evekhm/cms_iom_500 huggingface dataset:
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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
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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:
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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 cost assessment includes NCDs with CED. The thresholds for significant cost are specified in  422.109(a)(1) and (a)(2). The assessment generally applies to each NCD or legislative change in benefits that occurs after the rate announcement for a contract year such that the change in costs was not incorporated into the capitation rates for the contract year. Costs are estimated for a particular NCD or legislative change in benefits so the thresholds specified in  422.109(a)(1) and (a)(2) apply to each NCD or legislative change in benefits rather than to the aggregate number of such changes over the course of a contract year. Comment: A commenter stated it did not believe regulations beyond those proposed were necessary for NCDCED policies and that it believes that the agency is taking appropriate steps to ensure that NCDCEDs generate meaningful clinical data. Response: We thank the commenter for its input on this proposal. Comment: A
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were necessary for NCDCED policies and that it believes that the agency is taking appropriate steps to ensure that NCDCEDs generate meaningful clinical data. Response: We thank the commenter for its input on this proposal. Comment: A commenter was concerned that with respect to NCD VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00140 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222259 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations CEDs, our proposal would shift costs from Medicare Advantage to Traditional Medicare. The commenter was also concerned that the NCDCED proposal could permit obstacles to emerging care for especially patients with rare diseases because of utilization management policies permitted under the Medicare Advantage program. Response: Currently, Traditional Medicare covers clinical trials under 310.1 for MA enrollees while MA plans are responsible for covering NCDCED and AB IDE trials. Because MAOs already cover NCDCEDs there will be no cost-shifting from the Medicare Advantage program to Traditional Medicare. As with any benefit for which it is responsible, an MA plan may require utilization management, including prior authorization, subject to the requirements in Part C of the Medicare statute and MA regulations in 42 CFR part 422. We direct readers to section III.E., Utilization Management Requirements: Clarifications of Coverage Criteria for Basic Benefits and use of Prior Authorization, Additional Continuity of Care Requirements, and Review of Utilization Management Tools for new requirements related to prior authorization and other utilization management policies being finalized in this rule. After considering the comments revised and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing this provision without modification. L. Update of Terminology to Individuals With Intellectual Disabilities ( 423.154) We proposed a terminology update at  423.154(c) to the outdated term mentally retarded. We inadvertently neglected to update this terminology in our regulations following two previous terminology updates found in the Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction final rule which appeared in the Federal Register
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We inadvertently neglected to update this terminology in our regulations following two previous terminology updates found in the Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction final rule which appeared in the Federal Register on May 16, 2012 (77 FR 29001) and the Medicare Program; Contract Year 2016 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs final rule which appeared in the Federal Register on February 12, 2015 (80 FR 7911). Consequently, we proposed to update the current language at  423.154(c) (that is, update it to use the term individuals with intellectual disabilities). We solicited comments on this proposal. Comment: A commenter indicated their support for the transition to the term intellectual disabilities. They stated that CMS should prioritize the use of compassionate language when engaging with patient populations and noted that the intent of the proposed rule is consistent with CMS updates that have taken place over the last decade. Response: CMS agrees that the language currently used at  423.154(c) is outdated and inappropriate. The terminology update will improve the consistency of language used in regulations while following the intent and spirit of Rosas Law (Pub. L. 111 256). We are therefore finalizing the proposed update to  423.154(c) without modification. M. Technical Correction To Restore the Substantial Difference Requirement ( 423.265) We proposed to make a technical correction to  423.265(b)(2) to restore language on requirements for substantial differences between Medicare Part D sponsors bids that was inadvertently removed in a recent revision of the section. In the Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for- Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program final rule, which appeared in the Federal Register on April 16, 2018 (hereinafter referred to as the April 2018 final rule, 73 FR 16440), we reorganized paragraph (b)(2) to incorporate a general rule in paragraph (b)(2)(i) and an exception in paragraph (b)(2)(ii), the latter of which excluded enhanced alternative plan bid submissions from the substantial difference requirement. We added language placing limits on the number of
