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Payment Rule Waivers

• Participation Waiver
  • The Centers for Medicare and Medicaid Services (“CMS”) and the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) have made available waivers of certain federal fraud and abuse laws in connection with the operation of accountable care organizations (“ACOs”) that have entered into a participation agreement under the Medicare Shared Savings Program (“MSSP”).
  • In order to receive the benefit of such waivers, the governing body of Northwest Ohio ACO, LLC (“Northwest Ohio ACO”) has made a bona fide, detailed determination that the following arrangement is reasonably related to the purposes of the MSSP.
  • Northwest Ohio ACO has authorized a waiver of certain federal fraud and abuse laws for the ownership and operation of Surgery Center at Regency Park, LLC, an ambulatory surgery center (“ASC”) among certain physicians, some of whom are participating providers in Northwest Ohio ACO and/or affiliated with The Toledo Clinic, Inc., a participant in Northwest Ohio ACO, which provides dialysis vascular and peripheral arterial disease services to patients within the community, including Medicare beneficiaries attributed to Northwest Ohio ACO (the “Arrangement”). As part of the Arrangement, the ASC will create a plan of clinical integration with Northwest Ohio ACO, which may include, without limitation, the ASC sharing quality and claims data for purposes of enhancing the triple aim.
  • The governing body of Northwest Ohio ACO authorized the application of the waiver to the Arrangement on September 10, 2019, following a determination that the Arrangement supports the goals of Northwest Ohio ACO and is reasonably related to the purposes of the MSSP, in each case because the Arrangement: (i) increases the quality of vascular/PAD services and reduces the costs of healthcare for the community, which include Medicare beneficiaries attributed to Northwest Ohio ACO; (ii) allows for greater access to vascular/PAD services in the community, including for Medicare beneficiaries attributed to Northwest Ohio ACO; (iii) encourages investment in infrastructure for high quality and efficient service delivery for patients, including Medicare beneficiaries attributed to Northwest Ohio ACO; and (iv) enhances physician engagement for driving true performance and clinical integration, including for physicians affiliated with Northwest Ohio ACO participants.
• Participation Waivers
  • The Centers for Medicare and Medicaid Services (“CMS”) and the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) have made available waivers of certain federal fraud and abuse laws in connection with the operation of accountable care organizations (“ACOs”) that have entered into a participation agreement under the Medicare Shared Savings Program Pathways to Success (“MSSP”).
  • In order to receive the benefit of such waivers, the governing body of Northwest Ohio ACO, LLC (the “Company”) has made a bona fide, detailed determination that the following arrangement is reasonably related to the purposes of the MSSP.
  • The Company has authorized a waiver of certain federal fraud and abuse laws for the following arrangements (the “Arrangements”):
    • Allocation of an amount of up to the entire amount of the Company’s agreed upon 20% set-aside of the CMS shared savings distribution for ACO participants to invest in physician recruitment, including the provision of start-up income guarantees and/or bonuses for primary care physicians (“PCPs”) and certain specialists and bonuses to residents in compliance with applicable law in exchange for their commitment to remain in Northwest Ohio after graduation from residency;
    • Provision of profit shares of the Toledo Clinic ambulatory surgery center to non-Toledo Clinic surgeons that contractually commit to participating in coordinating patient care and certain quality and utilization metrics; and
    • Provision of a care coordination bonus to community PCPs that contractually agree to care coordination and certain quality and utilization metrics.
