Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
07/31/2027
36 Months From Approved
07/31/2027
2,000
0
2,000
26,000
0
26,000
0
0
0
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 manufacturersâ 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 âMarketing Start Dateâ 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.
Our CY 2026 PFS NPRM (CMS-1832-P, OMB 0938-AV50) published in the Federal Register on July 16, 2025 (90 FR 32352). Overall, the rule would increase our active burden estimates by 610 responses and 7,495 hours.
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-10110 Product Data Template
CMS-10110_Supporting_Statement_A_(CMS-1832-P_version_5)_clean.docx
Manufacturers to Report Drug Pricing Information for Part B (§§ 414.802 and 414.902)