evekhm/cms_iom_500 huggingface dataset:
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to Original Medicare, in the case where a patient in an MA plan receives a cancer diagnosis and is unable to access needed treatment in a timely manner. The commenter also recommended that CMS create an ongoing open enrollment window for patients diagnosed with cancer, which would automatically provide the benefits of having comprehensive in- network care. Response: We thank the commenters for their feedback; however, we proposed to add corresponding exceptional condition SEPs for MA and Part D enrollment to align with the new Medicare premium-Part A and B exceptional condition SEPs that CMS has finalized, and these comments are outside of the scope of this rulemaking. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing, the MA SEP at  422.62(b)(26) with a minor edit to the regulation text to clarify that this SEP applies to an individual submitting an application for Part B only if they are already entitled to Part A, or are enrolling in premium-free Part A within the timeframe of this SEP. We are finalizing the Part D enrollment SEP at 423.38(c)(34) as proposed without modification. D. Transitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the Limited Income Newly Eligible Transition (LI NET) Program ( 423.2500 Through 423.2536) 1. Background on the LI NET Demonstration and Introduction to the Proposals a. Background on the LI NET Demonstration The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) established the Medicare Part D prescription drug benefit, which became effective on January 1, 2006. Prior to 2006, beneficiaries who were eligible for both Medicaid and Medicare (dually eligible) received prescription drug benefits through Medicaid. When the MMA went into effect, dually eligible beneficiaries began receiving their prescription drug benefits through Medicare Part D. From the beginning of Part D, CMS recognized the need to provide both immediate and retroactive coverage for full-benefit dually eligible (FBDE) beneficiaries who were newly identified by either CMS or a State. Prior to 2010, CMS automatically enrolled newly identified beneficiaries eligible for the Part D low-income subsidy (LIS) into a Part D plan with a premium at or below the low-income benchmark
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CMS or a State. Prior to 2010, CMS automatically enrolled newly identified beneficiaries eligible for the Part D low-income subsidy (LIS) into a Part D plan with a premium at or below the low-income benchmark (benchmark plans), which have no or reduced premiums for LIS-eligible beneficiaries. Each benchmark plan receiving these beneficiaries was required to grant retroactive coverage to the beginning of a beneficiarys LIS- eligible status or their last uncovered month, whichever date was later. At the time, there were around 300 Part D benchmark plans, and each needed to develop the capacity to provide transitional and retroactive coverage for these beneficiaries. Conducting retroactive claims adjudication and providing point-of-sale coverage was not efficient for Part D sponsors and accordingly, in 2010, CMS established the Medicare Part D Demonstration for Retroactive and Point of Sale Coverage for Certain Low-Income Beneficiaries, also known as Medicares Limited Income Newly Eligible Transition (LI NET) demonstration. The LI NET demonstration consolidates administration of transitional and retroactive Part D coverage for eligible beneficiaries to a single Part D sponsor. Part D coverage under the LI NET demonstration differs from coverage under traditional Part D plans in that the LI NET demonstration provides point-of-sale coverage for beneficiaries who demonstrate an immediate need for prescriptions, and also provides retroactive and/or temporary coverage for beneficiaries determined to be eligible, or likely to be eligible, for the Part D LIS by the Social Security Administration (SSA) or a State. The LI NET demonstration provides temporary, transitional Part D prescription drug coverage for LIS-eligible beneficiaries, including beneficiaries who are eligible for the Part D LIS but who are not yet enrolled in a Part D drug plan, or are enrolled in a plan but for whom coverage has not yet taken effect. The purposes of the demonstration are to provide the following: More efficient prescription drug coverage and claims reimbursement for newly eligible low-income beneficiaries, including periods of retroactive eligibility; More efficient prescription drug coverage and claims reimbursement for individuals who are not enrolled in a PDP and whose LIS status is not yet established in CMS systems, but who arrive at a pharmacy with an immediate need for their
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More efficient prescription drug coverage and claims reimbursement for individuals who are not enrolled in a PDP and whose LIS status is not yet established in CMS systems, but who arrive at a pharmacy with an immediate need for their prescription. This may occur, for instance, when a State has determined that a beneficiary is eligible for Medicaid but that information does not yet appear in CMS systems; A seamless transition for LIS- eligible beneficiaries from LI NET into a qualifying PDP with basic prescription drug coverage absent a beneficiarys choice otherwise; and More efficient prescription drug coverage and claims reimbursement for LIS-eligible beneficiaries who are losing existing coverage in a PDP. For example, a beneficiary could be terminated for moving out of the service area of their current PDP. The beneficiary would be automatically enrolled into LI NET for that month and the following month, with enrollment into a qualifying PDP with basic prescription drug coverage that would become effective at the end of the LI NET enrollment absent the beneficiarys choice otherwise. b. Introduction to the Proposals To Implement LI NET as a Permanent Program Division CC, title I, subtitle B, section 118 of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116260) modified section 1860D14 of the Act by redesignating subsection (e) of section 1860D14 as subsection (f) and by establishing a new subsection (e) Limited Income Newly Eligible Transition Program. New subsection (e)(1) requires the Secretary to carry out a program to provide transitional coverage for covered Part D drugs for LI NET eligible individuals . . . no later than January 1, 2024. This directive in section 118 of the CAA makes LI NET a permanent program within Part D, beginning in 2024. The proposed rulemaking to establish the LI NET program is consistent with President Bidens Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021) and Executive Order 14085 on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government (December 13, 2021). LI NET ensures that low-income beneficiaries transitioning from Medicaid to Medicare do not experience a gap in coverage for their prescription medications.
