View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1474
ICR Reference No:
202405-0938-025
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Rebate Reduction Requests underSections 11101 and 11102 of the Inflation Reduction Act (CMS-10858) - IRA
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/11/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/04/2024
Terms of Clearance:
Prior to the submission of the information collection request (ICR) for Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation Reduction Act, OMB requests that CMS provide analysis of the justification and durations of manufacturer’s rebate reduction requests/extensions for a severe supply chain disruption. Also, prior to its next ICR submission, CMS is requested to address how it made improvements to the agency’s ability to audit and verify the manufacturers’ information and any recommended improvements to the information collection from its analysis.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2027
36 Months From Approved
Responses
20
0
0
Time Burden (Hours)
620
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of data collection related to section 11101 and 11102 of the Inflation Reduction Act of 2022 (IRA; P.L. 117-169). Under the authority in sections 11101 and 11102 of the IRA, CMS is implementing the Medicare Part B Drug Inflation Rebate Program and the Medicare Part D Drug Inflation Rebate Program codified in section 1847A(i) and section 1860D-14B of the Social Security Act (“the Act”), respectively. The statute provides that CMS must reduce or waive the rebate amount for a Part B biosimilar biological product and generic Part D rebatable drug or biosimilar when CMS determines there is a severe supply chain disruption, such as a disruption caused by a natural disaster or other unique or unexpected event. CMS also must reduce or waive the rebate amount for a generic Part D rebatable drug if CMS determines that without such reduction or waiver, the drug is likely to be described as in shortage during a subsequent applicable period. Some of the information and supporting documentation needed for CMS to make a determination regarding a severe supply chain disruption and the likelihood of a future shortage are held by manufacturers and are not available to CMS. For CMS to determine whether there is a severe supply chain disruption or likelihood of future shortage, in accordance with sections 1847A(i)(3)(G)(ii), 1860D-14B(b)(1)(C)(ii), and 1860D-14B(b)(1)(C)(iii) of the Act, a manufacturer must submit a request and supporting documentation (as described in Appendix A, B, C, and D, as applicable) to CMS to receive consideration for a rebate reduction.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11101 and 11102
Name of Law: Inflation Reduction Act of 2022
US Code:
42 USC 1395w–3a
Name of Law: Use of Average Sale Price Payment Methodology
US Code:
42 USC 1395w–114b
Name of Law: Manufacturer rebate for certain drugs with prices increasing faster than inflation
Citations for New Statutory Requirements:
PL: Pub.L. 117 - 169 11101 and 11102 Name of Law: Inflation Reduction Act of 2022
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 5548
01/29/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 47563
06/03/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Rebate Reduction Extension Request Form
CMS-10858, CMS-10858
Appendix A and BSevere Supply Chain Disruption forms
,
Appendix C and D Likely to be in Shortage forms
Rebate Reduction Request Form
CMS-10858, CMS-10858
Appendix A and BSevere Supply Chain Disruption forms
,
Appendix C and D Likely to be in Shortage forms
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
20
0
20
0
0
0
Annual Time Burden (Hours)
620
0
620
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection request.
Annual Cost to Federal Government:
$336,264
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
06/04/2024
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