2023-07115.pdf

organization may directly employ a provider in one of the listed specialties. In those instances, assuming the participants have sufficient access to the type of specialist that is employed by the PACE organization, the PACE organization would not be required to contract with additional providers in that specialty. However, the organization must have the specialist actively employed prior to enrollment of participants in order for the exception to be met and cannot rely on future employment to satisfy this requirement. We believe that by modifying this provision as proposed we would not increase the burden on PACE organizations as they are already required to either obtain and maintain contracts with or employ medical specialists. Comment: The majority of commenters supported the proposal to add the 25 specialty types back into regulation under  460.70(a)(1), but requested that CMS consider ways PACE organizations can meet the requirement to contract with the specialties listed. Methods suggested include contracting with telehealth providers and/or contracting for a specified duration of time with an out- of-network specialist to provide a limited service (or services) to a participant when that specialty provider is not immediately available in the PACE organizations network. Commenters specifically quoted  422.116(d)(5), which allows MA organizations 10 percentage point credits for telehealth when the plans contract with certain specified providers to meet network adequacy requirements. These commenters indicated that  422.116(d)(5) supports the spirit of allowing telehealth providers into contracted networks as a tool to provide benefits. Response: We thank commenters for their support for our proposal to add the list of 25 medical specialties for which PACE organizations must have written contracts in place prior to enrolling participants. PACE organizations are already permitted flexibility in providing required services with specialists via alternative methods. Nothing in current regulation prohibits PACE organizations from contracting with telehealth specialists, contracting with providers outside of the service area, or creating temporary contracts to meet participant needs. PACE is distinctive from Medicare Advantage because PACE covers more than the Medicare benefit under  460.92, which requires PACE to cover all Medicare- covered services, all Medicaid-covered services per the States approved Medicaid plan, and any other necessary services approved by the IDT. Additionally,  460.90(a) states that Medicare and Medicaid benefit limitations and conditions relating to amount, duration, scope of services, deductibles, copayments, coinsurance, or other cost-sharing do not apply. While we do not believe that telehealth services are prohibited in PACE, PACE organizations must ensure that all other regulatory requirements are met when providing services in that manner. For example, decisions to provide a service must be based on the participants current medical, physical, emotional, and social needs as required under  460.92(b)(1). When considering the participants condition, the IDT should also consider the service in question. The IDT may determine telehealth is appropriate for one participant in one situation, but not another participant based on the participants condition. For example, a dental visit would very rarely be appropriate for telehealth services; however, a behavioral health visit may be appropriate depending on the participants condition. Additionally, the PACE organization would have to ensure all other regulatory requirements are met, including contracting requirements for telehealth providers, and the PACE organization would not be able to utilize telehealth for services that are specifically required to be in- person per the regulations, such as routine assessments under  460.104. Additionally, if a PACE organization determines that a participant needs a service, and the PACE organization does not have a long-term contract in place, organizations may utilize flexibilities such as Letters of Agreement or Memoranda of Understanding with out- of-network providers, in order to ensure participants have access to the care and services they need. Comment: Numerous commenters requested that CMS add palliative medicine to the list of contracted services in response to our solicitation for comment. Several commenters also requested that CMS consider adding other specialties to the proposed list of 25 medical specialties, including physical medicine and rehabilitation, infectious disease, and neurology. Another commenter requested that the list of required medical specialties include other behavioral health specialties in addition to psychiatry, as well as all eight specialties for which we solicited comment, namely: endocrinology, hematology, immunology, neurology, colorectal surgery, palliative medicine, infectious disease, physical medicine and rehabilitation. Response: We agree with the addition of palliative medicine to the list of required specialties based on the needs of the population in PACE, and we are modifying the proposed regulation to include palliative medicine. We are not persuaded to require any of the additional proposed specialties at this time due to the often-limited availability of specialty providers, particularly in rural areas. However, as we stated in the proposed rule, the specialties included at  460.70 are not an exhaustive list of all medical specialties that the PACE organization may be required to provide access to (87 FR 79647). While we are not including endocrinology, hematology, immunology, neurology, colorectal surgery, infectious disease, physical medicine and rehabilitation, or additional behavioral health specialties in the required contracted services, nothing precludes the PACE organization from contracting with any specialty, nor does this provision eliminate or change the requirement for a PACE organization to have in place a written contract for a specialty service when the IDT has deemed the service necessary to meet the needs of participants. Ultimately, PACE organizations are required to provide VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00183 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222302 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations services that are necessary for participants, even if the PACE organization does not have a specific contract in place for that service. Additionally, in the proposed rule, we identified neurosurgery as one of the 25 required medical specialties; however, it was inadvertently left out of the proposed regulation text. We are therefore adding it back in to the regulation text at  460.70(a)(1)(x). Comment: Another commenter suggested that CMS define reasonable and timely attempts to contract and timely access to services. Response: As we stated in the proposed rule, we specifically chose not to include language defining reasonable and timely attempts to contract as what is reasonable would depend on the facts and circumstances of the case (87 FR 79647). It is not possible for CMS to anticipate every circumstance that may arise which may prevent or substantially impact a PACE organizations ability to contract with one of the required specialties. Our intent is to work with PACE organizations and review their efforts to contract with the required specialties, as well as their ability to provide medically necessary services to meet participant needs in the event the PACE organization is unable to contract