I. Introduction Madison Avenue, New York, NY tel: toll free: fax:

Transcription

1 I. Introduction The Ralph Lauren Center for Cancer Care ( RLCCC or The Center ) operates a freestanding diagnostic and treatment center, licensed under Article 28 of the New York State health law, located in the City of New York. RLCCC provides a broad range of health services to a largely medically underserved population. Many of the services provided by RLCCC are funded by the U.S Department of Health and Human Services ( DHHS ) grants or reimbursed by the New York State Medicaid program. Both sources of funding require the Center to comply with specified conditions and program requirements. RLCCC seeks to formalize its commitment to Compliance with applicable statutes, regulations, program requirements and grant conditions through its Corporate Compliance Program ( Compliance Program ) as set forth in this Corporate Compliance Plan ( Compliance Plan ), which sets forth RLCCC s Global Standards of Business Conduct and Ethics ( Code of Conduct ) as well as standards and procedures for how RLCCC conducts business. The Compliance Plan applies to all RLCCC employees, Board Members and RLCCC contractors. All RLCCC employees, Board Members and contractors have a personal obligation to assist in making the Program successful and are expected to: (1) Familiarize themselves with the Center s Code of Conduct and compliance procedures (2) Review and understand the key policies governing their particular functions and responsibilities (3) Report any fraud, abuse or other improper activity through the mechanisms established under the Program (4) Cooperate in the Center s audits and investigations (5) Carry out their functions and responsibilities in a manner that demonstrates a commitment to honesty, integrity and compliance with the law The RLCCC Corporate Compliance Officer shall be responsible for implementing and operating the Compliance Program in accordance with the Plan. The Plan and Program are regularly reassessed and are constantly evolving to address new compliance challenges and maximize the use of the Center s resources. As necessary, the Compliance Program, this Plan, the Code of Conduct and related relevant Compliance documents will be revised to incorporate regulatory and industry changes, as well as changes in RLCCC operations. Employees, officers, directors and contractors are encouraged to provide suggestions on how the Program might be expanded or improved.

2 II. Statement of Purpose The RLCCC Compliance Program is designed to promote the Center s compliance with all applicable federal, state and local laws and regulations as well as government contracts and conditions of participation in public programs. The primary goals of the Program, as set forth in the Plan are to: Prevent fraud, abuse and other improper activity by creating a culture of compliance within RLCCC Detect any misconduct that may occur at an early stage before it creates a substantial risk of civil or criminal liability for the Center Respond swiftly to compliance problems through appropriate disciplinary and corrective action The Program reflects RLCCC s commitment to operating in accordance not only with the strict requirements of the law, but also in a manner that is consistent with high ethical and professional standards. The Plan and Program apply to the full range of RLCCC activities and initiatives. III. The Elements of the Program The Program s design is based on the compliance guidance provided by the U.S. Department of Health and Human Services Office of Inspector General and the requirements imposed on health care providers under Section 363-d of the New York State Social Services Law and Part 521 of Title 18 of the New York State Codes, Rules and Regulations. The key elements of the Program, which are discussed in greater detail in the Plan section referenced below, are as follows: General Responsibilities (Section IV) Code of Conduct and Key Policies and Procedures (Section V) Compliance Oversight (Section VI) Compliance Training (Section VII) Reporting Compliance Problems and Prohibition on Retaliation (Section VIII) Disciplinary Measures (Section IX) Risk Identification and Internal Audits and Reviews (Section X) Internal Investigations and Government Audits and Investigations (Section XI) Corrective Action (Section XII)

