Response to comment document (60day)

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Centers for Medicare and Medicaid Services Response to Public Comments Received for
CMS-10844, OMB 0938-1443
The Centers for Medicare and Medicaid Services (CMS) received three public submissions
commenting on the Negotiation Program Drug Selection for Initial Price Applicability Year 2028
under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request
(CMS-10844, OMB 0938-1443) (hereinafter, the Drug Selection ICR) issued May 13, 2025.
These submissions by two pharmaceutical manufacturers and one anonymous commenter
included some comments that were outside the scope of the information collection request (ICR).
These out-of-scope public comments are not addressed in this summary and response document.
CMS refers those who submitted out-of-scope comments, including with respect to, for example,
defined terms, the identification criteria for renegotiation-eligible drugs, the selection criteria for
renegotiation-eligible drugs, the factors that contribute to an initial offer by CMS of a maximum
fair price (MFP), and the process of renegotiating an MFP for drugs selected for renegotiation, to
the Medicare Drug Price Negotiation Program: Final 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 “final
guidance”).
Summaries of the public comments that are within the scope of the Drug Selection ICR and
CMS’ responses to those public comments are set forth in this document under the appropriate
heading.
Request for a Small Biotech Exception
Comment: One commenter asked CMS to maintain consistency between the information
requested for a small biotech exception for a drug covered under Part D and for drugs payable
under Part B and only require that manufacturers submit the New Drug Application(s) (NDA(s))
/ Biologics License Application(s) (BLA(s)) for which they are seeking a request for a small
biotech exception.
Response: As described in section 30.2.1 of the final guidance, to determine whether a
qualifying single source drug meets the requirements for the exception for small biotech drugs
(the “Small Biotech Exception” (SBE)), CMS will make separate determinations with respect to
the Part B criteria pursuant to section 1192(d)(2)(A)(ii) of the Act (the “Part B Track”), and the
Part D criteria pursuant to section 1192(d)(2)(A)(i) of the Act (the “Part D Track”).
In applying the Part D track, the statute requires CMS to consider Total Expenditures under Part
D for all covered Part D drugs during 2021, Total Expenditures under Part D for the qualifying
single source drug during 2021, and Total Expenditures under Part D during 2021 for all covered
Part D drugs for which the Part D 2021 Manufacturer and its controlled group had a Medicare
Coverage Gap Discount Program (CGDP) Agreement in effect on December 31, 2021. In order
to calculate Total Expenditures under Part D for the qualifying single source drug during 2021,
CMS needs to collect the NDA(s)/BLA(s) for the qualifying single source drug that the
manufacturer that seeks the SBE for its qualifying single source drug(s) (the “Submitting
Manufacturer”) would like to be considered for an SBE. In order to calculate Total Expenditures

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under Part D during 2021 for all covered Part D drugs for which the Part D 2021 Manufacturer
and its controlled group had a CGDP Agreement in effect on December 31, 2021, CMS needs to
collect information about (1) the entity that had a CGDP Agreement in effect on December 31,
2021 for the qualifying single source drug for which the Submitting Manufacturer seeks the SBE
(i.e., the Part D 2021 Manufacturer); and (2) identifying information and labeler codes owned by
any other entities in the Part D 2021 Manufacturer’s controlled group as of December 31, 2021
that had a CGDP Agreement in effect on December 31, 2021.
In applying the Part B Track, the statute requires CMS to consider Total Expenditures under Part
B during 2021 for all qualifying single source drugs, Total Expenditures under Part B during
2021 for the qualifying single source drug, and Total Expenditures under Part B in 2021 for all
qualifying single source drugs of the Part B 2021 Manufacturer and its controlled group. As in
applying the Part D Track of the SBE, in order to calculate Total Expenditures under Part B
during 2021 for the qualifying single source drug, CMS needs to collect the NDA(s)/BLA(s) for
the qualifying single source drug that the Submitting Manufacturer would like to be considered
for an SBE. However, because the Part B Track of the SBE, unlike the Part D Track, requires
consideration of Total Expenditures under Part B in 2021 for all qualifying single source drugs
of the Part B 2021 Manufacturer and its controlled group, the agency needs to collect all
NDA(s)/BLA(s) held by the Part B 2021 Manufacturer and its controlled group as of December
31, 2021.
Comment: One commenter stated that they believe that the agency’s revised burden estimate for
submission of an SBE for initial price applicability year 2028 underestimates the burden
associated with the submission of an SBE for initial price applicability year 2028.
Response: CMS thanks this commenter for their thoughts on the burden estimate. In revising the
format of the burden estimate to provide the low, base, and high estimates for initial price
applicability year 2028, CMS modeled the burden estimates on the type of SBE requests that
CMS estimates to be the most common type of request for initial price applicability year 2028.
CMS estimates that the Part B Track will have a slightly higher burden than the Part D Track.
CMS’ initial price applicability year 2028 burden estimate ranges were informed by the initial
price applicability year 2027 burden estimate ranges (which only included SBE eligibility for
drugs covered under Part D), the agency’s assessment of the relative burden associated with SBE
submissions anticipated for initial price applicability year 2028 (i.e., including the Part B Track
only and Part B and Part D Track submissions), and the agency’s assessment of the volume of
information provided with actual applications submitted for the SBE for initial price applicability
year 2027. Based on its review of initial price applicability year 2027 SBE submissions, CMS
found that the initial price applicability year 2027 burden estimates tended to overestimate the
burden associated with such submissions. Nonetheless, CMS recognizes that the initial price
applicability year 2027 submissions may not reflect all Part D Track SBE submissions and does
not account for all tracks, which is why CMS revised the burden estimate to include a range of
estimates. CMS believes the high estimate is sufficient to capture the variety of larger burden
estimates that may apply to situations in which a Submitting Manufacturer is making an SBE
request for both the Part D Track and the Part B Track, or making an SBE request wherein CMS

