2023-07115.pdf

enrollees when the plan network is not sufficient by both arranging or covering the out-of-network benefits and only charging in-network cost sharing for those out-of-network benefits. To reflect this important and well-established enrollee protection in the MA program, we proposed to amend  422.112(a)(1) and (a)(3) to more clearly state the scope of the MA organizations VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00057 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222176 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations obligation to ensure adequate access to medically necessary covered benefits. Currently, the regulation text at  422.112(a)(3) does not fully account for the scope of an MA organizations obligations when medically necessary benefits are only accessible out of network in two key ways. First, the regulation text refers to specialty care only, not all medically necessary covered benefits. This oversight does not align with the statutory requirement at section 1852(d)(1)(D) of the Act, which states broadly that the organization must provide access to appropriate providers, including credentialed specialists, and does not limit the requirement to specialists only. Second, the aspect of maintaining in- network cost sharing when the MA organization arranges for the benefit outside of the network is not clearly stated in  422.112(a)(3). Therefore, CMS proposed to amend  422.112 to be consistent with current, longstanding sub-regulatory policy and our implementation of section 1852(d) of the Act. CMS proposed to codify this policy by revising  422.112(a)(3) and adding new regulatory text to  422.112(a)(1) to reflect the longstanding policy. Specifically, we proposed to move the sentence requiring the MA organization to arrange for out-of-network care currently in paragraph (a)(3) to a new paragraph (a)(1)(iii) and revise and supplement it with additional text to better state the full scope of the current policy. We proposed that new paragraph (a)(1)(iii) would require MA organizations offering coordinated care plans to arrange for any medically necessary covered benefit outside of the plan provider network, but at in- network cost sharing, when an in- network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. CMS currently monitors MA organization compliance with this existing policy through account management activities, complaint tracking and reporting, and auditing activities. These oversight operations alert CMS to any issues with access to care, and CMS may require MA organizations to address these matters if they arise. We stated in the proposed rule that, if finalized, CMS intends to continue these oversight operations to ensure MA organizations compliance with the proposed regulation. This proposal to amend  422.112 codifies the agencys existing interpretation of applicable law and longstanding guidance. CMS has not been made aware of any issues of MA organization non-compliance with this policy and, as such, believes that MA organizations have been complying with this longstanding guidance. Therefore, we stated in the proposed rule that the proposed amendment to  422.112(a)(1) and (a)(3) would not impose new information collection requirements (that is, reporting, recordkeeping, or third-party disclosure requirements), and we did not provide burden estimates in the Collection of Information section of the proposed rule. In addition, this provision is not expected to have any economic impact on the Medicare Trust Fund. We solicited comment on this proposal, including on the accuracy of our assumptions regarding information collection requirements and regulatory impact. We did not receive comment on our information collection requirements nor regulatory impact. We thank commenters for their input on CMSs proposed amendment to  422.112. We received the following comments on this proposal, and our response follows: Comment: The majority of comments were supportive of this proposal. Commenters agreed with codifying at  422.112(a)(1)(iii) CMSs existing interpretation of the statute and longstanding guidance that MA organizations offering coordinated care plans must arrange for any medically necessary covered benefit outside of the plan provider network, but at in- network cost sharing, when an in- network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. They believed that MA organizations are obligated to ensure adequate access to medically necessary covered benefits by maintaining a strong network, and when it fails, the enrollee should be entitled to in-network cost sharing. Response: We thank commenters for their support, and we agree that this codification at  422.112(a)(1)(iii) is a necessary and important enrollee protection. Comment: Some comments requested that CMS develop more guidance surrounding this policy. For example, a commenter suggested that CMS apply a definition of unavailable that accounts for the specific patient, their medical condition, and the urgency of their medical need. Another commenter believed CMS should specify what arranges for means and also define what constitutes necessary specialty care, suggesting that this is a determination that should be made by an enrollee and their provider, not the MA organization. This commenter also recommended that CMS clarify that an enrollee can maintain continuity of care and complete their treatment plan with an out-of-network provider who has specialized expertise that cannot be found in-network, once it has been determined that such care is medically necessary. Other commenters requested that CMS further clarify that it is the MA organizations responsibility to ensure medically necessary care is provided in a timely manner, even when care must be accessed out of network. A commenter believed CMS could further enhance enrollee protections and access to care by establishing timelines such as a requirement to ensure services are available within one business day of an approved authorization. Another commenter sought specific CMS guidance regarding the MA organizations obligation around arranging timely out-of-network care for cancer diagnoses. Response: Regarding the definition of unavailable, we clarify here that an in-network provider or benefit being unavailable means that there is no provider or benefit in the current plan provider network to meet the enrollees medical needs, as we noted in the proposed rule. In other words, the MA plans network is inadequate or otherwise does not address the medically necessary benefit required by an enrollee. For instance, if an enrollee requires the services of a particular specialty or subspecialty that is not in the plan network, then we would view this as fitting the description of unavailable. We believe that this is inclusive of the specific patient, their medical condition, and the urgency of their medical need, and thus MA organizations must take these factors into consideration when determining unavailability and complying with this requirement. The term arranges for means that the MA organization may need to enter into case-by-case agreements with non- contracted, out-of-network providers to ensure enrollees access to services. In the example previously discussed, if an enrollee needs to see a particular out-of- network specialist or subspecialist, the MA