3 IV. General Responsibilities RLCCC recognizes that operating in an ethical and legal manner is not only an obligation of the Center itself, but that it is an obligation of each and every individual providing administrative, clinical and business services on its behalf. In this spirit, the following compliance-related responsibilities apply to Board Members, employees and contractors respectively: A. Responsibilities of Board Members Board Members, through a duly adopted Board resolution, have assumed the compliance related responsibilities described herein. 1. Duty to Comply 1.1 Board Members, in the course of exercising their duties as Board Members, shall comply with the applicable Medicaid and other payor requirements, and avoid violating prohibitions against fraud and abuse. 1.2 All Board Members shall annually review and adhere to the Center s Code of Conduct attached hereto as Appendix All Board Members shall annually complete a Conflict of Interest Disclosure Statement. Disclosure Statements shall be periodically reviewed and shall be updated as necessary to ensure it is accurate and complete. 2. Duty to Promote Organizational Compliance 2.1 In General: Board Members shall strive to promote, throughout RLCCC and among its employees and contractors, a commitment to compliance with Medicaid and other payor requirements, and an awareness of prohibitions against fraud and abuse. 2.2 Duty to Oversee Organizational Compliance: Board Members shall assume, among its other responsibilities, the responsibility to oversee the development, implementation, operation and evaluation of the Center s Compliance Program. The Board shall periodically and timely receive updates and reports from the Compliance Officer on compliance related initiatives and activity. 2.3 Oversight of Compliance Officer Compliance Committee: Board Members shall exercise oversight to ensure that the Compliance

4 Officer and Compliance Committee are performing their respective responsibilities as they relate to compliance. 3. Duty to Attend Board Educational Programs To enable the Board Members to meet their compliance related responsibilities, the Board Members shall periodically attend educational programs in: (a) applicable key Medicaid and other payor requirements; (b) prohibitions against fraud and abuse; (c) compliance risk areas; and (d) the benefits and elements of a compliance program. The time, place, manner and amount of such programs shall be determined by the Compliance Officer. 4. Duty to Respond 4.1 Board Members are obligated to respond appropriately to reports or other indications of possible fraud, abuse or other noncompliance within the Center that are actually observed or made known to them. Such response should include ensuring that Management follows the procedures set forth in Sections XI and XII hereof relating to investigating and appropriately responding to reports of fraud, abuse or other noncompliance. 4.2 Board Members are obligated to cooperate in any internal or external audits or investigations by duly authorized internal or external auditors or investigators, regarding possible fraud, abuse or other noncompliance. B. Responsibilities of Employees / Staff Members 1. Duty to Know Applicable Requirements 1.1 Employees are obligated to know the following information, to the extent it is pertinent to the employee s responsibilities: (a) applicable Medicaid and other payor requirements; (b) the prohibitions against fraud and abuse; (c) relevant compliance risk areas; and (d) the benefits and elements of a compliance program. 1.2 In order to acquire and maintain the requisite knowledge, employees are obligated to attend periodic training related to their job responsibilities in: (a) applicable Medicaid and other payor requirements; (b) the prohibitions against fraud and abuse; (c) relevant compliance risk areas; and (d) the benefits and

5 elements of a compliance program. The time, place, manner and duration of such training shall be determined by the Compliance Officer. 2. Duty to Comply with Applicable Requirements Employees are obligated to comply with the applicable Medicaid and other payor requirements and internal policies and procedures, and to avoid violating prohibitions against fraud and abuse. 3. Duty to Document 3.1 Contractors who provide billable services are obligated to create appropriate documentation of such services meaning documentation that is: (a) Accurate (b) Legible (c) Complete (identifies the patient, the individual providing the services, the care, services, supplies, equipment or tasks provided, the date and time and any other required information) (d) Signed by patient or patient representative, where required (e) Signed by the individual providing the care/services (f) Timely 4. Duty to Report 4.1 Employees are obligated to report instances of possible fraud, abuse and other noncompliance that they know of or reasonably suspect to one of the following: (a) The RLCCC Compliance Hotline (855) (b) The employee s Supervisor or any other Supervisor or Director (c) The RLCCC Compliance Officer at (212) or csmith@ralphlaurencenter.org