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is requesting additional information, such as those in which the Submitting Manufacturer was
acquired after December 31, 2021.
Request for a Biosimilar Delay
Comment: One commenter suggested that CMS grant manufacturers of a biosimilar a
“meaningful opportunity” to request a biosimilar delay, which included the commenter
suggesting that CMS use the most recently available information to make a determination of the
high likelihood that a biosimilar will be marketed within the requisite time period.
Response: CMS thanks the commenter for their feedback. Consistent with final guidance and
CMS’ responses to similar comments received on the draft guidance regarding the timing for
submission of a request for a biosimilar delay, CMS reiterates that the Drug Selection ICR
deadline is based upon the statute and operational constraints related to the drug selection
process. CMS already includes an additional date for updating CMS on the status of the
Biosimilar application for licensure in instances where updates since the submission of the
request for the biosimilar delay may satisfy the eligibility criteria.
Finally, for the clear and convincing evidence required for the high likelihood determination
specified in section 1192(f)(3)(B) of the Act (where CMS will review Biosimilar Delay Requests
to determine whether there is a high likelihood that the Biosimilar will be licensed and marketed
before the High Likelihood Deadline, which is February 1, 2028 for drugs selected for initial
price applicability year 2028), CMS directs the commenter to section 30.3.1.3 of the final
guidance where CMS added revisions to two items related to patents to address certain concerns
about timing by: (1) extending the date by which there must be no unexpired patents relating to
the reference product included in the Reference Drug that are applicable to the Biosimilar (from
none at the filing of the request for the biosimilar delay to none by the High Likelihood
Deadline), and (2) permitting the Biosimilar Manufacturer to be involved in pending patent
litigation so long as neither a court nor the United States Patent and Trademark Office
(USPTO)’s Patent Trial and Appeal Board (PTAB) has adversely ruled against the Biosimilar
Manufacturer’s legal patent assertion(s) pertaining to an unexpired patent or patent(s) relating to
the reference product included in the Reference Drug applicable to the Biosimilar and the
Biosimilar Manufacturer has specified a launch date for the Biosimilar that is a calendar date
before the requisite deadline.
Identification and Selection of a Renegotiation-Eligible Drug
Comment: One commenter disagreed with CMS’ instructions that Primary Manufacturers
“should not report any data or costs that were previously reported to CMS under a previous data
submission” and “should only include data not previously reported to CMS” because the
commenter said a Primary Manufacturer should be able to provide any information that the
Primary Manufacturer believes may be influential to CMS’ identification and selection of a
renegotiation-eligible drug. The commenter stated, as an example of previously-submitted data
that should be included, previously reported data that may have been undervalued by the Primary
Manufacturer in the Primary Manufacturer’s original data submission to CMS.
Response: CMS thanks the commenter for this feedback. The Drug Selection ICR is an

