evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
to make either lump-sum payments or adjustments based on the risk corridor calculations. Proposed  423.2524(e) would establish that the LI NET contract is subject to the existing provision at  423.346 pertaining to payment reopenings. Per  423.346, CMS may reopen and revise an initial or reconsidered final payment determination for up to 5 payment years. Under the demonstration, each LI NET reconciliation has been in alignment with  423.346 and included the prior 5 years of PDEs. The most recently completed payment year gets reconciled for the first time along with reopening the prior 4 years. For example, in 2019, PBP 008 for payment year 2018 was reconciled for the first time while PBPs 004007 (for payment years 2014 through 2017) were reopened. Sequestration is not used or accounted for in reconciliation, consistent with how we apply sequestration for other Part D plans. Under the demonstration, we maintain consistency between LI NETs PDE and DIR reporting deadlines and the reporting deadlines that apply to Part D plans (for example, the yearly deadline for data used for payment year reconciliation is June 30th). Enrollment, risk adjustment, and PDE certifications (attestations) are collected under the LI NET demonstration just like other contracts, and we proposed to adopt the requirements in  423.505(k)(1) through (5), except for certifying to reinsurance data because LI NET does not receive a reinsurance subsidy. This proposal would require the LI NET sponsor to certify to the accuracy, completeness, and truthfulness of all data related to payment. As noted earlier in this section of this final rule, as a general matter, all payment rights and responsibilities under Part D that otherwise apply and are not explicitly waived in proposed  423.2536 would apply to the LI NET program, as appropriate. Proposed  423.2524(f) would provide that the LI NET sponsor could appeal the payment calculation under  423.350. Proposed  423.2524(g) would establish that the LI NET contractor is subject to the report and return overpayment requirements under  423.360. 7. Part D Program Waivers Because the LI NET sponsor is a Part D sponsor and the LI NET contract is a PDP contract,
2023-07115.pdf
is subject to the report and return overpayment requirements under  423.360. 7. Part D Program Waivers Because the LI NET sponsor is a Part D sponsor and the LI NET contract is a PDP contract, many existing provisions in Part 423 apply to LI NET. The exceptions are those provisions waived by the statute, those provisions that are inapplicable to LI NET, and the requirements we proposed to waive through this rulemaking. Section 1860D14(e)(5)(A) of the Act provides that paragraphs (1) and (3)(B) of section 1860D4(a) of the Act, subparagraphs (A) and (B) of section 1860D4(b)(3) of the Act, and paragraphs (1)(C) and (2) of section 1860D4(c) of the Act do not apply to the LI NET program; thus, requirements relating to dissemination of general information and the provision of formulary information, formulary requirements, and medication therapy management (MTM) program requirements do not apply to LI NET. For this reason, we proposed to waive formulary requirements in  423.120(b), 423.128(e)(5), and 423.128(e)(6) and MTM program requirements in  423.153. Section 1860D14(e)(5)(B) of the Act contains broad waiver authority to waive such other requirements of title XI and this title as may be necessary to carry out the purposes of the program established under this subsection. We also proposed to waive for LI NET some of the cost control and quality improvement requirements in Part 423 VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222146 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Subpart D, except for the provisions we explicitly proposed to adopt in  423.2508(d)(1) through
2023-07115.pdf
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Subpart D, except for the provisions we explicitly proposed to adopt in  423.2508(d)(1) through (d)(5) that relate to appropriate dispensing, patient safety, electronic dispensing, QIO activities, compliance, and accreditation. This proposal would waive requirements that would not make sense in the context of temporary coverage with access to an open formulary. The requirements we proposed to waive pertain to drug utilization management programs, medication therapy management programs, and consumer satisfaction surveys. We solicited comment on whether we should waive any additional regulatory provisions related to paragraphs (1) and (3)(B) of section 1860D4(a) of the Act and subparagraphs (A) and (B) of section 1860D4(b)(3) of the Act. We proposed that the LI NET sponsor submit most of the certifications listed in  423.505(k), with the exception that we are waiving the certification of accuracy of data for price comparison in paragraph (k)(6), given that the LI NET plan is not one for which beneficiaries shop. Part D beneficiaries receiving a low- income subsidy are not eligible for the coverage gap discount program, and under the demonstration LI NET is not subject to coverage gap discount requirements under subpart W of Part 423. Thus, we proposed in  423.2536(i) to waive subpart W in full for LI NET. We proposed in  423.2536(j) to waive the MLR requirements in subpart X of Part 423. Section 1857 of the Act as incorporated into section 1860D14(e) does not speak to MLR requirements for LI NET. Under the LI NET demonstration, CMS does not require the LI NET sponsor to meet the minimum medical loss ratio (MLR) requirement or to report the MLR for the LI NET contract as it does for other Part D contracts. This is due to the unique payment structure for the contract. Under Part D, a sponsor submits a single bid including estimated administrative costs, returns on investment, and drug costs, which are risk-adjusted. After a payment year concludes, Part D sponsors are required under
