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pdfSmall Biotech Exception and Biosimilar Delay Negotiation Program Drug Selection for
Initial Price Applicability Year 2028
under Sections 11001 and 11002 of the Inflation Reduction Act
Information Collection Request (ICR) Forms for Initial Price Applicability Year 2027
(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 Small Biotech Exception and Biosimilar Delay Information Collection Request Negotiation
Program Drug Selection for Initial Price Applicability Year 2027 2028 under Sections 11001 and
11002 of the Inflation Reduction Act Information Collection Request (ICR) includes twothree
parts: Part 1 (Small Biotech Exception Information Collection RequestICR Form) and), Part 2
(Biosimilar Delay Information Collection RequestICR Form).), and Part 3 (Identification and
Selection of Renegotiation-Eligible Drugs ICR Form).
Terms used in this information collection request (ICR)ICR have the meaning set forth in the
Medicare Drug Price Negotiation Program: FinalDraft Guidance, Implementation of Sections
1191 – 1198 of the Social Security Act for Initial Price Applicability Year 20272028 and
Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 20272028
(expected to be issued in Fall 2024Spring 2025 concurrently with this ICR; referenced
hereinafter as the “finaldraft guidance”) 1.”).
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PART 1
Small Biotech Exception Information Collection RequestICR 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”).
In order to 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 for. 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 2027 in accordance2028, section 1192(d) of the Act requires
CMS to evaluate whether a qualifying single source drug qualifies for the SBE based on
Medicare expenditures under Part D or Part B. CMS intends to make separate determinations
Available at: https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-andmanufacturer-effectuation-mfp-2026-2027.pdf.
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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 applicability year 2028, the term “negotiation-eligible drug” will
exclude any qualifying single source drug that meets either the Part B or Part D criteria to qualify
for the SBE.
For the purposes of the SBE, 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 athe Medicare Coverage Gap Discount Program (CGDP)
Agreement under section 1860D-14A for the for the drug in effect for the qualifying single
source drug on December 31, 2021 (the “. The Part B 2021 Manufacturer”), including all other
entities is the entity that, as of 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
with that entity(i.e., part of the same controlled group) under subsection (a) or (b) of section 52
of the Internal Revenue Code (IRC) 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 Medicare CGDP Agreement in effect on December 31, 2021.
Accordingly,CMS also collects information regarding the unique identifier assigned by CMS (P
Number) and labeler code(s) for the purpose of the SBE, “these entities. The controlled group”
of the Part B 2021 Manufacturer meanscomprises all corporations or partnerships, sole
proprietorships, and other entitiesentities that, as of December 31, 2021, were treated as a single
employer with the Part B 2021 Manufacturer under section 52(a) or (b) of. CMS also collects
information regarding the NDA(s) and/or BLA(s) for qualifying single source drugs held by the
IRCPart B 2021 Manufacturer and the Department of the Treasury regulations thereunder.
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 manufacturerSubmitting 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) 2. Because the). 3 The earliest effective date for this limitation is January 1, 2025
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See section 50.1 of the Medicare Part D Manufacturer Discount Program Final Guidance, dated November 17,
2023, available at https://www.cms.gov/files/document/manufacturer-discount-program-final-guidance.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-and-specified-small-manufacturermethodology.pdf, for more information.
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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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for acquisitions prior to January 1, 2025, this requirement applies to requests for the SBE starting
in initial price applicability year 2027or January 1, 2026, for acquisitions occurring during 2025.
Note: A Submitting Manufacturer must submit a request for an SBE for initial price applicability
year 2027 regardless of whether the manufacturer submitted a request for initial price
applicability year 2026.Note: This ICR only collects information relevant to a manufacturer’s
request for the SBE for initial price applicability year 2027.2028. 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. The Submitting Manufacturer must submit a request for the drug to be
considered for the 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
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:
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A Submitting Manufacturer must complete and submit the information requested on this
form in order for the drug to be considered for the exception for initial price applicability
year 2027an 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 draft guidance.
As described in section 30.2.1 of the finaldraft 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 New Drug Application(s) (NDA)(s) or Biologics License
Applications(s) (BLA)(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).
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If the Submitting Manufacturer seeks the Small Biotech Exception for a qualifying single
source drug it acquired after December 31, 2021, the Submitting Manufacturer must also
submit information related to the separate entity that had the CGDP Agreement for the drug
on December 31, 2021.
• A separate form must be submitted for each qualifying single source drug for which the
Submitting Manufacturer seeks the SBE.
• Submitting Manufacturers will submit a request for an SBE for initial price applicability year
20272028 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. 4 Instructions for gaining signatory access to the CMS HPMS are also included in this
PDF. 5 Technical assistance will also be made available.
• RequestsA request for an SBE that areis 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. This form must be completed and submitted withinThe
certification of the CMS HPMSICR should be executed by (1) the date specified by CMS in
program instruction.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).
