OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.
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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.
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-10611 v508MOONsupportingstatement2.docx
Medicare Outpatient Observation Notice