Crosswalk

Negotiation Data Elements ICR Crosswalk of Changes Between 60-Day Notice and 30-Day Notice
Location of Edits i

Summary of Changes (Following
60-day Comment Period)

o

Supporting Statement
(throughout), Negotiation Data
Elements ICR Form (hereinafter,
“ICR Form” (throughout))

Revisions to terminology, for
consistency with the revised
program guidance issued
concurrently with the 30-day
comment period, including:
o Section B: Clarified
definition of non-FAMP
and added definition of
non-FAMP dosage form
unit;
o Section C, Question 2
definition: Clarified that
the basic pre-clinical
research period is
determined in reference
to each indication of the
selected drug;
o Section C, Question 3
definition: Broaden and
clarified direct costs that
should be included in
post-IND costs;
o Section C, Question 4
definition: Added
definition of therapeutic
class for purposes of
reporting costs of failed
or abandoned products

Type of Change

Explanation of Changes

Modify / Add

Technical changes to be
consistent with policy changes in
response to comments and / or
due to internal or administrative
review, including guidance review

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
related to the selected
drug.
o Section C, Question 6
definition: Moved
definitions of U.S. net
revenue from Section G;
added questions,
instructions, and
definitions for 6a and 6b.
o Section F: Modified
language in patent and
exclusivity definitions and
clarified types of FDA
applications and
approvals about which
CMS is seeking
information;
o Section G: Clarified
patient assistance
programs to explain
definition; removed
certain definitions (e.g.,
340B ceiling price, 340B
prime vendor program
price, covered entity,
quarterly total U.S. unit
volume, manufacturer
average net unit price);

Type of Change

Explanation of Changes

Location of Edits i

Summary of Changes (Following
60-day Comment Period)

o
o

o

o
o

o

o

and removed definition
of gross revenue;
Section G: Added
footnote to Big Four price
definition;
Section G, Question 16:
Changed reporting for
WAC from NDC-9 to NDC11;
Section G, Questions 2425: Changed reporting for
U.S. commercial average
net unit price from NDC-9
to NDC-11;
Section H, Question 28:
Added definition of
therapeutic alternative;
Section H, Question 29:
Added definitions of
therapeutic alternative,
outcomes, and patientcentered outcome;
Section H, Question 30:
Added definition of
specific populations and
health equity; and
Section H, Question 31:
Revised definition of
unmet medical need.

Type of Change

Explanation of Changes

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

Supporting Statement
(Justification)

•

•
Supporting Statement (Federal
Register)

Supporting Statement (Cost to
the Federal Government,
Changes to Burden)
ICR Form (throughout)

•

•

Type of Change

Explanation of Changes

Moved location of
information required by the
Primary Manufacturer, added
data factors CMS will
consider in negotiating a
maximum fair price and
removed inapplicable
examples, revised language
to be consistent with
guidance revisions
Updated language regarding
submission methods to be
consistent with guidance
revisions

Modify / Add

Changes due to internal or
administrative review, including
guidance review

Revised language consistent
with publishing a revised
package for a 30-day public
comment period and for
added specificity

Add

Technical update

Revised federal burden
estimate to include the cost
for modifications to the CMS
HPMS system to include this
ICR

Modify

Changes due to internal or
administrative review

Revised section lettering and
question numbering

Modify

Technical changes to be
consistent with policy changes in
response to comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

ICR Form (General Instructions)

ICR Form (General Instructions)

•

•
ICR Form (General Instructions)

•
ICR Form (General Instructions)
•
ICR Form (Section A, Instructions
and Questions)

ICR Form (Section B, Instructions
and Question)

•

•
ICR Form (Section C, Instructions)

Revised formatting of
sections and language to
clarify submission method for
the public
Removed references to
questions removed from this
ICR in Section G
Modified language about
calculating and reporting
monetary values consistent
with the ICR and generally
accepted accounting
principles
Revised instructions for
Primary Manufacturers to not
adjust any reported dollar
amounts for inflation
Revised instructions and
questions to explain that CMS
will pre-populate certain
information for NDC-11s and
ask Primary Manufacturers to
supplement as applicable
Revised instructions and
table to include submission of
dosage form unit
Revised introductory
language and instructions to
match revisions made to
questions

Type of Change

Explanation of Changes

Modify

Technical update

Modify

Policy change in response to
comments

Modify

Technical changes to be
consistent with guidance and
external review

Modify

Policy change in response to
comments

Modify / Add

Technical changes to be
consistent with guidance and
external review

Modify

Policy change in response to
comments

Modify

Policy change in response to
comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

ICR Form (Section C, Question 1)
•

ICR Form (Section C, Questions 3
and5)

ICR Form (Sections C and E,
Questions 3, 5, and 10)

•

ICR Form (Section C, Question 5)

•
•
•

ICR Form (Section C, Questions 6,
6a, and 6b)
•

Type of Change

Moved and modified
definition, questions, and
Modify/Revise
instructions for reporting of
acquisition costs from Section
G to new question 1
Revised “Post-Investigational
New Drug (IND) Application
Costs” to include “Completed
U.S. FDA-Required Postmarketing Trials” and “Other
Modify
R&D Direct Costs” to include
other post-marketing trials
and clarified how “all other
R&D direct costs” should be
reported
Increased word limit because
multiple questions were
combined
Added definition and
instructions
Split question 6 into two
components: 6a and 6b
Revised to add information
previously in Section G to
questions 6, 6a and 6b
regarding global and U.S. net
revenue metrics
Revised reporting of U.S. net
revenue from quarterly to
lifetime

Explanation of Changes

Policy change in response to
comments

Policy change in response to
comments

Modify

Technical update

Modify

Change due to internal or
administrative review

Modify / Add

Policy change in response to
comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