• 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) 6), and all labeler codes;);
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, Employer Identification Number(s) (EIN(s)),), and mailing address, as well as
any P number(s) and labeler codes 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) or active ingredient (for biological products);
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https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.
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https://www.cms.gov/about-cms/information-systems/hpms/user-id-process.
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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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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 that had a Medicare CGDP Agreement in effect on December
31, 2021.; and/or
o All submissions that are incomplete or not timely submitted will not be accepted. For a
submission to be timely for initial price applicability year 2027, the Small Biotech
Manufacturer must submit a complete exception form to CMS via the CMS HPMS by
the date specified by CMS. Under the Part B track:
Identifying information as of December 31, 2021 for the entity that held the NDA(s) /
BLA(s) for
All submissions require certification. The certification of the ICR should be
executed by (1) the chief executive officer (CEO)qualifying single source drug
paid under Part B as of the 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, (2) the chief financial officer (CFO) of 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, (3) an individual other than a CEO or CFO, who has authority equivalent to a
CEO or a CFO was acquired after December 31, 2021 and information related to the active
moiety / active ingredient and list of NDA(s) / BLA(s) associated with the qualifying single
source drug for which the Submitting Manufacturer, or (4) an individual with the directly
delegated authority to perform is requesting the SBE.
Question 1: Information on the certification on behalf of one of the individuals mentioned in
(1) through (3).Submitting Manufacturer
Questions:
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.
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Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P
number) 7
Labeler Code(s)
Response
Text
nn-nnnnnnn
Text
Pnnnn
6F
Nnnnn
Question 2: Acquisition of the Submitting Manufacturer
Instructions for Question 2a: Was the Submitting Manufacturer holding, the New Drug
Application (entity that currently holds the NDA(s) or Biologics License Applications (BLA)(s)
for the qualifying single source drug for which you seek the Small Biotech Exception, acquired
after December 31, 2021?
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 acquiring entity.entity that acquired the Submitting
Manufacturer.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Address
Unique Identifier Assigned by CMS (P
number), if any
Labeler Code(s), if any
Response
Text
nn-nnnnnnn
Text
Pnnnn
Nnnnn
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.
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Question 3: Qualifying Single Source Drug Information
Instructions for Question 3a: Please list the active moiety (for drug products) or), 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.
Active Moiety / Active Ingredient
Text
Instructions for Question 3b: Please list all New Drug Applications (NDAsNDA(s) held by the
Submitting Manufacturer for any drug products with the active moiety(ies) listed in Question 3a
or all Biologics License Applications (BLAsBLA(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
Number
(123456)
Nnnnnn
Application
Type (NDA;
BLA)
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.
Question 4: Part D 2021 Manufacturer Coverage Gap 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? 8
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A manufacturer that participated in the 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.
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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 to Question 5a4b and answer Question 4c.
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))
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)
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
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))
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)
Labeler Code(s)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
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
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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 to certification.Question 5b and proceed to Section C (if applying for the Part B
Track) or certification to complete the Part D Track.
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
Address
Text
Unique Identifier Assigned by CMS (P number) if any
Pnnnn
Labeler Code(s) owned by this entity that are associated with this
entity’s unique identifier (P number)
Labeler Code(s)Labeler Code(s) owned by this entity that are
nnnnn
associated with unique identifier(s) (P number(s)) owned by other
entities, if any
Add a separate entry with the fivesix data elements for each member of the entity’s controlled
group.
C. Part B Track: Information for Qualifying Single Source Drugs Paid 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 questions 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”). Section C also contains
questions that collect information about the NDA(s) or BLA(s) held by that entity and the
members of that entity’s controlled group (if any).
Question 6: 2021 NDA/BLA Holder Information
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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
Employer Identification Number(s) (EIN(s))
Address
Unique Identifier Assigned by CMS (P number) if any
Response
Text
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.
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
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
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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.
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
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 draft 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
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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: [ ]
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).Yes/No
Contact Information
Field
Name of the Person Responsible for the
Submission
Signature
Date
Text
Response
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 11/30/2025). 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 8.259.75 hours per response for
Submitting Manufacturers that had a CGDP Agreement for such qualifying single source drug in effect and were not acquired after December 31,
2021, 10.25 per response for Submitting Manufacturers that had a CGDP Agreement for such qualifying single source drug in effect and were
acquired after December 31, 2021, 16 hours for the Submitting Manufacturers that did not have a CGDP Agreement for such qualifying single
source drug in effect and were not acquired after December 31, 2021, and 18 hours for the Submitting Manufacturer that did not have a CGDP
Agreement for such qualifying single source drug in effect and were acquired after December 31, 2021, 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.
PART 2
Biosimilar Delay Information CollectionICR 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
12
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 20262027; therefore, no Reference Drugs would be the subject of an
Additional Delay Request in initial price applicability year 20272028.
