2023-07115.pdf

or prior authorization, is necessary. We believe it is important to implement these rules as soon as possible. After careful consideration of all comments received, and for the reasons set forth in the final rule and in our responses to the related comments in sections III.E.3 of this final rule, we are adopting the new regulation at  422.138 substantially as proposed with minor modifications to clarify the text. Specifically, we are including that prior authorization processes include all policies and procedures used in prior authorization unless otherwise noted. 4. Continuity of Care In addition to the requirements of section 1852(d) of the Act,  422.112(b) requires MA organizations that offer coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers. Requirements in  422.112(b)(1) through (b)(7) detail specific arrangements with contracted providers by which MA coordinated care plans are to ensure effective continuity and integration of health care services for their enrollees. This includes requiring MA coordinated care plans to have policies and procedures that provide enrollees with an ongoing source of primary care, programs for coordination of plan services with community and social services, and procedures to ensure that the MA coordinated care plan and its provider network have the information required for effective and continuous patient care and quality review. a. Stakeholder Feedback Stakeholders have communicated to CMS that MA coordinated care plans prior authorization processes sometimes require enrollees to interrupt ongoing treatment. We also have received feedback that MA plans require repetitive prior approvals for needed services for enrollees that have a previously-approved plan of care or are receiving ongoing treatments for a chronic condition. When MA plans require repetitive prior approvals, enrollees may face delays in receiving medically necessary care or experience gaps in care delivery that threaten an enrollees health. b. Proposed Regulatory Changes We believe the inclusion of additional continuity of care requirements at  422.112 will help ensure coordinated care plans comply with and implement the statutory requirement (in section 1852 of the Act) that MA plans provide access to all medically necessary Traditional Medicare (that is, Part A and Part B) benefits that MA plans must cover. We proposed to add a new paragraph (b)(8)(i) and (ii) at  422.112 to establish two new requirements for the use of prior authorization by MA coordinated care plans for covered Part A and B services (that is, basic benefits as defined in  422.100(c)). Section 422.112(b) requires MA organizations offering coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers that include the types of policies, procedures and systems that are specified in current paragraphs (b)(1) through (b)(7). First, we proposed at  422.112(8)(i) that MA coordinated care plans must have, as part of their arrangements with contracted providers, policies that when enrollees are undergoing an active course of treatment, approved prior authorizations must be valid for the duration of the entire approved course of treatment or service. Under our proposal, if an MA coordinated care plan has approved a prescribed or ordered course of treatment or service for which the duration is 90 days, then the MA coordinated care plans prior authorization approval must apply to VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00087 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222206 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations the full 90 days, and the MA coordinated care plan may not subject this treatment or service to additional prior authorization requirements prior to the completion of the approved 90- day treatment or service. We also explained that if the MA coordinated care plan approves a prescribed or ordered course of treatment for a series of five sessions with a physical therapist, the MA coordinated care plan may not subject this active course of treatment or service to additional prior authorization requirements. We solicited comment on whether the prior authorization should be required to be valid for the duration of the prescribed order or ordered course of treatment provided that the criteria in proposed  422.101(b) and (c) are met. Second, at  422.112(b)(8)(ii)(A), we proposed to define course of treatment as a prescribed order or ordered course of treatment for a specific individual with a specific condition, as outlined and decided upon ahead of time, with the patient and provider and clarified that a course of treatment may, but is not required to be part of a treatment plan. We also proposed to define an active course of treatment at  422.112(b)(8)(ii)(B) as a course of treatment in which a patient is actively seeing a provider and following the prescribed or ordered course of treatment as outlined by the provider for a particular medical condition. Additionally, we proposed at  422.112(b)(8)(i)(B) that MA organizations offering coordinated care plans must have, as part of their arrangements with contracted providers, policies for using prior authorization that provide for a minimum 90-day transition period for any ongoing course(s) of treatment when an enrollee has enrolled in an MA coordinated care plan after starting a course of treatment, even if the course of treatment was for a service that commenced with an out- of-network provider. We explained that this includes enrollees who are new to an MA coordinated care plan having either been enrolled in a different MA plan with the same or different parent organization, or an enrollee in Traditional Medicare and joining an MA coordinated care plan, and beneficiaries new to Medicare and enrolling in an MA coordinated care plan. We explained that under our proposal, during the initial 90 days of an enrollees enrollment with an MA coordinated care plan, the MA coordinated care plan would not be permitted to subject any active course of treatment (as defined at the proposed  422.112(b)(8)(ii)(B)) to additional prior authorization requirements, even if the service is furnished by an out-of- network provider. We explained how we expect any active course of treatment to be documented in the enrollees medical records so that the enrollee, provider, and an MA plan can track an active course of treatment to avoid disputes over the scope of this proposed new requirement. We also explained that we intended that an active course of treatment covered by the proposal could include scheduled procedures regardless of whether there are specific visits or activities leading up to the procedure. We explained that under the proposal, if an enrollee has a procedure or surgery planned for January 31st at the time of enrollment in a new MA coordinated care plan effective January 1st, the new MA coordinated care plan would be required to cover the procedure without subjecting the procedure to prior authorization because it is within the 90-day timeframe. In this example, the planned surgery is a part of an active course of treatment and thus would not be subjected to prior authorization by the MA coordinated care plan in which the beneficiary has newly enrolled under the proposed new  422.112(b)(8)(B). In proposing to limit the way MA coordinated care plans use prior authorization for enrollees undergoing an active course of treatment, CMS seeks to ensure the