60-day Response to Comment

Centers for Medicare & Medicaid Services Response to Public Comments Received for
CMS-10849, OMB 0938-NEW
The Centers for Medicare & Medicaid Services (CMS) received 16 timely public submissions
from patient organizations, professional trade associations, pharmaceutical manufacturers,
research organizations, and the general public on the Drug Price Negotiation Process Information
Collection Request (CMS-10849, OMB 0938-NEW) that was issued April 18, 2023 for a 60-day
public comment period. We note that some of the public comments were outside the scope of the
information collection request (ICR). These out-of-scope public comments are not addressed in
this summary and response. Rather, many of the issues raised in these out-of-scope comments
are found in CMS’ responses to the more than 7,500 timely public submissions CMS received in
response to the Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation
of Sections 1191—1198 of the Social Security Act for Initial Price Applicability Year 2026, and
Solicitation of Comments (the “initial memorandum”)1, which was released on March 15, 2023
and open for comment until April 14, 2023. CMS refers commenters to the Medicare Drug Price
Negotiation Revised Guidance (the “revised guidance”)2, which was released on June 30, 2023,
for these responses, which address, among other things, the definition of qualifying single source
drugs; the drug selection process; orphan drugs; Primary and Secondary Manufacturers;
opportunities to submit section 1194(e) data; corrective action process; confidentiality and data
use; data security; transparency; the initial offer and factors considered; 30-day equivalent supply
calculation; methodology for applying the MFP across dosage forms and strengths; CMS’
response to Primary Manufacturer counteroffers; negotiation meetings; public explanation of the
MFP; formulary placement and utilization management; engagement with interested parties;
statutory and agency authority; and broader comments on the structure and impacts of the
Medicare Drug Price Negotiation Program.
This ICR (CMS-10849, OMB 0938-NEW) is being published for a 30-day public comment
period.
Summaries of the public comments that are within the scope of this ICR and responses to those
public comments are set forth in this document under the appropriate heading.
General
Comment: A few commenters expressed concern that they do not have sufficient information on
various elements of the negotiation process to be able to offer comments on the counteroffer
process. One commenter stated that they find it difficult to respond to the counteroffer process
when they do not know what the initial offer, justification, and agreement will look like.
Response: CMS understands commenters’ concerns regarding being able to fully comment on
this ICR. Since the 60-day comment period for this ICR closed, CMS has issued the revised
guidance, the Negotiation Data Elements ICR for a 30-day comment period, and the Medicare

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2

https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf.
https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.

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Drug Price Negotiation Program Agreement.3 These documents will provide a fuller picture of
the negotiation process. Interested parties may submit additional comments on this ICR during
the 30-day comment period.
Data Security for Confidential, Proprietary, and Sensitive Information
Comment: One commenter recommended that CMS consider the safeguards already present
under the Medicaid Drug Rebate Program (MDRP) when determining how to secure proprietary
and sensitive data shared for the counteroffer process.
Response: The MDRP requires users to create their own user ID that cannot be shared and is
verified for identity. MDRP users must also use multi-factor authentication and apply for rolebased access. Like MDRP, the CMS HPMS employs many protocols and procedures for
ensuring appropriate user access to specific sections of the CMS HPMS. An individual must
apply for and obtain a CMS-issued user account and password in order to access the CMS
HPMS. In addition to the CMS-issued user ID and password, internal CMS staff must use a
Personal Identity Verification (PIV) card when accessing the website on the CMS network, while
all users accessing the system from outside of the CMS network must use multi-factor
authentication. The CMS HPMS further employs role-based access, ensuring that each user is
granted access only to those functions required by their position. Each manufacturer is limited to
the data associated with its assigned pending contract “P” number(s), and each manufacturer user
can only perform the functions in the modules that have been approved and assigned, such as
only certain manufacturer users can obtain signatory access to the modules. In addition to the
current numerous privacy and security protections safeguarding sensitive product and pricing
data submitted by manufacturers in the CMS HPMS, CMS is further restricting internal access to
the manufacturer modules to critical, specific personnel for troubleshooting and ensuring
technical support, and restricting internal access to the submitted data to a limited set of users
directly relevant to the drug price negotiation process. Any system outside of HPMS used to
store or analyze any submitted manufacturer data will be required to adhere to all applicable
policies, procedures, controls, and standards required by the HHS/CMS information security and
privacy programs to ensure the confidentiality of the manufacturer information and protect the
integrity of the government information systems.
Comment: One commenter asked CMS to specify how it will protect information that will be
submitted through Box. The commenter requested information on how information will be kept
confidential in Box and protected from misuse by Box staff.
Response: CMS clarifies that Box is mentioned in this ICR as a back-up option to the CMS
HPMS for data submission. CMS will provide technical assistance to manufacturers and other
interested parties submitting information in response to this ICR. CMS does not anticipate
needing to use Box as a back-up as CMS has determined that the CMS HPMS infrastructure and
design should be able to accommodate the business and technical needs of the Drug Price
Negotiation functionality. However, in the event that information needs to be shared via Box,
CMS will provide submission instructions consistent with CMS controls, including password
protection and encryption, and will ensure this process adheres to all applicable policies,
3

