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CMS will monitor GUIDE Participants on a regular, ongoing basis. CMS will use GUIDE Participant care delivery reporting, beneficiary and caregiver assessment data, GUIDE Practitioner Rosters, Partner Organization Rosters, claims, cost, utilization, and quality data in its monitoring strategy.
Regular program monitoring may result in audits of select GUIDE Participants. Data that GUIDE Participants submit to CMS, performance on utilization and quality measures, referral and billing patterns, and other practice information may trigger an audit of GUIDE Participants with anomalous findings. CMS may also randomly select GUIDE Participants for audit.
GUIDE Participants will be informed of the possibility of being selected for an audit and will be required to maintain copies of all documentation related to their use of model payments and their implementation of the GUIDE Model in case of an audit. More information related to the GUIDE Model’s record retention policy will be provided in the Participation Agreement.
CMS reserves the right to terminate a GUIDE Participant’s Participation Agreement at any time during the term of the Participation Agreement for reasons associated with poor performance, program integrity issues, non-compliance with the terms and conditions of the Participation Agreement, or as otherwise specified in the Participation Agreement or required by section 1115A(b)(3)(B) of the Social Security Act.
All GUIDE Participants will be required to cooperate with CMS efforts to conduct an independent, federally-funded evaluation of the GUIDE Model, which may include completion of surveys and participation in interviews, site visits, and other activities that CMS determines necessary to conduct a comprehensive evaluation. The evaluation will use a mixed-methods approach to assess both model impact and implementation experience.
The GUIDE Model will be operated under Section 1115A of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act) (42 U.S.C. 1315a). Section 1115A of the Act establishes the Innovation Center for the purpose of testing innovative payment and service delivery models to reduce Medicare and Medicaid expenditures while preserving or enhancing the quality of care furnished to beneficiaries of such programs.
Section 1115A(b)(2) of the Act requires the Secretary “to select models to be tested from models where the Secretary determines that there is evidence that the model addresses a defined population for
which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures.” The GUIDE Model addresses a defined population (community-dwelling, Medicare FFS beneficiaries, including beneficiaries dually eligible for Medicare and Medicaid, who have dementia) for which there are deficits in care resulting in both poor outcomes and potentially avoidable expenditures in unnecessary hospital, emergency department (ED), and post-acute care utilization.
Under section 1115A(d)(1) of the Act, the Secretary of Health and Human Services may waive such requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and certain provisions of section 1934 of the Act as may be necessary solely for purposes of carrying out section 1115A with respect to testing models described in section 1115A(b).
For this model and consistent with the authority under section 1115A(d)(1), the Secretary may consider issuing waivers of certain fraud and abuse provisions in sections 1128A, 1128B, and 1877 of the Act. No fraud or abuse waivers are being issued in this document; fraud and abuse waivers, if any, would be set forth in separately issued documentation. Any such waiver would apply solely to the GUIDE Model and could differ in scope or design from waivers granted for other programs or models. Thus, notwithstanding any provision of this RFA, GUIDE Participants must comply with all applicable laws and regulations, except as explicitly provided in any such separately documented waiver issued pursuant to section 1115A(d)(1) specifically for the GUIDE Model.
In addition to or in lieu of a waiver of certain fraud and abuse provisions in sections 1128A and 1128B of the Act, CMS may determine that the anti-kickback statute safe harbor for CMS-sponsored model arrangements and CMS-sponsored model patient incentives (42 C.F.R. § 1001.952(ii)) is available to protect remuneration exchanged pursuant to certain financial arrangements or patient incentives permitted under the GUIDE participation documentation. No such determination is being issued in this document. Such determination, if any, would be set forth in documentation separately issued by CMS.
The GUIDE Model will use the authority under section 1115A(d)(1) of the Act to make available the telehealth benefit enhancement and the environmental modification beneficiary engagement incentive.