2023-07115.pdf

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 be required to translate required materials and, for MA SNPs, ICPs into more than one language. Therefore, we do not agree that plans will be required to translate materials into several languages. Also, the current regulations at  422.2267(a)(2) and 423.2267(a)(2) already require plans to translate required materials into languages that meet the 5 percent threshold. We also 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. For auxiliary aids and services, section 504 of the Rehabilitation Act of 1973, section 1557 of the ACA, and the regulations at 45 CFR 92.102(b) already require plans to provide appropriate auxiliary aids and services 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. The requirement we are finalizing at  422.2267(a)(3) and 423.2267(a)(3) only clarifies that plans must provide the materials based on the enrollees preference on a standing basis. While we understand that plans may need to make some adjustments to vendor contracts and make system updates, plans should already have resources in place to provide these materials translated into the languages required currently under  422.2267(a)(2) and 423.2267(a)(2) and accessible formats. In addition, plans should have systems in place that can be adjusted to track standing requests since they are already required to track a request for hard copy materials as described in  422.2267(d)(2)(i)(E) and 423.2267(d)(2)(i)(E). We believe the benefit of ensuring access to materials that can be easily understood by enrollees so that they can receive timely access to care outweighs any additional effort that plans may need to undertake. As stated earlier in this section and in the proposed rule at 87 FR 79522, we believe it is a substantial burden for enrollees to have to request each material in a non-English language or request accessible formats for each material and that requiring enrollees to do so could cause a critical delay to timely access to care. Thus, we are finalizing the provisions at  422.2267(a)(3) and 423.2267(a)(3) as proposed, without a delay in implementation. Comment: Many commenters recommended that CMS provide plans with flexibility to meet the requirements in other ways and believe that it is critical to provide materials in a way that is preferred by the enrollee or what the plan believes is in the best interest of the enrollee. They noted that an enrollee may not want all communications in the same language or format. Other commenters inquired if they may ask the enrollees whether they would like a material in an alternate format as a one-time request or as a standing basis. A commenter questioned whether the plan could offer telephonic translation services to the member, by bringing a translator or TTY on the line to help answer any questions in lieu of fulfilling the translated or alternate format document request. Some commenters noted that verbal communication is the most valuable language access method. A commenter noted that enrollees may not find value in an audio recording of the formulary or provider directory, or receiving an entire EOC in large print that would be nearly 600 pages and arrive in a box. Response: We thank commenters for suggestions to allow flexibility to provide materials based on the request of the enrollee, provided the request is reasonable. We agree that materials should be provided in the manner requested by the enrollee. We note at 87 FR 79522 and earlier in the preamble of our proposed rule that once the plan receives a request for materials in another language or for using auxiliary aids and services, the plan must provide required materials in the language and/ or accessible format as long as the enrollee remains enrolled in the plan or until the enrollee requests that the plan provide materials in a different manner. CMS believes that enrollees are in the best position to determine their needs for translation or an accessible format, and the plan should ensure that there is flexibility to accommodate different needs for different materials as requested by the enrollee. However, if a plan has concerns that a specific format may not be an effective way to provide information based on the enrollees needs, then it is appropriate for the plan to reach out to the enrollee to confirm their need for specific materials, provided that this outreach meets the entitys obligations for translation or interpretation services under Title VI (45 CFR part 80), Section 504 (45 CFR part 84), and Section 1557 (45 CFR part 92). For example, if an enrollee states that they would rather receive certain information included in specific materials translated verbally instead of a translated written copy of the document, it is acceptable for the plan to fulfill that request without sending a written copy. However, the plan must ensure that it documents this information in the plans systems. It is also acceptable for the plan to inquire whether an enrollee would like a material in a non-English language or alternate format on a one-time or standing basis. Comment: Numerous commenters raised concerns regarding the turnaround time needed to create non- standardized enrollee-specific materials in non-English languages and alternate formats, such as braille or non-English braille. Some commenters described concerns about producing materials quickly, such as coverage determination or organization determination notices which must be provided under tight timelines. These commenters stated that they would need to provide the materials first in English and then in non-English language(s) and the alternate formats to meet timeliness standards. Some commenters also noted that the turnaround time to create translations such as braille can be as much as four weeks. A commenter also expressed concerns that this requirement would further burden contracted vendors that work with multiple plans that would all be subject to these new requirements and believed VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00109 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222228 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 122CMS Office of Hearings and Inquiries, 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), August 30, 2017. Retrieved from 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.