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and is available at this link: https://www.cms.gov/Medicare/Health-Plans/ MedicareAdvtgSpecRateStats/Downloads/ Advance2019Part2.pdf. 133The Announcement of Calendar Year (CY) 2011 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter addresses this in a response to a comment on page 2021 and is available at the following link: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/ Downloads/Announcement2011.pdf. 134In addition, the See page 31 of the MA Payment Guide for Out of Network Payments, page 31, addresses this topic. The guide is available at the following link: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/ downloads/oonpayments.pdf. Office of the Actuary, MA plans are not responsible for coverage until the cost to provide the new benefit is calculated into the plans payment rate. CMS has previously determined, as discussed in the CY 2019 Advance Notice,132that the multiple clinical trials covered under NCD 310.1 trigger the significant cost threshold. Therefore, Traditional Medicare has covered the Medicare- covered routine costs of clinical trials that are covered under NCD 310.1 for MA enrollees. To ensure continued clarity and transparency for this longstanding policy, discussed in section 10.7.1 of Chapter 4 of the Medicare Managed Care Manual, we proposed to codify this policy by adding new  422.109(e). In  422.109(e)(1), we proposed to codify that traditional Medicare is responsible for coverage of routine costs of qualifying clinical trials for MA enrollees for clinical trials covered under the Clinical Trials National Coverage Determination 310.1 and all reasonable and necessary items and services used to diagnose and treat complications from participating in clinical trials. Deductibles and MA Responsibility for Differences in Cost-Sharing Traditional Medicare pays for all routine costs of clinical trials for MA enrollees and, as explained in the CY 2011 Rate Announcement,133MA enrollees do not pay the traditional Medicare Part A and B deductibles when Traditional Medicare pays the Medicare-covered costs associated with the clinical trial.134In  422.109(e)(2), we proposed to codify this policy that MA enrollees participating in clinical trials are not subject to Part A and B deductibles. MA plans are responsible for paying the difference between traditional Medicare cost-sharing incurred for qualifying clinical trial items and services and the MA plans in-network cost-sharing for the same category of items and services. We proposed to codify this requirement for MA plans to pay the difference between traditional Medicare and plans cost sharing in  422.109(e)(3). We also proposed in  422.109(e)(4) to codify that the enrollees in-network cost-sharing portion must be included in the plans maximum out-of-pocket (MOOP) calculation. As the clinical trial costs within the scope of NCD 310.1 are covered by Part A and/or Part B, these are basic benefits within the scope of the MOOP requirements in  422.100(f)(4) and (5) and 422.101(d)(2) and (3), but for clarity we proposed to codify at  422.109(e)(4) the requirement that the enrollees in- network cost-sharing must be included in the plans MOOP calculation. In requiring MA organizations to provide in-network cost sharing for clinical trial services, CMS is requiring that MA plan enrollees have coverage for clinical trial services that is consistent with coverage they have for all other Medicare Part A and Part B services. In paragraph (e)(5), consistent with our guidance in section 10.7.1 of Chapter 4 of the Medicare Managed Care Manual, we proposed that MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollees participation in a non-plan-sponsored clinical trial under NCD 310.1. This protection is necessary in order to ensure that MA enrollees have access to and coverage of clinical trials within the scope of NCD 310.1 to the same extent as Medicare beneficiaries enrolled in the traditional Medicare program. While MA plans are responsible for covering any differences in cost-sharing between traditional Medicare and MA plan in- network costs for services in the same category, traditional Medicare, through the MACs, is responsible for all other costs included in clinical trials within the scope of NCD 310.1. Finally, in accordance with  422.109(c)(2), CMS requires MA organizations to provide coverage for: (1) services to diagnose conditions covered by clinical trial services; (2) most services furnished as follow-up care to clinical trial services; and (3) services already covered by the MA organization. Because  422.109(c) adequately addresses how MA organizations are required to cover certain benefits and costs even when the traditional Medicare program pays for changes in benefits as a result of an NCD or legislative change, we do not believe that additional regulation text is necessary to apply those rules in the context of NCD 310.1. Comment: A commenter supported the proposal to codify clinical trial- related policies under NCD 310.1 and stated it believes there is sufficient information on expectations of MA organizations with respect to clinical trial coverage. The commenter also suggested that CMS continue to provide MA organizations with information about coverage responsibilities for Medicare-covered trials to include information in the final decision memo for the NCD regarding significant cost as well as information on policy implications for Part D, dually eligible, and Medicaid. Response: We thank the commenter for its support of our proposal. We note that, for clinical trials that are outside the scope of NCD 310.1 and are conducted under a separate NDC, coverage of items and services under that separate NCD is addressed by the existing regulation at  422.109(a) through (d). We also appreciate the commenters suggestion that significant cost information be included with the decision memo for the NCD and will work with our colleagues in Traditional Medicare about including this information in future decision memos. With respect to information about other programs, unless the NCD has specific information relevant to other programs, we believe that each program can best explain through its guidance for the program any issues in implementation or coverage. Comment: A commenter recommended that CMS reconsider its proposal to permit MA enrollees to participate in clinical trials without prior authorization from an enrollees MA plan. The commenter expressed concern that the enrollee or the MA organization would have no control over whether the enrollee would, for example, receive a placebo, or the treatment being tested in the trial which could put the enrollees health and quality of care at risk while also undermining the MA