evekhm/cms_iom_500 huggingface dataset:
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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
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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
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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
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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
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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 existing requirement. Elsewhere in this final rule, we discuss proposed changes to amend  422.101(b) and (c) to clarify the obligations and responsibilities for MA plans in covering basic benefits. Specifically,  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). Comment: A commenter recommended that CMS require that plans provide documentation of the physician reviewers compliance with qualification standards with each denial notice, in addition to the factual basis for the denial of coverage. This commenter suggested that this will provide for monitoring and enforcement of compliance
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recommended that CMS require that plans provide documentation of the physician reviewers compliance with qualification standards with each denial notice, in addition to the factual basis for the denial of coverage. This commenter suggested that this will provide for monitoring and enforcement of compliance with physician reviewer criteria and this information may be VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00105 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222224 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations used in the administrative appeals process, QIO reviews, and complaints made to CMS. Another commenter recommended that CMS require physician reviewers to provide the beneficiary and treating physician with a notice/certification that their medical necessity review did not involve the use or consideration of screening criteria. Another commenter recommended that CMS require the MA organization to include its rationale for the supporting reviewers expertise for a given service at issue in each denial notice. Response: We thank the commenter for these suggestions. We did not propose that the plan be required to produce specific documentation of the plan reviewers relevant expertise with a denial notice or that there by a certification that medical necessity review didnt use screening criteria. Existing rules require plans to have processes in place for receipt and documentation of initial determination requests. MA organizations are also required to adhere to the maintenance of records and disclosure of information requirements at  422.504(d)(1)(ii) and 422.504(f)(2)(v), respectively. In addition, we expect that the administrative case file would include documentation relevant to the medical necessity review conducted in each organization determination. Comment: Several commenters recommended that CMS add more specific guardrails to ensure appropriately qualified reviewers are involved in the decision-making around coverage for particularly complex services. Commenters suggested that CMS require MA organizations to give deference to the treating physician when the MA organization is unable to obtain a reviewer of the same specialty or subspecialty unless the patient record directly contradicts the medical necessity determination. A commenter recommended that, if this proposal is finalized, coverage be mandatory in cases where sections
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the MA organization is unable to obtain a reviewer of the same specialty or subspecialty unless the patient record directly contradicts the medical necessity determination. A commenter recommended that, if this proposal is finalized, coverage be mandatory in cases where sections  422.566(d) and 422.629(k)(3) are violated; that is, where the physician reviewer did not have expertise in the field of medicine appropriate to the case or where required documentation was not maintained by the MA organization and provided to the enrollee and the physician whose order for services become the subject of a notice of denial of coverage. This commenter also recommended that decisions to deny coverage be effective no earlier than the date a denial notice is communicated in writing and received by the affected enrollee and the practitioner whose order for medical services was subject to medical necessity review. Response: We appreciate the commenters suggestions, but our proposal to establish minimum requirements for who reviews an organization determination before the plan issues a denial on the basis of medical necessity did not include requirements for mandatory or automatic coverage of the requested service in the event the plan reviewer does not have expertise in the field of medicine related to the requested item or service. Further, we did not propose a change to existing requirements related to denial notices. Plans are responsible for determining the medical necessity of an organization determination request on a case-by-case basis and nothing about this proposal obviates the need for an individualized review of medical necessity. Section III.E. 2.b. of this final rule amends  422.101(c)(1) to establish that plans must made 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. Comment: A commenter strongly opposed this proposal and requested that it be withdrawn. The commenter stated that it is not practical or advisable at the organization determination level of review. This commenter asserted that there is evidence that many clinicians are leaving frontline medicine to become consultants who perform independent reviews. The commenter also suggested that this proposal would result in increased demand for clinicians to perform these roles and create shortages in hospitals and medical practices. Further, the commenter stated that under current Medicare Advantage rules, consumers have access to specialists during the independent review process and requiring specialists to participate in organization determinations will increase pressures on the workforce and costs for taxpayers and
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shortages in hospitals and medical practices. Further, the commenter stated that under current Medicare Advantage rules, consumers have access to specialists during the independent review process and requiring specialists to participate in organization determinations will increase pressures on the workforce and costs for taxpayers and beneficiaries. Response: We appreciate the commenters perspective and concerns related to staffing issues. In developing this proposal, we attempted to balance enhancing the quality of medical reviews at the organization determination level with maintaining plan flexibility in leveraging reviewer resources. Based on that balance, we did not propose and are not finalizing a requirement that plans must use a physician or other health care professional with the same specialty as the treating physician. We believe it is reasonable for plans to have physicians and other health care professionals with various types of clinical expertise in order to conduct robust medical reviews in addition to the beneficiary protections afforded by the independent review entity level of adjudication. Comment: A commenter requested clarification related to how this proposal would affect reviews under Part D, while another commenter recommended that this requirement also apply to Part D. We also received a comment related to consistency on the part of the IRE, noting that if there is not uniformity, the IRE could make a difference in clinical judgement on a case. Response: We thank the commenters, but these comments are outside the scope of this rule. Based on the feedback we received from commenters, we are finalizing this requirement as proposed by revising  422.566(d) and 422.629(k)(3) to state if 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, the organization determination 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. We also proposed a technical correction at  422.590(b)(1) to include the correct cross reference regarding favorable decisions on payment requests at  422.618(a)(2). We did not receive comments on this technical correction and we are finalizing this correction. H. Updating Translation Standards for Required Materials and Content ( 422.2267 and
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requests at  422.618(a)(2). We did not receive comments on this technical correction and we are finalizing this correction. H. Updating Translation Standards for Required Materials and Content ( 422.2267 and 423.2267) 1. Standing Request for Translated Materials and Materials in Accessible Formats In accordance with our authority to interpret and implement the requirements and limitations in sections 1851(h), 1851(j), 1852(c), 1860D 1(b)(1)(B)(vi), 1860D4(a), and 1860D 4(l) of the Act,  422.2267(a)(2) and 423.2267(a)(2) of the regulations require MA organizations and Part D sponsors to translate materials into any non- English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area. In addition, per  417.428, cost plans with contracts under section 1876 of the Act must follow the same VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00106 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222225 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 118CMS released the contract year 2023 version of this HPMS memorandum titled, Contract Year 2023 Translated Model Materials Requirements and Language Data Analysis on September 23, 2022. This memorandum can be retrieved at: https://www.cms.gov/httpseditcmsgovresearch-statistics- data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memos-wk-4- september-19-23. 119CMS Office of Hearings and Inquiries, Frequently Asked Questions Regarding Accessible Communications for Individuals with Disabilities, Pursuant to Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557), August 30, 2017. Retrieved from https://www.cms.gov/