of the final guidance.
• As described in section 30.2.1 of the final guidance, to the extent that more than one entity
meets the statutory definition of a manufacturer of a qualifying single source drug, only the
holder of the NDA(s) / BLA(s) for the qualifying single source drug may be the Submitting
Manufacturer.
• If the Submitting Manufacturer holding the NDA(s) / BLA(s) for the drug was acquired by
another entity after December 31, 2021, the Submitting Manufacturer must provide
information regarding that acquiring entity for CMS to assess whether the acquisition triggers
the limitation at section 1192(d)(2)(B)(ii) of the Act.
• Submitting Manufacturers will submit a request for an SBE for initial price applicability year
2028 via the CMS Health Plan Management System (the “CMS HPMS”).
• Instructions for manufacturers to gain access to the CMS HPMS can be found in the
“Instructions for Requesting Drug Manufacturer Access in the CMS Health Plan
Management System (CMS HPMS) for the Medicare Drug Price Negotiation Program”
PDF.2 Instructions for gaining signatory access to the CMS HPMS are also included in this
PDF. Technical assistance will also be made available.
• A request for an SBE that is incomplete or not timely submitted via the CMS HPMS in
accordance with these instructions and applicable guidance will not be accepted.
• All submissions require certification. The certification of the ICR should be executed by (1)
the chief executive officer (CEO) of the Submitting Manufacturer; (2) the chief financial
officer (CFO) of the Submitting Manufacturer; (3) an individual other than a CEO or CFO,
who has authority equivalent to a CEO or a CFO of the Submitting Manufacturer; or (4) an
individual with the directly delegated authority to perform the certification on behalf of one
of the individuals mentioned in (1) through (3).
2

https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.

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•

To complete this form, the Submitting Manufacturer must provide the following:
o Identifying information about the Submitting Manufacturer as of the date of
submission, including the Submitting Manufacturer’s name, Employer Identification
Number(s) (EIN(s)), mailing address, and the unique identifier(s) assigned by CMS to
the Submitting Manufacturer (P number(s)3);
o Disclosure of whether the Submitting Manufacturer holding the NDA(s) / BLA(s) for
the drug was acquired by another entity after 2021, and if so, identifying information
about the acquiring entity as of the date of submission, including the acquiring entity’s
name, EIN(s), and mailing address, as well as any P number(s) of the acquiring entity;
o Identifying information about the qualifying single source drug for which the
Submitting Manufacturer seeks the SBE:
▪ Active moiety (for drug products), active ingredient (for biological products), or
distinct combination of active moieties / active ingredients;
▪ All NDAs held by the Submitting Manufacturer for any drug products with the
active moiety or all BLAs held by the Submitting Manufacturer for any biological
products with the active ingredient; and
o Under the Part D track:
▪ Identifying information as of December 31, 2021 for the entity that had a
Medicare CGDP Agreement for the qualifying single source drug covered under
Part D in effect on December 31, 2021, and for all members of that entity’s
controlled group as of December 31, 2021 that had a Medicare CGDP Agreement
in effect on December 31, 2021; and/or
o Under the Part B track:
▪ Identifying information as of December 31, 2021 for the entity that held the
NDA(s) / BLA(s) for the qualifying single source drug payable under Part B as of
December 31, 2021, and all NDA(s) and/or BLA(s) held by that entity and its
controlled group as of December 31, 2021.

A. Submitting Manufacturer and Qualifying Single Source Drug Information
Section A contains three questions regarding the Submitting Manufacturer and qualifying single
source drug, including information related to an acquiring manufacturer if the Submitting
Manufacturer was acquired after December 31, 2021, and information related to the active
moiety / active ingredient or distinct combination of active moieties / active ingredients, and the
NDA(s) / BLA(s) associated with the qualifying single source drug for which the Submitting
Manufacturer is requesting the SBE.
Question 1: Information on the Submitting Manufacturer

3

A P number is a unique identifier assigned by CMS when the manufacturer enters into an agreement under section
1860D-14A or 1860D-14C of the Act. CMS uses P Numbers to identify manufacturer accounts in the CMS HPMS
for various programs such as the Manufacturer Discount Program, the Medicare Drug Price Negotiation Program,
the Medicare Prescription Drug Inflation Rebate Program, and the Medicare Part B Discarded Drug Program.

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Instructions for Question 1: Please provide the following information about the Submitting
Manufacturer as of the date of submission of this form. The Submitting Manufacturer must be
the current holder of the NDA(s) or BLA(s) for the qualifying single source drug.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P
number)4, if any

Response
Text
nn-nnnnnnn
Text
Pnnnn

Question 2: Acquisition of the Submitting Manufacturer
Instructions for Question 2a: Was the Submitting Manufacturer, the entity that currently holds
the NDA(s) or BLA(s) for the qualifying single source drug for which you seek the Small
Biotech Exception, acquired after December 31, 2021? Note: This question is about the
acquisition of the Submitting Manufacturer and is not about the acquisition of the qualifying
single source drug.
Yes/No
Note: If the answer to question 2a is ‘Yes,’ answer Question 2b. If the answer to Question 2a is
‘No,’ skip to Question 3a.
Instructions for Question 2b: If you answered “Yes” to Question 2a above, please provide the
following information about the entity that acquired the Submitting Manufacturer.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P
number), if any

Response
Text
nn-nnnnnnn
Text
Pnnnn

Question 3: Qualifying Single Source Drug Information
Instructions for Question 3a: Please list the active moiety (for drug products), active ingredient
(for biological products), or distinct combination of active moieties / active ingredients for the
qualifying single source drug for which the Submitting Manufacturer seeks the Small Biotech
Exception.

4

A P number is a unique identifier assigned by CMS when the manufacturer enters into an agreement under section
1860D-14A or 1860D-14C of the Act. CMS uses P Numbers to identify manufacturer accounts in the CMS HPMS
for various programs such as the Medicare Drug Price Negotiation Program, the Medicare Prescription Drug
Inflation Rebate Program, Manufacturer Discount Program, and the Medicare Part B Discarded Drug Program.

6
Active Moiety / Active Ingredient / Distinct Combination of Active Moieties/Active
Ingredients)
Text
Instructions for Question 3b: Please list all NDA(s) held by the Submitting Manufacturer for any
drug products with the active moiety(ies) listed in Question 3a or all BLA(s) held by the
Submitting Manufacturer for any biological products with the active ingredient(s) listed in
Question 3a, as applicable, for which the Submitting Manufacturer is requesting a Small Biotech
Exception. Additional rows may be added if needed.
Application Application Type (NDA; BLA)
Number
(123456)
Nnnnnn
Select NDA or BLA

Approval Date

NDA/BLA holder

MM/DD/YYYY Text

Add a separate row for each additional NDA / BLA.

B. Part D Track: Information for Qualifying Single Source Drugs Covered Under Part D
If requesting the SBE under the Part D Track for the qualifying single source drug, please
complete Section B of this ICR in its entirety. Otherwise, please skip to the Part B Track in
Section C.
Section B contains two questions for the SBE determination under the Part D track for a
qualifying single source drug that is covered under Part D. Section B contains one question about
the entity that had a Coverage Gap Discount Program Agreement in effect for the qualifying
single source drug as of December 31, 2021 (“Part D 2021 Manufacturer”). The other question
collects information about the members of that entity’s controlled group (if any) as of December
31, 2021 that had a Coverage Gap Discount Program Agreement in effect on December 31,
2021.
Question 4: Part D 2021 Manufacturer Coverage Gap Discount Program Agreement
Information
Instructions for Question 4a: On December 31, 2021, did the Submitting Manufacturer have a
Coverage Gap Discount Program Agreement in effect for the qualifying single source drug for
which the Submitting Manufacturer seeks the Small Biotech Exception?5
Yes/No
Note: If the answer to Question 4a is ‘No,’ answer Question 4b and skip Question 4c. If the
answer to Question 4a is ‘Yes,’ skip Question 4b and answer Question 4c.

5

A manufacturer that participated in the Coverage Gap Discount Program (CGDP) in 2021 by means of an
arrangement whereby its labeler codes were listed on another manufacturer’s CGDP Agreement would be
considered to have had an agreement in effect during 2021.

7
Instructions for Question 4b: Please provide the following information as of December 31, 2021
about the entity that had a Coverage Gap Discount Program Agreement in effect on December
31, 2021, for the qualifying single source drug for which the Submitting Manufacturer seeks the
Small Biotech Exception.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any
Labeler Code(s) owned by this entity that are associated with
this entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
unique identifier(s) (P number(s)) owned by other entities, if any

Response
Text
nn-nnnnnnn
Text
Pnnnn
nnnnn
nnnnn

Instructions for Question 4c: Please provide the following information as of December 31, 2021
about the Submitting Manufacturer.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any
Labeler Code(s) owned by this entity that are associated with
this entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
unique identifier(s) (P number(s)) owned by other entities, if any

Response
Text
nn-nnnnnnn
Text
Pnnnn
nnnnn
nnnnn

Question 5: Part D 2021 Manufacturer Controlled Group Information
Instructions for Question 5a: Did the entity that had a Coverage Gap Discount Program
Agreement in effect on December 31, 2021 for the qualifying single source drug for which the
Submitting Manufacturer seeks the Small Biotech Exception (i.e., either the Submitting
Manufacturer or the entity identified in Question 4b, as applicable) have other members in its
controlled group as of December 31, 2021 that had a Medicare Coverage Gap Discount Program
Agreement in effect on December 31, 2021? For the purpose of this information collection
request, “controlled group” means all corporations or partnerships, sole proprietorships, and
other entities treated as a single employer under subsection (a) or (b) of section 52 of the Internal
Revenue Code of 1986.
Yes/No
Note: If the answer to Question 5a is ‘Yes,’ answer Question 5b. If the answer to Question 5a is
‘No,’ skip Question 5b and proceed to Section C (if applying for the Part B Track) or
certification to complete the Part D Track.

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Instructions for Question 5b: If yes, provide the following information as of December 31, 2021,
for each such member of the controlled group of the entity that had the Coverage Gap Discount
Program Agreement in effect on December 31, 2021, for the qualifying single source drug for
which the Submitting Manufacturer seeks the Small Biotech Exception.
Field
Response
Entity Name
Text
Employer Identification Number(s) (EIN(s))
nn-nnnnnnn
Mailing Address
Text
Unique Identifier Assigned by CMS (P number), if any
Pnnnn
Labeler Code(s) owned by this entity that are associated with this
nnnnn
entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
nnnnn
unique identifier(s) (P number(s)) owned by other entities, if any
Add a separate entry with the six data elements for each member of the entity’s controlled group
that had a Coverage Gap Discount Program Agreement in effect on December 31, 2021.
C. Part B Track: Information for Qualifying Single Source Drugs Payable Under Part B
If requesting the SBE under the Part B Track for the qualifying single source drug, please
complete Section C of this ICR in its entirety. Otherwise, please skip to Section D.
Section C contains two questions that pertain to information required to make a determination
under the Part B Track for a qualifying single source drug that is payable under Part B. Section C
contains one question about the entity that held the NDA(s) or BLA(s) for the qualifying single
source drug as of December 31, 2021 (“Part B 2021 Manufacturer”). The other question collects
information about the members of that entity’s controlled group (if any) as of December 31,
2021.
Question 6: 2021 NDA/BLA Holder Information
Instructions for Question 6a: On December 31, 2021, did the Submitting Manufacturer hold the
NDA(s) / BLA(s) for the qualifying single source drug for which you seek the Small Biotech
Exception?
Yes/No
Note: If the answer to Question 6a is ‘Yes,’ skip to Question 6d. If the answer to Question 6a is
‘No,’ answer Question 6b and Question 6c, and skip Question 6d.
Instructions for Question 6b: Please provide the following information as of December 31, 2021
about the entity that held the NDA(s) or BLA(s) on December 31, 2021 for the qualifying single
source drug for which the Submitting Manufacturer seeks the Small Biotech Exception.
Field
Entity Name

Response
Text

9
Field
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any

Response
nn-nnnnnnn
Text
Pnnnn

Instructions for Question 6c: Please list the NDA(s) and/or BLA(s) that were held as of
December 31, 2021 by the entity that held the NDA(s) or BLA(s) on December 31, 2021 for the
qualifying single source drug for which the Submitting Manufacturer seeks the Small Biotech
Exception (i.e., the entity identified in Question 6b). List all NDA(s) and/or BLA(s), including
for drugs and biological products other than the qualifying single source drug for which the
Submitting Manufacturer seeks the Small Biotech Exception.
Application
Application Type (NDA;
Approval Date
Number (123456)
BLA)
Nnnnnn
Select NDA or BLA
MM/DD/YYYY
Add a separate row for each additional NDA / BLA.

NDA/BLA holder
Text

Instructions for Question 6d: Please list all NDA(s) and/or BLA(s) held by the Submitting
Manufacturer as of December 31, 2021, including for drugs and biological products other than
the qualifying single source drug for which the Submitting Manufacturer seeks the Small Biotech
Exception. Please check the box if the Submitting Manufacturers held no other NDA(s) or
BLA(s) as of December 31, 2021.
Application
Application Type (NDA;
Approval Date
Number (123456)
BLA)
Nnnnnn
Select NDA or BLA
MM/DD/YYYY
Add a separate row for each additional NDA / BLA.

NDA/BLA holder
Text

[ ] Please check this box if the Submitting Manufacturer held no other NDA(s) and/or BLA(s) as
of December 31, 2021, other than those for the qualifying single source drug for which the
Submitting Manufacturer seeks the Small Biotech Exception.
Question 7: Part B 2021 Manufacturer Controlled Group Information
Instructions for Question 7a: Did the entity that held the NDA(s) or BLA(s) on December 31,
2021 for the qualifying single source drug for which the Submitting Manufacturer seeks the
Small Biotech Exception (i.e., either the Submitting Manufacturer or the entity identified in
Question 6b, as applicable) have other members in its controlled group as of December 31,
2021? For this information collection request, “controlled group” means all corporations or
partnerships, sole proprietorships, and other entities treated as a single employer under
subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986.
Yes/No
Note: If the answer to Question 7a is ‘Yes,’ answer Question 7b. If the answer to Question 7a is
‘No,’ skip to certification.

