2023-07115.pdf

a plan uses a generalist as suggested by the commenter, to satisfy this standard, that reviewer would need to have relevant training or experience in the field of medicine related to the requested service in order to determine the medical necessity of the requested item or service. Comment: Numerous commenters expressed concern with the use of the term expertise as it relates to this proposal, suggesting it is too vague. Commenters requested that we clarify what this term means and provide additional examples. A commenter was concerned that by not including specifics about the level of training or expertise of the reviewer, there would be no meaningful change to the current review standard. Commenters offered several suggestions on how to better define the scope of expertise as it relates to the physician or other health care professional who must review medical necessity decisions. Specifically, another commenter VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00101 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222220 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations recommended that CMS revise the proposal to specify years of specialized training, while other commenters suggested that CMS specify that relevant expertise means that the physician involved must be of the exact same specialty or sub-specialty as the treating physician. Another commenter suggested that we require the plan reviewer to be of the same or similar specialty relevant to the services under review. Similarly, another commenter recommended that any coverage denial should be issued by a reviewer with equal or greater expertise in the relevant field of medicine to the treating physician. Additionally, this commenter questioned that CMS explore various measures for determining relevant expertise, such as setting thresholds requiring reviewers to have successfully performed a set number of relevant procedures, to the extent possible. Another commenter suggested that CMS require physician reviewers comply with the same requirement as Traditional Medicare where the physician must be engaged in the active practice of medicine in the State and be a specialist in the same field as the physician whose services are under review. It was noted that the same specialty standard for physician reviewers is verifiable by documentation of physician credentialing, while the proposed expertise in the field is not readily verifiable. This commenter also suggested that the physician reviewer should attest no less frequently than annually that they and their immediate family members do not have a conflict of interest in the MA organization for whom they provide medical necessity review services. Numerous commenters requested that CMS strengthen the proposed policy by requiring the physician reviewer to have the same clinical expertise as the health care professional under FFS who can request the item or service. Several commenters cited the example of a determination on a request for a patient to be admitted to an inpatient rehabilitation facility (IRF) and stated their opinion that the plan should utilize the expertise of a physician trained in inpatient rehabilitation, as is required for patients to be admitted by an IRF in traditional Medicare. Other commenters offered examples of what they believe should constitute an appropriate reviewer in the context of this proposal, such as, decisions involving treatment of patients with cancer and blood disorders should be explicitly limited to board certification in oncology or hematology, respectively. Additionally, a commenter requested that CMS require more specific physical therapy expertise for adverse decisions on therapy services given the widespread availability of physical therapists to perform medical necessity reviews and the high rate of physical therapy and rehabilitation services that are subject to prior authorization requirements. Response: We thank the commenters for their suggestions regarding how the concept of appropriate expertise should be interpreted if we finalize this proposal. We did not propose that the plan reviewer be of the same specialty or subspecialty as the treating physician. This proposal attempted to balance enhancing the quality of medical reviews at the organization determination level when the plan expects to issue a partially or fully adverse medical necessity determination, with maintaining plan flexibility in leveraging reviewer resources. We recognize that where there are few practitioners in a highly specialized field of medicine, a plan may not be able to retain the services of a physician of the same specialty or sub- specialty to review the organization determination. Nor did we propose that an appropriate reviewer have a minimum number of years of specialized training in the field of medicine related to the requested service. We believe there are a number of ways a plan can ensure that the reviewing physician or other health care professional has expertise in the field of medicine that is appropriate for the item or service being requested. In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician. In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine. As stated in the proposed rule, we intend the revisions to  422.566(d) and 422.629(k) to permit plans to determine on a case-by-case basis what constitutes appropriate expertise based on the services being requested and relevant aspects of the enrollees health condition. Ultimately, the goal of determining the appropriate reviewer for the requested service is to ensure that denials based on medical necessity are based on a thorough clinical review by someone with sufficient expertise so that enrollees receive the benefits to which they are entitled. Decisions to deny coverage on the basis of medical necessity require the exercise of clinical judgment based on the considerations specified in  422.101(c) as finalized in this rule. With respect to the IRF example cited by several commenters, the plan reviewer reviewing a request for IRF care would need to have the background and knowledge to determine that the enrollees medical condition requires intensive rehabilitation, continued medical supervision, and coordinated care. Accurately assessing the enrollees diagnoses, conditions and functional status requires clinical expertise that is appropriate to the requested item or service and could be made, for example, by a physical medicine and rehabilitation doctor, a neurosurgeon, a physical therapist or a rehabilitation nurse. Finally, given the related provisions in this rule with respect to determinations of medical necessity and utilization management tools, including prior authorization, we do not believe that this review standard requiring appropriate expertise needs to be unduly prescriptive to make an overall positive impact in the thoroughness of medical necessity reviews. For example, the codification of existing policy at  422.101(c)(1)(i)(C) that MA organizations consider the enrollees medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes dovetails with the proposed requirement that plans utilize reviewers with appropriate expertise in the requested service. In addition, there are several other related provisions in this rule regarding utilization management and prior authorization at  422.112, 422.137 and 422.138 that we believe will strengthen medical necessity reviews, such as the proposal that prior authorization policies for coordinated care plans may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary based on standards specified in this rule. Again, decisions to deny coverage on the basis of medical necessity require the exercise