2023-07115.pdf

Memo-Archive-%3F-2017-Qtr3.https://www.cms.gov/Research-Statistics-Data-and- Systems/Computer-Data-and-Systems/HPMS/ HPMS-Memos-Archive-Annual-Items/SysHPMS- Memo-Archive-%3F-2017-Qtr3.https://www.cms.gov/Research-Statistics-Data-and- Systems/Computer-Data-and-Systems/HPMS/ HPMS-Memos-Archive-Annual-Items/SysHPMS- Memo-Archive-%3F-2017-Qtr3. Response: We are happy to clarify which materials are required to be provided in non-English languages and accessible formats. The requirement we are finalizing at  422.2267(a)(3) applies to all of the required materials described at  422.2267(e) and ICPs, but it does not extend to other supplemental documents, such as health education materials. We also noted at 87 FR 79522 of the proposed rule that on a standing basis means that once a plan learns of an enrollees primary language and/or need for an alternate formatwhether through an enrollee request, 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 reiterate that it is acceptable for an enrollee to request to receive a material in a non-English language or alternate format on a one-time or standing basis and that the plan may inquire as to the enrollees needs. Comment: A commenter requested that we define the word enrollee. Another commenter questioned how an enrollee can request alternate formats and whether a representative can make the request. This commenter questioned if CMS can provide model scripting to discuss requests with enrollees. Another commenter questioned if CMS has considered developing model documents in large print and the 15 nationally most-common languages and braille and Spanish braille. Response: We are happy to clarify this information for the commenters. As defined at  422.2 and  422.561, an MA plan enrollee, or enrollee, means an MA eligible individual who has elected an MA plan offered by an MA organization. The terms Part D enrollee and enrollee are used in a similar way in 42 CFR part 423. At 87 FR 79522 of the proposed rule, we described multiple enrollee touch points that plans can use to capture an enrollees preference for alternate languages or accessible formats. Examples of these touch points include welcome calls, health risk assessments, nurse advice lines, and other interactions associated with member services, enrollment, prescription services, appeals and grievances, and care management. As described at  422.119, MA plans must make information accessible to current enrollees or the enrollees personal representative. Therefore, they can make a request for non-English languages or alternate formats on behalf of an enrollee. Since, as previously described, there are a variety of ways a plan can obtain information regarding an enrollees preference for alternate languages or accessible formats, CMS does not provide model scripting to discuss requests with enrollees. In addition, we noted in the August 30, 2017 HPMS 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)124that it is the responsibility of the MA plans to produce its materials in accessible formats when requested. Comment: A commenter requested that CMS clarify that both existing and proposed translation standard requirements do not apply to third-party marketing organizations (TPMOs) or first-tier, downstream, and related entities (FDR) unless otherwise agreed upon between the MA organization and the TPMO or FDR, or the Part D sponsors and the TPMO or FDR. Response: We clarify that per  422.2274(g), in addition to all applicable FDR requirements at  422.504(i), when doing business with a TPMO, the MA organization is responsible for ensuring that the TPMO adheres to any requirements that apply to MA plans, including the existing and proposed translation standard requirements. Comment: Several commenters requested that CMS expand the list of languages provided in HPMS for MA contracts to the 15 most commonly spoken non-English languages spoken in a service area. These commenters believed that this change would allow plans to see how close service areas are to meeting the 5 percent threshold for updating materials and content and plan accordingly. A few of them also recommended that CMS designate the effective date for updating new materials and content as the plan year that begins a year after the date the 5 percent threshold is met and recommended that CMS delay enforcement for a period of time. Response: We appreciate the comments. Sections 422.2267(a)(2) and 423.2267(a)(2) require that MA organizations and Part D sponsors translate required materials into any non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package (PBP) service area. In HPMS, we currently provide MA organizations and Part D sponsors with information noting the languages they are required to translate materials into based on this standard. We will consider expanding the list of languages provided in HPMS for MA and Part D plans to the 15 most commonly spoken non-English languages in a service area in a future HPMS update to assist plans in monitoring which languages may be getting close to the 5 percent threshold. We remind plans that they must also comply with translation requirements under 45 CFR 92.101 and any future requirements under 45 CFR parts 80 and 92. We also acknowledge the recommendation that CMS designate the effective date for updating new materials and content as the plan year that begins a year after the date the 5 percent threshold is met and the recommendation that CMS delay enforcement for a period of time. We note that the languages requiring translation based on the 5 percent threshold have not changed for several years. Thus, we do not anticipate that plans will need to translate required materials in many new languages in the future and decline to delay the applicability date of the requirement we are finalizing at  422.2267(a)(3) to the year after the date the 5 percent threshold is met. Also, we decline to delay enforcement of the requirement. We believe that the benefits of enrollees being provided required materials in non-English languages and alternate formats outweighs any additional burden by plans and are finalizing the requirement as applicable for all required materials related to CY 2024. Comment: A few commenters requested that CMS revisit the threshold requirement at  422.2267(a)(2) and 423.2267(a)(2) for translation by MA and Part D plans. The commenters recommended setting a threshold that, in addition to the percentage of individuals in a PBP service area, includes a numerical threshold based either on the number of enrollees speaking a non-English language in the PBP service area or the number enrolled in the plan. They noted that with very VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00112 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222231 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations few exceptions, the 5 percent standard means that the translation requirement applies only to Spanish, yet close to one million Medicare beneficiaries speak a non-English language other than Spanish. They also stated that using a percentage measure without any