2023-07115.pdf

4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222218 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations appropriate to adopt this standard for the medical necessity review of organization determinations by physicians and other appropriate health professionals in  422.566(d) and 422.629(k)(3) where the plan expects to issue an adverse decision. We received the following comments on the proposal related to the review of medical necessity decisions by a physician or other health care professional with expertise in the field of medicine appropriate to the requested service. Comment: Most commenters expressed strong support for this proposal and many agree that, if finalized, this standard would likely enhance the overall decision-making process and the quality of medical necessity reviews. Many of the commenters agreed that health care professionals making coverage decisions should have the expertise in the field of medicine or health care that is appropriate for the service at issue and were supportive of the decision not to require the case reviewer involved to be of the exact same specialty or sub- specialty as the treating physician. Many MA organizations noted that requiring the reviewer to be of the same specialty would be restrictive, cost- prohibitive and highly problematic. In addition, a commenter recommended that CMS develop a reasonableness standard to ensure that this approach, if finalized, is balanced and sensitive to the clinical workforce shortage that could be impacted by an overly decisive policy. This commenter cited the example of an internal medicine or family practice physician who has experience caring for the elderly and the disabled as an appropriate health care professional who could review medical necessity. Another commenter referenced the example from the proposed rule that if a plan intends to deny a request for a home nebulizer, the organization determination request should be reviewed by a health professional with respiratory expertise, such as a respiratory therapist. This commenter believes that the language in the final rule should provide sufficient flexibility to support plan use of a physician specialized in, for example, internal medicine. The commenter further stated that internal medicine physicians are also familiar with the reasons why a home nebulizer may be medically necessary, such as for severe asthma or Chronic Obstructive Pulmonary Disease (COPD). Many commenters were supportive of flexibility for 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 and recommended that we make this clear in the regulatory text. Response: CMS thanks the commenters for their support of this proposal. As noted in the proposed rule, our goal is to strengthen the quality of medical necessity reviews at the organization determination level when the plan expects to issue a partially or fully adverse medical necessity determination. We believe requiring expertise in the field of medicine or health care that is appropriate for the requested service advances that goal. If the plan reviewer is not of the same specialty or subspecialty as the treating physician, its our expectation that the physician or other appropriate health care professional have specialized training, certification, or clinical experience in the applicable field of medicine in order to satisfy the requirement of expertise in the field of medicine that is appropriate for the requested item or service. Comment: A few commenters expressed concern related to the ability of MA organizations to implement this requirement in practice and questioned whether or not the proposal will solve the problem we are seeking to address. A commenter was particularly concerned by the lack of detail provided by CMS under this proposal and the challenges it creates in terms of implementation noting that, as proposed, it would be difficult for a plan to identify that a provider has expertise in a specific field. Another commenter provided that there is marginal benefit seen in practice when common specialty cases are reviewed peer-to-peer, which begs the question of whether this proposal will improve medical necessity determination accuracy or reduce burden. Commenters also expressed concern about the limited availability of some provider specialties and the difficulty for plans to hire enough providers to cover all possible utilization management review cases. A commenter questioned how CMS expects plans to comply with this requirement in the event that the item or service involves a more unusual medical specialty or item or service. Another commenter, requested that CMS consider the difference in resources available to large, dominant national MA organizations and those with a more limited geographic footprint and resource availability. The commenter noted that in many service areas that are served by small and medium-sized MA organizations, there may only be one or two specialists of a certain type, or all the specialists of the same type are in the same group, resulting in a conflict of interest, as this would necessitate those physicians reviewing the care in which they have an economic interest. Several commenters were also concerned about the cost associated with implementing this requirement. A commenter suggested that this proposal could result in plans being required to scale back available benefits due to the cost of specialist reviews. Commenters also expressed concern that the requirement to find a specialist with appropriate expertise could delay access to necessary care as plans work to find the appropriate reviewer and recommended that, if finalized, we provide as much flexibility for plans as possible in determining what constitutes appropriate expertise on a case-by-case basis. Another commenter, indicated that the costs could be excessive and further add to administrative expense, thereby increasing beneficiary premiums, especially when not scalable to smaller regional not-for-profit health plans that may not see the volume of subspecialty review over a given period. Another commenter provided the example of MA plans offering dental, vision and hearing benefits as a supplemental benefit, and questioned if CMS expects each MA plan to have these provider types on call 24/7 for medical necessity review. This commenter indicated that most plans do not have dentists, for example, on staff, so to require these physician types be on call, this requirement will be costly and CMS should evaluate the aggregate costs of this proposal across the program and determine whether the benefit outweighs the cost. Response: We appreciate the commenters concerns related to staffing, associated costs and implementation, but we believe the proposed approach strikes a reasonable balance between ensuring a robust review when the plan expects to issue a partially or fully adverse medical necessity organization determination and