of clinical judgment based on the considerations specified in  422.101(c) as finalized in this rule. Exercising that type of judgment necessarily requires that the reviewer have knowledge and experience relevant to the requested services to reasonably determine when a requested service is reasonable, necessary and covered under the clinical coverage criteria that plans must use under  422.101(b) as finalized in section III.E of this rule. We believe the totality of the provisions addressed in this rule will enhance the overall decision- making process and the quality of the VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00102 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222221 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations review conducted at the organization determination level, particularly when a prior authorization or other utilization management requirement is involved. Since we did not specifically propose that the reviewer be of the same specialty or sub-specialty as the physician requesting the service on the enrollees behalf, we decline to finalize this proposal with such a requirement. As stated in the proposed rule, CMSs goal is to balance strengthening clinical review in the organization determination process when the plan expects to issue a partially or fully adverse medical necessity determination, with plan flexibility and operational efficiency in selecting appropriate reviewers. We plan to monitor implementation of this standard to assess whether future rulemaking may be necessary related to additional specificity on what constitutes expertise appropriate to the requested service. Comment: A commenter recommended CMS use the term qualified health professional rather than other health professional to avoid ambiguity and to align with the National Committee for Quality Assurance (NCQA) utilization management terminology. Response: The existing regulation at  422.566(d) related to who must review organization determinations states that if the MA organization expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the organization determination must be reviewed by a physician or other appropriate health care professional with sufficient medical and other expertise, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision. The physician or other health care professional must have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. We did not propose to modify this existing reference to appropriate health care professional as we believe it affords proper flexibility for plans in selecting and allocating reviewer resources while establishing the level of qualification necessary to protect beneficiaries. Comment: Several commenters recommended that CMS strengthen the proposed policy by specifying that medical necessity decisions must be made by a licensed physician in the state where care is being provided and the reviewing physician must have experience in the treatment being requested. Another commenter suggested that CMS require the physician reviewer to have an active licensure or relevant certification in the field of medicine specific to the request. Response: Existing regulations at  422.566(d) require the reviewing physician or other appropriate health care professional to have a current and unrestricted license to practice within the scope of his or her profession in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. We do not believe that it is necessary for the reviewer be of the same specialty as the treating physician because we also believe there is sufficient overlap in training and clinical knowledge among health care providers to ensure appropriateness in decision making. Additionally, the requirement at  422.590(h), which requires a physician with expertise in the field of medicine that is appropriate for the service at issue to reconsider an adverse organization determination, does not require the physician to be of the exact same specialty or subspecialty as the treating physician. This is a longstanding requirement in the MA program, which has demonstrated that enrollees are adequately protected by requiring the reviewer to have expertise in the field of medicine appropriate to the service at issue. The reviewer could satisfy the expertise standard in a number of ways including, but not necessarily limited to, specialized training, a certification in the applicable or related field of medicine, or related clinical experience. Comment: Multiple commenters expressed concern related to CMS allowance of plan discretion. Specifically, a commenter was concerned in instances where there are few practitioners in a highly specialized field of medicine, and the plan may not be able to retain the services of a physician of the same specialty or sub- specialty to review the organization determination. This commenter recognized that while it may be difficult for MA organizations to retain the services of the wide variety of specialists and sub-specialists needed to adequately review adverse determinations, it detrimentally impacts patient safety to have coverage determinations reviewed by health care professionals that lack the requisite knowledge, experience, and training of the relevant specialist or sub-specialist. This commenter suggested that rather than allowing MA organizations to risk beneficiary safety due to inadequate staffing, CMS should instead require that MA organizations retain the services of the necessary specialists and sub-specialists prior to implementing a particular utilization management policy, and further, suggested that impacted PA requirements due to inadequate staffing should be suspended until the MA organization can secure adequate staffing to review medical necessity decisions. We received a similar comment related to care that is often unavailable at other institutions, noting that it may not be possible to meet this standard if the treatment in question is for the specialized and sub-specialized care provided only at teaching hospitals. This commenter suggested that when it is not possible for the reviewing physician to have the same level of expertise and training as the treating physician, then the reviewing physician should be required to consult with the treating physician to inform their decision making. Several commenters expressed concern related to the plans discretion to determine the appropriate expertise on a case-by-case basis. These commenters recommended that CMS require MA organizations to develop a list to be shared with its contracted providers each year of services which require prior authorization and delineate the specific provider types and specialties, noting requisite training and rationale, who will be conducting medical necessity reviews, prior authorization reviews and peer-to-peer consults for those services. Another commenter suggested that the Utilization Management Committee, as proposed in this rule, should play a prominent role in developing this list of provider types and specialties in order to ensure compliance. A commenter requested that CMS ensure that this proposal also extends to inpatient care decisions and to the reporting of medical diagnoses that support inpatient care. Response: CMS thanks the commenters for their perspective and feedback. Our proposal did not include a requirement that plans be required to develop a list that delineates the specific provider types and specialties, noting requisite training and rationale, who will be conducting medical necessity reviews, prior authorization reviews and peer-to-peer consults for services subject to PA. MA organizations are currently required under  422.202(b) to establish a formal mechanism to consult with its