6 4.2 Employees shall cooperate in any internal audits or investigations regarding possible fraud, abuse or other noncompliance. 4.3 Employees shall comply with any legal requirement to provide documents and information in any external audits or investigations by duly authorized governmental auditors or investigators, regarding possible fraud, abuse or other noncompliance. 5. Duty to Respond Employees are obligated to respond appropriately to reports of possible fraud, abuse or other noncompliance that are reported to them by patients, other employees, contractors, etc. Such response should include following the procedure set forth in Sections XI and XII hereof for investigating and responding to the possible noncompliance. 6. Duty to Promote Organizational Compliance 6.1 Employees shall promote, among other employees and contractors, a commitment to compliance with Medicaid and other payor requirements, and to an awareness of prohibitions against fraud and abuse. 6.2 Employees shall cooperate with and assist the Compliance Officer in the performance of his/her responsibilities. C. Responsibilities of Contractors (including non-employed Referring Physicians) Contractors have the compliance-related duties, which are described herein. These duties should be referenced in any formal agreement between RLCCC and the Contractor, Physician, etc. 1. Duty to Know Applicable Requirements 1.1 Contractors shall know: (a) the pertinent Medicaid and other payor requirements; (b) the pertinent prohibitions against fraud and abuse; (c) the pertinent compliance risk areas; and (d) the benefits and elements of a compliance program. 1.2 Contractors shall use their best efforts to keep informed on significant changes in: (a) applicable Medicaid and other payor requirements; (b) the prohibitions against fraud and abuse; (c)

7 compliance risk areas for the Center; and (d) the benefits and elements of a compliance program. 2. Duty to Comply with Applicable Requirements Contractors shall comply with the applicable Medicaid and other payor requirements, and to avoid violating prohibitions against fraud and abuse. 3. Duty to Document 3.1 Contractors who provide billable services are obligated to create appropriate documentation of such services meaning documentation that is: (a) Accurate (b) Legible (c) Complete (identifies the patient, the individual providing the service, the care, services, supplies, equipment or tasks provided, the date and time and any other required information) (d) Signed by patient or patient representative, where required (e) Signed by the individual providing the care/services (f) Timely 4. Duty to Report Independent Contractors shall report instances of possible fraud, abuse and other noncompliance that they know or reasonably suspect within the Center to either: (a) The RLCCC Compliance Hotline (855) (b) The RLCCC Compliance Officer at (212) or csmith@ralphlaurencenter.org 5. Duty to Provide Information

8 Contractors shall, upon request, furnish the Center with information, or with permission to obtain information, to conduct compliance background / exclusion checks of such contractor and its employees. V. Code of Conduct and Key Policies and Procedures RLCCC is committed to conducting all of its activities with honesty and integrity. The Code of Conduct, attached hereto as Attachment 1, sets forth the basic principles that guide RLCCC decisions and actions. The Code of Conduct is not intended to address every potential compliance issue that may arise in the course of the Center s business. All employees and contractors are expected to familiarize themselves with the Code of Conduct and should rely on the standards contained in the Code in carrying out their duties. While the Code of Conduct establishes broad principles to promote ethical behavior, RLCCC also recognizes that the development and distribution of comprehensive policies and procedures promoting ethical conduct is an essential component of an effective compliance program. These policies and procedures must clearly articulate responsibilities and provide employees and contractors with sufficient guidance and direction in fulfilling those responsibilities. The Center has developed several policies and procedures in support of its compliance program including: 1. Avoiding Kickback and Referral Fees 2. Disclosing and Managing Conflicts of Interest 3. Internal and External Investigations 4. Non-retaliation 5. Employee and Contractor Screening 6. Employee Discipline 7. Identifying, Tracking and Repaying Overpayments All employees and contractors are required to review and carry out their duties in accordance with the policies applicable to their functions and responsibilities. VI. Compliance Oversight A. Compliance Officer The Compliance Officer is responsible for overseeing the implementation and modification of the Program. The Compliance Officer s duties include, but are not limited to, the following:

