2023-07115.pdf

with RULES222209 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations described in the matter following clause (v) of section 1886(d)(1)(B) of the Act, or a long-term care hospital (described in section 1886(d)(1)(B)(iv)) that begin before, and carry over to, the effective date of enrollment in a new MA plan. Under section 1853(g) and  422.318, when MA plan coverage begins during an inpatient stay, the previous MA plan or Traditional Medicare if the enrollee is joining an MA plan from Traditional Medicare is responsible for payment. CMS reminds commenters that all other relevant Traditional Medicare regulations must also be followed, including those regarding inpatient admissions and terminations. Comment: One commenter requested that, in addition to ensuring that prior authorizations remain active for a patients entire course of treatment, CMS adopt language to ensure that surgical or other procedures/services performed incident to a procedure that has received prior approval may not be denied for failure to obtain prior approval. Response: We thank the commenter for the suggestion, but decline to explicitly prohibit an MA plans from denying coverage of a service provided incident to a course of treatment but not expressly included in the approved course of treatment, because of a failure to obtain prior approval. In the case where a service is provided incident to a procedure, it may be appropriate for the MA plan to conduct a concurrent or retrospective review to determine medical necessity of the incidental procedure. Our proposal was about prior authorization, and we are not adding requirements or limitations on concurrent or retrospective reviews in the final rule. Comment: A majority of commenters expressed support for requiring a 90-day transition period when an enrollee is new to an MA plan. Other commenters expressed concern that this transition period restricts plans ability to conduct concurrent reviews, which are necessary for quality control and to prevent waste, fraud, and abuse. Some commenters were concerned that the proposal could potentially require an MA plan to be held responsible for the long-term cost of care provided by an out-of-network provider, or for a treatment that may not meet the standards of their internal coverage criteria, where such criteria are consistent with CMS policies, but utilization management policies may vary. A few commenters stated that the goal of this proposal is already achieved through existing plan specific practices where prior authorization approvals are continued, allowing a provider to demonstrate to the new MA plan that the prior approval already took place and was granted by the previous plan. Several commenters suggested that the transition requirement will put patients at risk of receiving care that is no longer medically necessary. Other commenters expressed concern that requiring a blanket transition period on all services creates a significant burden to MA plans from a technical and procedural perspective, as well as from a claims adjudication perspective. Other commenters requested additional guidance regarding how CMS expects MA plans to implement this requirement. One commenter requested clarification on whether the continuity of care provisions proposed in this rule are satisfied by a plan approving continuation of services or treatment for 90 days to ensure continuity of care if a new member is receiving care from a non-contracted provider when their enrollment in the plan becomes effective, while working with the enrollee to find in-network providers as needed. Finally, a few commenters expressed concern that the transition period may be used as a tactic to delay care by either the plan or by providers aiming to receive a different reimbursement ratethat is, postpone care until the new plan takes over and is, therefore, responsible for paying for services. Response: As outlined in the preamble and proposed regulatory text, the 90-day transition period only applies to active courses of treatment when an enrollee has enrolled in the MA plan after starting a course of treatment. See also our discussion in the proposed rule at 87 FR 79504 through 79505 about active courses of treatment. As proposed and finalized at  422.112(b)(8)(ii)(B), an active course of treatment is one in which a patient is actively seeing the provider and following the course of treatment. This does not mean that the active course of treatment must last for the full 90-days, rather this means that the new plan may not subject an active course of treatment to an additional prior authorization for a period of 90 days, beginning the day enrollment in the new plan becomes effective. Because this new requirement is tied to an active course of treatment that began before enrollment in the new MA plan, the transition period applies for the shorter of the 90-day period (though MA plans have the discretion to extend this period) or the end of the active course of treatment. For example, if an enrollee is undergoing an active course of treatment that is 60 days in duration, and the enrollee transfers to a new MA plan 30 days into that course of treatment, then the MA plan may not subject that course of treatment to a prior authorization requirement for the next 30 days. After that time, the course of treatment is complete and any future treatments may be subject to prior authorization as appropriate. This does not mean that an MA plan may not apply prior authorization to any services in the first 90-days of enrollment, but only that active courses of treatment may not be subjected to prior authorization within a 90-day timeframe. We expect that MA plans would use this period to coordinate with the treating provider, or find (or help the enrollee find) a new provider as needed, to satisfy any utilization management policies that may apply at the completion of the 90 days to ensure that there is not a disruption in treatment for the patient. Further,  422.112(b)(8)(i)(B), as proposed and finalized, does not prohibit concurrent or retrospective review of an active course of treatment. A plan may conduct concurrent reviews as necessary, as long the review does not interfere with an active course of treatment. The MA plan cannot deny coverage of such active courses of treatment on the basis that the active course of treatment did not receive prior authorization (or was furnished by an out-of-network provider) but may review the services furnished during that active course of treatment against permissible coverage criteria when determining payment. In response to the comments that the proposal is redundant due to many MA plans already utilizing internal practices for continuing prior authorization approvals, or allowing for a continuation of services, CMS continues to believe that codification