availability and accessibility of basic benefits, which is consistent with section 1852 of the Act. CMS proposed to use a 90-day transition policy here because it mirrors Part D transition requirements and using the same period will ensure consistency across the MA and Part D programs. In addition, use of one consistent transition period will likely make it easier for new enrollees to understand their transition coverage. We solicited public comment on alternative timeframes for transition periods of ongoing treatment, including the clinical and economic justification for alternative proposals. We outlined in the proposed rule CMSs authority to adopt the proposed new requirements for MA coordinated care plans. In addition, we noted and briefly explained how CMS implemented a similar policy regarding coverage during a transition period using CMSs authority to negotiate bids and with a similar explanation in the 2005 final rule (70 FR 4193); CMS has similar negotiation authority in the MA program. As explained in the December 2022 proposed rule, we believe it is appropriate to incorporate a similar beneficiary protection and coverage requirement in the MA program to address the transition for new enrollees. Coordinated care plans are already required to ensure continuity of care and integration of services through arrangements with contracted providers at 422.112(b). Therefore, some MA organizations may already be exercising discretion to eliminate or waive prior authorization for enrollees undergoing an active course of treatment. However, prior to our proposed rule, CMS received anecdotal feedback from stakeholders that care transitions can be difficult for enrollees due to MA plan processes that require new coverage decisions when an enrollee transitions from one MA plan to another. We are not aware of the extent to which current MA plans are already ensuring continuity of care in the way our proposals would require, nor do we have a strong basis upon which to quantify how often this type of transition occurs. Therefore, we solicited stakeholder input on both of these assumptions: that some MA plans are providing continuity of care, as defined in the proposed  422.112(b)(8) today and the lack of available data by which to quantify it. In summary, CMS proposed to add new continuity of care requirements to  422.112(b)(8), to require that approval of a prior authorization be valid for the entire duration of the approved course of treatment, and that plans provide a minimum 90-day transition period when an enrollee who is currently undergoing an active course of treatment switches to a new MA plan. We thank commenters for their input on CMSs proposed new MA continuity of care requirements. We received the following comments on this proposal, and our response follows: Comment: A majority of commenters expressed support for the proposal to require that any plan approval of a prior authorization request from a provider on behalf of an enrollee, or from an enrollee directly, for a course of treatment be valid for the entire duration of the approved course of treatment. Supporters cited that MA plans often approve treatments in increments that may not be clinically supported or medically appropriate, which can be disruptive to care. Other commenters requested clarification as to whether a plan is required to approve the exact course of treatment included in the original coverage request, or whether an MA plan may approve a course of treatment that differs from what was ordered or prescribed by the provider. Several commenters requested that CMS give deference to providers VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00088 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222207 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations when establishing a course of treatment. Several other commenters expressed concern that requiring a prior authorization be valid for an entire duration of the approved course of treatment is overly broad, and could lead to the continuation of treatments that are no longer medically necessary. Several commenters stated that the requirement conflicts with MA plans obligations to ensure access to medically necessary care, and impedes MA plans ability to manage care through strategies that ensure quality and control unnecessary cost. Some commenters suggested that there are situations where a prior authorization and plan of care should be revisited, and the course of treatment be revised, if the patient is not responding as expected. Some commenters suggested that CMS allow limitations on the duration of approvals to ensure there are opportunities to reassess medical necessity at reasonable intervals. One commenter suggested that CMS modify the proposal to allow limits on the duration of the prior authorization that are consistent with guideline- suggested reassessment of disease, in cases where treatments may be indefinite (for example, in cases of chronic illnesses). Another commenter suggested that the definition of active course of treatment should be aligned with industry standards, specifically: (1) a course of treatment for a serious and complex condition, which includes a condition that is serious enough to require specialized medical treatment to avoid the reasonable possibility of death or permanent harm, or a condition that is life threatening, potentially disabling, degenerative, or congenital, and requires specialized medical care over a prolonged period of time; (2) course of institutional or inpatient care; (3) scheduled nonelective surgery, including related postoperative care; (4) a course of treatment for a pregnancy; and (5) treatment for a terminal illness. Several commenters requested clarification as to whether there are a minimum number of days that constitute a course of treatment. Another commenter requested that CMS explicitly define course of treatment in reference to Traditional Medicare coverage and benefits benchmarks (for example, the mean Length of Stay for a given Medicare Severity Diagnosis Related Group). Finally, one commenter requested additional examples of what is and is not permissible to ensure treatments that are not medically necessary under Traditional Medicare guidelines are not required to be covered under this policy. Response: CMS would like to thank all commenters for providing feedback on the proposed regulation. We understand the concerns that the proposal could result in the continuation of medically unnecessary care, which in turn could result in waste and increased costs. However, as highlighted in the preamble, over the past several years, we have received feedback from many stakeholders, including enrollees and providers, that MA plans often require repetitive prior approvals for needed services, even when enrollees have a previously- approved course of treatment, plan of care, or are receiving ongoing treatments for a chronic condition. The feedback we have received consistently outlines how this practice delays medically necessary care and can cause gaps in care delivery that threaten an enrollees health, sometimes leading to negative outcomes. For that reason, we believe this proposal is essential to minimize such delays and disruptions to care for MA enrollees. We agree that clarification of the policy being finalized will help ensure the new regulation is implemented appropriately. Therefore, we are finalizing the revisions at