2023-07115.pdf

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 LI NET coverage would begin on the date an individual is identified as full-benefit dual or an SSI benefit recipient, or 36 months prior to the date such individual enrolls in (or opts out of) Part D coverage, whichever is later. This duration of time is similar to retroactive coverage under the demonstration, which provides for a maximum retroactive period of 36 months for Full Subsidy LIS eligible individuals.5As with LI NET beneficiaries without retroactive coverage, we proposed that LI NET coverage would end with enrollment into a Part D plan or opting out of Part D coverage. We proposed in  423.2504(d) that enrollment in LI NET would end on the date that coverage under Part D takes effect, consistent with section 1860D 14(e)(3) of the Act. In the case of immediate need beneficiaries for whom LIS-eligibility is not confirmed and who are not enrolled into a PDP, enrollment would end 2 months after the immediate need enrollment begins. No matter the method of enrollment, we proposed that the minimum duration of LI NET enrollment is 2 months unless the beneficiary elects to disenroll from LI NET or to enroll in a Part D plan. For example, an individual whom we auto- assign into LI NET starting April 1, 2024 would remain in LI NET for April and May 2024 before being enrolled into an appropriate Part D plan starting June 1, 2024. We provided the following two examples to further explain how LI NET enrollment and disenrollment would work under our proposals: Example 1: Beneficiary Kristy is a full-benefit dually eligible individual and arrives at a pharmacy on May 5, 2024, with documentation showing that her LIS application is pending. She would have immediate coverage in LI NET for May and June 2024. If, in the course of adjudicating her LIS application, it is discovered that she was actually LIS-eligible dating back to January 2016, Kristy would be retroactively enrolled in LI NET as of July 1, 2021, which is the later of 36 months prior to the date she is enrolled in a Part D plan or the date she was first LIS eligible (since January 2016 is more than 36 months prior to her Part D plan enrollment, her retroactive coverage under LI NET is capped at 36 months prior to such enrollment). Kristys LI NET coverage would end June 30, 2024, upon her enrollment into a benchmark PDP starting July 1, 2024, unless she makes the choice to opt-out. Example 2: The Social Security Administration notifies CMS in February 2024 that Beneficiary Ilan was eligible for both Medicare and SSI starting in November 2022. CMS provides Ilan retroactive Medicare drug coverage from November 2022, which is the later of 36 months prior to enrollment in a Part D plan or the date Ilan was first LIS eligible, through March 2024. After March 2024, if Ilan does not actively enroll in a plan of their choosing, CMS would randomly enroll them into a benchmark PDP with an April 1, 2024 effective date. As noted previously, our goal in the proposals is to match current eligibility and enrollment policy in effect in the demonstration and the Part D program, to the extent the statute permits. We requested comment on whether revised or additional regulations were needed to achieve accurate, streamlined, and beneficiary-friendly eligibility determinations and enrollment in the LI NET program. 3. Benefits and Beneficiary Protections Section 1860D14(e)(4)(B)(i) of the Act requires the LI NET program to provide eligible beneficiaries with access to all Part D drugs under an open formulary. The statute, at clauses (ii) and (iii) of section 1860D14(e)(4)(B) of the Act, also requires the LI NET program to permit all pharmacies that are determined by the Secretary to be in good standing to process claims under the program, and to be consistent with such requirements as the Secretary considers necessary to improve patient safety and ensure appropriate dispensing of medication. These requirements are consistent with how the LI NET demonstration has operated, and we proposed to codify the requirement that the LI NET program provide access to all Part D drugs under an open formulary in  423.2508(a). We proposed in  423.2508(b) to require the LI NET sponsor to permit all pharmacies that CMS determines to be in good standing to process claims under the program, whether or not the pharmacy is a network or out-of-network (OON) pharmacy for the LI NET sponsor. Under the demonstration, we consider a pharmacy, including retail, mail-order, and institutional pharmacies, to be in good standing when it is licensed and does not have a fraud, waste, or abuse determination against it. For the permanent LI NET program, we proposed that a pharmacy would be in good standing if it is licensed, has not been revoked from Medicare under  424.535, does not appear on the Office of Inspector Generals list of entities excluded from Federally funded health care programs pursuant to section 1128 of the Act and from Medicare under section 1156 of the Act (unless the OIG waives the exclusion, which the OIG has authority to do in certain specified circumstances), and does not appear on the preclusion list as defined in  423.100. A pharmacy will appear on the preclusion list if it: Is currently revoked from Medicare, is under an active reenrollment bar, and CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program, including LI NET; Has engaged in behavior for which CMS could have revoked the entity to VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222141 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 6Cost-sharing amounts in Part D are established each year in the Rate Announcement. Final Part D benefit parameters can be found for a plan year at https://www.cms.gov/Medicare/Health-Plans/ MedicareAdvtgSpecRateStats/Announcements-and- Documents. the extent applicable if it had been enrolled in Medicare, and CMS determines that the underlying conduct that would have led to the revocation is detrimental to the best interests of the Medicare program, including LI NET; or Has been convicted of a felony under Federal or State law within the previous 10 years that CMS deems detrimental to the best interests of the Medicare program, including LI NET. In  423.2508(c), we proposed requirements we consider necessary to improve patient safety and ensure appropriate dispensing of medication consistent with subpart D of the Part D regulations. Existing Part D requirements related to appropriate dispensing, patient safety, electronic dispensing, quality improvement organization (QIO) activities, compliance, and accreditation would improve patient safety and appropriate dispensing. Specifically, we proposed to apply the following provisions to the LI NET program and LI NET sponsor, as appropriate:  423.153(b) and (c) for dispensing and point-of-sale safety edits.  