evekhm/cms_iom_500 huggingface dataset:
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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 particular organization that uses these products. However, use of such tools and their proprietary nature does not absolve MA plans from their responsibilities under this final rule. For an MA plan to use the coverage criteria in these tools, the MA plan will need to understand the external clinical evidence relied upon in these products and how that evidence supports the coverage criteria applied by these tools. The MA plan must make the evidence that supports the internal criteria used by (or used in developing) these tools publicly available, along with the internal coverage policies themselves. Furthermore, under  422.504, MA organizations must provide information and access to CMS (and HHS and the OIG) as it conducts its oversight of MA plans and their compliance with MA program requirements. CMS may, therefore, review all aspects of the plans decision- making including whatever evidence might be contained within a decision tool, or support the determinations made from the use of decision tool, including such tools provided by third- parties as discussed here. We expect MA plans already using these tools, or those that may plan to use these tools in the future, to work with third parties that provide these tools to revise any utilization management products and ensure that these products meet the requirements at  422.101(b), (c), and  422.566(d). Comment: Several commenters expressed concern that requiring MA plans to strictly adhere to Traditional Medicare coverage policies undermines MA plans ability to appropriately manage care. Commenters stated that adhering to Traditional Medicare coverage policies will impede a plans ability to make medical necessity decisions. Commenters also stated that the proposed policies would restrict a plans ability to direct patients to clinically-equivalent, lower-cost alternative treatments or therapies first. Several commenters warned that our proposal could lead to increased costs and duplicative and unnecessary services. Several commenters stated that our proposal will undermine the transition to value-based care and similar payment models. Some commenters expressed concern that adherence to 42 CFR 412.3, part 409, and  412.622 will remove the existing flexibility of MA plans to provide the same level of care in different settings. One
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and similar payment models. Some commenters expressed concern that adherence to 42 CFR 412.3, part 409, and  412.622 will remove the existing flexibility of MA plans to provide the same level of care in different settings. One commenter stated that removing the flexibility for plans to provide care in alternate settings could shift care from beneficiary homes to institutional settings, resulting in increased costs for both the plans and beneficiaries. For example, one commenter expressed concern that Traditional Medicare Skilled Nursing Facility payment rules in particular incentivize facilities to prolong Skilled Nursing Facility stays regardless of patient need. Response: We proposed to codify at  422.101(c)(1)(A) that MA organizations must make medical necessity determinations based on coverage and benefit criteria as specified at  422.101(b) and (c) and may not deny coverage for basic benefits based on coverage criteria that are not specified in  422.101(b) or (c). This means that when an MA organization is making a coverage determination on a Medicare covered item or service and that item or service has fully established coverage criteria, the MA organization cannot deny coverage of the item or service based on internal, proprietary, or external clinical criteria not found in Traditional Medicare coverage policies. However, this rule does not mean that an MA organization must deny coverage of all other treatment alternatives for an MA enrollee. MA plans may have supplemental benefits that cover of items and services that are not covered under Parts A or B. In addition, where Traditional Medicare would cover services in specific or various settings or from specific or various providers or cover alternative services or treatment options for the beneficiary, an MA organization must also cover those as basic benefits. An MA plan may make its enrollees aware of other covered treatment options or encourage specific treatment options as part of the MA plans coordination and management of care for enrollees. We reiterate that when an item or service has fully established coverage criteria under Traditional Medicare, use by an MA plan of certain utilization management processes, such as clinical treatment guidelines that require another item or service be furnished prior to receiving the requested item or service, violate the requirements proposed, and being finalized in this rule, at  422.101(b) and VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00077 Fmt 4701
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and being finalized in this rule, at  422.101(b) and VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00077 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222196 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations (c). Utilization management processes that are specified within the applicable NCD or LCD or Medicare statute or regulation are permissible. By contrast, when coverage criteria are not fully established and MA organizations are allowed to adopt internal coverage criteria based on current evidence in widely used treatment guidelines or clinical literature, clinical treatment guidelines that require another item or service to be furnished prior to receiving the requested item or service must be expressly cited in the evidence in order for it to be acceptable under our rule. Clinical criteria that restrict access to a Medicare covered item or service, unless another item or service is furnished first, are not based on current evidence if the evidence does not cite or discuss the use of a different item or service first. When not specifically required in a Medicare law, NCD or LCD or part of the clinical evidence that supports an internal coverage policy that is permitted because Traditional Medicare coverage criteria are not fully established, use of a try first or similar utilization management process would be additional internal coverage criteria prohibited by  422.101(b)(6) as finalized in this rule. We believe this policy provides enough flexibility for MA organizations to manage care so long as that management is grounded in current evidence in widely used treatment guidelines or clinical literature and made publicly available. Use of this flexibility by MA organizations is only allowed when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD as stated at  422.101(b)(6)(i). Comment: Some commenters also expressed concern about the appropriateness of Traditional Medicare coverage guidelines. These commenters suggested that these guidelines may need to be updated and are not in line with current medical standards. Response: NCDs are made and updated through an evidence-based process, with opportunities for public participation through a public comment and review process. NCDs are updated through CMS-generated reviews and through requests by an external party for a
