Crosswalk (60day to 30day)

Drug Price Negotiation Process ICR Crosswalk of Changes Between 60-Day Notice and 30-Day Notice
Summary of Changes (Following
60-day Comment Period)

Location of Edits i
Supporting Statement
(Background and
Justification)

•

•
Supporting Statement
(throughout) and ICR
Form (throughout)
Supporting Statement
(Background) and Drug
Price Negotiation
Process ICR Form
(hereinafter, “ICR
Form,” (Introduction))

•

•

Supporting Statement
(throughout) and ICR
Form (throughout)
Supporting Statement
(Background) and ICR
Form (Introduction)
1

•

Modified the “Background” and
“Justification” headers to “A.
Background” and “B.
Justification” for organization
Revised language around the 10
high expenditure, single source
drugs covered by Medicare Part
D that will be selected for
negotiation to align with the
revised guidance 1
Revised language around when
the negotiation period starts for
initial price applicability year
2026
Removed references to the initial
guidance and “Negotiation Data
Elements” Information
Collection Request. Replaced
with references to the revised
guidance.
Revised language around the
goal of the offer and counteroffer
process to align with the revised
guidance

Type of
Change
Modify

Explanation of Changes
Changes due to internal or
administrative review

Impact to Burden
None

None
Modify/Add

Changes due to internal or
administrative review,
including guidance review
None

Modify

Changes due to internal or
administrative review,
including guidance review
None

Modify/Add

Changes due to internal or
administrative review,
including guidance review

Modify/Add

Changes due to internal or
administrative review,
including guidance review

https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation

None

Summary of Changes (Following
60-day Comment Period)

Location of Edits i
Supporting Statement
(Background) and ICR
Form (Introduction)

•

Supporting Statement
(Background)

•

Supporting Statement
(Need and Legal Basis)

•
•

Supporting Statement
(Information Users)

•
Supporting Statement
(Use of Information
Technology)
•
Supporting Statement
(throughout) and ICR
Form (throughout)

Revised language detailing the
negotiation process after the
written initial offer to align with
the revised guidance
Added information on what the
Counteroffer Form will collect
Clarified that the written initial
offer for the MFP is for a
selected drug
Revised language to state that
CMS will use information
submitted by Primary
Manufacturers and other
interested parties to seek to reach
agreement on an MFP for a
selected drug
Added language saying that the
Drug Price Negotiation Process
ICR Form will be available and
must be submitted in the CMS
Health Plan Management System
(HPMS)
Revisions to refer to “the CMS
HPMS” when discussing the
system where Primary
Manufacturers will submit
information, in alignment with
the revised guidance

Type of
Change

Explanation of Changes

Modify/Add

Changes due to internal or
administrative review,
including guidance review

Add

Changes due to internal or
administrative review

Add

Changes due to internal or
administrative review

Impact to Burden
None

None
None
None

Add

Changes due to internal or
administrative review

None
Add

Changes due to internal or
administrative review
None

Modify

Changes due to internal or
administrative review,
including guidance review

Summary of Changes (Following
60-day Comment Period)

Location of Edits i
Supporting Statement
(Small Business)
Supporting Statement
(Special Circumstances)
Supporting Statement
(Footnote 3)
Supporting Statement
(Footnote 4)
Supporting Statement
(Federal
Register/Outside
Consultation)
Supporting Statement
(Federal
Register/Outside
Consultation)
Supporting Statement
(Payments/Gifts to
Respondents)

•
•

•

•

Added a citation to the statute
when discussing the small
biotech exception
Revised language around how
proprietary information would be
protected from disclosure to
align with the revised guidance
Updated footnote language
regarding the Small Biotech
Exception ICR to reflect that it
was approved
Added a footnote to a DOJ
webpage around data disclosure
and FOIA

Type of
Change

Explanation of Changes

Add

Changes due to internal or
administrative review

Modify

Changes due to internal or
administrative review,
including guidance review

Modify

Changes due to internal or
administrative review

Add

Changes due to internal or
administrative review

Impact to Burden
None
None

None

None
None

•

Replaced placeholders with the
date and Federal Register citation Add
for the 60-day package

•

Added a summary of the
comments received during the
60-day comment period

•

Removed language around excise
Modify
tax liability

Changes due to internal or
administrative review

Supporting Statement
(Confidentiality)

