evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
and AIPs translate materials into any languages required by Medicare plus the Medicaid translation standard of the State in which the plan operates. MACPAC reported that dually eligible individuals are more likely to be from racial or ethnic minority groups than Medicare-only beneficiaries. For example, MACPAC noted in 2020, 17 percent of dually eligible individuals were Hispanic compared to 6 percent of Medicare beneficiaries who are not dually eligible. A commenter noted that when culturally and linguistically- appropriate services are not provided, some dually eligible recipients of home and community-based services have had trouble accessing the care they need. This commenter also expressed that, if done well, integrating Medicare and Medicaid in a culturally-appropriate way could advance health equity. Another commenter stated that plans participating in the Financial Alignment Initiative (FAI) demonstrations have had to do targeted and culturally competent education and outreach, so some plans may have the necessary experience to do so in the DSNP environment. A few commenters noted that a similar requirement was successfully applied to the MMPs in FAI and resulted in improved communication to plan enrollees. Response: We appreciate the commenters support for our proposed changes to require that FIDE SNPs, HIDE SNPs, and AIPs translate materials into any languages required by Medicare plus the Medicaid translation standard of the State in which the plan operates. Based on our experience with MMPs, we agree with the commenters that these changes can help improve access to care and advance health equity. Comment: A few commenters recommended that CMS apply this translation requirement to all DSNPs, including those that do not have affiliated Medicaid managed care plans. A commenter noted that DSNPs are designed for and required to offer at least some coordination between Medicare and Medicaid benefits, even when Medicaid benefits are provided on a fee-for-service basis. This commenter explained that sending communications to a plan enrollee about Medicare in Englisha language that the individual cannot understandwhen that same member is receiving information about Medicaid benefits in another language the individual can understand is the antithesis of coordination. According to the commenter, conforming to State translation standards should be one of the core minimum requirements for all DSNPs. Response: We appreciate the commenters perspectives on this issue. The requirement we are finalizing at
2023-07115.pdf
According to the commenter, conforming to State translation standards should be one of the core minimum requirements for all DSNPs. Response: We appreciate the commenters perspectives on this issue. The requirement we are finalizing at  422.2267(a)(4) will require HIDE SNPs, FIDE SNPs, and AIPs in certain States to translate Medicare materials into additional languages. The finalized requirement will not apply to HIDE SNPs, FIDE SNPs, and AIPs in all States because the Medicaid translation standard does not require translation for languages that exceed the Medicare translation standard in all States. However, based on the number of HIDE SNPs, FIDE SNPs, and AIPs offered by MA organizations in contract year 2022, we estimate that the requirement will result in 73 plans having to translate materials into additional languages. We believe it is best to take an incremental approach by focusing on these DSNPs that have capitated contracts with State Medicaid agencies and must already translate Medicaid materials to comply with their Medicaid managed care contracts. We believe these DSNPs would likely either have staff that are capable of translating materials into these languages or contract with organizations to perform these translations. Comment: A few commenters requested that CMS align translation thresholds at the Federal level rather than set State-specific standards. A commenter indicated that working across CMS silos to create a single Medicare and Medicaid standard would also be beneficial to enrollees. Response: We appreciate the commenters input; however, the languages spoken by Medicare and Medicaid enrollees varies greatly throughout the country, so we prefer to set policy for translation requirements based on the languages needs for these programs within a service area. Comment: A commenter requested that CMS specify that translation into State-required alternate languages apply to annual required communications only. The commenter noted that this would ensure enrollees receive their benefit information in their selected language while retaining the option to request translated transactional communications as needed. The commenter further explained that CMS could permit the States to specify in the State Medicaid agency contract (SMAC) the documents the State requires be translated into specific languages. Response: We appreciate the commenters perspective on this issue. However, we believe it is important for this population to receive all Medicare materials listed in
2023-07115.pdf
