[IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
ICR 202512-0938-022 · OMB 0938-0921 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0938-0921 can be found here:
[IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
Section 1847A of the Social Security Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturersâ average sales price data submitted quarterly to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR part 414, subpart J.
The revisions in this iteration are associated with our November 5, 2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F, OMB 0938-AV50). Other changes are based on internal review (plus 1 hr for the certifier to log into the system, review the data, and certify the data and maximize burden by including all possible voluntary reporters).
This iteration revises the following user guides:
⢠Medicare Part B Average Sales Price (ASP) Module Submitter User Guide
⢠Medicare Part B Average Sales Price (ASP) Module Certifier User Guide
⢠Medicare Part B Average Sales Price (ASP) Module Registration User Guide
This iteration also adds the following user forms:
⢠Reasonable Assumptions Form
⢠Bona Fide Service Fee Certification Form
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 Bona Fide Service Fee Certification Form
CMS-10110_Supporting_Statement_A_(2025 version_16).docx
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)