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paragraph (b)(2)(i) and an exception in paragraph (b)(2)(ii), the latter of which excluded enhanced alternative plan bid submissions from the substantial difference requirement. We added language placing limits on the number of Part D plan offerings as part of the final rule titled Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All- Inclusive Care for the Elderly which appeared in the Federal Register on January 19, 2021 (hereinafter referred to as the January 2021 final rule, 86 FR 5864). However, the new language was incorrectly added to  423.265(b)(2) rather than  423.256(b)(3), and the previous regulatory text on substantial differences was inadvertently overwritten. To correct this inadvertent deletion, we proposed to: Redesignate the regulatory text from our January 2021 final rule limiting the number of bids a Part D plan sponsor may submit currently at  423.265(b)(2) as  423.265(b)(3); Restore the language from our April 2018 final rule on substantial differences at  423.265(b)(2)(i) and (ii); and Redesignate the regulatory text currently at  423.265(b)(3) as paragraph (b)(4). As described previously, all of the regulatory language that we proposed to restore at  423.265(b)(2) has previously undergone the full notice and comment process. This proposal would merely correct a technical error made by the January 2021 final rule. We received no comments on the proposed technical correction to  423.265(b)(2) and are finalizing our proposal without modification. N. Gross Covered Prescription Drug Costs ( 423.308) Section 1860D15(b)(3) of the Act defines gross covered prescription drug costs as, with respect to a part D eligible individual enrolled in a prescription drug plan or MAPD plan during a coverage year, the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year and costs relating to
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in a prescription drug plan or MAPD plan during a coverage year, the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year and costs relating to the deductible. Such costs shall be determined whether they are paid by the individual or under the plan, regardless of whether the coverage under the plan exceeds basic prescription drug coverage. In our final rule, Medicare Program; Medicare Prescription Drug Benefit, which appeared in the Federal Register on January 28, 2005 (70 FR 4194), we codified the definition of gross covered prescription drug costs at  423.308. This regulatory definition refers to gross covered prescription drug costs as actually paid costs. The term actually paid has a specific meaning in Medicare Part D and is separately defined at  423.308 to mean costs actually incurred by the plan that are net of direct and indirect remuneration (DIR), including discounts, rebates, or other price concessions typically received and applied after the point of sale (POS). However, unlike the statutory definitions of allowable reinsurance costs and allowable risk corridor costs at sections 1860D 15(b)(2) and 1860D15(e)(1)(B) of the Act, respectively, the statutory definition of gross covered prescription drug costs at section 1860D15(b)(3) of the Act does not use the phrase actually paid or otherwise specify that such costs must be net of all DIR. As we explained in the December 2022 proposed rule (87 FR 79611), because VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00141 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222260 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 135We noted that this logic is borne out in the portion of our current regulatory definition of GCPDC at  423.308 that states that GCPDC
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88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 135We noted that this logic is borne out in the portion of our current regulatory definition of GCPDC at  423.308 that states that GCPDC reflect actual costs. Actual cost is defined at  423.100 as the negotiated price for a covered Part D drug when the drug is purchased at a network pharmacy, and the usual and customary price when a beneficiary purchases the drug at an out-of-network pharmacy. 