CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND MB2 DENTAL SOLUTIONS, LLC, TRUNG TANG, D.D.S., CHRIS VILLANUEVA, D.D.S., MAURICIO DARDANO, D.D.S., GABRIEL SHAHWAN, D.D.S., AND AKHIL REDDY, D.D.S. I. PREAMBLE Trung Tang, D.D.S., Chris Villanueva, D.D.S., Mauricio Dardano, D.D.S., Gabriel Shahwan, D.D.S., Akhil Reddy, D.D.S., and MB2 Dental Solutions, LLC (collectively, MB2 Dental) hereby enter into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, MB2 Dental is entering into a Settlement Agreement with the United States. MB2 represents that, prior to this CIA, MB2 voluntarily established a Compliance Program that provides for a Compliance Officer, a compliance committee, maintenance of various policies and procedures, and auditing and monitoring activities aimed at ensuring MB2’s participation in the Federal health care programs conforms to all Federal and State laws and Federal health care program requirements. II. TERM AND SCOPE OF THE CIA A. The period of the compliance obligations assumed by MB2 Dental under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one- year period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) MB2 Dental’s final Annual Report or (2) any additional materials submitted by MB2 Dental pursuant to OIG’s request, whichever is later. MB2 Dental Corporate Integrity Agreement 1 C. For purposes of this CIA, the term “Covered Persons” includes: (1) all owners, officers, and employees of MB2 Dental; (2) all MB2 Affiliates, and their owners and employees; and (3) all contractors, subcontractors, agents, and other persons who furnish patient care items or services or who perform billing or coding functions on behalf of MB2 Dental, excluding vendors whose sole connection with MB2 Dental is selling or otherwise providing medical supplies or equipment to MB2 Dental. D. The term “MB2 Affiliate(s)” shall mean any dental clinic or other entity that is not owned or controlled by MB2 but for which MB2 furnishes practice management services, including but not limited to, coding and billing functions. III. CORPORATE INTEGRITY OBLIGATIONS MB2 Dental shall establish and maintain a Compliance Program that includes the following elements: A. Compliance Officer, Compliance Committee, and Management Compliance Obligations 1. Compliance Officer. Within 90 days after the Effective Date, MB2 Dental shall appoint a Compliance Officer and shall maintain a Compliance Officer for the term of the CIA. The Compliance Officer shall be an employee and a member of senior management of MB2 Dental, shall report directly to the President of MB2 Dental, and shall not be or be subordinate to the General Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for MB2 Dental. The Compliance Officer shall be responsible for, without limitation: a. d eveloping and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health care program requirements; b. making periodic (at least quarterly) reports regarding compliance matters directly to the President of MB2 Dental and shall be authorized to report on such matters to the President at any time. Written documentation of the Compliance Officer’s reports to the President shall be made available to OIG upon request; and MB2 Dental Corporate Integrity Agreement 2 c. m onitoring the day-to-day compliance activities engaged in by MB2 Dental as well as any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. MB2 Dental shall report to OIG, in writing, any changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change. 2. Compliance Committee. Within 90 days after the Effective Date, MB2 Dental shall appoint a Compliance Committee. The Compliance Committee shall, at a minimum, include the Compliance Officer and other members of senior management necessary to meet the requirements of this CIA (e.g., senior executives of relevant departments, such as billing, clinical, human resources, audit, and operations). The Compliance Officer shall chair the Compliance Committee and the Committee shall support the Compliance Officer in fulfilling his/her responsibilities (e.g., shall assist in the analysis of MB2 Dental’s risk areas and shall oversee monitoring of internal and external audits and investigations). The Compliance Committee shall meet at least quarterly. The minutes of the Compliance Committee meetings shall be made available to OIG upon request. MB2 Dental shall report to OIG, in writing, any actions or changes that would affect the Compliance Committee’s ability to perform the duties necessary to meet the obligations in this CIA, within 30 days after such a change. 3. Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain MB2 Dental employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable MB2 Dental department is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: each individual named as a party to this CIA, the Chief Executive Officer, President, Chief Operating Officer, Chief Financial Officer, Chief Revenue Officer, Vice-President of Business Development, and the Director of Market Strategy. For each Reporting Period, each Certifying Employee shall sign a certification that states: MB2 Dental Corporate Integrity Agreement 3 “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and MB2 Dental policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of MB2 Dental is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. B. Written Standards Within 90 days after the Effective Date, MB2 Dental shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and