Prescription Drug and Health Care Spending (CMS-10788)

ICR 202603-0938-013

OMB: 0938-1407

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
250669 Modified
250668 Modified
250667 Modified
ICR Details
0938-1407 202603-0938-013
Received in OIRA 202404-0938-028
HHS/CMS CCIIO - 10788
Prescription Drug and Health Care Spending (CMS-10788)
No material or nonsubstantive change to a currently approved collection   Yes
Regular 04/01/2026
  Requested Previously Approved
12/31/2027 12/31/2027
356 356
668,952 668,952
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, “the Departments”) 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, “Prescription Drug and Health Care Spending” (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.

PL: Pub.L. 93 - 406 725 Name of Law: ERISA
   PL: Pub.L. 116 - 260 204 Name of Law: Consolidated Appropriations Act, 2021
  
PL: Pub.L. 93 - 406 725 Name of Law: ERISA
PL: Pub.L. 116 - 260 204 Name of Law: Consolidated Appropriations Act, 2021

Not associated with rulemaking

  89 FR 6118 01/31/2024
89 FR 34249 04/30/2024
Yes

3
IC Title Form No. Form Name
Issuers and FEHB Carriers
PBMs
TPAs

  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 356 356 0 0 0 0
Annual Time Burden (Hours) 668,952 668,952 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.

$4,200,000
No
    No
    No
Yes
No
No
No
Jamaa Hill 301 492-4190

  Yes
 
Agency/Sub Agency RCF ID RCF Title RCF Status IC Title

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.
04/01/2026

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