evekhm/cms_iom_500 huggingface dataset:
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requirements related to continuity of care, citing that operationalizing these new requirements will involve significant information technology and administrative resources. Commenters requested that the implementation date be moved to 2025 at the earliest. Other commenters suggested an effective date of 2026 would align with CMS proposed 2026 effective date for its Advancing Interoperability and Improving Prior Authorization proposed rule that also impacts MA plans. Response: CMS appreciates the intricacies involved with implementing new regulatory requirements. However, since several MA plans indicated they already have existing policies in place that are similar to what CMS proposed at  422.112(b)(8), and we continue to receive feedback from stakeholders that medically necessary care is being disrupted by unnecessary prior authorization, we believe that it is important to implement this requirement as soon as possible. The new requirements at  422.112(b)(8) are applicable beginning on and after January 1, 2024, for MA coordinated care plans. 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, we are finalizing  422.112(b)(8) largely as proposed but with modifications. We are finalizing  422.112(b)(8)(i)(A) with revisions to require approval of a prior authorization request for a course of treatment be valid for as long as medically necessary to avoid disruptions in care, in accordance with the applicable coverage criteria, the individual patients medical history, and the treating providers recommendation. 5. Mandate Annual Review of Utilization Management (UM) Policies by UM Committee ( 422.137) We proposed procedural improvements to ensure that utilization management policies are reviewed on a timely basis and have the benefit of provider input. Any authority for MA organizations to use utilization management policies with regard to basic benefits is subject to the mandate in section 1852(a)(1) of the Act that MA plans cover Medicare Part A and Part B benefits (subject to specific, limited statutory exclusions) and, thus, to CMSs authority under section 1856(b) of the Act to adopt standards to carry out the MA provisions. In light of the feedback we received and our concern that enrollees may be facing unreasonable barriers to needed care, we proposed to require MA organizations to establish a Utilization Management (UM) committee to operate similar to a Pharmacy and Therapeutics, or P&T,
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of the feedback we received and our concern that enrollees may be facing unreasonable barriers to needed care, we proposed to require MA organizations to establish a Utilization Management (UM) committee to operate similar to a Pharmacy and Therapeutics, or P&T, committee. We proposed to add requirements pertaining to this UM committee in a new regulation at  422.137. a. Review and Approval of UM Policies At  422.137(a), we proposed that an MA organization that uses UM policies, such as prior authorization, must establish an UM committee that is led by an MA plans medical director (described in  422.562(a)(4)). Section 422.562(a)(4) requires every MA organization to employ a medical director who is responsible for ensuring the clinical accuracy of all organization determinations and reconsiderations involving medical necessity and establishes that the medical director must be a physician with a current and unrestricted license to practice medicine in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. We also proposed, at  422.137(b), that an MA plan may not use any UM policies for basic or supplemental benefits on or after January 1, 2024, unless those policies and procedures have been reviewed and approved by the UM committee. This proposal would ensure that plan policies and procedures meet the standards set forth in this final rule beginning with the contract year after the finalization of this proposed rule. We explained that we anticipate that there will be sufficient time between our issuance of a final rule and January 1, VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00093 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222212 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations 2024, for each MA organization to engage in the necessary administrative activity to establish the UM committee and have its existing UM policies reviewed and, if they meet the standards in this proposed regulation, approved for use. We proposed the committee responsibilities at  422.137(d). The responsibilities would include that the UM committee, at least annually, review the policies and
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UM policies reviewed and, if they meet the standards in this proposed regulation, approved for use. We proposed the committee responsibilities at  422.137(d). The responsibilities would include that the UM committee, at least annually, review the policies and procedures for all utilization management, including prior authorization, used by the MA plan. We proposed at  422.137(d)(1)(i) through (iii) that such review must consider The services to which the utilization management applies; Coverage decisions and guidelines for original Medicare, including NCDs, LCDs, and laws; and Relevant current clinical guidelines. We proposed at  422.137(d)(2)(i) though (iv) the committee approve only utilization management policies and procedures that: Use or impose coverage criteria that comply with the requirements and standards at  422.101(b); Comply with requirements