MB2 Dental’s compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, MB2 Dental shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At least annually (and more frequently, if appropriate), MB2 Dental shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons. All Policies and Procedures shall be made available to OIG upon request. C. Training and Education 1. Covered Persons Training. Within 90 days after the Effective Date, MB2 Dental shall develop a written plan (Training Plan) that outlines the steps MB2 Dental will take to ensure that all Covered Persons receive at least annual training regarding MB2 Dental’s CIA requirements and Compliance Program and the applicable Federal health care program requirements, including the requirements of the Anti- MB2 Dental Corporate Integrity Agreement 4 Kickback Statute, the Stark Law, and the Beneficiary Inducement Statute as well as appropriate billing and medical documentation requirements. The Training Plan shall include information regarding the following: training topics, categories of Covered Persons required to attend each training session, length of the training session(s), schedule for training, and format of the training. MB2 Dental shall furnish training to its Covered Persons pursuant to the Training Plan during each Reporting Period. 2. Training Records. MB2 Dental shall make available to OIG, upon request, training materials and records verifying that Covered Persons have timely received the training required under this section. D. R eview Procedures 1. General Description a. Engagement of Independent Review Organization. Within 90 days after the Effective Date, MB2 Dental shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter “Independent Review Organization” or “IRO”), to perform the reviews listed in this Section III.D. The applicable requirements relating to the IRO are outlined in Appendix A to this CIA, which is incorporated by reference. b. Retention of Records. The IRO and MB2 Dental shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exchanged between the IRO and MB2 Dental) related to the reviews. 2. Claims Review. The IRO shall review claims submitted by MB2 Dental and reimbursed by the Federal health care programs, to determine whether the items and services furnished were medically necessary and appropriately documented and whether the claims were correctly coded, submitted and reimbursed (Claims Review) and shall prepare a Claims Review Report, as outlined in Appendix B to this CIA, which is incorporated by reference. 3. Independence and Objectivity Certification. The IRO shall include in its report(s) to MB2 Dental a certification that the IRO has (a) evaluated its professional independence and objectivity with respect to the reviews required under this MB2 Dental Corporate Integrity Agreement 5 Section III.D and (b) concluded that it is, in fact, independent and objective, in accordance with the requirements specified in Appendix A to this CIA. The IRO’s certification shall include a summary of all current and prior engagements between MB2 Dental and the IRO. E. Risk Assessment and Internal Review Process Within 90 days after the Effective Date, MB2 Dental shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with MB2 Dental’s participation in the Federal health care programs, including but not limited to the risks associated with the submission of claims for items and services furnished to Federal health care program beneficiaries. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. MB2 Dental shall maintain the risk assessment and internal review process for the term of the CIA. F. Disclosure Program Within 90 days after the Effective Date, MB2 Dental shall establish a Disclosure Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with MB2 Dental’s policies, conduct, practices, or procedures with respect to a Federal health care program believed by the individual to be a potential violation of criminal, civil, or administrative law. MB2 Dental shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas). The Disclosure Program shall emphasize a nonretribution, nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of MB2 Dental’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by MB2 Dental. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant MB2 Dental Corporate Integrity Agreement 6 information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, MB2 Dental shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Compliance Officer (or designee) shall maintain a disclosure log and shall record each disclosure in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. G. I neligible Persons 1. Definitions. For purposes of this CIA: a. an “Ineligible Person” shall include an individual or entity who: i. is currently excluded from participation in any Federal health care program; or ii. has been convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded. b. “Exclusion List” means the HHS/OIG List of Excluded Individuals/Entities (LEIE) (available through the Internet at http://www.oig.hhs.gov). 