https://www.cms.gov/files/document/inflation-reduction-act-manufacturer-agreement-template.pdf.

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procedures, controls, and standards required by the HHS/CMS information security and privacy
programs to ensure the confidentiality, integrity, and availability of manufacturer information
and government information systems.
Comment: A few commenters asked that CMS ensure it has adequate agreements with
contractors and others that will have access to data submitted by manufacturers to properly
safeguard proprietary data.
Response: CMS staff and contractors are subject to all applicable policies, procedures, controls,
and standards required of HHS/CMS information security and privacy programs and
nondisclosure requirements.
Burden Estimate for Primary Manufacturers to Develop and Submit a Counteroffer
Comment: Some commenters indicated that CMS’ burden estimate for manufacturers to
develop and submit a counteroffer was significantly underestimated and requested that CMS
recalculate this amount. Commenters noted that manufacturers will need to review CMS’ initial
offer and justification in addition to developing and submitting their counteroffer, which will
require more time and money than currently estimated. A few commenters also noted that the
burden estimate created concern about the comprehensiveness of CMS’ initial offer justification.
A few commenters also noted that CMS’ burden estimate to review and make a decision on
manufacturer counteroffers was significantly higher than the burden estimate for manufacturers
to develop and submit a counteroffer.
Response: CMS thanks commenters for this feedback. In response to these comments and the
added burden due to policy updates in the revised guidance that provide CMS will aim to share
section 1194(e)(2) data submitted by other interested parties with the Primary Manufacturer of a
selected drug when feasible, CMS revised the burden estimate for the counteroffer development
and submission by increasing the expected time burden from 79 hours per selected drug to 204
hours per selected drug. CMS notes that that CMS’ burden estimate to support the counteroffer
process estimates 2,273 hours for all selected drugs where a counteroffer is submitted. Of these
total hours, 233 are allocated to building the CMS HPMS module for the counteroffer data
submission. After removing these hours for the technical build, CMS estimates it will spend 204
hours on the counteroffer process per selected drug. Revisions to this ICR increase the Primary
Manufacturer burden estimate to reflect CMS’ belief, after reviewing these comments, and
further consideration of the negotiation offer process, that the burden estimate in the initial ICR
was understated. CMS also updated the burden estimate to use wage estimates from the Bureau
of Labor Statistics’ May 2022 National Industry-Specific Occupational Employment and Wage
Estimates for the Pharmaceutical and Medicine Manufacturing industry. Cost estimates were also
updated accordingly in section B, item 12, in the Supporting Statement.
Comment: One commenter noted that it is difficult to provide informed comments on the burden
associated with this ICR because interested parties do not know what CMS will provide in its
initial offer justification.

