evekhm/cms_iom_500 huggingface dataset:
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be required to provide access to. For example, if the IDT determines that a participant needs to see a hematologist, the PACE organization would be required to provide access to that specialist in a timely manner. The specialties we proposed to add in  460.70(a)(1) would represent a minimum requirement for all PACE organizations; each PACE organization should consider the needs of its participants to determine what additional medical specialists may be necessary for its network to be sufficient. While we proposed to add back into regulation the 25 medical specialty services identified in the original PACE protocol, we solicited comment on whether CMS should include the following additional specialty services in the list of minimum required services: endocrinology, hematology, immunology, neurology, colorectal surgery, palliative medicine, infectious disease, physical medicine and rehabilitation. Additionally, we solicited comment on whether the proposed list of medical specialties should include any types of behavioral health specialties in addition to psychiatry such as psychologists or licensed clinical social workers. When submitting comments on this proposal, we requested that commenters indicate whether they have any concerns with CMS adding any or all of the previously discussed specialty services to the list, and that commenters describe any such concerns with specificity to help us understand the nature and basis of those concerns. We believe a PACE organization must be able to provide access to all of these specialty services when a participant needs them and, based on our oversight experience, that additional specialty services are often necessary for the PACE population. We proposed at new  460.70(a)(2) to require a PACE organization to execute contracts with specialists prior to enrollment of participants, and to require the PACE organization to maintain such contracts on an ongoing basis to ensure participants receive appropriate and timely access to all necessary care and services. We clarified that we are not requiring PACE organizations to contract with individual specialists in situations where the PACE organization has contracted with a provider or practice that offers multiple specialties. In an instance of a medical provider or practice offering multiple specialties, the contract between the practice or provider, such as a hospital group, and the PACE organization would meet the requirement to have contracts in place for whatever specialties are included under the contract between the practice or provider group and the PACE organization. In the event a hospital group only contracts with a PACE organization to provide some of the specialty services it offers within its practice, the PACE organization would be expected to
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specialties are included under the contract between the practice or provider group and the PACE organization. In the event a hospital group only contracts with a PACE organization to provide some of the specialty services it offers within its practice, the PACE organization would be expected to contract separately for any services not covered under the contract. We believe it is appropriate for PACE organizations to be able to demonstrate that they have contracts in place that provide participants with sufficient and direct access to these commonly needed specialists prior to participants enrolling in the organization, and that PACE organizations maintain sufficient and direct access to these commonly needed specialists for enrolled participants on an ongoing basis. Through our auditing and oversight efforts, we have seen lengthy delays in specialist referrals when an organization has to contract with a new specialist, and waiting until a participant enrolls or has need of the specialist may create unreasonable delays in the participant being able to access that specialist. Additionally, as we noted in the 2006 PACE final rule (71 FR 71296), PACE organizations are financially responsible for all of their participants health care needs, and delays in referrals for specialist services may have a significant impact on the PACE organizations financial viability. Failure to provide timely specialist referrals may lead to more expensive care, including the need for institutionalization, which can drive up operating costs for a PACE organization. We proposed to establish at  460.70(a)(3) that a PACE organization must make reasonable and timely attempts to contract with medical specialists. PACE organizations are responsible for ensuring that participants have reasonable and timely access to medical specialty services, and that PACE organizations are responsible for taking appropriate steps in ensuring that they have suitable contracts in place in order to facilitate timely access to medical specialty services. We did not propose to establish specific criteria for determining whether reasonable attempts have been made for purposes of proposed  460.70(a)(3), as what is reasonable would depend on the facts and circumstances of the case. For example, in an area with multiple providers in a specific medical specialty, it would not be reasonable to only attempt to contract with a single provider, if that provider indicated they were unwilling to contract with the PACE organization. We further proposed to establish at  460.70(a)(3)(i) that if at any time a PACE organization is unable to directly contract with a specific entity to provide specialist services to participants, the PACE organization must still ensure ongoing access to necessary care and services
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 460.70(a)(3)(i) that if at any time a PACE organization is unable to directly contract with a specific entity to provide specialist services to participants, the PACE organization must still ensure ongoing access to necessary care and services that would otherwise be provided to participants by a contracted specialist, and that the participants needs are met, through a different mechanism which may include hospitalization. As noted in the 2006 PACE final rule (71 FR 71296), we understand that in certain circumstances executing multiple contracts for a specific specialty may be difficult due, in part, to a limited number of specialists in certain geographic areas; however, we stress that PACE organizations continue to be responsible for meeting all of the participants needs, even if there is not a direct contract in place. Additionally, under our proposal at  460.70(a)(3)(ii) we expect an organization to promptly report any contracting problems to CMS and the SAA, and include information on what attempts were made, the reason why a contract was not effectuated, and the PACE organizations plan to provide access to the necessary services. This reporting may be initiated by the PACE organization when reasonable attempts to contract have been made, and were unsuccessful; or it may be done in response to CMS or the SAA inquiring as to the status of the contracts. For example, during the State readiness review, the SAA may inquire as to the status of the PACE organizations contracts with medical specialists. When reporting these contracting issues to CMS or the SAA, the PACE organization should be prepared to VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00182 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222301 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations describe its attempt(s) to contract with medical specialists, why a contract was not able to be effectuated, and how the PACE organization plans to ensure participants needs are met. For example, if there is only one specialist in a service area, and they are not accepting new participants, the PACE organization must show it attempted to contract and how it will ensure participants
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how the PACE organization plans to ensure participants needs are met. For example, if there is only one specialist in a service area, and they are not accepting new participants, the PACE organization must show it attempted to contract and how it will ensure participants are able to receive the services that the specialist would have provided. In other words, in this example, the PACE organization must show that it reached out to the one specialist in the area, attempted to contract with that specialist, and was unsuccessful. Finally, in order to account for PACE organizations that may choose to employ some medical specialists directly, such as dentists and podiatrists, proposed  460.70(a)(4) exempts a PACE organization from the contract requirements in  460.70(a)(1) and (2) with respect to a particular medical specialty if a PACE organization employs one or more individuals prior to contracting who are legally authorized and, if applicable, board certified, in that medical specialty. While we generally expect that PACE organizations would have contracts in place for most of the specialties in this list, we understand that there are times when a PACE 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
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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
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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.
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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
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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
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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