10
Instructions for Question 7b: If yes, provide the following information as of December 31, 2021,
for each such member of the controlled group of the entity.
Field
Response
Entity Name
Text
Employer Identification Number(s) (EIN(s))
nn-nnnnnnn
Mailing Address
Text
NDA(s) and/or BLA(s) the entity held as of December 31, 2021 nnnnnn
Add an additional row for each NDA and BLA the entity held as of December 31, 2021.
Add a separate entry with the four data elements for each member of the entity’s controlled
group.
D. Certification
In accordance with section 1192(d)(2) of the Act, the manufacturer of a small biotech drug
(“Submitting Manufacturer”) may submit a request for an SBE for a given initial price
applicability year. As described in section 30.2.1 of the final guidance, the Submitting
Manufacturer eligible to submit the request is the holder of the NDA(s) or BLA(s) for the
qualifying single source drug.
Read the following statement and check the box if accurate:
I confirm that I am an authorized representative of the Submitting Manufacturer of the qualifying
single source drug named in this Small Biotech Exception Request and am submitting this Small
Biotech Exception Request on behalf of the Submitting Manufacturer of the qualifying single
source drug named in this Small Biotech Exception Request.
Check box for attestation: [ ]
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 is being provided to and will
be relied upon by CMS for Medicare reimbursement purposes, including to determine whether
the qualifying single source drug of the Submitting Manufacturer qualifies for the Small Biotech
Exception, as described in section 1192(d)(2) of the Social Security Act. I also certify that I will
timely notify CMS if I become aware that any of the information submitted in this form has
changed or is otherwise inaccurate. I also understand that any misrepresentations may also give
rise to liability, including under the False Claims Act and/or in the form of civil monetary
penalties pursuant to section 1196(a)(7) of the Act.
Check box for certification: [ ]

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Contact Information
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
(information is prepopulated by CMS based
on the CMS HPMS user information)
Text
Date

PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1443 (Expires XX/XX/XXXX). This is a required
information collection to retain or obtain a benefit. Specifically, a manufacturer must submit the ICR in order for its qualifying single source drug
to be considered for the SBE. The time required to complete this information collection is estimated to average 9.75 hours per response for
Submitting Manufacturers to review instructions, search existing data resources, gather the data needed, and complete and review the information
collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

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PART 2
Biosimilar Delay ICR 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, codified in sections 1191 through 1198 of the Social Security
Act (“the Act”). In accordance with section 1192(f)(1)(B) of the Act, the manufacturer of a
biosimilar biological product (“Biosimilar Manufacturer” of a “Biosimilar”) may submit a
request, prior to the selected drug publication date, for CMS’ consideration to delay the inclusion
of a negotiation-eligible drug that includes the reference product for the Biosimilar (such a
negotiation-eligible drug is herein referred to as a “Reference Drug”) on the selected drug list for
a given initial price applicability year (the “Biosimilar Delay”).
Section 1192(f) of the Act contemplates two potential requests under the Biosimilar Delay: (1) a
request to delay the inclusion of a Reference Drug by one initial price applicability year (“Initial
Delay Request”), as stated in section 1192(f)(1)(B)(i)(I) of the Act; and (2) a request to delay the
inclusion of a Reference Drug for which an Initial Delay Request has been granted for a second
initial price applicability year (“Additional Delay Request”) as stated in section
1192(f)(1)(B)(i)(II) of the Act. CMS did not grant any Initial Delay Requests for initial price
applicability year 2027; therefore, no Reference Drugs would be the subject of an Additional
Delay Request in initial price applicability year 2028.The current version of this ICR Form
collects information necessary to determine eligibility only for an Initial Delay Request.6
In accordance with section 30.1 of the final guidance,42 CFR 429.110(c) and (f), in order for
CMS to determine if the requirements in section 1192(f) of the Act for an Initial Delay Request
are met, the Biosimilar Manufacturer must submit information and make attestations as follows:
1. Identifying information for the Biosimilar Manufacturer, the Biosimilar, the Biosimilar’s
reference product, and the manufacturer of the Reference Drug ((“Reference
Manufacturer);”);
2. Attestation that the Biosimilar Manufacturer is not the same as the Reference
Manufacturer and is not treated as being the same pursuant to section 1192(f)(1)(C) of the
Act;
3. Attestations that the Biosimilar Manufacturer and the Reference Manufacturer have not
entered into an agreement that either:
a) requires or incentivizes the Biosimilar Manufacturer to submit an Initial Delay
Request; or
b) directly or indirectly restricts the quantity of the Biosimilar that may be sold in the
United States over a specified period of time. For Initial Delay Requests
submitted with respect to initial price applicability year 2028,Consistent with 42
CFR 429.110(c)(1)(iv)(B)(2), CMS will consider any agreement between the
6

As described in section II.B.3.a. of the rule, CMS did not grant any Initial Delay Requests for initial price
applicability year 2028; therefore, no Reference Drugs would be the subject of an Additional Delay Request in
initial price applicability year 2029.

13

4.

Biosimilar Manufacturer and the Reference Manufacturer that directly or
indirectly restricts the quantity of the Biosimilar that the Biosimilar Manufacturer
may sell during any period of time on or after February 1, 2026the selected drug
publication date for the initial price applicability year for which the Biosimilar
Manufacturer submits this Initial Delay Request, as violating this requirement;
Information on the status of licensure for the Biosimilar under section 351(k) of the
Public Health Service Act (“PHS Act”);
All agreements related to the Biosimilar filed with the Federal Trade Commission or the
Assistant Attorney General pursuant to subsections (a) and (c) of section 1112 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003;
The manufacturing schedule for the Biosimilar submitted to the Food and Drug
Administration (FDA) during its review of the application for licensure under section
351(k) of the PHS Act, if submitted; and
All of the Biosimilar Manufacturer’s disclosures pertaining to the marketing of the
Biosimilar (e.g., in filings with the Securities and Exchange Commission required under
section 12(b), 12(g), 13(a), or 15(d) of the Securities Exchange Act of 1934 or
comparable documentation distributed to the shareholders of privately held companies)
about capital investment, revenue expectations, and other actions typically taken by a
manufacturer in the normal course of business in the year (or the 2 years, as applicable)
before marketing of a biosimilar biological product.

5.

6.

7.

Note: This ICR only collects information relevant to a manufacturer’s request for the
Biosimilaran Initial Delay Request for initial price applicability year 202820XX.
A determination by CMS that a Reference Drug is removed from the list of negotiation-eligible
drugs due to an Initial Delay Request for the first initial price applicability year 2028 does not
mean that such Reference Drug will continue to qualify for the Biosimilar Delay for an
Additional Delay Request for a second initial price applicability year (initial price applicability
year 2029).. The process for submitting an Initial Delay Request for initial price applicability
year 2029 andinformation collection form for submitting an Additional Delay Request will be
addressed in future guidance or rulemaking and a future version of this ICR.
Instructions:
•

7

Biosimilar Manufacturers will submit an Initial Delay Request for initial price applicability
year 2028 via the CMS Health Plan Management System (the “CMS HPMS”). Instructions
for manufacturers to gain access to the CMS HPMS can be found in the “Instructions for
Requesting Drug Manufacturer Access in the CMS Health Plan Management System (CMS
HPMS) for the Medicare Drug Price Negotiation Program” PDFdocument.7 Instructions for
gaining signatory access to the CMS HPMS are also included in this PDFdocument.
Technical assistance will also be made available.

https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.

14
•

•

•
•

•

As described in section 30.3.1 of the final guidance42 CFR 429.20, the Biosimilar
Manufacturer eligible to submit the request is the holder of the Biologics License
Application (BLA) for the Biosimilar or, if the Biosimilar has not yet been licensed, the
sponsor of the BLA for the Biosimilar that has been submitted for review by FDA. If
neither the Biosimilar has been licensed nor the BLA has been submitted to the FDA, the
Biosimilar Manufacturer eligible to submit the request is the organization planning to be
the sponsor of the BLA submitted for review by the FDA.
Initial Delay Requests that are incomplete or not timely submitted will not be accepted. For
an Initial Delay Request to be timely for initial price applicability year 2028, the Biosimilar
Manufacturer must submit a complete Initial Delay Request to CMS via the CMS HPMS
by the date specified by CMS. CMS will deem an Initial Delay Request to be incomplete if
it does not include the following documentation, as applicable:
o
All agreements related to the Biosimilar filed with the Federal Trade Commission or
the Assistant Attorney General pursuant to subsections (a) and (c) of section 1112 of
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003;
o
The manufacturing schedule for the Biosimilar submitted to the Food and Drug
Administration during its review of the application for licensure under section
351(k) of the Public Health Service Act, if submitted; and
o
All of the Biosimilar Manufacturer’s disclosures pertaining to the marketing of the
Biosimilar (e.g.,for example, in filings with the Securities and Exchange
Commission required under section 12(b), 12(g), 13(a), or 15(d) of the Securities
Exchange Act of 1934 or comparable documentation distributed to the shareholders
of privately held companies) about capital investment, revenue expectations, and
other actions typically taken by a manufacturer in the normal course of business in
the year (or the 2 years, as applicable) before marketing of a biosimilar biological
product.Biosimilar.
A separate form must be submitted for each Biosimilar with a separate BLA for which the
Biosimilar Manufacturer requests an Initial Delay Request.
All submissions require certification. The certification of the Initial Delay Request should
be executed by (1) the chief executive officer (CEO)an Authorized Representative of the
Biosimilar Manufacturer; (2) the chief financial officer (CFO) of the Biosimilar
Manufacturer; (3) an individual other than a CEO or CFO, who has authority equivalent to
a CEO or a CFO of the Biosimilar Manufacturer; or (4) an individual with the directly
delegated authority to perform the certification on behalf of one of the individuals
mentioned as defined in (1) through (3).42 CFR 429.20.
The CMS HPMS response fields are limited to a maximum character count. Field sections
provide a character count and a corresponding estimated word count if a free text field is
included. Spaces between words are included in the character count.

15

Questions:
Section 1: Identifying information
Identifying information for Biosimilar Manufacturer
Question 1. Provide the following identifying information for the Biosimilar Manufacturer.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number8), if
any

Response
Text
nn-nnnnnnn
Text
Pnnnn

Identifying information on Biosimilar
Question 2. Provide the following identifying information for the Biosimilar.
Field
Biosimilar Name
Active Ingredient(s)

Response
Text
Text

Question 3. List the application for licensure for the Biosimilar under section 351(k) of the
Public Health Service Act regardless of status (i.e., including if an application is approved,
accepted for review, and submitted but not yet accepted for review). Select the current status and
relevant date. If no application has been submitted, select that Question 3 is not applicable.
Application Submission Application
Number
Number
status
Select the
nnnnnn
nnn
current status:

Relevant Date Indication Dosage Form and Strength

Text

Text

Text

☐Approved
8

A P number is a unique identifier assigned by CMS when the manufacturer enters into an agreement under section
1860D-14A or 1860D-14C of the Act. CMS uses P Numbers to identify manufacturer accounts in the CMS HPMS
for various programs such as the Manufacturer Discount Program, the Medicare Drug Price Negotiation Program,
the Medicare Prescription Drug Inflation Rebate Program, and the Medicare Part B Discarded Drug Program.

16
Application Submission Application
Number
Number
status

Relevant Date Indication Dosage Form and Strength

☐Accepted for
Review
☐Submitted
[ ] Not applicable
Identifying information on Reference Productreference product and Reference
Manufacturer
Question 4. Provide the following identifying information for the reference product for the
Biosimilar and the Reference Manufacturer (i.e., holder of the Biologic License Application for
the reference product).
Field
Reference Productproduct (the brand name and/or
the name of the Reference Product’sreference
product’s active ingredient)
Reference Manufacturer

Response
Text
Text

Question 5. Provide the following information for the BLA of the reference product, including
the holder of the BLA.
Note: Consistent with 42 CFR 429.110(c)(1)(i), it is required that the Reference Drug9 would
meet the definition of an extended-monopoly drug (defined at 42 CFR 429.20) for the initial
price applicability year for which the Initial Delay Request is submitted, which means that at
least 12 years but fewer than 16 years will have elapsed since the date of licensure under section
351(a) of the PHS Act. For example, for initial price applicability year 20XX, the Reference
Drug must have received its initial BLA licensure between January 1, 20XX and January 1,
20XX.10
Application Number (123456)
Nnnnnn

Approval Date
MM/DD/YYYY

BLA Holder
Text

Section 2: Attestations to Requirements for Granting an Initial Delay Request
In accordance with section 1192(f)(2)(D)(iv) of the Act, CMS will not delay inclusion of a
biological product on the list of selected drugs if the Biosimilar Manufacturer meets any of the
statutory criteria for an excluded manufacturer. Questions 6 through 8 address whether the
Biosimilar Manufacturer is an excluded manufacturer.
9

A Reference Drug means a negotiation-eligible drug that includes the reference product for the biosimilar as
described in section 1192(f)(1)(B) of the Act (see 42 CFR 429.20).
10
For example, for initial price applicability year 2029, the Reference Drug must have received its BLA licensure
between January 1, 2013 and January 1, 2017.

