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:
0938-1390
ICR Reference No:
202402-0938-003
Status:
Active
Previous ICR Reference No:
201912-0938-024
Agency/Subagency:
HHS/CMS
Agency Tracking No:
OIT
Title:
Administrative Simplification HIPAA Compliance Review (CMS-10662)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/26/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/20/2024
Terms of Clearance:
As discussed in August 2026, the agency is transitioning this ICR to a new contractor and will be significantly revising the instruments within the next year. When this revision is submitted, the revised instruments shall incorporate the revised public burden statement to include all information as required by 5 CFR ยง 1320.8(b)(3), as well as attestation language that outlines the consequences of non-compliance.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
08/31/2024
Responses
60
0
20
Time Burden (Hours)
1,000
0
600
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of this collection is to retrieve information necessary to conduct a compliance review as described in CMS-0014-N (68 FR 60694). These forms will be submitted to the Centers for Medicare & Medicaid Services (CMS), Program Management National Standards Group, from entities covered by HIPAA Administrative Simplification regulations. It is expected that covered entities under HIPAA (health plans, health care clearinghouses, and health care providers who electronically transmit any health information in connection with transaction for which HHS has adopted standards) will complete these forms during a CMS scheduled compliance review. CMS enforcement staff would use the information provided by covered entities to review HIPAA Administrative Simplification compliance in regards to adopted transaction standards, code sets, unique identifiers and operating rules.
Authorizing Statute(s):
PL:
Pub.L. 104 - 191 264
Name of Law: HIPAA
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:
88 FR 78367
11/15/2023
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 12846
02/20/2024
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Compliance Review
CMS-10662, CMS-10662
ASETT_Assessment_All_Operating_Rule_Response_Attestation
,
ASETT_Notice of Assessment_Package
Corrective Action Plan and Monitoring
CMS-10662, CMS-10662
Notice_of_Corrective_Action_508
,
Corrective_Action_Followup_Letter_508
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
60
20
0
0
40
0
Annual Time Burden (Hours)
1,000
600
0
0
400
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 has increased due to the increase in the number of reviews to be conducted annually-up to 50 annually. The more compliance reviews that are able to conducted, the greater impact the program will have on advancing their authority to ensure widespread compliance across all covered entities. This update has adjusted the annual time burden to 1000 from the previously approved 600 burden hours.
Annual Cost to Federal Government:
$3,224
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:
Stephan McKenzie 410 786-1943 stephan.mckenzie@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:
02/20/2024
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