agency contract (SMAC) the documents the State requires be translated into specific languages. Response: We appreciate the commenters perspective on this issue. However, we believe it is important for this population to receive all Medicare materials listed in  422.2267(e) and 423.2267(e) and ICPs in their preferred language. We believe it would cause confusion for HIDE SNP, FIDE SNP, and AIP enrollees to receive all of their Medicaid materials in their preferred language, some of their Medicare materials in their preferred language, and other Medicare materials in English. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00115 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222234 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 127Refer to https://www.cms.gov/medicare/ health-plans/managedcaremarketing/ marketngmodelsstandarddocumentsandeducationalmaterial and https://www.cms.gov/Medicare/Prescription-Drug- Coverage/PrescriptionDrugCovContra/Part-D- Model-Materials. Comment: A commenter requested that if CMS finalizes the translation requirement as proposed, CMS or the relevant State should provide the translated templates for any required communications and CMS should provide flexibility to meet the enrollees needs using methods other than documents sent via U.S. Mail. The commenter estimated that industry cost to implement the requirements as proposed would significantly exceed the combined $12.5 million estimate CMS has noted. While the annual required materials could be plan-specific and the financial impact could be somewhat limited, the transactional communications are not plan-specific, so all of them would have to be translated to meet the proposed requirement. The commenter also emphasized there would be a significant ongoing cost to maintain translated communications after the initial implementation. Response: We thank the commenter for these comments. CMS has translated several forms to Spanish and Chinese, including the EOC, ANOC, Formulary, LIS Rider, Part D transition letter, enrollment form, and Pharmacy
2023-07115.pdf
initial implementation. Response: We thank the commenter for these comments. CMS has translated several forms to Spanish and Chinese, including the EOC, ANOC, Formulary, LIS Rider, Part D transition letter, enrollment form, and Pharmacy and Provider Directories.127In addition, in response to the comment for flexibility to use other delivery methods besides U.S. mail, as we noted in a previous response,  422.2267(d)(2)(i) states 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 in their primary language or accessible format: the Evidence of Coverage, Provider and Pharmacy Directories, and Formulary. Thus, plans do have flexibility with these materials. On average, we expect these plans to translate materials into one additional language based on our experience with MMPs where, out of nine states, only two states (California and Rhode Island) required translation of materials into additional languages that exceeds the Medicare translation standard. California required MMPs to translate materials into nine additional languages in certain counties and Rhode Island required MMPs to translate materials into two additional languages. Comment: Other commenters suggested that CMS defer to the States translation standard, which is based on the States understanding of their population and access needs. A commenter noted that the disconnect between the Medicare and Medicaid requirements will result in confusion, overlapping requirements, and burden on FIDE SNPs, because State languages are more relevant to the particular dually eligible individuals served than the nationally standardized set of languages. As an example, this commenter identified that FIDE SNPs in the State of Minnesota are required to translate documents into German, despite the very few German speakers in the State and many of the languages spoken by higher percentages of Minnesotans, like Somali and Oromo, are not included in the Medicare standard. These commenters recommended that Medicaid languages should supersede the Medicare languages to reduce burdens on both plans and consumers and to better service the populations in each State. Response: We appreciate the commenters perspective on this issue. We agree that States have a good understanding of their Medicaid population and the needs of that population. However, we disagree that there is a disconnect between the Medicare and Medicaid standards since the Medicare standards for MA, cost, and Part D plans are based
2023-07115.pdf
a good understanding of their Medicaid population and the needs of that population. However, we disagree that there is a disconnect between the Medicare and Medicaid standards since the Medicare standards for MA, cost, and Part D plans are based on the population of the specific service area. It is more likely that the State Medicaid program translation standard will include those languages required by Medicare plus additional languages based on the Medicaid standard. For contract year 2023, in addition to those service areas that meet the threshold to translate materials into Spanish, only 16 MA contracts have service areas that meet the Medicare threshold to translate materials into Chinese and 19 MA plans and PDPs meet the threshold to translate materials into other Asian languages. There are no other service areas with additional languages that currently meet the 5 percent threshold for translation at  422.2267(a)(2) and 423.2267(a)(2). While the commenter noted that that plans in Minnesota are required to translate materials into German, we believe that the commenter may be referring to the requirement that all MA plans, per  422.2267(e)(31), must include the multi-language insert in several languages, including German. While the multi-language insert itself is required to include German among other languages, there are no MA, cost, or Part D plan service areas that currently meet the Medicare 5 percent threshold to require translation into German. Comment: A commenter requested that CMS incorporate the State-specific requirements into HPMS, along with the Medicare requirements, to save plans from having to find the information themselves and keep everyone consistent in the languages they are using. Response: We appreciate the suggestion. We provided similar information in HPMS for MMPs and will consider updating HPMS to include the State-specific Medicaid requirements into HPMS for those plans that are impacted by this requirement. In addition, we note that FIDE SNPs, HIDE SNPs, and AIPs all have contracts with the State or an affiliated plan which should include information regarding the States translation requirements for the Medicaid managed care organization or where they may obtain this information. After considering the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the requirement at  422.2267(a)(4) and 423.2267(a)(4) as proposed.
