Crosswalk (60day changes)

Negotiation Program Drug Selection for Initial Price Applicability Year 2028
under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR):
Crosswalk of Changes Between Initial Price Applicability Year 2027 Final ICR and Initial Price Applicability Year 2028 60-Day ICR Documents
Location of Edits

Summary of Changes
(Included for 60-day Comment Period)

Type of
Change

Explanation of Changes

Burden Change (Yes/No)

•

Add/Modify Technical updates related to
updating program guidance
references; Revisions and
additions to address statutory
requirements at sections
1192(d)(2)(A) and 1194(f) of the
Social Security Act (the “Act”)

Yes

Add/Modify Technical update

No

Supporting Statement – Part A
Throughout

•

•
•
Federal Register

•

Revisions to incorporate reference to
the Medicare Drug Price Negotiation
Program: Draft Guidance,
Implementation of Sections 1191 –
1198 of the Social Security Act for
Initial Price Applicability Year 2028
and Manufacturer Effectuation of the
Maximum Fair Price (MFP) in 2026,
2027, and 2028 (hereinafter, the
“draft guidance”)
Revisions to address the inclusion of
the Identification and Selection of
Renegotiation-Eligible Drugs ICR Form
within this package
Revisions to address the inclusion of
drugs payable under Part B for small
biotech exception (SBE) requests
Revisions to align with the draft
guidance
Revisions to capture that the initial
price applicability year 2028 materials
are being published for a new 60-day
comment period

1

Location of Edits

Summary of Changes
(Included for 60-day Comment Period)

Burden Estimates

•

•
•

•

Changes to Burden

•

Type of
Change

Modify
Revisions to the SBE manufacturer
burden estimate, including for
manufacturers with drugs payable
under Part B
Revisions to the Biosimilar Delay
government burden estimate
Addition of burden estimates to
capture the inclusion of the
Identification and Selection of
Renegotiation-Eligible Drugs ICR Form
for initial price applicability year 2028,
including a request for public
comment regarding the ICR Form
instructions on the time period of the
data requested
Updated government burden
estimate to account for 2025 salary
and benefits data
Add/Modify
Addition of language to capture
revisions in the 60-day package

Explanation of Changes

Burden Change (Yes/No)

Technical updates; Revisions to
capture burden changes related
to ICR Form revisions within the
Centers for Medicare &
Medicaid Services Health Plan
Management System (the “CMS
HPMS”) module; Additions to
address statutory requirements
at sections 1192(d)(2)(A) and
1194(f) of the Act

Yes

Technical update

No

Information Collection Forms
Throughout

•

Revisions to incorporate reference to
the draft guidance

Modify

Technical update

No

•

Revisions to update the CMS HPMS
technical access materials
Revisions to address the inclusion of
drugs payable under Part B for SBE
requests

Add/Modify Technical update; Revisions and
additions to address statutory
requirements at section
1192(d)(2)(A) of the Act

No

Small Biotech Exception
Instructions

•

2

Location of Edits

Summary of Changes
(Included for 60-day Comment Period)

Section A

•

•
•
Section B

•
•
•

Section C

•

Section D

•

•

Type of
Change

Modify
Revisions to separate questions that
are applicable to both drugs payable
under Part B and covered under Part
D
Technical revisions to clarify terms
used in Questions 1-3
Removal of collection of “labeler
code” in Questions 1 and 2
Modify
Revisions to separate questions
specific to drugs covered under Part D
and renumbering of questions
Addition of instructions for section
Technical revisions to the collection of
“labeler code(s)” in Questions 4 and 5
Revisions to add questions specific to Modify
drugs payable under Part B

Addition of attestation that the
individual completing the ICR form is
authorized to make the request for
the Submitting Manufacturer
Addition of language to identify the
statutory authority for civil monetary
penalties (CMPs) pertaining to false
information

Modify

Explanation of Changes

Burden Change (Yes/No)

Technical updates; Revisions to
address statutory requirement
at section 1192(d)(2)(A) of the
Act; Administrative changes
based on lessons learned from
review of initial price
applicability year 2027
submissions
Technical updates

Yes

Additions to address statutory
requirement at section
1192(d)(2)(A) of the Act first
relevant for initial price
applicability year 2028
Administrative change based on
lessons learned from review of
initial price applicability year
2027 submissions; Technical
update

Yes

No

No

Biosimilar Delay

3

Location of Edits

Summary of Changes
(Included for 60-day Comment Period)

Type of
Change

Explanation of Changes

Burden Change (Yes/No)

Instructions

•

Revisions to update the CMS HPMS
technical access materials
Clarification that character counts
include spaces
Revision to make the request for
information related to Biologics
License Application (BLA) singular
instead of plural to conform with
statutory language regarding the
application for the Biosimilar (see
section 1192(f)(1)(A) of the Act)
Removal of labeler code as a field for
identifying information

Modify

Technical updates

No

Modify

No

Revisions to request a singular BLA
application submission information
Addition of instructions to move to
Question 10, only if the Biosimilar
Manufacturer selects Option A in
Question 9
Removal of two columns from the
table in Question 3 asking if licensing
and marketing were planned prior to
February 1 of the applicable year
Removal of Option C in Question 10
that would state that the Biosimilar
Manufacturer does not expect the
Biosimilar to be marketed by
February 1 of the applicable year
Revisions to Option B in Question 10
to provide the option to state that the
Biosimilar has not yet been marketed

Modify

Administrative change based on
lessons learned from review of
initial price applicability year
2027
Technical updates

Modify

Technical updates

Yes

Modify

Administrative change based on
lessons learned from review of
initial price applicability year
2027, the information
requested in the prior version
was conclusory and duplicative
of more detailed information
sought with respect to the high
likelihood of marketing prior to
the statutory deadline

No

•
•

Question 1

•

Question 3 and 5 and Certification

•

Question 9

•

Questions 3 and 10

•

•

•

No

4

Location of Edits

Summary of Changes
(Included for 60-day Comment Period)

Type of
Change

Explanation of Changes

Burden Change (Yes/No)

Question 12

•

Modify

Technical update

No

Section 4

•

Inclusion of explanation of supporting
documentation
Addition of an attestation that the
individual completing the ICR form is
authorized to make the request for
the Biosimilar Manufacturer
Addition of language to identify the
statutory authority for CMPs
pertaining to false information

Modify

Administrative changes based
on lessons learned from review
of initial price applicability year
2027; Technical update

No

Addition of instructions and questions
that a Primary Manufacturer may
voluntarily provide to CMS for
consider in CMS’ identification and
selection of renegotiation-eligible
drugs for initial price applicability year
2028

Add/Modify Additions to address statutory
requirements at section 1194(f)
of Act first relevant in initial
price applicability year 2028

Yes

•

Selection of Renegotiation-Eligible Drugs
Throughout

•

5