17

Question 6. Relationship between Biosimilar Manufacturer and Reference Manufacturer:
In accordance with section 1192(f)(2)(D)(iv) of the Act, CMS will not approve an Initial Delay
Request if the Biosimilar Manufacturer is the same as the Reference Manufacturer or is treated
as being the same as the Reference Manufacturer based on the aggregation rule in section
1192(f)(1)(C) of the Act. This aggregation rule provides, “all persons treated as a single
employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986, or in a
partnership, shall be treated as one manufacturer” for purposes of the Biosimilar Delay. Further,
section 1192(f)(1)(C)(ii) of the Act establishes that “the term ‘partnership’ means a syndicate,
group, pool, joint venture, or other organization through or by means of which any business,
financial operation, or venture is carried on” by two or more parties for the purposes of the
Biosimilar Delay.
Read the following statement and check the box if accurate:
I confirm consistent with sections 1192(f)(1)(C) and 1192(f)(2)(D)(iv) of the Act that
the Biosimilar Manufacturer submitting this request is not the same and is not treated as
being the same as the Reference Manufacturer named in this request.

☐

Question 7. Incentives: In accordance with section 1192(f)(2)(D)(iv)(II)(aa) of the Act, CMS
will not approve any Initial Delay Request submitted by a Biosimilar Manufacturer that has
entered into an agreement with the Reference Manufacturer that requires or incentivizes the
Biosimilar Manufacturer to submit an Initial Delay Request.
Read the following statement and check the box if accurate:
I confirm consistent with section 1192(f)(2)(D)(iv)(II)(aa) of the Act that the Biosimilar ☐
Manufacturer submitting this request has not entered into an agreement with the
Reference Manufacturer named in this request that requires or incentivizes the
Biosimilar Manufacturer to submit this or any other Initial Delay Request.
Question 8. Quantity Restriction: In accordance with section 1192(f)(2)(D)(iv)(II)(bb) of the
Act, CMS will not approve any Initial Delay Request submitted by a Biosimilar Manufacturer
that has entered into an agreement with the Reference Manufacturer that restricts the quantity,
either directly or indirectly, of the Biosimilar that may be sold in the United States over a
specified period of time.
Read the following statement and check the box if accurate:
I confirm consistent with section 1192(f)(2)(D)(iv)(II)(bb) of the Act that the
Biosimilar Manufacturer submitting this request has not entered into an agreement with
the Reference Manufacturer named in this request that restricts the quantity, either
directly or indirectly, of the Biosimilar that may be sold in the United States over a
specified period of time.

☐

In accordance with section 1192(f)(1)(A) of the Act, CMS will only approve an Initial Delay
Request for the initial price applicability year 2028 if CMS determines there is a high likelihood
that the Biosimilar will be licensed and marketed before February 1, 2028the High Likelihood
Deadline, which is the date that is two years after the statutorily defined selected drug

18
publication date for the initial price applicability year for which the reference drug would be
included on the selected drug list absent a successful Initial Delay Request (additional
information regarding this determination is included in section 30.3.1 of the Medicare Drug Price
Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social
Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the
Maximum Fair Price (MFP) in 2026, 2027, and 2028).42 CFR 429.110(d)).11 Questions 9 and 10
are relevant for this determination.
Question 9. Licensure: In accordance with section 1192(f)(1)(A) of the Act, CMS will only
approve an Initial Delay Request for the initial price applicability year 2028 if CMS determines
there is a high likelihood that the Biosimilar will be licensed before February 1, 2028the High
Likelihood Deadline, which is the date that is two years after the statutorily defined selected drug
publication date for the initial price applicability year for which the reference drug would be
included on the selected drug list absent a successful Initial Delay Request. For the purposes of
this Initial Delay Request, ‘licensed’ means approved by the Food and Drug Administration
under section 351(k) of the Public Health Service Act.
Select the following option that best describes the current licensure status of the Biosimilar as of
the submission of this Initial Delay Request (only one of the following options may be
selected). Biosimilar Manufacturers who select Option C or Option D have until 11:59 PM
Pacific Time (PT) on January 15, 2026, tomay update CMS on the status of the Biosimilar’s
application for licensure. by no later than 11:59 PM Pacific Time (PT) on the date in January in
the calendar year of the selected drug publication date for the initial price applicability year for
which the Biosimilar Manufacturer requests this Initial Delay Request that is published on CMS’
public website by December of such prior calendar year (consistent with 42 CFR 429.110(d)(1)
and (f)).12
(A) I confirm consistent with section 1192(f)(1)(A) of the Act that the Biosimilar
Manufacturer has submitted an application for licensure of the Biosimilar under section
351(k) of the Public Health Service Act and the Biosimilar has been licensed.
(B) I confirm consistent with section 1192(f)(1)(A) of the Act that the Biosimilar
Manufacturer has submitted an application for licensure of the Biosimilar under section
351(k) of the Public Health Service Act and the Food and Drug Administration has
accepted such application for review.
(C) I confirm consistent with section 1192(f)(1)(A) of the Act that the Biosimilar
Manufacturer has submitted an application for licensure of the Biosimilar under section
351(k) of the Public Health Service Act and has not received a determination from Food
and Drug Administration that such application has been accepted for review.
(D) I confirm consistent with section 1192(f)(1)(A) of the Act that the Biosimilar
Manufacturer has not submitted an application for licensure of the Biosimilar under
section 351(k) of the Public Health Service Act.
11

☐
☐

☐

☐

For example, for initial price applicability year 2029, the High Likelihood Deadline would be February 1, 2029.
For example, for initial price applicability year 2029, CMS could publish on the CMS website by December 31,
2026 that a Biosimilar Manufacturer, who selected Option C or D with the submission of such manufacturer’s Initial
Delay Request for initial price applicability year 2029, may submit an update to CMS no later than 11:59 PM PT on
January 8, 2027 about the status of the Biosimilar’s application for licensure.
12

19
If the Biosimilar Manufacturer selects Option A in Question 9, answer Question 10. If the
Biosimilar Manufacturer selects Options B, C, or D in Question 9, skip to Section 3.
Question 10. Marketing: In accordance with section 1192(f)(1)(A) of the Act, CMS will only
approve an Initial Delay Request for an initial price applicability year 2028 if CMS determines
there is a high likelihood that the Biosimilar will be marketed before February 1, 2028the High
Likelihood Deadline, which is the date that is two years after the statutorily defined selected drug
publication date for the initial price applicability year for which the reference drug would be
included on the selected drug list absent a successful Initial Delay Request.
Select the following option that best describes the current marketing status of the Biosimilar as
of the submission of this Initial Delay Request (only one of the following options may be
selected):
(A) I confirm consistent with section 1192(f)(1)(A) of the Act, the Biosimilar is
☐
currently marketed.
(B) I confirm consistent with section 1192(f)(1)(A) of the Act, the Biosimilar has not
☐
yet been marketed.
Section 3: Supporting Documentation
Question 11. Manufacturing schedule: In accordance with section 1192(f)(1)(B)(ii)(III)(aa) of
the Act, an Initial Delay Request must include, to the extent available, the manufacturing
schedule for the Biosimilar submitted to the Food and Drug Administration during its review of
the Biosimilar’s application for licensure.
Upload the manufacturing schedule for the Biosimilar submitted to the Food and Drug
Administration for the application listed in Question 3. If no supporting documentation is
available, check the box and provide an explanation of why supporting documentation was not
available.
No supporting documentation is available □

Explanation: Text (2,400 character count
limit, which is approximately 200 words)

Question 12. Disclosures: In accordance with section 1192(f)(1)(B)(ii)(III)(bb) of the Act, an
Initial Delay Request must include, to the extent available, all of the Biosimilar Manufacturer’s
disclosures pertaining to the marketing of the Biosimilar (e.g.,for example, in filings with the
Securities and Exchange Commission required under section 12(b), 12(g), 13(a), or 15(d) of the
Securities Exchange Act of 1934 or comparable documentation distributed to the shareholders of
privately held companies) about capital investment, revenue expectations, and other actions
typically taken by a manufacturer in the normal course of business in the year (or the 2 years, as
applicable) before marketing of a biosimilar biological productBiosimilar.
Upload the disclosure(s) that pertain to the marketing for the Biosimilar. If no supporting
documentation is available, check the box and provide an explanation of why supporting
documentation was not available.

20
No supporting documentation is available □

Explanation: Text (2,400 character count
limit, which is approximately 200 words)

Supporting documentation submitted includes
documentation distributed to the shareholders
of privately held companies that is
comparable to filings with the Securities and
Exchange Commission required under section
12(b), 12(g), 13(a), or 15(d) of the Securities
Exchange Act of 1934 □

Explanation of how the documentation
submitted is comparable: Text (2,400
character count limit, which is approximately
200 words)

Question 13. Agreements: In accordance with section 1192(f)(1)(B)(ii)(I)(bb) of the Act, an
Initial Delay Request must include all agreements related to the Biosimilar filed with the Federal
Trade Commission or the Assistant Attorney General pursuant to subsections (a) and (c) of
section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Upload the agreement(s) related to the Biosimilar. If no supporting documentation is available,
check the box and provide an explanation of why supporting documentation was not available.
No supporting documentation is available □

Explanation: Text (2,400 character count
limit, which is approximately 200 words)

Section 4: Certification
In accordance with section 1192(f)(1)(B) of the Act, the Biosimilar Manufacturer may submit the
request for a Biosimilar Delay for a given initial price applicability year. As described in section
30.3.1 of the final guidance42 CFR 429.20, the Biosimilar Manufacturer eligible to submit the
request is the holder of the BLA for the Biosimilar, the sponsor of the BLA submitted for review
by the FDA or, if neither the Biosimilar has been licensed nor the BLA has been submitted to the
FDA, the Biosimilar Manufacturer eligible to submit the request is the organization planning to
be the sponsor of the BLA submitted for review by the FDA.
Read the following statement and check the box if accurate:
I confirm that I am an authorized representative ofto represent the Biosimilar Manufacturer of
the Biosimilar named in this Initial Delay Request and am submitting this Initial Delay Request
on behalf of the Biosimilar Manufacturer of the Biosimilar named in this Initial Delay Request.
Check box for attestation: [ ]
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

21
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its
content.
Check box for attestation: [ ]
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 is being provided to and will
be relied upon by CMS for Medicare reimbursement purposes, including to determine whether
CMS should delay the selection of a biological product that would, absent this request, be
included on the selected drug list for initial price applicability year 202820XX as described in
section 1192(f) of the Social Security Act. I also certify that I will timely notify CMS if I become
aware that any of the information submitted in this form has changed or is otherwise inaccurate. I
also understand that any misrepresentations may also give rise to liability, including under the
False Claims Act and/or in the form of civil monetary penalties pursuant to section
1196(a)(71197(d) of the Act.
Check box for certification: [ ]
Contact Information
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
(information is prepopulated by CMS based
on the CMS HPMS user information)
Text
Date

PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1443 (Expires XX/XX/XXXX). This is a required
information collection to retain or obtain a benefit. Specifically, a Biosimilar Manufacturer must submit the Biosimilar Delay Information
Collection Request in order for a BiosimilarReference Drug to be considered for the Biosimilar Delay. The time required to complete this
information collection is estimated to average 26 hours per response, including the time to review instructions, search existing data resources,
gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850.

22
PART 32
Identification and Selection of Renegotiation-Eligible Drugs ICR Form
Section 1194(f) of the Social Security Act (“the Act”) establishes the requirements governing the
identification of renegotiation-eligible drugs, the selection of drugs for renegotiation, and the
renegotiation process. CMS will identify renegotiation-eligible drugs in accordance with section
1194(f)(2) of the Act, as described in section 130.1 of the final guidance.42 CFR 429.605. Next, CMS
will select certain renegotiation-eligible drugs for renegotiation in accordance with section 1194(f)(3) of
the Act, as described in section 130.2 of the final guidance.42 CFR 429.610. Finally, CMS will
renegotiate the maximum fair price (MFP) for such drugs selected for renegotiation, in accordance with
section 1194(f)(4) of the Act, as described in section 130.4 of the final guidance42 CFR 429.620.
This information collection request (ICR) offers Primary Manufacturers13 the voluntary option, as
described in 42 CFR 429.615(a), to submit information to CMS to inform CMS’ determinations of
which selected drugs qualify as a renegotiation-eligible drug and may be selected for renegotiation in
accordance with sections 1194(f)(2)(A), 1194(f)(2)(D), and 1194(f)(3)(C) of the Act.
Note: This ICR focuses on information that may be submitted for selected drugs from prior initial price
applicability years 2026 and 2027 for the identification and selection of renegotiation-eligible drugs for
initial price applicability year 2028.20XX. For clarity, information may be submitted for drugs that were
selected for negotiation or renegotiation with respect to prior initial price applicability years.
General Instructions
• All questions included in this ICR Form are optional. However, if the Primary Manufacturer
responds to a series of questions that includes a free response explanation field for a reported
numerical value in the same question series, the Primary Manufacturer must provide an explanation
if the Primary Manufacturer reports a numerical value in the same series.
• These “General Instructions” and the “Additional Instructions” below apply to this entire ICR Form,
in addition to any question-specific instructions. If a term included in this ICR Form is also included
and defined in the final guidance42 CFR 429.20, the term’s definition in this form is the same as in
the final guidance42 CFR 429.20. Definitions otherwise included in this form are intended for
purposes related to this form and the Medicare Drug Price Negotiation Program only. Questions
about the final guidancerule, including questions about terms defined in this ICR Form should be
sent to [email protected]@cms.hhs.gov.
• Do not report any data or costs that were previously reported to CMS under a previous data in any
prior full submission. of section 1194(e)(1) data from the Primary Manufacturer. Information
reported in this ICR Form should only include data not previously reported to in Drug Price
Negotiation under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) Information
Collection Request (CMS-10844, OMB 0938-1452) (the “Drug Price Negotiation ICR”), which
13

To the extent that more than one entity meets the statutory definition of manufacturer (specified in section 1193(a)(1) of
the Act) for a selected drug for purposes of initial price applicability year 2028, CMS will designate the entity that holds the
New Drug Application(s) (NDA(s)) / Biologics License Application(s) (BLA(s)) for the selected drug to be “the
manufacturer” of the selected drug (hereinafter the “Primary Manufacturer”). The manufacturer identified by CMS as the
NDA holder or the BLA holder for the selected drug.

