2023-07115.pdf

the materials required under  422.2267(e) and 423.2267(e) to be vital to the beneficiary decision making process; ensuring beneficiaries with limited English proficiency are aware of and are able to access interpreter services provides a clear path for this portion of the population to properly understand and access their benefits (87 FR 27821). We remind MA organizations and Part D sponsors that as recipients of Federal financial assistance, they have independent language access requirements under Title VI of the Civil Rights Act of 1964 and section 1557 of the Affordable Care Act and implementing regulations at 45 CFR parts 80 and 92, respectively. In addition, MA organizations and Part D sponsors must comply with section 504 of the Rehabilitation Act of 1973 and section 1557 of the Affordable Care Act, and the Department of Health and Human Services implementing regulations at 45 CFR parts 84 and 92. As recipients of Federal financial assistance, MA organizations and Part D sponsors must provide appropriate auxiliary aids and services, including interpreters and information in alternate formats, to individuals with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question. Auxiliary aids and services can include braille, large print, data/audio files, relay services, and TTY communications. We further explained the obligation of plans to provide accessible communications for individuals with disabilities in an August 30, 2017, Health Plan Management System memorandum titled, Frequently Asked Questions Regarding Accessible Communications for Individuals with Disabilities, Pursuant to Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557).119 These requirements notwithstanding, CMS has learned from oversight activities, enrollee complaints, and stakeholder feedback that enrollees often must make a separate request each time they need material in an alternate language or in an alternate format. In addition, during CMS program audits and oversight activities, we have found that special needs plans (SNPs) do not always translate individualized care plans (ICPs) into enrollees primary languages, even when the enrollee has expressed a need for translation as part of completing the health risk assessment. To address these issues, we proposed, based on our authority under the Medicare statute, to adopt regulations to impose additional Medicare marketing and communications standards on plans to ensure access to important information and materials for individuals who have limited English proficiency and individuals with disabilities. The materials required under  422.2267(e) and 423.2267(e) and ICPs are vital to how individuals access services and make decisions about their health care. These materials furnish important information about coverage and benefits under Medicare health and drug plans. We noted our belief that our proposal would make it easier for beneficiaries to understand the full scope of available Medicare benefits (as well as Medicaid benefits available through the DSNPs, where applicable), increasing their ability to make informed health care decisions, and promote a more equitable health care system by increasing the likelihood that MA enrollees have access to information and necessary health care. At 87 FR 79521 through 79522 of the proposed rule, we described the need for providing materials in non-English languages and in any accessible formats. We explained that communication and language barriers are associated with decreased quality of care and poorer health outcomes. In addition, individuals with limited English proficiency are less likely to have routine health visits, more likely to defer needed health care, and more likely to leave the hospital against medical advice.120Effective communication or meaningful access are critical to providing high-quality care. We believe that it is a substantial burden for enrollees to have to request each material in a non-English language or accessible format and that requiring enrollees to do so could impede access to care. It is also possible that enrollees may require materials in both an alternate format and a non-English language (for example Spanish braille). In addition, to ensure the ICPs are developed in consultation with the enrollee as required at  422.101(f)(1)(ii), it is important that ICP materials be provided in the enrollees primary language and, where appropriate, in an accessible format. As described at 87 FR 79522 of the proposed rule, research has found patients with limited English proficiency experience negative health outcomes due to the barriers they encounter, including when interacting with their doctors and care team members. We have become attuned to this issue through our work with Medicare-Medicaid Plans (MMPs), as explained at 87 FR 79522 of the proposed rule. We believe that there are many ways for MA organizations and Part D sponsors to learn of an enrollees need for an accessible format and language needs and maintain this information. We outlined examples at 87 FR 79522 of the proposed rule. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00107 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222226 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations We would like to minimize barriers for enrollees (and potential enrollees) with limited English proficiency and/or with disabilities who need materials in non-English languages and accessible formats and remove any ambiguity associated with MA and Part D plan responsibilities. Therefore, we proposed to re-designate the paragraphs at  422.2267(a)(3) and 423.2267(a)(3) as  422.2267(a)(5) and 423.2267(a)(5) and add new paragraphs at  422.2267(a)(3) and 423.2267(a)(3). In these new paragraphs, we proposed to require that MA organizations and Part D sponsors provide materials to enrollees on a standing basis in any non-English languages that are the primary language of at least 5 percent of the individuals in a plan benefit package service area as defined under  422.2267(a)(2), 423.2267(a)(2) and proposed  422.2267(a)(4) and 423.2267(a)(4), which are discussed later in this section, and in any accessible formats upon receiving a request for the materials in another language or otherwise learning of the enrollees preferred language or need for an accessible format. This means that once a plan learns of an enrollee with limited English proficiencys primary language and/or an enrollee with a disabilitys need for an alternate formatwhether through an enrollee requesting a material in a primary non-English language or alternate format, during a health risk assessment, or another touch pointthe plan must provide required materials in that language and/or accessible format as long as the enrollee remains enrolled in the plan or until the enrollee requests that the plan provide required materials in a different manner. We also proposed language at  422.2267(a)(3) and 423.2267(a)(3) to explicitly apply this requirement the individualized plans of care described in  422.101(f)(1)(ii) for