Centers for Medicare and Medicaid Services Response to Public Comments Received for CMS-10849, OMB 0938-1452

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Centers for Medicare and Medicaid Services Response to Public Comments Received for
CMS-10849, OMB 0938-1452
Negotiation Data Elements
Instructions for Sections A through G
Comment: A couple of commenters provided insight into their experience using the CMS
Health Plan Management System (“the CMS HPMS”) to submit data and provided
recommendations to reduce burden on utilizing the system. Such suggestions included
standardization of field names, bulk upload templates, and export functionality. A commenter
provided recommendations to improve the submission process, including timely notifications for
refiling data, submission templates, and simplification of data requests. A commenter suggested
that respondents should be able to include an executive summary in submissions to present their
submissions succinctly and stated that doing so would minimize CMS’ burden reviewing and
processing the information. A commenter proposed methodological changes to the ICR such as
the ability for a manufacturer to submit a crosswalk for its dossier that matches dossier content to
ICR question 43, and supplemental submission for non-manufacturers through which
information related to ICR questions 60 and 61 can be provided.
Response: CMS appreciates the commenters sharing their experience with data submission and
recommendations. CMS continues to identify opportunities to apply lessons learned and to
improve this ICR, including by considering respondent feedback and suggestions. CMS
appreciates the suggestions brought forward by commenters on potential submission options and
will consider these suggestions for future updates. However, in order to continue to meet
statutory timing requirements, CMS will not adopt these suggestions at this time. Manufacturers
and other interested parties have been able to make successful submissions in the current system,
which indicates that the current approach is effective. CMS reminds interested parties that it
provides technical assistance throughout the ICR submission process if a Primary Manufacturer
has questions about this ICR and/or the CMS HPMS.
Section C: Research and Development (R&D) Costs and Recoupment
Comment: A couple of commenters suggested that manufacturers be allowed to include R&D
costs from failed candidates and from all indications of the selected drugs. Inclusion of such
costs would support ongoing drug development.
Response: CMS thanks these commenters for their feedback. Consistent with our response in the
Negotiation Program Guidance, CMS declines to revise the definitions for R&D costs beyond
these changes because CMS believes the information included in the definitions is consistent
with the statutory intent to collect “research and development costs of the manufacturer for the
drug” as specified in section 1194(e)(1)(A) of the Act.

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Section F: Patents, Exclusivities, and Approvals
Comment: A few commenters provided suggestions to revise the data collected about patents,
exclusivities, and approvals in Section F. One commenter stated that requests for patent
information related to the selected drug are overbroad, ambiguous, and contradict the
constitutional framework that is intended to protect and encourage innovation. This commenter
requested that CMS narrow the patent information required under Section F to only those patents
necessary to provide contextual information about the selected drug for purposes of the
negotiation process. One commenter maintained its previous position that it is inappropriate for
CMS to require manufacturers to identify “composition of matter” patents in their reporting
because all patents must be new, useful, and non-obvious and therefore should be considered
equally by CMS, and it is unclear how this new requirement would be relevant to negotiating an
MFP.
Response: We thank the commenters for their feedback. We believe the information requested in
Section F is consistent with the statutory requirement to collect data on “pending and approved
patent applications, exclusivities recognized by the [FDA], and applications and approvals under
section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public
Health Service Act for the drug” as specified in section 1194(e)(1)(D) of the Act. We believe
that asking Primary Manufacturers to identify “composition of matter” patents is consistent with
and relevant to our consideration of data as required by section 1194(e)(1)(D) of the Act.
Comment: Some commenters requested that CMS remove question 12, stating that loss of
exclusivity is dictated by a range of factors that are beyond the manufacturer’s control, difficult
to predict, and that the question will increase manufacturer burden without improving CMS’
ability to accurately assess the selected drug. A couple of commenters raised concerns that
sharing this information could create significant legal, commercial, and confidentiality risks by
compromising future patent strategies, anticipated litigation outcomes, or settlement positions. A
couple of commenters stated that it is unclear how CMS intends to use this information in
negotiations and requested that CMS provide clarity. A couple of commenters stated that while
some public documents, such as a Form 10K filing pursuant to section 13 or 15(d) of the
Securities and Exchange Act of 1934, may provide estimates of loss of exclusivity for other
purposes, they do not represent a comprehensive “best estimate’ of the date of generic or
biosimilar entry, and the relevance of those estimates to pricing of a selected product has not
been demonstrated.
Response: We appreciate the feedback. Information about predicted loss of exclusivity is
relevant to evaluating Primary Manufacturer’s concerns about the impact of an MFP on their
business, and is a foundational element to understanding the market in the U.S. We acknowledge
that loss of exclusivity is dictated by a range of factors but note that question 12 directs Primary
Manufacturer’s to provide and explain a “best estimate” for loss of exclusivity. Additionally, we
believe question 12 provides sufficient guidance on what information a Primary Manufacturer
may choose to include in providing and explaining such best estimate.
In response to the concerns about legal, commercial, and confidentiality risk of sharing
information on predicted loss of exclusivity, we refer readers to section 1193(c) of the Act and