423.154 for appropriate dispensing of prescription drugs in long-term care facilities.  423.159, requiring an electronic prescription drug program.  423.160, excepting the requirements pertaining to formulary standards in  423.160(b)(5), setting forth standards for electronic prescribing.  423.162, for quality improvement organization (QIO) activities.  423.165, regarding compliance deemed on the basis of accreditation. We solicited comment on whether any of these provisions would not be compatible with the LI NET program as proposed. Section 1860D14(e)(4)(B)(iv) of the Act provides the Secretary the authority to establish requirements for the LI NET coverage provided to LI NET eligible individuals. As noted in the proposed rule, we drew upon our experience under the demonstration to develop our proposed cost sharing and appeals policies for LI NET, which we proposed to codify in  423.2508(d) and (e), respectively. We proposed in  423.2508(d)(1) that LI NET beneficiaries under  423.2504(a)(1) (that is, beneficiaries whose LIS-eligibility is established and who have not yet enrolled in a prescription drug plan or MAPD plan, or who have enrolled in a prescription drug or MAPD plan but coverage under such plan has not yet taken effect) would pay the applicable cost sharing for their low-income category as established in the yearly Announcement of Calendar Year Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement publication specified in  422.312). Under the demonstration, LI NET beneficiaries pay the reduced cost- sharing aligned with the LIS categories defined in the Part D program. Because there is already the existing statutory requirement for CMS to update the parameters for the LIS benefit each year using statutory indexing methods, and because CMS and pharmacy systems are already set up to reflect the appropriate cost-sharing based on the LIS category of the individual, we believe it is reasonable to calculate and charge cost- sharing in alignment with the Part D LIS categories. For immediate need beneficiaries, we proposed in  423.2508(d)(2) these individuals would by default pay the cost-sharing associated with the category of non- institutionalized FBDE individuals with incomes above 100 percent of the Federal poverty level and full-subsidy- non-FBDE individuals (that is, Category Code 1).6Of the four LIS eligibility categories, this category has the highest level of cost-sharing. Proposed  423.2508(d)(2) would further provide that if the beneficiary is later confirmed to belong to a different LIS category, the beneficiary would be refunded by the LI NET sponsor for the difference between the cost sharing they paid versus what they would have paid in their confirmed LIS category. This approach allows for the least government liability for individuals whose LIS eligibility is unable to be confirmed while still allowing prescription drug access for immediate need individuals. We proposed in  423.2508(e) that LI NET enrollees have rights with respect to Part D grievances, coverage determinations, and appeals processes set out in subpart M of the Part D regulations. The established processes would adequately adjudicate LI NET beneficiary concerns. This approach of using existing processes avoids needing to devote resources to establishing separate processes for grievances, coverage determinations, and appeals processes. Furthermore, consistency with other Part D contracts with respect to grievances, coverage determinations, and appeals would be simplest for the LI NET sponsor. 4. LI NET Sponsor Requirements Section 1860D14(e)(4)(A) of the Act specifies that, as determined appropriate by the Secretary, the LI NET program is to be administered through a contract with a single administrator. Since the beginning of the demonstration, CMS has had one Part D sponsor serve as the sole contractor for administering LI NET. We have found that this approach supports our goal of administrative simplicity by making it unnecessary for each individual plan sponsor to check eligibility and conduct a retroactive enrollment/reimbursement process. In our experience, the benefits of having a single Part D sponsor administer LI NET include the following: Providing a single point of contact for beneficiaries and pharmacies attempting to have their claims paid. Providing a single point of contact for State Medicaid agencies submitting Medicaid eligibility and attempting to reconcile and coordinate claims. Simplifying the filing of retroactive beneficiary claims. There may be circumstances in which CMS may want to consider contracting with more than one Part D sponsor to administer LI NET. Though we have had stability in LI NET in terms of only having a single LI NET sponsor for the duration of the demonstration, we recognize the need for some protections should it become necessary for another entity to take over as LI NET sponsor and assume responsibility for providing LI NET coverage. The downside of consolidating LI NET functions into a single sponsor is the potential for beneficiary impact should there be a reason that the single LI NET sponsor no longer continues its functions. We believe that this potential for beneficiary impact is mitigated by our proposals to non-renew or terminate the LI NET contract per proposed  423.2520. Accordingly, while we proposed at new  423.2512 that the program will be operated by