2023-07115.pdf

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 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 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 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 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 to the coverage criteria and summary of evidence presented by MACs as a guide and best practice for how to present this information publicly. We are finalizing  422.101(b)(6)(ii) with modifications to make everything listed in paragraphs (b)(6)(i) through (iii) of the proposed rule publicly accessible and to enhance transparency requirements related to the use of internal coverage criteria. Comment: Some commenters requested that CMS require MA plans to adhere to Traditional Medicare coding policies related to how MA organizations pay providers. Another commenter suggested CMS also require MA plans to use only CMS software and billing processes. Response: We thank commenters for their suggestions. We remind commenters that section 1854(a)(6)(B)(iii) of the Act and MA regulations at  422.256(a)(2)(ii) expressly prohibit CMS from interfering in price structures agreed to by an MA plan and its contracted providers. Whether or how a MAO pays its providers for furnishing covered services through use of a particular CPT code or some other mechanism can vary depending on the contract between the MA plan and the provider. We note that while MA organizations can develop their own payment methodologies for in-network providers for different diagnoses or procedure codes, national standard code sets for ICD10 codes and CPT/HCPCS codes, along with respective coding guidelines, as required under HIPAA, must be followed. In this sense, the code sets and associated coding guidelines used in Traditional Medicare are the same as those required to be used by MA organizations. Further, when submitting encounter data to CMS, MA organizations must comply with the data structure and coding vocabularies established by CMS for such data and MA encounter data must conform to CMS requirements for data equivalent to Medicare fee-for-service data, when appropriate, and to all relevant national standards. (See  422.310(d)) For non- contract providers, section 1852(a)(2) requires MA organization to pay non- contracted providers what they would receive in the Traditional Medicare program (that is, the FFS program) for furnishing the Part A or Part B services. Because Traditional Medicare uses specific codes and payment procedures, when a non-contracted provider uses those codes to request payment from an MA organization, the MA organization may not deny payment on the basis that the codes that were submitted are not used by the MA organization and its contracted providers. Comment: With respect to medical necessity determinations, several commenters stated that plan medical directors often issue determinations without up to date patient data. These commenters suggested that CMS require that prior to issuing a medical necessity determination, the plan medical director must have direct access to all of the relevant information available to the plan and the responsibility to review all this information. Several commenters stated that peer-to-peer reviews often include medical directors without relevant expertise. These commenters suggested CMS require plans to use a reviewing medical director who has specific expertise in the relevant areas. Response: We thank commenters for their suggestions. We proposed, and are finalizing in this rule, at  422.101(c)(1)(i)(C), that MA organizations must make medical necessity determinations based on, among other things, the enrollees medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes. This regulation requirement means that the MA organization, and its staff that review requests for an organization determination related to medical necessity, must review these materials that are specific to the enrollee and the contemplated services. We do not believe that our regulation needs to require that MA plan medical directors have direct access to all of the relevant information available to the plan and the responsibility to review all this information before any medical necessity determinations are made. As proposed and finalized,  422.101(c)(1)(D) requires involvement of the MA plan medical director where appropriate. Per  422.562(a)(4), which has not been amended in this rule, MA plan medical directors are responsible for ensuring the clinical accuracy of all organization determinations and reconsiderations involving medical necessity. MA organizations must have adequate procedures and systems in place to fulfill their obligations under part 422, including making organization determinations about coverage. (See for example,  422.503(a)(4) 422.504(a)(16) and 422.566(a)). Section 422.101(c)(1)(C) requires that medical necessity determinations be made based on, among other things, the enrollees medical history, physician recommendations, and clinical notes. This effectively means that all relevant clinical information is to be used by the MA plan in making the determination. Also, we are also finalizing the proposal to revise  422.566(d) and 422.629(k)(3), in section III.G of this rule, to state that the physician or other appropriate health care professional who conducts the organization determination review must have expertise in the field of medicine that is appropriate for the item or service being requested before the MA organization or applicable integrated plan (AIP) issues an adverse decision on medical necessity. In response to the comment that that peer-to-peer reviews often include medical directors without relevant expertise, we interpret peer to peer review to mean a discussion between the patients doctor and a medical professional at the MA plan to obtain a prior authorization