with one of the required specialty services. The meaning of timely access to services also depends on the facts and circumstances of each case and the participants condition and assessed needs. The PACE organization will need to consider the nature of the participants condition and the urgency with which it must be treated when determining what constitutes timely access to services. Comment: A commenter did not support the proposed requirements for PACE organizations to have contracts in place for the listed 25 medical specialties because the commenter did not believe the proposal addressed the issue of ensuring timely access to services identified as necessary. The commenter noted that even enrollees of larger insurers with broad and diverse networks have struggled to obtain necessary specialist appointments in a timely manner. Response: While we acknowledge that not all cited instances of a PACE organization failing to provide medically necessary services in a timely manner were a direct result of not having contracts with specialists, the proposed requirement is meant to mitigate situations where not having an executed contract in place with specialists caused significant delay in participants accessing necessary services. For instance, we have seen on audit where PACE organizations did not have a contract with a specialty service prior to enrollment, and delays in obtaining services for participants were exacerbated because of a lack of a contract. We believe the failure to execute contracts until the need for the service arises substantially contributes to the delay in participants receiving medically necessary care. We also acknowledge that specialty provider availability continues to be a struggle across some health care settings. However, because of the time and effort required in negotiating contracts, we believe it is best practice to complete contract negotiations prior to participant enrollment to reduce additional delays in receiving services and that it is imperative for PACE organizations to maintain contracts on an ongoing basis to mitigate delays in participants receiving timely care. Comment: Several commenters expressed concern regarding CMSs reliance on 2021 audit data when determining to include the list of 25 medical specialties in the contracted services provision. These commenters noted that this audit data was collected during the COVID19 pandemic which impacted medical specialty services on a national level and, therefore, is not an accurate reflection of failures on the part of PACE organizations but evidence of a broader issue in health care nationally. Response: The discussion of the approximately 70 percent of organizations that were cited during the 2021 audit cycle for a failure to provide necessary services was meant to serve as the most recent example of concerning trends seen as part of our oversight and monitoring efforts where participants experienced delays in access to necessary care. It was not intended to be understood as the only data CMS reviewed when determining to engage in rulemaking and deciding which medical specialties to include in the required contracted services provision. We considered all oversight efforts, including audits, when drafting these provisions. We have seen through those oversight efforts that a lack of contracts with medical specialists have resulted in unnecessary delays in participants receiving medically necessary care. While we recognize the difficulties PACE organizations and other health care providers experienced during the COVID19 pandemic, the delays in access to medically necessary services caused by a lack of contracts with medical specialists were occurring prior to the pandemic. After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the changes at  460.70(a)(2), (3), and (4) as proposed. We are finalizing the changes at  460.70(a)(1) with two slight modifications: first, by adding neurosurgery, which was inadvertently left out of the proposed regulation text, and second, by adding palliative medicine to the list of required contracted services. D. Service Determination Request ( 460.121) Sections 1894(b)(2)(B) and 1934(b)(2)(B) of the Act specify that PACE organizations must have in effect written safeguards of the rights of enrolled participants, including procedures for grievances and appeals. Along with the regulations at  460.120 related to grievances, and  460.122 related to appeals, CMS created a process for service determination requests, the first stage of an appeal, at  460.121, including the extension requirements as specified in  460.121(i)(1). In the February 2020 proposed rule (85 FR 9002), CMS proposed to add a requirement at  460.121(i)(2) that required, in part, that the IDT notify the participant or the designated representative of a service determination request extension in writing. The proposed requirement was based on the MA organization determination requirements in  422.568, which require written notification when an extension is taken. In response to our proposal, PACE organizations and industry advocacy groups recommended we modify the proposal to allow either oral or written notification when the IDT extends the timeframe for a service determination request, rather than requiring written notification only. When CMS responded to these comments in the January 2021 final rule, we expressed that we were not persuaded to modify the requirement to allow PACE organizations to notify participants orally instead of in writing, because we believed written notification of the extension was important in order to ensure the participant received a full explanation (86 FR 6022), and as a result, we finalized our proposal to require that the IDT notify the participant or their designated representative in writing when the IDT extends the timeframe for a service determination request. As discussed in the December 2022 proposed rule preamble (87 FR 79670), since finalizing this requirement in the January 2021 final rule (86 FR 5864), CMS has received additional feedback from PACE organizations, particularly VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00184 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222303 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations regarding their experiences engaging and communicating with participants in different ways during the COVID19 pandemic. In light of that feedback and experience, CMS has determined that allowing the IDT to provide either oral or written notice of service determination request extensions should not adversely impact participants, as both oral and written communication can be an effective means of communication when providing notice of a service determination request extension. Therefore, we proposed to revise the requirement at  460.121(i)(2) to allow the IDT to provide notification either orally or in writing to the participant or their designated representative when the IDT extends the timeframe for a service determination request, as permitted under  460.121(i)(1) (87 FR 79670). Additionally, the proposed rule discussed that allowing the IDT to provide either oral or written notice of service determination request extensions increases operational flexibility for PACE organizations (87 FR 79670). As stated in the proposed rule (87 FR 79670), in order to ensure participants are fully informed of the reason(s) for an extension, CMS would expect oral notice of the service determination request extensions to meet the same requirements as written notice, including the expectations