evekhm/cms_iom_500 huggingface dataset:
2023-07115.pdf
1934(a)(9) of the Act define the trial period for PACE organizations as the first 3 contract years operating a PACE program under a PACE program agreement. Sections 1894(e)(4) and 1934(e)(4) of the Act require CMS, in cooperation with the State administering agency, to conduct a comprehensive annual review of the PACE organizations operation of the PACE program during the trial period to assure compliance with all significant requirements. The rule titled Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE), which appeared in the November 24, 1999 issue of the Federal Register (64 FR 66234) (hereinafter referred to as the 1999 PACE interim final rule) defined a contract year at  460.6 as the term of the PACE program agreement, which is a calendar year, except that a PACE organizations initial contract year may be from 12 to 23 months, as determined by CMS. This enables CMS to adjust the length of the initial contract year so that it always ends on December 31 and subsequent contract years align with a standard annual calendar year consisting of 12 months (64 FR 66236). As discussed in the proposed rule (87 FR 79635), CMS is required to conduct comprehensive reviews during a PACE organizations trial period to assess all significant regulatory requirements, and these reviews must be conducted on an annual basis for the first 3 contract years. CMS must conduct the first trial period review (for example, audit) within the first contract year in order to comply with the statutory and regulatory requirements. However, CMSs ability to schedule and conduct the first trial period audit is limited by when a PACE organization enters into a program agreement, when the PACE organization begins enrolling participants during their first contract year, and the initial contract year timeframe in the current contract year definition in  460.6. The timing of the initial contract year audit impacts the timing of subsequent audits, leaving CMS with increasingly narrow timeframes to audit within statutory and regulatory requirements. We proposed to amend the definition of contract year at  460.6 to state that a PACE organizations initial contract year may be 19 to 30 months, as determined by CMS, but in any event will end on December 31. Under the proposed contract year definition, although the duration of the initial contract year of the trial period would change, the initial contract
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contract year may be 19 to 30 months, as determined by CMS, but in any event will end on December 31. Under the proposed contract year definition, although the duration of the initial contract year of the trial period would change, the initial contract year would continue to begin when the program agreement goes into effect on the first day of the relevant month and end on December 31 to ensure subsequent contract years follow the standard annual calendar year cycle. For PACE organizations with an initial contract year start date of January 1 through June 1, CMS would extend the initial contract year through the following year, and for PACE organizations with an initial contract year start date of July 1 through December 1, CMS would extend the initial contract year through the second succeeding year. The proposed rule solicited comment on whether we should consider a different timeframe for the initial contract year, such as 25 to 36 months. As explained in the proposed rule at 87 FR 79636, we do not believe revising the definition of contract year as proposed would create any additional burden for PACE organizations, as the effect of the proposed change would be to provide CMS with more flexibility when scheduling initial trial period audits without placing new requirements on CMS or PACE organizations, and we do not anticipate that the proposed change would have an impact on the Medicare Trust Fund. VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00179 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222298 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations Comment: Comments on CMSs proposal to amend the contract year definition at  460.6 varied. A commenter supported the contract year definition change as proposed. Another commenter agreed with CMSs need for greater flexibility with scheduling PACE organizations first year trial period audits, but recommended a longer initial contract year timeframe of 25 to 36 months to allow for even more flexibility with scheduling PACE organizations first trial period audits than the 19 to 30 month timeframe. However, the majority of commenters expressed concern with the proposal to amend the definition of contract year  460.6 to state that a PACE organizations initial contract year may be 19
