Reinstatement without change of a previously approved collection
No
Regular
12/09/2025
Requested
Previously Approved
36 Months From Approved
2,073,991
0
518,498
0
0
0
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.
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.
$1,572
No
No
No
No
No
No
No
Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov
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:
(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;
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.
Form CMS-10611 Medicare Outpatient Observation Notice
CMS Response to 60-day Public Comments - CMS-10611.docx
Crosswalk Changes MOON.pdf
Medicare Outpatient Observation Notice