2023-07115.pdf

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 finalizing language providing a non- exhaustive list of the information CMS may request from MA organizations under this policy. Finally, we are not finalizing regular reporting of the data alongside other Part C reporting requirements. In the proposed rule, we provided that our proposal to amend  422.112(b) (finalized at  422.100(n)) would impact MA organizations in terms of the burden required to both identify enrollees with low digital health literacy and to develop digital health education programs for these enrollees. We also described how our estimated analysis of these impacts was qualitative in nature as we were proposing to provide MA organizations flexibility in determining how they wish to implement these proposed CMS requirements. We indicated that CMS does not currently collect data regarding digital health literacy among MA enrollees. Consequently, we would have no way of knowing or estimating the extent of low digital health literacy specifically among MA organizations enrollees; how MA organizations would approach digital health literacy screening and digital health education; how much spending they would engage in related to these efforts; how much savings they would encounter (due to improved enrollee health outcomes because of improved digital health literacy), for example, how much time they would spend on these efforts; or how the MA program would grow as we see the effects of the proposed regulation. We estimated the direct non-quantified burden consists of MA organization staff hours spent, resources purchased, and any digital health education for enrollees performed. We further noted that MA organizations may differ in how their spending for the proposed requirements evolves over time as they test strategies and redevelop their approaches to complying with the regulation. Thus, we concluded that the proposed provision would impose an unknown amount of information collection requirements (that is, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222162 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations reporting, recordkeeping, or third-party disclosure requirements) because burden cannot be quantified. We solicited comment from MA organizations on how much burden they expect this proposed provision might add. Regarding the impact of the proposed requirement for the MA organization to make information about its digital health literacy screening and digital health education programs available to CMS upon request, we noted that we did not anticipate requesting this information from more than nine MA organizations in a given year. We noted, however, that we believed it important to reserve the right to ask for this information if necessary, and that we structured the proposed regulation text accordingly. We also provided that since we estimate fewer than ten respondents, the information collection requirement was exempt (5 CFR 1320.3(c)) from the requirements of the PRA of 1995 (44 U.S.C. 3501 et seq.). Consequently, we found that there would be no need for review by OMB under the authority of the PRA. In terms of economic impact on the Medicare Trust Fund, we indicated that we did expect that improved digital health literacy would increase telehealth visits, which in turn would increase prevention of MA enrollee illness, both of which affect Medicare Trust Fund spending. Yet, as we discussed in the proposed rule, we have no way of knowing or estimating how much of an increase in telehealth visits there would be, for what specific services they would increase, or the effects of prevented future illnesses among MA enrollees. Thus, we concluded that this provision is expected to have an unknown economic impact on the Medicare Trust Fund. In summary, CMS proposed to add a new requirement at  422.112(b) that all MA organizations offering coordinated care plans have procedures to identify enrollees with low digital health literacy and offer them digital health education 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, as defined in  422.135. We solicited comments on this proposal, including whether this requirement should be expanded to all MA organizations rather than only those offering coordinated care plans. In addition, CMS proposed to include a requirement that MA organizations make information about these programs available to CMS upon request, and questioned whether we should require regular reporting of data related to these from MA organizations alongside other Part C reporting requirements. We solicited comment on these proposals. We received the following comments on these proposals, and our responses follow: Comment: Most comments were generally supportive, especially of the proposal to allow MA organizations flexibility and discretion in implementing the proposed requirement. Response: We thank commenters for their support. Comment: Many commenters requested that CMS explain what MA organization compliance and effectiveness would look like under this policy. Response: We acknowledge that many MA organizations will be building digital health education programs from scratch and may face logistical challenges unique to their population, service area and network. As such, we will consider future compliance standards carefully, but we reaffirm that MA organizations have discretion to enact practices that best suit their unique situations. CMS recognizes best efforts in this new and emerging area of need among the MA population may evolve, and we expect that MA organizations will similarly evolve their programs as they gain experience with digital health literacy screening and programming. Comment: Many commenters requested CMS define terminology surrounding digital health literacy. Response: We appreciate this suggestion. However, we are concerned that establishing definitions of certain terminology may detract from the flexibility we intend to provide MA organizations during their initial development and implementation of digital health education programs. As such, we will not provide standard definitions for digital health literacy terms at this time beyond those referred to in the preamble to this final rule. In developing future policy or guidance documents, we may consider providing or compiling such a list of relevant definitions. Comment: Many commenters suggested CMS establish standardized reporting metrics and resources for screening enrollees digital health literacy. Response: We thank commenters for this suggestion and will consider establishing standards and reporting metrics in future policymaking. However, as we noted in the preamble to this final rule, CMS does not anticipate requesting information from more than