Non-Substantial Justification Document

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Janet Miller

Center for Medicare (CM)

Medicare Enrollment and Appeals Group (MEAG)

Date: December 19, 2022

Subject: Non-Substantive Change Request – Medicare Outpatient Observation Notice (MOON) (OMB# 0938-1308; CMS-10611)

This memo requests approval of non-substantive changes to the approved information collection, Medicare Outpatient Observation Notice (MOON) (CMS-10611; OMB 0938-1308).

BACKGROUND

The Medicare Outpatient Observation Notice (MOON) serves as the written notice component of this mandatory notification process. The standardized content of the MOON includes all informational elements required by statute, in language understandable to beneficiaries, and fulfils the regulatory requirements at 42 CFR Part 489.20(y).

The MOON is a standardized notice delivered to persons entitled to Medicare benefits under Title XVIII of the Act who receive more than 24 hours of observation services, informing them that their hospital stay is outpatient and not inpatient, and the implications of being an outpatient. This information collection applies to beneficiaries in Original Medicare and enrollees in Medicare health plans.

The collection was last approved by OMB on November 22, 2022 and expires on November 30, 2025.

Overview of Requested Changes

Subsequent to OMB’s approval, this Non-material/Non-substantive Change request includes the Spanish translation of the Medicare Outpatient Observation Notice. Otherwise, there are no program changes or burden adjustments.