2023-07115.pdf

workgroups to ensure appropriate expertise is represented. One commenter suggested that the UM committee be required to seek outside assistance when the committee does not have expertise in a certain area. Response: CMS appreciates the feedback received and will take it into consideration as part of future policy development. We believe that the requirements in  422.137(d)(1) and (2) that set the standards for the review by UM committees, including that utilization management policies comply with  422.101(b) (which includes compliance with Traditional Medicare coverage rules and limits on MA plan internal coverage criteria) and that the committee review relevant current clinical guidelines, are sufficient to ensure that appropriate evidence is reviewed and relied upon by the committee during its annual (or more frequent) review of utilization management policies. Therefore, we are not adopting an additional requirement for the UM committee to have specialty focused subcommittees and workgroups. We are not finalizing an additional requirement for participation or involvement by a specific specialty provider or health care provider with expertise related to each individual UM policy. We believe that is unnecessary because, as previously noted, all utilization management policies must comply with  422.101(b), which requires any permissible internal coverage criteria must be based on current evidence in widely used treatment guidelines or clinical literature. Current widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions. Therefore, we do not believe it is necessary for additional involvement of specialists when reviewing utilization management policies and procedures. CMS encourages plans to include relevant experts when feasible during the review process. Comment: One commenter requested clarification on the definition of practicing physician who is an expert regarding care of elderly or disabled individuals. Response: CMS considers someone an expert who, per the dictionary definition of expert,116has special skill or knowledge derived from training or experience; here that level of skill or knowledge must be in the area of providing care for elderly or disabled individuals. Because the UM policies under review by the committee will be used for coverage and services furnished to Medicare beneficiaries, it is critical to ensure that a provider with knowledge relevant to the population eligible for enrollment in the MA plan (that is, Medicare enrollees) is represented on the UM committee. We encourage MA organizations that offer SNPs to include providers with experience and expertise related to the special needs of the enrollees served by the SNP. Comment: A commenter suggested that the UM committee be required to review any prior authorization policies used by the MA organization, including those developed and managed by third party entities. Another commenter requested clarification as to how proposed  422.137 would apply when an MA plan has delegated utilization management functions, including whether and how the requirements of proposed  422.137 would be shared or divided between the MA plan and its delegate(s) Response: Per  422.138 as proposed and finalized, the UM committee is required to, at least annually, review the policies and procedures for all utilization management, including prior authorization, used by the MA plan. This means that any UM policy or procedure that is used by the plan, whether developed or managed by a third-party entity, must be reviewed and approved by the UM committee. Comment: A few commenters requested that CMS not require a committee to review and approve all UM policies and procedures. Response: CMS declines this suggestion. For the reasons outlined in the proposed rule and our responses to other comments and in light of feedback CMS has received and concern that enrollees may be facing unreasonable barriers to needed care, CMS believes ensuring UM policies and procedures are reviewed on a timely and consistent basis to ensure that the UM policies meet minimum standards is of paramount importance. Comment: A commenter supported involving the UM committee in developing mechanisms to address system vulnerabilities. Another commenter suggested revise  422.137(d) to require the UM Committee to review data on manual review errors, system errors, and excessive denials, to revise UM policies and procedures as appropriate to reduce the risk of such errors, and to identify and implement system changes to mitigate the risk of manual review errors and system errors. Response: CMS thanks the commenters for their comment. At this time, we decline to make these revisions and are finalizing as proposed. We will consider these suggestions in future rulemaking. We thank all commenters for their comments. After careful consideration of all comments received, and for the reasons set forth in the proposed rule and in our responses to the related comments, as previously summarized, we are finalizing the new regulation  422.137 and the modification to  422.202(b)(1)(i) as proposed. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00098 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222217 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 117See interim final rule with request for comments titled Additional Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency CMS 9912 IFC, 85 FR 71142. 