23

•

•
•

CMS is publishing concurrently for a 60-day public comment period with this ICR,14 or not
previously reported in a predecessor ICR to the Drug Price Negotiation ICR, following the specific
question instructions for each section.
Throughout this form, references to the “most recent full submission” in instructions refers to the
Primary Manufacturer’s most recent submission of the Negotiation Data Elements Form for the
selected drug and do not include any submissions of updates or corrections to information submitted
in the Negotiation Data Elements Form in accordance with section 50.1 of the revised guidance for
initial price applicability year 2026, the final guidance for initial price applicability year 2027, the
final guidance for initial price applicability year 2028, and 42 CFR 429.100(e), 429.495(b),
429.505(c), and 429.615(b)(2), as applicable. All response fields are limited to a character count.
The field and response format sections provide a character count and an estimated word count.
Character counts are inclusive of all characters, including spaces between words.
This submission should be completed by an individual authorized by the Primary Manufacturer.
The certification of the submission must be executed by (1) the chief executive officer (CEO)an
Authorized Representative of the Primary Manufacturer; (2) the chief financial officer (CFO) of the
Primary Manufacturer; (3) an individual other than a CEO or CFO, who has authority equivalent to a
CEO or a CFO; or (4) an individual with the directly delegated authority to perform the certification
on behalf of one of the individuals mentioned as defined in (1) through (3).42 CFR 429.20.

Submission Method
• Submission of the email included as an Appendix to this ICR Form (which is also described in
section 130.3.1 of the final guidance) indicating the Primary Manufacturer’s intent to submit this
ICR Form for the specified initial price applicability year 2028 should be sent to CMS by the date
and time to be specified by CMS upon approval from the Office of Management and Budget (OMB)
for this information collection.
• CMS will provide access to a specific Box15 folder for a Primary Manufacturer prior to the Primary
Manufacturer’s submission of any information in response to the questions in this ICR Form to
CMS.
o In addition, upon receipt of the Primary Manufacturer’s email to CMS indicating intent to submit
this ICR Form for the specified initial price applicability year 2028, CMS will provide the
Primary Manufacturer with a template of this ICR Form that the Primary Manufacturer must
complete and upload to Box in order to submit this ICR Form.
o The template provided by CMS will include Word and/or Excel files that replicate only the
questions and data field requirements in this ICR Form. Primary Manufacturers should refer to
this ICR Form for any additional instructions and/or definitions applicable to a section/question.
• The Primary Manufacturer must adhere to the character limit specified in a question and CMS will
not review information submitted that exceeds the character limit. CMS will only review the
maximum number of citations or uploaded files permitted in the instructions.
• The information submitted for visual representations in Questions 1415 and 1516 should only
include the table/chart/graph, and no additional text. CMS will not review any additional text
14

Previous versions of the Drug Price Negotiation ICR (CMS-10844, OMB 0938-1452) approved by OMB are available on
OMB’s website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202411-0938-010 and are collectively referred
to as the Drug Price Negotiation ICR in this ICR Form.
15
In the event that CMS transitions to an alternative secure location, CMS will specify a successor location and necessary
instructions for access and use.

24

•

included beyond the titles, labels, legends, and footnotes in the visual representations.
o The Primary Manufacturer should provide the file in the format specified by CMS, and clearly
label any visual representations submitted in Question 1415 or Question 1516, as applicable.
When information in a free text response is supported by a citation in Questions 1415 and 1516,
please label the end of the sentence in the free text response with a number in the order the citation
first appears (e.g., [1], [2]) and submit the citations in the same order in response to Questions 1415
and 1516. Use the number originally assigned to the same source citation each time the citation is
used throughout Section 6.

Additional Instructions
• The Primary Manufacturer should provide data only with regard to a selected drug identifiedwith
an agreed-upon MFP from a prior negotiation or renegotiation under section 11921194 of the
Act for initial price applicability year 2026 or 2027 with an agreed-upon MFP. If a Primary
Manufacturer has more than one selected drug for which it chooses to submit information to inform
renegotiation eligibility and selection, the Primary Manufacturer must submitmake separate
submissions for each selected drug. If a selected drug will have a change in monopoly status to a
long-monopoly drug, such drug will automatically be selected for renegotiation per section
1194(f)(3)(B) of the Act, and as described in 42 CFR 429.610(a), and any voluntary submissions
under this form by the Primary Manufacturer with regard to such drug will not inform CMS’
determinations of such drug’s eligibility or selection for renegotiation.
• The Primary Manufacturer should submit, if applicable to the questions in a section, the applicable
data for all dosage forms and strengths of the selected drug, including for dosage forms and strengths
that were sold, labeled, or packagedmanufactured, marketed, controlled, or sold by a Secondary
Manufacturer.16
o Section 50.1 of the final guidance includes information regarding a Primary Manufacturer’s
obligation to provide information about new 11-digit National Drug Codes (NDC-11s) marketed
by the Primary Manufacturer or any Secondary Manufacturer(s).
o If applicable to the question, include data regarding all 11-digit National Drug Codes (NDC-11s)
of the selected drug that:
(1) are marketed by the Primary Manufacturer or any Secondary Manufacturer(s), and
(2) are covered under Part D and/or payable under Part B.
▪ Do not include sample packages.
▪ The Primary Manufacturer should include data regarding NDC-11s that are inner packages,
outer packages and NDC-11s that are discontinued if they otherwise meet criteria (1) and (2)
above.
o In accordance with 42 CFR 429.100(e), the Primary Manufacturer has an ongoing obligation
to update the information provided to CMS under 42 CFR 429.100(d) to ensure the list of
NDC-11s of the selected drug identified in accordance with 42 CFR 429.100(c) remains
16

For initial price applicability year 2028, CMS will refer to any other entity that meets the statutory definition ofA
manufacturer forof a drug product included in the selected drug, that is not the Primary Manufacturer for the selected drug,
and that either: (1) is listed as a manufacturer in an NDA or BLA for the selected drug; or (2) markets the selected drug
pursuant toin accordance with an agreement with the Primary Manufacturer but is not listed on thean NDA or BLA as a
“Secondary Manufacturer.”of the selected drug. A Secondary Manufacturer will includeincludes any manufacturer of any
authorized generic drug(s) and any repackager or relabeler of the selected drug that meet these criteria. A manufacturer that is
not listed as a manufacturer on the NDA / BLA and without an agreement in place with the Primary Manufacturer would not
be considered a Secondary Manufacturer.meets either of these criteria.

25

•
•
•

•

complete and accurate, such as providing information about new NDC-11s marketed by the
Primary Manufacturer or any Secondary Manufacturer.
For non-monetary numeric amounts, include up to three decimal places.
Response formats are indicated within any charts (e.g., # to indicate a numerical response is required).
Sections 1 through 5 in this ICR Form include references to Sections C through G of the forthcoming
Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of
the Inflation Reduction Act (IRA) Information Collection Request (CMS-10844, OMB 0938-1452)
(the “Drug Price Negotiation ICR”), which CMS intends to publish for a 30-day public comment
period in late Fall 2025.17Drug Price Negotiation ICR.
Instructions within each of Sections 1 through 5 of this ICR Form specify the applicable reporting
time period for the section.
o If a Primary Manufacturer has new updates to the original statutorily-required submission of
1194(e)(1) datainformation related to the section 1194(e)(1) factors for negotiation or
renegotiation, the Primary Manufacturer should notify CMS of these updates separately from this
ICR Form in accordance with section 50.1 of the revised guidance for initial price applicability
year 2026, the final guidance for initial price applicability year 2027, and the final guidance for
initial price applicability year 2028, and 42 CFR 429.505(c) or 429.615(b)(2), as applicable.

Instructions for Reporting Monetary Amounts
• When calculating and reporting monetary values, the information should be determined using the
methodologies described throughout the document and consistent with the Generally Accepted
Accounting Principles (GAAP), when applicable. Describe the policies and methodologies used in
the calculations in the free response field for the relevant question, as well as the standard used if it
is inconsistent with GAAP.
• When calculating and reporting monetary values, do not adjust responses for cost of capital.
• Monetary amounts must be reported in United States dollars (USD) and include two decimal places
(i.e., dollars and cents), unless otherwise specified. Use the free response field of an applicable
question, when it is available, to clarify any rounding limitations or alternative rounding standard
relied on.
• The geographic area for data on United States (U.S.) Commercial markets, Medicare markets, and
Medicaid markets is based on the definition of the United States in 42 C.F.R §CFR 400.200, unless
the geographic area is specified in the authority for the data source.
• When converting another currency to USD, use the exchange rate in effect on the date the cost was
incurred. If that rate is unavailable, use the monthly or annual average exchange rate for the year in
which the cost was incurred.
o All new conversions should follow the principles of the GAAP Accounting Standard
Certification (ASC) 830, the U.S. accounting standard for translating foreign currency values.
o If a currency conversion was completed prior to this instruction using a different method, and
recalculating using ASC 830 would impose a significant burden, CMS will accept the previously
calculated value without requiring recalculation. In the free response field, report the amount, the
currency, the exchange rate, and time period(s) used in the calculation.
• Do not report the same costs in multiple places unless the additional specific instructions for that
question instruct you to do so.
17

Previous versions of the Drug Price Negotiation ICR (CMS-10844, OMB 0938-1452) approved by OMB are available on
OMB’s website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202411-0938-010 and are collectively referred
to as the Drug Price Negotiation ICR in this ICR Form.

26
•
•

Do not include any costs that are unallowable under an applicable law or costs that are otherwise
expressly excluded from this ICR Form.
Do not make any adjustments for inflation to any dollar amounts reported unless the additional
specific instructions for that question instruct you to do so. When reporting an inflation adjusted
value, inflation adjustments should be made to 2025the same calendar year in which this ICR is due
by using the annual percentage increase of the consumer price index for all urban consumers (CPIU)18 for 2025.such calendar year (e.g., 2026 for initial price applicability year 2029).

Section 1: Research and Development (R&D) Costs and Recoupment (Section C of the Drug Price
Negotiation ICR)
This section contains three data questions related to global research and development (R&D) costs
incurred by the Primary Manufacturer related to the selected drug and the Primary Manufacturer’s
global and U.S. net revenue for CMS’ consideration of the extent to which R&D costs have been
recouped by the Primary Manufacturer related to the selected drug.
Definitions for Section 1:
R&D costs is defined as a combination of costs incurred by the Primary Manufacturer for a drug falling
into two categories: (1) Costs Related to the Selected Drug, Including Basic Pre-Clinical Research of the
Selected Drug, Post-Investigational New Drug (IND) Costs of the Selected Drug, and Other Allowable Costs
and (2) Costs for Failed and Abandoned Products Related to the Selected Drug.
• Basic pre-clinical research costs are defined as the sum of (1) direct research expenses; and (2) the
appropriate proportion of indirect research expenses (defined below).
o Direct basic pre-clinical research costs are costs that can be specifically attributed to the
discovery and pre-clinical development of the selected drug. Direct research expenses could
include personnel (monetary and non-monetary compensation for investigators and staff)
researching the selected drug, materials for conducting basic pre-clinical research, and the costs
of in vivo and in vitro studies on the selected drug before an IND application went into effect.
o Indirect basic pre-clinical research costs and relevant general and administrative expenses are
operating costs for basic pre-clinical research beyond the basic pre-clinical research costs for the
selected drug, including administrative personnel and overhead costs (expenses for clinical
facilities and equipment) that are shared across multiple potential drugs or biological products.
• Post-IND costs are defined as direct costs associated with dosing and preparing the selected drug for
clinical trials and the selected drug’s Phase I, Phase II, and Phase III clinical trials. Post-IND costs
also include direct costs associated with completed Food and Drug Administration (FDA)-required,
postmarketing trials that are conducted after the FDA has approved a product.
o Direct post-IND costs are defined as Institutional Review Board (IRB) review and amendment
costs, user fees, patient recruitment, per-patient costs, research and data collection costs,
personnel (compensation for investigators and staff) researching the selected drug, and facility
costs that are directly related to conducting the dosing and Phase I, Phase II, and Phase III
clinical trials. Direct post-IND costs also include personnel, patient recruitment, and per-patient
costs, research and data collection costs, and facility costs that are directly related to conducting
the completed FDA-required, postmarketing trial.
18

The “CPI-U” means, consistent with 42 CFR 429.20, the consumer price index for all urban consumers (United States city
average) as published by the Bureau of Labor Statistics (https://www.bls.gov/cpi/data.htm).

27
▪

•

•

Personnel, patient recruitment, and per-patient costs include monetary and nonmonetary compensation. Any non-monetary compensation for investigators and
staff included in the total amount should reflect the fair market value for such
compensation at the time it was provided.
Other allowable costs for costs related to the selected drug are defined as direct costs associated with
conducting FDA-required postmarketing trials and other FDA postmarketing requirements and
commitments that were not completed, Phase IV postmarketing studies, direct post-IND costs
(following the definitions and instructions for calculating direct post-IND costs above), direct costs
associated with researching and utilizing devices for the selected drug, direct costs to support or
satisfy a postmarketing requirement or commitment, and direct costs for patient recruitment, perpatient costs, research and data collection costs, personnel, and facility costs that are directly related
to conducting Phase IV and postmarketing trials.
Failed or abandoned product costs are defined as the sum of (1) direct basic pre-clinical research
costs on drugs with the same mechanism of action as the selected drug that did not make it to clinical
trials and (2) direct post-IND costs for drugs with the same mechanism of action as the selected drug
that did not receive FDA approval.