9 Developing policies and procedures governing the operation of the Program Managing day-to-day operation of the Program Periodically reviewing and updating the Compliance Plan, Code of Conduct and related policies Overseeing operation of the Compliance Hotline described in Section VIII below Receiving, evaluating and investigating compliance-related questions, concerns and complaints Tracking issues on a compliance log, including the nature and results of any investigation and any remedial actions taken Ensuring proper reporting of violations to duly authorized enforcement agencies as appropriate or required Working with others as appropriate to develop the compliance training program described in Section VII below Evaluating the effectiveness of and strengthening the Program The Compliance Officer reports directly to the CEO/Medical Director and shall make regular reports to the Board of Trustees on the operation of the Program. Employees and contractors should view the Compliance Officer as a resource to answer questions and address concerns related to the Program or compliance issues. As discussed in Section VIII below, the Compliance Officer maintains an open door policy and may be contacted directly by any employee or contractor regarding a compliance-related matter. B. Compliance Committee The Compliance Committee is comprised of the CEO/Medical Director, Clinical Services Director, Controller and the Compliance Officer. The CEO/Medical Director may appoint additional members to the Compliance Committee with varying backgrounds and experience to ensure that the Committee has the expertise to handle the full range of clinical, administrative, and operational issues relevant to the Program. As it relates to Compliance, the Compliance Committee s functions include, but are not limited to, the following: Receiving regular reports from the Compliance Officer and providing him or her with guidance regarding the operation of the Program Approving the annual work plan carried out under the Program (see Section X below)

10 Approving the compliance training program provided to all employees Reviewing and confirming the adequacy of all investigations of suspected fraud or abuse and any corrective action taken as a result of such investigations Recommending and approving any changes to the Compliance Plan The Compliance Committee is chaired by the Compliance Officer. The Compliance Committee shall meet no less than quarterly. A. Board of Trustees The Board of Trustees has ultimate authority for the governance of the Center, including oversight of the Center s compliance with applicable law. The Board of Trustees will receive reports on the operation of the Program directly from the Compliance Officer at least two times a year. The Compliance Officer has the right to bring matters directly to the Board at any time. VII. Compliance Training Every employee must attend the basic compliance training session offered by the Center within 30 days of the commencement of employment. Board Members must also receive compliance training as part of their orientation. This session covers the contents of the Code of Conduct and the key elements of the Program. Employees and Board Members must acknowledge in writing that they have received this training, understand the Code of Conduct and will fulfill their obligations under the Compliance Plan. Employees must also participate in annual refresher training sessions. Employees are required to participate in any advanced compliance training sessions recommended by the Compliance Committee which are designed to focus on the specific compliance issues associated with their functions. The handling of contractor Compliance training requirements should be addressed in the relevant contract or other materials outlining the relationship and obligations of the respective parties. VIII. Reporting Compliance Problems and Non-Retaliation RLCCC is committed to open communication. Effective communication will empower RLCCC personnel to fulfill the goals and objectives of the Compliance Program of promoting ethical conduct and preventing or internally detecting and resolving compliance related issues. To that end, RLCCC believes an open door culture is a critical compliance tool.

11 A. Reporting Options In accordance with its Duty to Disclose Reporting Policy, the Center maintains open lines of communication for the reporting of suspected improper activity. Employees and contractors are expected to promptly report any such activity of which they become aware in one of the following ways: Employees may notify their supervisor Notifying the Compliance Officer, who has an open door policy Notifying any other member of the Compliance Committee with whom they feel comfortable Filing a report through the Compliance Hotline B. Compliance Hotline The Compliance Hotline may be accessed by dialing (855) To encourage full and frank reporting of suspected fraud or abuse, the Center gives employees the option of filing complaints through the Compliance Hotline anonymously. The Compliance Officer is responsible for reviewing all Compliance Hotline reports, assessing whether they warrant further investigation and ensuring that any compliance problems are identified and corrected. Employees should understand that the Compliance Hotline is designed solely for the good-faith reporting of fraud, abuse and other compliance problems; it is not intended for complaints relating to the terms and conditions of an employee s employment. Any such complaints should be directed to the Human Resources Coordinator. C. Non-Retaliation No employee or contractor who files a report of suspected fraud, abuse or other improper activity in good faith will be subject to retaliation by the Center in any form. Prohibited retaliation includes, but is not limited to, terminating, suspending, demoting, failing to consider for promotion, harassing or reducing the compensation of any employee due to the employee s intended or actual filing of a report. Employees should immediately report any perceived retaliation to the Compliance Officer. IX. Disciplinary Measures The standards set forth in the Code of Conduct and obligations under the Compliance Plan are important to RLCCC and must be taken seriously by all