In accordance with section 30.1 of the finaldraft guidance, 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 identifying 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 mustis not be the same as the Reference
Manufacturer and mustis not be 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 musthave
not have 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 20272028, CMS will
consider any agreement between the 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, 20252026, as violating this requirement;
4. Information on the status of licensure for the Biosimilar under section 351(k) of the
Public Health Service Act (“PHS Act”);
5. 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;
6. 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
13
7. 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 before marketing of a
biosimilar biological product.
Note: This ICR only collects information relevant to a manufacturer’s request for the Biosimilar
Delay for initial price applicability year 20272028.
A determination by CMS that a Reference Drug is removed from the list of negotiation-eligible
drugs due to an Initial Delay Request for initial price applicability year 20272028 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
20282029). The process for submitting an Initial Delay Request for initial price applicability year
20282029 and for submitting an Additional Delay Request will be addressed in future guidance
or rulemaking and a future ICR.
Instructions:
•
Biosimilar Manufacturers will submit an Initial Delay Request for initial price applicability
year 20272028 via the CMS Health Plan Management System (the “CMS HPMS. 9”).
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 10. Instructions for gaining signatory access to the CMS HPMS are also included in
this PDF. 11 Technical assistance will also be made available.
As described in section 30.3.1 of the finaldraft guidance, 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 20272028, the
8F
9F
10F
•
•
The new automated tool for the Biosimilar Delay is scheduled to be available by Fall 2024; in the event that its
completion is delayed, CMS will use the same submission process deployed for initial price applicability year 2026,
which relied on e-mail and a secured Box location for uploading of necessary files. Refer to the Supporting
Statement – Part A for this ICR for additional information.
10
https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.
11
https://www.cms.gov/about-cms/information-systems/hpms/user-id-process.
9
14
•
•
•
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:
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., 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
before marketing of a biosimilar biological product.
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) 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 in (1) through (3).
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.
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 (EIN(s))
Address
Response
Text
nn-nnnnnnn
Text
15
Field
Response
Pnnnn
Unique Identifier Assigned by CMS (P number 12)
Nnnnn
Labeler Code(s)
11F
Identifying information on Biosimilar
Question 2. Provide the following identifying information for the Biosimilar.
Field
Biosimilar Name
Active Ingredient
Response
Text
Text
Question 3. List all applicationsthe application for licensure for the Biosimilar under section
351(k) of the Public Health Service Act regardless of status (i.e., including applications that areif
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.
Additional rows may be added if necessary within the CMS HPMS.
Applicati Submissi Application Relevant
on
on
status
Date
Number Number
Indicatio Dosage Form and
n
Strength
nnnnnn nnn
Text
Select the
current
status:
Text
Licensure
planned
before
February
1, 2027
Yes/No
Marketing
planned
before
February
1, 2027
Yes/No
☐Approved
☐Accepted
for Review
☐Submitte
d
[ ] Not applicable
Identifying information on Reference 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).
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.
12
16
Deleted Cells
Deleted Cells
Field
Reference Product
Reference Manufacturer
Response
Text
Text
Question 5. Provide the following information for the BLA of the reference product, including
the holder of the BLA.
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.
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.
17
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 initial price applicability year 20272028 if CMS determines there is a high likelihood
that the Biosimilar will be licensed and marketed before February 1, 20272028 (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 20272028 and Manufacturer Effectuation of the
Maximum Fair Price (MFP) in 2026, 2027, and 2027 (available at: ).2028. 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 initial price applicability year 20272028 if CMS determines
there is a high likelihood that the Biosimilar will be licensed before February 1, 20272028. 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 p.m. PM
Pacific Time (PT) on January 15, 20252026, to update CMS on the status of the Biosimilar’s
application for licensure.
(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
☐
☐
18
☐
☐
☐
(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.
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.
☐
☐
☐
☐
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 initial price applicability year 20272028 if CMS determines
there is a high likelihood that the Biosimilar will be marketed before February 1, 20272028.
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 but the Biosimilar Manufacturer expects it to be marketed by
February 1, 2027.
(CB) I confirm consistent with section 1192(f)(1)(A) of the Act, the Biosimilar has not ☐
yet been marketed and the Biosimilar Manufacturer does not expect it to be marketed
by February 1, 2027..
Section 3: Supporting Documentation
Question 11. Manufacturing schedule: In accordance with section 1192(f)(1)(B)(ii)(I) 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(s) for the Biosimilar submitted to the Food and Drug
Administration for each 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)
19
Question 12. Disclosures: In accordance with section 1192(f)(1)(B)(ii)(I) 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., 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.
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.
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) 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 draft guidance, the Biosimilar Manufacturer eligible to submit the request is the
holder of the BLA for the Biosimilar, is 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,
20
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 of 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
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 2027,2028 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)(7) 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 Yes/No
XX/XX/XXXX).Contact
Information
Field
Name of the Person Responsible for the
Submission
Signature
Date
Response
Text
Text
Date
21
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 11/30/2025). 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 Biosimilar 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 3
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 draft guidance. 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 draft guidance. 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 draft guidance.
