Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) - IRA

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10110 Product Data Template	Form	Modified	Available
Form CMS-10110 Financial Data Template	Form	Modified	Available
CMS-10110_Supporting_Statement_A.docx	Supporting Statement A	Uploaded 2024-05-14	Repair queued
Crosswalk Document for CMS 10110 -20240130.pdf	Supplementary Document	Uploaded 2024-05-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Product Data Template
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Financial Data Template
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Instruction	Modified

ICR Details

OMB Control No: 0938-0921	ICR Reference No: 202405-0938-015
Status: Historical Active	Previous ICR Reference No: 202304-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) - IRA
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/09/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/17/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	08/31/2026
Responses	2,000	0	2,000
Time Burden (Hours)	26,000	0	26,000
Cost Burden (Dollars)	0	0	0

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Abstract: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the manufacturers’ average sales price (ASP) data submitted to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J. In the Calendar Year (CY) 2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. CMS migrated the submission of ASP data and signatures to an internet-based automated system in July 2020. The data that is being collected has not changed. As part of an ASP modernization effort, the data collection system has been modified and enhanced to improve the design and flow through the use of Human-Centered Design best practices. These modifications include changes to the design and function of the data collection system, the addition of new data fields, and revisions to the product and financial data templates. The field “Marketing Start Date” is being added so that the user can input the marketing date for the drug. The marketing date of the drug is used to determine how the payment will be calculated and to assign the benchmark quarter used to calculate inflation adjusted coinsurance and rebates per IRA 11101.

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Authorizing Statute(s): US Code: 42 USC 1395u(o)
   US Code: 42 USC 1395(a)(1)(S)
   US Code: 42 USC 1395w-3
   PL: Pub.L. 108 - 17 303 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   Statute at Large: 18 Stat. 1847
   Statute at Large: 19 Stat. 1927
   US Code: 42 USC 1395w–3a
   PL: Pub.L. 117 - 169 11001 Name of Law: The Inflation Reduction Act
  

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

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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 12844	02/20/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 41968	05/12/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	CMS-10110, CMS-10110	Financial Data Template ,   Product Data Template

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ICR Summary of Burden

table that charts list 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	2,000	2,000	0	0	0	0
Annual Time Burden (Hours)	26,000	26,000	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:

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Annual Cost to Federal Government: $2,239,300

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: 05/17/2024

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