2. Screening Requirements. MB2 Dental shall ensure that all prospective and current Covered Persons are not Ineligible Persons, by implementing the following screening requirements. a. MB2 Dental shall screen all prospective Covered Persons against the Exclusion List prior to engaging their services and, as part of the hiring or contracting process, shall require MB2 Dental Corporate Integrity Agreement 7 such Covered Persons to disclose whether they are Ineligible Persons. b. MB2 Dental shall screen all current Covered Persons against the Exclusion List within 90 days after the Effective Date and on a monthly basis thereafter. c. MB2 Dental shall implement a policy requiring all Covered Persons to disclose immediately if they become an Ineligible Person. Nothing in this Section III.G affects MB2 Dental’s responsibility to refrain from (and liability for) billing Federal health care programs for items or services furnished, ordered, or prescribed by an excluded person. MB2 Dental understands that items or services furnished, ordered, or prescribed by excluded persons are not payable by Federal health care programs and that MB2 Dental may be liable for overpayments and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether MB2 Dental meets the requirements of Section III.G. 3. Removal Requirement. If MB2 Dental has actual notice that a Covered Person has become an Ineligible Person, MB2 Dental shall remove such Covered Person from responsibility for, or involvement with, MB2 Dental’s business operations related to the Federal health care program(s) from which such Covered Person has been excluded and shall remove such Covered Person from any position for which the Covered Person’s compensation or the items or services furnished, ordered, or prescribed by the Covered Person are paid in whole or part, directly or indirectly, by any Federal health care program(s) from which the Covered Person has been excluded at least until such time as the Covered Person is reinstated into participation in such Federal health care program(s). 4. Pending Charges and Proposed Exclusions. If MB2 Dental has actual notice that a Covered Person is charged with a criminal offense that falls within the scope of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion during the Covered Person’s employment or contract term or during the term of a physician’s or other practitioner’s medical staff privileges, MB2 Dental shall take all appropriate actions to ensure that the responsibilities of that Covered Person have not and shall not adversely affect the quality of care rendered to any beneficiary or the accuracy of any claims submitted to any Federal health care program. MB2 Dental Corporate Integrity Agreement 8 H. Notification of Government Investigation or Legal Proceeding Within 30 days after discovery, MB2 Dental shall notify OIG, in writing, of any ongoing investigation or legal proceeding known to MB2 Dental conducted or brought by a governmental entity or its agents involving an allegation that MB2 Dental has committed a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. MB2 Dental also shall provide written notice to OIG within 30 days after the resolution of the matter and a description of the findings and/or results of the investigation or proceeding, if any. I. Overpayments 1. Definition of Overpayment. An “Overpayment” means any funds that MB2 Dental receives or retains under any Federal health care program to which MB2 Dental, after applicable reconciliation, is not entitled under such Federal health care program. 2. Overpayment Policies and Procedures. Within 90 days after the Effective Date, MB2 Dental shall develop and implement written policies and procedures regarding the identification, quantification, and repayment of Overpayments received from any Federal health care program. J. R eportable Events 1. Definition of Reportable Event. For purposes of this CIA, a “Reportable Event” means anything that involves: a. a substantial Overpayment; b. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; c. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or d. the filing of a bankruptcy petition by MB2 Dental. MB2 Dental Corporate Integrity Agreement 9 A Reportable Event may be the result of an isolated event or a series of occurrences. 2. Reporting of Reportable Events. If MB2 Dental determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, MB2 Dental shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists. 3. Reportable Events under Section III.J.1.a. and III.J.1.b. For Reportable Events under Section III.J.1.a and b, the report to OIG shall include: a. a complete description of all details relevant to the Reportable Event, including, at a minimum, the types of claims, transactions or other conduct giving rise to the Reportable Event; the period during which the conduct occurred; and the names of individuals and entities believed to be implicated, including an explanation of their roles in the Reportable Event; b. a statement of the Federal criminal, civil or administrative laws that are probably violated by the Reportable Event, if any; c. the Federal health care programs affected by the Reportable Event; d. a description of the steps taken by MB2 Dental to identify and quantify any Overpayments; and e. a description of MB2 Dental’s actions taken to correct the Reportable Event and prevent it from recurring. If the Reportable Event involves an Overpayment, within 60 days of identification of the Overpayment, MB2 Dental shall repay the Overpayment, in accordance with the requirements of 42 U.S.C. § 1320a-7k(d) and 42 C.F.R. § 401.301-305 (and any applicable CMS guidance) and provide OIG with a copy of the notification and repayment. 4. Reportable Events under Section III.J.1.c. For Reportable Events under Section III.J.1.c, the report to OIG shall include: MB2 Dental Corporate Integrity Agreement 10