Non-Substantive Justification Memo

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: AnhViet Nguyen

Centers for Medicare and Medicaid Services (CMS)

Medicare Enrollment and Appeals Group (MEAG/Division of Eligibility and Enrollment (DEEP)

Date: December 4, 2023

Subject: Non-substantive Change Request – Medicare Part C and Medicare Part D Enrollment Form Interviews (CMS-10816;OMB 0938-1440)

This memo requests approval of non-substantive changes to the approved information collection, Medicare Part C and Medicare Part D Enrollment Form Interviews (CMS-10816, OMB 0938-1440).

Background

Section 4001 of the Balanced Budget Act of 1997 (Public Law 105-33) enacted August 5, 1997, established Part C of the Medicare program, known as the Medicare + Choice program, now referred to as Medicare Advantage (MA). As required by 42 CFR 422.50(a)(5), an MA eligible individual who meets the eligibility requirements for enrollment into an MA or MA-PD plan may enroll during the enrollment periods specified in §422.62, by completing an enrollment form with the MA organization or enrolling through other mechanisms that the Centers for Medicare & Medicaid Services (CMS) determines are appropriate.

Section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108–173) enacted December 8, 2003, established Part D of the Medicare program, known as the Voluntary Prescription Drug Benefit Program. As required by 42 CFR 423.32(a) and (b), a Part D-eligible individual who wishes to enroll in a Medicare prescription drug plan (PDP) may enroll during the enrollment periods specified in §423.38, by completing an enrollment form with the PDP, or enrolling through other mechanisms CMS determines are appropriate.

With the long-term goal of collecting race and ethnicity data from all Medicare enrollees, CMS requested and received OMB approval of the revised collection of information (CMS-10718; OMB 0938-1378) based on the inclusion of race and ethnicity data on the model MA and Part D enrollment form. The detailed race and ethnicity categories collected through the enrollment form are compliant with the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status to provide granular information for plans and CMS to understand the diversity of the beneficiary population. CMS initially focused efforts on individuals who newly elect or are already enrolled in an MA or PDP plan and change coverage starting January 1, 2023 during the Medicare Advantage Open Enrollment Period (MA-OEP).

  

On March 14, 2023, OMB approved the collection of information from non-responders to the race and ethnicity questions on the updated enrollment form (CMS-10816, OMB 0938-1440).

The data collection consists of cognitive interviews to understand how people who elect not to respond to the race and ethnicity questions perceive the addition of those questions on the form. CMS’ primary objective for the interviews is to identify the drivers of nonresponse to the race and ethnicity questions, specifically whether and what concerns drive individuals’ nonresponse to these items, including (but not limited to) (a) concerns about confidentiality of their data, (b) concerns about how their race and ethnicity data would be used, including concerns about whether disclosing such information could in any way affect eligibility for Medicare benefits (which it would not), or (c) concerns about response options (e.g. missing response options for race or ethnicity groups in which they may identify).

The first phase of the cognitive interviews (Wave 1) was conducted April through July 2023 and included cognitive interviews with individuals newly electing or changing coverage during the MA-OEP. The second phase of cognitive interviews (Wave 2) is planned for early 2024 and will include interviews with non-responders who enroll or switch MA or PDP plans during the October 15 – December 7, 2023 Annual Election Period (AEP). Based on the results from the Wave 1 interviews, CMS is requesting three non-substantive changes to the approved data collection to improve the quality and utility of the data collected in Wave 2.

Overview of Requested Changes

CMS seeks change requests to 1) revise the interview protocol to accurately reflect the order of the race question on the updated enrollment form, 2) add prompts for cognitive interview participants who do not recall the race and ethnicity questions on the enrollment form, and 3) increase the total number of cognitive interviews from 120 to 130, to ensure a sufficient number of interviews with Spanish-speaking members and PDP members.

1. Revision to protocol to accurately reflect the order of the response options for the race question on the updated enrollment form

OMB’s terms of clearance for the approved information collection, Medicare Part C and Medicare Part D Enrollment Form Interviews (CMS-10816, OMB 0938-1440), required that CMS submit a non-substantial change request to revise its new race question to ensure appropriate and tested alphabetization of race categories with nested sub-categories of race rather than alphabetization of all sub-categories together. This revision also clarifies that there are subcategories for the “Asian” and “Native Hawaiian/Pacific Islander” categories. See the revised interview protocol in Attachment A. The revised layout of the race question (Question 5) is highlighted in yellow. A crosswalk of the original and revised race question is contained in Attachment B.

2. Additional prompts for cognitive interview participants who do not recall the race and ethnicity questions on the enrollment form

Based on the results from the Wave 1 cognitive interviews conducted in April-July 2023, CMS is requesting the addition of prompts to the interview protocol to aid in CMS’ understanding of participant recall of the race and ethnicity questions on the enrollment form. To clarify that the interview is asking about recall of the race and ethnicity questions, we have added prompts for participants who indicate that they do not recall the questions. After stating the question, e.g., “Are you Hispanic, Latino/a, or Spanish origin?,” we will ask again if they recall the question and then list and ask about the response options. See the revised interview protocol in Attachment A. The additional prompts are in Questions 9 and 10, highlighted in yellow.

3. Increase total number of interviews from 120 to 130 to ensure sufficient number of Spanish-speaking members and PDP members

CMS originally planned to complete 80 cognitive interviews during Wave 1 and 40 interviews during Wave 2. In Wave 1 interviews were completed with 90 participants including some Spanish-speaking members and PDP members. For Wave 2, CMS aims to complete a total of 40 interviews to ensure a sufficient number of Spanish-speaking and PDP members are represented in the interview data. CMS is therefore requesting to increase the number of interviews for the approved data collection from 120 to 130. This represents an increase in total burden hours from 90 to 95.

The additional burden hours are reflected in revised Supporting Statement A, “Burden Estimates (Hours & Wages), marked in tracked changes (See Attachment C). The updated sampling assumptions are contained in Supporting Statement B, “Respondent Universe and Sampling Methods,” marked in tracked changes (see Attachment D).

Time Sensitivities

The Medicare Part C and Medicare Part D Enrollment Form Interviews has a current OMB expiration date of March 31, 2026. However, timely approval of these non-substantive change requests will allow for timely interviews in January and February with non-responders who enroll or switch MA or PDP plans during the October 15 – December 7, 2023 AEP, thereby reducing potential recall issues. 

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