organizations care coordination efforts for the enrollee. Response: Under the current policy that we proposed to codify, Traditional Medicare pays for MA enrollees for clinical trials under 310.1. MA organizations do not cover these trials for MA enrollees and the costs of what is covered is paid by the Traditional Medicare program; therefore, MA organizations cannot require prior authorization. MA organizations may, however, require prior authorization for A and BIDE trials and NCDCEDs. Although MA organizations may not require prior authorization for clinical VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00139 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222258 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations trials under 310.1, enrollees, if they choose, may notify plans of their participation in clinical trials and MA organizations may help facilitate communication with the trial leaders and enrollee. MA enrollees in clinical trials also receive the same protections as those in Traditional Medicare, including informed consent requirements and discussion of the trials features, such as, whether a placebo will be used. After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing  422.109(e) as proposed with a minor modification to the heading for paragraph (e) to clarify the scope of the paragraph is limited to NCD 310.1. 2. AB Investigational Device Exemption Trials The regulation at  405.211 specifies Medicare coverage of Category A and B investigational device exemption (IDE) studies. Providers of device trials must submit evidence of an FDA approved IDE for the devices studied, as part of their application to CMS for approval of a trial. Once a trial has been approved by CMS, it is listed on the CMS website. In addition to including assessment of devices, IDE trials differ from clinical trials under NCD 310.1, as they are not covered as a result of an NCD nor are they subject to a significant cost assessment. As a result, MA organizations are responsible for payment of claims related to enrollees participation in both Category A and B IDE studies that are covered under traditional Medicare. This is part of the MA organizations obligation to cover the items and services (other than hospice care or coverage for organ acquisitions for kidney transplants) for which benefits are available under Parts A and B for their enrollees under section 1852 of the Act. MA plans are responsible for payment of routine care items and services in CMS-approved Category A and Category B IDE studies. An MA plan is also responsible for coverage of CMS- approved Category B devices. While CMS will cover routine care items and services, it will not approve coverage of Category A devices themselves because they are considered experimental and excluded from coverage under  405.211(a). As with other benefits for which it is responsible for coverage, an MA plan may apply utilization management, including prior authorization, consistent with  422.4(a)(1)(ii). Section 10.7.2 of Chapter 4 of the Medicare Managed Care Manual addresses this policy. In order to clarify this scope of required coverage for MA plans and avoid any inadvertent confusion between the coverage requirements associated with clinical trials under NCD 310.1, we proposed to add  422.109(f) to specify MA plan coverage of the routine items and services, including the Category B IDE device and related items and services in the context of a Category A and B IDE studies, that are covered by Medicare under  405.211(a) and (b). Comment: A couple of commenters expressed support for the clinical trial- related proposals, but requested that it was especially necessary in the case of BIDE coverage to have some mechanism to indicate an enrollees MA status. The commenters stated that inability for MA plans and providers to distinguish MA enrollees from other enrollees in commercial plans can lead to confusion and delays in coverage. Response: Per  422.111(i), MA plans must issue and reissue (as appropriate) member identification cards that enrollees may use to access covered services under the MA plan. Such cards indicate that the enrollee is in an MA plan and must meet, at a minimum, the content requirements at  422.2267(e)(30). The minimum required information includes the MA plans website, customer service number, and contract/PBP number; the cards should also include information on how to contact the plan if there are questions about coverage. Providers also have access to the HIPAA Eligibility Transaction System (HETS), which permits providers to view Medicare eligibility and coverage. We believe compliance with these regulations and use of the HETS website are sufficient to allow providers and plans to determine plan coverage for BIDE. After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing  422.109(f) without modification. 3. National Coverage Determinations With Coverage With Evidence Development As with other Part A and B benefits (aside from hospice and the cost of kidney acquisition for transplant), MA plans must cover items and services covered by Medicare under NCDs. This is true for NCDs that also have a trial or registry component that is required as part of the coverage, which is explained in section 10.7.3 of Chapter 4 of the Medicare Managed Care Manual. This is referred to as coverage with evidence development (CED), as authorized under section 1862(a)(1)(E) of the Act. CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of CMS approved clinical studies or with the collection of additional clinical data (for example, registry). A list of NCDCEDs with the coverage protocol for each is available at: https://www.cms.gov/Medicare/ Coverage/Coverage-with-Evidence- Development. As in the proposed rule, we are merely reiterating here that MA plans must cover NCDs with CED and CMS has not proposed or finalized a change in coverage requirements or policy for MA plans on this topic. We solicited comment whether additional regulations are needed to address NCDs with CED; we believe that  422.101(b) is sufficient that these NCDs are within the scope of the traditional Medicare benefits that MA plans must cover and that additional regulations are unnecessary. MA plans may apply utilization management, including prior authorization, to the Medicare benefits covered under these NCDs, consistent with  422.4(a)(1)(ii) of the MA program regulations. Significant Cost In cases of a new NCD or legislative change in benefits, CMS determines, consistent with  422.109(b), whether the benefit or service is a significant cost to MA plans. As in the December 2022 proposed rule, CMS is including this discussion to make clear that significant cost requirements apply to all new NCDs, that is, that the significant