SNP enrollees. The proposed requirement would allow enrollees to avoid having to submit a request to receive required materials in their primary language and/or alternate format each time the MA or Part D plan distributes a required material. We note that plans are responsible for providing materials in both an identified non- English primary language and accessible format when needed (for example Spanish braille). These modifications at  422.2267 and 423.2267 and other requirements at Parts 422 and 423 regarding translation obligations and accessible formats are in addition to plan obligations under 45 CFR parts 80 (Title VI), 84 (Section 504), and 92 (Section 1557) that govern meaningful access for individuals with limited English proficiency and effective communication for individuals with disabilities. MA and Part D plans must comply with both the rules at  422.2267 and  423.2267 and the non- discrimination requirements in 45 CFR parts 80, 84, and 92. Where one set of regulations imposes a higher or different standard, but it is possible for the plan to comply with both, the plan must comply with both. Because cost plans, per  417.428, are subject to the regulations in part 422, subpart V, these requirements also apply to cost plans. As we noted in the proposed rule at 87 FR 79523, there are no information collections related to creating a standing request for translated materials or materials in alternate formats. We believe the burden associated with these proposed requirements is exempt from the requirements of PRA as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. We believe most cost plans, MA organizations, and Part D sponsors have translators on staff or access them via contractors because of existing translation and auxiliary aid requirements. We received the following comments, and our responses follow. Comment: Many commenters supported CMS plan to require MA plans to provide standardized materials to enrollees on a standing basis in any non-English language that is the primary language of at least 5 percent of individuals in a plan benefit package service area and in accessible formats. They noted that untranslated materials can create barriers in accessing care and poor outcomes for patients with limited English proficiency (LEP). A few commenters appreciated that disability communication access is also a part of the effort to address language and cultural barriers to care and stated that the standardization of language access requirements will help patients reliably expect what their language access to health information will be. Another commenter noted that without access there can be no equity, and the CMS proposal changes the emphasis to ensure everyone has access to necessary care as a foundation for equity. A commenter was pleased to see the proposed requirement extend to individualized plans of care (ICPs) for special needs plans and noted that research has shown enrollees often are not aware of benefits that address social needs or do not know how to access them. A commenter also expressed that enrollees should not have to repeat requests for information, including critical information like ICPs, from plans as this poses unnecessary barriers to needed care and such communication and language barriers are associated with decreased quality of care and poorer health outcomes. Response: We appreciate the widespread support for our proposal. We agree that the proposed requirements will help to strengthen access to care and improve equity. Comment: A few commenters opposed the proposal and stated that the current policy was sufficient to meet enrollee needs. Several commenters noted that information regarding how to access translation services is included in materials. Another commenter stated that providers can assist enrollees in understanding the information. Response: We appreciate the perspective raised by these commenters. However, as stated in the proposed rule at 87 FR 79522, we believe that it is a substantial burden for enrollees to have to request each material in anon-English language or request alternate formats for each material and that requiring enrollees to do so could cause a critical delay to timely access to care. Comment: A number of commenters expressed concern over the financial investment that would be needed in developing an organization-wide process for capturing language and alternate format needs and implementing the requirement on a standing basis, including an investment in IT and vendor contracts. Numerous commenters also noted that it would take time to implement these processes including the system updates, updating vendor contracts, staff training, etc., and requested that CMS delay implementation until CY 2025. A commenter also requested a delay in implementing this requirement since these materials are often prepared well in advance of open enrollment for the following plan year. A few commenters expressed concern over the cost of translating materials into several languages on a standing basis. A commenter believed the proposed requirement would necessitate plans translating materials into more than 30 languages. Another commenter noted that they will still have to provide English versions of the materials for providers, even when enrollees request information in other languages. Response: We appreciate the commenters concerns regarding the infrastructure updates that will be needed to capture an enrollees preference for receiving materials in non-English languages and/or accessible formats and then using this information VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00108 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222227 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 121CMS released the contract year 2023 version of this HPMS memorandum titled, Contract Year 2023 Translated Model Materials Requirements and Language Data Analysis on September 23, 2022. This memorandum can be retrieved at: https://www.cms.gov/httpseditcmsgovresearch-statistics- data-and-systemscomputer-data-and- systemshpmshpms-memos-archive/hpms-memos- wk-4-september-19-23. to send out materials in the requested format on a standing basis. We also understand that some commenters are concerned about the cost of translating materials into several languages on a standing basis. Each fall, we release an HPMS memorandum announcing that plans can access in the HPMS marketing review module a list of all languages that meet the 5 percent threshold for plan service areas, which is the threshold for translation.121For contract year 2023, the threshold requires few contracts to translate into languages beyond Spanish: 16 MA contracts meet the threshold that requires translating materials into Chinese, and 19 MA and PDPs meet the threshold that requires translating materials into other Asian languages. There are no other service areas with additional languages that currently meet the 5 percent threshold for translation. As a result, there are very few MA organizations or PDPs that will