2023-07115.pdf

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 contracted physicians regarding the organizations medical policy, quality VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00103 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222222 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations improvement programs and medical management procedures to ensure that certain standards are met. These standards include practice guidelines and utilization management guidelines that are developed based on reasonable medical evidence or a consensus of health care professionals in a particular field and in consultation with contracting physicians. Further, these guidelines are reviewed and updated periodically and are communicated to providers, and, as appropriate, to enrollees. We will consider the merit of these suggestions for future policy proposals. In terms of the comment suggesting 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,  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. In exercising its judgement to determine the type of reviewer that has the appropriate expertise to decide whether a service is medically necessary for an enrollee, the plan should be guided by medical necessity principles set forth at  422.101(c). As a whole, this final rule adopts new provisions and requirements designed to strengthen the prior authorization process. We believe these provisions will strengthen the overall decision-making process in the adjudication of organization determinations, including those that involve utilization management. With respect to the comment on inpatient care decisions, any organization determination where the plan expects to make an adverse decision based on medical necessity will be subject to this provision. If an organization determination is requested for authorization of an inpatient admission and the plan has a prior authorization requirement that a particular diagnosis or diagnoses be present and the plan intends to issue an adverse decision based on its initial review of the request, the request 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 services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision. Comment: A few commenters expressed concern related to the time it will take an MA organization to identify the appropriate reviewer in certain cases. These commenters requested that CMS ensure that this proposal does not result in MA organizations extending the timeframe to review prior authorization requests. Response: Under existing rules at  422.566(a), MA plans must have a procedure for making timely organization determinations (in accordance with the requirements of 42 CFR 422 subpart M) regarding the benefits an enrollee is entitled to receive under an MA plan. This proposal is not intended to allow plans additional time to review organization determinations where the plan expects to issue a partially of fully adverse medical necessity decision. Existing regulations prescribe adjudication timeframes for organization determinations, which include pre-service requests subject to PA. Under the rules at  422.572(a)(1) related to an expedited organization determination request for a medical item or service (which could include an item or service subject to PA), the MA organization must make its determination and notify the enrollee (and the physician involved, as appropriate) of its decision, whether adverse or favorable, as expeditiously as the enrollees health condition requires, but no later than 72 hours after receiving the request. For a standard organization determination request for a medical item or service (again, which could include an item or service subject to PA), the rules at  422.568(b)(1) require the MA organization to notify the enrollee of its determination as expeditiously as the enrollees health condition requires, but no later than 14 calendar days after the date the organization receives the request for a standard organization determination. Under certain limited circumstances, an MA organization may extend these adjudication timeframes. Comment: Many commenters requested clarification on how this requirement will be enforced. Another commenter stated the belief that MA organizations currently have the ability to deny medically necessary care with little recourse. A commenter suggested the need for enrollees and providers to have a mechanism to challenge whether the standard has been met by the plan. Response: CMS thanks the commenters for their interest in how we intend to enforce this standard and for the feedback related to medical necessity denials. We are assessing the best options for oversight of this requirement, including leveraging existing resources for monitoring Part C IRE reversals of plan decisions. We expect plans to 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. Determining who has the appropriate expertise to conduct a review of medical necessity must be made on a case-by-case basis. Plans have additional flexibility at the organization determination level because they can utilize other appropriate health care professionals. As finalized in this rule,  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. In exercising its 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 medical necessity principles set forth at  422.101(c). Applying these principles 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. Further, the enrollee (or the treating physician acting on behalf of the enrollee) always has recourse through the appeals process if the enrollee is dissatisfied with the plans decision. This proposal in no way affects the enrollees right to appeal a denied organization determination or to file a grievance expressing dissatisfaction with any aspect of an MA organizations or a providers operations or activities. As stated in the proposed rule, the goal of this proposed policy change is to enhance medical necessity reviews at the initial coverage decision level which should ultimately reduce the number of cases that get into the appeals process. We expect this policy to result in a decrease in the number of denied