evekhm/cms_iom_500 huggingface dataset:
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12APR2ddrumheller on DSK120RN23PROD with RULES222151 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations (a)(3)). If no documentation is submitted and accepted, the LI NET sponsor will periodically check for eligibility and enroll applicants once LIS eligibility is confirmed; add for clarity the term Extra Help to  423.2504(a)(3)(ii).  423.2508: removing CMS role in determining pharmacies good standing for LI NET and adding a reference to OIGs authority to exclude State health care programs; and  423.2512(c)(6): adding a cross reference to the good standing standard we are adopting in  423.2508(b). E. Expanding Eligibility for Low-Income Subsidies Under Part D of the Medicare Program ( 423.773 and 423.780) The Part D low income subsidy (LIS) helps people with Medicare who meet certain statutory income and resource criteria pay for prescription drugs and lowers the costs of prescription drug coverage. Individuals who qualify for the full LIS receive assistance to pay their full premiums and deductibles (in certain Part D plans) and have reduced cost sharing. Individuals who qualify for the partial LIS pay reduced premiums (on a sliding scale based on their income) and also have reduced deductibles and cost sharing. Section 11404 of the IRA (Pub. L. 117169), enacted on August 16, 2022, amended section 1860D14 of the Act to expand eligibility for the full LIS to individuals who are determined to have incomes below 150 percent of the FPL and who meet either the resource standard in paragraph (3)(D) or paragraph (3)(E) of section 1860D14(a) of the Act, with respect to plan years beginning on or after January 1, 2024. This change will provide the full LIS for individuals who currently qualify for the partial subsidy. To implement the changes to the LIS income requirements, we proposed to amend  423.773(b)(1) to add that to be eligible for the full subsidy for plan years beginning on or after January 1,
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partial subsidy. To implement the changes to the LIS income requirements, we proposed to amend  423.773(b)(1) to add that to be eligible for the full subsidy for plan years beginning on or after January 1, 2024, an individual must have an income below 150 percent of the FPL. To coordinate with this change, we also proposed to amend  423.773(d) to specify that the requirement that an individual have an income below 150 percent of the FPL to be eligible for the partial subsidy applies only to plan years beginning before January 1, 2024. This latter change is consistent with the IRA effectively sunsetting the partial LIS after 2023. To implement the changes to the resource limits, we proposed to amend  423.773 to state that the current resource limits applicable for the full subsidy at paragraph (b)(2)(ii) apply to years 2007 through 2023. We also proposed to add a new  423.773(b)(2)(iii) to state that for years beginning on or after January 1, 2024, the resource limits at paragraph (d)(2) of  423.773the resource standards currently applicable for the partial subsidywould apply to full subsidy eligible individuals. This result of this change is that individuals are able to have a higher value of resources and still be eligible for the full subsidy. Lastly, we proposed to amend  423.780(d) to specify that the sliding scale premium amounts currently applicable for individuals with the partial subsidy apply with respect to plan years beginning before January 1, 2024. These individuals who have incomes between 135 and 150 percent of the FPL and who meet the resource requirements will now qualify for the full subsidy beginning in 2024, and will be entitled to a premium subsidy of 100 percent of the premium subsidy amount, as outlined in  423.780(a). We received the following comments, and our responses follow. Comment: Commenters overwhelmingly supported our proposal to implement section 11404 of the IRA and expand eligibility for the Part D LIS. Commenters stated that this change will advance health equity, increase the affordability of prescription drugs, and facilitate access to care, especially for individuals with ESRD, and Black and Hispanic beneficiaries, who may disproportionately fall within the partial subsidy category. Commenters also believed that the change
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affordability of prescription drugs, and facilitate access to care, especially for individuals with ESRD, and Black and Hispanic beneficiaries, who may disproportionately fall within the partial subsidy category. Commenters also believed that the change would simplify the LIS benefit structure, resulting in less beneficiary confusion and a reduction in administrative burden. Response: We appreciate the support for the proposal and agree that the expansion of the LIS benefit will increase beneficiaries access to prescription drugs and improve treatment adherence, leading to better health outcomes. Comment: While voicing their support, many commenters recommended that CMS explore opportunities to educate beneficiaries newly eligible for the full benefit, as well as those currently eligible for but not enrolled in the LIS. They recommended that all Medicare outreach materials, and specifically communications with Medicare Savings Program (MSP) enrollees, include information about the Part D LIS and that CMS should consider increasing outreach and enrollment efforts for low- income beneficiaries. One commenter questioned whether CMS would be notifying beneficiaries of the change and whether plans are expected to continue to send LIS notices. Another commenter requested that we simplify existing application forms and outreach materials, as well as translate