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medical standards. Response: NCDs are made and updated through an evidence-based process, with opportunities for public participation through a public comment and review process. NCDs are updated through CMS-generated reviews and through requests by an external party for a new NCD, for reconsideration of an existing NCD, or by an aggrieved party to issue an NCD when no NCD exists as established in Final Notice 78 FR 48164 in 2013. CMS makes proposed NCD decisions available on the CMS website for a 30-day public comment period after which comments are reviewed and a final decision is issued not later than 60 days after the conclusion of the comment period. A summary of the public comments received and responses to the comments are included in the decision memorandum. In some cases, CMSs own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). When developing LCDs, MACs use published, original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Further, LCDs undergo a similar process to that for NCDs, including public participation. Because Traditional Medicare follows a process of expert consultation and public review and comment in order to stay up-to-date and align with current medical standards and practices as it develops the coverage guidelines governing Traditional Medicares basic benefits, we believe that these processes are sufficient in creating appropriate coverage guidelines. Comment: Some commenters noted that the proposed language at  422.101(b)(2) no longer includes a reference to complying with original Medicare manuals and instructions. Some commenters noted that manual guidance often includes necessary coverage guidance not included in Medicare regulations. These commenters requested that CMS maintain compliance with manual guidance at  422.101(b)(2). Response: We thank commenters for their observations. Section 422.101(b)(2), with the proposed revisions (which we are finalizing with modifications) references Traditional Medicare laws and existing  422.101(b)(1) and (b)(3) require compliance by MA plans with NCDs and LCDs based on how section 1852(a)(2)(C) and (a)(5) of the Act make clear that MA plans must cover benefits consistent with NCDs and LCDs. Although
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MA plans with NCDs and LCDs based on how section 1852(a)(2)(C) and (a)(5) of the Act make clear that MA plans must cover benefits consistent with NCDs and LCDs. Although  422.101(b) will no longer refer to original Medicare manuals and instructions, those materials are invaluable in interpreting and understanding the scope of Part A and Part B benefits and what benefits are available under Parts A and B in order to determine what Traditional Medicare covers in specific situations. Substantive legal standards about Medicare benefits may be established through rulemaking and NCDs. In revising  422.101(b)(2) to refer to Traditional Medicare regulations and statutes, we are not diminishing the content and value that these manuals and instructions provide in interpreting and defining the scope of Part A and Part B benefits. 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 making coverage decisions on individual claims, so we expect that MA plans will consult the Medicare Benefit Policy Manual, Medicare Program Integrity Manual, and similar CMS guidance materials. Comment: We received some comments requesting that CMS establish a minimum number of days of initial Inpatient Rehabilitation Facilities or Skilled Nursing Facility coverage. Response: We thank commenters for their suggestion and note that the minimum scope of IRF and SNF benefits are statutory requirements under the Medicare statute. We did not propose a separate MA coverage requirement for initial Inpatient Rehabilitation Facilities or Skilled Nursing Facility coverage, nor did we propose to make changes to the structure of basic benefits covered under Parts A and B. Our proposal aims to align the applicable coverage criteria in MA with Traditional Medicare to ensure comparable coverage for beneficiaries across both programs. Therefore, we consider changes to scope or structure of Part A or B benefits outside of the scope of this rule. Comment: Some commenters expressed concern about MA plans ability to provide a summary of evidence for all services. One commenter stated that sources often lack evidence to support all types of care. Some commenters also requested that CMS clarify what exactly is meant by summary of the evidence that was considered. These commenters requested that CMS clarify whether this includes a citation to an article or a comprehensive synthesis of each study
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Some commenters also requested that CMS clarify what exactly is meant by summary of the evidence that was considered. These commenters requested that CMS clarify whether this includes a citation to an article or a comprehensive synthesis of each study used, stating that the latter would be time consuming and extremely burdensome. Other commenters requested CMS provide guidance on how this information should be shared publicly, noting that some resources may be behind a paywall. One commenter suggested that plans be required to post this information in a visible location on their websites. A few commenters suggested that CMS also require MA plans to make any internal coverage criteria publicly available and that this information should be available at least 30 days prior to implementation. One commenter suggested CMS require MA plans to consult with up to date clinical databases if we determined that a full in-depth review of evidence was too burdensome. Another commenter VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00078 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222197 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations requested that CMS require that a summary of evidence be provided upon request instead of publicly posted. One commenter requested that CMS clarify and provide examples of appropriate widely used treatment guidelines. Some commenters stated that consideration should be given to quality of literature and not only how often it is used. Other commenters suggested that CMS should require that the draft coverage policy be available for review and public comment. Finally, some commenters expressed concern that there is not enough data or widely used treatment guidelines available on certain conditions, including rare diseases. Given these challenges, some commenters requested CMS provide plans with flexibility in meeting this requirement. One commenter expressed concern that the public summary of evidence would require significant time and administrative effort. Response: We thank commenters for their comments. We proposed, and are finalizing at  422.101(b)(6), that MA organizations internal clinical criteria must be based on current evidence in widely used treatment guidelines or clinical literature. In the proposed regulation text, we stated that current, widely-used treatment guidelines are those