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42 CFR 429.300(a) and (b), which establish that information deemed proprietary will only be
used by CMS or disclosed to and used by the Comptroller General of the United States for
purposes of carrying out the Negotiation Program. We would deem proprietary information,
including trade secrets and confidential commercial or financial information, as confidential
information exempt from disclosure if the information meets the requirements set forth under
Exemption 3 or Exemption 4 of the Freedom of Information Act (5 U.S.C. 552(b)(3), (4)).
Section G: Market Data and Revenue and Sales Volume Data
Comment: A few commenters opposed the proposed changes to the ICR. A couple of
commenters questioned the justification for the newly added payer category breakdowns. At the
same time, they noted that CMS decreased the character limits for some narrative responses,
which causes manufacturers to spend more time condensing complex technical information
rather than reducing their overall workload. They recommend that CMS eliminate the global
revenue requirement, remove the new payer mix estimation requirement, restore the character
limits that were decreased, and improve transparency around how submitted data is used.
A few commenters requested the removal of question 27. They noted that the payer mix and
indication-level information requested in question 27 is a substantial burden to produce and CMS
did not clearly explain why it is necessary for the negotiation process. In addition, due to the
complexity involved with identifying payers, reported data could result in misleading
conclusions.
Response: CMS thanks these commenters for their feedback. Based on experience thus far,
CMS determined that additional information was needed to ensure a holistic evaluation of the
selected drug. For example, payer mix is core to understanding 1194(e)(1)(E) market pricing
data in the US. CMS believes this additional information is a low burden for manufacturers as
this information is estimated in the ordinary course of business. In response to comments
regarding Question 27, CMS is removing Question 27b, removed “Manufacturer-run patient
assistance” as a payer type in Question 27a, and revised the remaining payer types to simplify
the level of granularity. Question 27c is now revised to be 27b and prompts manufacturers to
describe assumptions, methodologic steps, and other information relied on to provide the
responses to Question 27a.
CMS reduced the maximum character limit for certain questions in Section I as part of CMS’
ongoing effort to identify opportunities to streamline this ICR. CMS found that some
respondents duplicate information across certain questions, which may increase respondents’
response burden in preparing and responding to this ICR, along with CMS’ internal review
burden due to the duplicate information. CMS believes the proposed character limits available
are adequate to address the questions. However, CMS notes that the ICR maintains the larger
number of characters permitted for a number of questions.
Comment: A commenter noted potential confusion with the wording in Section G of the ICR:
"If an NCPDP BUS of EA is used, one EA must represent a single individual dosage form or
dispensable unit (e.g., one tablet, capsule, vial, syringe, inhaler, or patch) and should match what
is reported in Section A." The inclusion of inhaler in the examples may lead to confusion as dry