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Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government (December 13, 2021). LI NET ensures that low-income beneficiaries transitioning from Medicaid to Medicare do not experience a gap in coverage for their prescription medications. Executive Order 14085 calls for the Federal Government to design and deliver services with a focus on the actual experience of the people whom it is meant to serve and deliver services more equitably and effectively, especially for those who have been historically underserved. We have designed the LI NET program with beneficiary needs foremost in mind, ensuring continuous drug coverage and access for eligible low- income individuals. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222138 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 4Of the 80 percent of immediate need LI NET beneficiaries whose LIS status is ultimately confirmed, for 89 percent confirmation was within 10 days, and for 97 percent confirmation was within 21 days. In the demonstration, beneficiaries whose LIS status is not able to be confirmed within 21 days continue to be enrolled in LI NET for two months, but they can no longer fill prescriptions after 21 days. LI NET policies, infrastructure, and operations have evolved over the past 13 years to balance providing needed coverage with responsible stewardship of taxpayer dollars and efficiency in administering the program. The LI NET demonstration has proven successful in providing low-income individuals transitional Part D coverage. Approximately 8 million low-income individuals received the benefits of the LI NET program under the demonstration, with over 100,000 beneficiaries enrolled in LI NET in any given month. It has become a program that beneficiary advocacy groups rely on when supporting low-income individuals and connecting them with services. LI NET works directly with over a dozen advocacy groups and 51 State Health Insurance Assistance Programs (SHIPs), which collectively work with LIS beneficiaries to remove access barriers and provide health insurance counseling. We believe the LI NET demonstration is a reliable, stable program that has been successful in providing transitional and retroactive Part D coverage
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Programs (SHIPs), which collectively work with LIS beneficiaries to remove access barriers and provide health insurance counseling. We believe the LI NET demonstration is a reliable, stable program that has been successful in providing transitional and retroactive Part D coverage to millions of beneficiaries. In developing our proposals for implementing the permanent LI NET program, we took into consideration our experience under the LI NET demonstration. Where appropriate, we discuss the policies and practices under the LI NET demonstration that informed our proposals for how to implement aspects of the LI NET program that are not directly specified by the statute. We rely on the premise that Part D regulations apply to the LI NET program and to the LI NET sponsor as part of the Part D program and as a type of Part D sponsor, except for when the statute requires us to deviate or when existing regulations would not apply. For example, as discussed further in this final rule, because the LI NET sponsor is required to have an open formulary, existing Part D requirements on formulary development would not be applicable. Our proposals to make LI NET a permanent program started with  423.2500. In  423.2500(a), we proposed the LI NET program would be based on section 1860D14 of the Act. We proposed in  423.2500(b) the scope of the LI NET program, which would begin no later than January 1, 2024. Under this program, eligible individuals would be provided transitional coverage for Part D drugs. Section  423.2504 sets forth the LI NET eligibility and enrollment proposals and  423.2508 proposed LI NET benefits and beneficiary protections. Next, we proposed in  423.2512 the requirements to be an LI NET sponsor and  423.2516 proposed how the Part D sponsor administering LI NET in partnership with CMS would be selected and the requirements set forth in the LI NET contract to provide services and coverage. In  423.2518, we included a proposal for intermediate sanctions in the event of contract violations. In  423.2520, we proposed how an LI NET contract would be non- renewed or terminated. In  423.2524, we included our proposals for bidding and determining the LI NET payment rate. Finally,  423.2536 enumerated the Part D requirements we proposed waiving for LI NET. We proposed to align sunsetting the demonstration seamlessly with the