and standards at  422.138(a)(c); Comply with requirements and standards at  422.202(b)(1); and Apply and rely on medical necessity criteria that comply with  422.101(c)(1). Currently,  422.202(b) requires MA organizations to establish a formal mechanism to consult with the physicians who have agreed to provide services under the MA plan offered by the organization, regarding the organizations medical policy, quality improvement programs and medical management procedures; that formal mechanism for consultation must ensure that certain standards are met. Specifically,  422.202(b)(1)(i) through (iv) require that MA plan practice guidelines and UM guidelines must: (i) be based on reasonable medical evidence or a consensus of health care professionals in the particular field; (ii) consider the needs of the enrolled population; (iii) be developed in consultation with contracting physicians; and (iv) be reviewed and updated periodically. We proposed to modify  422.202(b)(1)(i) to align it with our standard for creating internal coverage criteria. We therefore proposed to replace the requirement that practice and UM guidelines be based on reasonable medical evidence or a consensus of health care professionals in the particular field with a requirement that UM guidelines be based on current widely used treatment guidelines or clinical literature. This is consistent with the proposed coverage criteria requirements at  422.101(b)(6), which are discussed in detail in section III.E.2.
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requirement that UM guidelines be based on current widely used treatment guidelines or clinical literature. This is consistent with the proposed coverage criteria requirements at  422.101(b)(6), which are discussed in detail in section III.E.2. of this final rule. We solicited comment on whether we should also require the UM committee to ensure that the UM policies and procedures are developed in consultation with contracted providers; whether the UM committee should ensure that the MA organization, as required by  422.202(b)(2), communicates information about practice guidelines and UM policies to providers and, when appropriate, to enrollees; and whether the UM committee should have an ongoing or active oversight role in ensuring that decisions made by an MA plan throughout the year are consistent with the final, approved practice guidelines and UM policies. We also proposed at  422.137(d)(3) that the committee must revise UM policies and procedures as necessary, and at least annually, to comply with the standards in the regulation, including removing requirements for UM for services and items that no longer warrant UM so that UM policies and procedures remain in compliance with current clinical guidelines. We explained that mandating annual review of utilization management policies using these standards will help ensure that medically necessary services are accessible to all enrollees. Because prior authorization and referral or gatekeeper policies are included in UM policies and procedures, these proposed requirements would apply as well to those polices and CMS expects MA organizations to update their UM policies after the UM committee approves or revises them. As this final rule as a whole makes clear, ensuring that enrollees have access to and are furnished covered benefits is a priority. We solicited comment on whether to require the UM Committee to review all internal coverage criteria used by the MA plan. We also solicited comment on the extent to which the proposed regulation text sufficiently and clearly establishes the standards and requirements discussed here. b. Utilization Management Committee Membership At  422.137(c)(1) through (4), we proposed that the UM committee must include a majority of members who are practicing physicians; include at least one practicing physician who is independent and free of conflict relative to the MA organization and MA plan; include at least one practicing physician who is an expert regarding care of elderly or disabled individuals; and include members representing various clinical specialties (for example, primary care, behavioral health) to ensure that a wide range of conditions are adequately
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and MA plan; include at least one practicing physician who is an expert regarding care of elderly or disabled individuals; and include members representing various clinical specialties (for example, primary care, behavioral health) to ensure that a wide range of conditions are adequately considered in the development of the MA plans utilization management policies. These composition requirements are in addition to the proposal that the medical director, required for each MA plan under  422.562(a)(4), lead the UM committee. We solicited comment on recommendations for other types of providers, practitioners, or other health care professionals that should also be included on the UM committee and whether additional standards for composition of the UM committee are necessary with regard to expertise, freedom from conflicts of interest, or representation by an enrollee representative. We also solicited comment on whether we should include a requirement, that when the proposed UM committee reviews UM policies applicable to an item or service, that the review must be conducted with the participation of at least one UM committee member who has expertise in the use of, or medical need for that specific item or service. c. Documentation of Determination Process We proposed at  422.137(d)(4) that the UM committee must