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powder inhalers use a billing unit of pre-metered blisters instead of inhalers. They recommended
removing the parenthetical examples or remove the word inhaler from the list of examples.
Response: CMS thanks this commenter for sharing their insight. The word “inhaler” was
removed from the list of examples. In addition, instructions for Question 14 include a request to
specify the units that one EA represents if the NCPDP BUS of EA is used.
Comment: A few commenters expressed concern that certain sections of the ICR request
proprietary pricing information — such as Federal Supply Schedule prices and payer mix
breakdowns — that goes beyond what the law requires and could expose commercially sensitive
business data. A commenter encouraged strengthening confidentiality protections.
Response: CMS thanks the commenters for their feedback. Section 1194(e) of the Act authorizes
CMS to collect confidential commercial and financial information from manufacturers for the
purpose of negotiating the MFP of a selected drug. Specifically, section 1194(e)(1)(E) of the Act
provides that “market data and revenue and sales volume data for the drug in the United States”
is in scope. CMS understands that the specific data elements mentioned by commenters are
inclusive in this statutory authorization.
With regards to the comment regarding confidentiality protections, consistent with our responses
in the revised guidance for initial price applicability years 2026, 2027, and 2028, section 1193(c)
of the Act requires that information submitted to CMS by the manufacturer of a selected drug
that is proprietary information, as determined by CMS, shall be used only by CMS or disclosed
to and used by the Comptroller General of the United States for purposes of carrying out the
Negotiation Program. CMS is committed to protecting confidential and proprietary information
obtained from manufacturers throughout the negotiation process. CMS refers to § 429.300 of this
final rule for further details regarding the confidentiality policy.
Section I: Evidence about Alternative Treatments
Comment: A couple of commenters opposed the inclusion of Question 30 and asked that CMS
remove or revise the question stating that the request to identify if the respondent is “affiliated
with the manufacturer of the selected drug or its potential therapeutic alternative(s)” may be
confusing or otherwise dissuade stakeholders from responding to the ICR. One commenter stated
that a manufacturer could inform stakeholders, such as a patient advocacy organization or
medical professional society, about the ICR without meaning to ask them to respond to the ICR.
One commenter supported the inclusion of Question 30 and asked that CMS also require the
disclosure of relevant financial relationships with manufacturers of the selected drug or its
therapeutic alternative(s), including indirect support.
Response: We thank the commenters for their feedback. Consistent with CMS’ response to
similar comments received in response to the initial price applicability year 2027 and 2028
versions of this ICR, we reiterate that we will review all submitted information. We believe
information regarding relationships with manufacturers is important to promote transparency in
the negotiation process. We believe that Question 30 provides sufficient information on a
respondent’s relationship with the manufacturer of the selected drug or a therapeutic
alternative(s). We refer interested parties to §§ 429.520 and 429.525 regarding how information

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provided in response to Section I is used in the development of the initial offer and concise
justification.
General Instructions for Section I
Comment: A couple of commenters opposed the reduction of character limits in various
questions in Section I stating that reduced character limits will limit the amount and types of
information available to CMS. Similarly, a couple of commenters opposed the revision to
combine questions on unmet medical need and therapeutic advance when such topics were
previously addressed separately stating that by combining these questions limits the amount of
information that can be provided to CMS. A commenter supported the combination of certain
questions in the ICR for the purpose of streamlining, including the questions regarding unmet
medical need and therapeutic advance.
Response: We thank commenters for their feedback. Based on our review of responses
received in previous submissions for initial price applicability years 2027 and 2028, we found
that information submitted in response to the separate questions regarding therapeutic advance
and unmet need in the previous versions of this ICR were often duplicative. We believe that
these questions could be combined while maintaining the opportunity for a respondent to provide
information about each of these aspects of a selected drug and its potential therapeutic
alternative(s). In an effort to streamline the information requested in this ICR, CMS combined
these questions.
Patient or Caregiver-Focused Input
Comment: A commenter requested that CMS retain questions concerning treatment risks.
Response: We appreciate this commenter’s feedback. Based on our review of responses
received in previous submissions we found responses to be duplicative in questions that
referenced safety and/or treatment risk. We revised this ICR such that respondents can discuss
safety and/or treatment risks in response to the same questions in an effort to streamline
the information requested. We assure this commenter that several questions in this ICR
(Questions 46f, 46f1, and 46f2) explicitly request information on treatment risk or safety
(Questions 39, 46, 52).
Comment: A couple of commenters suggested that CMS remove the requirement for
respondents to provide citations in the Patient or Caregiver-Focused Input section. A commenter
requested that CMS allow patients, clinicians, and patient organizations to submit a letter or
direct entry form without citations or technical requirements. A commenter stated that CMS
should not use the CMS HPMS for submissions for the public. A commenter stated that CMS
should ensure that the structure and content of Section I accommodate a wide range of
quantitative and qualitative inputs from various stakeholders types while maintaining
transparency and methodological rigor. One commenter suggested that CMS conduct targeted
outreach to increase participation in the ICR and create user-friendly materials and resources to
aid in the completion of the submission. A couple of commenters suggested including
a glossary with system functionality to view the definitions as a pop-up window

