Medicare Outpatient Observation Notice (MOON) (CMS-10611)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10611 Moon Form	Form	Unchanged	Available
Form CMS-10611 MOON Form	Form	Unchanged	Available
CMS-10611_Supporting Statement_.docx	Supporting Statement A	Uploaded 2023-01-04	Repair queued
2022Crosswalk for CMS-10611_SPANISH.xlsx	Supplementary Document	Uploaded 2022-12-16	Repair queued
(0938-1308) Nonsub Memo_CMS-10611.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-01-04	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
221292	Medicare Outpatient Observation Notice	Form	Unchanged	Moon Form
221292	Medicare Outpatient Observation Notice	Form	Unchanged	MOON Form
221292	Medicare Outpatient Observation Notice	Instruction	Unchanged

ICR Details

OMB Control No: 0938-1308	ICR Reference No: 202212-0938-016
Status: Historical Active	Previous ICR Reference No: 202212-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Outpatient Observation Notice (MOON) (CMS-10611)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/05/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/05/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	11/30/2025	11/30/2025
Responses	683,222	0	683,222
Time Burden (Hours)	170,806	0	170,806
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 1395c(a)(1) Name of Law: Social Security Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 32028	05/26/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 51984	08/24/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Medicare Outpatient Observation Notice	CMS-10611, CMS-10611	MOON Form ,   Moon Form

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ICR Summary of Burden

table that charts list 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	683,222	683,222	0	0	0	0
Annual Time Burden (Hours)	170,806	170,806	0	0	0	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: We estimate that hospitals and CAHs will deliver 683,222 notices, annually. This represents a decrease of 262,987 from our last collection. This is likely due to consequences of the pandemic.

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Annual Cost to Federal Government: $0

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

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Common Form ICR:  No

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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: 01/05/2023

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