Common use of Healthcare Regulatory Clause in Contracts

Healthcare Regulatory. Except as would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole: (a) Each of the Company and its Subsidiaries is, and has been for the past three (3) years, in compliance with all applicable Healthcare Laws. There are no Actions pending or, to the Knowledge of the Company and its Subsidiaries, threatened alleging non-compliance by Company, any of its Subsidiaries or Healthcare Professionals while acting on behalf or at the request of the Company or any of its Subsidiaries with respect to any such Healthcare Laws. During the past three (3) years, none of the Company, the Subsidiaries, or any Company Employee, has received written notice of any Action against the Company or any Subsidiary related to Healthcare Laws from any Governmental Entity. (b) Without limiting the generality of Section 4.20(a), currently, and for the past three (3) years: (i) Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, director, managing employee, agent (as those terms are defined in 42 C.F.R. § 1001.1001) or Healthcare Professional of the Company or any of its Subsidiaries or Company Employee: (i) is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal agreement with any Governmental Entity concerning compliance with Healthcare Laws; (ii) has been debarred, excluded or suspended from participation in any Federal or State Healthcare Program or excluded from participation in, or, within the past three (3) years subject to a formal disciplinary Action by, any Payor or Governmental Entity; (iii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title ▇▇, ▇▇▇▇▇▇▇ ▇, ▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Code; or (iv) is currently listed on the U.S. General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. (ii) The Company and each of its Subsidiaries has adopted a code of ethics and has an operational healthcare compliance program, covering and implementing the seven elements of an effective compliance program described in the Compliance Program Guidance published by the Office of Inspector General, U.S. Department of Health and Human Services, which governs all employees, including sales representatives and their interactions with their physician, Healthcare Professional and hospital customers. (iii) Each Healthcare Professional that has provided any clinical services on behalf of the Company or any Company Subsidiary has been at all relevant times during the past three (3) years and is duly licensed, authorized and registered, as applicable, to practice his or her profession in the states in which he or she provides services and in any other jurisdiction necessary under any applicable Healthcare Law in respect of the provision of services on behalf of the Company or any Subsidiary. Each Company employee or independent contractor who has fitted patients for Company supplied orthotics, or has provided any other service that is necessary for a patient to receive a Company product, has been at all relevant times duly licensed, authorized, certified or acted under the supervision of a physician, as required by applicable Healthcare Laws. (iv) Except as set forth on Section 4.20(b)(iv) of the Company Disclosure Schedule, none of the Company and the Subsidiaries has billed or received in the past six (6) years any payment or reimbursement in excess of amounts allowed by applicable Law, except as and to the extent that liability for such overpayment has already been refunded to the applicable Payor, has been duly contested but only if the amount contested is less than $5,000 or is adequately reserved for in accordance with GAAP in the Latest Balance Sheet. (v) Each of the Company and the Subsidiaries has billing practices, including for the identification and refunding of overpayments, that are in compliance with all applicable Healthcare Laws and Payor policies and rules governing reimbursement and claims submitted to such Payors (including all workers’ compensation and insurance laws and regulations), including compliance with Section 1128J(d) of the Social Security Act (“the 60-Day Rule”) and the regulations at 42 C.F.R. Part 401, Subpart D. There is no pending or, to the Knowledge of the Company, threatened appeal, adjustment, challenge, audit (including notice of an intent to audit) or other Action related to such claims, other than those occurring in the ordinary course of business. Except as set forth in Section 4.20(b)(v) of the Company Disclosure Schedule, for the last three (3) years, there are no unpaid refunds due to a Payor in excess of $50,000 based on the findings of any internal or external audit. Section 4.20(b)(v) of the Company Disclosure Schedule sets forth any overpayments or payment denials, recoupments, withholds, or suspensions owed by the Company or any of the Subsidiaries to a Payor in excess of $50,000. (c) Each of the Company and the Subsidiaries has timely and accurately filed (i) all reports, returns, data and other information that are required to be filed by all Governmental Entities that control, directly or indirectly, any of the Company’s or any of the Subsidiaries’ activities and has paid all sums due with respect thereto and (ii) all reimbursable claims and other reports that are required to be filed in connection with all state and federal Medicare and Medicaid programs and that are due.