This information collection request (ICR) offers Primary Manufacturers 13 the voluntary option 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.
12F
Note: This ICR focuses on information that may be submitted for selected drugs from initial price
applicability years 2026 and 2027 for the identification and selection of renegotiation-eligible drugs
for initial price applicability year 2028.
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 draft guidance, the term’s definition in this form is
the same as in the draft guidance. 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 draft guidance, including questions about terms defined in this ICR Form
should be sent to [email protected].
• Do not report any data or costs that were previously reported to CMS under a previous data
submission. Information reported in this ICR Form should only include data not previously
reported to CMS, following the specific question instructions for each section.
• 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
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”).
13
23
•
Manufacturer.
The certification of the submission must be executed by (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; 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).
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 draft guidance) indicating the Primary Manufacturer’s intent to submit this
ICR Form for 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 for this
information collection. CMS will provide access to a specific Box folder for a Primary
Manufacturer prior to the Primary Manufacturer’s submission of any information included in
response to the questions in this ICR Form to CMS.
Additional Instructions
•
•
The Primary Manufacturer should provide data only with regard to a selected drug
identified under section 1192 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 submit 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 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 packaged by a Secondary Manufacturer. 14
o Section 50.1 of the draft 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 When providing data to CMS about the selected drug, a Primary Manufacturer should
include NDC-11s of the selected drug that may be payable under Part B (if any) but are
not covered under Part D.
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).
13F
•
•
For initial price applicability year 2028, CMS intends to refer to any other entity that meets the statutory definition
of manufacturer for a drug product included in 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 to an agreement with the Primary
Manufacturer but is not listed on the NDA or BLA as a “Secondary Manufacturer.” A Secondary Manufacturer will
include 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.
14
24
•
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 (CMS10844, OMB 0938-1452) (the “Drug Price Negotiation ICR”), which CMS intends to publish
for a 60-day public comment period in Summer 2025. 15
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) data, 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 and the final guidance for initial price applicability year
2027.
14F
•
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 U.S. Commercial markets, Medicare markets, and Medicaid
markets is based on the definition of the United States in 42 C.F.R § 400.200, unless the
geographic area is specified in the authority for the data source.
When converting another currency to USD, specify in the free response field of the
applicable question which of the following options were used:
1. the exchange rate applicable at the time the costs were incurred. The Internal Revenue
Service (IRS) website lists government and external sources where historical exchange
rates can be found to the day. 16 If the exact date of a sale or conversion is not known, use
the yearly average exchange rate for that currency for the year the costs were incurred. 17
In the free response field, report the amount, the currency, the exchange rate, and time
period(s) used in this calculation, or
2. the GAAP Accounting Standard Certification (ASC) 830 for translating foreign
currencies.
Do not report the same costs in multiple places unless the additional specific instructions for
15F
16F
•
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.
16
See: https://www.irs.gov/individuals/international-taxpayers/foreign-currency-and-currencyexchange-rates.
17
See: https://www.irs.gov/individuals/international-taxpayers/yearly-average-currency-exchangerates.
15
25
•
•
that question instruct you to do so.
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, inflate to the most recent calendar year prior to the submission of
this ICR Form. For example, for drugs selected in initial price applicability year 2028 where
data is submitted in calendar year 2026, inflation adjustments should be made to 2025.
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 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 mean a combination of costs incurred by the Primary Manufacturer for indications 18
of a drug falling into the two categories below, and excluding the following: (a) prior Federal
financial support and (b) costs associated with applying for and receiving foreign approvals:
• R&D: Costs Related to the Selected Drug, Including Basic Pre-Clinical Research for Indications
of the Selected Drug, Post-IND Costs for Indications of the Selected Drug and Other Allowable
Costs
• R&D: Costs for Failed and Abandoned Products Related to the Selected Drug
17F
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
The definitions and 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.
• 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.
For purposes of this ICR and the Negotiation Data Elements and Drug Price Negotiation Process ICR, CMS
distinguishes between the use of the word “indication” and the term “FDA-approved indication” such that “FDAapproved indication” refers to the information included in drug labeling per 21 C.F.R. § 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.
18
26
•
Reported R&D costs are allowable for the following applicable time periods:
o R&D costs meeting the definitions below that were incurred after 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 through September 30, 2025; and
o R&D costs meeting the definitions below for new FDA-approved indications with the
date of FDA approval for the new indication occurring on or after the date the Primary
Manufacturer was statutorily-required to certify the Primary Manufacturer’s original full
submission (hereinafter, referred to as the “date of certification of the Primary
Manufacturer’s original full submission”). 19 For a new FDA-approved indication, a
Primary Manufacturer may report applicable: (1) direct and proportion of indirect costs
for basic pre-clinical research, (2) direct post-IND costs, and (3) direct costs on other
allowable costs from the date of initial discovery or the date the Primary Manufacturer
acquired the right to hold the potential NDA(s) / BLA(s) or NDA(s) / BLA(s) of the
selected drug (whichever is later) through September 30, 2025.