CMS is including both the global and U.S. net revenue for the selected drug in its consideration of the
extent to which the Primary Manufacturer has recouped R&D costs.
• Recoupment: Global and U.S. Net Revenue for the Selected Drug
o Global net revenue for the selected drug is defined as the direct sales and payments from all
other entities, minus the discounts, chargebacks, rebates, cash discounts, free goods
contingent on a purchase agreement, up-front payments, coupons, goods in-kind, free or
reduced-price services, grants, other price concessions or similar benefits offered to any
purchasers or any royalty payments or percentage payments in purchase contracts.
o U.S. net revenue for the selected drug is defined as the direct sales and payments from U.S.
entities, minus the discounts, chargebacks, rebates, cash discounts, free goods contingent on
a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price
services, grants, other price concessions or similar benefits offered to any purchasers or any
royalty payments or percentage payments in purchase contracts.
The associated time periods for these terms are included below.
Instructions for Questions 1 through 3:
• For each dollar amount listed below, the Primary Manufacturer may report one dollar amount in the
numerical response field. If a dollar amount is provided, the Primary Manufacturer must provide an
explanation of the value(s), including any calculations or conversions and any assumptions made in
the free response field.
o All dollar figures submitted to CMS must be cash-outlay costs to the Primary Manufacturer.
They must exclude any costs to entities that are not the Primary Manufacturer.
• Reported R&D costs are allowable for the following applicable time periods:period(s):
• (1) R&D costs that were incurred after the last date for which the Primary Manufacturer
reported data in the Primary Manufacturer’s originalmost recent full submission of section
1194(e)(1) data for the negotiation period in which the selected drug’s MFP was negotiated
through September 30, 2025 of the current calendar year during which this ICR is submitted; and
• (2)(2) for Primary Manufacturers of a drug that was selected originally for negotiation for
initial price applicability year 2026 or 2027 and has not been subsequently selected for

28

•

•

•

•

•

•

renegotiation, R&D costs incurred on or before the last date for which the Primary
Manufacturer reported data in the Primary Manufacturer’s originalmost recent full submission of
section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP was
negotiated that meet the definition of R&D costs specified in this ICR/Appendix A of the final
guidance for initial price applicability year 2028 and the Primary Manufacturer has not
previously reported the same data in the Primary Manufacturer’s originalany prior full
submission of section 1194(e)(1) data starting from when initial research began, or when the
drug was acquired by the Primary Manufacturer, whichever is later.19
Global and U.S. net revenue incurred for the selected drug must be reported from the last date for
which data was reported for net revenue in the Primary Manufacturer’s originalmost recent full
submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP
was negotiated through September 30, 2025 of the current calendar year during which this ICR is
submitted.
For Questions 1 through 3, if R&D costs and/or net revenue for the selected drug are not available
for the exact dates specified above in these instructions, the R&D costs and/or net revenue may be
reported through the most recent quarter for which such data are available. The Primary
Manufacturer should specify the time period used in the free response field for each question.
If the Primary Manufacturer received any prior Federal financial support, as defined in Section 3 in
this ICR (Section E in the Drug Price Negotiation ICR), for any of the costs listed in Questions 1
through 2 below (e.g., basic pre-clinical research, clinical trials, etc.), deduct such funding from the
final calculated numerical amount before answering the relevant question and note that deduction in
the applicable free response field. CMS will be collecting additional information on prior Federal
financial support in Questions 6, 7, and 8. Please reference Section 3 (Section E of the Drug Price
Negotiation ICR Form) for instructions on reporting prior Federal financial support.
o Do not include prior Federal financial support and costs associated with applying for and
receiving foreign approvals in Section 3.
If the Primary Manufacturer shared the expenses described in Questions 1 through 2 (after any
acquisition of the selected drug, if relevant) for any period of time or activity with any entity that is
not the Primary Manufacturer, then the Primary Manufacturer must report only costs the Primary
Manufacturer incurred. Report how shared expenses were allocated among the Primary
Manufacturer and any other entity or entities in the free response field for the relevant question.
Follow the instructions for Reporting Monetary Amounts, including those related to converting to
USD if R&D costs occurred in other countries. While R&D may occur in other countries and those
costs may be included and reported in USD, costs associated with applying for and receiving foreign
approvals must not be included.
Acquisition costs are not allowable in Section 1 in this ICR.

Question 1: Costs Related to the Selected Drug, Including Basic Pre-Clinical Research of the
Selected Drug, Post-IND Costs of the Selected Drug, and Other Allowable Costs
19

For initial price applicability year 2026 and initial price applicability year 2027, CMS did not permit R&D costs to be
reported for indications that had not yet received FDA approval at the time of ICR submission; however, CMS will permit,
consistent with the definitions in this ICR, now permits reporting of such R&D costs related to the selected drug for initial
price applicability year 2028. Therefore, this Section 1 also permits the Primary Manufacturer to report R&D costs that may
have occurred on or before the last date for which the Primary Manufacturer reported data in the Primary Manufacturer’s
originalmost recent full submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP
was negotiated that a Primary Manufacturer has not reported as an R&D cost for the selected drug previously.

29

Provide the following information about R&D costs (for the time periods as specified in the instructions
above) incurred by the Primary Manufacturer for the selected drug related to basic pre-clinical research,
post-IND costs for the selected drug, and other allowable costs.
Instructions for Question 1a:
• In the numerical response field for “Cost Related to the Selected Drug,” report the sum of the (1)
direct and proportion of indirect costs for basic pre-clinical research for the selected drug,; (2) direct
post-IND costs,; and (3) direct costs onfor other allowable costs.
o To calculate the proportion of pre-clinical indirect costs, the Primary Manufacturer must use
proportional allocation, whereby the same proportion of spending allocated for direct research on
the selected drug is used to estimate the proportional spending for indirect research.20, 21 For
example, if the direct pre-clinical research costs spent on the selected drug were approximately
10 percent of a Primary Manufacturer’s total direct basic pre-clinical research costs for that
period of time, then indirect costs should be allocated proportionally. Thus, for the selected drug,
they should be 10 percent of the total spending on indirect pre-clinical research costs during that
time period.
• In the response field for “Cost Related to the Selected Drug Adjusted for Inflation,” report the cost
included for the “Cost Related to the Selected Drug” data field adjusted for inflation.
Costs Related to the Selected Drug Costs Related to the Selected Drug Adjusted for
Inflation
$
$
Instructions for Question 1b:
• List the direct and indirect costs for the selected drug that were included in the reported amount in
Question 1a.
FIELD
RESPONSE FORMAT
List of the direct and indirect costs for the Text (6,000 character count limit, which is
selected drug included in Question 1a
approximately 500 words)

Instructions for Question 1c:
• Explain how the numerical value reported in Question 1a waswere calculated, including the
allocation and apportionment methods. This explanation should include whether any of the reported
20

Wouters OJ, McKee M, Luyten J., Estimated Research and Development Investment Needed to Bring a New Medicine to
Market, 2009-2018. JAMA. 2020;323(9):844–853. doi:10.1001/jama.2020.1166.
21
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL., Methods for the Economic Evaluation of Health
Care Programme. 3rd ed. Oxford, UK: Oxford University Press, 2005, see

https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-care-programmethird-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.

30

•

costs are costs incurred on or before the last date for which the Primary Manufacturer reported data
in the Primary Manufacturer’s originalmost recent full submission of section 1194(e) data and the
total costs for this period of data.
Explain any methodology relevant to the cost included in response to Question 1a adjusted for
inflation in the free response.
FIELD
Explanation of Costs Related to the Selected Drug, Including
Allocation and Apportionment Methods, and an Explanation of
the Methodology for the Inflation Adjustment

RESPONSE FORMAT
Text (30,000 character count
limit, which is approximately
2,500 words)

Question 2: Costs of Failed or Abandoned Products Related to the Selected Drug
The Primary Manufacturer may report direct costs spent on basic pre-clinical research and
clinical research for failed or abandoned products that are related to the selected drug (for
the time periods as specified in the instructions above).
Instructions for Question 2a:
• In the numerical response field for “Costs of Allowable Failed or Abandoned Products Related to
the Selected Drug,” only include basic pre-clinical research or post-IND costs that can be directly
attributed to failed or abandoned product(s) with the same mechanism of action as the selected drug
that did not receive FDA approval.
• In the response field for “Costs of Allowable Failed or Abandoned Products Related to the Selected
Drug Adjusted for Inflation,” report the cost included for the “Costs of Allowable Failed or
Abandoned Products Related to the Selected Drug” data field adjusted for inflation.
Costs of Allowable Failed or Abandoned Costs of Allowable Failed or Abandoned
Products Related to the Selected Drug
Products Related to the Selected Drug Adjusted
for Inflation
$
$
Instructions for Question 2b:
• List all the applicable direct costs included in the numerical value given in Question 2a.
FIELD
RESPONSE FORMAT
List of the direct costs included in this question Text (6,000 character count limit, which is
approximately 500 words)
Instructions for Question 2c:
• In the free response field, detail how these costs were determined, what portion of direct costs was
included for basic pre-clinical research and direct post-IND costs, and how any allocation was done.
• Explain any methodology relevant to the cost included in response to Question 2a adjusted for
inflation in the free response.

31
FIELD
Explanation of Costs on Allowable Failed or Abandoned Products
Related to the Selected Drug, Including Allocation and
Apportionment Methods, and an Explanation of the Methodology for
the Inflation Adjustment

RESPONSE FORMAT
Text (30,000 character
count limit, which is
approximately 2,500
words)

Question 3: Global and U.S. Net Revenue for the Selected Drug
CMS will use both the Primary Manufacturer’s global and U.S. net revenue for the selected drug to
determine the extent to which the Primary Manufacturer has recouped R&D costs for the selected drug
(for the time periods as specified in the instructions above).
Instructions for Question 3a:
• In the numerical response field for “Global Net Revenue for the Selected Drug” in questionQuestion
3a, report the global net revenue.
• In the numerical response field for “Global Net Revenue for the Selected Drug Adjusted for
Inflation” in Question 3a, report the global net revenue reported adjusted for inflation.
Global Net Revenue for the Selected Drug
$

Global Net Revenue for the Selected Drug
Adjusted for Inflation
$

Instructions for Question 3b:
• In the free response field, explain how the final global net revenue was calculated, including any
relevant currency conversions.
• Explain any methodology relevant to the net revenue included in response to Question 3a adjusted
for inflation in the free response.
FIELD
RESPONSE FORMAT
Explanation of Global Net Revenue for the Selected Drug Text (30,000 character count limit,
and an Explanation of the Methodology for the Inflation
which is approximately 2,500 words)
Adjustment
Instructions for Question 3c:
• In the numerical response field for “U.S. Net Revenue for the Selected Drug” in Question 3c, report
the U.S. net revenue.
• In the numerical response field for “U.S. Net Revenue for the Selected Drug Adjusted for Inflation”
in Question 3c, report the U.S. net revenue reported adjusted for inflation.
U.S. Net Revenue for the Selected Drug
$

U.S. Net Revenue for the Selected Drug Adjusted
for Inflation
$

32
Instructions for Question 3d:
• In the free response field, explain how the U.S. net revenue was calculated.
• Explain any methodology relevant to the net revenue included in the response to Question 3c
adjusted for inflation in the free response.
FIELD
Explanation of U.S. Net Revenue for the Selected Drug and
an Explanation of the Methodology for the Inflation
Adjustment

RESPONSE FORMAT
Text (30,000 character count limit,
which is approximately 2,500
words)

Section 2: Current Unit Costs of Production and Distribution (Section D of the Drug Price
Negotiation ICR)
This section contains two questions on current unit costs of production and distribution for the selected
drug (for the time period as specified in the instructions below). Question 4 is a table in which to report
the average unit costs of production and distribution for each NDC-11 of the selected drug. Question 5
provides a free response field for explaining the methodology for calculating the amount reported in
Question 4.
Definitions:
• In accordance with section 1191(c)(6) of the Act, the term “unit” means, with respect to a drug or
biological product, the lowest identifiable amount (e.g., capsule or tablet, milligram of molecules,
grams, international units) of the drug or biological product that is dispensed, furnished, or
administered.
• Units must be reported in one of the three National Council for Prescription Drug Programs (NCPDP)
Billing Unit Standard (BUS)).22. The three NCPDP BUS are: each (EA), milliliter (mL), and gram
(GM). For certain volume data of the selected drug, CMS is requesting units be reported using the
NCPDP BUS to facilitate comparison with the amounts in the quantity dispensed field found in PDE
data, which also uses the NCPDP BUS.
• Costs of production are defined as all (direct and allocation of indirect) costs related to:
o Purchase of raw ingredients, including intermediates, active pharmaceutical ingredients,
excipients, and other bulk chemicals;
o Formulation and preparation of the finished drug product;
o Quality control and testing of the drug; and
o Operating costs for personnel, facilities, transportation, importation (if any), and other expenses
related to the preparation of the finished drug product for the selected drug.
• Costs of distribution are defined as all (direct and allocation of indirect) costs related to:
o Packaging and packaging materials;
o Labeling (e.g., the mechanical aspects of printing and affixing the approved label);
o Shipping to any entity (e.g., distributor, wholesaler, retail or specialty pharmacy, physician office
or hospital, etc.) that acquires the drug from the Primary Manufacturer or any Secondary
Manufacturer; and
o Operating costs for facilities, transportation, and other expenses related to packaging, labeling,
22

See: NCPDP BUS: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.