136The different components of the negotiated price of a drug, and ultimately of GCPDC, are required to be reported separately using the following cost fields on the Prescription Drug Event (PDE) record submitted to CMS by Part D plan sponsors for payment purposes, the sum of which must equal GCPDC: Ingredient Cost, Dispensing Fee, Vaccination Administration, and Sales Tax. GCPDC are also required to be reported using the following two payment fields on the PDE record depending on whether the costs fall in the catastrophic phase: Gross Drug Cost Below the Out of Pocket (OOP) Threshold (GDCB) and Gross Drug Cost Above the OOP Threshold (GDCA). The amounts reported in these fields are then used to update the Total Gross Covered Drug Cost (TGCDC) Accumulator on the PDE record, which tracks and indicates which non-catastrophic phase of the Part D benefit the beneficiary is in. See, for example, 2006 Prescription Drug Event Data Training Participant Guide, available at https://www.csscoperations.com/internet/csscw3_ a.nsf/ DIDC/K3V5B8PN1HPrescription%20Drug%20Program%20(Part%20D)Training, and 2011 Regional Prescription Drug Event Data Technical Assistance Participant Guide, available at https://www.csscoperations.com/internet/ csscw3.nsf/DIDC/FJUKANFCP1Prescription%20Drug%20Program%20(Part%20D)Training. the definition of gross covered prescription drug costs was codified in regulation for the sole purpose of describing the methodology for calculating the reinsurance payment amount, in using the phrase actually paid in the regulatory definition of gross covered prescription drug costs, CMS was incorporating a requirement from the
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regulation for the sole purpose of describing the methodology for calculating the reinsurance payment amount, in using the phrase actually paid in the regulatory definition of gross covered prescription drug costs, CMS was incorporating a requirement from the statutory definition of allowable reinsurance costs to emphasize that DIR would be netted out in the calculation of costs eligible for Part D reinsurance. In light of certain provisions added to the Social Security Act by the Inflation Reduction Act of 2022 (IRA) that refer to gross covered prescription drug costs as defined in section 1860D 15(b)(3) [of the Act] (see sections 1191(c)(5) and 1860D14C(g)(4)(D) of the Act), we revisited the regulatory definition of gross covered prescription drug costs. We proposed to revise the regulatory definition of gross covered prescription drug costs to mirror the language in the statutory definition and to remove any ambiguity that might arise from the current regulatory definition as it may now also be applicable outside of the reinsurance context. Specifically, we proposed to amend the definition of gross covered prescription drug costs at  423.308 to remove the phrase actually paid. As we explained in the proposed rule, the proposed revisions to the definition would not change the fact that Part D reinsurance is ultimately based on net drug costs or change the final reinsurance payment amount a Part D sponsor receives. Rather, allowable reinsurance costs would continue to be defined at  423.308 as the subset of gross covered prescription drug costs actually paid. Thus, the revision would not constitute a change in policy or require a change in operations under Part D, and would not place any additional burden or reduce existing burden on Part D sponsors, nor result in government savings or costs. 1. Background The term gross covered prescription drug costs (hereinafter referred to as GCPDC) is defined and used at section 1860D15(b) of the Act for the purpose of describing the methodology for calculating the reinsurance payment amount. As specified in section 1860D 15(b)(1)(A) of the Act, the reinsurance payment amount for a year preceding 2025 is equal to 80 percent of the allowable reinsurance costs (as
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amount. As specified in section 1860D 15(b)(1)(A) of the Act, the reinsurance payment amount for a year preceding 2025 is equal to 80 percent of the allowable reinsurance costs (as specified in paragraph (2)) attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D 2(b)(4)(B). Although the statutory definition of allowable reinsurance costs at paragraph (2) of section 1860D15(b) of the Act specifies that such costs are the subset of GCPDC that are actually paid (net of discounts, chargebacks, and average percentage rebates), the statutory definition of GCPDC at paragraph (3) of section 1860D15(b) of the Act does not use the phrase actually paid or otherwise specify that such costs must be net of all DIR. As we explained in the proposed rule, this distinction, coupled with the use of the modifier gross to describe these costs, indicates that the best reading of section 1860D15(b)(3) of the Act is that GCPDC should reflect gross costs, not net costs that reflect all DIR that a Part D sponsor may receive. We also stated that CMS use of the phrase actually paid in the current regulatory definition of GCPDC was intended to emphasize that all DIR would be netted out in the calculation of costs eligible for Part D reinsurance consistent with the plain language of the statute, which requires that the reinsurance payment amount be based on net drug costs. While the use of the phrase in the current regulatory definition of GCPDC is consistent with the statute for this reason, we recognized that it may have led to ambiguity as to when the DIR would be netted out. We also recognized that the use of the phrase could create ambiguity when GCPDC is referenced outside of the reinsurance context. We further noted in the proposed rule that the statutory definition of GCPDC describes these costs as not including administrative costs, but including costs directly related to the dispensing of covered Part D drugs during the year and costs relating to the