maintaining flexibility in how plans manage their review resources. We did not propose to require that plans use reviewers of the same specialty as the enrollees treating physician. In addition, unlike the requirement at the reconsideration level that requires review by a physician, plans are able to utilize other appropriate health care professionals to review organization determinations that involve medical necessity. We believe there is sufficient overlap in training and clinical knowledge among health care providers to ensure flexibility in how plans allocate their staffing resources. While VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00100 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222219 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations we acknowledge there will be some unique circumstances that may necessitate input by a specialist, because the revisions to  422.566(d) and 422.629(k) do not require the plan reviewer to be of the same specialty or subspecialty, there is a degree of flexibility for plans to manage clinical staffing resources. As proposed and finalized, the level of expertise in the field of medicine or health care that is appropriate for the services at issue is the same standard that applies at the reconsideration level. Plans should implement this requirement at the organization determination level with respect to reviews performed by physicians or other health care providers in the same manner as plans have implemented the existing requirement for expertise of physician reviewers at the reconsideration level. Further, as proposed and finalized, this requirement does not apply to all organization determinations. Rather, per our proposal, the requirement applies to those organization determination requests where the plan expects to issue a partially or fully adverse decision on medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) based on the initial review of the request. Comment: Several commenters noted the nationwide shortage of primary care physicians and recommended that CMS include registered nurses, clinical psychologists, and pharmacists as appropriate reviewers in the final rule. Response: As proposed and finalized, the review at the organization determination level may be by a physician or other appropriate health care professional, which could include a registered nurse, so long as the individual has expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria. In addition, the existing regulations at  422.566(d) and 422.629(k)(3) require that 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 reiterate our intended approach that plans 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. In satisfying this requirement, plans should be guided in determining what constitutes appropriate expertise in a given case by the related requirements on medical necessity determinations that are being finalized in  422.101(c) of this final rule. Section 422.101(c) requires MA organizations to make medical necessity determinations based on: applicable coverage and benefit criteria; whether the provision of items or services is reasonable and necessary under section 1862(a)(1) of the Act; the enrollees medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes; and, where appropriate, involvement of the plans medical director. This final rule requires the plan to exercise judgement to determine the type of reviewer (or identify an individual reviewer among its staff) who has sufficient expertise to make an informed and supportable decision whether a service is not medically necessary for the enrollee, such that coverage should be denied on the basis of a lack of medical necessity. We believe that applying the principles in  422.101(c) to the decision-making around who is an appropriate reviewer in a given case will guide the plan to a reasonable and supportable interpretation of this review standard. Comment: A commenter requested that CMS clarify that appropriate health care professional also includes subcontracted vendors. Response: Pursuant to  422.566(a), each MA organization must have a procedure for making timely organization determinations regarding the benefits an enrollee is entitled to receive under an MA plan, including basic benefits and mandatory and optional supplemental benefits. Plan functions can be performed directly by plan employees or under an arrangement between the plan and a first tier, downstream or related entity (FDR) consistent with the regulatory requirements at 42 CFR part 422, particularly  422.504(i). If a plan uses an FDR, which includes subcontractors, to perform plan functions, the plan remains responsible under the MA regulations and its contract with CMS. Comment: Another commenter, requested that we establish a standard of reasonableness in how to demonstrate the appropriateness of the clinician that does not place undue burden on the process. This commenter recommends that health plans not be required to litigate these instances on a case-by-case basis. This commenter noted that health plans work to ensure that the clinician conducting medical necessity reviews has the requisite experience and expertise. Further, it was noted that, for practical reasons, health plans cannot have clinicians representing each specialty or subspecialty employed to conduct medical necessity reviews and therefore rely on qualified generalists in some circumstances to provide the necessary expertise. Response: Our intent in proposing this change is that plans ensure that when the plan expects to issue a partially or fully adverse medical necessity determination, the plan reviewer have expertise in the field of medicine that is appropriate for the item or service that is the subject of the organization determination request. As such, the expectation is that the plan determine on a case-by-case basis which physician or other health care professional has the requisite expertise to conduct the review. We agree with the commenter on applying a reasonableness standard in determining the appropriateness of the reviewing clinician. As previously stated, when exercising judgement to determine the type of reviewer who has appropriate expertise to decide whether a service is medically necessary for an enrollee, the plan should be guided by the medical necessity principles being established in this final rule at  422.101(c). We believe that applying these principles to the decision-making on who is an appropriate reviewer in a given case will guide the plan to a reasonable and supportable interpretation of this review standard. We understand the commenters concern regarding the difficulties a plan may encounter in employing a specialist in every field of medicine, which is why our proposal did not include a requirement that the plan reviewer be of the same specialty as the treating physician. To the extent 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