33
and shipping to any entity that acquires the drug from the Primary Manufacturer or any
Secondary Manufacturer.
• Current unit costs of production and distribution of the selected drug are defined to include:
o Units (and associated costs) marketed by the Primary Manufacturer and any Secondary
Manufacturer(s);
o Only units (and associated costs) produced and distributed for U.S. sales; costs incurred outside
of the U.S. are included, provided that they are incurred for the production or distribution of units
produced and distributed for use in the U.S.;
o Only costs incurred by the Primary Manufacturer and any Secondary Manufacturers; such costs
may include payments to third-party vendors (e.g., contractors) performing activities that qualify
as production or distribution, as specified above; and
o Allocated shared operating and other indirect costs (such as capitalized production facility costs,
benefits, generalized and administrative costs, and overhead expenses) specific to each NDC-11
based on unit volume.
• Current unit costs of production and distribution of the selected drug do not include:
o R&D costs;
o Marketing costs; and
o Transfer prices.
• “Marketing costs” are defined as expenditures incurred in the introduction or delivery for
introduction into interstate commerce of a drug product, specifically including media
advertisements, direct-to-consumer promotional incentives including patient assistance programs,
promotion of the drug to health professionals, including providing free products to health
professionals or patients, and other paid promotion.
• “Transfer prices” are defined as prices charged for goods, services, or other intangible assets in
transactions between two members of the same controlled group of the Primary Manufacturer or any
Secondary Manufacturer, including sales of a drug product, provision of services (e.g., contract
manufacturing), or transfer of intellectual property. For the purposes of the definition of transfer
prices, “controlled group” of the Primary Manufacturer or any Secondary Manufacturer refers to all
entities that were treated as a single employer under subsection (a) or (b) of section 52 of the Internal
Revenue Code and the Department of the Treasury regulations thereunder.
Instructions:
Follow the instructions below when answering Questions 4 and 5:
• Production and distribution unit costs must be reported separately for each NDC-11 of the selected
drug, including any NDC-11 of the selected drug manufactured, marketed, controlled, or sold by a
Secondary Manufacturer.
• Unit costs reported must represent the average per unit cost (1) within the time period specified
below, (2) across all package types, and (3) calculated according to the instructions and using the
definitions specified below.
• Use the response field in Question 5 to explain any shared operating and other indirect costs that
were included in the response to Question 4.
• Costs may be reported up to three decimal places (USD).
Question 4: Per Unit Production and Distribution Costs
Please complete the following table using additional rows as necessary for the following periods:

34
•

forFor a drug that was selected for negotiation or renegotiation for any prior initial price
applicability year 2026, forthat is two initial price applicability years or more prior to the initial price
applicability year for which this ICR is submitted: the 12-month period ending September 30, 2025,
of the current calendar year during which this ICR is submitted,23 and
forFor a drug that was selected for negotiation or renegotiation for the initial price applicability year
2027,prior to the initial price applicability year for which this ICR is submitted: the 9-month period
ending September 30, 2025. of the current calendar year during which this ICR is submitted.24

•

NDC-11

123456789-01

Average
Per Unit
Production
Cost
$XX.XXX

Average Per
Unit
Distribution
Costs
$XX.XXX

NCPDP
Total
Unit (EA, Unit
ML, GM) Volume

Costs are
Not
Available

Explanation of
Why Costs are
Not Available

Text

Select if
applicable

Text (30,000
character count
limit, which is
approximately
2,500 words)

#

Question 5: Explanation of Calculation of Per Unit Production and Distribution Costs
Please describe the methodology used to calculate the average per unit costs of production and
distribution reported in Question 4, including which indirect costs were included, specific allocation
methodologies, assumptions, and whether such assumptions apply to all or a subset of the data reported.
Specifically, include any other assumptions about costs, if applicable, including but not limited to:
• Allocated general and administrative overhead;
• Cost of capital;
• Labor compensation;
• Any included costs that were incurred outside of the U.S.;
• Allocated shared facility costs;
• Allocated shared transportation or other operational costs;
• Depreciation of facilities, equipment, or other assets involved in the production and distribution of
the selected drug; and
• Number of units of drug samples and how their cost was determined.
FIELD
Explanation of Unit Production and Distribution
Costs

RESPONSE FORMAT
Text (30,000 character count limit, which
is approximately 2,500 words)

Section 3: Prior Federal Financial Support (Section E of the Drug Price Negotiation ICR)

23
24

For example, for initial price applicability year 2029, the 12-month period ending September 30, 2026.
For example, for initial price applicability year 2029, the 9-month period ending September 30, 2026.

35
This section focuses on capturing Federal financial support incurred for novel therapeutic discovery and
development with respect to the selected drug (for the time periods as specified in the instructions
below).
Definitions:
• “Federal financial support for novel therapeutic discovery and development” refers to tax credits,
direct financial support, grants or contracts, in-kind contributions (e.g., support in the form of
office/laboratory space or equipment), and any other funds provided by the federal government that
support discovery, research, and/or development related to the selected drug.
• Prior Federal financial support includes the manufacturer’s reasonable estimate of the dollar value of
in-kind contributions and Cooperative Research and Development Agreements (CRADAs) that do
not have a readily ascertainable value.
• Direct prior federal financial support costs are costs that can be specifically attributed to the
discovery, pre-clinical development, and clinical trials of the selected drug.
Instructions:
Follow the instructions below when answering Questions 6, 7, and 8:
• Include prior Federal financial support provided by U.S. federal agencies or Federally-supported
grants or contracts that contributed to any of the costs described in Question 1 of this ICR Form of
the selected drug to the Primary Manufacturer only (do not include Federal financial support
provided to applicable Secondary Manufacturers of a selected drug) that was received during the
time period from the last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e)(1) data for the negotiation
period in which the selected drug’s MFP was negotiated through September 30, 2025 of the current
calendar year prior during which this ICR is submitted.
▪ As described in Section 1As described in Section 1, for Primary Manufacturers of a drug
that was selected originally for negotiation for initial price applicability year 2026 or 2027
and has not previously been selected for renegotiation in initial price applicability year
2028 or thereafter, if the Primary Manufacturer incurred R&D costs on or before the last date
for which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost
recent full submission of section 1194(e)(1) data for the negotiation period in which the
selected drug’s MFP was negotiated that meet the definition of R&D costs specified in this
ICR/Appendix A of the final guidance for initial price applicability year 2028 and, the Primary
Manufacturer has not previously reported the same data in the Primary Manufacturer’s
originalany prior full submission of data related to the section 1194(e)(1) datafactors, and the
Primary Manufacturer is reporting such R&D costs under Section 1, include all applicable
prior Federal financial support from when initial research began, or when the drug was
acquired by the Primary Manufacturer, whichever is later, through September 30, 2025.25 of

25

For initial price applicability year 2026 and initial price applicability year 2027, CMS did not permit costs to be reported
for indications that had not yet received FDA approval at the time of ICR submission; however, CMS will permit reporting of
such prior Federal financial support related to the selected drug for initial price applicability year 2028. Therefore, this
Section 3 also permits a Primary Manufacturer to report support that may have occurred on or before the last date for which
the Primary Manufacturer reported data in the Primary Manufacturer’s original full submission of section 1194(e)(1) data for
the negotiation period in which the selected drug’s MFP was negotiated that a Primary Manufacturer has not reported for the
selected drug previously.

36

•

•

26

the current calendar year during which this ICR is submitted.26
▪ For Question 6, if prior Federal financial support for the selected drug is not available for the
exact dates specified above in these instructions, the prior Federal financial support may be
reported through the most recent quarter for which such data are available. The Primary
Manufacturer should specify the time period used in Question 7.
Include prior Federal financial support received for indirect costs of developing the selected drug.
These indirect costs are operating costs such as administrative personnel and overhead costs
(expenses for clinical facilities and equipment) that are shared across multiple potential drugs or
biological products.
▪ To calculate the proportion of indirect costs, the Primary Manufacturer must use proportional
allocation, whereby the same proportion of spending allocated for direct research on the
selected drug is used to estimate the proportional spending for indirect research.27, 28 For
example, if the direct costs spent on the selected drug were approximately 10 percent of a
Primary Manufacturer’s total direct basic pre-clinical research costs, then indirect costs must
be allocated proportionally, thus for the selected drug they must be 10 percent of the total
spending on indirect costs during that time period.
▪ For grants, Primary Manufacturers should use the indirect cost rate at the time of data
submission to calculate the proportion of funds that should be allocated to indirect costs. This
indirect cost rate could be the fixed rate, provisional/final rate, or predetermined rate.
▪ For in-kind contributions and CRADAs, if the dollar value of the in-kind contribution or
CRADA is not readily ascertainable, the recipient should provide a reasonable estimate.
If the Primary Manufacturer shared the prior Federal financial support described in Questions 6
through 8 for any period of time or activity with any entity that is not the Primary Manufacturer, then
the Primary Manufacturer must report support received only for costs the Primary Manufacturer
incurred. ExpensesPrior Federal financial support should be allocated across entities based on each
entity’s respective stake in the selected drug’s discovery and development. The allocation to the
Primary Manufacturer should be reported as a dollar amount and the percentage of the total amount
allocated to the Primary Manufacturer should be included in the free response field in Question 8.
For example, if the Primary Manufacturer was allocated 80 percent of the prior Federal financial
support for a period of the selected drug’s development, the Primary Manufacturer would include 80
percent of that support in its total number for prior Federal financial support in Question 6. Then, it
would note the source of the shared prior Federal financial support and that it received 80 percent of
that support in Question 7. If the shared support came in the form of an agreement, the Primary
Manufacturer would include this in the “Nature of Agreement” section of Question 8.

For initial price applicability year 2026 and initial price applicability year 2027, CMS did not permit R&D costs to be
reported for indications that had not yet received FDA approval at the time of ICR submission; however, CMS, consistent
with the definitions in this ICR, now permits reporting of such R&D costs related to the selected drug. Therefore, if such
R&D costs were reported under Section 1, this Section 3 requires a Primary Manufacturer to report prior Federal financial
support associated with such R&D costs that may have occurred on or before the last date for which the Primary
Manufacturer reported data in the Primary Manufacturer’s most recent full submission of data related to the section
1194(e)(1) factors for the negotiation period in which the selected drug’s MFP was renegotiated that a Primary Manufacturer
has not reported for the selected drug previously.
27
Wouters OJ, McKee M, Luyten J., Estimated Research and Development Investment Needed to Bring a New Medicine to
Market, 2009-2018. JAMA. 2020;323(9):844–853. doi:10.1001/jama.2020.1166.
28
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL., Methods for the Economic Evaluation of Health
Care Programme. 3rd ed. Oxford, UK: Oxford University Press, 2005,
https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-care-programme-thir/.

37

Question 6: Federal Funding Support Amount
Instructions for Question 6:
• In the numerical response field for “total Federal financial support,” report the total Federal
financial support.
• In the numerical response field for “total Federal financial support adjusted for inflation,” report
the total Federal financial support reported adjusted for inflation.
Total Federal Financial Support
$

Total Federal Financial Support Adjusted for Inflation
$

Question 7: Explanation of Calculation of Federal Financial Support
Instructions for Question 7a:
• In the free response field, disaggregate the total Federal financial support amount reported above by
the amounts allocated to the sources in the list below. Please list amounts in order of highest to
lowest.
o In addition, describe assumptions, methodological steps, and other information needed to
calculate the estimates provided in Question 6.
o If you report a value for “other Federal financial support not otherwise included elsewhere” in
your response to this question, please list the source(s) of that Federal financial support.
o Please include the identification number for grants and comparable awards.
List of sources for Question 7a
• Tax credits (General, R&D)
• Orphan Drug Act and other specific tax credits
• National Institutes of Health (NIH) funding
• Department of Defense (DOD) Congressionally Directed Medical Research (CDMR) funding
• Biomedical Advanced Research and Development Authority (BARDA) funding
• Defense Advanced Research Projects Agency (DARPA) funding
• Federal financial support for failed or abandoned indications for the selected drug
• CRADA support
• In-kind contributions not included elsewhere
• Other Federal financial support not included elsewhere
FIELD
Explanation of Federal Financial Support, including
disaggregated amounts as applicable

RESPONSE FORMAT
Text (36,000 character count limit,
which is approximately 3,000 words)

Instructions for Question 7b:
• Explain any methodology relevant to the total Federal financial support adjusted for inflation
included in the response to Question 6 in the free response.
• Report each total Federal financial support disaggregated amount adjusted for inflation, and explain

38
the methodology used to adjust for inflation.
FIELD
Explanation of methodology used to
adjust for inflation

RESPONSE FORMAT
Text (6,000 character count limit, which is
approximately 500 words)

Question 8: Agreements Between Primary Manufacturer and Federal Government
List and describe any new licensing agreement, pricing agreement, purchasing agreement, and other
agreements in place between your company and any federal government agency related to the discovery,
research, and/or development of the selected drug if the agreement was either not finalized and/or not in
effect as of the last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e) data for the negotiation period in
which the selected drug’s MFP was negotiated. Add additional rows to your response to Question 8 as
needed.
•

In the “Nature of Agreement” field, please provide details on the terms of the agreement, such as
information on pricing, the nature and amount of goods/services agreed upon, an explanation of the
allocation methodology to the selected drug, timelines to delivering goods/services, conditions on
the agreement (exclusivity, sole supplier, etc.) and effective dates and expiration dates, if applicable.
For example, this field could detail an agreement between the Primary Manufacturer and Federal
Government where the Primary Manufacturer agrees to produce a certain quantity of a drug that is
being developed and has not yet been approved or licensed, deliver it to the Federal Government
within a specified timeline, and not contract with other state or local governmental entities or
insurers while this agreement is in place.
Type of Agreement

Federal Agency(ies)
Participating in Agreement
Select the agreement option:
Text (1,200 character count
licensing, pricing, purchasing, limit, which is approximately
other, none
100 words)

Nature of Agreement
Text (12,000 character count
limit, which is approximately
1,000 words)

Section 4: Patents and Exclusivities (Section F of the Drug Price Negotiation ICR)
This section focuses on capturing data on the selected drug related to pending and approved patent
applications, exclusivities recognized by the FDA, and applications under section 505(c) of the Federal
Food, Drug, and Cosmetic Act (“FD&C Act”) or section 351(a) of the Public Health Service (“PHS
Act”) (for the time periods as specified in the instructions below).
Follow the instructions below when answering Questions 9 through 11.
Definitions:
• Patents, Exclusivities and Approvals. CMS considers relevant patents, both expired and unexpired,
and relevant patent applications to include:
• All patents issued by the United States Patent and Trademark Office (USPTO), both expired and