organization may need to enter into a limited contract with the closest available qualified specialist to ensure its enrollee has access to the medically necessary specialist services. (We note that except for emergency services, non- contracted providers are generally not legally required to treat MA enrollees.) Or the MA organization may authorize and cover services furnished by a non- contracted provider selected by the enrollee without the MA organization engaging in a short-term agreement with the provider. Regarding what constitutes necessary specialty care, the MA organization must make medical VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00058 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222177 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations necessity determinations as discussed in section III.E.2. of this final rule. In addition, we agree with the commenter that an enrollee should be able to maintain continuity of care and complete their treatment plan with an out-of-network provider who has specialized expertise that cannot be found in-network, once it has been determined that such care is medically necessary. We believe that this policy is embodied in current regulatory guidance in  422.206(a)(1), which prohibits or otherwise restricts MA organizations from interfering with a health care professional, acting within the lawful scope of practice, from advising, or advocating on behalf of, an individual who is a patient and enrolled under an MA plan. We understand commenters concerns around timeliness of access to care. Per current CMS regulations at  422.112(a)(6)(i), MA organizations must establish written access standards for timeliness of access to care that meet or exceed standards established by CMS, timely access to care within a plans provider network must be continuously monitored to ensure compliance with these standards, and the MA organization must take corrective action as necessary. CMS does not (and will not under the revisions to  422.112(a)(6)(i) adopted elsewhere in this final rule) apply the same wait time standards for out-of- network care because MA organizations do not have contracts with out-of- network providers to require timely access to care; we appreciate that MA organizations have no contractual mechanism to hold out-of-network providers accountable and ensure out- of-network care is provided timely to their enrollees. While these requirements for timeliness of access to care apply to in-network care only, per  422.568, MA organizations must notify the enrollee of its determination to in or out-of-network care as expeditiously as the enrollees health condition requires, but no later than 14 calendar days after the MA organization receives the request for a standard request, and no later than 72 hours for an expedited request, with the exception that the MA organization may extend the timeframe by up to 14 calendar days if the extension is justified and in the enrollees interest. If an MA organization chose to enter into a case- by-case agreement or limited contract with a non-contracted provider, as described in the preceding paragraph, then they may be able to include a clause about timely access to care in their agreement or contract with an expedited review time no greater than the requirement established in  422.568(b)(1)(i)(B), but CMS does not require this. In general, while MA organizations may not have the same level of control when it comes to care provided outside of their plan provider network, we still expect MA organizations to make their best effort to ensure that the out-of- network care they arrange for is provided timely, including for cancer diagnoses. The manner in which they do so is at the MA organizations discretion, however, enrollees best interests should always be prioritized. We note that the inability to offer in- network care may be evidence that an MA organization is failing to meet CMSs required network adequacy standards. Arranging for care outside of the network, while a responsibility of MA organizations, should not be the norm. Any out-of-network alternative arrangements should only be made in the rare circumstance that an in-network provider or benefit is unavailable or inadequate to meet an enrollees medical needs. We also note that MA organizations are required to arrange for medically necessary covered out-of- network care at in-network cost sharing if in-network care is unavailable or inadequate to meet the enrollees medical needs, despite the type of care (cancer or otherwise). We are finalizing  422.112(a)(1)(iii) as proposed and not adding any definitions to the regulatory text, however, we hope our response provides some helpful clarification and guidance to commenters on how we interpret and will implement these changes. Comment: Other comments discussed the benefits of this requirement for ensuring adequate access to medically necessary covered care particularly for more vulnerable enrollees with cancer, enrollees with rare conditions, and dually eligible enrollees. Commenters stressed that these types of enrollees often face higher cost sharing (especially out-of-network), higher out-of-pocket expenses, risk of exhaustion of savings or personal bankruptcy, challenges in accessing the care they need in a timely manner and in their geographic area, and, for individuals with rare conditions, pools of experienced providers that are relatively small. Further, they expressed that some of these implications have a disproportionate effect on those with lower incomes, for example, dually eligible enrollees. As such, commenters believed that enrollees should not be penalized when an MA network is not adequate to provide necessary and life- saving care and treatment. Response: We agree that this requirement, which seeks to guarantee access when in-network providers or services are unavailable or inadequate to meet an enrollees medical needs, is particularly beneficial for protecting more vulnerable enrollees, such as those with cancer or rare conditions, and dually eligible enrollees. We thank the commenters for expressing these sentiments and for their support. Comment: A few commenters recommended that, in addition to CMSs existing oversight processes, CMS establish a provider complaint mechanism that would allow providers to report MA organization behavior that potentially violates these requirements. They stated that providers are likely to recognize patterns of enrollees inability to access care through network providers, inappropriate delays in care, and denials from MA organizations, and could therefore raise concerns that could guide heightened enforcement of this requirement. A commenter specifically suggested CMS track MA enrollees appeals of requests for obtaining out-of-network services in order to better identify MA organizations that are not following this rule. Response: We operationally support the ability of providers to submit complaints to CMS regarding MA organization behavior that potentially violates these requirements. Contracted providers are instructed to resolve their complaints directly with the MA organizations since the contract is between the MA organization and the provider. In addition, the definition of organization determination in  422.566(b) includes both an MA organizations refusal to provide or pay for