12 RLCCC employees, managers, officers and agents. Accordingly, violations of these standards and applicable regulations and laws, will not be tolerated. Employees who engage in fraud, abuse or other misconduct are subject to disciplinary action in accordance with the Center s Employee Discipline Policy. Any such sanctions related to non-compliant behavior or practices addressed under the Compliance Program will be carried out in consultation with the Compliance Officer. Depending on the nature of the offense, discipline may include counseling, oral or written warnings, modification of duties, suspension or termination but must be consistently applied while taking into account several factors including the severity of the incident, the employment and disciplinary action history of the employee, the employee s knowledge of the subject matter and appreciation of their actions, etc. Management shall not receive preferential treatment related to disciplinary action. Disciplinary actions related to compliance matters should be routinely monitored for consistent application. Corrective action against contractors will be in accordance with the terms of their contract. X. Risk Identification and Internal Compliance Audits and Reviews The Center obtains the majority of its reimbursement from government programs, including Medicaid, for health care services provided to its clients. The submission of accurate bills to government payors is one of the Center s key legal obligations. The Center seeks to identify compliance issues at an early stage before they develop into significant legal problems. One way to proactively address potential compliance issues is by identifying key risks. For the Center, these risks include: Billing for clients not actually served by the Center Billing for health care services rendered to clients that are not appropriately, accurately, thoroughly and timely documented in the Center s records Billing twice for the same service Employing an excluded individual or billing for services ordered or provided by an excluded individual Product pricing billing at a rate in excess of the rate permitted under the applicable program Billing for services that are knowingly also being billed to the government by another health care provider

13 Billing the Medicaid program as the primary payor when the client has other public or private health insurance coverage The integrity of data submitted to the federal health care programs Practices related to interactions with prescribers and purchasers of RLCCC services Additional risk areas can be identified through annual review of the Department of Health and Human Services Office of the Inspector General s (OIG) and New York State Office of the Medicaid Inspector General s (OMIG s) annual work plans and other resources from those offices. Another key method of risk mitigation is the performance of internal audits and compliance reviews. The Compliance Committee of the Center will annually develop a compliance work plan that includes a schedule of internal audits for the upcoming year. The audits will cover aspects of the Center s operations that pose a heightened risk of non-compliance, including but not limited to, Medicaid billing, cost reporting, grant administration, medical chart documentation and adherence to clinical protocols. A written report is prepared summarizing the findings of each audit and recommending any appropriate corrective action. Reports will be timely presented at a Compliance Committee meeting. Significant findings will be tracked for additional oversight and accountability of the corrective action process. All employees and contractors are required to participate in and cooperate with internal and external audits as requested by the Compliance Officer. This includes assisting in the production of documents, explaining program operations or rules to auditors and implementing any corrective action plans. XI. Internal Investigations and Government Audits and Investigations A. Internal Investigations All reports of fraudulent, abusive or other improper conduct, whether made through the Compliance Hotline or otherwise, shall be promptly reviewed and evaluated by the Compliance Officer. The Compliance Officer determines, in consultation with other RLCCC personnel as necessary, whether the report warrants an internal investigation. If so, the Compliance Officer coordinates the investigation, issues a written report of its findings and proposes any corrective action that may be appropriate. In accordance with the Center s Internal Investigations Policy, employees and contractors are expected to fully cooperate in all audits and investigations. Any employee who fails to provide such cooperation will be subject to