2023-07115.pdf
the unique payment structure for the contract. Under Part D, a sponsor submits a single bid including estimated administrative costs, returns on investment, and drug costs, which are risk-adjusted. After a payment year concludes, Part D sponsors are required under subpart X of Part 423 to report the MLR for each contract, and if the MLR for a contract is below 85 percent, the sponsor is required to remit payment to CMS. Enrollment sanctions are applied to contracts that fail to meet the minimum MLR requirement for 3 consecutive years, and contracts that fail to meet the requirement for 5 consecutive years are subject to termination. The minimum MLR requirement is intended to create incentives for Part D sponsors to reduce administrative costs such as marketing costs, profits, and other such uses of plan revenues, and to help ensure that taxpayers and enrolled beneficiaries receive value from Medicare health plans. Because of the limits we proposed to place on how much administrative costs in LI NET under Payment Rate A can increase year over year and because of the differing payment structure, we do not believe MLR reporting should be applicable to LI NET. The Affordable Care Act amended section 1893(h) of the Act to expand the use of Recovery Audit Contractors (RACs) to include the MA and Part D programs. Section 1893(h)(9) of the Act specifies that, under contracts with the Secretary, Part D RACs are required to ensure that each PDP has an anti-fraud plan in effect and to review the effectiveness of each such anti-fraud plan, to examine claims for reinsurance payments to determine whether PDPs submitting such claims incurred costs in excess of the costs allowed, and to review estimates submitted by PDPs with respect to the enrollment of high- cost beneficiaries and compare such estimates with the numbers of such beneficiaries actually enrolled by such plans. Because the LI NET sponsor must enroll every eligible LI NET beneficiary, and because LI NET does not receive reinsurance, a Part D RACs review or examination of LI NET claims would likely be extremely limited in scope. As other audit, oversight, and compliance requirements would continue to apply to the LI NET program, the other program integrity safeguards we have proposed for the LI NET program would be adequate, and we therefore proposed to waive application of the RAC requirements in subpart Z of Part 423. In surveying the items under Part 423 for the Voluntary Medicare
2023-07115.pdf
integrity safeguards we have proposed for the LI NET program would be adequate, and we therefore proposed to waive application of the RAC requirements in subpart Z of Part 423. In surveying the items under Part 423 for the Voluntary Medicare Prescription Drug Benefit, we attempted to categorize existing requirements as applicable, inapplicable, or a candidate for waiver. We solicited comment on whether there are additional provisions in part 423 that we did not mention in the proposed rule and that we should address for LI NET. 8. Technical Corrections In the course of this rulemaking, we noticed the need for a technical correction in  423.505(b)(22), which requires Part D sponsors to address and resolve complaints received by CMS against the Part D sponsor. The regulation text currently refers to MA organization when it should refer to Part D sponsor, and thus we proposed to make the correction. We also proposed to make a technical correction in the header of subpart Z of Part 423. The header in regulation text currently is Recovery Audit Contractor Part C Appeals Process when it should be referring to Part D. Thus, we proposed to make the technical correction so the header correctly reads, Recovery Audit Contractor Part D Appeals Process. We received a number of comments on the LI NET proposals. Summaries of the comments and our responses follow. Comment: All comments we received on the LI NET provision stated broad support of our proposals to make LI NET a permanent program. One commenter specifically noted that our proposal will simplify and expand access for the dually eligible population, in addition to the partial-benefit dually eligible population. Response: We thank commenters for their support. Comment: One commenter questioned whether each MA organization needs to have programs in place to track low- income beneficiaries eligibility for LI NET, provide LI NET benefits, and manage LI NET enrollment. Response: Only the LI NET sponsor appointed by CMS in accordance with  423.2516 will have responsibility for administering the LI NET program. Other Part D benchmark plans may receive beneficiary enrollments automatically from CMS, and such enrollments could include beneficiaries who were enrolled in LI NET. The process of identifying low-income beneficiaries who may be eligible for LI NET is set forth in  423.2504. Comment: A few commenters encouraged us
2023-07115.pdf
