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

Forms and Documents

Document Name	Status
Form CMS-10611 Medicare Outpatient Observation Notice Form	Modified
CMS-10611_Supporting Statement_.docx Supporting Statement A	2022-08-25
CMS-10611 - Crosswalkv508.pdf Supplementary Document	2022-08-23

IC Document Collections

IC ID	Document Title	Status
221292	Medicare Outpatient Observation Notice Form	Modified

ICR Details

OMB Control No: 0938-1308	ICR Reference No: 202208-0938-020
Status: Received in OIRA	Previous ICR Reference No: 201911-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Outpatient Observation Notice (MOON) (CMS-10611)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/26/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2022
Responses	683,222	946,209
Time Burden (Hours)	170,806	236,552
Cost Burden (Dollars)	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

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

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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	683,222	946,209	0	0	-262,987	0
Annual Time Burden (Hours)	170,806	236,552	0	0	-65,746	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: 08/26/2022

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