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when included in an applicable instruction and/or question. A commenter suggested CMS
provide a structured crosswalk through which a manufacturer can identify the dossier pages or
sections related to ICR questions to avoid duplicative web-form entry.
Response: Consistent with our response to the ICR for initial price applicability year 2028, we
note that the Additional Instructions to Section I indicates that responses that are sharing a
personal experience with prescribing or taking the selected drug and/or its potential therapeutic
alternative(s) or responses by a respondent that is a caregiver describing the experience of the
person taking the selected drug and/or its potential therapeutic alternative(s) do not need to
include citations.
We appreciate concerns about the user interface for the CMS HPMS. Consistent with our
response to similar comments in the initial price applicability year 2028 version of this ICR, we
reiterate that we appreciate and collect feedback shared by interested parties to continue to
identify opportunities to improve the user interface for the submission of responses to this ICR.
We also note that the CMS HPMS adheres to CMS and HHS policies, procedures, controls, and
standards for information security and privacy. Additionally, CMS conducts outreach to patient
advocacy organizations, disease groups, and other consumer associations regarding public
engagement opportunities, including the section 1194(e)(2) data submission.
Comment: A couple of commenters expressed concern that the ICR does not require
respondents to disclose whether their response(s) include quality-adjusted life-years (QALYs)
and recommended that CMS require anyone submitting evidence to disclose whether the
underlying studies used QALYs, equal value of life years gained (evLYG), or similar measures.
Response: We thank commenters for their input. Consistent with our response to similar
comments in the initial price applicability year 2028 version of this ICR, we note that in previous
ICRs that included a requirement for respondents to indicate if a QALY or other prohibited
measure was included in their response, the response rate was low. We believe this may be
because not all respondents to this ICR are familiar with cost-effectiveness measures sufficiently
to provide relevant information to fulfill the requirement. We also note that CMS reviews all
cost-effectiveness measures used in studies relevant to a selected drug to determine whether the
use of the measure is permitted in accordance with section 1194(e)(2) of the Act as described at
paragraph (e) of this section, as well as section 1182(e) of the Act and other applicable law per §
429.505(e)(1). Additionally, we reaffirm that per § 429.505(e), we will not use evidence from
comparative clinical effectiveness research in a manner that treats extending the life of an
elderly, disabled, or terminally ill individual as of lower value than extending the life of an
individual who is younger, nondisabled, or not terminally ill.
Comment: A commenter recommended that CMS create a dedicated ICR section for patient
organizations to include information on formulary placement, utilization management, and
affordability across the patient population they represent.
Response: We appreciate this commenter’s suggestion. However, we believe that the questions
grouped under “Patient or Caregiver Input” in combination with the opportunity to respond to
any question in Section I of this ICR provide ample opportunity for a patient organization to

