Negotiation Program Drug
Selection for Initial Price Applicability Year 2028 (CMS-10844) -
IRA
Revision of a currently approved collection
No
Regular
09/30/2025
Requested
Previously Approved
36 Months From Approved
11/30/2025
65
25
3,677
415
0
0
In accordance with section 1192(d)(2)
of the Act, the term “negotiation-eligible drug” excludes, with
respect to the initial price applicability years 2026, 2027, and
2028, a qualifying single source drug that meets the requirements
for the exception for small biotech drugs (the “Small Biotech
Exception,” or “SBE”). This information is required in order for
CMS to accurately identify whether a given drug meets the criteria
for the Small Biotech Exception in accordance with section
1192(d)(2) of the Act. To ensure that drugs covered under Part B
and/or Part D that meet the requirements for the SBE are excluded
from the term “negotiation-eligible drug,” a manufacturer that
seeks the SBE for its drug covered under Part B and/or Part D
(“Submitting Manufacturer”) must submit information to CMS about
the company and its products in order for the drug to be considered
for the exception. If the Submitting Manufacturer seeks the SBE for
a drug covered under Part B and/or Part D it acquired after
December 31, 2021, the Submitting Manufacturer must also submit
information related to the separate entity that had the Medicare
Coverage Gap Discount Program agreement for the drug on December
31, 2021 for drugs covered under Part D and information related to
the holder of the New Drug Application(s) (NDA)(s) or Biologics
License Applications(s) (BLA)(s) as of December 31, 2021 for drugs
covered under Part B. If the Submitting Manufacturer was acquired
by another entity after December 31, 2021, the Submitting
Manufacturer must provide information regarding that acquiring
entity for CMS to assess whether the acquisition triggers the
limitation at section 1192(d)(2)(B)(ii) of the Act. Under section
1192(f)(1)(B) of the Act, the manufacturer of a biosimilar
biological product (“Biosimilar Manufacturer” of a “Biosimilar”)
may submit a request, prior to the selected drug publication date,
for CMS’ consideration to delay the inclusion of a
negotiation-eligible drug that includes the reference product for
the Biosimilar (such a negotiation-eligible drug is herein referred
to as a “Reference Drug”) on the selected drug list for a given
initial price applicability year. CMS needs to collect information
to identify the Biosimilar Drug, the Reference Drug, the Biosimilar
Manufacturer and the Section 1194(f) of the Act establishes the
requirements governing the identification of renegotiation-eligible
drugs and selection of drugs for renegotiation. CMS must collect
information from Primary Manufacturers to determine which selected
drugs qualify as a renegotiation-eligible drug and may be selected
for renegotiation in accordance with section 1194(f)(3) of the Act.
Specifically, section 1194(f)(2)(D) of the Act instructs CMS to
identify whether a selected drug is eligible for renegotiation
based on a material change to any of the factors listed in section
1194(e) of the Act, which include the data in section 1194(e)(1)
that must be submitted by the Primary Manufacturer of a selected
drug. Additionally, once a drug has been selected for
renegotiation, CMS must also consider section 1194(e)(1) data
during the renegotiation period in the development of offers and
consideration of counteroffers.
Burden has increased due the
revisions made to the Small Biotech Exception request and the new
burden estimate for a Primary Manufacturer’s voluntary completion
of the identification and selection of renegotiation-eligible
drugs. As a result, respondents has increased and the overall
burden has increased from the previously approved 415 to
3,677.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form CMS-10844 Identification and Selection of Renegotiation-Eligible Drugs
CMS -10844 Initial Price Applicability Year 2028_Negotiation Program Drug Selection Information Collection Supporting Statement - Part A.docx
CMS-10844 Initial Price Applicability Year 2028 60-day Negotiation Program Drug Selection ICR Responses to Public Comments.pdf
Identification and Selection of Renegotiation-Eligible Drugs