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Response: CMS thanks the commenter for this note and points the commenter to sections 60.3
and 60.4 of the revised guidance, which detail how the initial offer will be formulated and what
information will be shared in the initial justification.
Counteroffer Form, Justification, and Word Limits
Comment: One commenter expressed concern that the Counteroffer Form does not provide
meaningful insight into how CMS will evaluate drugs or the factors it will consider during the
drug price negotiation process.
Response: CMS thanks the commenter for this comment. Sections 60.3 and 60.4 of the revised
guidance detail how CMS will evaluate selected drugs for purposes of developing an initial offer
and the factors it will consider during the negotiation process.
Comment: One commenter suggested CMS allow manufacturers to submit any information
relevant to the negotiation process as part of the counteroffer and not be restricted to just section
1194(e) information. The commenter also suggested CMS should consider all information
submitted when evaluating the manufacturer’s counteroffer. One commenter also expressed
concern that off-label use of a selected drug for certain conditions may not be considered in the
initial offer and recommended manufacturers be able to submit information on unmet needs, and
other relevant information, in the counteroffer process.
Response: CMS clarifies that Primary Manufacturers are not restricted in the type of information
they can submit, but CMS will focus on section 1194(e) elements when considering the
counteroffer. As described in section 60.4.2 of the revised guidance, the Primary Manufacturer’s
counteroffer justification should focus on the elements described in section 1194(e) and indicate
the reasons the Primary Manufacturer believes that the information submitted by the Primary
Manufacturer on the factors described in section 1194(e)(1) or (e)(2) of the Social Security Act
(the “Act”), or other available data related to the selected drug and its therapeutic alternatives as
described in section 1194(e)(2) of the Act, does not support the written initial offer made by
CMS. Primary Manufacturers may also include in their counteroffer justification new
information regarding the selected drug and its therapeutic alternative(s) as described in section
1194(e)(2) that supports the counteroffer.
Comment: One commenter noted that the ICR does not contemplate a manufacturer response to
feedback from other interested parties on a selected drug. The commenter asked if manufacturers
would be able to review data submissions from other parties and if manufacturers could
incorporate this information into their counteroffer justification.
Response: As discussed in the revised guidance, CMS will share section 1194(e)(2) data
submissions from other interested parties with the Primary Manufacturer of the selected drug
when feasible. These data will be appropriately redacted and will not include proprietary
information, protected health information (PHI) / personally identifiable information (PII), or
information that is protected from disclosure under other applicable law. Primary Manufacturers
may include and/or respond to information from section 1194(e)(2) submissions from other
interested parties, as available, in their counteroffer justifications.
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Comment: One commenter suggested CMS structure the Counteroffer Form to promote
transparent exchange and evaluation of evidence on the value and benefit of selected drugs.
Response: CMS thanks the commenter for this suggestion. The counteroffer justification, with a
now increased word limit of 2,500 words and the ability to submit additional materials to support
the justification (i.e., up to 50 citations and up to 10 tables/charts/graphs), should be used to
provide evidence on the selected drug’s value and clinical benefit.
Comment: Many commenters requested that CMS either increase or eliminate the 1,500-word
limit for counteroffer justifications. Commenters stated that they found the word limit arbitrary,
and that the word limit is insufficient to explain a manufacturer’s rationale for the counteroffer
and would result in manufacturers omitting key information. Commenters also stated that the
complexity and amount of information available around a selected drug makes it challenging to
provide a meaningful justification in 1,500 words. One commenter suggested that CMS eliminate
the word limit for initial price applicability year 2026 and identify a limit for future years if
necessary.
Response: CMS thanks commenters for this suggestion. In response to these comments, CMS
revised this ICR to increase the counteroffer justification word limit from 1,500 words to 2,500
words and has additionally provided for the submission of visual representations of information
(see the comment and response directly below). CMS believes that this increased word limit will
be sufficient for Primary Manufacturers to share key information in support of their counteroffer
as it can be supplemented by these visual representations of information.
Prior to the initial offer and possible counteroffer, Primary Manufacturers would have had the
opportunity to submit longer written submissions about the section 1194(e) factors in the data
submission due on October 2, 2023 and meet with CMS to provide context for their submissions.
These Fall 2023 activities will provide foundational information about the selected drug prior to
CMS’ initial offer and allow Primary Manufacturers to focus on presenting the key, compelling
information to support their counteroffer in the counteroffer justification.
CMS declines to eliminate the word limit for the counteroffer justification as a word limit is
needed due to statutory time constraints in the negotiation process. Pursuant to sections
1191(b)(4)(B) and 1191(d)(2)(B) of the Act, the statutory deadline for the conclusion of
negotiations is August 1, 2024 for initial price applicability year 2026. As discussed in the
revised guidance, following CMS’ initial offer and any Primary Manufacturer counteroffer, the
negotiation process may include up to three post-counteroffer negotiation meetings and a final
offer, as applicable. To allow sufficient time for these processes, CMS must be judicious about
the amount of information Primary Manufacturers may submit in the Counteroffer Form. CMS
believes that the revisions discussed above provide an appropriate balance between affording
Primary Manufacturers the opportunity to share relevant information and ensuring that the
negotiation process can be completed within the statutory time limits.
Comment: Some commenters recommended that the Counteroffer Form should allow
manufacturers to upload studies, charts and tables, key information sources, and supplemental
information to support the counteroffer.
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Response: CMS thanks commenters for their suggestions. After consideration of the comments,
CMS updated this ICR to permit submission of visual representations of information by adding
an option to upload up to 10 tables, charts, and/or graphs alongside the counteroffer justification.
CMS will not consider information uploaded as part of this submission that is not a visual
representation of data, i.e., a table or chart consisting only of text.
30-Day Equivalent Supply Methodology
Comment: One commenter expressed that interested parties could not contribute meaningful
feedback to this ICR without additional information on how CMS will apply a single MFP across
diverse indications with variable unmet needs and varying alternative treatment options.
Response: CMS points the commenter to section 60.5 of the revised guidance, which was
published after this ICR’s 60-day comment period closed, for additional information on the 30day equivalent supply methodology.
Comment: One commenter noted that manufacturers may be unwilling or unable to calculate the
30-day equivalent supply price for a counteroffer as it ties the price to a possible length of
therapy as opposed to a specific dosage form and strength. The commenter suggested that CMS’
initial offer include a price sheet that lists the offered MFP for all, or the highest volume, NDC11s for the selected drug. The commenter further stated that the Counteroffer Form should
include a similar price sheet where the manufacturer may input the expected MFP for each NDC11.
Response: CMS thanks the commenter for this suggestion. CMS will use the single 30-day
equivalent supply approach described in the revised guidance when negotiating the MFP. As
described in section 60.1 of the revised guidance, during the negotiation period, CMS will share
with the Primary Manufacturer the inputs for the methodology CMS will use to translate the
MFP across dosage forms and strengths of the selected drug. This information will be shared so
that the Primary Manufacturer will have visibility into the implied unit prices based on the MFP
for each dosage form and strength throughout the negotiation process (i.e., any offer or
counteroffer that identifies a single price would be clearly translatable to per unit prices at the
dosage form and strength level). As discussed in section 40.5 and 60.4.1 of the revised guidance,
CMS will provide a Primary Manufacturer with information on the computation of how CMS
will apply a single MFP across dosage forms and strengths of the selected drug in advance of the
initial offer. Aligned with this information, CMS will provide MFPs applied at the NDC-9 level
as an attachment to CMS’ initial offer to promote a common understanding of how the single
MFP would translate to each NDC-9 of the selected drug. Primary Manufacturers may use this
information when developing a counteroffer to understand how the counteroffer price per 30-day
equivalent supply will convert into prices by NDC-9. CMS reaffirms that for the counteroffer,
the Primary Manufacturer is expected to submit a counteroffer to the 30-day equivalent supply
MFP proposed by CMS in its initial offer. CMS will not consider alternative MFP methodologies
for each NDC-9 or NDC-11 that are inconsistent with the 30-day equivalent supply approach
described in revised guidance.

