2023-07115.pdf

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 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 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  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 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 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/ Research-Statistics-Data-and-Systems/Computer- Data-and-Systems/HPMS/HPMS-Memos-Archive- Annual-Items/SysHPMS-Memo-Archive-%3F-2017- Qtr3. 120Refer to https://www.healthaffairs.org/doi/ full/10.1377/hlthaff.24.2.435. marketing and communication regulations; we apply the same standards to cost plans under this regulation based on our authority in section 1876(i)(3)(D) of the Act. Each fall, we release an HPMS memorandum announcing that plans can access in the HPMS marketing review module a list of all languages that are spoken by 5 percent or more of the population for every county in the U.S.118In the Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drugs Benefit Program; Policy and Regulatory Provisions in Response to the COVID19 Public Health Emergency; Additional Policy and Regulatory Provisions in Response to the COVID19 Public Health Emergency final rule, which appeared in the May 9, 2022 Federal Register (87 FR 27704) (hereinafter referred to as the May 2022 final rule), we also adopted a requirement that MA and Part D plans use a multi-language insert (MLI), which informs the reader in the fifteen most commonly spoken non-English languages used in the U.S., as well as any additional non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area, that interpreter services are available for free. In accordance with  422.2267(e)(31) and 423.2267(e)(33), the MLI must be included with all CMS required materials provided to current or prospective enrollees. As discussed in the May 2022 final rule, CMS considers the materials required under  422.2267(e) and 423.2267(e) to be vital to the beneficiary decision making process; ensuring beneficiaries with limited English proficiency are aware of and are able to access interpreter services provides a clear path for this portion of the population to properly understand and access their benefits (87 FR 27821). We remind MA organizations and Part D sponsors that as recipients of Federal financial assistance, they have independent language access requirements under Title VI of the Civil Rights Act of 1964 and section 1557 of the Affordable Care Act and implementing regulations at 45 CFR parts 80 and 92, respectively. In addition, MA organizations and Part D sponsors must comply with section 504 of the Rehabilitation Act of 1973 and section 1557 of the Affordable Care Act, and the Department of Health and Human Services implementing regulations at 45 CFR parts 84 and 92. As recipients of Federal financial assistance, MA organizations and Part D sponsors must provide appropriate auxiliary aids and services, including interpreters and information in alternate formats, to individuals with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question. Auxiliary aids and services can include braille, large print, data/audio files, relay services, and TTY communications. We further explained the obligation of plans to provide accessible communications for individuals with disabilities in an August 30, 2017, Health Plan Management System memorandum