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opportunity for a Primary Manufacturer to share information with CMS that will be used by
CMS to identify and select renegotiation-eligible drugs based on a new indication or a material
change in a section 1194(e) factor. (The Drug Selection ICR does not collect information for
drugs with a monopoly status change, as these drugs are automatically eligible, and must be
selected, for renegotiation.) Therefore, the information collected in the Drug Selection ICR
should be distinct from the information that was previously reported to CMS for the prior
negotiation period. To ensure that the Drug Selection ICR is appropriately streamlined and
targeted to reduce manufacturer burden, CMS will not repeat the collection of information
provided previously.
Additionally, CMS reminds Primary Manufacturers of the ongoing obligation to provide CMS
with updates to the originally submitted section 1194(e)(1) data. In accordance with section 50.1
of the revised guidance for initial price applicability year 2026, the final guidance for initial price
applicability year 2027, and the final guidance for initial price applicability year 2028, the
Primary Manufacturer should notify CMS of these updates separately from the Drug Selection
ICR. CMS may consider updates to the Primary Manufacturer’s original data submission to
inform renegotiation eligibility and selection and to inform renegotiation if the drug is selected
for renegotiation.
Otherwise, consistent with sections 130.1.3 and 130.1.4 of the final guidance (to determine if
there is a new indication or a material change in a section 1194(e) factor to identify and select
renegotiation-eligible drugs), CMS is requesting information on the applicable data elements
from the last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s original full submission of section 1194(e)(1) data for the negotiation period in
which the selected drug’s MFP was negotiated through September 30, 2025 (with only a few
exceptions related to, for example, the expansion of reportable research and development (R&D)
costs for initial price applicability year 2028 that permits Primary Manufacturers to report certain
information that predates the original full submission of section 1194(e)(1) data because it was
not previously reportable).
Comment: One commenter disagreed with CMS’ instructions to adjust certain values for
inflation because the commenter stated that the values are not traditionally adjusted for inflation.
The commenter also stated that CMS’ methodology for inflation adjustment is not consistent
with U.S. Generally Accepted Accounting Principles (GAAP) standards for inflation adjustment.
Response: CMS thanks the commenter for their feedback. CMS no longer includes any requests
to adjust values for the cost of capital because CMS does not believe this is consistent with
industry standards or GAAP. CMS has revised the instruction for inflation adjustment to specify
that, for a question where CMS requests the Primary Manufacturer to adjust for inflation, the
Primary Manufacturer use the annual percentage increase of the consumer price index for all
urban consumers (CPI-U) for 2025. CMS disagrees with the commenter that inflation adjustment
is not appropriate. However, CMS requests both the nominal and adjusted values because CMS
recognizes that due to the varied development histories of the selected drugs, the relevant inputs
for each selected drug may have occurred at different points in time.

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Comment: One commenter suggested the 300-word limit for Question 9, related to the
Explanation of Patents (Expired and Non-Expired) and Patent Applications, was insufficient to
capture the long and complex process of discovery and development of new medicines. This
commenter also raised concerns that the information requested in response to the question was
too broad and ambiguous.
Response: CMS thanks the commenter for this feedback. CMS clarifies that the approximately
300-word limit (or 3,600-character limit) is for each patent listed by the Primary Manufacturer in
Questions 9A, 9B, 10 and 11. As for the commenter’s suggestion that CMS’ request for
information is too broad and ambiguous, CMS provides instructions to include a narrow response
that is not intended to capture the entire history of the discovery and development of the drug.
For example, for Question 9A, CMS requests the Primary Manufacturer explain for new patents
or patents with changes since the previous negotiation, as applicable to a particular listing in the
table, the patented invention, the manner and process of making or using the invention, the
patent’s relation to the other patents, and the reason a patent was removed from the Orange Book
(if applicable). Further, to the degree the commenter feels the word limit in Question 9,
specifically, is insufficient for the answer the commenter wishes to provide, CMS notes that the
explanation fields for Questions 10 and 11 are open fields for which the Primary Manufacturer
may choose to provide additional information.
Comment: One commenter suggested that CMS should either separate total unit volumes
between the collection of the “manufacturer U.S. commercial average net unit price” and the
“manufacturer U.S. commercial average net unit price— best,” or remove these elements from
the ICR because this commenter suggested that the two price points are offered with different
sets of volumes. Specifically, this commenter contends that “manufacturer U.S. commercial
average net unit price— best” is offered to a limited set of customers but, this commenter
suggests, CMS may erroneously interpret the data to correlate the price with a total commercial
unit volume.
Response: CMS thanks the commenter for raising these concerns. CMS directs the commenter
to Appendix A of the final guidance where CMS has included technical corrections to
“manufacturer U.S. commercial average net unit price” to clarify the items that should or should
not be deducted from the price. CMS declines to revise these data elements in the Drug Selection
ICR. CMS believes that the Primary Manufacturer has access to the specific data required to
calculate these data elements and CMS provides terms and instructions to clarify which specific
data should be included in this set of metrics. In addition, Question 13 asks the Primary
Manufacturer to describe the assumptions, methodological steps, and other information used by
the Primary Manufacturer to calculate the “manufacturer U.S. commercial average net unit
price,” and the related prices requested in Question 12, where the Primary Manufacturer could
include the information raised by the commenter regarding prices available to different sets of
customers.
Comment: One commenter suggested the 3,000-word count was insufficient to provide the
information requested in Questions 14 and 15 for all potential indications of a selected drug with

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sufficient detail and evidence. This commenter also requested CMS allow the submission of
supporting exhibits (i.e., charts, graphs, etc.).
Response: CMS thanks the commenter for their concerns. As stated in the instructions for
Questions 14 and 15, because the information requested in the Drug Selection ICR is only about
“new information or evidence” since the date of the initial agreed-upon maximum fair price
(MFP) for the selected drug, CMS maintains that that the 36,000-character count (approximately
3,000-word count) is sufficient. CMS has added the opportunity to submit up to five visual
representations (which may include charts and graphs) with Questions 14 and 15 to provide new
evidence or data. CMS also added the opportunity to provide citations of new evidence with
Question 15 to be consistent with Question 14.