6. Additional Areas for Consideration and Comment CMS solicited comment on three areas: (1) termination of services in post- acute care, (2) gold carding, and (3) addressing vulnerabilities that can lead to manual review errors and system errors. Since no regulations were proposed, we are not finalizing anything in these areas at this time. We thank commenters for their input, and will consider all comments during future rulemaking. F. Section 1876 Cost Contract Plans and Cost-Sharing for the COVID19 Vaccine and Its Administration ( 417.454) Section 3713 of The Coronavirus Aid, Relief, and Economic Security (CARES) Act (2020) (Pub. L. 116136) requires coverage of the COVID19 vaccine and its administration at zero cost-sharing for enrollees of Traditional Medicare and Medicare Advantage. The CARES Act revised section 1861(s)(10)(A) of the Act to include among services provided at zero cost-sharing in the Medicare FFS program, the COVID19 vaccine and its administration. As amended by section 3713 of the CARES Act, section 1852(a)(1)(B)(iv)(VI) of the Act prohibits MA plans from using cost-sharing that exceeds the cost-sharing imposed under Traditional Medicare for a COVID19 vaccine and its administration when the MA plan covers this Traditional Medicare benefit. Cost plans are coordinated care plans and share many of the same features as Medicare Advantage plans, but have a separate statutory authority (section 1876 of the Act) and are paid on a reasonable cost basis. In addition, unlike with MA plans, enrollees in cost plans may receive services from original Medicare in addition to services from the cost plans network; when they receive benefits from health care providers that are not contracted with the cost plan, cost plan enrollees are covered by Traditional Medicare, with the same cost sharing and coverage as the Traditional Medicare program. The CARES Act did not include the zero cost-sharing provision for section 1876 cost contract plans (cost plans), so using its authority under section 1876(i)(3)(D) of the Act, which authorizes CMS to impose other terms and conditions not inconsistent with [section 1876] that are deemed necessary and appropriate, CMS established a requirement for cost plans to use cost sharing that does not exceed the cost sharing in Traditional Medicare for a COVID19 vaccine and its administration in an interim final rule, titled Additional Policy and Regulatory Revisions in Response to the COVID19 Public Health Emergency, which appeared in the Federal Register on November 6, 2020.117Because of the cost sharing used in Traditional Medicare per sections 1833(a)(1)(B) and 1861(s)(10)(A) of the Act, this is effectively a requirement to cover this benefit with zero cost sharing. In a newly adopted  417.454(e)(4), we specified the timeline for coverage of a COVID19 vaccine and its administration with zero cost-sharing for cost plans coverage of cost-sharing for cost plans that may not exceed cost sharing under Traditional Medicare as the duration of the PHE for the COVID19 pandemic, specifically the end of the emergency period defined in paragraph (1)(B) of section 1135(g) of the Act, which is the PHE declared by the Secretary on January 31, 2020 and any renewals thereof. However, the CARES Act did not specify an end date for the zero cost-sharing requirement for MA plans and we believe that it is appropriate that enrollees in a section 1876 cost plan have the same cost sharing protection for a COVID vaccine and its administration that enrollees in Traditional Medicare and in MA plans have when these cost plan enrollees get this benefit from health care providers that are in-network with the cost plan. Therefore, we proposed to replace the provision adopted at  417.454(e)(4) in the November 2020 interim final rule with a new requirement that section 1876 cost plans cover the COVID19 vaccine and its administration without cost-sharing as described in section 1861(s)(10)(A) of the Act. This proposal is based on authority in section 1876(i)(3)(D) of the Act to add requirements for cost plans. CMS believes that it is necessary and appropriate to ensure that cost plan enrollees, like other Medicare beneficiaries, are provided access to the COVID19 vaccine and its administration without cost-sharing in- network. Requiring cost plans to comply with the same cost-sharing protections available to Medicare beneficiaries in Traditional Medicare and those enrolled in MA plans would ensure equitable access to care and that cost is not a barrier for beneficiaries to receive the COVID19 vaccine. CMS has extended to cost plans other statutory requirements related to cost-sharing via regulation for those services that the Secretary determines require a level of predictability and transparency for beneficiaries. For example, in a final rule which appeared in the Federal Register on April 15, 2011, CMS, using its authority under section 1876(i)(3)(D) of the Act, extended to cost plans the statutory requirements specifying that in-network cost-sharing for MA enrollees could not be higher than cost- sharing for Traditional Medicare enrollees for chemotherapy administration services, renal dialysis services, and skilled nursing care in those cost sharing protections are  417.454(e)(1) through (e)(3). Comment: Several commenters expressed support for our proposal requiring cost plans to cover the COVID19 vaccine and its administration without cost-sharing. Response: We thank the commenters for their support of our proposal. We received several supportive comments on this proposal and are finalizing the provision as proposed. G. 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 and Technical Correction to Effectuation Requirements for Standard Payment Reconsiderations ( 422.566, 422.590, and 422.629) We proposed to revise  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. This is the same standard of review with respect to expertise that applies to physician review of reconsiderations at  422.590(h)(2). The rule at  422.590(h)(2) interprets and implements the requirement in section 1852(g)(2)(B) of the Act that any reconsideration that relates to a determination to deny coverage based on a lack of medical necessity be made only by a physician with appropriate expertise in the field of medicine which necessitates treatment to mean a physician with an expertise in the field of medicine that is appropriate for the covered services at issue. As stated in the proposed rule, we believe it is VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00099 Fmt 4701 Sfmt 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,