clearly articulate and document processes to determine that the requirements under paragraphs (c)(1) through (4) of this section have been met, including the determination by an objective party of whether disclosed financial interests are conflicts of interest and the management of any recusals due to such conflicts. Finally, we proposed at  422.137(d)(5) that the UM committee must document in writing the reason for its decisions regarding the development of UM policies and make this documentation available to CMS upon request. We explained that the documentation should provide CMS with an understanding of the UM committees rationale for their decision, and may include, but is not limited to, information such as meeting minutes outlining issues discussed and any relevant supporting documentation. d. Interchangeable Use of the P&T and Utilization Management Committees As discussed in our proposal, we believe it is appropriate that the establishment of an MA plan UM committee, with certain exceptions, largely mirror the requirements in  422.136 that MA organizations have a VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00094 Fmt 4701 Sfmt 4700
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mirror the requirements in  422.136 that MA organizations have a VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00094 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222213 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations pharmacy and therapeutic committee that reviews and approves step therapy programs for Part B drugs and the requirements regarding membership, scope, and responsibilities of that P&T committee. We believe that similar requirements, which were modeled after the longstanding Part D P&T committee requirements at  423.120(b), are generally adequate for the purposes of the UM committee. We explained that this proposal was designed to require review and approval of utilization management policies, including utilization management policies that use or impose coverage criteria, to ensure that these policies and procedures are medically appropriate, consistent with Medicare coverage rules, and do not negatively impact access to medically necessary services. To meet the existing requirements at  422.136(b), MAPDs are permitted to utilize an existing P&T committee established for purposes of administration of the Part D benefit under part 423 of this chapter. In the proposed rule, we stated that we anticipate that some of the requirements proposed for the UM committee may overlap or duplicate existing P&T committee requirements in connection with coverage of and utilization management policies for Part B drugs. We solicited comment on whether an MA plan should be permitted to utilize the proposed UM committee at  422.137 to also meet the existing P&T committee requirements of  422.136(b), provided that elements and requirements of all applicable regulations governing the committees and their functions (that is,  422.136, proposed 422.137, and 423.120) are met. To the extent that LCD policies and localized or regional professional standards of practice are used by the proposed UM committee in performing its duties, it may not be advisable to permit use of one UM committee to serve multiple functions for diverse service areas. We also solicited comment on whether to explicitly permit an MA organization, or the parent organization of one or more MA organizations, to use one UM committee to serve multiple MA plans,
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of one UM committee to serve multiple functions for diverse service areas. We also solicited comment on whether to explicitly permit an MA organization, or the parent organization of one or more MA organizations, to use one UM committee to serve multiple MA plans, including whether that should be limited to MA plans that are offered under the same contract. In summary, CMS proposed to require at  422.137 that all MA organizations that use utilization management policies, such as prior authorization, must establish an UM committee that is led by an MA plans medical director. Further, we proposed than an MA plan may not use any UM policies for basic or supplemental benefits on or after January 1, 2024, unless those policies and procedures have been reviewed and approved by the UM committee. We thank all commenters for their input on CMSs proposed new requirements. We received the following comments on this proposal, and our response follows: Comment: CMS solicited comment on whether MA organizations should be permitted to use one committee to serve multiple plans. Many commenters expressed support for making this allowance. Some commenters recommended that plans maintain the flexibility to define the structure and appropriate additional responsibilities of the UM committee. One commenter requested clarification as to the number of UM committees required, and whether committees are required per plan or per MA organization. One commenter stated that if an MA organization is permitted to use one committee for multiple MA plans, then the final rule should contain specific requirements related to UM committee membership composition and input from external stakeholders. Response: CMS appreciates the comments and input regarding this issue. We will allow MA organizations the discretion regarding whether the UM committee is best served at the organization or plan level, and we will not prescribe whether UM committees must be formed at the plan or organization level. This flexibility does not, however, extend to the parent organization of the MA organization (that is, an UM committee cannot serve multiple MAOs). Regardless of whether the MA organization decides to organize its UM committee at the plan or organization level, the MA organization must ensure that the committees review functions cover the needs of all plans under its organization. If at any time it appears that MA organizations are not fulfilling regulatory requirements regarding the UM committee, then we may engage in further rulemaking regarding whether the UM committee must operate at the organization or the plan level. As proposed,  422.137(a) requires the UM committee to be led by a plans