reference to the absolute number of individuals in a service area leaves significant swaths of individuals with LEP, particularly those in large diverse service areas, without access to any translated materials from their MA plans. Response: We appreciate the commenters perspectives and agree that there are few service areas in which plans are required to translate materials in non-English languages beyond Spanish. The requests for us to change the threshold for the translation requirement at  422.2267(a)(2) and 423.2267(a)(2) are out of scope of this regulation. We believe policy making on this issue would benefit from further study and engagement with interested parties, including notice to the public and the opportunity to submit comments on this topic. We require MA and Part D plans to provide the multi- language insert that will inform the reader in the fifteen most commonly spoken non-English languages used in the U.S., as well as any additional non- English language that is the primary language of at least 5 percent of the individuals in a PBP service area, that interpreter services are available for free. We remind plans that they must also comply with translation requirements under 45 CFR 92.101 and any future requirements under 45 CFR parts 80 and 92. Comment: A few commenters stated that the translation requirement should also apply to original Medicare materials such as the Medicare & You Handbook. Response: We appreciate the comments. Materials sent directly by CMS are beyond the scope of this rulemaking, but we note that when individuals request the Medicare & You Handbook in Spanish or an accessible format, we continue to send them the Medicare & You Handbook every year in the requested format (and use that preference for other CMS mailings as well). Comment: A commenter requested that CMS increase its oversight of plan performance through secret shopper testing of language access, monitoring of language access grievances, focus groups, and other measures to hold plans accountable for compliance with language access requirements. Response: We appreciate the suggestions for oversight of plan performance for language access. Oversight of plan performance is very important to us, and we will continue to use multiple methods to ensure that plans meet the regulatory requirements and enrollees have access to the information needed to make informed health care decisions. Comment: A commenter highlighted the opportunity plans have to use community-based organizations (CBOs) to create, operationalize, and maintain the capacity to supply translation services as well as auxiliary aids and supports. The commenter asserted that such plan-CBO capacity-building can reach historically-underserved and linguistically and culturally diverse pockets of the country with (1) adaptive interventions and (2) interventions to improve provider-patient interactions and relationships. They noted the importance of working with community partners who may be best suited to provide these language and cultural competencies, but they also emphasized that Medicare language is highly technical in nature and not every CBO partner can translate this type of language. The commenter highlighted how State Health Insurance Assistance Program (SHIP) offices and their agencies are stepping up to fulfill the need for translation services where that capacity does not currently exist. They stated that CMSs proposed language access provisions for the 2024 calendar year are necessary because SHIP counselors have limited resources and are merely scratching the surface to meet the need for translation services in their communities. Another commenter expressed that health plan materials should provide clear information on plan benefits to both enrollees and providers, and care coordinators and navigators should be available to discuss the options with enrollees. They noted that accountable care organizations (ACOs) can help with this, because they are more likely to have a longitudinal relationship with the patient and have a care team in place to help with outreach and coordination. The commenter also stated that ACOs and practices participating in advanced alternative payment models often have the infrastructure to use data to better identify, outreach, and successfully engage harder-to-reach patients, but they cannot do it as efficiently on their own. According to the commenter, the more standardization there is in how health plans communicate to patients and providers on how to access benefits and what resources are available to them, the better partners primary care physician practices can be in helping dually eligible individuals navigate the complex health care landscape. Response: We thank the commenters for highlighting the important roles that CBOs, SHIPs, and ACOs play in providing potential enrollees and enrollees with their health care options. We agree that these organizations can play a vital role in working with Medicare beneficiaries with LEP since they often have close relationships with these communities. Comment: A commenter noted the importance of using medical interpreters as a means of improving the quality of care provided to patients with LEP and patients with sensory impairments. This commenter expressed concern about the cost of providing interpreter services and that limited reimbursement is available for language access services. The commenter noted the cost of these services should be paid for by health plans and not providers. The commenter also stated that it is important that MA organizations, cost plans, and Part D sponsors adequately inform their enrollees of the ability to access interpreters and/or with written materials in their primary language or an accessible format. Finally, the commenter indicated that CMS needs to ensure the competency of interpreters. Another commenter encouraged CMS to ensure access to a translation service that helps address gaps between patient and provider fluency by continuously evaluating the quality of interpreters. Response: We appreciate the commenters perspectives on this issue. These comments are outside the scope of this rulemaking to address the requirement of MA, cost, and Part D plans to provide written materials to enrollees on a standing basis in any non-English languages that is the primary language of at least 5 percent of the individuals in a plan benefit package service area and in accessible formats. However, we note that 45 CFR 92.101(b)(2) discusses language assistance services requirements and requires that services must be provided free of charge, be accurate and timely, and protect the privacy and independence of individuals with LEP. Section 92.101(b)(3) also requires that services be provided by an interpreter who adheres to generally accepted interpreter ethics principles, including client confidentiality; has demonstrated proficiency in speaking and understanding at least spoken English and the spoken language in need of interpretation; and is able to interpret effectively, accurately, and impartially, both receptively and expressly, to and from