evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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
2023-07115.pdf
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,
2023-07115.pdf
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, not MA organizations. Response: As we noted in the proposed rule, research indicates that, Individuals 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.47 We further explained that a large body of research indicates that a lack of digital health literacy has an impact on overall health. To this end, we believe that MA organizations have an opportunity to meaningfully impact the health of their enrollees by implementing robust digital health education programs. We acknowledge the commenters concerns that these programs may increase MA organization burden or costs, and we agree that these requirements will impose some level of burden and cost on MA organizations. However, commenters did not provide specific feedback or data regarding the anticipated increased costs and/or burdens imposed on MA organizations, and as a result, CMS is unable to make broadly applicable estimates regarding either. Additionally, for reasons set forth in this final rule, CMS
2023-07115.pdf
provide specific feedback or data regarding the anticipated increased costs and/or burdens imposed on MA organizations, and as a result, CMS is unable to make broadly applicable estimates regarding either. Additionally, for reasons set forth in this final rule, CMS is not able to provide quantitative estimates regarding probable MA organization burden for implementing this provision. CMS does not agree that digital health literacy and education should be exclusively dependent on, nor under the exclusive purview of, individual providers. MA organizations are often better positioned than individual providers to coordinate the care of their enrollees, and this digital health education programming is part of such care coordination. Further, we note that providing support for digital health education programs falls outside the scope of daily work assignments for most MA network providers and medical staff. Placing such a burden on providers to educate all patients who are MA enrollees in the context of hospital, clinic, or other health-related visits would therefore be counter to the principles of this provision. While providers may be well suited to give occasional guidance and support to enrollees regarding digital health literacy, CMS notes that many individuals with lower digital health literacy may attend fewer provider appointments. The potential lack of or limited access for these vulnerable enrollees means that providers may not be providing support to those who have the greatest need. In addition, we note that hospital, clinical, and other health- related visits are often brief and focused on specific medical issues, and that digital health education would not fit well into enrollees medical visits. We believe MA organizations are better positioned than providers and suppliers to evaluate their enrollee populations digital health literacy and provide meaningful digital health education to enrollees. MA organizations are well situated to leverage data they have that providers VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222164 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 48https://telehealth.hhs.gov/providers/health- equity-in-telehealth. may not, and to promulgate surveys and other relevant materials in an efficient manner. Moreover, in efforts to comply with the provision of this
2023-07115.pdf
equity-in-telehealth. may not, and to promulgate surveys and other relevant materials in an efficient manner. Moreover, in efforts to comply with the provision of this final rule, MA organizations may be able to collaborate with providers and suppliers to provide digital health education in a manner that is efficient and effective for a large group of enrollees. Comment: A few commenters expressed concern about implementation of the digital health education programs, specifically relating to lack of access to broadband or devices for low-income or rural enrollees. In addition, one commenter noted that because this population tends to be older, sicker, and often less mobile, an effective program might require in-home one-on-one training, which can be time-consuming and costly to MA organizations without additional funding. Moreover, if MA organizations were to provide equipment to enrollees, it would be challenging to limit use to only health services and would likely confuse enrollees. Response: CMS appreciates this feedback and acknowledges that challenges faced by enrollees regarding access to technology or broadband services are likely to persist. However, as noted in both the proposed and final rules, MA organizations have the option to provide certain enrollees with supplemental benefits (including SSBCI) which address some of these challenges when enrollees meet the eligibility requirements to receive such supplemental benefits. We acknowledge that not all enrollees may be able to take advantage of these services due to access or eligibility; however, we believe that this number of enrollees would likely be small given the research and statistics48showing that enrollees with low digital health literacy are likely to correlate highly with enrollees who are eligible for relevant supplemental benefits. Therefore, at this time, CMS is not finalizing any requirements or provisions related to implementing digital health literacy screenings or the digital health education program specific to low- income or rural enrollees. As previously noted, MA organizations are encouraged to innovate and improve their digital health education programs as they gain experience in this field, as such CMS may consider additional flexibilities or policies in the future to address this specific challenge. We note the commenters concerns about providing in-home training and agree that, in some cases, such a digital health education program would be beneficial to enrollees. However, we also note that this is a broad generalization, and that MA organizations are best suited to make this determination based on the mobility, health status, and other factors
2023-07115.pdf
cases, such a digital health education program would be beneficial to enrollees. However, we also note that this is a broad generalization, and that MA organizations are best suited to make this determination based on the mobility, health status, and other factors unique to each enrollee. Additionally, as noted previously, CMS agrees that there may be some cost involved in implementing a digital health literacy screening and a digital health education program. However, we are unable at this time to provide specific cost estimates. We also note commenters concerns about their ability to limit use of digital equipment to health services. However, we disagree. Current digital capability allows for a variety of controls, firewalls, and other programs that are designed to limit or otherwise curate the functions available to individuals utilizing digital equipment. Moreover, CMS has established standards in regulation relating to allowable supplemental benefits, and we believe that these regulations effectively clarify when MA organizations may offer specific supplement benefits and to whom MA organizations may offer them. We encourage MA organizations that provide digital equipment to their enrollees to take advantage of controls, firewalls, and other capabilities that would safeguard against enrollees using such equipment in an unintended or otherwise noncompliant manner. Comment: One commenter suggested CMS work with community-based advocacy and research groups to ensure concerns of vulnerable communities are addressed in the planning and implementation of this regulation. Response: We thank commenters for this recommendation and encourage MA organizations as a part of any care coordination activities to connect with and create links for enrollees with local advocates and groups with expertise in the area of digital health literacy and education. We encourage MA organizations to engage these groups where appropriate when creating plans for implementing digital health education programs. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing, with modification, the requirement that MA organizations must establish procedures to identify and offer digital health education to enrollees with low digital health literary 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 are finalizing the proposal with modifications to apply the new requirement to all MA organizations, rather than only to MA organizations offering coordinated care plans by finalizing the revision at  422.100(n) instead of  422.112(b)(9). In addition, we are