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regarding the UM committee, then we may engage in further rulemaking regarding whether the UM committee must operate at the organization or the plan level. As proposed,  422.137(a) requires the UM committee to be led by a plans medical director. In light of our decision to interpret and implement  422.137 by permitting one UM committee to serve multiple MA plans offered by the same MA organization, one plans medical director may fulfill this role for the MA organization. Comment: A majority of comments were supportive of requiring MA organizations to establish UM committees. Several commenters pointed out that some accrediting bodies require MA plans to maintain active committees that serve a similar function to the proposed UM committee, and that many plans are already accredited and therefore already have such standing committees. For that reason, some commenters suggested that CMS permit plans to adopt existing committees to fulfil the regulatory requirements of the UM committee. Some commenters also requested that CMS require MA plans to be accredited. One commenter questioned if it would it be permissible to incorporate an UM committee with a credential committee, since both are provider specific and include applicable attendees. CMS also solicited comment on whether plans should be permitted to use existing P&T Committee to serve as the UM committee. Commenters were generally supportive, but requested that MA plans retain discretion when deciding whether and how to adapt committees to serve multiple functions. Response: CMS thanks all commenters for providing input regarding the proposed regulations. We appreciate that many plans already have existing committees that are similar in composition and function to the proposed UM committee, including committees required by various accrediting bodies. While we do not believe requiring MA plans to be accredited is necessary or within the scope of this rule, we do believe it is appropriate to permit MA organizations to leverage existing committees to satisfy the new regulatory requirement. Therefore, MA organizations may adapt or alter existing committees, including committees required by accrediting bodies and existing P&T committees, to conform with the regulatory requirements of  422.137. We emphasize, however, that this flexibility does not change or lessen the composition requirements or duties of the UM committee; all of the requirements in  422.137 finalized in this rule must be met for the UM committee and if the MA organization is also using that committee to satisfy the requirements of  422.136 and 423.120 for a P&T committee, those requirements must be met as
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finalized in this rule must be met for the UM committee and if the MA organization is also using that committee to satisfy the requirements of  422.136 and 423.120 for a P&T committee, those requirements must be met as well. Comment: A few commenters requested that CMS delay the effective date to at least January 1, 2025, citing the administrative burden associated with forming and operationalizing a committee, as well as the requirement to review all UM policies and procedures. One commenter expressed concern that the requirement to review all policies by January 1, 2024, will result in good policies being discarded and cause confusion among providers and enrollees. The commenter suggested VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00095 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222214 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations that policies should remain active during the review period and be reviewed in accordance with the transparent processes. Some commenters requested CMS delay the implementation date to 2026 to better align with the requirements in the Interoperability rule (87 FR 76238). Response: CMS declines these suggestions. We are finalizing the proposal that beginning on and after January 1, 2024, MA plans may not use any policies that have not been reviewed or approved by the UM committee established for the plan. Any policy that has not been reviewed or approved by the deadline may not be used by the MA plan until it has been reviewed (and revised as necessary) and approved by the UM committee. Because plans are permitted to leverage existing committees, and some plans indicated they already had committees in place serving a similar function to what was proposed (for example, when required by an, accrediting organization and P&T committees established to review utilization management associated with covered drugs), we believe there is sufficient time for MA organizations and MA plans to form UM committees and review UM policies within the proposed timeframe. Further,  422.111(d) permits MA plans to change plan rules (including prior authorization and utilization management policies) during the plan year. To make mid-year changes, MA plans must provide a