Waivers
Waivers of the Federal Fraud and Abuse Laws
ACO Participation Waiver
Physician Organization of Michigan ACO, LLC (“ POM ACO”) Operational Waivers
POM ACO has entered into a Medicare Shared Savings Program (“MSSP”) Participation Agreement with Centers for Medicare and Medicaid Services (“CMS”), effective January 1, 2013 (“Participation Agreement”). CMS and the Office of Inspector General for the United States Department of Health and Human Services (“HHS OIG”) jointly issued waivers in connection with the MSSP that waive the application of the federal fraud and abuse laws to certain MSSP arrangements, including the federal Anti-Kickback Statute and Physician Self- Referral Law so long as certain conditions prescribed by the final waivers are satisfied. One such waiver is the ACO Participation Waiver, which waives the federal fraud and abuse laws provided certain conditions are met, including the following: (i) the ACO has entered into a participation agreement and remains in good standing; (ii) the ACO satisfies certain governance, leadership and management requirements; (iii) the ACO’s governing body has made and duly authorized a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program; (iv) the arrangement and its authorization are documented; and the description of the arrangement is publicly disclosed, pursuant to certain additional guidance set forth by CMS and OIG.
This document is intended to meet the public disclosure requirements set forth in the final waivers. This document will be supplemented as additional arrangements arise consistent with the timing requirements set forth by CMS and OIG in the final rule.
At a meeting on January 22, 2016, of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that certain agreements between Quality Review Organizations (“QROs”) (a list is set forth in Appendix A to this document) and QRO participants (which are defined as ACO participants) are reasonably related to the purposes of the shared savings program. In furtherance of the goals of the MSSP, POM ACO contracts with QROs to ensure quality of care provided by QRO participants in a particular region and each QRO makes payments to each of its QRO participants in a manner detailed to CMS in the Participation Agreement.
At a meeting on Janury 22, 2016, of the Board, the Board made a bona fide determination that agreements between POM ACO and each QRO are reasonably related to the purposes of the shared savings program. Each QRO provides quality improvement and similar functions at a regional level on behalf of POM ACO and furthermore, makes distributions of the shared savings payment (if earned) to its QRO participants based upon certain metrics that have been previously provided to CMS in the Participation Agreement.
At a meeting on April 22, 2016, of the Board, the Board made a bona fide determination that a Management Services Agreement between POM ACO and University of Michigan is reasonably related to the purposes of the shared savings program. University of Michigan retains highly-trained staff experienced in certain areas, including, without limitation, providing clinical leadership and health informatics services. The Board has made the determination that from a cost-effectiveness standpoint, it is efficient to secure these services for POM ACO through an agreement with University of Michigan. The services provided pursuant to the agreement are explicitly defined in a budget that is pre-approved by the Board.
Care Collaboration Arrangement Waiver (St. Joseph Mercy Hospital Ann Arbor)
At a meeting on August 24, 2018 of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that a collaborative arrangement among IHA Health Services Corporation (“IHA”), St. Joseph Mercy Hospital, Ann Arbor (“St. Joseph Mercy Ann Arbor”), and Regents of the University of Michigan (“University of Michigan Health System”) is reasonably related to purposes of the Medicare Shared Savings Program, specifically, care coordination and efficient service delivery and meets the necessary requirements to grant an ACO Participation Waiver. The arrangement involves the development of a general medicine unit at St. Joseph Mercy Ann Arbor that will be staffed by University of Michigan faculty pursuant to a contractual arrangement between University of Michigan Health System and IHA. Both IHA and St. Joseph Mercy Ann Arbor are part of Trinity Health – Michigan, and both IHA and the University of Michigan Health System are currently participants in POM ACO, and anticipate transitioning to ACO tracks that are risk-bearing such that any incentive for overutilization of Medicare-payable items and services would be eliminated. The arrangement is in furtherance of ensuring care is delivered in the most efficient setting possible, in an effort to reduce costs to the Medicare program and to taxpayers, and improve patient satisfaction and quality of care. As part of this arrangement, patients will be transported by ambulance from University of Michigan Health System to St. Joseph Mercy Ann Arbor pursuant to a contractual arrangement between University of Michigan Health System and an ambulance vendor. Such ambulance transfers are medically necessary but do not meet Medicare coverage guidelines for ambulance services. Under this arrangement, Medicare beneficiaries will at all times retain freedom of choice to receive health care services from any facility. At a meeting on March 26, 2021, the Board approved a material amendment to this arrangement to add financial support from University of Michigan Health System to IHA to support the addition of an Advance Practice Provider (“APP”) as reasonably related to the purposes of the Medicare Shared Savings Program. The addition of the APP assures timely patient care and is in furtherance of assuring high quality care which is demonstrated by the metrics that are regularly reviewed by the Board.