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we included our proposals for bidding and determining the LI NET payment rate. Finally,  423.2536 enumerated the Part D requirements we proposed waiving for LI NET. We proposed to align sunsetting the demonstration seamlessly with the start of the LI NET program under this section. Specifically, the LI NET demonstration will continue to operate until December 31, 2023, and the LI NET program would start to operate on January 1, 2024 according to the regulations that we finalize. 2. Eligibility and Enrollment a. Eligibility Section 1860D14(e)(2) of the Act provides that an individual is eligible for LI NET coverage if they: (A) meet the requirements of section 1860D 14(a)(3)(A)(ii) and (iii) of the Act; and (B) have not yet enrolled in a prescription drug plan or an MAPD plan, or, who have so enrolled, but with respect to whom coverage under such plan has not yet taken effect. This means that to be eligible, the individual would need to be a full-benefit dual- eligible individual or low-income subsidy (LIS) eligible individual as defined at  423.773 and Not yet be enrolled in a prescription drug plan or an MAPD plan; or Be enrolled but their coverage has not yet taken effect. Under these requirements, LI NET would be available to all categories of individuals who are LIS-eligible, including Full Subsidy-Full Benefit Dually Eligible (FBDE) individuals, including institutionalized beneficiaries and beneficiaries receiving home and community-based services; Full Subsidy-Non-FBDE Individuals, including those who have applied or are eligible for QMB/SLMB/ QI or SSI, with income and resource thresholds at or below the amounts set by CMS each year; and Partial Subsidy Individuals, including those who have applied and have income and resource amounts below the thresholds set by CMS each year. We proposed to codify at Subpart Y the LI NET eligibility requirements set forth in section 1860D14(e)(2) of the Act. We proposed to establish in paragraph (a) of new  423.2504 two categories of individuals eligible to enroll in LI NET that encompass the previously noted categories of low- income individuals recognized by Part D. The first category, which we
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We proposed to establish in paragraph (a) of new  423.2504 two categories of individuals eligible to enroll in LI NET that encompass the previously noted categories of low- income individuals recognized by Part D. The first category, which we term LIS-eligible in proposed paragraph (a)(1), would be composed of individuals whose low-income status has been confirmed either through CMSs data in our system of record or because the individual can demonstrate their current or future low-income status. The second category, which we term immediate need in proposed paragraph (a)(2), would consist of individuals whose low-income status has not been confirmed, because CMSs data do not yet reflect the individuals low-income status, but the individual has indicated that they are eligible for the LIS. We refer to the individuals in the category established in proposed paragraph (a)(2) as immediate need because they present at a pharmacy or to the LI NET sponsor in immediate need of a prescription and have no Part D coverage. Ideally, these beneficiaries would be able to show documentation of their pending LIS status, such as a letter received from the State showing the beneficiarys LIS status. However, we do not believe an absence of documentation in hand at the point-of- sale should be a barrier to entry to LI NET for immediate need individuals. This is because our experience in the demonstration is that 80 percent of immediate need individuals do have their eligibility confirmed,4and we would not want to turn away these individuals who imminently require access to their prescription drugs. Under the LI NET demonstration, individuals can indicate the likelihood of their low- income status by providing the evidence they have, which can include verbal explanations of why they consider themselves eligible. We proposed in  423.2504(a)(2) to grant immediate access to covered Part D drugs at the point-of-sale for individuals whose eligibility as defined at  423.773 cannot be confirmed at the point-of-sale. We proposed to permit VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on
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Apr 11, 2023 Jkt 259001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222139 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations immediate need individuals to provide documentation to the LI NET sponsor to confirm LIS eligibility. Documentation could include, but would not be limited to A copy of the beneficiarys Medicaid card that includes their name and eligibility date; A copy of a letter from the State or SSA showing LIS status; The date that a verification call was made to the State Medicaid agency, the name and telephone number of the State staff person who verified the Medicaid period, and the Medicaid eligibility dates confirmed on the call; A copy of a State document that confirms active Medicaid status; A screen-print from the States Medicaid systems showing Medicaid status; or Evidence at point-of-sale of recent Medicaid billing and payment in the pharmacys patient profile. Under our proposal, if an immediate need individuals LIS status cannot be confirmed within a period of 2 months, that individual would not be automatically enrolled into a Part D plan. This is the same as current practice under the LI NET demonstration. We solicited comment on the proposal to align the 2 months of enrollment with the ability to fill prescriptions for these immediate need beneficiaries. We proposed to permit immediate need beneficiaries whose eligibility cannot be confirmed to continue to fill prescriptions throughout their 2-month enrollment in LI NET. We believe this ensures access to LI NET benefits and is an administratively simple approach as compared with alternative ideas, such as the approach under the demonstration of keeping immediate need beneficiaries with uncertain eligibility enrolled in LI NET but unable to fill prescriptions. We proposed that if, by the end of an immediate need individuals enrollment in LI NET, neither CMSs systems nor the beneficiarys provision of documentation confirms low-income status, then that individual would not be auto-enrolled into a qualifying standalone Part D plan following their LI NET coverage. b. Enrollment Section 1860D14(e) of the Act does