could include beneficiaries who were enrolled in LI NET. The process of identifying low-income beneficiaries who may be eligible for LI NET is set forth in  423.2504. Comment: A few commenters encouraged us to consider additional outreach to LI NET beneficiaries during their temporary enrollment in LI NET to support beneficiaries in selecting an appropriate Part D plan for themselves if they so choose. Response: All beneficiaries who are enrolled into the LI NET demonstration receive information at the beginning of their LI NET enrollment that describes how they can choose a specific plan for their individual circumstances or allow CMS to automatically enroll them into a benchmark plan following their enrollment in LI NET. In the demonstration, the beneficiarys welcome letter states in plain language that the LI NET beneficiary has the right to choose a plan, and lists resources like 1800MEDICARE, a link to Plan Compare (Plan Finder), and the phone number for Eldercare Locator. Under the demonstration, CMS automatically enrolls beneficiaries into a benchmark plan. LIS-eligible beneficiaries who wish to change plans may use a special VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222147 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations election period (SEP) to move to another plan, and instructions for how to join a different plan are also described in CMS notices to beneficiaries. As is routine for all beneficiary communications regarding Medicare, instructions that include the phone number for LI NET beneficiaries to call for language assistance services are provided in numerous languages to broaden the reach of beneficiary communications. We are finalizing  423.2512(c)(3), which will require the LI NET sponsor to conduct outreach in consultation with CMS, as proposed. We anticipate that outreach under the LI NET program will be substantially similar to outreach that has been conducted under the demonstration to date. Comment: A few commenters believed that CMS was not intending
2023-07115.pdf
outreach in consultation with CMS, as proposed. We anticipate that outreach under the LI NET program will be substantially similar to outreach that has been conducted under the demonstration to date. Comment: A few commenters believed that CMS was not intending to allow a letter from the Social Security Administration indicating a beneficiarys LIS eligibility to be sufficient evidence for enrollment into LI NET. Two of the commenters also referenced best available evidence (BAE) standards in relation to LI NET. One commenter relayed a belief that the CMS contractor reviewing BAE is too strict and improperly excludes LTC residents from receiving LIS status. According to the commenter, this causes LTC pharmacies to unfairly absorb the cost of prescription drugs and related LTC pharmacy services that they are legally obligated to provide to LTC facility residents for whom LIS status does not get established. Response: We proposed at  423.2504(a)(2)(i)(A) through (F) a list of documents that would be sufficient for an immediate need beneficiary to demonstrate LIS eligibility. A copy of a letter from SSA showing LIS status is item (B) on the list. The documentation listed in proposed  423.2504(a)(2)(i)(A) through (F) would be appropriate for any individual to submit in order to enroll in LI NET in circumstances where they are not automatically enrolled. After consideration of these comments, we are modifying our proposal to clarify that these documents can be submitted by any individual to determine LIS eligibility, regardless of whether they are enrolling in LI NET at the POS, through a direct reimbursement request, or by submitting an LI NET application form. We are modifying our proposed regulations at  423.2504(b) to make conforming changes. We also take this opportunity to clarify that the list of documentation of LIS eligibility in proposed  423.2504(a)(2)(i)(A) through (F) is a non-exhaustive list of types of best available evidence as defined in  423.772. Best available evidence in  423.772 means evidence recognized by CMS as documentation or other information that is directly tied to State or Social Security Administration systems that confirm an
2023-07115.pdf
defined in  423.772. Best available evidence in  423.772 means evidence recognized by CMS as documentation or other information that is directly tied to State or Social Security Administration systems that confirm an individuals low-income subsidy eligibility status, and that must be accepted and used by the Part D sponsor to change low- income subsidy status. As applied to LI NET, when a beneficiary chooses to provide documentation at the POS, with their direct reimbursement request form, or with their LI NET application form, the documentation is reviewed by CMS and upon approval the LI NET sponsor would change the beneficiarys LIS status appropriately. In  423.2504(b)(3), the proposed rule refers to individuals submitting receipts for reimbursement for claims paid out of pocket when making a direct reimbursement request. We finalize  423.2504(b)(3) with a modification to clarify that that we are referring to eligible claims. This change makes explicit that eligible claims, namely those for Part D drugs from dates when the person was retroactively LIS eligible, are needed for enrollment to successfully occur using a direct reimbursement request. In  423.2504(b)(4), for consistency in referring to the documentation that may be optionally submitted along with the LI NET application form, we revise the proposed language of supporting documentation demonstrating their LIS status to optional documentation of LIS eligibility listed in [new] paragraph (a)(3) and clarify that if no documentation is submitted and accepted, the LI NET sponsor will periodically check for eligibility and enroll applicants once LIS eligibility is confirmed. In making these clarifications, we note that LI NET individuals will be enrolled via one of the four enrollment options. Though they can, for example, submit an LI NET application form and a direct reimbursement request form at the same time, the first in time to effectuate the enrollment will be the way in which the beneficiary is enrolled. In sum, to clarify the role of documentation in LI NET, we are finalizing  423.2504 with the following revisions: Renumber proposed  423.2504(a)(2)(i) to