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Comment: A few commenters requested that CMS share the MFP for each NDC-9 of the
selected drug in the initial offer. These commenters also asked that CMS provide the total units
dispensed for each NDC-9 of the selected drug in the 2022 Part D Prescription Drug Event
(PDE) data and a tool or spreadsheet detailing CMS’ methodology for applying the 30-day
equivalent supply MFP across different dosage forms and strengths.
Response: CMS thanks commenters for these requests. As discussed in the comment and
response directly above, CMS will share information on the computation of how CMS will apply
a single MFP across dosage forms and strengths of the selected drug in advance of the initial
offer. As described in section 60.1 of the revised guidance, CMS will share inputs on the 30-day
equivalent supply methodology so that the Primary Manufacturer will have visibility into the
implied unit prices based on the MFP for each dosage form and strength throughout the
negotiation process. Therefore, CMS’ initial offer will include, in addition to the initial offer
MFP, an attachment with the MFPs applied across the NDC-9s of the selected drug. CMS
declines to share PDE unit data for each NDC-9 of a selected drug.
Comment: One commenter asked that CMS include a field in the Counteroffer Form where a
manufacturer can include its methodology for calculating the 30-day equivalent supply MFP in
case the methodology is different from CMS’ approach.
Response: CMS declines to include a field in the Counteroffer Form where a Primary
Manufacturer may include its methodology for calculating the 30-day equivalent supply. CMS
will employ the methodology described in Section 60.5 of the revised guidance to develop its
initial offer for the 30-day equivalent supply MFP. As discussed in section 60.4.1 of the revised
guidance, as feasible, CMS will provide information on the calculation of the statutorilydetermined ceiling and the computation of how CMS will apply a single MFP across dosage
forms and strengths of the selected drug to the Primary Manufacturer within 60 days of the
Primary Manufacturer’s submission of data that complies with the requirements described in
section 50.1 of the revised guidance. As described in section 40.5 of the revised guidance, a
Primary Manufacturer may submit a suggestion of error regarding the ceiling calculation or
computation of how CMS will apply a single MFP across dosage forms and strengths.
Public Explanation of MFP
Comment: One commenter suggested CMS include a field in the Counteroffer Form for the
manufacturer to request that certain information shared in the Counteroffer Form be included in
the public explanation of the MFP. The commenter also suggested CMS provide an explanation
in the revised guidance or updated Counteroffer Form if CMS plans to implement an alternative
form or process for this purpose.
Response: Primary Manufacturers may request that certain information be included in the public
explanation of the MFP in any data submission and may utilize the free text response on the
Counteroffer Form for this purpose for the counteroffer process. CMS will consider a Primary
Manufacturer’s request but cannot guarantee the requested details will be included in the public
explanation of the MFP. As described in the revised guidance, CMS will publish redacted