2023-07115.pdf
received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the requirement at  422.2267(a)(4) and 423.2267(a)(4) as proposed. 3. Exclude Member ID Cards From New Paragraphs Proposed at  422.2267(a)(3) and (a)(4) and  423.2267(a)(3) and (a)(4) Currently,  422.2267(e)(30)(vi) and 423.2267(e)(30)(vi) exclude the member ID card from the translation requirement under  422.2267(a)(2) and 423.2267(a)(2). We proposed to amend the member ID card provision at  422.2267(e)(30)(vi) and 423.2267(e)(30)(vi) to expand the exclusion for member ID cards to include the new paragraphs proposed in this section,  422.2267(a)(3) and (a)(4) and  423.2267(a)(3) and (a)(4), respectively. We received no comments on this proposal. We are finalizing these revisions as proposed for the reasons outlined in the proposed rule. I. Medicare Advantage (MA) and Part D Communications and Marketing (Subpart V of Parts 422 and 423) In the December 2022 proposed rule, we proposed a number of changes to Subpart V of both  422 and 423 regulations. These changes include submitting marketing materials into the Health Plan Management System, prohibiting the use of the Medicare name, CMS logo, and products or information issued by the Federal Government in a misleading way; prohibiting the use of superlatives (for example, words like best or most) in marketing without supporting data which reflects content for the current or VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00116 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222235 Federal
2023-07115.pdf
Frm 00116 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222235 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 12873 FR 2257, 78 FR 32257 and 83 FR 659. prior year; prohibiting marketing of benefits in a service area where those benefits are not available; requiring TPMOs to list or mention all of the MA organization or Part D sponsors that they sell; prohibiting marketing based on information about the savings available to potential enrollees that are based on a comparison of typical expenses borne by uninsured individuals, costs for which dually eligible beneficiaries are not responsible, or other unrealized costs of a Medicare beneficiary; clarifying that the prohibition on door-to-door contact without a prior appointment applies even after an agent or broker has collected a BRC or SOA; notifying enrollees annually that they can opt out of plan business calls; prohibiting the distribution of Scope of Appointment and Business Reply Card forms at educational events; prohibiting sales events to directly follow educational events; requiring 48 hours between the Scope of Appointment and an agent meeting with a beneficiary; limiting Scope of Appointments and Business Reply Cards to a six month timeframe from the submission of a Scope of Appointment (SOA) or Business Reply Card (BRC); requiring website provider directories be searchable by all required elements (for example, name, phone number, address); adding effect on current coverage to the Pre-enrollment Checklist (PECL), as well as requiring agents to review the PECL with enrollees; requiring plans to list benefits at the beginning of the Summary of Benefits (SB) and in a specified order; labeling the non-renewal notice as standardized rather than a model, consistent with CMSs guidance instructions; modifying the TPMO disclaimer to add State Health Insurance Programs (SHIPs) as an option for beneficiaries to obtain additional help; requiring MA organizations and Part D sponsors to have an oversight plan that monitors agent/broker activities and reports agent/broker non-compliance to CMS; requiring agents and brokers to go over a CMS list of required elements with an enrollee prior to enrollment; limiting the requirement to record
2023-07115.pdf
have an oversight plan that monitors agent/broker activities and reports agent/broker non-compliance to CMS; requiring agents and brokers to go over a CMS list of required elements with an enrollee prior to enrollment; limiting the requirement to record calls between third-party marketing organizations (TPMOs) and beneficiaries to marketing (sales) and enrollment calls; clarifying the requirement to record calls between TPMOs and beneficiaries such that it is clear that the requirement to record applies only to calls that result in an enrollment and includes virtual connections such as Zoom and FaceTime; and, prohibiting the distribution of data by TPMOs. We are finalizing, in some cases with modifications, the majority of the proposed policies in this final rule. We are not addressing our proposal to prohibit the distribution of data by TPMOs in this final rule but, may address it in a future final rule. The regulatory changes for Subpart V of Parts 422 and 423 are applicable for the 2024 Contract Year and beyond; thus applying to marketing and communications materials and activities beginning for the 2024 Contract Year; current regulations require the distribution of 2024 materials beginning September 30, 2023. Sections 1851(h) and 1851(j) of the Act, which address MA, provide CMS the