2023-07115.pdf
In sum, to clarify the role of documentation in LI NET, we are finalizing  423.2504 with the following revisions: Renumber proposed  423.2504(a)(2)(i) to  423.2504(a)(3) and add a heading that reads Documentation of LIS Eligibility; Renumber the succeeding subsections under proposed  423.2504(a)(2)(i) accordingly; Insert  423.2504(a)(4) to say CMS uses documentation submitted under paragraph (a)(3) of this section to confirm LIS eligibility; Renumber proposed  423.2504(a)(2)(ii) to  423.2504(a)(5) and revise to specify that If CMS cannot confirm an immediate need individuals eligibility during the period of LI NET coverage, the individual will not be auto-enrolled into a standalone Part D plan in accordance with  423.34(d) following their LI NET coverage; Finalize  423.2504(b)(2) as follows: (2) Point-of-sale enrollment. An individual who is not automatically enrolled in accordance with paragraph (b)(1) of this section and whose claim is submitted at the point-of-sale and accepted by the LI NET sponsor will be enrolled into the LI NET program by the LI NET sponsor; Finalize  423.2504(b)(3) as follows: (3) Direct reimbursement request. An individual described in paragraph (a)(1) of this section who is not automatically enrolled in accordance with paragraph (b)(1) or at the point-of-sale as provided in paragraph (b)(2) and who submits a direct reimbursement request form, receipts for reimbursement for eligible claims paid out of pocket (with optional documentation of LIS eligibility listed in paragraph (a)(3)), will be retroactively enrolled into the LI NET program by the LI NET sponsor. The LI NET sponsor has 14 calendar days to reply with a coverage decision; and Finalize  423.2504(b)(4) as follows:
2023-07115.pdf
enrolled into the LI NET program by the LI NET sponsor. The LI NET sponsor has 14 calendar days to reply with a coverage decision; and Finalize  423.2504(b)(4) as follows: (4) LI NET application form. An individual who is not enrolled through one of the methods in paragraphs (b)(1) though (3) of this section may submit an LI NET application form to the LI NET sponsor (with optional documentation of LIS eligibility listed in paragraph (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. Recognizing that the SSA letter uses the terminology Extra Help instead of LIS, we also add for clarity the term Extra Help to  423.2504(a)(3)(ii). Comment: One commenter noted that the proposed definition for point-of-sale enrollment in  423.2504(b)(2) would not adequately capture the full range of POS enrollees, such as those who are eligible for LI NET but do not necessarily demonstrate an immediate need for medication. Response: We agree that beneficiaries who present at the point-of-sale who do not have an immediate need for medication as defined in  423.2504(a)(2) may use the POS mechanism of enrollment if they are otherwise eligible for LI NET and have VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222148 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations not been automatically enrolled. Thus, we finalize this provision to include these beneficiaries by striking with an immediate need from the description of point-of-sale enrollment in  423.2504(b)(2). The change would allow for individuals to use the POS enrollment mechanism if they are either an immediate need individual per
2023-07115.pdf
the description of point-of-sale enrollment in  423.2504(b)(2). The change would allow for individuals to use the POS enrollment mechanism if they are either an immediate need individual per  423.2504(a)(2) or if they present documentation as evidence of LIS eligibility as listed in newly numbered  423.2504(a)(3). Note that this change from the proposed regulation allows for individuals who are not in immediate need of prescriptions to take advantage of the POS enrollment mechanism when they have documentation specified in  423.2504(a)(3). Making this change allows for those with evidence of LIS eligibility by way of presenting documentation to not be turned away from the pharmacy counter at the POS and avoid an unnecessary delay enrolling into LI NET. Under the demonstration, this subset of non- immediate need individuals, though very few in number, can enroll in LI NET at the POS with documentation, which is consistent with the way we finalize this provision. Though beneficiaries with an immediate need who state their LIS status are not required to show documentation at the POS to have their prescription filled, they must either successfully go through the BAE process or have their LIS status reflected in CMS systems in order to be included in the auto-enrollment process into a standalone Part D plan in accordance with  423.34(d) following their LI NET coverage. We also note the need for a technical correction in  423.2504(b)(2), to specify that the claim submitted at the point-of- sale must be accepted by the LI NET sponsorit must pass the edits for the LI NET sponsor to accept the claim into its system. For instance, a claim that is billed but is rejected due to a misspelling of the beneficiarys name would not be sufficient to complete an LI NET enrollment. We finalize  423.2504(b)(2) to say, An individual who is not automatically enrolled in accordance with paragraph (b)(1) of this section and whose claim is submitted at the point- of-sale and accepted by the LI NET sponsor will be enrolled into the LI NET program by the LI NET sponsor. Comment: One commenter suggested expanding the definition of pharmacies that are