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