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. that this would result in reduced capacity. A commenter noted that the proposed rule is in addition to existing obligations under 45 CFR part 92 and that plans are expected to comply with both, even if one imposes a higher or different standard, unless it is impossible to do so. This commenter stated that the lack of clarity in the proposal on whether the standards under 45 CFR part 92 for determining reasonableness apply to the draft regulation could cause confusion for plans in implementing the guidance and, in turn, result in differential application across payers. The commenter explained that such ambiguity could result in beneficiary confusion and unnecessary cost for plans. The commenter included an example where a visually impaired enrollee could request an alternate format of braille, which the commenter noted under 45 CFR part 92 plans are permitted to determine the reasonableness by applying the applicable standards. The commenter suggested that CMS revise the current proposal to include explicit language that the same standards under 45 CFR part 92 apply to the proposed CMS requirement for providing all CMS required materials in both the preferred format and/or language. A few commenters raised concerns regarding their ability to meet the September 30 deadline for providing a translated or accessible format Annual Notice of Change (ANOC) to current enrollees. Several commenters recommended that CMS establish a stakeholder workgroup that includes translation contractors to discuss how turnaround times can be improved and which communications can be translated fast enough to meet the need of the beneficiaries. Response: We appreciate the commenters concerns regarding the turnaround time needed for required materials, and we acknowledge the specific concern for enrollee-specific materials, such as coverage determination notices. However, the proposed requirement to provide materials on a standing basis did not change a plans current obligation to provide materials timely in alternate languages under  422.2267(a)(2) or alternate formats under 45 CFR part 92, nor do they change a plans current obligations under 45 CFR parts 80 and 84. As outlined in the 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) dated August 30, 2017,122which is guidance that interprets these laws, MA plans are responsible for having appropriate processes in place to meet the applicable regulatory adjudication and notice timeframes at 42 CFR 422 Subpart M and  423 Subpart M. This includes cases where an MA plan has to produce a notice in an alternate format. This guidance informs MA plans of their obligation to provide materials in an alternate format, if requested by the enrollee, so long as the requests are reasonable requests. MA plans are responsible for complying with the timely-notice requirements (set forth at  422, Subpart M, and  423, Subpart M, respectively) in all cases. If there are certain facts and circumstances when the plan has difficulty producing an alternate format within the applicable adjudication timeframe, the plan should first work proactively with the individual to achieve equivalent communications, but nevertheless document the facts and circumstances, including an explanation of why the documentation could not be produced within the regulatory timeframe, and make best efforts to communicate the information to the individual via the most effective means. If communications are not provided in a timely manner, potential impacts include disadvantaging an individuals opportunity to take full advantage of enrollment periods, the appeals process, the opportunity to pay premiums in a timely manner, etc. Section 504 and section 1557 require reasonable modification. For example, the August 30, 2017 memorandum describes one scenario which could occur if an individual with a disability used an out-of-network provider and now requests instructions in an alternate format. This scenario describes how an individual could request that the MA plan reimburse them for the out- of-pocket claim. If the MA plan requires the claim to be filed within a certain amount of time, the August 30, 2017 memo states that the MA plan must take into account any added time needed to provide the instructions in the alternate format if the request is reasonable as required under section 504 and section 1557. If it took the MA plan an extra three days to put the instructions into the alternate format, three days should be added to the length of time in which the MA plan will accept the individuals claim. The MA plan should document how it ensured that the individual had an equal opportunity to participate in the program or activity. If an MA plan denies a request, the MA plan should document its decision and be able to share it with CMS or the HHS Office for Civil Rights (OCR) upon request. If CMS or HHS OCR reviews an MA plans decision, it will give weight to the individuals request based on the communications standards in 45 CFR 84.52(d), and