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View ICR - Agency Submission
COMMENT
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OMB Control No:
0938-1455
ICR Reference No:
202512-0938-016
Status:
Received in OIRA
Previous ICR Reference No:
202305-0938-021
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CCSQ
Title:
Requirement for Electronic Prescribing for Controlled Substances (EPCS) for a Covered Part D Drug Under a Prescription Drug Plan or an MA–PD Plan (CMS-10834)
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
12/17/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
306
0
Time Burden (Hours)
52
0
Cost Burden (Dollars)
0
0
Abstract:
Section 2003 of the SUPPORT for Patients and Communities Act of 2018 requires that prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions, which HHS may specify. In the calendar year (CY) 2021 and 2022 Physician Fee Schedule (PFS) final rules, CMS finalized the electronic prescribing for controlled substances (EPCS) requirements and exceptions at 42 CFR 423.160(a)(5). Compliance for prescribers not in long-term care facilities begins in CY 2023. Compliance for prescribers in long-term care facilities begins in CY 2025. EPCS requirements do not require prescribers or pharmacies to submit additional data to CMS; however, CMS did finalize one exception that requires data collection. The EPCS exception, at § 423.160(a)(5)(iv), requires a prescriber to apply for a waiver if the prescriber is unable to conduct EPCS due to circumstances beyond the prescriber's control. This document covers the burden associated for the request for the waiver exclusion at § 423.160(a)(5)(iv).
Authorizing Statute(s):
US Code:
42 USC 1395w-104(e)(7)
Name of Law: Requirement of e-prescribing for controlled substances.
PL:
Pub.L. 115 - 271 2003
Name of Law: SUPPORT for Patients and Communities Act
Citations for New Statutory Requirements:
None
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:
90 FR 45214
09/19/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 58566
12/17/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Requirement for Electronic Prescribing for Controlled Substances (EPCS) for a Covered Part D Drug Under a Prescription Drug Plan or an MA–PD Plan
CMS-10834
EPCS Waiver Application
ICR Summary of Burden
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
306
0
0
206
0
100
Annual Time Burden (Hours)
52
0
0
35
0
17
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The number of respondents increased from 100 to 306. The annual burden hours increased from 17 to 52.
Annual Cost to Federal Government:
$8,886
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]?
No
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:
Denise King 410 786-1013 Denise.King@cms.hhs.gov
Common Form ICR:
No
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:
12/17/2025
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