• The Primary Manufacturer may only report costs with respect to a new FDAapproved indication if those R&D costs were not already reported in the prior
submission.
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 original 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.
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.
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
18F
•
•
•
•
•
For a drug selected for initial price applicability year 2026, the statutory deadline for submission of the section
1194(e)(1) data was October 2, 2023. For a drug selected for initial price applicability year 2027, the statutory
deadline was March 1, 2025.
19
27
•
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.
Definitions for Section 1:
• 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
for each FDA-approved indication. Post-IND costs also include direct costs associated with
completed FDA-required, postmarketing trials that are conducted after the FDA has approved
a product.
• 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 during the post-IND period. Direct post-IND costs also include
patient recruitment, per-patient costs, research and data collection costs, personnel, and
facility costs that are directly related to conducting the completed FDA-required,
postmarketing trial.
• Personnel, patient recruitment, and per-patient costs include monetary and non-monetary
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.
Question 1: Costs Related to the Selected Drug, Including New Basic Pre-Clinical Research
for Indications of the Selected Drug, Post-IND Costs for Indications of the Selected Drug
and Other Allowable Costs
Provide the following information about R&D costs (for the time periods as specified in the
instructions above) incurred by the Primary Manufacturer for indications for the selected drug
related to basic pre-clinical research, post-IND costs for the selected drug, and other allowable
costs, as described in more detail below.
Additional Definitions for Question 1:
R&D: Basic Pre-Clinical Research Costs Related to the Selected Drug
• Basic pre-clinical research costs are the sum of (1) direct research expenses; and (2) the
appropriate proportion of indirect research expenses (defined below).
• 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.
• 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
28
products.
Other Allowable Costs:
• Other allowable costs for all 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, direct costs associated
with Phase IV postmarketing studies for FDA-approved indications that were not required by
FDA, direct post-IND costs for indications that did not receive FDA approval (following the
definitions and instructions for calculating direct post-IND costs above), direct costs
associated with researching and utilizing devices for the selected drug, and direct costs
associated with generating real-world evidence that was submitted to FDA to support the
safety or effectiveness of a selected drug and direct costs to support or satisfy a
postmarketing requirement or commitment.
• Direct costs for other allowable costs include patient recruitment, per-patient costs, research
and data collection costs, personnel, and facility costs that are directly related to conducting
Phase IV and postmarketing trials.
Instructions for Question 1a:
• In the numerical response field, report the sum of the new (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 on other allowable costs.
• Do not make adjustments for inflation or for the cost of capital.
• 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 preclinical research costs during that time period.
19F
20F
FIELD
Costs Related to the Selected Drug
RESPONSE FORMAT
$
Instructions for Question 1b:
•
List the direct and indirect costs for the selected drug that were included in the reported
amount in Question 1a.
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
20
https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-careprogramme-third-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
29
FIELD
RESPONSE FORMAT
List of the direct and indirect costs for the selected drug included Text (6,000 character count
in Question 1a
limit, which is approximately
500 words)
Instructions for Question 1c:
•
•
Explain how the numerical value reported in Question 1a was calculated, including the
allocation and apportionment methods. This explanation should include whether any of the
reported costs are associated with a new indication(s) and the total costs that are attributable
to the new indication(s). If there are multiple new indications, please differentiate costs by
indication, where applicable.
Report the cost included in the response to Question 1a adjusted for inflation, and explain
any methodology relevant to this reported amount.
FIELD
Explanation of Costs Related to the Selected Drug, Including
Allocation and Apportionment Methods, and an Inflation
Adjusted Value with 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 directly
attributable to the selected drug (for the time periods as specified in the instructions
above).
Additional Definitions for Question 2:
R&D: Costs of Failed or Abandoned Products Related to the Selected Drug
• Failed or abandoned product costs include 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.
o Direct research expenses are costs that can specifically be attributed to the discovery and
pre-clinical development of the drug.
o Direct research expenses include personnel (monetary and non-monetary compensation
for investigators and staff) researching the drug, materials for conducting basic preclinical research, and in vivo and in vitro studies on the drug.
• Failed or abandoned products costs include direct post-IND costs for drugs with the same
mechanism of action as the selected drug that did not receive FDA approval.
o Direct post-IND costs are costs that can specifically be attributed to the dosing and
clinical trials for the drug.
• Acquisition costs for failed or abandoned products are not allowable.
30
Instructions for Question 2a:
• In the numerical response field, 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.