  • The governing body of the Company authorized the application of the waiver to the Arrangements on November 12, 2019, following a determination that the Arrangements support the goals of the Company and is reasonably related to the purposes of the MSSP, in each case because the Arrangements: (i) assist in the coordination of care across service offerings for all MSSP ACO patients, as well as other patients in the community, including for Medicare beneficiaries attributed to Northwest Ohio ACO, which allows for the delivery of higher quality healthcare services; (ii) assist in reducing the costs of healthcare for patients, including Medicare beneficiaries attributed to Northwest Ohio ACO, by treating patients outside the hospital setting and reducing the number of medically unnecessary procedures; (iii) enhance physician engagement for driving true performance and clinical integration among physicians in the community by contractually requiring participating providers to coordinate patient care and satisfy certain quality and utilization metrics; (iv) enhance access to primary care and specialty services in the community, including for Medicare beneficiaries attributed to Northwest Ohio ACO, and provide additional healthcare services to the community, which allows for more opportunities for care coordination and the delivery of higher quality healthcare services; (v) promote widespread use of an electronic medical record platform (“EMR”) closely connected with the Company, and allow physicians to timely read patient medical, lab, and imaging results, as well as enhance coordination of care; and (vi) encourage investment in infrastructure for high quality and efficient service delivery for patients, including Medicare beneficiaries attributed to Northwest Ohio ACO, by relocating and adding more PCPs and specialists to the community.
• DME Waiver
  • The Centers for Medicare and Medicaid Services (“CMS”) and the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) have made available waivers of certain federal fraud and abuse laws in connection with the operation of accountable care organizations (“ACOs”) that have entered into a participation agreement under the Medicare Shared Savings Program (“MSSP”).
  • IIn order to receive the benefit of such waivers, the governing body of Northwest Ohio ACO, LLC (the “Company”) has made a bona fide, detailed determination that the following arrangement is reasonably related to the purposes of the MSSP.
  • The Company has authorized a waiver of certain federal fraud and abuse laws for an arrangement whereby The Toledo Clinic, Inc. (“TTC”), through TTC and/or its pharmacy, provides durable medical equipment (“DME”) to patients who are Medicare or Medicaid beneficiaries, including Medicare beneficiaries attributed to the Company (the “Arrangement”).
  • The governing body of the Company authorized the application of the waiver to the Arrangement on October 10, 2017, following a determination that the Arrangement supports the goals of the Company and is reasonably related to the purposes of the MSSP, in each case because the Arrangement: (i) assists in the coordination of care across all of TTC’s service offerings for its patients, including for Medicare beneficiaries attributed to the Company, which allows for the delivery of higher quality healthcare services; (ii) allows for greater access to preventive care items in the community, including for Medicare beneficiaries attributed to the Company; (iii) advances adherence to a treatment regime, adherence to a follow-up care plan, and/or management of a chronic disease or condition for TTC patients, including for Medicare beneficiaries attributed to the Company; and (iv) allows patients, including Medicare beneficiaries attributed to the Company, to have a cost-efficient alternative for DME items and supplies.
• Cardiology Revenue Allocation
• The Centers for Medicare and Medicaid Services (“CMS”) and the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) have made available waivers of certain federal fraud and abuse laws in connection with the operation of accountable care organizations (“ACOs”) that have entered into a participation agreement under the Medicare Shared Savings Program (“MSSP”).
• In order to receive the benefit of such waivers, the governing body of Northwest Ohio ACO, LLC (the “Company”) has made a bona fide, detailed determination that the following arrangement is reasonably related to the purposes of the MSSP.
• The Company has authorized a waiver of certain federal fraud and abuse laws for an arrangement involving the allocation of ancillary revenues among The Toledo Clinic, Inc.’s (“TTC”) cardiologists (the “Arrangement”).
• The governing body of the Company authorized the application of the waiver to the Arrangement on November 13, 2018, following a determination that the Arrangement supports the goals of the Company and is reasonably related to the purposes of the MSSP, in each case because the Arrangement: (i) assists in the coordination of care across TTC’s cardiology service offerings for its patients, including for Medicare beneficiaries attributed to the Company, which allows for the delivery of higher quality healthcare services; (ii) assists in reducing the costs of healthcare for patients, including for Medicare beneficiaries attributed to the Company, by treating patients outside of the hospital setting and reducing the number of medically unnecessary procedures; (iii) enhances physician engagement for driving true performance and clinical integration among physicians in the community; (iv) promotes timely reads of patient medical results; and (v) promotes widespread use of an electronic medical record platform across TTC.