Care Coordination Arrangement Waiver (St. Joseph Mercy Chelsea Hospital)
At a meeting on January 25, 2019 of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that a collaborative arrangement between St. Joseph Mercy Chelsea Hospital (“Chelsea Hospital”) and Regents of the University of Michigan (“University of Michigan Health System”) is reasonably related to purposes of the Medicare Shared Savings Program (“MSSP”), specifically, care coordination and efficient service delivery. Both Chelsea Hospital and University of Michigan Health System will transition to MSSP models that are risk-bearing such that any incentive for overutilization of Medicare-payable items and services would be eliminated. The arrangement is in furtherance of ensuring care is delivered in the most efficient setting possible, in an effort to reduce costs to the Medicare program and to taxpayers, and improve patient satisfaction and quality of care. As part of this arrangement, patients will be transported by ambulance from University of Michigan Health System to Chelsea Hospital pursuant to a contractual arrangement between University of Michigan Health System and an ambulance vendor. Such ambulance transfers are medically necessary but do not meet Medicare coverage guidelines for ambulance services and will not be billed to any federal program, or any other payor. Furthermore, such costs will not be included on any cost report. Under this arrangement, Medicare beneficiaries will at all times retain freedom of choice to receive health care services from any facility.
At a meeting on May 29, 2020 of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that an arrangement between St. Joseph Mercy Chelsea Hospital (“Chelsea Hospital”) and Regents of the University of Michigan (“UMHS”) is reasonably related to purposes of the Medicare Shared Savings Program (“MSSP”), specifically, care coordination and efficient service delivery. Both Chelsea Hospital and UMHS participate in MSSP models that are risk-bearing such that any incentive for overutilization of Medicare-payable items and services is mitigated. The arrangement is in furtherance of ensuring care is delivered in the most efficient setting possible, in an effort to reduce costs to the Medicare program and to taxpayers and improve patient satisfaction and quality of care. As part of this arrangement, Chelsea Hospital and UMHS will enter a Professional Services Agreement to allow UMHS hospitalists to provide services to low acuity Chelsea Hospital patients. The compensation arrangement could be indirectly tied to the volume or value of referrals between the parties such that an MSSP ACO Participation Waiver is appropriate to facilitate this arrangement. Metrics related to patient safety and quality of care will be presented to the Board on a regular basis. Under this arrangement, Medicare beneficiaries will at all times retain freedom of choice to receive health care services from any facility.
Care Coordination Arrangement Waiver – Packard Health, Inc.
At a meeting on January 17, 2020 of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that a collaborative arrangement between Packard Health, Inc. (“Packard Health”), a Section 330 community health center, and Regents of the University of Michigan (“UMHS”) is reasonably related to the purposes of the Medicare Shared Savings Program (“MSSP”). Specifically, the collaborative arrangement is intended to facilitate care coordination and timely access to primary care services in the local community. Both Packard Health and UMHS participate in MSSP models that are risk-bearing such that any incentive for overutilization of Medicare-payable items and services is mitigated. As part of this arrangement, patients presenting to the UMHS Emergency Department who do not have a primary care medical home (“PCMH”) may be assigned to Packard Health as a PCMH on a strictly voluntary basis. In addition, to facilitate this collaborative arrangement, Packard Health will provide a dedicated care manager to the UMHS Emergency Department to partner with the UMHS care manager to facilitate access to Packard Health as patients’ PCMH for those patients making this voluntary selection. Finally, as part of the collaborative arrangement, UMHS will provide renewable funding support to Packard Health to support the salary and benefit expenses of care managers who will provide care coordination services. The funding support for care managers would be renewable based upon Packard Health’s satisfactory performance on quality metrics developed by UMHS.
Payment Rule Waivers
Our ACO uses the SNF 3-Day Rule Waiver, pursuant to 42 CFR § 425.612.
Retired Waivers ( Waivers no longer in use by the ACO).
