Drug Price Negotiation for Initial Price Applicability Year 20XX Under Sections 11001 and 11002 of the Inflation Reduction Act I

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Drug Price Negotiation for Initial Price Applicability Year 20XX
Under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR)
Crosswalk of Changes Between Initial Price Applicability Year 2028 Final Documents and Initial Price Applicability Year 20XX Final Documents*

Location of Edits

Summary of Changes
(Included in Final)

Type of
Change

Explanation of
Changes

Burden
Change
(Yes/No)

• Updated references to reflect policies codified in the Negotiation Program final
rule (CMS-4215-F) (hereinafter, the “final rule”)
• Revised instructions for certification to include “Authorized Representative” as
defined in the final rule
• Revisions to amend initial price applicability year references from “initial price
applicability year 2028” to “initial price applicability year 20XX” and/or
references to terms in the final rule (e.g., calendar year prior to the selected
drug publication date for the applicable initial price applicability year) because
CMS intends to incorporate non-substantive date revisions to within the
ICR Forms upon review and approval of the package from the Office of
Management and Budget annually for each initial price applicability year
• Addition of information to incorporate the Small Biotech Floor ICR Form,
pursuant to section 1194 of the Social Security Act (the “Act”)
• Clarified date of service period for calculating Total Expenditures

Modify

Revisions
consistent with the
statutory
requirements at
section 1194 of the
Act;
Technical updates

Yes

Modify

Technical update

No

Addition of burden for the Temporary Floor for Small Biotech Drugs ICR Form
Revision of the number of respondents estimated for the Negotiation Data
Elements and the Counteroffer Process ICR Forms based on an increase in the
statutory maximum number of drugs which could be selected for a given year,
starting in initial price applicability year 2029, and the number of selected
drugs that may be potentially selected for renegotiation for one year
of submission based on the example of initial price applicability year 2029 as
the base year
Revisions to update the burden estimates for submitters to incorporate the
average labor costs using the May 2025 data from the Bureau of Labor
Statistics
Revisions to update the government burden estimate to incorporate 2026
federal pay scales

Modify

Revisions
consistent with the
statutory
requirements at
section 1194 of the
Act;
Technical updates

Yes

Supporting Statement
Throughout

Section A
Burden Estimate

•
•

•
•

1

Location of Edits

Summary of Changes
(Included in Final)
•

Type of
Change

Explanation of
Changes

Burden
Change
(Yes/No)

Modify

Revisions
consistent with the
statutory
requirements at
section 1194 of the
Act;
Technical updates

No

Modify

Technical updates,
Changes in
response to
comments

No

Modify

Changes due to
internal or
administrative
review;
Technical updates

No

Modify

Revisions
consistent with the
statutory
requirements at
sections 1194(e)(1)

No

Revisions to update table numbers and formatting of government cost
estimate tables

Information Collection Request (ICR) Forms
ICR Form – Negotiation Data Elements
Throughout

Sections A and F

Sections C and E

Sections D, F and G

• Updated references and definitions to reflect policies codified in the final rule
• Standardized format for reporting calendar quarters to YYYY-QN
• Revisions to update calendar year references to include placeholder dates
applicable to the collection of information for each initial price applicability
year (e.g., 20XX) and/or references to terms in the final rule (e.g., calendar year
prior to the selected drug publication date for the applicable initial price
applicability year)
• Renumbering of questions due to revisions in Sections F and G
• Corrected wording error in Section A for consistency and alignment with the
final rule
• Revision to the instructions in Question 12 to specify that 6,000 characters is
approximately 500 words
• Added instruction to specify what unit one EA represents in the written
response in Questions 13
• Revisions to streamline questions 1, 2, 3, 6, and 7 for a drug selected for
renegotiation with no revenue to report
• Clarified which agreements between the Primary Manufacturer and Federal
government agencies should be included for drugs selected for renegotiation
• Revision to specify that the instruction related to research and development
(R&D) costs incurred on or before the last date of the Primary
Manufacturer’s original full submission of section 1194(e)(1) data applies to any
Primary Manufacturers of drugs originally selected for negotiation
for initial price applicability years 2026 or 2027 only
• Addition of instructions to specify the time period of data requested for
drugs originally selected for negotiation for the drugs selected for the most
recent prior initial price applicability year (which is initial price applicability year
2028)
• Deleted “inhaler” from the list of examples for the NCPDP BUS unit of EA in
Question 13