FIELD
Costs of Allowable Failed or Abandoned Products Related to the
Selected Drug
RESPONSE FORMAT
$
Instructions for Question 2b:
List all the applicable direct costs included in the numerical value given in Question 2a.
•
FIELD
List of the direct costs included in this question
RESPONSE FORMAT
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.
• Report the cost included in response to Question 2a adjusted for inflation, and explain any
methodology relevant to this reported amount.
•
FIELD
Explanation of Costs on Allowable Failed or Abandoned Products
Related to the Selected Drug, Including Allocation and
Apportionment Methods, and an Inflation Adjusted Value with 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).
Definitions for Question 3a: Global, including U.S., Net Revenue for the Selected Drug:
• 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.
FIELD
Global Net Revenue for the Selected Drug
RESPONSE FORMAT
$
31
•
•
In the free response field, explain how the final global net revenue was calculated, including
any relevant currency conversions.
Report the net revenue included in response to Question 3a adjusted for inflation, and explain
any methodology relevant to this reported value.
FIELD
RESPONSE FORMAT
Explanation of Global Net Revenue for the Selected Drug Text (30,000 character count limit,
and an Inflation Adjusted Value with an Explanation of the which is approximately 2,500 words)
Methodology for the Inflation Adjustment
Definitions for Question 3b: U.S. Net Revenue for the Selected Drug:
• 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.
FIELD
U.S. Net Revenue for the Selected Drug
•
•
RESPONSE FORMAT
$
In the free response field, explain how the U.S. net revenue was calculated.
Report the net revenue included in response to Question 3b adjusted for inflation, and explain
any methodology relevant to this reported value.
FIELD
Explanation of U.S. Net Revenue for the Selected Drug and
an Inflation Adjusted Value with 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 or
furnished.
• Units must be reported in one of the three National Council for Prescription Drug Programs
32
(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, 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 to 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
21F
See: NCPDP BUS: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
22
33
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 marketed 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:
• for a drug that was selected for negotiation for initial price applicability year 2026, for the
12-month period ending September 30, 2025, and
• for a drug that was selected for negotiation for initial price applicability year 2027, for the 9-month period ending September 30, 2025.
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 assumptions about costs including but not limited to:
34
•
•
•
•
•
•
•
•
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)
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 indications 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 Federallysupported grants or contracts that contributed to direct costs for the basic pre-clinical
research and clinical trials phase of research and development for indications 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 issued during the time
period from 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 through September 30, 2025.
If a new indication was added since the date of certification of the Primary
Manufacturer’s original full submission of section 1194(e) data, include all
applicable prior Federal financial support for that new indication from when
35
•
•
initial research began (as defined above in the R&D Costs subsection (which
is Section 1)), or when the drug was acquired by the Primary Manufacturer,
whichever is later, through September 30, 2025.
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 new 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. 23, 24 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 received new prior Federal financial support for a failed or
abandoned product with the same mechanism of action as the selected drug that did not make
it to clinical trials and/or drugs with the same mechanism of action as the selected drug that
did not receive FDA approval, including indications for the selected drug that did not receive
approval, the Primary Manufacturer should not include this amount in its answer for
Question 6. Instead, the Primary Manufacturer must include this amount as a separate
quantity when explaining prior Federal financial support in Question 7.
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. Expenses 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
22F
•
•
23F
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.
24
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-thirdedition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
23
36
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.
Question 6: Federal Funding Support Amount
Complete the table below. Do not make adjustments for inflation.
FIELD
Total Federal Financial Support
RESPONSE FORMAT
$
Question 7: Explanation of Calculation of Federal Financial Support
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. In addition,
describe assumptions, methodological steps, and other information needed to calculate the
estimates provided in Question 6. 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. Please include the identification number for grants and comparable
awards.
•
•
•
•
•
•
•
•
•
•
•
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
Federal financial support for failed or abandoned products related to the selected drug (as
described in the definitions for this section)
CRADA support
In-kind contributions not included elsewhere
Other Federal financial support not included elsewhere
FIELD
Federal Financial Support
RESPONSE FORMAT
Text (36,000 character count limit, which is
approximately 3,000 words)
Report each total Federal financial support disaggregated amount adjusted for inflation, and
explain the methodology used to adjust for inflation.
37
FIELD
Federal Financial Support
disaggregated amount adjusted
for inflation
Explanation of methodology
used to adjust for inflation
RESPONSE FORMAT
Text (36,000 character count limit, which is
approximately 3,000 words)
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 not
finalized or in effect as of the date of the statutorily required certification of the Primary
Manufacturer’s original full submission. 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:
38
All patents issued by the United States Patent and Trademark Office (USPTO), both
expired and 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; 25 patents that claim the drug product (e.g., the final product taken by
or administered to a patient), drug substance (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); 26
o New Chemical Entity Exclusivity (NCE); 27
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for Qualified
Infectious Disease Products (QIDP); 28
o New Clinical Investigation Exclusivity (NCI); 29
o Pediatric Exclusivity (PED); 30 and
o Reference Product Exclusivity for Biological Products. 31
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.