and standardization are necessary. While some plans may have internal processes in place to allow for a continuation of services, we are not aware that these practices have been universally adopted and consistently applied by all plans. If plans are already allowing for these types of transitions, then existing practices may already comply with what is proposed. Finally, since the provision only applies to active courses of treatment, CMS does not foresee the possibility that medically necessary services could or would be delayed solely for the purpose of requiring another plan to pay for that service. If treatment is medically necessary at the time it is ordered, it would be highly inappropriate for that treatment to be delayed solely for the purposes of shifting payment responsibility. While, as stated in the preamble, we have interpreted active VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00091 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222210 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations course of treatment to include scheduled procedures, regardless of whether there are specific visits or activities leading up to the procedure, it would seem unrealistic for a plan or a provider to know in advance that an enrollee is anticipating leaving an MA organization to join another plan, anticipate the enrollees departure, and decide to delay a course of treatment so as to pass those costs onto the new plan. Such an action would be a violation of our rules to provide all necessary and appropriate care to enrollees. Further, the new rule requires that the course of treatment must be active at the time the patients enrollment in the new MA plans becomes effective, so the 90-day transition period would not be implicated if care had not begun at the time of enrollment. Comment: Several commenters requested clarification as to whether after 90 days a plan may apply out-of- network limits, conduct a new review, and issue a new decision. Some commenters stated that plans should be required to extend coverage, on a case- by-case basis, for patients receiving care after the 90-day period expires and should not impose additional prior authorization requirements (for example. in cases of life sustaining care). Several commenters requested that CMS require plans to notify new enrollees about the transition period, and any changes in benefits. Response: As outlined in the preamble and the proposed regulation, the minimum 90-day transition period prohibits an MA plan from disrupting or requiring reauthorization for an active course of treatment for new plan enrollees for a period of at least 90 days. The transition period is intended to provide enrollees with an assurance of continued care when changing plans, and to minimize disruptions when moving to a new plan that may have differing benefits. After the transition period, a plan may reassess medical necessity and apply out-of-network limits in accordance with plan benefits and other relevant requirements as appropriate. We clarify that  422.112(b)(8)(i)(B) does not mandate that the new MA plan cover the active course of treatment regardless of other applicable coverage rules (for example,  422.101(b) or plan coverage policies for supplemental benefits). The MA plan cannot deny coverage of such active courses of treatment on the basis that the active course of treatment did not receive prior authorization or was furnished by an out-of-network provider, but may apply permissible coverage criteria. At this time, CMS is not adding a requirement for notification to enrollees because pursuant to  422.111(b)(7), MA organizations are required to disclose information to enrollees regarding prior authorization and review rules. This includes the continuity of care provisions outlined in this proposal. CMS urges plans and their contracted providers to work with these transitioning enrollees and their previous treating providers, even if those previous treating providers are not contracted with the receiving plan, during the transition period to ensure that care is continued in the least disruptive manner possible. CMS also notes that the 90-day transition period is a minimum requirement. Therefore, if an active course of treatment is approved by the previous treating provider or plan to last longer than the 90-day minimum, an MA plan that is newly covering the enrollee may elect to permit the enrollee to finish the course of treatment, which lasts beyond 90 days, before imposing additional prior authorization(s). CMS will consider adding an additional notice requirement during future policymaking. Comment: One commenter requested CMS require plans to notify enrollees that they should check whether an enrollees ongoing prescriptions would be covered with the same level of cost- sharing after the initial 90 days of enrollment and, if so, whether any utilization management protocols will apply to these medications. Response: As outlined in the previous comment response, CMS is not requiring any additional notification requirements at this time. If an on-going Part B prescription is an active course of treatment under the definition at  422.112(b)(8), then the MA plan may not subject the treatment to additional prior authorization for the first 90 days of enrollment. After the 90-days, prior authorization may be applied in accordance with the prior authorization provisions in this rule. Cost-sharing levels will be based on the specific plan, and are not within the scope of this rule. Comment: One commenter requested that the 90-day transition period apply when an enrollee who is currently undergoing treatment switches to a new MA plan, switches from a traditional Medicare plan to an MA plan, or is new to Medicare. Another commenter requested clarification on whether MA plans must provide the proposed transition period for any ongoing course of treatment that had been covered under a traditional Medicare coverage policy, regardless of whether there was a prior authorization requirement for that course of treatment in traditional Medicare. Response: As stated in the regulatory text at  422.112(b)(8)(i)(B), the transition requirement applies to . . . enrollees new to a plan and enrollees new to Medicare . . . who are currently undergoing an active course of treatment. This means the requirement applies for any active course of treatment when an enrollee switches to a new MA plan, switches from a traditional Medicare plan to an MA plan, or is new to Medicare. Further, the plan must provide the transition period, wherein an active course of treatment may not be subjected to prior authorization, for all new enrollees who are undergoing an active course of treatment, regardless of whether the treatment was subject to a prior authorization 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