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COMMENT
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OMB Control No:
0938-1308
ICR Reference No:
202512-0938-009
Status:
Received in OIRA
Previous ICR Reference No:
202212-0938-016
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Medicare Outpatient Observation Notice (MOON) (CMS-10611)
Type of Information Collection:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
12/09/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
2,073,991
0
Time Burden (Hours)
518,498
0
Cost Burden (Dollars)
0
0
Abstract:
The Centers for Medicare & Medicaid Services (CMS) requests a new collection named the Medicare Outpatient Observation Notice (MOON), Form CMS-10611, as the written notice promulgated by the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) Public Law 114-42 enacted by Congress on August 6, 2015 and effective 12 months after the date of the enactment which is August 6, 2016. The NOTICE Act amended Section 1866(a)(1) of the Social Security Act (the Act) (42 U.S.C. 1395cc(a)(1)) by adding subparagraph (Y) which sets forth requirements for Medicare participating hospitals and critical access hospitals (CAHs) to provide outpatient notification to persons entitled to Medicare benefits under Title XVIII of Act, who are hospital observation patients for more than 24 hours. Notification must be given no later than 36 hours after the initiation of observation services. This notification process consists of a written notice as determined by the Secretary, which will be the MOON, and an oral explanation of the written notice. The notice must include the reason the individual is receiving observation services and must explain the implications of receiving outpatient observation services, such as cost sharing, and post-hospitalization eligibility for Medicare coverage of skilled nursing facility (SNF) services. The MOON is a standardized notice written in plain language that includes all of the informational elements required by statute.
Authorizing Statute(s):
US Code:
42 USC 1395c(a)(1)
Name of Law: Social Security 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 45939
09/24/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 56763
12/08/2025
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
Medicare Outpatient Observation Notice
CMS-10611, CMS-10611
MOON Form
,
MOON Form - Spanish version
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
2,073,991
0
0
0
1,390,769
683,222
Annual Time Burden (Hours)
518,498
0
0
0
347,692
170,806
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:
CMS estimates that 5,817 hospitals and CAHs will deliver 2,073,991 notices, annually. This represents an increase of 1,390,769 from our last collection. This is due to our recent capacity to capture Medicare Advantage data in addition to Original Medicare. There are no associated policy changes, but solely the ability to fully account for the existing burden. Hourly burden has increased from 170,806 to 518,498 due to the growth in hospitals/CAHs and notices submitted.
Annual Cost to Federal Government:
$1,572
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:
12/09/2025
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