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contribute on behalf of the population they represent. We recognize that patient organizations
may have broad perspectives on a patient population, and we encourage such entities to respond
to all questions in Section I that may be relevant to their expertise. We also note that Question 47
of Section I inquires about health insurance coverage or access issues related to the selected drug
and its therapeutic alternative(s) and that Question 49 provides an opportunity for respondents to
share additional information that they believe CMS should consider.
Comment: A commenter suggested the ICR should more clearly prioritize evidence related to
therapeutic impact, unmet medical need, patient experience, and improvements in health
outcomes.
Response: We appreciate this commenter’s input. The ICR is not intended to prioritize evidence
but rather to collect evidence related to the factors listed at section 1194(e) of the Act for
consideration in developing the initial offer and counteroffers. We refer the commenter to section
II.F.3. and § 429.510 of the Negotiation Program final rule for more information on how we
consider the information provided in this ICR.
Manufacturer-Focused Input
Comment: A commenter suggested CMS provide a template to standardize the parameters that
may be included in manufacturers’ responses, such as cost, prevalence, and utilization.
Response: CMS thanks this commenter for their feedback. Consistent with our response to a
similar suggestion in the initial price applicability year 2028 version of this ICR, we decline
to provide a template for responses to Section I. Per § 429.510(e), we will collectively consider
the information provided by the interested parties in response to questions about section
1194(e)(2) factors.
Clinical-Focused Input and Health Research-Focused Input
Comment: A commenter suggested CMS request information from clinicians about observed
differences in treatment access including among individuals living in rural areas, people with
disabilities, and others who may experience reduced access due to geographic, socioeconomic, or
functional factors. The commenter also stated that such responses should address relevant
patient-centered outcomes in addition to traditional clinical endpoints.
Response: CMS thanks this commenter for their feedback. We refer the commenter to Question
47 which requests treatment-related information on access and patient information from clinician
respondents or others who chose to answer Question 47. Similarly, a respondent may provide
any additional information they would like CMS to consider in its evaluation of the selected drug
in each of the respondent subsections. Finally, we remind interested parties that any member of
the public, including community organizations, clinicians, and other providers, may respond to
Section I. We believe these questions provide sufficient opportunity for respondents to contribute
information on treatment access and patient-centered outcomes as they see fit.

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Question 57: Identification of Information Submitted in Section I that the Respondent
Believes Should be Withheld as Proprietary Information
Comment: A commenter requested that CMS publish anonymous, aggregated versions of all
responses. A commenter suggested that CMS adopt a narrow approach to proprietary
designations such that redactions be narrowly limited to trade secrets or information
demonstrably likely to cause competitive harm if disclosed. The commenter stated this would
support transparency.
Response: Consistent with our response to a similar comment in the initial price applicability
year 2028 version of this ICR, we note that we include redacted copies of all submissions to
Section I with the explanation of agreed-upon MFPs. Section II.D.1. of the proposed rule (91 FR
36273) states that a Primary Manufacturer may indicate for CMS which information the Primary
Manufacturer believes should be withheld from disclosure by CMS consistent with existing
Federal requirements for protecting proprietary information, including Exemptions 3 and/or 4 of
the FOIA, and that are not included under proposed § 429.300(c) as data that must be deemed
proprietary information by CMS. We direct commenters to § 429.300 for more information.
Questions 57 through 59: Other Public Input
Comment: A commenter suggested the “Other Public Input” section should clarify that
responses may include information from community-based organizations, health systems, or
other civic institutions to provide information on the indirect effects that CMS should consider
such as impacts on the caregiving workforce or public health infrastructure as well as
information on areas where evidence is lacking, particularly for conditions that are less common
or for patient populations with limited access to necessary treatments.
Response: We appreciate the suggestions offered by the commenter. Similar to the response
above, we reiterate that Section I of this ICR is open to any interested party and that respondents
may answer any questions in this section, including open-ended questions that offer
opportunities to discuss the points laid out by this commenter. We will consider the information
provided in this ICR in accordance with § 429.510(e).
Questions 60 and 61: Visual Information and Citations
Comment: A couple of commenters requested that CMS remove the limit on submission of
visual representations allowed in Question 60 as it is arbitrary and may be restrictive for some
respondents. A commenter requested that CMS remove the limit on the number of citations that
may be provided in Question 61 for the same reasons. A commenter asked that CMS clarify
whether the limitations in Questions 60 and 61 are per drug or per respondent.
Response: We thank these commenters for their feedback. Consistent with our response to
similar concerns in the initial price applicability year 2028 version of this ICR, we believe that
the number of visual representations permitted in Question 60 and the number of citations
permitted in Question 61 (250 citations total) is appropriate to capture the estimated amount of
information necessary to provide a sufficient answer to the questions posed in Section I. This

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is based on our review of actual responses submitted for Section I in initial price applicability
years 2026, 2027, and 2028. We have also observed in past submission years that respondents
may rely on the same source across questions, and for these instances, the respondent should
only include a citation one time in response to Question 61. We also note that the limitations in
Question 60 and 61 are per drug. Further, we believe that the volume and breadth of information
identified among public submissions and CMS’ review captures adequate evidence
about potential therapeutic alternatives for the selected drug.