organization determinations because we believe requiring reviewers with VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00104 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222223 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations appropriate expertise in the requested item or service will enhance the accuracy and overall clinical supportability of the medical necessity decisions. To the extent this requirement increases the likelihood of beneficiaries getting medically necessary covered services, the need for a beneficiary to appeal a denial will be reduced. Comment: Several commenters recommended that we extend this proposal to apply to medical professionals who participate in peer-to- peer (P2P) discussions. These commenters suggested that many encounters during such discussions are with medical professionals who do not have applicable expertise for the service at issue, yet are responsible for making medical necessity decisions. Several commenters recommended that we add this clarification on applicability to P2P discussions to the regulatory text. Response: We proposed that if a plan expects to issue an unfavorable organization determination decision, the request must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine that is appropriate for the item or service being requested before the plan issues an adverse organization determination decision. We note that if a P2P discussion occurs between a treating physician and a plan reviewer in the course of a plan reviewing a coverage request, the P2P discussion is not separate and distinct from an organization determination. Rather, P2P discussions take place during adjudication of an organization determination. To the extent a plan reviewer engages in a P2P with the enrollees treating physician during adjudication of an organization determination request, this standard of review related to expertise in the field of medicine appropriate for the requested service would apply to that aspect of the organization determination process. Because a P2P is part of the organization determination process, to the extent such a discussion occurs, and not a separate process, we do not believe the regulatory text needs to explicitly reference P2P discussions if this standard is finalized. Comment: Several commenters suggested that CMS clarify that this proposal applies to expedited requests in addition to standard requests for prior authorization. Response: The regulations at  422.566 regarding organization determinations refer to the procedures plans must have in place per the rules at  422.568 and 422.572. The regulations at  422.629(k) regarding decision-making requirements for integrated organization determinations establish the individuals who make decisions per the rules at  422.631 for standard and expedited integrated organization determinations. As proposed and finalized, this review standard applies to organization determinations where the MA organization or applicable integrated plan 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 regardless of the timeframe on which the plan is required to make the decision. This includes organization determinations (including those involving prior authorization) whether the organization determination is adjudicated under the standard timeframe per  422.568, the expedited timeframe per  422.572, or the timeframes for integrated organization determinations at  422.631(d). Comment: A commenter, requested that CMS explain how it envisions medical necessity review processes to work when there are multiple items and services being reviewed. Response: As proposed and finalized, the amendment to  422.566(d) and 422.629(k) does not change the plans responsibility for making individualized medical necessity determinations based on the item or service being requested and relevant aspects of the enrollees health condition, as well as applicable Medicare coverage rules. As previously noted, this final rule amends  422.101(c)(1) to establish that plans must make medical necessity determinations based on specific standards and information, which will apply to all medical necessity determinations, even if a request for multiple services is under review. If multiple services are requested, and the plan expects to issue a partially or fully adverse medical necessity determination, the plan must make a determination as to the appropriate expertise for each service and ensure that the decision to deny coverage on the basis of medical necessity for each service is made by a reviewer with the appropriate expertise. If the services are interrelated for the same condition, it may be appropriate to use a single reviewer. Again, this determination must be made on a case-by-case basis. Comment: A commenter noted that this rule does not include the requirement which is imposed on medical necessity reviews conducted under Traditional Medicare, that is, physician reviewers must determine if the medical services which are subject to review are reasonable and necessary. This commenter recommended that these program integrity provisions be referenced in  422.566(d) and 422.629(k)(3). The commenter believes this is necessary to provide compatible coverage between the Medicare Advantage program and Traditional Medicare program. Response: Under existing rules at  422.566(a), MA plans must have a procedure for making timely organization determinations (in accordance with the requirements of 42 CFR 422 subpart M) regarding the benefits an enrollee is entitled to receive under an MA plan, including basic benefits as described under  422.100(c)(1) and mandatory and optional supplemental benefits as described under  422.102, and the amount, if any, that the enrollee is required to pay for a health service. Organization determinations and integrated organization determinations made under the provisions at  422.629 are made on the basis of whether the item or service is reasonable and necessary for the enrollee. The proposal related to the expertise of the plan reviewer if the plan expects to issue a partially or fully adverse medical necessity determination does not alter this