•

Supporting Statement
(Footnote 5)

•

Updated confidentiality language
to reflect policy in the revised
guidance
Updated footnote links to DOJ
documents on FOIA Exemptions

Changes due to internal or
administrative review,
including guidance review
Changes due to internal or
administrative review

Technical update
None

Add

Modify
Modify

Technical update
None
None
None

Summary of Changes (Following
60-day Comment Period)

Location of Edits i
Supporting Statement
(Burden Estimate)

•
•

•
Supporting Statement
(Burden Estimate)

•
•

•

Supporting Statement
(Changes to Burden)

•

Type of
Change

Clarified when a Primary
Modify
Manufacturer must submit the
Counteroffer Form
Updated the time and cost burden
estimate for a Primary
Manufacturer to develop and
submit a counteroffer
Updated the source of the wage
estimates used for burden
calculations; industry-specific
wage estimates were used when
Modify
available
Added statutory references for
the initial offer and counteroffer
process
Updated the list of roles
accounted for the burden
estimate to prepare and submit
the Counteroffer Form
Added language saying that the
burden estimate for Primary
Manufacturers developing and
submitting a counteroffer was
modified
Add
Updated the source of the wage
estimates used for burden
calculations; industry-specific
wage estimates were used when
available

Explanation of Changes
Changes due to internal or
administrative review

Impact to Burden
None
None

Changes due to internal or
administrative review;
Changes in response to
comments

None
Changes due to internal or
administrative review;
Changes in response to
comments

Summary of Changes (Following
60-day Comment Period)

Location of Edits i
•

•
ICR Form (Instructions)

•

•
ICR Form (Instructions)

•

ICR Form (Instructions)

•

Revised language on what the
counteroffer justification should
entail to align with the revised
guidance
Added language on possible
sources for 1194(e) data,
including the Primary
Manufacturer’s October 2, 2023
data submission, other interest
parties’ October 2, 2023 data
submission, and information
otherwise available and
considered by CMS
Added counteroffer justification
instructions on the revised word
limit and new fields to upload
supporting information and
include citations
Added instructions on how
Primary Manufacturers should
input the counteroffer price as a
30-day equivalent supply of the
selected drug
Added language on how CMS
will review information
submitted for use of costeffectiveness measures
Added instructions on how
Primary Manufacturers should
use new fields added to the form

Type of
Change

Explanation of Changes

Impact to Burden
None

Modify/Add

Changes due to internal or
administrative review,
including guidance review

None

Add

Changes in response to
comments

Add

Changes due to internal or
administrative review

None

Summary of Changes (Following
60-day Comment Period)

Location of Edits i

ICR Form (Form,
Introduction)

•
•

•

ICR Form (Question 2)

•

•
ICR Form (Question 3)

•

that indicate if information
submitted uses cost-effectiveness
measures
Revisions for clarity, an updated
statutory citation, and to align
with the revised guidance
Clarified how CMS will interpret
the single counteroffer for the
MFP submitted by Primary
Manufacturers
Added that CMS will provide
information on computation of
how CMS will apply a single
MFP across dosage forms and
strengths of the selected drug in
advance of the initial offer,
which Primary Manufacturers
can use to see how a single MFP
would apply to different dosage
forms and strengths
Streamlined language for clarity
and to align with the revised
guidance
Updated the word limit for the
counteroffer justification
Added a field where Primary
Manufacturers may upload
information to support the
counteroffer justification

Type of
Change

Modify

Explanation of Changes

Changes due to internal or
administrative review

Impact to Burden

None
None

Add

Add

Changes due to internal or
administrative review,
changes in response to
comments

Changes in response to
comments, changes due to
internal or administrative
review

Moderate, accounted for in
increased burden estimate.
Respondents will upload
supporting documents and
citations in addition to their
justification. Respondents

Summary of Changes (Following
60-day Comment Period)

Location of Edits i
•
•
•

ICR Form (PRA
Disclosure Statement)

i

•

Added a field for citations
Added questions to determine if
any information submitted uses
cost-effectiveness measures
Streamlined language for clarity
and to align with the revised
guidance
Updated the burden estimate to
develop and submit a
counteroffer

Type of
Change

Explanation of Changes

Impact to Burden
will review information
submitted for use of costeffectiveness measures and
attest accordingly

Changes in response to
comments

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

None