14 termination of employment. Any contractor who fails to provide such cooperation will be subject to termination of contract. B. Government Audits and Investigations In accordance with RLCCC s Government Investigations Policy, employees and contractors are expected to fully cooperate in all government audits and investigations. All subpoenas and other governmental requests for RLCCC documents should be forwarded to the Compliance Officer, who is responsible for reviewing and responding to such requests. Employees and contractors are strictly prohibited from destroying, improperly modifying or otherwise making inaccessible any documents that the employee or contractor knows are the subject of a pending government subpoena or document request. Employees and contractors are also barred from directing or encouraging another person to take such action. These obligations override any document destruction policies that would otherwise be applicable. If an employee or contractor receives a request from a government investigator to provide an interview, the employee should immediately contact the Compliance Officer. The Compliance Officer will, as appropriate, seek to coordinate and schedule all interview requests with the relevant government entity. Employees and contractors are expected to answer all questions posed by government investigators truthfully and completely. Any employee who fails to provide cooperation or follow the Government Investigations Policy will be subject to disciplinary action including termination of employment. Any contractor who fails to provide such cooperation will be subject to termination of contract. XII. Corrective Action The Center is committed to taking prompt corrective action to address any fraud, abuse or other improper activity identified through internal audits, investigations, reports by employees or other means. The Compliance Officer, in consultation with the Administrator, is generally responsible for reviewing and approving all corrective action plans. However, the Compliance Officer is authorized to recommend corrective action directly to the Board of Trustees if the Compliance Officer believes, in good faith, that the Administrator is not promptly acting upon such a recommendation. In cases involving clear fraud or illegality, the Compliance Officer also has the authority to order interim

15 measures, such as a suspension of billing, while a recommendation of corrective action is pending. Corrective action may include, but not be limited to, any of the following steps: Modifying RLCCC s existing policies, procedures or business practices Providing additional training or other guidance to employees or contractors Seeking interpretive guidance of applicable laws and regulations from government agencies Disciplining employees (see Section IX above) or terminating contractors Notifying appropriate authorities of criminal activity by employees, contractors or others Returning overpayments or other funds to which RLCCC is not entitled to the appropriate government center or program Self-disclosing fraud or other illegality through established state and federal self-disclosure protocols * * * * * The governmental and industry standards as well as the laws and regulations applicable to RLCCC operations are dynamic and complex. Moreover, RLCCC business operations may change and expand in the future. The Corporate Compliance Plan is designed to enable RLCCC to adapt to these changes and maintain compliance with these standards, laws and regulations. Accordingly, the RLCCC Corporate Compliance Plan will be reviewed annually by the Compliance Officer in consultation with the Corporate Compliance Committee. The fact of the review will be recorded in minutes of the Compliance Committee. Any recommended changes will be subject to approval by the Compliance Committee and Board of Trustees In summary, RLCCC has adopted this Compliance Plan with the goal of carrying out all of its activities in accordance with law and the highest ethical standards. The effectiveness of the overall Compliance Program hinges on the active participation of all Board Members, employees and contractors in preventing, detecting and appropriately responding to fraud, abuse or other misconduct. Working together, we can make the Center a model of excellence and integrity in the community.

