2023-07115.pdf

by a previous plan. As a reminder, course of treatment and active course of treatment are defined at  422.112(b)(8)(ii). Comment: CMS solicited public comment on alternative timeframes for transition periods of ongoing treatment, including the clinical and economic justification for alternative proposals. Several commenters stated that a 30-day policy would provide a more reasonable timeframe to review a previously approved and ongoing plan of treatment, but longer periods could be permitted if medically necessary. One commenter requested that CMS modify the proposal at  422.112(b)(8)(i)(B) to require MA plans to provide continued coverage for an active course of treatment authorized by the members prior plan for the remainder of the authorized period or units of service. At least one plan provided feedback that they already have 90-day continuation of care policy in place, and other plans indicated they have similar policies for continuing approvals for ongoing treatments. A few commenters commented that the Part D transition period and the proposed transition period are not analogous. Commenters stated that the costs of Part D drugs are often lower than the costs for medical services, and that differing clinical opinions can lead to differing courses of treatment based on the resources available to the MA plan. Some commenters stated that a 90-day timeframe would be both financially and administratively burdensome to MA plans. Response: While some commenters indicated that a 90-day timeframe could be financially and administratively burdensome to some MA plans, CMS did not receive specific details to demonstrate that the burden to MA plans outweighs the value of ensuring VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00092 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222211 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations continuity of care for enrollees. Further, we believe that 90 days is an appropriate amount of time to minimize disruptions in treatment, and to allow plans and providers to ensure continuity and coordination of care. As outlined in the proposed rule, we believe a 90-day transition policy is beneficial because it mirrors Part D transition requirements and using the same period will ensure consistency across the MA and Part D programs. We understand that there are differences in the costs associated with Part D drugs and with certain medical procedures, however the Part D transition period mandates coverage, whereas  422.112(b)(8), as previously explained, only prohibits the application of prior authorization requirements for the pre- existing active course of treatment. Regarding the comments that different plans may offer differing courses of treatment, we do not find this a compelling reason to alter the transition time frame. Since this requirement only affects active courses of treatment, altering the course of treatment when the enrollee enrolls in a new MA plans is precisely the type of disruption this requirement aims to eliminate. Comment: One commenter requested that CMS clarify that the 90-day transition period applies only to basic benefits and not to supplemental benefits. Response: As proposed and finalized, the new rules at  422.112(b)(8)(i) apply to basic benefits only. Per this new regulation, MA coordinated care plans must have, as part of their arrangements with contracted providers, policies for using prior authorization for basic benefits that include the new restrictions on use of prior authorization for a course of treatment and an active course of treatment for a new enrollee. An MA organization may elect to extend this policy to supplemental benefits. We note that MA PFFS plans may not use prior authorization processes at all and that MA PPO plans may not use prior authorization processes for out of network services. Comment: One commenter requested that plans be permitted to conduct their own prior authorization or utilization management review for treatments extending beyond the 90-day transition period. The commenter stated that plans should also be permitted to support an enrollees transition to an in-network provider at the end of the transition period. Response: The 90-day period prohibits prior authorization on active courses of treatment, including when the service is furnished by an out-of- network provider. Once the 90 days has elapsed, the plan is permitted to impose prior authorization requirements on the service. After the 90-day transition period is complete (or the course of treatment has concluded, whichever comes first), the new plan may direct care through in-network providers and apply prior authorization. Comment: CMS solicited stakeholder input as to whether some MA plans are already providing continuity of care consistent with what CMS proposed at  422.112(b)(8), as well as any additional information that may be useful for CMS to quantify the burden associated with this proposal. Several stakeholders indicated that some MA plans provide some similar level of continuity care today. Commenters did not provide additional information regarding quantifying the burden associated with implementing the proposal. Response: CMS thanks the commenters for their feedback. Comment: Several commenters requested additional time to implement the 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, 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 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. 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 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),