2023-07115.pdf

well as their ability and willingness to use technology for telehealth purposes.37 As outlined in this final rule, research indicates that older adults, people with disabilities, people from some racial and ethnic groups, rural communities, underserved populations, and those adversely affected by persistent poverty and inequality are all disadvantaged by limited access to modern information and communications technology (sometimes referred to as a digital divide).38Individuals with a higher degree of digital health literacy receive more health care information, are better equipped to evaluate the quality of information regarding their health care, and report higher telehealth usage.39 Further, individuals with chronic diseases also benefit from digital health literacy; when such individuals possess digital health literacy, they tend to monitor and manage their diseases more competently, are more satisfied with the telemedicine services, and respond faster to changes that might adversely affect their situation, thereby improving their overall health.40This is significant because individuals with two or more chronic diseases are more likely to be individuals 65 and over.41 As we described in the proposed rule, CMS does not currently have requirements for MA organizations in the area of digital health literacy. Given the need to increase digital health literacy in many communities with MA enrollees and the goal to achieve health equity in telehealth, we believe it is necessary to implement regulations addressing digital health literacy in the MA program. CMS expects that these VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222160 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 42https://telehealth.hhs.gov/providers/health- equity-in-telehealth/. 43https://link.springer.com/content/pdf/10.1007/ s00520-021-06629-4.pdf. 44https://www.digitalinclusion.org/definitions/ . 45https://www.telehealthequitycoalition.org/ improving-digital-literacy-to-improve-telehealth- equity.html. digital health literacy policies, once implemented, will help underserved communities in need of assistance to improve their digital health literacy and help advance the goal of achieving health equity in telehealth.42 In the proposed rule, we proposed to add requirements for certain MA organizations to develop and maintain procedures to identify and offer digital health education to enrollees with low digital health literacy to assist them with accessing any medically necessary covered telehealth benefits. Specifically, we proposed to amend current continuity of care requirements for MA organizations offering coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers at  422.112(b), by adding a new paragraph (9). We indicated that the new proposed paragraph would require MA organizations to develop and maintain procedures to identify and offer digital health education to enrollees with low digital health literacy to assist with accessing any medically necessary covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange; we used the term electronic exchange as it is broadly defined in  422.135. We noted that this proposed new continuity of care requirement would apply to all MA organizations offering coordinated care plans (that is, HMOs, PPOs, HMOPOSs, and SNPs) and would be relevant for all types of covered telehealth benefits, including basic telehealth benefits, ATBs, and supplemental telehealth benefits offered by MA coordinated care plans. We solicited comment on whether to amend  422.100 instead of  422.112(b) in order to apply this new requirement to all MA plans and not just coordinated care plans. As we indicated in the proposed rule, this additional standard was proposed to ensure that MA enrollees would be able to access covered benefits and that MA organizations met their obligations under section 1852(d) of the Act to make covered benefits available and accessible to enrollees in the plan. Section 1856(b) of the Act authorizes the adoption of standards that are consistent with and to carry out the Part C statute. As telehealth benefits become more prevalent in the MA program, taking steps to provide enrollees with digital health education will ensure that these telehealth benefits are truly accessible and available to enrollees. After considering the comments received, and for reasons described in this section of the rule, we are finalizing this policy, but we are amending  422.100 rather than  422.112(b) as we originally proposed to apply this new requirement to all MA plans and not just coordinated care plans. This policy will be a first step for MA organizations to assess the landscape of health equity in telehealth in their plans and help enrollees navigate telehealth. We noted in the proposed rule that, under this policy CMS would provide a degree of discretion for MA organizations in the procedures developed and used to identify enrollees with low digital health literacy and the digital health education services the MA organization provides for those enrollees. We also explained that compliance with the proposal, if finalized, would require that MA organizations introduce a digital health literacy screening program or other similar procedure to identify current enrollees with low digital health literacy; however, MA organizations would have flexibility to design their own screening program or procedure. We noted in the proposed rule that some experts recommend such an assessment should examine patient- level barriers such as telehealth readiness, broadband access, and inaccessible or unusable information and communication technologies by individuals with disabilities that limit patient use of telehealth.43Others recommend considering certain digital foundation skills based on a specific framework.44CMS encourages MA organizations to research current trends and successes in the field when developing their own methods to identify enrollees with low digital health literacy. CMS anticipates that some MA organizations could ask enrollees, for example, if they have internet access and reliable connectivity, if they have a device that meets appropriate telehealth system requirements, if they use email, if they can download a mobile app, or if they can change applicable settings on a device (for example, browser or camera settings), as a means to identify which enrollees have low digital heath literacy.45 Once the MA organization determines which enrollees experience low digital health literacy, the MA organization will then have to implement a digital health education program to offer to these enrollees. CMS did not propose to identify explicit parameters for this digital health education requirement, and we are not finalizing any such parameters. Rather, we have chosen to keep it flexible and allow for innovation in this area by MA organizations. Depending on the specific enrollment in an MA plan, the procedures to identify enrollees and the mechanisms and content of the digital health education could vary. However, some examples of digital health education designs include: distributing educational materials