2023-07115.pdf

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 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 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 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 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 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  423.34(d)(1)) has not taken effect will be automatically enrolled by CMS into the LI NET program unless they have affirmatively declined enrollment in Part D per  423.34(e). LIS-eligible beneficiaries who have made the decision to opt out of enrollment in Part D must take a proactive step to contact CMS for us to record that decision in our systems by placing a flag on the beneficiarys record. Beneficiaries may opt out of Part D enrollment if they have other insurance or do not want to participate as a matter of principle. We assume that a beneficiary who opts out of Part D enrollment would also want to opt out of transitional coverage under the LI NET program. Therefore, proposed  423.2504(b)(1) provided that when a beneficiary affirmatively declines enrollment in Part D per  423.34(e), VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222140 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 5The LI NET demonstration provides an exception to the 36-month maximum period of retroactive enrollment if there is a Medicaid determination within the last 90 days that confers Medicaid eligibility going back further than 36 months. In these situations, LI NET enrollment under the demonstration goes back to the start of Medicaid eligibility. We did not propose an exception to the 36-month limit on retroactive coverage in this rulemaking as the statute does not provide for such an exception. that would also entail opting out of LI NET enrollment. In defining transitional coverage for LI NET, the statute sets forth requirements for the duration of LI NET coverage under section 1860D14(e)(3) of the Act. Section 1860D14(e)(3)(A) establishes that immediate access to covered part D drugs at the point of sale during the period that begins on the first day of the month such individual is determined to meet the requirements of clauses (ii) and (iii) of subsection (a)(3)(A) and ends on the date that coverage under a prescription drug plan or MAPD plan takes effect with respect to such individual. The starting point of enrollment into LI NET for these types of LIS-eligible beneficiaries, whether they are automatically enrolled or immediate need individuals, is required by statute but the duration of time they prospectively remain enrolled in LI NET is not specified. Under the demonstration, we typically cap non- retroactive coverage in LI NET to 2 months. Consistent with the statute and with our operations under the demonstration, in  423.2504(c), we proposed that LI NET enrollment begins on the first day of the month an individual is identified as eligible under  423.2504 and ends after 2 months. Section 1860D14(e)(3)(B) of the Act sets a limit on how far back retroactive LI NET coverage can extend. Full- benefit dually eligible individuals (as defined in section 1935(c)(6)) and recipients of supplemental security income (SSI) benefits under title XVI are eligible for up to 36 months of retroactive coverage. In proposed  423.2504(c)(2), retroactive