39

•

•
•

•

unexpired, for which a claim of patent infringement could reasonably be, or has been, asserted
against a person or manufacturer engaged in the unlicensed manufacture, use, or sale of the
selected drug in any form or any person or manufacturer seeking FDA approval of a product that
references the selected drug.
o All patents relevant to the selected drug, both expired and unexpired, where the Primary
Manufacturer is not listed as the assignee/applicant (for example, for a joint venture product
or if any patents related to the selected drug are held by a federal agency).
o All patent applications related to the selected drug that are pending issuance by the USPTO.
Patents and patent applications relevant to the selected drug include, but are not limited to, any
patents that are, have been, or may be listed for the selected drug in the FDA Orange Book or Purple
Book;29 patents that claim the composition of matter (e.g., active ingredient, including its chemical
or biological structure), drug product (e.g., the final product taken by or administered to a patient),
drug substance (e.g., active ingredient) or other chemicals related to the active ingredient of a
selected drug (e.g., crystalline forms, polymorphs, salts, metabolites, or intermediates); patents that
claim a formulation of the drug; method-of-use patents (e.g., patents that claim an indication or use
of the drug for treating a particular disease); process patents (e.g., patents that claim technologies
and method(s) of manufacturing the drug); device patents (e.g., patents that claim the device used to
administer the selected drug); and design patents (e.g., patents that claim a design on the packaging
of the selected drug).
Relevant patents and patent applications do not include patent applications that were denied by the
USPTO.
Exclusivity periods under the FD&C Act or the PHS Act refer to certain delays on the submission or
approval of applications for competitor drug products. An NDA or BLA holder is eligible for
exclusivity if statutory requirements are met. Exclusivities include:
o Orphan Drug Exclusivity (ODE);30
o New Chemical Entity Exclusivity (NCE);31
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for Qualified Infectious
Disease Products (QIDP);32
o New Clinical Investigation Exclusivity (NCI);33
o Pediatric Exclusivity (PED);34 and
o Reference Product Exclusivity for Biological Products.35
Active and pending FDA applications and approvals include all applications for approval under
section 505(c) of the FD&C Act or section 351(a) of the PHS Act, including those not yet decided.

Instructions:
For Questions 9 through 11, the relevant time period for reporting is:
• for a drug selected that was selected for negotiation for initial price applicability year 2026, include
(1) Include any patents, approvals and exclusivities not previously reported to CMS in any prior full
29

FDA serves a ministerial role with regard to the listing of patent information in the Orange Book and Purple Book.
Section 527 of the FD&C Act.
31
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
32
Section 505E(a) of the FD&C Act.
33
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
34
Section 505A(b) & (c) of the FD&C Act.
35
Section 351(k)(7) of the PHS Act.
30

40

•

•

submission of section 1194(e)(1) data issued (and related items) after September 1, 2023 throughor
filed as of September 30, 2025 and (2) of the current calendar year during which this ICR is
submitted; and
Include any patents and exclusivities (and related items) for which , approvals, and exclusivities
issued or filed that were previously reported to CMS in any prior full submission of section
1194(e)(1) data where there has been a change after September 1, 2023 throughsince the most recent
full submission as of September 30, 2025, if requested below; and of the current calendar year
during which this ICR is submitted.
for a drug selected that was selected for negotiation for initial price applicability year 2027, include
(1) patents and exclusivities issued after February 1, 2025 through September 30, 2025 and (2)
patents and exclusivities (and related items) for which there has been a change after February 1,
2025 through September 30, 2025, if requested below.

Question 9A: Patents (Expired and Non-Expired)
In the table below, for the time period specified in the instructions, please list each patent that is relevant
to the selected drug for the applicable time period specified in the instructions (e.g., a , please list: (1)
each new patent that was not previously reported to CMS since the last date for whichin any prior full
submission of data reported by the Primary Manufacturer reported data in the Primary Manufacturer’s
original full submission of related to the section 1194(e)(1) data for the negotiation period in which the
selected drug’s MFP was negotiated)factors; and list(2) any previously-reported patent where there has
been a change since the last date for which the Primary Manufacturerthat was not previously reported
data in the Primary Manufacturer’s originalmost recent full submission(s) of section 1194(e)(1) data for
the negotiation period in which the selected drug’s MFP was negotiated (e.g., patent was removed from
the Orange Book).. As noted at the beginning of this ICR form, do not report relevant patents included
in any of the Primary Manufacturer’s originalmost recent full submission of section 1194(e)(1) data
where no change has occurred, or in the case of renegotiation, where such change has already been
reported to CMS in the most recent submission of section 1194(e)(1) data.
If you are reporting a new approved patent that was not previously included on this list in yourany prior
full submission, for each such patent (expired or unexpired) listed in the table below, in the patent
explanation field, please provide a clear and concise written description of the patented invention and, if
relevant, of the manner and process of making and using the invention, as well as how a patent relates to
any other patents listed in the table. For example, if a listed patent is a parent or child of another patent,
include the patent number and how the two patents relate to each other.
If there has been a change in the patent since the last submissiondate for which the most recent full
submission required reporting of such data, please include an explanation detailing what has changed
(e.g., if the patent was previously listed in the FDA Orange Book or Purple Book but is no longer listed,
please explain what was the change and explain why the change occurred).
A Zip file of the USPTO patent application(s) may be uploaded but is not required for this question 9A.
Add additional rows to your response to Question 9A as needed.

41
Patent
Date
Number Filed

Patent
Expiry
Date

Patent Type

#Text

MM/
DD/
YYYY*

Select patent
type (allow
more than one
to be selected):
composition of
matter patent;
drug product
patent; drug
substance
patent;
formulation
patent; process
patent; methodof-use patent;
device patent;
other (e.g.,
patent that
claims other
chemicals
related to the
active
ingredient,
design patent)

MM/
DD/
YYYY
(not
applic
able
itif
patent
expire
d)

Never,
Previously, or
Currently
Listed in FDA
Orange
Book/Purple
Book
Never/
Previously/
Currently

Explanation of
Patent or
Explanation of
What Changed
Since Last
Submission

Patent
Application

Text (3,600
character count
limit, which is
approximately
300 words

Optional.
Upload
correspondi
ng patent
application

*If no expiration date is available, enter 12/31/9999.
Question 9B: Patent Applications
In the data fieldstable below, please list each patent application that is relevant to the selected drug for
the applicable time period specified in the instructions (for example, a , please list: (1) each new patent
application or applications that have experienced a change since the last date for which the Primary
Manufacturerwas not previously reported data in the Primary Manufacturer’s originalany prior full
submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP was
negotiated). As noted at the beginning of this ICR form, do not report relevant; and (2) any previouslyreported patent applications included in the originalwhere there has been a change that was not
previously reported in the most recent full submission of the section 1194(e)(1) data where no change
has occurred..

42
For each patent application listed in the table below, in the patent explanation field, please provide a
clear and concise written description of the invention and, if relevant, of the manner and process of
making and using the invention, as well as how a patent application relates to any other patents if you
are reporting a new patent application that was not previously included on this list in your prior
submission. Do not include patent applications that were denied.
If there has been a change in the patent application since the last date for which the most recent full
submission of section 1194(e)(1) data required reporting of such data, please include an explanation
detailing what has changed.
Please upload a Zip file of a PDF file of the USPTO patent application. Add additional rows to your
response to Question 9B as needed.
Patent
Patent
Patent
Date
Patent Type
Explanation, or Application
Number Filed
Explanation of
What Changed
Since Last
Submission
#Text
MM/ DD/ Select patent type (allow more than
Text (3,600
Upload
YY
one to be selected): composition of
character count corresponding
YYYYYY
matter patent; drug product patent;
limit, which is
patent
(not
drug substance patent; formulation
approximately
application.
applicable patent; process patent; method-of-use
300 words)
if patent
patent;
pending)
device patent; other (e.g., patent that
claims other chemicals related to the
active ingredient, design patent)
Question 10: Exclusivity Periods
As applicable, please report all exclusivity periods under
In the FD&C Act or the PHS Act that are listed or were listed in the Orange Book or the Purple Book
and are in effect or have expired for the selected drugtable below, for the applicable time period
specified in the instructions (for example, a , please list: (1) each new exclusivity since the last date for
which the Primary Manufacturerthat was not previously reported data in the Primary Manufacturer’s
originalin any prior full submission(s) of section 1194(e)(1) data; and (2) any previously-reported
exclusivities where there has been a change that was not previously reported in the most recent full
submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP was
negotiated). Do not report exclusivity periods listed in the Primary Manufacturer’s original full
submission of section 1194(e)(1) data where no change has occurred. .
Complete table for Question 10 by adding rows as needed.

43
Type of Exclusivity

Select exclusivity type: Orphan
Drug Exclusivity, New Chemical
Entity Exclusivity, Generating
Antibiotic Incentives Now
Exclusivity for Qualified Infectious
Disease Products, New Clinical
Investigation Exclusivity, Pediatric
Exclusivity, Reference Product
Exclusivity for Biological Products

Exclusi
Application
vity
(NDA /
Expira
BLA)
tion
Number
Date
MM/DD/YY #
YY*

NDC-9s
Covered by
Exclusivity

Comments

Text

Text
(3,600
characte
r count
limit,
which is
approxi
mately
300
words)

*If no expiration date is available, enter 12/31/9999.
Question 11: All Active and Pending FDA Applications
List all active and pending FDA applications for the selected drug under section 505(c) of the FD&C Act
or section 351(a) of the PHS Act for the applicable time period specified in the instructions (for
example, a new application or applications that have experienced a change since the last date for which
the Primary Manufacturer reported data in the Primary Manufacturer’s original full submission of
section 1194(e)(1) data for the negotiation period in which the selected drug’s MFP was negotiated).. Do
not report active or pending FDA applications listed in the Primary Manufacturer’s originalmost recent
full submission of section 1194(e)(1) data where no change has occurred. In the table below, for the
applicable time period specified in the instructions, please list: (1) each new application that was not
previously reported in any prior full submission of section 1194(e)(1) data; and (2) any previously
reported patent where there has been a change that was not previously reported in the most recent full
submission of section 1194(e)(1) data.
Complete table for Question 11 by adding rows as needed using the indicated format.
Please submit any efficacy supplements that are pending FDA approval but exclude manufacturing
supplements for the applicable time period specified in the instructions.

44
Applicati
on (NDA
/ BLA)
Number

Applicati
on Type
(NDA;
BLA)

Classification
Code36

Approval
Date

Indicat
ion

#

Select the
application
type: NDA,
BLA

Select one or
more of the
following
options:
Options: Type 1
— New
Molecular
Entity, Type 2
— New Active
Ingredient,
Type 3 — New
Dosage Form,
Type 4
— New
Combination,
Type 5 — New
Formulation or
Other
Differences
(e.g., new
indication, new
applicant, new
manufacturer)
, Type 6 — New
Indication or
Claim, Same
Applicant, Type
7 — Previously
Marketed But
Without an
Approved NDA,
Type 8
— Rx to
OTC, Type
9
New Indication
or Claim, Drug
Not to be

MM DD,
YYYY (an
approval
date entry is
not required
if approval
pending)

Text

36

Dosag
e
Form
and
Streng
th
Text

Spons
or

Applicat
ion
Status

Commen
ts

Text

Select
one of
the
following
ng
options:
tentativel
y
approved
, pending,
withdraw
n, or
other

Text
(3,600
charact
er
count
limit,
which
is
approxi
mately
300
words)

These classification code options apply only to the “NDA” application type. If “BLA” is selected, this dropdown will be
grayed out as BLAs do not use classification codes.

45
Applicati
on (NDA
/ BLA)
Number

Applicati
on Type
(NDA;
BLA)

Classification
Code36

Approval
Date

Indicat
ion

Dosag
e
Form
and
Streng
th

Spons
or

Applicat
ion
Status

Commen
ts

Marketed
Under Type 9
– NDA After
Approval, Type
10 — New
Indication or
Claim, Drug to
be Marketed
Under Type 10
NDA After
Approval
Question 12: Predicted Loss of Exclusivity
Provide and explain the Primary Manufacturer’s best estimate for loss of exclusivity (earliest expected
date on which a generic drug or biosimilar of the selected drug37 would be allowed to enter the market)
for the selected drug. The Primary Manufacturer may choose to include the following information in
providing a “best estimate” and explaining such estimate: how specific patents reported in response to
Question 9A and/or exclusivities reported in response to Question 10 may protect the selected drug for a
given length of time for different strengths, formulations, and indications; the role of any legal decisions
or settlement agreements with the manufacturer(s) of, or other applicable third-party, that may impact
when generic drug(s) or biosimilar(s) of the selected drug are or may be coming to market; or references
to public documents (e.g., a Form 10K filing pursuant to section 13 or 15(d) of the Securities and
Exchange Act of 1934) or public statements where the Primary Manufacturer has provided commentary
on the expected loss of exclusivity of the selected drug.
FIELD
Predicted loss of exclusivity

RESPONSE FORMAT
Text (6,000 characters which is 500 words)

Section 5: Market Data and Revenue and Sales Volume Data (Section G of the Drug Price
Negotiation ICR)
The purpose of Questions 1213 and 1314 in this section is to collect the market data and revenue and
sales volume data described in section 1194(e)(1)(E) of the Act.
Definitions:

37

Refer to 42 CFR 429.20 for definitions of “generic drug” and “biosimilar”.

