View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1407
ICR Reference No:
202404-0938-028
Status:
Active
Previous ICR Reference No:
202206-0938-018
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CCIIO - 10788
Title:
Prescription Drug and Health Care Spending (CMS-10788)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
Yes
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/16/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/30/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2027
36 Months From Approved
01/31/2026
Responses
356
0
356
Time Burden (Hours)
668,952
0
1,684,080
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 93 - 406 725
Name of Law: ERISA
PL:
Pub.L. 116 - 260 204
Name of Law: Consolidated Appropriations Act, 2021
Citations for New Statutory Requirements:
PL: Pub.L. 93 - 406 725 Name of Law: ERISA
PL: Pub.L. 116 - 260 204 Name of Law: Consolidated Appropriations Act, 2021
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 6118
01/31/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 34249
04/30/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Issuers and FEHB Carriers
PBMs
TPAs
ICR Summary 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
356
356
0
0
0
0
Annual Time Burden (Hours)
668,952
1,684,080
0
0
-1,015,128
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:
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.
Annual Cost to Federal Government:
$4,200,000
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]?
Yes
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
Agency Contact:
Jamaa Hill 301 492-4190
Common Form ICR:
Yes
Description/Changes for Common Form Usage:
Approved RCFs using this ICR
Agency/Sub Agency
RCF ID
RCF Title
RCF Status
IC Title
TREAS/IRS
202412-1545-001CF
Prescription Drug and Health Care Spending (CMS-10788)
Active
Issuers and FEHB Carriers, PBMs, TPAs
DOL/EBSA
202412-1210-001CF
Prescription Drug and Health Care Spending (CMS-10788)
Active
Issuers and FEHB Carriers, PBMs, TPAs
OPM
202412-3206-001CF
Prescription Drug Data Collection (RxDC) Reporting Instructions
Active
Issuers and FEHB Carriers
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:
04/30/2024
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