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trial period audits than the 19 to 30 month timeframe. However, the majority of commenters expressed concern with the proposal to amend the definition of contract year  460.6 to state that a PACE organizations initial contract year may be 19 to 30 months, as determined by CMS, but in any event will end on December 31. These commenters agreed with CMSs rationale for the proposed changes to the contract year definition, particularly CMSs concern that PACE organizations should have sufficient time to operate before their first trial period audit, which must take place during the initial contract year. However, most of these commenters recommended that CMS keep the current contract year definition, which has an initial contract year timeframe of 12 to 23 months, as determined by CMS, and utilize current administrative flexibilities to schedule trial year audits. They expressed concern that the proposed contract year definitions longer initial contract year could delay service area expansions, since PACE organizations must successfully complete their first trial period audit and implement acceptable corrective action plans, if applicable, before CMS and the State administering agency will approve a service area expansion or PACE center site expansion, as required at  460.12(d). Another commenter suggested that CMS should amend the contract year definition to allow PACE organizations to choose their initial contract year timeframe, either the codified timeframe of 12 to 23 months, as determined by CMS, or the proposed timeframe of 19 to 30 months, as determined by CMS, and ending on December 31. This commenter recommended providing both options to PACE organizations for reasons similar to those discussed by other commenters. They suggested that the proposed initial contract year definition timeframe may give PACE organizations more time to stabilize operations before their first trial period audit, but expressed concern about the longer timeframes consequences for PACE organizations growth and expansion. Response: Although a majority of commenters expressed support for flexibility when scheduling PACE organizations first trial period audit, they also expressed concern that amending the definition of contract year at  460.6 to lengthen the initial contract year timeframe to 19 to 30 months, as proposed, could affect the timing of the first trial period audit, and subsequently, the PACE organizations ability to expand their service areas. As a result, the commenters recommended that CMS maintain the current initial contract year timeframe of 12 to 23 months to balance the timing of the first trial period
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period audit, and subsequently, the PACE organizations ability to expand their service areas. As a result, the commenters recommended that CMS maintain the current initial contract year timeframe of 12 to 23 months to balance the timing of the first trial period audit, such that PACE organizations have sufficient time to operate before their first trial period audit, with consideration for services area expansions. We are not persuaded to maintain the current initial contract year timeframe of 12 to 23 months, as the majority of commenters recommended. As discussed in the proposed rule, CMS has limited flexibility when scheduling audits under the current contract year definition at  460.6. This presents significant operational challenges for CMS, since CMS must review PACE organizations within the timeframes required by statute and regulation. These operational challenges are especially prevalent for shorter initial contract year durations, such as 12 to 18 months, which would be alleviated under the proposed longer initial contract year timeframe of 19 to 30 months. As stated in the proposed rule, we understand how the timing of the first trial period audit affects service area and PACE center site expansion applications, and we reiterate our commitment to ensuring timely completion of PACE organizations first trial year audit in order to balance the impact on those applications with CMSs responsibilities related to program integrity and ensuring the wellbeing of PACE participants. Although our proposal, if finalized, would lengthen the initial contract year timeframe to 19 to 30 months, we still intend to promptly schedule first year reviews taking into consideration when organizations begin enrolling participants and whether an organization has had sufficient time to operate. We are also not persuaded to modify the proposal to lengthen the initial contract year timeframe to 25 to 36 months, as suggested by a commenter. Although the commenter expressed general support for the flexibility of a longer initial contract year timeframe, the commenter did not provide a specific justification for lengthening the initial contract year timeframe to 25 to 36 months. We do not believe this additional time is necessary to ensure that PACE organizations have sufficient time to operate before their first year trial period audits, nor that it is necessary in order for CMS to have sufficient flexibility in scheduling first year trial period audits. Additionally, since the current contract year definition and initial contract year timeframe do not offer CMS necessary flexibility for scheduling PACE organizations first trial period annual review, we are unable to provide PACE organizations with the option to choose their preferred timeframe
