Waivers

Waivers of the Federal Fraud and Abuse Laws

Physician Organization of Michigan ACO, LLC (“POM ACO”) Waiver Establishment

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 January 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.

ACO Participation Waiver

Care Coordination Arrangement Waiver (St. Joseph Mercy Health System)

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 Health System  (SJMHS) 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 SJMHS and UMHS 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 UMHS to SJMHSpursuant 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.

Patient Incentive Waiver

Transportation Patient Incentive Program (Regents of the University of Michigan)

At a meeting on November 22, 2019 of the POM ACO Board of Managers (“Board”), the Board made a bona fide determination that an arrangement between the Regents of the University of Michigan (“UMHS”) and Physician Organization of Michigan ACO, LLC (“POM ACO”) is reasonably related to purposes of the Medicare Shared Savings Program (“MSSP”), specifically, care coordination and efficient service delivery.  The arrangement is in furtherance of ensuring care is delivered in the most efficient and timely manner 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, UMHS will utilize the Waiver to provide Services for patients meeting the following conditions: (i) traveling to and from greater than 25 miles from UMHS; and (ii) when medically necessary, transporting patients to a post-acute care facility where no existing treatment relationship is in place; provided, however, that patients at all times shall retain freedom of choice, both as to whether to accept the Services and as to facility selection.

ACO Participation Waiver

Care Coordination Arrangement Waiver (St. Joseph Mercy Chelsea, Inc)

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 (SJMC) 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 SJMC 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, SJMC and UMHS will enter a Professional Services Agreement to develop a new general medicine unit at SJMC dedicated to servicing the acute care inpatient needs of a broader general medicine population and allow UMHS hospitalists to provide services to low acuity SJMC 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.

Payment Rule Waivers

Skilled Nursing Facility (SNF) 3-Day Rule Waiver:

Our ACO uses the SNF 3-Day Rule Waiver, pursuant to 42 CFR § 425.612.

At a meeting on May 18, 2018 of the POM ACO Board of Managers (“Board”), the Board approved the SNF (Skilled Nursing Facility) 3-Day Waiver Rule Communication Plan, allowing the use of the waiver across all of its Quality Review Organizations (QROs) with the aim of reducing cost and improving quality of care.  The SNF 3-Day Waiver Rule waives the requirement for a three-day inpatient hospital stay prior to a Medicare-covered, post-hospital, extended care service for eligible beneficiaries who are prospectively assigned to an applicable accountable care organization and who receive care from an eligible SNF.

On an annual basis, the ACO and its partners will nominate SNFs who are eligible to apply for a SNF Affiliate agreement with the ACO and either have an Overall Rating of three (3) stars or higher in the CMS 5-Star Quality Rating System; or be a hospital or Critical Access Hospital (CAH) operating under swing bed agreements, in this situation there is no CMS Star Rating requirement. The ACO will monitor SNF star ratings continuously to ensure that they meet CMS requirements.

The ACO, in partnership with its QROs and SNF Affiliates, are required to develop a Communication Plan, Care Management Plan and Beneficiary Evaluation and Admission Plan to ensure the timely referral, smooth transition and appropriate management of eligible patients under SNF 3-Day Waiver Rule.   Additionally, the SNF Affiliate shall submit all data and information related to ACO activities, including as may be applicable encounter data, medical records, data on quality performance measures or other information that may be requested by POM ACO and/or CMS.  Such data shall be provided by SNF Affiliate in a timely manner to enable POM ACO to fulfill its obligations under the Participation Agreement and 42 CFR Part 425.  SNF Affiliate, upon request by POM ACO, shall certify its compliance with MSSP requirements and the accuracy, completeness, and truthfulness of data and information.

Retired Waivers (Waivers no longer in use by the ACO). 

Medical Director Waiver At a meeting on January 22, 2016, of the Board, the Board made a bona fide determination that an agreement for independent contractor Medical Director services between POM ACO and one of its QROs was reasonably related to the purposes of the shared savings program. Consistent with existing regulatory requirements at 42 CFR Part 425, POM ACO is required to obtain the services of a Medical Director. The Medical Director provides a broad range of medico-administrative services, including, without limitation, programmatic development around various clinical initiatives, and assistance to ACO Participants with ACO readiness activities.

Pharmacy Consultation Services Waiver At a meeting on September 22, 2017 of the Board, the Board made a bona fide determination that a Pharmacy Consultation Services arrangement between POM ACO and its Quality Review Organizations is reasonably related to the purposes of the shared savings program. Through this arrangement, POM ACO provides pharmacy consultation services to its Quality Review Organizations at no cost, and indirectly, provides this support to ACO participants in furtherance of patient care and medication management by integrating pharmacists within the health care team at the physician organization and practice level. The Board made the determination that this pharmacy support is reasonably related to the purposes of the shared savings program, including clinical integration and ensuring the availability of medication therapy management, that is beneficial to Medicare beneficiaries and is in furtherance of the quality goals of POM ACO.

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 – 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.