them into languages beyond English and Spanish. Response: CMS agrees that it is vital that beneficiaries eligible for the low- income subsidy understand that extra help is available to them through low- income savings programs like MSP and LIS. We currently have targeted language for people with limited income and resources in the Get Ready for Medicare booklet individuals receive when they become eligible for Medicare and Medicare & You which is mailed to beneficiaries on an annual basis. We continue to explore efforts to increase awareness of these savings programs through our publications, online resources, and training materials and note that CMS is planning to conduct direct to consumer outreach to promote MSP and LIS enrollment in 2024. We are contemplating sending notices in the Fall of 2023 to individuals who will be transitioning from the partial LIS subsidy to the full subsidy to inform them of the increased assistance they will be receiving beginning January 1, 2024. We did not propose any changes to the LIS notice requirements, therefore, plans will continue to be responsible for sending their members required information (for example, the LIS rider). Lastly, we are always exploring avenues
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January 1, 2024. We did not propose any changes to the LIS notice requirements, therefore, plans will continue to be responsible for sending their members required information (for example, the LIS rider). Lastly, we are always exploring avenues for improving and simplifying our communication materials to beneficiaries, including enrollment forms. We will continue to work to refine materials, but note that there can be limitations in how much we are able to simplify forms given the information we are conveying to beneficiaries and the required information we need from them to process their request. We note that beneficiaries who require materials in a language other than English and Spanish can contact 1800MEDICARE to request translated materials. Comment: A few commenters expressed concern that beneficiaries with incomes between 135 percent and 150 percent of the FPL are not auto- enrolled into a benchmark plan. In addition, a few commenters questioned whether CMS would be transitioning individuals eligible for the partial subsidy to the full subsidy so these individuals do not have to take any action to receive the additional benefits. Response: Individuals who currently qualify for the partial LIS subsidy and continue to qualify in 2024 will not have to take any action to transition to full subsidy status. As a part of our implementation efforts, we will work with governmental (for example, SSA, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222152 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 786 FR 7009 through 7013, available at https:// www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/ 2021-01753.pdf. 8https://www.cms.gov/cms-strategic-plan . 9https://www.cms.gov/pillar/health-equity . States) and non-governmental (for example, plans) stakeholders to operationalize this transition and make it as seamless as possible for affected beneficiaries. We would note that
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. States) and non-governmental (for example, plans) stakeholders to operationalize this transition and make it as seamless as possible for affected beneficiaries. We would note that while a few commenters stated that individuals with incomes between 135 percent and 150 percent of the FPL are not automatically enrolled into LIS-eligible plans, this is not entirely accurate. Since the beginning of the Part D program, CMS has had a mechanism in placereferred to as facilitated enrollmentthat enrolled partial benefit individuals into benchmark plans. This is essentially the same as the auto-enrollment that CMS conducts for full-benefit dually eligible beneficiaries and results in LIS-eligible individuals without prescription drug coverage being enrolled into Part D plans. Comment: A few commenters, while supporting our proposal, noted concerns about how other changes to the Part D program will affect LIS beneficiaries. They noted how IRA-related changes to maximum out-of-pocket costs and requirements for coverage of insulin and recommended vaccines, as well as the introduction of the new definition of negotiated price will lead to an unknown impact on the national average monthly bid amount and the LIS benchmark, which then could result in a higher number of reassignments in the Fall. Commenters stated that reassignments create disruption for beneficiaries and recommended that we consider pathways within our authority to minimize this. These commenters recommended options such as increasing the de minimis amount to $5, allowing Part D sponsors to offer a fourth PDP in a region that is LIS-only for plan years 2024 and 2025, and launching a demonstration to narrow the risk corridors between 2024 and 2026 to account for the changes to the Part D program and unknown impact to bids. Additionally, one commenter also requested that CMS assess the potential disproportionate impact of this proposed rule and the 2022 final rule on pharmacy reimbursements. Response: We thank the commenters for expressing their concerns for how other upcoming changes to the Part D program may disproportionately have a negative effect on low income beneficiaries. While the recommendations provided by commenters are outside the scope of this particular proposal, we agree that it will be important to ensure that individuals receiving the LIS do not face undue disruption as a result of broader changes in Part D. Comment: One commenter noted that the Part D LIS is
