Non-Substantive Change Memo

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: William N. Parham III

Office of Strategic Operations and Regulatory Affairs (OSORA)

Centers for Medicare and Medicaid Services (CMS)

Date: February 9, 2024

Subject: Non-Substantive Change Request – End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration (OMB No: 0938-0046; CMS-2728)

This memo requests approval of a non-substantive change to the approved information collection titled End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration (OMB No: 0938-0046; CMS-2728)

Background

The End Stage Renal Disease (ESRD) Medical Evidence (CMS-2728) is completed for all ESRD patients either by the first treatment facility or by a Medicare-approved ESRD facility when it is determined by a physician that the patient’s condition has reached that stage of renal impairment that a regular course of kidney dialysis or a kidney transplant is necessary to maintain life. The data reported on the CMS-2728 is used by the Federal Government, ESRD Networks, treatment facilities, researchers, and others to monitor and assess the quality and type of care provided to end stage renal disease beneficiaries. The data collection captures the specific medical information required to determine the Medicare medical eligibility of End Stage Renal Disease claimants. It also collects data for research and policy on this population.

Overview of Requested Changes

The Division of Kidney Health (DKH) in the Center for Clinical Standards and Quality (CCSQ) is requesting to make the following non-substantive edits to the currently approved information collection request. The requested edits will provide better alignment with other cognitively tested surveys used across Government Agencies. Please see the attached redline document for a visual illustration of the non-substantive edits to form CMS-2728. The following changes have no impact on the currently approved burden for this information collection.

• Section A #8: Reformatted question from “Sex at Birth” to “Sex Assigned at Birth, on Your Original Birth Certificate” and condensed responses to: Male or Female

• Section A #9: Revised “Gender Identity” category to “How Do you Currently Describe Yourself” and condensed responses to: Male, Female, Transgender Male, Transgender Female, and None of the Above.