Rebate Reduction Requests underSections 11101 and 11102 of the Inflation Reduction Act (CMS-10858) - IRA

Forms and Documents

Document Name	Status
Form CMS-10858 Rebate Reduction Extension Request Form Form and Instruction	Modified
Form CMS-10858 Rebate Reduction Request Form Form and Instruction	Modified
0938-1474 Non Substantive Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2024-07-19
Final clean Rebate Reduction Requests ICR SS.docx Supporting Statement A	2024-07-19
Final clean Rebate Reduction Requests ICR Comment Summary Responses_clean.docx Supplementary Document	2024-07-19
Rebate Reduction Requests ICR 30 Day to Final Cross Walk.docx Supplementary Document	2024-07-19

IC Document Collections

IC ID	Document Title	Status
268249	Rebate Reduction Extension Request Form Form and Instruction	Modified
268246	Rebate Reduction Request Form Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1474	ICR Reference No: 202407-0938-012
Status: Received in OIRA	Previous ICR Reference No: 202405-0938-025
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/19/2024

	Requested	Previously Approved
Expiration Date	07/31/2027	07/31/2027
Responses	20	20
Time Burden (Hours)	620	620
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): 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
   PL: Pub.L. 117 - 169 11101 and 11102 Name of Law: Inflation Reduction Act of 2022
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 169 11101 and 11102 Name of Law: Inflation Reduction Act of 2022

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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ICR Summary of Burden

	Total Request	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	20	0	0	0	0
Annual Time Burden (Hours)	620	620	0	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.

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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

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Common Form ICR:  No

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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: 07/19/2024

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