•
•
24F
•
•
25F
26F
27F
28F
29F
30F
•
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.
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
28
Section 505E(a) of the FD&C Act.
29
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
30
Section 505A(b) & (c) of the FD&C Act.
31
Section 351(k)(7) of the PHS Act.
25
26
27
39
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 patents and exclusivities issued after September 1, 2023 through September 30, 2025;
and
• for a drug selected that was selected for negotiation for initial price applicability year 2027,
include patents and exclusivities issued after February 1, 2025 through September 30, 2025.
Question 9A: Patents (Expired and Non-Expired)
In the table below, please list each patent that is relevant to the selected drug for the applicable
time period specified in the instructions. As noted at the beginning of this ICR form, do not
report relevant patents included in the Primary Manufacturer’s original full submission of section
1194(e)(1) data.
If you are reporting a new approved patent that was not previously included on this list in your
prior 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. Clearly identify which patent or patents is the composition of matter patent(s) in the
free response. If the patent was previously listed in the FDA Orange Book or Purple Book but is
no longer listed, please explain why.
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.
Patent
Date
Number Filed
#
Patent
Expiry
Date
MM/ MM/
DD/
DD/
YYYY YYYY
(not
applic
able it
patent
expire
d)
Patent Type Never,
Previously,
or Currently
Listed in
FDA
Orange
Book/Purple
Book
Select
Never/
patent type Previously/
(allow
Currently
more than
one to be
selected):
drug
product
patent;
drug
40
Patent Explanation Patent
Application
Text (3,600
character count
limit, which is
approximately
300 words
Optional.
Upload
corresponding
patent
application
Patent
Date
Number Filed
Patent
Expiry
Date
Patent Type Never,
Previously,
or Currently
Listed in
FDA
Orange
Book/Purple
Book
substance
patent;
formulatio
n patent;
process
patent;
method-ofuse patent;
device
patent;
other (e.g.,
patent that
Patent Explanation Patent
Application
claims
other
chemicals
related to
the active
ingredient,
design
patent)
Question 9B: Patent Applications
In the data fields below, please list each patent application that is relevant to the selected drug for
the applicable time period specified in the instructions. As noted at the beginning of this ICR
form, do not report relevant patent applications included in the original full submission of the
section 1194(e)(1) data.
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 that was not previously included on this list in
your prior submission. Do not include patent applications that were denied.
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.
41
Patent
Number
Date
Filed
Patent Type
Patent Explanation
Patent Application
#
MM/
DD/ YY
YY
Select patent type (allow
more than one to be
selected): drug product
patent; drug substance
patent; formulation patent;
process patent; method-ofuse patent;
device patent; other (e.g.,
patent that claims other
chemicals related to the
active ingredient, design
patent)
Text (3,600
character count
limit, which is
approximately 300
words)
Upload
corresponding
patent
application.
Question 10: Exclusivity Periods
As applicable, please report all exclusivity periods under 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 drug for the applicable time period specified in the instructions. Do not report
exclusivity periods listed in the Primary Manufacturer’s original full submission of section
1194(e)(1) data.
Complete table for Question 10 by adding rows as needed.
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
vity
Expira
tion
Date
MM/DD/YY
YY
42
Application
(NDA /
BLA)
Number
#
NDC-9s
Covered
by
Exclusivi
ty
Text
Comments
Text (3,600
character
count limit,
which is
approximat
ely 300
words)
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. Do not report active or pending FDA applications listed in the Primary
Manufacturer’s original 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.
32
Applica
tion
(NDA /
BLA)
Number
Applica
tion
Type
(NDA;
BLA)
Classification Code 32
Indic
ation
#
Select the
applicatio
n type:
NDA,
BLA
Select one or more of
Text
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
31F
Dosage
Form
and
Strength
Spon
sor
Applicatio
n Status
Comments
Text
Text
Select one
of the
following
ng options:
tentatively
approved,
pending,
withdrawn,
or other
Text
(3,600
character
count
limit,
which is
approxim
ately 300
words)
These classification code options apply only to the “NDA” application type. BLAs do not use classification codes.
43
Applica
tion
(NDA /
BLA)
Number
Applica
tion
Type
(NDA;
BLA)
Indic
ation
Classification Code 32
31F
Dosage
Form
and
Strength
Spon
sor
Applicatio
n Status
Comments
Claim, Drug Not to be
Marketed Under Type 9
NDA After Approval,
Type 10 — New
Indication or Claim,
Drug to be Marketed
Under Type 10 NDA
After Approval
Section 5: Market Data and Revenue and Sales Volume Data (Section G of the Drug Price
Negotiation ICR)
The purpose of Questions 12 and 13 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:
• The three NCPDP BUS 33 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
for all but Medicaid best price to facilitate comparison with the amounts in the quantity
dispensed field found in PDE data, which also uses the NCPDP BUS.