46
•

•

•

•

38

The three NCPDP BUS38 are: each (EA), milliliter (mL), and gram (GM). For certain volume data of
the selected drug, CMS requests units be reported using the NCPDP BUS to facilitate comparison with
the amounts in the quantity dispensed field found in PDE data, which also uses the NCPDP BUS. If
an NCPDP BUS of EA is used, one EA must represent a single individual dosage form or
dispensable unit (e.g., one tablet, capsule, vial, syringe, inhaler, or patch) and should match what is
reported in Section A.
Manufacturer U.S. commercial average net unit price: For the sole purpose of data collection under
section 1194(e)(1)(E) of the Act, the average net unit price of the selected drug for
privatecommercial health insurance plans, including small group and individual plans on- and offExchange and large group plans, excluding Original Medicare fee-for-service (Part(Parts A and Part
B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service, and Medicaid managed care.
The following items should be deducted from gross revenue in your calculation: discounts,
chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front
payments, goods in kind, free or reduced-price services, grants, or other price concessions or similar
benefits offered by the Primary Manufacturer and any Secondary Manufacturer(s) to any commercial
payer in the U.S. The following items should not be deducted from gross revenue in your
calculations: payments to wholesalers, group purchasing organizations (GPOs), pharmacies, or other
purchasers and manufacturer-run patient assistance programs that provide financial assistance such
as coupons, co-payment assistance, or free drug products to patients offered by the Primary
Manufacturer and any Secondary Manufacturer(s). The U.S. commercial average net unit price is
reported at the NDC-11 level. using NCPDP BUS.
Manufacturer U.S. commercial average net unit price─ net of patient assistance program: For the
sole purpose of data collection under section 1194(e)(1)(E) of the Act, the manufacturer U.S.
commercial average net unit price─ net of patient assistance is the manufacturer U.S. commercial
average net unit price, with the additional following items deducted: manufacturer-run patient
assistance programs that provide financial assistance such as coupons, co-payment assistance, or free
drug products to patients offered by the Primary Manufacturer and any Secondary Manufacturer(s).
The U.S. commercial average net unit price─ net of patient assistance program is reported at the
NDC-11 level using NCPDP BUS.
Manufacturer U.S. commercial average net unit price─ best: For the sole purpose of data collection
under section 1194(e)(1)(E) of the Act, the manufacturer U.S. commercial average net unit price─
best is the lowest U.S. commercial average net unit price offered by the Primary Manufacturer and any
Secondary Manufacturer(s) to any commercial payer in the U.S. The following items should be
deducted from gross revenue in your calculations: discounts, chargebacks or rebates, cash discounts,
free goods contingent on a purchase agreement, up-front payments, goods in-kind, free or reducedprice services, grants, or other price concessions or similar benefits offered by the Primary
Manufacturer or any Secondary Manufacturer(s) to any purchasers.commercial payers. The following
items should not be deducted from the gross revenue in your calculations: payments to wholesalers,
GPOs, pharmacies, or other purchasers and manufacturer-run patient assistance programs that provide
financial assistance such as coupons, co-payment assistance, or free drug products to patients offered
See: https://standards.ncpdp.org/Billing-Unit-

Request.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22. See:
https://standards.ncpdp.org/Billing-Unit-Request.aspx.

47
by the Primary Manufacturer and any Secondary Manufacturer(s). The U.S. commercial average net
unit price – best is reported at the NDC-11 level using NCPDP BUS.
Instructions:
• For Questions 1213 and 1314, information for the Primary Manufacturer and any Secondary
Manufacturer(s) must be reported.
• For Question 1213, for the sole purpose of data collection under section 1194(e)(1)(E) of the Act, as
applicable, the total unit volume must be reported at the NDC-11 level and reflect the NCPDP BUS.
The total unit volume must include the total unit volume sold by the Primary Manufacturer and any
Secondary Manufacturer(s) in the U.S. for the data reported.
Question 1213: Manufacturer U.S. Commercial Average Net Unit Price
Follow the instructions below when providing responses in the following table about the Manufacturer
U.S. commercial average net unit price:
• For each NDC-11, include the following:
o for a drug that was selected for negotiation for initial price applicability year 2026, a row for
each calendar quarter in calendar years 2023, 2024, and a row for each calendar quarter in
calendar year 2025 through the calendar quarter ending with September 30, 2025; and
o for a drug that was selected for negotiation for initial price applicability year 2027, a row for
each calendar quarter in calendar year 2025 through the calendar quarter ending with September
30, 2025.
o A row for each applicable calendar quarter, beginning with the calendar quarter after the last
calendar quarter of data that was submitted to CMS in a previous full section 1194(e)(1)
submission and ending with September 30 of the current calendar year during which this ICR is
submitted. If the period beginning with the calendar quarter after the
last calendar quarter of data that was submitted to CMS in the most recent full submission of
section 1194(e)(1) data and ending December 31 of the calendar year prior to the selected drug
publication date (defined at 42 CFR 429.20) for the initial price applicability year for which this
ICR is submitted is longer than three years, the reporting period is the three calendar years
ending with December 31 of the calendar year prior to the selected drug publication date
(defined at 42 CFR 429.20) for the initial price applicability year for which this ICR is
submitted.
• If the NDC-11 was ever marketed, sold, or distributed at any time during the quarter, please
complete all requested fields.
• If the NDC-11 was not marketed, sold, or distributed in a particular quarter, please enter “0” in the
total unit volume field and leave the three price fields blank and provide an explanation in the
“Explanation of why Manufacturer U.S. Commercial prices were not reported (if applicable)” field
of why the NDC-11 had no Manufacturer U.S. commercial prices for that calendar quarter (e.g., the
NDC-11 was first marketed in a later quarter).
• Exclude price and volume information for the selected drug for the following plans: Original
Medicare fee-for-service (Part(Parts A and Part B), Medicare Advantage, Medicare Part D, Medicaid
fee-for-service, and Medicaid managed care.
• If the Primary Manufacturer and Secondary Manufacturer(s) did not provide financial assistance to
patients, please leave the “U.S. commercial average net unit price─ net of patient assistance

48

•
•

programs” field blank.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (mL), or gram (GM).
Please do not include units associated with free samples in the calculated prices or reported total unit
volume.
In the “Explanation of Units and Why Manufacturer U.S. Commercial Prices Were Not Reported (if
applicable)” field, for each NDC-11 provide a written explanation of the specific unit provided for
this submission (e.g., the unit EA refers to a single capsule in a bottle of 30). You do not need to
duplicate response across quarters.

ND Quarter
C-11

Manufact
urer U.S.
Commer
cial
Average
Unit Net
Price

Manufact
urer U.S.
Commerc
ial
Average
Net Unit
Price- Net
of Patient
Assistance
Programs

Manufact
urer U.S.
Commer
cial
Average
Net Unit
PriceBest

NCP
DP
Unit
(EA,
mL,
GM)

Tota
l
Unit
Volu
me

Total
Unit
Volume
for U.S.
Comme
rcial
Average
Net Unit
Price Best

1234 QQYYY
5YYY Y6789 QN
-01

$

$

$

Text

#

#

Explanati
on of
whyUnits
and Why
Manufact
urer U.S.
Commerc
ial prices
were not
Reported
(if
applicabl
e)
Text (3,600
character
count limit,
which is
approximatel
y 300 words)

Question 1314: Explanation of Information Reported in Response to Question 1213: Manufacturer
U.S. Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics related to
Question 1213:
• How sales to enrollees of private health insurance plans, including small group and individual plans
on- and off-Exchange and large group plans were determined.
• How discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase
agreement, up-front payments, goods in-kind, free or reduced-price services, grants, or other price
concessions or similar benefits offered to any commercial payer were allocated across NDC-11s and
calendar quarters.
• If applicable, how financial assistance, such as coupons or co-payment assistance, to patients was
allocated across NDC-11s and calendar quarters.
• How information was used to calculate the “U.S. commercial average net unit price,” the “U.S.
commercial average net unit price─ net of patient assistance programs,” and the “U.S. commercial
average net unit price─ best”.
• Please indicate not applicable (N/A) in the free response field if no explanation is necessary.

49

FIELD
Explanation of manufacturer U.S. commercial
average net unit price data

RESPONSE FORMAT
Text (12,000 character count limit,
which is approximately 1,000 words)

Section 6: Indications39 and Evidence About Therapeutic Alternatives (Section I of the Drug Price
Negotiation ICR)
For Questions 1415 and 1516, the applicable time period to provide the requested responses is from the
date of the initial agreed-upon maximum fair price (the last written offer presented by either the Primary
Manufacturer or CMS, whichever is later, was input into CMS HPMS from the negotiation or
renegotiation period in which the selected drug’s MFP) was negotiated or renegotiated through
November 30, 2025.the due date of this ICR (consistent with 42 CFR 429.615(a)).
Question 1415. What new information or evidence do you think CMS should be aware of as it
evaluates the selected drug and therapeutic alternativesregarding new uses of the selected drug
regarding not related to an indicated disease or condition previously considered in negotiation or
renegotiation, including both new FDA-approved indications and off-label uses? For off-label use
of the selected drug, please indicate and include citations for evidence-based clinical practice
guidelines and ensure the off-label use is a medically-accepted indication(s) and/or material change
in one or more section 1194(e)(2) factors? for drugs covered under Part D or payable under Part B,
or both, taking into consideration the major drug compendia, authoritative medical literature,
accepted standards of medical practice, or some combination thereof. The submission may include
up to 25 citations of new evidence.
FIELD
Free response
Citations

RESPONSE FORMAT
Text (36,000 character count limit, which is approximately 3,000
words)
Up to 25 citations representing new evidence or data
•
•
•
•
•

Visual Representations

Numbered List
Citation
PubMed ID, if available
If the Pub Med ID is not available, the Digital Object Identifier, if
available
Hyperlink, if available

Up to 5 attachments representing visual representations of new
evidence or data

Question 1516. What new information or evidence do you think CMS should be aware of
regarding off-label usesas it evaluates the selected drug and therapeutic alternatives of the selected
drug not related to an indicated diseaseregarding a material change in one or condition previously
considered in negotiation? For off-label use of the selected drug, please indicate and include
39

For purposes of this ICR, CMS distinguishes between the use of the word “indication” and the term “FDA-approved
indication” such that “FDA-approved indication” refers to the information included in drug labeling per 21 C.F.R. §CFR
201.57(c)(2) or other applicable FDA regulation(s), and “indication” refers to the condition or disease state for which the
selected drug is used.

50
citations for evidence-based clinical practice guidelines and ensure the off-label use is a medicallyaccepted indication for drugs covered under Part D or payable under Part B, taking into
consideration the major drug compendia, authoritative medical literature, and/or accepted
standards of medical practice.more section 1194(e)(2) factors? The submission may include up to 25
citations of new evidence.
FIELD
Free response
Citations

Visual Representations

RESPONSE FORMAT
Text (36,000 character count limit, which is approximately 3,000
words)
Up to 25 citations representing new evidence or data
•
•
•
•

Numbered List
Citation
PubMed ID, if available
If the Pub Med ID is not available, the Digital Object Identifier, if
available
Hyperlink, if available

•
Up to 5 attachments representing visual representations of new
evidence or data

Certification of Submission
Required for Any Primary Manufacturer Voluntarily Submitting Responses to this ICR Instruction:
An individual eligible to certify this submission on behalf of the Primary Manufacturer must be
one of the following: (1) the chief executive officer (CEO) of the Primary Manufacturer; (2) the chief
financial officer (CFO) of the Primary Manufacturer; (3) an individual other than a CEO or CFO, who
has authority equivalent to a CEO or a CFO of the Primary Manufacturer; or (4) an individual with the
directly delegated authority to perform the certification on behalf of one of the individuals mentioned in
(1) through (3). an Authorized Representative of the Primary Manufacturer as defined in 42 CFR 429.20.
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 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 is being provided to and will be relied upon by CMS for
Medicare payment purposes, including determination of a potential MFP, as defined in section
1191(c)(3) of the Act. I also certify that I will timely notify CMS if I become aware that any of the
information submitted in this form has changed or is otherwise inaccurate. I also understand that any
misrepresentations may also give rise to liability, including under the False Claims Act and/or in the
form of civil monetary penalties pursuant to section 1197(c) of the Act.
Check box for certification: [ ]
Contact Information to be entered:

51
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
Text
Text (Electronic Dated Signature or Electronic
Copy of Wet Signature Accepted)
MMDDYYYY

Appendix: Email Template for a Primary Manufacturer to Indicate Intent to Submit Voluntary
Information for Purposes of Renegotiation Eligibility and Selection of the Selected Drug for Initial
Price Applicability Year 202820XX
Email subject line: Renegotiation: Notice of Intent to Submit Voluntary Information for
Initial Price Applicability Year 202820XX
Body of email:
Dear CMS,
I, an am authorized representativeto certify submissions of voluntary information for the identification
and selection of renegotiation-eligible drugs on behalf of [insert Primary Manufacturer name] for [insert
selected drug name],] and I am notifying CMS of my company’s intent to submit to CMS voluntary
information for the purposes of CMS’ consideration of the selected drug for renegotiation-eligibility and
selection for initial price applicability year 202820XX.
Signed, [Insert name of authorized representativeAuthorized Representative of the Primary
Manufacturer]

Paperwork Reduction Act Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control
number. The valid OMB control number for this information collection is 0938-1443 (Expires XX/XX/XXXX). This is a required information collection to
retain or obtain a benefit. Specifically, a Submitting Manufacturer must submit the Identification and Selection of Renegotiation-Eligible Drugs Information
Collection Request in order to provide information to CMS for use in determining which selected drugs are eligible for renegotiation and will be selected for
renegotiation. The time required to complete this information collection is estimated to average 125 hours per response, including the time to review
instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning
the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance
Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

****CMS Disclosure**** Please do not send applications, claims, payments, medical records or
any documents containing sensitive information to the PRA Reports Clearance Office. Please note
that any correspondence not pertaining to the information collection burden approved under the
associated OMB control number listed on this form will not be reviewed, forwarded, or retained.
If you have questions or concerns regarding where to submit your documents, please contact
Elisabeth Daniel ([email protected]).