2023-07115.pdf

of PACE organizations when determining whether to impose an enforcement action. Comment: A few commenters incorrectly stated that current regulations require CMS to provide PACE organizations 30 days to correct deficiencies prior to imposing a CMP or suspension of enrollment and/or payment in all cases. Response: We would like to clarify that CMS has the authority to impose enforcement actions without first providing a 30-day notice to PACE organizations under  460.40. We received comments on the following topics which were outside the scope of our proposal and to which we are therefore not responding: (1) the circumstances that exist prior to CMS imposing an enforcement action; and (2) the thresholds CMS uses in determining whether to impose an enforcement action. After consideration of the comments received, we are finalizing our proposed changes to  460.40(b) without modification. C. PACE Contracted Services ( 460.70) As discussed in the proposed rule at 87 FR 79646, CMS originally included a list of required medical specialties at  460.92 as part of the 1999 PACE interim final rule. The proposed rule explained that, in the 2006 final rule, CMS removed the list of medical specialties that appeared at  460.92 based on the rationale that it was not possible to include an exhaustive list of all required services in PACE in the regulation and that PACE organizations might misconstrue the omission of any medical specialty from the list of required services at  460.92 to mean that that type of specialty service was not required (Id.). The proposed rule further explained how, in the 2006 final rule, CMS revised  460.92 to state that PACE organizations are required to cover all Medicare-covered services, all Medicaid-covered services included in the State plan, and any other services determined necessary by the IDT (Id.). The proposed rule noted that, when CMS removed the list of medical specialties from  460.92, we stressed that PACE organizations were still expected to have contractual arrangements with primary care physicians (PCPs) and specialists to meet the needs of their participants (Id.). As explained in the proposed rule, we have seen through our monitoring and oversight efforts that some PACE organizations are not providing timely access to medical specialists (87 FR 79646). The proposed rule noted that we have found through our oversight activities that delays in accessing medical specialists sometimes occur as a result of PACE organizations not having contracts in effect for the medical specialties commonly utilized by PACE participants (Id.). We believe the delays experienced by participants may be reduced by PACE organizations effectuating contracts with medical specialists before a participant needs a particular medical specialty service. To address this issue, we proposed to add back into the PACE regulations the list of medical specialty services identified in the original PACE protocol as services that PACE organizations must ensure access to as a minimum requirement. Specifically, we proposed to amend  460.70(a) to specify that the written contracts that PACE organizations are required to have with each outside organization, agency, or individual that furnishes administrative or care-related services not furnished directly by the PACE organization must include, at a minimum, the medical specialties listed in  460.70(a)(1). We proposed to establish at new  460.70(a)(1) that, at minimum, except as provided for in  460.70(a)(4), PACE organizations must have contracts in place for the following medical specialties: anesthesiology, audiology, cardiology, dentistry, dermatology, gastroenterology, gynecology, internal medicine, nephrology, neurosurgery, oncology, ophthalmology, oral surgery, orthopedic surgery, otorhinolaryngology, plastic surgery, pharmacy consulting services, podiatry, psychiatry, pulmonary disease, radiology, rheumatology, general surgery, thoracic and vascular surgery, and urology. We considered adding this list of medical specialties to  460.92, where it was originally located; VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00181 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222300 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations however, as explained in the proposed rule, the requirement is better suited in  460.70(a)(1) for several reasons. First, most, if not all, medical specialists do not work directly for the PACE organization, and rather are contracted providers that would need to adhere to the other requirements in  460.70. Second, by adding this requirement into the contracted services provision of the regulation, we believe it will allow CMS and State administering agencies to better assess PACE organizations readiness to enroll by ensuring these contracts are in place prior to participants enrolling in the organization. While we proposed to add a list of medical specialty services back into the PACE regulations, we continue to maintain that this is not an exhaustive list of all medical specialists that the PACE organization may 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 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 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 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 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