• 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
group or individual commercial plans on- and off-Exchange, excluding Medicare fee-forservice (Part 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 purchasers. The following items should not be
deducted from gross revenue in your calculation: 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
32F
See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
33
44
•
•
Manufacturer(s). The U.S. commercial average net unit price is reported at the NDC-11
level.
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 following
items should be deducted from the gross revenue in your calculations: 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 following items should not 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 reduced-price services,
grants, or other price concessions or similar benefits offered by the Primary Manufacturer
and any Secondary Manufacturer(s) to any purchasers. The U.S. commercial average net unit
price─ net of patient assistance program is reported at the NDC-11 level.
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 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 reduced- price services, grants,
or other price concessions or similar benefits offered by the Primary Manufacturer or any
Secondary Manufacturer(s) to any purchasers. The following items should not be deducted
from the gross revenue in your calculations: 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 – best is reported at the NDC-11 level.
Instructions:
• For Questions 12 and 13, information for the Primary Manufacturer and any Secondary
Manufacturer(s) must be reported.
• For Question 12, 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 12: 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, including group and individual
commercial plans on- and off-Exchange of the selected drug:
• For each NDC-11, that is included in the Primary Manufacturer’s NDC-11s in the “Manage
NDC-11s” module in the CMS HPMS, 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
45
•
•
•
•
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.
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 Medicare fee-for-service
(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 programs” field blank.
ND
C11
Quart Manufact Manufac
er
urer U.S. turer
Comme U.S.
rcial
Commer
Average cial
Unit Net Average
Price
Net Unit
PriceNet of
Patient
Assistanc
e
Program
s
123 QQ
$
$
45- YYY
678 Y
9-01
Manufact
urer U.S.
Comme
rcia l
Average
Net Unit
PriceBest
$
NCP
DP
Unit
(EA,
ML,
GM)
Text
Tot
al
Unit
Vol
ume
Total
Unit
Volume
for U.S.
Comme
rcial
Averag
e Net
Unit
Price Best
#
#
Explanat
ion of
why
Manufac
turer
U.S.
Commer
cial
prices
were not
Reporte
d (if
applicabl
e)
Text (3,600
character
count limit,
which is
approximatel
y 300 words)
Question 13: Explanation of Information Reported in Response to Question 12:
Manufacturer U.S. Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics
related to Question 12:
• How sales to enrollees of group and individual commercial plans on- and off-Exchange were
determined.
• How discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase
46
•
•
•
agreement, up-front payments, goods in-kind, free or reduced-price services, grants, or other
price concessions or similar benefits offered to any purchasers were allocated across NDC11s 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.
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: New Indications and Evidence About Therapeutic Alternatives (Section
I of the Drug Price Negotiation ICR)
For Questions 14 and 15, the applicable time period to provide the requested responses is from
the last date for which the Primary Manufacturer reported data in the Primary Manufacturer’s
original submission of section 1194(e)(2) data to CMS through September 30, 2025.
Question 14. What new information or evidence do you think CMS should be aware of as it
evaluates the selected drug and therapeutic alternatives of the selected drug regarding new
FDA-approved indication(s) and/or material change in one or more section 1194(e)(2)
factor? 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
Numbered List
Citation
PubMed ID, if available
If the Pub Med ID is not available, the Digital Object
Identifier, if available
Hyperlink, if available
•
•
•
•
Question 15. What new information or evidence do you think CMS should be aware of
regarding new off-label uses of the selected drug not related to an indicated disease or
condition previously considered in negotiation? For off-label use of the selected drug, please
indicate and include citations for evidence-based clinical practice guidelines and ensure the offlabel use is a medically-accepted 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.
FIELD
RESPONSE FORMAT
47
Free response
Citations
Text (36,000 character count limit, which is
approximately 3,000 words)
•
•
•
•
•
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
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).
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 reimbursement purposes. 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:
Field
Name of the Person Responsible for the
Submission
Signature
Response
Text
Text (Electronic Dated Signature or Electronic
Copy of Wet Signature Accepted)
48
Field
Date
Response
MMDDYYYY
Appendix: Email Template for a Primary Manufacturer to Indicate Intent to Submit
Voluntary Information for Purposes of Renegotiation of the Selected Drug for Initial Price
Applicability Year 2028
Email subject line: Renegotiation: Notice of Intent to Submit Voluntary Information
for Initial Price Applicability Year 2028
Body of email:
Dear CMS,
I, an authorized representative of [insert Primary Manufacturer name] for [insert selected drug
name], 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 2028.
Signed, [Insert name of authorized representative]
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 Selection for 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]).
49
| File Type | application/pdf |
| Author | William A Brice |
| File Modified | 2025-11-07 |
| File Created | 2025-11-07 |