Crosswalk (60day changes)

Small Biotech and Biosimilar Delay ICR Crosswalk of Changes Between IPAY 2026 Final1 and IPAY 2027 60-Day Documents
Location of Edits

Summary of Changes (Included for 60day Comment Period)

Type of
Change

Explanation of Changes

Burden Change
(Yes/No/Not Applicable
(N/A) 2)

•

Add

Administrative decision to
streamline review of PRA
renewals of this notice

N/A

Supporting Statement – Part A
Introduction

•

Throughout (Small Biotech)

•

•

Addition of an Introduction to clarify
that OMB 0938-1443 will include the
Biosimilar Delay Information
Collection Request Form as well for
initial price applicability year 2027
Revisions to the applicability date of
this statement to initial price
applicability year 2027
Addition of language to capture the
statutory requirement regarding
limitation of the small biotech
exception to an acquiring entity that
is not a specified manufacturer as of
12/31/21, effective in the case of an
acquisition before 2025, effective
January 1, 2025
Reordering of questions to
accommodate questions related to
the limitation

Technical Update

Add/Modify Additions to address statutory
requirement at section
1192(d)(2)(B)(ii) of the Social
Security Act (the Act)

N/A

1

The IPAY 2027 Biosimilar Delay ICR Form was included as Appendix B in the Medicare Drug Price Negotiation Program: Revised Guidance, Implementation of Sections 1191 –
1198 of the Social Security Act for Initial Price Applicability Year 2026, available at https://www.cms.gov/files/document/revised-medicare-drug-price-negotiation-programguidance-june-2023.pdf.
2
N/A is listed under burden change when the revision is not a substantive revision to the information collection.

1

Location of Edits

Summary of Changes (Included for 60day Comment Period)

Type of
Change

Explanation of Changes

Throughout (Biosimilar Delay)

•

Add

Administrative decision to
streamline review of PRA
renewals of this notice

Justification, Information Collected
and Federal Register/Outside
Collection

•

Modify

N/A

Justification, Burden Estimates

•

Modify

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions
Technical Update

Modify

Technical Update

N/A

•

Justification, Cost to Federal
Government (Small Biotech)

•
•

Addition of language to capture the
inclusion of an information collection
request from a Biosimilar
Manufacturer for CMS’ consideration
to delay of a negotiation-eligible drug
that includes the reference product
for the Biosimilar drug on the
selected drug list for initial price
applicability year 2027
Revisions to information requested
from a Submitting Manufacturer to
align with Information Collection
Form revisions to Questions 2 and 3
Revisions to wages to incorporate
May 2023 Bureau of Labor Statistics,
Occupational Employment Statistics,
National Occupational Employment
and Wage Estimates
Revisions to hours to include time for
technical assistance in form(s)
completion
Revisions to hourly wages to
incorporate the 2024 general pay
schedule
Revisions to hourly estimates of a GS13 Federal employee providing
technical direction to a contractor to
maintain the existing information
technology system for this tool that
was built for the initial year of
approval of this OMB form

Burden Change
(Yes/No/Not Applicable
(N/A) 2)
Yes

N/A

2

Location of Edits

Summary of Changes (Included for 60day Comment Period)

Information Collection Request (ICR) Forms
Introduction
• Addition that OMB 0938-1443 will
include the Biosimilar Delay
Information Collection Request Form
as well for initial price applicability
year 2027

ICR Form – Small Biotech
Throughout

•

Instructions

•

•

Revisions to the applicability date of
this statement to initial price
applicability year 2027
Addition of language to capture the
statutory requirement regarding
limitation of the small biotech
exception to an acquiring entity that
is not a specified manufacturer as of
12/31/21, effective in the case of an
acquisition before 2025, effective
January 1, 2025
Revisions to information requested
from a Submitting Manufacturer to
align with Information Collection
Form revisions to Question 3 (e.g., 11digit National Drug Codes)

Type of
Change

Explanation of Changes

Burden Change
(Yes/No/Not Applicable
(N/A) 2)

Add

Administrative decision to
streamline review of PRA
renewals of this notice

N/A

Modify

Technical Update

No

Add

Additions to address statutory
requirement at section
1192(d)(2)(B)(ii) of the Social
Security Act (the Act)

Yes

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions

3

Location of Edits

Summary of Changes (Included for 60day Comment Period)

Question 2a and b

•

•
Previous Question 3

•

Reordering of remaining questions

•

Certification

•

Addition of new Question 2a
determine if the Submitting
Manufacturer was acquired after
2021 to align with the statutory
limitation at section 1192(d)(2)(B)(ii)
of the Act
If so, addition of Question 2b to
identify the acquiring entity
Removal of previous Question 3
(NDC-11s)

Type of
Change

Explanation of Changes

Additions to address statutory
requirement at section
1192(d)(2)(B)(ii) of the Social
Security Act (the Act)

Modify

Burden Change
(Yes/No/Not Applicable
(N/A) 2)
Yes

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions
Technical Update

Yes

Reordering of Questions 3-4 to
accommodate revisions to previous
and new Questions 2 and 3
Addition of signatory identifying
information to align with the
Biosimilar Delay

Modify

No

Add

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions

No

Revisions to introductory language to
include the information collection
form for a biosimilar delay submission
for initial price applicability year 2027
for OMB PRA approval
Revisions to the applicability date of
this statement to initial price
applicability year 2027
Addition of instructions regarding
HPMS user access and deadline for
initial price applicability year 2027

Modify

Administrative decision to
streamline review of PRA
renewals of this notice

N/A

Modify

Technical Update

No

Modify

Technical Update to use the
HPMS tool for initial price
applicability year 2027
submissions

No

ICR Form – Biosimilar Delay
Introduction

•

Throughout

•

Instructions

•

4

Location of Edits

Summary of Changes (Included for 60day Comment Period)

Type of
Change

Explanation of Changes

Questions, throughout

•

Modify

Technical Update

Question 1

•

Revisions to format table options and
documentation submission
mechanism for HPMS in lieu of a
fillable PDF and Box file uploads
Removal of “Entity Type”

Modify

Yes

Question 2

•

Modify

Question 3

•

Modify

Technical Update

Yes

Question 4

•

Revised “Product Name” to
“Biosimilar Name”
Revisions to “Approval Date” column
to allow a respondent to specify the
date for each type of “Application
Status” in the column prior
Revised “Product Name” to
“Reference Product”
Removal of “Active Ingredient” and
“NDC-9s”

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions
Technical Update

Modify

Technical Update

Yes

•

Question 5

•

Removal of “Entity Type”, “EIN”,
“Address”, “P number” and “Labeler
Code”

Modify

Question 9

•

Instructions added to clarify Option C
or D selections

Modify

Question 11

•

Revisions to the instructions when
Option C or D is selected

Modify

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions
Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions
Policy changes based on lessons
learned from initial price
applicability year 2026
submissions
Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions

Burden Change
(Yes/No/Not Applicable
(N/A) 2)
No

No

Yes

No

No

5

Location of Edits

Summary of Changes (Included for 60day Comment Period)

Type of
Change

Explanation of Changes

Questions 12-14

•

Modify

Policy changes based on lessons
learned from review of initial
price applicability year 2026
submissions

Addition of a request for explanation
when no supporting documentation is
available

Burden Change
(Yes/No/Not Applicable
(N/A) 2)
Yes

6