CMS-10338 - Change Justification Memo - 2025

To: XXXXX

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Leslie Wagstaffe

Consumer Support Group (CSG)

Center for Consumer Information and Insurance Oversight (CCIIO)

Centers for Medicare and Medicaid Services (CMS)

Date: February XX 2025

Subject: Non-Substantive Change Request – Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered and Grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338/OMB Control Number 0938-1099)

This memo requests approval of a non-substantive change to the approved information collection under Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered and Grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338/OMB Control Number 0938-1099).

Background

Sections 2715 and 2719 of the Public Health Service (PHS) Act require group health plans and health insurance issuers offering group or individual health insurance coverage (plans and issuers) to provide the summary of benefits and coverage (SBC) and internal claims and appeals and external review notices in a culturally and linguistically appropriate manner. To meet this requirement, regulations implementing sections 2715 and 2719 of the PHS Act specify that plans and issuers must provide the following in any applicable non-English language: (1) oral language services; (2) translated notices and SBCs upon request; and (3) taglines on notices and SBCs indicating how to access the language services provided by the plan or issuer.¹ These regulations specify that a non-English language is an applicable non-English language, with respect to an address in any United States county to which a notice is sent, if ten percent or more of the population residing in the county is literate only in the same non-English language, as determined in guidance published by the Secretary of Health and Human Services.

In January 2016, the Departments of Labor, Health and Human Services, and the Treasury (the Departments) published guidance² identifying Spanish, Chinese, Tagalog, and Navajo as applicable non-English languages that meet the ten percent threshold in a U.S. county.³ In November 2023, the Departments published updated guidance⁴ identifying four additional languages (Pennsylvania Dutch, Samoan, Carolinian, and Chamorro) based on recent U.S. Census data⁵.

To help plans and issuers meet this requirement, the Departments included model notices for adverse benefit determinations, external review decisions, and internal adverse benefit determinations in the internal claims and appeals and external review PRA package (CMS-10338). These model notices include taglines in Spanish, Chinese, Tagalog, Navajo, Pennsylvania Dutch, Samoan, Carolinian, and Chamorro. This guidance is applicable beginning with plan years (in the individual market, policy years) beginning on or after January 1, 2025.⁶

Overview of Requested Changes

To incorporate taglines in the four additional languages (Pennsylvania Dutch, Samoan, Carolinian, and Chamorro) identified in the updated CLAS guidance,⁷ CMS made a non-substantive change to the Internal Claims and Appeals and External Review package (CMS-10338). This update, which included revisions to the model notices for adverse benefit determinations, external review decisions, and internal adverse benefit determinations, was approved by OMB on December 13, 2024.

However, CMS inadvertently submitted an incorrect version of the "Internal Adverse Benefit Determination" model notice and is requesting to replace it with the corrected version.

Since this request only involves replacing an incorrect notice with the correct one, it does not impact any burden descriptions or estimates in the existing Internal Claims and Appeals and External Review PRA package. Additionally, we adjusted the font size in the model notice of external review decision to ensure consistency with the other model notices.

We believe this non-substantive change will help prevent confusion and ensure that plans and issuers use the correct model notices during the internal claims and appeals and external review processes.

Time Sensitivities

Plans and issuers must begin providing revised internal claims and appeals and external review notices starting with plan years (in the individual market, policy years) beginning on or after January 1, 2025. Therefore, we request that OMB approve this change as soon as possible to allow plans and issuers to implement the correct version of the internal adverse benefit determination model notice.

1 26 CFR 54.9815-2715(a)(5), 29 CFR 2590.715-2715(a)(5), and 45 CFR 147.200(a)(5); 26 CFR 54.9815-2719(e), 29 CFR 2590.715-2719(e), and 45 CFR 147.136(e).

2 CLAS County Data (January 2016), available at https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/CLAS-County-Data_Jan-2016-update-FINAL.pdf.

3 See FAQs about Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 63 (November 28, 2023), available at https://www.cms.gov/files/document/faqs-part-63.pdf.

4 County Data for Culturally and Linguistically Appropriate Services (CLAS County Data), November 2023, available at https://www.cms.gov/files/document/clas-county-data-2023.pdf.

5 See FAQs about Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 63 (November 28, 2023), available at https://www.cms.gov/files/document/faqs-part-63.pdf.

6 County Data for Culturally and Linguistically Appropriate Services (CLAS County Data), November 2023, available at https://www.cms.gov/files/document/clas-county-data-2023.pdf.

7 County Data for Culturally and Linguistically Appropriate Services (CLAS County Data), November 2023, available at https://www.cms.gov/files/document/clas-county-data-2023.pdf.