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 (âSmall Biotech Exceptionâ) in section 1192(d)(2) of the Social Security Act (the Act) will be excluded from the definition of ânegotiation-eligible drugâ 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, âcontrolled groupâ 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 Manufacturerâs 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.
Biosimilar Delay for initial price applicability year 2027