about how to access certain telehealth technologies in multiple languages, including sign language, and in alternative formats; holding digital health literacy workshops; integrating digital health coaching; offering enrollees in-person digital health navigators; and partnering with local libraries and/or community centers that offer digital health education services and supports. As we discussed in the proposed rule, as a best practice, CMS encourages MA organizations to ensure that there are no system requirements (for example, online portal enrollment) that could act as barriers to accessing covered telehealth benefits or digital health education for enrollees with low digital health literacy, so as to promote ease of access in the simplest way possible. However, we note that MA organizations must be mindful to remain compliant with all applicable health data privacy and security laws in establishing systems for enrollees with low digital health literacy. In addition, if an MA organization offers enrollees assistance with any necessary telehealth technologyfor instance, if the MA organization provides limited use smartphones/tablets or cellular data plans as supplemental benefits in order to aid in the use of telehealth services then the MA organization must comply with applicable laws about those benefits and make enrollees aware of these available benefits per section 1852(c)(1)(F) of the Act and  422.111(b)(6). This disclosure is especially important for enrollees identified as having low digital health literacy. Smartphones and tablets (or other similar equipment) must only be used for primarily health related purposes (and cellular data plans can only be provided if use of these plans is locked and limited to health-related activities), such as when the device is locked except for remote monitoring or to enable engagement with health care providers, in order for these items and services to be permissible supplemental VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222161 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 46https://www.hhs.gov/sites/default/files/ guidance-on-nondiscrimination-in-telehealth.pdf. benefits under  422.100(c)(2)(ii). However, furnishing or covering a cellular data plan without limitations might be permissible (under section 1852(a)(3)(D) of the Act and  422.102(f)) as a non-primarily health related special supplemental benefit for the chronically ill (SSBCI) when the benefit is limited to a chronically ill enrollee and has a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee. For more information on SSBCI, please see the June 2020 final rule and the Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly final rule which appeared in the Federal Register on January 19, 2021 (86 FR 5864) (hereinafter referred to as the January 2021 final rule). CMS encourages MA organizations whose plans have a high number of enrollees with low digital health literacy to consider offering the, previously discussed, supplemental benefits and pairing an appropriate digital health education program with the provision of such devices to enrollees, where permitted by applicable law. To further emphasize the importance of health equity and health equity in telehealth specifically, CMS reminds MA organizations that  422.112(a)(8) as it currently reads requires MA organizations offering coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees, including limited English proficient individuals or those with limited reading skills, and those with diverse cultural and ethnic backgrounds. CMS is finalizing changes in this rule to amend  422.112(a)(8) to better reflect the broad scope of potentially underserved populations and to emphasize how MA plans must ensure equitable access to services. As adopted and with the revisions we are finalizing in this rule,  422.112(a)(8) requires MA organizations offering coordinated care plans to ensure that services are provided in an equitable manner to all enrollees. MA organizations offering coordinated care plans must consider these additional obligations, as applicable, when developing and maintaining the digital health education programs they are required to implement under this final rule. Furthermore, the HHS Office for Civil Rights and the U.S. Department of Justice (DOJ) Civil Rights Division recently published new guidance providing clarity on how Federal nondiscrimination laws require accessibility for people with disabilities and limited English proficient individuals in health care provided via telehealth.46These Federal civil rights lawsincluding the Americans with Disabilities Act of 1990, section 504 of the Rehabilitation Act of 1973, title VI of the Civil Rights Act of 1964, and section 1557 of the ACArequire that telehealth be accessible to people with disabilities and limited English proficient individuals. CMS strongly encourages MA organizations and their contracted providers to review this new guidance issued by HHS and DOJ to ensure compliance with Federal civil rights laws pertaining to telehealth. We also proposed to require MA organizations to make information about their required digital health literacy screening and digital health education programs available to CMS upon request at proposed  422.112(b)(9)(i) (finalized at  422.100(n)(1)). We indicated that this would allow CMS to monitor the impact of the new requirement for these programs on MA organizations, providers, enrollees, and the MA program as a whole. In addition, we proposed that this requested information may include, but is not limited to, statistics on the number of enrollees identified with low digital health literacy and receiving digital health education, manner(s) or method of digital health literacy screening and digital health education, financial impact of the programs on the MA organization, evaluations of effectiveness of digital health literacy interventions, and demonstration of compliance with the requirements of proposed  422.112(b)(9) (finalized at  422.100(n)). We indicated that the purposes of requiring MA organizations to make such information available to CMS upon request would be to identify best practices for improving digital health literacy amongst MA enrollees and to determine whether CMS should make improvements to the regulation and/or guidance regarding this requirement. We noted that the regulation text, now at  422.100(n)(1), would include the language upon request, which would serve to communicate that while CMS does not intend to establish uniform data collection from all MA organizations at this time, CMS reserves the right to ask for this information from individual MA organizations. However, we noted that this provision would not limit CMSs audit access when program audits review the performance of MA organizations. We solicited comment on this aspect of our proposal and whether we should require regular reporting of data of this type from all MA organizations alongside other Part C reporting requirements. We are also finalizing the proposed requirement that the MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. We are further