evekhm/cms_iom_500 huggingface dataset:
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used in this context means MACs in Traditional Medicare. We understand that Traditional Medicare statutes, regulations, NCDs, and LCDs do not always contain specific criteria for making medical necessity determinations in every situation for every applicable Part A or B service. Thus, in the proposed rule, we stated that when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs, MA plans may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. We agree with commenters that in order to adequately adhere to this requirement, MA plans need additional clarity on what it means for Traditional Medicare coverage criteria to not be fully established, and thus allowed to apply internal coverage criteria based on current evidence in widely used treatment guidelines or clinical literature. Based on commenter recommendations, and in order to more explicitly state the circumstances under which MA organizations may apply internal coverage criteria, we are finalizing  422.101(b)(6) with additional modifications compared to the proposed version. We are finalizing a new paragraph (b)(6)(i) to explain in regulation text when coverage criteria are not fully established. At  422.101(b)(6)(i)(A)(C) we explain that coverage criteria are not fully established when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently; NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD; or there is an absence of any applicable Medicare VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00074 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222193 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 103https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?NCDId=176 statutes, regulations, NCDs or LCDs setting forth coverage criteria. This means that when any of these three circumstances are present, MA plans may develop and rely upon internal coverage criteria to make
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statutes, regulations, NCDs or LCDs setting forth coverage criteria. This means that when any of these three circumstances are present, MA plans may develop and rely upon internal coverage criteria to make medical necessity decisions. We agree with commenters that medical conditions and a patients medical history can be complex and that Medicare coverage guidelines are not specific enough to address every possible scenario when benefits are available under Medicare Parts A or B for every item or service. We also acknowledge, as commenters stated, that MACs are permitted to consider evidence-based guidelines when making individual medical necessity determinations. Based on these comments, and in order to clarify when Traditional Medicare coverage criteria are not fully established, this final rule will permit MA organizations to adopt publicly accessible internal coverage criteria based on current evidence in widely used treatment guidelines when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently. First, we proposed and address in more detail in the following pages how, in addition to basing internal coverage criteria on current evidence in widely established treatment guidelines, MA organizations must follow certain procedures. Second, as specified at  422.101(b)(6)(i)(A), the MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. We will use this interpretation in monitoring and evaluating compliance with this regulation. We also require in this rule that MA organizations make this explanation publicly accessible, along with the internal coverage criteria in use, and identify the general provisions that the internal coverage criteria supplement so that general provisions can be applied in specific factual circumstances. We explained in the proposed rule, that in some circumstances, NCDs or LCDs expressly include flexibility that allows coverage in circumstances beyond the specific coverage or non- coverage indications that are listed in the NCD or LCD. We also acknowledged in the proposed rule that there are some Part A or Part B benefits that do not have applicable Medicare NCDs, LCDs, or specific traditional Medicare coverage criteria in regulation for MA plans to follow when making medical necessity determinations. Commenters agreed with these statements, and therefore, we are finalizing in the regulation text at  422.101(b)(6)(i)(B) and (C) that coverage criteria are not fully established when NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that
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regulation text at  422.101(b)(6)(i)(B) and (C) that coverage criteria are not fully established when NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD or when there is an absence of any applicable Medicare statutes, regulations, NCDs or LCDs setting forth coverage criteria. When identifying whether there is an absence of applicable Medicare statutes, regulations, NCDs, or LCDs, the MA organization needs to look beyond the labels of payment rule or coverage rule, as both serve to establish coverage criteria in MA. Therefore, this rule prohibits MA organizations from applying internal coverage criteria in addition to the applicable Traditional Medicare statutes, regulations, NCDs, or LCDs, unless  422,101(b)(6)(i)(A) or (B) apply. As part of applying and complying with  422.101(b)(6), we expect that MA plans will consult the Medicare Benefit Policy Manual, Medicare Program Integrity Manual, and similar CMS guidance materials. These manuals contain significant explanations and interpretations of Traditional Medicare laws governing Part A and Part B benefits, most of it longstanding, to provide instructions and procedures for day to day operations for those responsible for administering the Medicare program and for making coverage decisions. Using these resources will ensure that MA plans are covering items and services for which benefits are available under Part A and Part B for their enrollees and minimize the number of potential situations where Traditional Medicare coverage policies have insufficient detail such that an MA plan must develop its own internal coverage criteria. When MA plans are permitted to adopt such internal criteria, however, it must be based on current evidence in widely used treatment guidelines or clinical literature and made publicly available. We believe that permitting the use of publicly accessible internal coverage criteria in these limited circumstances and contexts is necessary to promote transparent, and evidence- based clinical decisions by MA plans that are consistent with Traditional Medicare. We do not view the use of internal coverage criteria in these instances as being more restrictive than, or applying additional criteria beyond, Traditional Medicare because that is precisely what is contemplated, for example, by the NCDs or LCDs that provide for this type of flexibility and interpretation in Traditional Medicare. Use of internal policies based on current evidence in widely used treatment guidelines or clinical literature is appropriate to fill in gaps where coverage criteria cannot specify all possible