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Additionally, since the current contract year definition and initial contract year timeframe do not offer CMS necessary flexibility for scheduling PACE organizations first trial period annual review, we are unable to provide PACE organizations with the option to choose their preferred timeframe between the current and proposed initial contract timeframes. Therefore, we are finalizing our proposed changes to the definition of contract year at  460.6 without modification. B. Clarification of PACE Enforcement Authority for Civil Money Penalties and Intermediate Sanctions ( 460.40(b)) In the final rule titled Medicare and Medicaid Programs; Programs of All- Inclusive Care for the Elderly (PACE) (84 FR 25610), which appeared in the June 3, 2019 issue of the Federal Register, CMS amended  460.40 by adding paragraph (b), which establishes that CMS has the discretion to take alternative enforcement actions in the form of civil money penalties (CMP) or a suspension of enrollment of Medicare beneficiaries by, or payment to, a PACE organization if CMS makes a determination that could lead to a termination of a PACE program agreement under  460.50. In order to terminate a contract under paragraph (b) of  460.50, CMS or the State administering agency must determine that both of the following circumstances exist: (1) there are significant deficiencies in the quality of care furnished to participants; or the PACE organization failed to comply substantially with conditions for a PACE program or PACE organization under this part, or with terms of its PACE program agreement, including making payment to an individual or entity that is included on the preclusion list, defined in  422.2; and (2) within 30 days of the date of the receipt of written notice of a determination made under paragraph  460.50(b)(1), the PACE organization failed to develop and successfully initiate a plan to correct the deficiencies, or failed to continue implementation of the plan of correction. In circumstances where CMS has made a determination under  460.50 that could lead to termination, CMS VerDate Sep<11>2014 21:20 Apr 11, 2023 Jkt 259001 PO 00000 Frm 00180 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222299
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Frm 00180 Fmt 4701 Sfmt 4700 E:\FR\FM\12APR2.SGM 12APR2ddrumheller on DSK120RN23PROD with RULES222299 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations would likely impose a CMP or suspension of enrollment and/or payment on a PACE organization prior to terminating the PACE organization, as authorized by  460.40(b) (unless there was imminent risk to a PACE participant). This is because CMS views CMPs and suspensions of enrollment and/or payment as corrective in nature, since they are imposed when the PACE organization has been found noncompliant, and they provide time for the PACE organization to correct the issue(s) that led to the noncompliance with the ultimate goal of mitigating any actual or potential harm for PACE participants. As previously stated, in order for CMS to take any enforcement action (CMP, suspension of enrollment or payment, termination) on a PACE organization based on the grounds for termination set forth in  460.50(b), the PACE organization must fail to develop and successfully initiate a plan to correct the deficiencies, or fail to continue implementation of the plan of correction within 30 days of receiving notice. Given that CMPs and suspensions of enrollment and/or payment are corrective in nature and imposed prior to termination, CMS believes that providing PACE organizations an opportunity to correct prior to imposing a CMP or suspensions of enrollment and/or payment is unnecessary and most importantly an impediment to CMS ability to protect PACE participants from potential harm. For these reasons, we proposed to revise  460.40(b) by adding the following: If CMS or the State administering agency determines that the circumstances in  460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in 460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension. Comment: A few commenters suggested that this proposal would shift from a collaborative process of informing and providing PACE organizations an opportunity to self- disclose and self-correct deficiencies to a process that is overly punitive and has the potential to affect PACE organizations ability to render services
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suggested that this proposal would shift from a collaborative process of informing and providing PACE organizations an opportunity to self- disclose and self-correct deficiencies to a process that is overly punitive and has the potential to affect PACE organizations ability to render services due to the financial risk of CMPs and suspension of enrollment and/or payments. Response: We disagree with this comment. CMS has spent considerable time over the years increasing the amount of collaboration between CMS and PACE organizations before determining whether an enforcement action is warranted. This due diligence occurs both during the audit process, as well when CMS is reviewing a violation for a potential enforcement action. In addition, the proposal if finalized would not negatively impact PACE organizations ability to self-disclose and self-correct compliance deficiencies to CMS at any time, including during the audit and enforcement analysis stages. PACE organizations will continue to be permitted, and encouraged to self-disclose and self- correct issues found before or during audits, as well as issues discovered by PACE organizations outside of the audit. CMS considers such self-disclosure and self-correction as potential mitigating factors for violations/failures of the PACE program agreement and/or requirements. CMS also considers the financial condition 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
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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
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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