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that MA organizations internal clinical criteria must be based on current evidence in widely used treatment guidelines or clinical literature. In the proposed regulation text, we stated that current, widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions. We provided an example by referring to the Infectious Diseases Society of America for the Treatment of Clostridium Difficile. We also explained that current, widely-used treatment guidelines include those used to determine appropriate level of care (such as the American Society of Addiction Medicine Criteria for placement, continued stay, and transfer or discharge of patients with addiction and co-occurring conditions). We proposed that clinical literature acceptable for use to justify internal coverage criteria includes large, randomized controlled trials or prospective cohort studies with clear results, published in a peer-reviewed journal, and specifically designed to answer the relevant clinical question, or large systematic reviews or meta- analyses summarizing the literature of the specific clinical question. Evidence that is unpublished, is a case series or report, or derived solely from internal analyses within the MA organization, or that does not comply with the standards described in the regulation would not represent proper justification for instituting internal coverage guidelines that would restrict access to care. These types of evidence have not undergone peer-review, are not transparent, or are not research methodologies that can plausibly establish causality. This evidentiary standard is overall consistent with published frameworks that rank the reliability of different types of studies in the clinical literature. With regards to requiring MA plans to have a review and comment process for their internal coverage criteria, we remind commenters that per CMS regulations at  422.202(b), MA organizations that use a network of providers (for example, coordinated care plans) have obligations with regard to developing and using practice guidelines and utilization management guidelines, including establishing a formal mechanism to consult with the physicians who have agreed to provide services under the MA plan offered by the organization, regarding the organizations medical policy, quality improvement programs and medical management procedures. We believe that the regulations at  422.202(b) provide a formal and sufficient mechanism for MA organizations to receive comment from contracted providers on internal coverage criteria, instead of having a review and comment period open to the general public. Therefore, we proposed and are finalizing a revision to  422.202(b)(1)(i) to require practice guidelines and utilization
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providers on internal coverage criteria, instead of having a review and comment period open to the general public. Therefore, we proposed and are finalizing a revision to  422.202(b)(1)(i) to require practice guidelines and utilization management guidelines used by an MA organization that uses a network of providers to base those guidelines on current evidence in widely used treatment guidelines or clinical literature. Additionally, existing requirements under  422.202(b) require that MA plans practice guidelines and utilization management guidelines must consider the needs of the enrolled population; be developed in consultation with contracting physicians; be reviewed and updated periodically; and be communicated to providers and, as appropriate, to enrollees. Further, decisions with respect to utilization management, enrollee education, coverage of services and other areas in which the guidelines apply must be consistent with the guidelines. We believe that an additional requirement that plans go through a comment period is redundant of these existing requirements regarding provider participation and that no additional requirements along such lines are necessary. At 87 FR 79501, we proposed that an MA organization provide a publicly accessible summary of the evidence considered in developing the internal coverage criteria, a list of the sources of evidence, and an explanation of the rationale for the internal coverage criteria in order to protect beneficiaries by ensuring that coverage criteria are rational and supportable by current, widely used treatment guidelines and clinical literature and to provide transparency. However, the regulation text at proposed  422.101(b)(6)(i) through (iii) inadvertently limited the phrase publicly accessible to only the summary of evidence. We are finalizing the proposal with modifications to the regulation text to be consistent with the scope of the proposal described in the preamble. Additionally, we are renumbering these criteria to as (A) through (C) in newly established subparagraph (ii). Along with the new standards being adopted at  422.101(b)(6)(i)(A) to allow MA organizations to create internal coverage criteria when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently, we also are enhancing transparency requirements at  422.101(b)(6)(ii)(C). When an MA organization uses internal coverage criteria in accordance with  422.101(b)(6)(i)(A), they must also include in their publicly accessible explanation of the
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When an MA organization uses internal coverage criteria in accordance with  422.101(b)(6)(i)(A), they must also include in their publicly accessible explanation of the rationale that supports the adoption of the coverage criteria, an identification of the general provisions that are being supplemented or interpreted, and explain how 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. For example, the evidence supporting use of an internal policy may demonstrate that patients benefit from increased efficacy of treatment or increased patient safety and highly outweighs the potential for the criteria to be used as a barrier to care that delays or denies access to items or services. While we acknowledge that this new requirement in  422.101(b)(6)(ii) will increase burden on MA organizations, we believe that the benefits of transparency in the development of internal coverage criteria balances out that burden. We note that MA organizations may cite to policies or publicly available evidence that is behind a paywall without having to provide access to the policy directly. The standard at  422.101(b)(6) allows MA organizations to create publicly accessible internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature; it does not require that the MA organization to provide direct access to the source, but they must make VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00079 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222198 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations publicly available the information required at  422.101(b)(6)(ii). This could be in the form of a written summary that summarizes the evidence and treatment guidelines or clinical literature and provides a link or citation to the location of the evidence. This transparency provides assurances that coverage criteria are rational and supportable by current, widely used treatment guidelines and clinical literature, which we believe will protect MA enrollees. In an effort to provide plans with flexibility, we decline to require specific mechanisms for how the information is made publicly available. However, we do recommend MA plans refer