Small Biotech Exception and
Biosimilar Delay Information Collection Request for Initial Price
Applicability Year 2027 (CMS-10844) - IRA
Revision of a currently approved collection
No
Regular
10/02/2024
Requested
Previously Approved
36 Months From Approved
05/31/2025
25
10
415
68
0
0
the Drug Price Negotiation Program
established by the Inflation Reduction Act (IRA), a qualifying
single source drug that meets the requirements for the exception
for small biotech drugs (“Small Biotech Exception”) in section
1192(d)(2) of the Social Security Act (the Act) will be excluded
from the definition of “negotiation-eligible drug” with respect to
initial price applicability years 2026, 2027, and 2028. Among other
requirements for this exception, the statute requires that CMS
consider, for Part D drugs, total 2021 Medicare expenditures for
the drug under Part D; total expenditures for all covered Part D
drugs for such year; and total expenditures under Part D for all
covered Part D drugs for which the manufacturer has an agreement
under section 1860D-14A during 2021. For the purpose of this
information collection request, “controlled group” means all
corporations or partnerships, proprietorships and other entities
treated as a single employer under 26 U.S. Code section 52(a) or
(b). In order to accurately identify, at the request of a
manufacturer, whether a given covered Part D drug qualifies for the
Small Biotech Exception in accordance with section 1192(d)(2) of
the Act, CMS needs to collect information to identify the entity
that had a Medicare Coverage Gap Discount Program Agreement under
section 1860D-14A for the drug as of December 31, 2021,including
all other entities that, as of December 31, 2021, were treated as a
single employer with that entity under subsection (a) or (b) of
section 52 of the Internal Revenue Code of 1986.
CMS slightly revised the burden
estimate upwards for manufacturers to respond to the SBE ICR Form
when technical assistance in completion of the necessary
information may be needed by the manufacturer. CMS revised the
burden estimate for small biotech drugs owned by a manufacturer
when the manufacturer was acquired after 2021 to account for the
additional time needed to gather the information needed for CMS
determine if the acquisition renders the Submitting Manufacturer’s
drug ineligible for the SBE.
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 Biosimilar Delay for initial price applicability year 2027
CMS-10844_Supporting Statement_SBE Biosim Delay .docx
508_CMS-10844 60-day IPAY 2027 SBE and Biosimilar Delay ICR Crosswalk.pdf
Biosimilar Delay for initial price applicability year 2027