nine MA organizations regarding information about their digital health literacy screening tool or their digital health education programs. Establishing standardized reporting metrics would not be consistent with this intent. Moreover, at this time we believe that establishing such standardized resources and metrics would be counter to the principles of flexibility upon which this provision was established. We are concerned that any reporting metrics would limit the flexibility we intend to provide MA organizations in initially establishing and implementing digital health education programs tailored to their respective covered populations. However, we believe that reporting metrics may be appropriate to add in the future after MA organizations and enrollees have gained experience with these programs, and we may consider adding reporting metrics in the future. In addition, we note that both the proposed and final rules reference several sources of information on digital health literacy, the kinds of challenges that lack of digital health literacy pose to enrollees, especially those in vulnerable populations, and a range of additional information on this topic. While these references are not meant to serve as guidance, they may prove useful as a starting point for MA organizations beginning to build a digital health education program which is compliant with the new final rule. We further note that MA organizations are afforded the flexibility in this final rule to determine the most appropriate tools and methods for the populations they serve. As such, we encourage plans to engage with enrollees, providers, and other MA organization affiliated entities to determine the best methods for implementing this provision. Therefore, CMS is not finalizing any standard set of resources or reporting metrics at this time. Comment: Many commenters suggested that CMS convene an industry workgroup to study research-driven standards and effective methods for improving digital health literacy. One such commenter opposed finalizing these provisions until the workgroup could make recommendations regarding definitions and standards. This commenter recommended that CMS, in the interim, work with MA organizations to improve language used to describe telehealth services in EOCs. Response: We will take the suggestion to convene an industry workgroup into consideration; however, we will not finalize plans to convene such a workgroup in this final rule. We note that the provision regarding digital health education is sufficiently broad VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222163 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 47https://jamanetwork.com/journals/jama/ article-abstract/2426088. and flexible to allow for MA organizations to establish a range of methods and practices as they deem appropriate. Also, CMS will not be providing standard definitions or language for describing telehealth at this time due to concerns of limiting MA organization discretion. We encourage MA organizations to use resources referenced throughout the preamble to this final rule as well as other sources as deemed appropriate. We thank commenters for their suggestion to improve language used to describe telehealth services in EOCs and will consider adding language updates regarding telehealth to the EOC in the future. Comment: Several commenters recommended that this proposal be expanded to require all MA organizations, and not just coordinated care plans, to implement a digital health education program. No commenters expressed opposition to this policy change. Response: We appreciate feedback from commenters. Given the recommendations from commenters and the absence of any commenters opposed to expanding this requirement to all MA organizations, we are finalizing our proposal with modifications to expand the requirement to encompass all MA organizations, not just MA organizations that offer coordinated care plans. We are therefore finalizing the proposed regulation text at  422.100(n) instead of  422.112(b)(9). Section 422.112(b) applies to only MA organizations offering coordinated care plans while  422.100 sets forth general requirements related to benefits and coverage by MA plans. Comment: Some commenters requested that CMS delay the effective date or any data collection until contract year 2025 and use lessons learned to build a framework for measurement. Other commenters requested that CMS not include a digital health literacy or education section in the annual Part C reporting requirements. Response: We appreciate these comments and note these concerns. We appreciate that MA organizations may be establishing digital health education programs which are new to enrollees as well as MA organizations. However, with the flexibility and discretion afforded in this provision, we believe that MA organizations possess the capacity to develop and implement compliant programs by January 1, 2024, the effective date of these policies. We also note that this final rule does not establish a standard data collection effort or standard framework for measuring programs (aside from the broad statistics set forth in the regulation text and noted in this section of this final rule), and, as such, we do not believe that delaying the effective date of this provision would be reasonable. We note that the proposed rule reiterates the authority of CMS to collect information upon request, including but 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  422.100(n). However, MA organizations may record and keep this and any other information related to their digital health education programs in the manner they deem most appropriate, and CMS is not pursuing any uniform data collection effort (such as Part C reporting requirements) at this time. Comment: Some commenters expressed concern that this requirement may backfire and cause enrollees to believe that they are being targeted and/ or forced to participate, even though it would be voluntary. Response: While we appreciate the commenters concerns, we disagree. We note that while our proposed provision acknowledges the necessity of assessing enrollees digital health literacy, CMS discourages use of screening tools which ask specific questions related to age, income, educational attainment, or race and ethnicity toward assessing an enrollees digital health literacy. We note that such questions may make enrollees believe they are being targeted. Comment: Other opposing comments noted that there is insufficient evidence that these programs are beneficial, that these requirements will impose new burdens or costs on MA organization, and that digital health literacy and education should be dependent on and under the purview of providers,