Prescription Drug and Health Care Spending (CMS-10788)
No material or nonsubstantive change to a currently approved collection
Yes
Regular
Approved without change
04/13/2026
04/01/2026
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2027
12/31/2027
12/31/2027
356
0
356
668,952
0
668,952
0
0
0
On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed into law. Section 204 of Title II of Division BB of the CAA added parallel provisions at section 9825 of the Internal Revenue Code (the Code), section 725 of the Employee Retirement Income Security Act (ERISA), and section 2799A-10 of the Public Health Service Act (PHS Act) that require group health plans and health insurance issuers offering group or individual health insurance coverage to annually report to the Department of Treasury, the Department of Labor (DOL), and the Department of Health and Human Services (HHS) (collectively, âthe Departmentsâ) certain information about prescription drug and health care spending, premiums, and enrollment under the plan or coverage. This information will support the development of public reports that will be published by the Departments on prescription drug reimbursements for plans and coverage, prescription drug pricing trends, and the role of prescription drug costs in contributing to premium increases or decreases under the plans or coverage. The 2021 interim final rules, âPrescription Drug and Health Care Spendingâ (2021 interim final rules), issued by the Departments and the Office of Personnel Management (OPM) implement the provisions of section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act, as enacted by section 204 of Title II of Division BB of the CAA. OPM joined the Departments in issuing the 2021 interim final rules, requiring Federal Employees Health Benefits (FEHB) carriers to report information about prescription drug and health care spending, premiums, and plan enrollment in the same manner as a group health plan or health insurance issuer offering group or individual health insurance coverage.
Burden hours have decreased from 1,684,080 hours to 668,552 hours. The three-year average burden has been updated to remove the one-time first- and second-year implementation burdens that were incurred only in 2022 and 2023. Reporting instructions (document title: RxDC Reporting Instructions) have been revised to add clarifications in response to comments and questions from the respondents; however, these revisions did not result in a burden hour change.
Prescription Drug and Health Care Spending (CMS-10788)
Active
Issuers and FEHB Carriers, PBMs, TPAs
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.
RxDC Reporting Instructions for 2025 REDLINE.docx
Comment Response Document.pdf
PBMs