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by the NCDs or LCDs that provide for this type of flexibility and interpretation in Traditional Medicare. Use of internal policies based on current evidence in widely used treatment guidelines or clinical literature is appropriate to fill in gaps where coverage criteria cannot specify all possible circumstances where coverage of a Part A or Part B item or service may be available for a beneficiary. These policies provide MA organizations with limited discretion to interpret Traditional Medicare coverage rules and must not create barriers to access to care in a way that is not aligned with access in Traditional Medicare. In order to demonstrate how this rule applies, we discuss an example of an actual coverage policy to further elucidate the limited circumstances under which MA plans may apply internal coverage criteria to supplement the existing coverage guidelines. First, in NCD 220.1 for Computed Tomography (CT)103, the NCD states that, [s]ufficient information must be provided with claims to differentiate CT scans from other radiology services and to make coverage determinations. Carefully review claims to ensure that a scan is reasonable and necessary for the individual patient; that is, the use must be found to be medically appropriate considering the patients symptoms and preliminary diagnosis. Here, the NCD recognizes that individual circumstances are relevant in determining appropriate coverage, so the policy used the term sufficient in order for the medical necessity reviewer to make a more accurate coverage determination. Additionally, the NCD allows the MAC medical staff to make an individual case determination that use of a CT scan as the initial diagnostic test was not reasonable and necessary because it was not supported by the patients symptoms or complaints stated on the claims form. In this circumstance, the MA plan would be allowed to apply current evidence in widely used treatment guidelines or clinical literature that is made publicly available, as defined at  422.101(b)(6), to make consistent determinations about when it would be reasonable and necessary for the individual patient and what type of information is required to be submitted on the claim. The MA organization would need to demonstrate in its public explanation of the rationale that supports the internal coverage criteria that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. The MA VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00075 Fmt 4701
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any clinical harms, including from delayed or decreased access to items or services. The MA VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00075 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222194 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 104https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?ncdid=177 organization would also need to identify the general provisions that are being interpreted or supplemented. In this case, the MA organization may use internal coverage criteria to further establish what sufficient information must be provided with the claim or pre- service request for coverage (including a prior authorization request). In another example, NCD 220.2 for Magnetic Resonance Imaging (MRI),104 the NCD lists indications and limitations of coverage as well as the contraindications and other non- covered indications for appropriate use of an MRI. However, it also provides for coverage under a category of other when [a]ll other uses of MRI or MRA for which CMS has not specifically indicated coverage or non-coverage continue to be eligible for coverage through individual local MAC discretion. Here, the NCD explicitly includes flexibility that allows for coverage in circumstances beyond the specific indications that are listed in an NCD and gives the medical necessity reviewer discretion to make this judgment. In order to make consistent determinations on coverage in these other circumstances not specifically addressed by the NCD,  422.106(b) as finalized permits an MA plan to adopt an internal coverage policy based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. We proposed at 422.101(c)(1) that MA organizations must make medical necessity determinations based on a number of factors, including the criteria in  422.101(b), the enrollees medical history, and other factors. Thus, to the extent that an MA organization has developed internal coverage criteria as permitted by  422.101(b)(6) (including compliance with the procedures set forth in paragraphs
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the enrollees medical history, and other factors. Thus, to the extent that an MA organization has developed internal coverage criteria as permitted by  422.101(b)(6) (including compliance with the procedures set forth in paragraphs (b)(6)(i) through (ii)), the current evidence in widely used treatment guidelines or clinical literature that are the basis for the internal coverage policy should also be used in making individual medical necessity determinations. Therefore, MA organizations may use these internal criteria to deny coverage of an item or service. However, as required by  422.568 and 422.631 (for applicable integrated plans), MA organizations must give enrollees written notice of a denial and the notice must state the specific reasons for the denial. We clarify here that if an MA organization denies care based on internal criteria, that criteria must be clearly stated in the denial notice, just as other applicable Medicare coverage criteria must be stated under  422.568(e)(2), when used as the basis for a denial of coverage. Communicating all necessary information needed for the enrollee or provider to effectively appeal the decision, including the evidence used to support the internal coverage policy when applicable, is one of the purposes of the denial notice. The standardized Integrated Denial Notice is properly completed when it includes a specific and detailed explanation of why the medical services, items or Part B drugs were denied, including a description of the applicable coverage rule or applicable plan policy (for example, Evidence of Coverage provision) upon which the action was based, and a specific explanation about what information is needed to approve coverage must be included, if applicable. In light of the issues raised by commenters, we are finalizing 422.101(b) with modifications to clarify when Traditional Medicare coverage criteria are not fully established and what information about internal coverage criteria must be made publicly accessible. We will continue to conduct audit and monitoring activities to ensure that appropriate coverage criteria are applied during medical necessity reviews, and if CMS identifies abuses of this policy, we will consider future rulemaking on this topic. Comment: We received several comments asking CMS to prohibit use of commercial and proprietary criteria by MA plans. Many commenters stated that MA plan coverage criteria are often inconsistent, outside the scope of reasonable standards of practice, and more restrictive than Traditional Medicare guidelines. Some commenters requested that CMS not prohibit use of proprietary coverage criteria and tools, such as InterQual or MCG