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scope of this particular proposal, we agree that it will be important to ensure that individuals receiving the LIS do not face undue disruption as a result of broader changes in Part D. Comment: One commenter noted that the Part D LIS is offered only to individuals residing in the 50 states and the District of Columbia and expressed disappointment that the IRA did not extend the LIS to beneficiaries in Puerto Rico. Response: We acknowledge the commenters disappointment and agree that this type of change would have to be established in statute and, therefore, is outside the scope of this rulemaking. We appreciate the feedback we received from the commenters. After consideration of all public comments, we are finalizing our proposal with one minor change. We are revising the regulatory text of proposed  423.773(b)(2)(iii) by adding the word plan before years, so that the provision as finalized in this rule refers to plan years beginning on or after January 1, 2024. This change is consistent with the references to plan years in paragraphs (b)(1) and (d) of  423.773, as revised by this final rule. III. Enhancements to the Medicare Advantage and Medicare Prescription Drug Benefit Programs A. Health Equity in Medicare Advantage (MA) 1. Introduction On January 20, 2021, President Biden issued Executive Order (E.O.) 13985: Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, (hereinafter referred to as E.O. 13985).7E.O. 13985 describes the Administrations policy goals to advance equity across Federal programs and directs Federal agencies to pursue a comprehensive approach to advancing equity for all, including those who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. In response, CMS announced its 2022 CMS Strategic Plan, and Advance Equity is the first pillar of that Strategic Plan.8 This pillar emphasizes the importance of advancing health equity by addressing the health disparities that impact our health system. CMS defines health equity as the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender
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our health system. CMS defines health equity as the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.9This is the definition of health equity that we use for all health equity provisions in this final rule. CMS continues to work diligently to identify regulatory actions that can help support CMSs goal to advance health equity or that already address health equity topics but should be expanded in order to meet the increasingly diverse needs of enrollees served by MA organizations. In order to support the Administrations goal of advancing equity for all, it is imperative that we ensure our regulations address topics that enable disadvantaged populations to fully access the care that the regulations already allow them to receive. Consequently, in the proposed rule, we proposed several regulatory updates in the MA program related to health equity. These proposals included requirements intended to ensure equitable access to MA services, ensure MA provider directories reflect providers cultural and linguistic capabilities and notate MOUD-waivered providers, ensure MA enrollees with low digital health literacy are identified and offered digital health education to assist them in accessing any medically necessary covered telehealth benefits, and ensure MA organizations incorporate one or more activities into their overall quality improvement program that reduce disparities in health and health care among their enrollees. We are finalizing these proposals, some with modification. CMS believes that the changes included in this final rule will address health disparities in the MA program and could be essential to more broadly supporting other equity-focused efforts across CMS policies and programs. 2. Ensuring Equitable Access to Medicare Advantage (MA) Services ( 422.112) Currently,  422.112(a)(8) requires MA organizations that offer coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees, including those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds. We emphasized in our proposal and reiterate here that all enrollees indicates that all enrollees are included in this protection even if they do not identify as belonging to one of the groups specifically listed in the regulation. Additionally, all of the changes we proposed are designed to strengthen the regulations current application
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indicates that all enrollees are included in this protection even if they do not identify as belonging to one of the groups specifically listed in the regulation. Additionally, all of the changes we proposed are designed to strengthen the regulations current application or requirements. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222153 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Our proposal was two-part. First, we proposed to change the current paragraph heading from Cultural considerations to Ensuring Equitable Access to Medicare Advantage (MA) Services; the term equitable access is a broader and more suitable description for the paragraph, as it does not emphasize protecting access to care for one population over another. As we stated in our proposal, this change would more clearly reflect the inclusive nature of the protections MA organizations must guarantee for all enrollees under this provision. The second part of our proposal was to add more populations to the existing list of groups that appear in the regulation. Specifically, at  422.112(a)(8), CMS proposed to replace the phrase those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds after the word including and to add in its place additional paragraphs listing more examples of populations that an MA organization must ensure services are provided to in a culturally competent manner and promote equitable access to services for in order to satisfy the existing requirement: (i) people with limited English proficiency or reading skills; (ii) people of ethnic, cultural, racial, or religious minorities; (iii) people with disabilities; (iv) people who identify as lesbian, gay, bisexual, or other diverse sexual orientations; (v) people who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex; (vi) people who live in rural areas and other areas with high levels of deprivation; and (vii) people otherwise adversely affected by persistent poverty or inequality. As we noted in our proposal, MA organizations must provide all