ICR Form (Section D)

ICR Form (Section D)

•
•

ICR Form (Section E, Instructions)

•

•
ICR Form (Section E, Questions 9,
10)

ICR Form (Section F, Instructions)

•

•
ICR Form (Section F, Question
12)

Revised manufacturer
submission of production and
distribution costs from NDC-9
to NDC-11 (CMS will
aggregate multiple NDC-11s
to NDC-9s)
Added description of
“labeling”
Revised to clarify how
indirect costs should be
considered
Revised to describe how
responses to questions 9-11
should be calculated
Revised language to include
all funding in question 9 and
to specify sources of the
funding in question 10
Revised description of
relevant time period for
reporting patent information
Revised example language to
illustrate the types of patents
and patent applications
about which CMS seeks
information and modified
response format for pending
patent applications

Type of Change

Explanation of Changes

Modify

Policy change in response to
comments

Add

Changes due to internal or
administrative review

Modify / Add

Changes due to internal or
administrative review

Modify

Policy change in response to
comments

Modify

Policy change in response to
comments

Modify/Add

Policy change in response to
comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

ICR Form (Section F, Question
13)

ICR Form (Section F, Question
12)

•

•
ICR Form (Section F, Question
14)

•
ICR Form (Section F, Question
15)
•
ICR Form (Section F, Question
15)

•
ICR Form (Sections H-J

Revised language to clarify
that manufacturers should
describe patents for the
selected drug that are listed
in the FDA Orange or Purple
Book
Added example for
submission of information on
the purpose of a patent
Revised language to clarify
that exclusivities are
statutory and that FDA has
not determined the first
licensure for each 351(a)biological product in the
Purple Book
Added language for
manufacturers to submit any
efficacy supplements that
have been approved or are
pending FDA approval
Removed column for
manufacturers to enter
submission number and
modified response format for
application status and
classification code
Moved Certification of
Submission of Sections A
through G (formerly Section I)
to follow section G; moved

Type of Change

Explanation of Changes

Modify

Technical change in response to
comments

Modify/Add

Technical change in response to
comments

Modify

Technical change in response to
comments

Modify/Add

Policy change in response to
comments

Modify

Technical change in response to
comments; Change due to
internal or administrative review

Modify

Technical changes due to internal
or administrative review

Location of Edits i

Summary of Changes (Following
60-day Comment Period)

•
ICR Form (Section H)
•
ICR Form (Section I, Question 26)
•

•
ICR Form (Section I, Instructions
for Questions 27-31)
•
•

Evidence on Alternative
Treatments (formerly Section
H) to section I
Revised language to clarify
which individuals of the
Primary Manufacturer are
eligible to certify the data
submission
Revised language to capture
additional types of
respondents, including
researchers and caregivers
Revised language to clarify
evidence and documentation
requirements if evidence
includes or is related to
qualify-adjusted-life-years
(QALYs)
Added language to clarify
evidence and documentation
requirements if evidence is
related to cost-effective
measures
Clarified instructions
regarding use of citations
Added instructions pertaining
to caregivers who may
respond to questions in
Section H

Type of Change

Explanation of Changes

Modify

Changes due to internal or
administrative review

Modify

Technical change in response to
comments

Modify / Add

Policy change in response to
comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•

•

ICR Form (Section I, Instructions
for Questions 27-31)

•

•
ICR Form (Section I, Question 27)

ICR Form (Section I, Questions
28-30)

ICR Form (Section I, Questions
27-30)
ICR Form (Section I, Question 28)

•

•

•

•

Added instructions regarding
the permissible submission of
visual representations
Removed duplicate bullet
regarding instructions for
submission of materials
Added clarification of
question instructions for
unpublished material,
citations and visual
representations of
information
Added clarification of
question instructions for offlabel uses
Removed submission of FDA
labels, as CMS is able to view
this information
Added ability to submit visual
representation of
information (e.g.,
charts/tables/graphs)
Added language to checkbox
clarifying that the response
also includes measures used
in the evidence submitted
Clarified language regarding
outcome information
requested

Type of Change

Explanation of Changes

Modify

Technical change due to internal
review

Add / Modify

Policy change in response to
comments
Technical change due to internal
review

Add / Modify

Policy change in response to
comments

Add

Changes due to internal or
administrative review

Modify / Add

Policy change in response to
comments

Location of Edits i

Summary of Changes (Following
60-day Comment Period)
•
•

•
ICR Form (Section I, Question 29)
•
ICR Form (Section I, Question 30)

•
•

ICR Form (Section I, Question 31)

•

ICR Form (Section I, Question 32)

Added language requesting
key outcomes and
explanation of selection
Added language regarding
risks, harms, side effects or
unique scenarios or
considerations of the drug or
therapeutic alternative
Revised to clarify individuals
who are terminally ill and
request explanation of
specific populations noted
Added question regarding
health equity considerations
Added a question regarding
unmet medical need
Added a new question and
corresponding instructions to
capture patient and caregiver
experiences related to the
selected drug and/or
therapeutic alternatives
Added a new question
(required for manufacturers;
optional for the public—
except not permitted for
patients/caregivers) for
submission of an executive
summary of information
provided in response to
questions 27-30

Type of Change

Explanation of Changes

Modify / Add

Policy change in response to
comments

Add

Policy change in response to
comments

Add

Policy change in response to
comments

Add

Policy change in response to
comments

Location of Edits i

ICR Form (Section J)

i

Summary of Changes (Following
60-day Comment Period)
•

Type of Change

Revised certification language
Modify
for submissions of data in
response to Section I

References to section and question numbers reflect the lettering and numbering in the revised 30-day notice.

Explanation of Changes
Policy change in response to
comments