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provision of documentation confirms low-income status, then that individual would not be auto-enrolled into a qualifying standalone Part D plan following their LI NET coverage. b. Enrollment Section 1860D14(e) of the Act does not specify a process for enrollment into the LI NET program. Therefore, in forming our proposed enrollment process, we looked to the process used in the demonstration. Under the LI NET demonstration, there are four ways for eligible individuals to be enrolled into the demonstration. They are as follows: Automatic enrollment. Individuals who are LIS-eligible but do not yet have Part D coverage, and those individuals who have selected a Part D plan but whose enrollment has not taken effect, are enrolled by CMS into the LI NET demonstration unless the beneficiary has affirmatively declined enrollment in Part D. Point of sale enrollment. Immediate need individuals whose claims are submitted by the pharmacy at the point- of-sale and billed to LI NET are enrolled into the LI NET demonstration by the LI NET sponsor. Direct reimbursement request. Individuals who are LIS-eligible and who submit receipts for reimbursement for claims paid out of pocket are retroactively enrolled into the LI NET demonstration by the LI NET sponsor, with 36-month retroactive coverage for full dually eligible individuals and those who receive supplemental security income (SSI) benefits. LI NET application form. Beneficiaries who are not enrolled into LI NET through auto-enrollment, point- of-sale enrollment or via an approved direct reimbursement request may submit an application form to the LI NET sponsor with supporting documentation demonstrating their LIS status. The LI NET sponsor will periodically check for eligibility and enroll applicants once eligibility is confirmed. The majority of LI NET beneficiaries are enrolled into the LI NET demonstration automatically by CMS; about 90 to 95 percent of LI NET beneficiaries are those we identify in our systems and enroll into the demonstration. To do this, CMS sweeps our data monthly to identify all beneficiaries who are Eligible for LIS; Eligible for Part D; Not enrolled in a Part D plan or receiving the Retiree Drug Subsidy (RDS) or coverage through Veterans Affairs; Have not opted-out of Part D enrollment for any reason (for example, because they declined it); Not incarcerated, are lawfully present in the US, and do not live in another
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or coverage through Veterans Affairs; Have not opted-out of Part D enrollment for any reason (for example, because they declined it); Not incarcerated, are lawfully present in the US, and do not live in another country; and Are not enrolled in a Part C plan that disallows concurrent enrollment in a Part D plan. Beneficiaries identified in the monthly sweep are automatically enrolled into the LI NET demonstration for that month and the following month. CMS then prospectively enrolls the beneficiary into a traditional Part D plan, with coverage under that plan taking effect immediately after the LI NET coverage ends. This population of beneficiaries includes those who may be gaining Part D eligibility or LIS status but have not made an election into a Part D plan. A smaller number of beneficiaries, about five to ten percent of LI NET beneficiaries, enroll in the LI NET demonstration outside of the sweeps process. Some enroll at the point-of- sale, as described previously. An even smaller number of beneficiaries contact the LI NET sponsor directly to enroll in the LI NET demonstration. Individuals can submit a request for reimbursement to the LI NET sponsor. If the person is LIS-eligible, the LI NET sponsor enrolls them into the LI NET demonstration and reimburses them for eligible out-of- pocket costs for the duration of their retroactive enrollment. As with an individual who is enrolled at the point- of-sale, the start date of LI NET enrollment would be the first of the month the request is received. There may be individuals who do not have an immediate need for medication and believe they are eligible for LI NET. These individuals can either bring documentation of LIS status to a pharmacy or fill out an application form, which allows the LI NET sponsor to periodically check their eligibility and enroll them into LI NET if they become eligible. Consistent with the enrollment processes under the demonstration, we proposed in  423.2504(b) to codify the ways in which individuals can be enrolled into LI NET: auto-enrollment, point-of-sale for immediate need individuals, direct reimbursement, and LI NET enrollment form. In  423.2504(b)(1), we proposed that individuals who are LIS-eligible and whose auto-enrollment into a Part D plan (as outlined in