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information regarding the section 1194(e) data received, exchange of offers and counteroffers,
and the negotiation meetings, if applicable, in the public explanation of the MFP.
Certification of Submission and Signatures
Comment: One commenter suggested including fields on the Counteroffer Form for the Primary
Manufacturer and CMS to sign and countersign if the counteroffer price is accepted.
Response: CMS declines to add signature fields to the Counteroffer Form for the acceptance of
the counteroffer price, as any agreed-upon MFP will be effectuated via an Addendum to the
Medicare Drug Price Negotiation Program Agreement (herein referred to as an “Agreement”), as
described in section 40.3 of the revised guidance, which CMS and the Primary Manufacturer
would need to sign and execute. A template of the Agreement and Addendum was released for
manufacturer and other interested party review on CMS’ website on July 3, 2023.4 Concurrent
with the Primary Manufacturer’s submission of a written counteroffer, the Primary Manufacturer
will populate an Addendum in the CMS HPMS containing the price identified in the counteroffer
and sign the Addendum; if CMS wishes to accept the counteroffer, it will countersign the
Addendum in the CMS HPMS. CMS will determine that negotiations have concluded upon
execution by both parties of the Addendum setting forth the agreed-upon MFP.
Comment: A few commenters suggested CMS remove from the certification the requirement for
“completeness,” or to define what constitutes a complete submission. One commenter suggested
CMS remove the liability clause. A few commenters suggested CMS also remove the
requirement of timely notification of changed information. A few commenters suggested CMS
adopt a “good faith” approach to the certification, as done for Average Sales Price (ASP)
submissions.
Response: CMS affirms that its existing certification language is structured to ensure that the
Primary Manufacturer is submitting information that is complete and accurate based on the
respondent’s information, knowledge, and/or experience. This certification is necessary to ensure
the Primary Manufacturer’s counteroffer and the information about the selected drug’s profile
and therapeutic alternatives that supports the counteroffer allow for a full understanding of the
basis for the counteroffer within the confines of the limits provided in the ICR. A complete
submission is a full submission that reflects the standards described in this ICR and the revised
guidance and is within the respondent’s information, knowledge, and/or experience.
CMS believes that the timely notification of changed information requirement in the certification
is necessary for the Medicare Drug Price Negotiation Program as it ensures the MFP is
negotiated based on the most current data. Without this language in the certification, CMS’
ability to properly consider the information described in the counteroffer justification could be
compromised.
The ASP data collection is a quarterly collection that allows restatements of financial data. The
Counteroffer Form described in this ICR is a one-time information collection subject to statutory
4

https://www.cms.gov/files/document/inflation-reduction-act-manufacturer-agreement-template.pdf.

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deadlines with minimal margin for changing course based on a discovery of incomplete or
inaccurate information. Therefore, this certification language reflects CMS’ intent to collect
complete and accurate information for negotiation. CMS has revised the certification language in
this ICR to align with the certification language used in other information collection requests
related to the Negotiation Program.

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