Centers for Medicare & Medicaid Services Response to Public Comments Received for CMS-10844, OMB 0938-1443

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Centers for Medicare & Medicaid Services Response to Public Comments Received for
CMS-10844, OMB 0938-1443
Request for a Biosimilar Delay
Comment: A commenter noted that the 30-day submission window for the biosimilar initial
delay requests may not provide biosimilar manufacturers enough time to prepare and submit
requests as they cannot predict when OMB may approve the proposed information collection
request. The commenter also suggested that CMS provide notice to the Reference Drug
manufacturer when a biosimilar delay request is submitted.
Response: CMS thanks the commenter for their feedback. Consistent with CMS’ response to
similar comments in the final guidance for initial price applicability year 2027 and initial price
applicability year 2028, the timing for the submission of a request for a biosimilar delay in
accordance with section 1192(f) of the Act and proposed at § 429.110 and is based on a set
timeline in the statute and operational constraints related to the drug selection process. CMS
reiterates that it must make a full determination and may not immediately delay the selection of a
Reference Drug whilst making a complete determination of the requirements specified in section
1192(f) of the Act and proposed at § 429.110 to determine the outcome of a request to delay the
inclusion of a Reference Drug by one initial price applicability year (an “Initial Delay Request”).
Further, the deadline for an Initial Delay Request has been set as close to the selected drug
publication date as is administratively feasible. CMS adopted this timeline under the authority
granted to it in section 1192(f)(1)(B)(ii) of the Act to set the time, form, and manner of
Biosimilar Delay requests, and has exercised this authority to establish a timeline (which is
described in sections 30.3.1 and 30.3.1.1 of the final guidance) that allows CMS to carefully
review the Initial Delay Request documentation and, if applicable, to request follow-up
information from the manufacturer of a biosimilar (the “Biosimilar Manufacturer”) on its Initial
Delay Request.
Identification and Selection of a Renegotiation-Eligible Drug
Comment: A commenter expressed support for making the Drug Selection ICR voluntary for
the Primary Manufacturer to provide input to inform renegotiation eligibility and selection.
Response: We thank this commenter for their support.
Comment: A commenter requested that CMS increase the word count for Questions 15 and 16
and allow for submission of supporting documentation such as charts or graphs. The commenter
stated that the 36,000 character limit (approximately 3,000 words) may not be sufficient to
provide comprehensive information, for example in situations where a selected drug has multiple
indications.
Response: We appreciate the commenter’s feedback. Consistent with our response to a similar
suggestion in the initial price applicability year 2028 version of this ICR, we reiterate that the
instructions for Questions 15 and 16 indicate responses should be limited to “new information or

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evidence” since the date of the previously agreed-upon maximum fair price (MFP) for the
selected drug. Therefore, we believe that that the 36,000-character count (approximately 3,000
words) is sufficient. We also note that both Question 15 and 16 provide for the opportunity
to submit up to five visual representations (which may include charts and graphs) in addition to
submitting up to 25 citations of new evidence for each question.