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(vi) people who live in rural areas and other areas with high levels of deprivation; and (vii) people otherwise adversely affected by persistent poverty or inequality. As we noted in our proposal, MA organizations must provide all enrollees, without exception, accommodations to equitably access services according to applicable statutory, regulatory, and other guidance. In other words, the presence of this list should not be construed to mean that accommodations or steps necessary to ensure cultural competency in delivering benefits are required only for enrollees who belong to the groups listed herein. Instead, the proposed changes, with respect to a revised list of populations, are clarifying in nature, non-exhaustive, and are intended to provide additional examples of populations MA organizations should be mindful of in their plan designs. We again emphasize that the regulation already explicitly applies to all enrollees without exception; therefore, the protections of this provision, which were already in effect prior to our proposal, must continue to be part of an MA organizations work to ensure that all Medicare-covered items and services are available and accessible to all enrollees. Comment: Commenters generally supported the changes we proposed for this provision. We received no modification requests for the proposed heading change from Cultural considerations to Ensuring Equitable Access to Medicare Advantage (MA) Services. Some commenters suggested that CMS include additional populations in the proposed list of groups. For example, one commenter recommended a slight change to the language rural areas and other areas with high levels of deprivation to include under-resourced areas. Another commenter suggested that CMS change the language persistent poverty and inequality to include and/or lack of access to health care services. Some commenters suggested that we address intersectional conditions affecting some enrollees. Response: We appreciate these suggestions. We consider an enrollee in an under-resourced area or who experiences a lack of access to health care services to be among those that an MA organization must ensure are served equitably because the regulation extends this protection to all enrollees. We also note that intersectional conditions are already included, not specifically, but by virtue of the regulation applying to all enrollees, and should likewise be addressed when they could result in inequitable access to services. In order to avoid redundancy and keep
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note that intersectional conditions are already included, not specifically, but by virtue of the regulation applying to all enrollees, and should likewise be addressed when they could result in inequitable access to services. In order to avoid redundancy and keep our language generally consistent with E.O. 13985, we will not be adding additional groups at this time. However, we reiterate that the protections of this provision continue to apply to all enrollees, not just the populations listed in the regulation. Comment: Some commenters recommended that CMS further define the newly listed populations (for example, under what conditions would an area qualify as having high levels of deprivation) to ensure it is properly understood to whom the provisions apply and when. Response: Because this provision applies to all enrollees, it would be of limited practical value for CMS to define each group listed in the regulation in detail. Instead, MA organizations should continue to identify remedies whenever it is evident that enrollees equitable access to services might be challenged by conditions such as a disability, race, geographic location, or other factors. Comment: Some commenters recommended that CMS delay the finalization of this proposal in order to allow MA organizations to prepare for the changes. Response: As we discussed in our proposal, the obligation on MA coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees was originally finalized in June 2000 (65 FR 40170). Because this regulation has already been in effect for a significant amount of time and our proposal makes no changes to the regulations current application or requirements, a delay in the finalization of this proposal would unlikely benefit enrollees or the MA organizations who serve them. Finally, all public comments received on this proposal were generally supportive, including those that requested that modifications be made to the final rule. After consideration of the comments and for the reasons outlined in the proposed rule and our responses to comments, including that the requested modifications would not produce substantive changes to either the application or requirements of the provisions (which were in effect prior to the proposal), we are finalizing the revision to  422.112(a)(8) as proposed. 3. Medicare Advantage (MA) Provider Directories ( 422.111) Section 1852(c)(1) of the Act requires an MA organization to disclose, among other things, the number, mix, and distribution of plan providers in a clear,