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  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 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 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 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 finalizing without modification the proposed policy 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 our proposed language providing a non- exhaustive list of the information CMS may request from MA organizations under this policy. 5. Quality Improvement Program ( 422.152) In accordance with section 1852(e) of the Act, all MA organizations must have an ongoing Quality Improvement (QI) Program for the purpose of improving the quality of care provided to enrollees. Per  422.152(a), MA organizations must develop a QI plan that sufficiently outlines the QI program elements; have a chronic care improvement program (CCIP) that meets the requirements at  422.152(c) and addresses populations identified by CMS based on a review of current quality performance; and, encourage its providers to participate in CMS and HHS quality improvement initiatives. Section 422.152(c) provides that CCIPs must include methods for identifying MA enrollees with multiple or sufficiently severe chronic conditions that would benefit from participating in a CCIP; mechanisms for monitoring MA enrollees that are participating in the CCIP and evaluating participant outcomes, such as changes in health status; performance assessments that use quality indicators that are objective, clearly and unambiguously defined, and based on current clinical knowledge or research, and systematic and ongoing follow-up on the effect of the CCIP. Organizations must report the status and results of each program to CMS as requested. The intent of the CCIPs is to promote effective chronic disease management and improve care and health outcomes for enrollees with chronic conditions. Furthermore, CCIPs should support the CMS Quality Strategy; include interventions that surpass MA organizations inherent care coordination role and overall management of enrollees; engage enrollees as partners in their care; promote utilization of preventive services; facilitate development of targeted goals, specific interventions, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222165 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 49https://www.cms.gov/Medicare/Health-Plans/ Medicare-Advantage-Quality-Improvement- Program/5CCIP. 50Disparities in Health Care in Medicare Advantage by Race, Ethnicity and Sex, April 2022. 51Lindenauer, P.K., Lagu, T., Rothberg, M.B., Avrunin, J., Pekow, P.S., Wang, Y., Krumholz, H., & Hines, H. (2013). Income Inequality and 30-Day Outcomes After Acute Myocardial Infarction, Heart Failure, and Pneumonia: Retrospective Cohort Study. British Medical Journal. 52Trivedi, A.N., Nsa, W., Hausmann, L.R.M., Lee, J., Ma, A., Bratzler, D., Mor, M., Baus, K., Larbi, F., & Fine, M. (2014). Quality and Equity of Care in U.S. Hospitals. New England Journal of Medicine. 371(24):22982308. 53Polyakova, M., Udalova, V., Kocks, G., Genadek, K., Finlay, K., & Finkelstein, A.N. (2021). Racial Disparities In Excess All-Cause Mortality During The Early COVID19 Pandemic Varied Substantially Across States. Health affairs (Project Hope), 40 (2), 307316. https://doi.org/10.1377/ hlthaff.2020.02142. 54Rural Communities: Age, Income, and Health Status. Rural Health Research Recap. (2018). Rural Health Research Gateway. https://www.ruralhealthresearch.org/recaps/5. 552020 Update on the Action Plan to Reduce Racial and Ethnic Health Disparities. (2020). 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