2

Location of Edits

Summary of Changes
(Included in Final)

Type of
Change

• Addition of instructions that, in cases where the NCPDP Unit is “EA,” to specify
the unit of measure represented by one “EA” in the Explanation of Unit
response in Questions 13 and 23
Section F

• Revisions to the response format for Questions 9A, 9B and 10 to accommodate
text responses in the patent type
• Addition of Question 12 regarding the predicted loss of exclusivity for the
selected drug

Section G

Modify
• Revisions to the numbering of questions throughout the section
• Revisions to the instructions for reporting Average Sales Price (ASP) in response
to Question 14 when a drug is not payable under Part B
• Addition of Question 27 regarding the payer mix of prescriptions for the selected
drug by indication
• Addition of Question 28 to report the agreed-to maximum fair price of the
selected drug from the original negotiation
• Revisions to definitions in Section G to clarify meaning of “Manufacturer
Medicare Part D average net unit price” and “Manufacturer Medicare Part D
average net unit price – best"
• Revisions to instructions for certification to include “Authorized Representative” Modify
as defined in the final rule
Modify
• Revisions to streamline General Instructions for Section I
• Revisions to individual question instructions to include references to supporting
citations as applicable
• Clarifying revisions to question prompts for Questions 31, 32, 33, 34, 40, 41, 45,
46, 48, 52
• Addition of Question 35 to report medical needs related to condition(s)

Section H
Section I

Modify

Explanation of
Changes
and (f)(4) of the
Act;
Changes in
response to
comments
Revisions
consistent with the
statutory
requirements at
sections 1192(e)(1)
and (f)(4) of the
Act; Changes in
response to
comments;
Technical changes
Changes due to
internal or
administrative
review; Changes in
response to
comments

Burden
Change
(Yes/No)

Yes (regarding
addition of
question only)

Yes (regarding
addition of
questions
only)

Technical update

No

Revisions
consistent with the
statutory
requirements at
section
1194(e)(2)(A);
Technical updates

Yes (regarding
addition of
questions
only)

3

Location of Edits

Summary of Changes
(Included in Final)

Type of
Change

Explanation of
Changes

Burden
Change
(Yes/No)

Modify

Revisions
consistent with the
statutory
requirements at
section 1194 of the
Act

Yes

Modify

Technical updates

No

Modify

Technical updates

No

Modify

Technical updates

No

• Addition of Question 55 to request therapeutic advance and unmet medical
need from researcher respondents
• Addition of costs associated with therapeutic alternatives for Question 41
• Removed redundant footnote 46
ICR Form – Temporary Floor for Small Biotech Drugs
Throughout

•

Addition of the form pursuant to section 1194 of the Act

ICR Form – Counteroffer Process
Throughout

•
•

Instructions

•
•

Question 2

•
•

Updated references to reflect policies codified in the final rule
Revisions to update calendar year references to include placeholder dates
applicable to the collection of information for each initial price applicability year
(e.g., 20XX) and/or references to terms in the final rule (e.g., calendar year prior
to the selected drug publication date for the applicable initial price applicability
year)
Revisions to the instructions to clarify submission requirements for citations and
visual representations
Revisions to instructions for certification to include “Authorized Representative”
as defined in the final rule
Revisions to Question 2 to remove the response field for submission of citations
and visual representations
Addition of Question 3 and 4 for submission of citations and visual
representations, respectively

*Question numbering matches final document.

4