authority to review marketing materials, develop marketing standards, and ensure that marketing materials are accurate and not misleading. These provisions also provide CMS with the authority to prohibit certain marketing activities. Section 1856(b)(1) of the Act authorizes CMS to adopt standards, through rulemaking, standards that are consistent with, implement and carry out the Medicare Advantage statutory provisions. In addition, sections 1876(i)(3)(D), 1857(e)(1) and 1860D 12(b)(3)(D) of the Act provide CMS the authority to adopt additional contract terms for cost plans, MA plans, and Part D plans when necessary and appropriate. Likewise, section 1860D 1(b)(1)(B)(vi) of the Act directs that the Secretary use rules similar to and coordinated with the MA rules at section 1851(h) of the Act for approval of marketing materials and application forms for Part D plan sponsors. Section 1860D4(l) of the Act applies certain prohibitions under section 1851(h) of the Act to Part D sponsors in the same manner as such
2023-07115.pdf
the Act for approval of marketing materials and application forms for Part D plan sponsors. Section 1860D4(l) of the Act applies certain prohibitions under section 1851(h) of the Act to Part D sponsors in the same manner as such provisions apply to MA organizations. In addition, sections 1852(c) and 1860D4(a) of the Act require organizations to provide certain materials to Medicare beneficiaries concerning MA and Part D plan choices, benefits coverage, and other information to make informed enrollment decisions. These statutory provisions help ensure Medicare beneficiaries are informed, and thus have sufficient knowledge to assist in protecting them when making an election to enroll in an MA (including MAPD) or Part D plan. We believe the changes proposed and adopted in this rulemaking strengthen CMS ability to ensure MA and Part D marketing to beneficiaries is not misleading, inaccurate, and/or confusing. Additionally, under 42 CFR 417.428, most marketing requirements in subpart V of part 422 apply to section 1876 cost plans as well. (75 FR 19783 through 19785) 1. Requirement for TPMOs To Submit Materials Into the Health Plan Management System (HPMS) In accordance with regulations at  422.2261(a) and 423.2261(a), MA organizations and Part D sponsors (MA organizations/Part D sponsors) must submit all marketing materials, all election forms, and certain designated communications materials for CMS review. The HPMS is CMS system of record for marketing materials.128In the past,  422.2261(a)(3) and 423.2261(a)(3) prohibited third-party and downstream entities from submitting materials directly to CMS, unless specified by CMS. In the January 2021 final rule, we modified  422.2261(a)(3) and 423.2261(a)(3) to provide CMS the flexibility to allow third parties to submit materials directly to CMS in the future (86 FR 5998). CMS made this modification in anticipation of operational changes to HPMS, which occurred in May 2021. Prior to the HPMS changes, third-party materials were submitted into HPMS, but the TPMO was required to send materials to an MA organization or Part D sponsor and have the MA organization or Part D sponsor submit the materials on
2023-07115.pdf
2021. Prior to the HPMS changes, third-party materials were submitted into HPMS, but the TPMO was required to send materials to an MA organization or Part D sponsor and have the MA organization or Part D sponsor submit the materials on the TPMOs behalf. These system changes permitted third parties and downstream entities, such as TPMOs, to submit materials directly to CMS following the receipt of prior approval from at least one MA organization or Part D sponsor. In cases where a TPMO document only markets one MA organization/Part D sponsor, there would be no change for the TPMO, meaning they would still send the document in through the MA organization/Part D sponsor who would submit it into HPMS. For TPMOs that develop materials for more than one MA organization/Part D sponsor, the TPMO would submit the material directly to CMS. Based on CMS operational change, we proposed to require TPMOs, as defined at  422.2260 and 423.2260, to submit their marketing materials developed for multiple MA organizations and Part D sponsors (and their specific plans) to CMS through HPMS. Specifically, we proposed to remove  422.2261(a)(3) and 423.2261(a)(3), which as implemented prohibited TPMOs from submitting materials the TPMO alone developed, and modify  422.2261(a)(2) and 423.2261(a)(2) to require that marketing materials developed by a TPMO for multiple plans must be submitted into HPMS by the TPMO. In addition, submission may only occur after the TPMO receives the prior approval of VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00117 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222236 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations each of the MA organizations or Part D sponsors on whose behalf the materials were designed and developed by the TPMO. CMS believes these changes are beneficial to the MA and Part D programs, for CMS, and plans. By