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that MA plan coverage criteria are often inconsistent, outside the scope of reasonable standards of practice, and more restrictive than Traditional Medicare guidelines. Some commenters requested that CMS not prohibit use of proprietary coverage criteria and tools, such as InterQual or MCG systems, stating that that these tools help plans consolidate Medicare regulations and assist plans in making evidence-based, clinically appropriate medical necessity determinations. Another commenter requested that CMS continue to allow plans to use independent third-party, proprietary tools to guide medical necessity determinations. Response: We thank commenters for expressing their concerns. However, use of these tools, in isolation, without compliance with requirements in this final rule at  422.101(b), (c), and  422.566(d), is prohibited. We understand that utilization management tools such as InterQual or MCG, among others, are coverage criteria products created to assist the plans, providers and others, in clinical review processes and to help guide medical necessity determinations. We understand from commenters that these products were created with the intention of serving as a single source that consolidates clinical data, medical literature, and CMS guidance and coverage policies to assist MA plans in making medical necessity determinations. We understand from commenters that these tools are often used in conducting inpatient, post-acute and home care medical necessity reviews, in particular. As finalized,  422.101(b), (c) and 422.566(d) address different aspects of how these products appear to be used so consideration of all three regulations is necessary. As proposed and finalized in  422.101(b)(2), MA plans must comply with general coverage and benefit conditions included in Traditional Medicare laws, unless superseded by laws applicable to MA plans. This includes criteria for determining whether an item or service is a benefit available under Traditional Medicare, such as payment criteria for inpatient admissions at 42 CFR 412.3, services and procedures that the Secretary designates as requiring inpatient care under 42 CFR 419.22(n), and requirements for payment of Skilled Nursing Facility (SNF) Care, Home Health Services under 42 CFR part 409, and Inpatient Rehabilitation Facilities (IRF) at 42 CFR 412.622(a)(3)). Thus, MA plans may not use InterQual or MCG criteria, or similar products, to change coverage or payment criteria already established
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Inpatient Rehabilitation Facilities (IRF) at 42 CFR 412.622(a)(3)). Thus, MA plans may not use InterQual or MCG criteria, or similar products, to change coverage or payment criteria already established under Traditional Medicare laws. We recognize that there are some Part A or Part B benefits that do not have applicable Medicare NCDs, LCDs, or specific traditional Medicare coverage criteria in regulation for MA plans to follow when making medical necessity determinations. Therefore, we proposed at  422.101(b)(6) that when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, an MA plan may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. In creating these internal policies, we proposed that MA organizations must follow rules similar to those CMS and MACs follow when creating NCDs or LCDs. Specifically, MA organizations must provide publicly available information that discusses the factors the MA organization considered in making coverage criteria for medical necessity determinations. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00076 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222195 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Under this final rule, when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, MA plans may create internal coverage criteria under specific circumstances described at  422,101(b)(6)(i). In these circumstances, an MA plan is permitted to choose to use a product, such as InterQual or MCG or something similar, to assist in creating internal coverage criteria only so long as the requirements in  422.101(b), (c), and  422.566(d) are met. Specifically, MA plans must comply with  422.101(b) and (c) as to: (i) what coverage criteria are applied; (ii) how, if those criteria are not only from Medicare laws, NCDs or LCDs, the coverage criteria were developed and what they are based on, and (iii) how
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as to: (i) what coverage criteria are applied; (ii) how, if those criteria are not only from Medicare laws, NCDs or LCDs, the coverage criteria were developed and what they are based on, and (iii) how individualized determinations of medical necessity take into account the information and considerations specified in  422.101(c)(1). In addition, if the organization determination made using the product is expected to be a full or partial denial, the MA plan must ensure that the additional review requirements in  422.566(d) are met. (See section III.G of this final rule.) The MA plan must therefore ensure that the coverage criteria used in these products are based on current evidence in widely used treatment guidelines and clinical literature consistent with the definitions and standards in  422.101(b)(6) before using the product as the MA plans internal coverage policy. Further, MA organizations must comply with specific procedures, which we discuss in more depth later in this preamble, before an internal coverage policyincluding a product such as those described by the commentersmay be used; the MA plan must provide, in a publicly accessible way, the internal coverage criteria in use; a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination. This includes, when applicable, how the additional criteria interpret or supplement general provisions in Traditional Medicare and provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. MA organizations must ensure that they are making medical necessity determinations based on the circumstances of the specific individual, as outlined at  422.101(c), as opposed to using an algorithm or software that doesnt account for an individuals circumstances. Finally, MA organizations must comply with amended  422.566(d), as in section III.G of this final rule, which requires that a denial based on a medical necessity determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue. We understand from commenters that many of these products and their software are proprietary in nature and may be proprietary to the