evekhm/cms_iom_500 huggingface dataset:
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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/
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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.
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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
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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 92.102. We note that CMS provides translated models for the ANOC and EOC each summer in Spanish and Chinese so that plans then can focus on including the plan-specific information prior to the September 30 annual deadline. For CY 2023, CMS also provided Spanish and Chinese versions of the ANOC and EOC for the DSNP specific models. We plan to provide these translated models for CY 2024 as well. Finally, we will consider establishing a stakeholder workgroup to discuss how turnaround times can be improved. 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. For these reasons and those noted previously, we are finalizing and implementing these requirements for CY 2024. As such, these requirements will be applicable
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that they can receive timely access to care outweighs any additional effort that plans may need to undertake. For these reasons and those noted previously, we are finalizing and implementing these requirements for CY 2024. As such, these requirements will be applicable for all required materials related to CY 2024. Comment: A commenter suggested that CMS ensure any requirements imposed on plans are consistent and implemented in coordination with changes issued by the HHS OCR. They suggested that CMS delay the requirements of this rule, since any change in OCR regulations that CMS wishes to impose on plans will not have been available for public comment. Response: We appreciate the comment. We do not believe that the requirements we are finalizing conflict with obligations for MA and Part A plans under section 1557 of the ACA. Further, as discussed in more detail in VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00110 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222229 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 123CMS 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-
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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. other responses to public comments, we do not believe that the scope of this final rule necessitates a delay in the requirements we are finalizing at  422.2267(a)(3) and 423.2267(a)(3). We also note that the OCR Section 1557 proposed rule was published on August 4, 2022, and there was the opportunity to comment on that rule until October 3, 2022. We are finalizing the requirements at  422.2267(a)(3) and 423.2267(a)(3) as applicable for all required materials related to CY 2024. We expect the tracking and use of standing requests can begin with requests received from enrollees in connection with materials for coverage in CY 2024. Unless an MA plan already has an existing process to track and use standing enrollee requests, we do not expect MA plans to go back to past enrollee requests to apply them as standing requests for 2024 materials. Consistent with Question 14 in the August 30, 2017 HPMS memo, an MA plan must make a best effort to ensure that an enrollee needs to only make the request of an MA plan once during the time the beneficiary is enrolled with the MA plan. If the enrollee leaves the MA plan and returns, the individual may need to make the request to the MA plan again. Comment: A commenter encouraged CMS to clarify the application of this requirement in regard to 42 CFR 422.2267(d)(2)(i). Response: Sections 422.2267(d)(2)(i) and 423.2267(d)(2)(i) state that, without prior authorization from the enrollee, MA organizations may mail new and current enrollees a notice informing enrollees how to electronically access the following required materials: the Evidence of Coverage, Provider
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state that, without prior authorization from the enrollee, MA organizations may mail new and current enrollees a notice informing enrollees how to electronically access the following required materials: the Evidence of Coverage, Provider and Pharmacy Directories, and Formulary. The option for plans to use electronic delivery is not changed by this final rule, but if a plan elects to use the procedures for electronic delivery of those materials, the notice informing the enrollee how to electronically access these materials is a required material subject to the translation requirements in existing paragraph (a)(2) and new paragraphs (a)(3) and (a)(4), as finalized in this rule, of  422.2267 and 423.2267. In addition,  422.2267(d)(2)(i)(E) and 423.2267(d)(2)(i)(E) indicate that the notice must provide the enrollee with the option to request hard copy materials; requests for the hard copy materials may be material specific and must have the option of a one-time request or a permanent request that must stay in place until the enrollee chooses to receive electronic materials again. Delivery of the hard copy materials is also subject to the translation requirements. This means that plans can send the notice in the enrollees primary non- English language or accessible format stating how the enrollee can access the materials electronically in lieu of sending a hard copy in the primary non- English language or accessible format. However, if an enrollee confirms that they want a hard copy of the material on a standing basis in their primary non-English language or alternate format, then the plan must provide that material in the primary non-English language or alternate format on a standing basis unless the enrollee noted that it is a one-time request. We also note that websites must be compliant with Section 508 of the Rehabilitation Act so that individuals can read sites and materials with screen reader technology. Also, as discussed 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)123plans must ensure that a beneficiary can access and use the MA plans electronic means of communications such as the plans website in order
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and Section 1557 of the Affordable Care Act (Section 1557)123plans must ensure that a beneficiary can access and use the MA plans electronic means of communications such as the plans website in order to be compliant with 45 CFR 92.202 and 92.204. Comment: Numerous commenters noted that they support the concept of making ICPs accessible to all enrollees, but, as proposed, they expressed concern about the time it would take to translate ICPs as well as the high cost of translating them on a standing basis since the materials are individualized based on the enrollee. Some commenters suggested that a care team member verbally review the ICP with the enrollee following updates to the ICP. This approach would have the added benefit of improving enrollee understanding and adherence to the ICP as they would have a team member to review the plan with them and the opportunity to ask questions. Following such a review, if the enrollee requested written translation, the plan could then be required to translate the ICP into the enrollees requested language. A commenter noted that if a provider makes treatment notes, it may not be possible for the plan to ensure that those notes are translated or provided in accessible formats such as braille. This commenter also stated that even for items that the plan can translate, ICPs often involve complex and technical termsterms that may not be easily translated immediately. Response: We appreciate the commenters perspectives on this issue and understand the effort that it takes to translate an ICP and/or provide it in an accessible format. Section 422.101(f)(1)(ii) requires SNPs to develop and implement a comprehensive ICP through an interdisciplinary care team in consultation with the beneficiary, as feasible, identifying goals and objectives including measurable outcomes as well as specific services and benefits to be provided. We agree that SNPs should have the care team verbally review and develop the ICP in consultation with the enrollee. However, we have often found through CMS program audits that SNPs do not always discuss ICPs with enrollees. In addition, we believe it is essential for enrollees to have ICP information in writing in a format that they can understand so that they can refer to it beyond an initial meeting with a care team and work towards the goals included in the ICP. We also note that
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it is essential for enrollees to have ICP information in writing in a format that they can understand so that they can refer to it beyond an initial meeting with a care team and work towards the goals included in the ICP. We also note that enrollee-facing ICP information should be provided in an easily understandable manner. While an ICP may include physician notes and medical terminology, we encourage plans to keep the ICP focused on enrollee- specific goals and objectives, including measurable outcomes and the specific services to be provided. In addition, as previously described, the 5 percent threshold requires few contracts to translate into languages beyond Spanish. Comment: A few commenters requested that CMS clarify which materials are required to be provided in alternate formats or languages. A commenter suggested that CMS clarify that the requirement does not apply to supplemental documents, such as health education materials. Other commenters requested that CMS confirm expectations for providing materials on a standing basis. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00111 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222230 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 124CMS 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-
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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. 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
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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,