16 Attachment 1 RALPH LAUREN CENTER FOR CANCER CARE GLOBAL STANDARD OF BUSINESS CONDUCT AND ETHICS Introduction This Global Standards of Business Conduct and Ethics policy is a statement regarding the ethical standards to which each director, officer and employee of the Ralph Lauren Center for Cancer Care ( RLCCC or The Center ) is expected to adhere in the course of RLCCC s business. This Policy is a summary of the broad ethical and legal principles under which RLCCC operates and does not describe all laws, regulations or policies applicable to RLCCC, nor does it give full details on any single such law, regulation or policy. This Policy applies to the RLCCC s directors, officers and employees, and to RLCCC as a whole. Each of us should read and become familiar with the ethical standards described in this Policy. In addition, each of us is responsible for becoming familiar with, and following, all the laws, regulations and policies that apply to our jobs and for seeking advice when needed, raise any concerns and report any violations of law or policy. This Policy has been approved by RLCCC s Board of Trustees and will be monitored by the Board of Trustees with the assistance of management. Any questions regarding these policies should be addressed to RLCCC s Compliance Officer. 1. Compliance with Laws and Regulations: RLCCC will comply with all laws and regulations that may be applicable to its business and expects that all employees and contractors will obey the letter and the spirit of the law. Although not all directors, officers, employees or agents are expected to know the details of these laws, it is important to know enough to determine when to seek advice from supervisors, managers or appropriate personnel. The management of RLCCC has access to legal advice and will seek such advice as is necessary. RLCCC is subject to complex regulation by governmental authorities in the United States and other countries. RLCCC maintains positive relations with those authorities by ensuring that all our activities, including research and development, meet or exceed the requirements of applicable laws and regulations. RLCCC has established a Compliance Committee of its Board of Trustees as well as a Management Compliance Committee to develop, implement, administer and enforce RLCCC s Compliance Plans. Such

17 programs are designed to ensure that RLCCC is in compliance with its policies and all applicable laws and regulations concerning good clinical, laboratory, regulatory, labeling, third-party reimbursement of the cost of its products, human resources and environmental practices. These programs are more detailed than the general statements of ethical business conduct contained in this Policy. You should contact the RLCCC Compliance Officer with any questions. 2. Health Care Fraud and Abuse Laws: RLCCC is eligible for reimbursement under federal and state health care programs such as Medicare and Medicaid. Federal and state laws designed to prevent fraud and abuse under these programs prohibit RLCCC from offering valuable items or services to customers or potential customers to induce them to buy, prescribe or recommend RLCCC s services. These laws also prohibit the Council from submitting any false information to government programs or from assisting or encouraging customers to submit false claims for payment from these programs. RLCCC is committed to conducting the sales and marketing of its products in strict compliance with these laws. RLCCC has adopted separate policies that further explain these laws and describe how to comply with them in specific circumstances. Those employees involved in sales and marketing will receive training in these policies, must be familiar with them and must adhere to them. 3. Patient Privacy: RLCCC will strive to guard the confidentiality of any and all medical information in our possession and will strive to comply with all applicable laws and regulations governing the use of personally identifiable healthcare information. 4. Government Officials: The use of RLCCC funds or other RLCCC assets for any unlawful purpose is strictly prohibited. This includes making payments, giving gifts or providing anything else of value to government officials, political parties, political party officials, candidates for public office or employees of public international organizations, in each case whether foreign or domestic, for the purposes of improperly influencing any of their actions or decisions, or securing any improper advantage with respect to RLCCC s business. This also includes making payments, giving gifts or providing anything else of value to third persons while knowing that they will make payments, give gifts or provide anything else of value for such purposes to any of those described above. Any payment, gift or the provision of anything else of value, such as reimbursement for travel or lodging, to any of those described above for purposes of promoting, demonstrating or explaining RLCCC s products or services or executing or performing a contract must also be approved in advance in writing by the

18 CEO/Medical Director except to the extent he/she issues exemptions in writing for items not exceeding certain minimal amounts. Any payment, gift or the provision of anything else of value to any of those described above must be recorded in RLCCC s books and records in reasonable detail, accurately and fairly and in accordance with RLCCC s accounting principles and procedures. 5. Corporate Hospitality towards Public Officials: Hospitality towards public officials should be of such a scale and nature so as to avoid compromising the integrity and reputation of the public official or RLCCC. All such hospitality should occur with the expectation that it will become a matter of public knowledge. RLCCC expects the use of good judgment and moderation when giving services. No hospitality should ever be conditioned upon, or be a reward for, purchasing, prescribing or promoting RLCCC s services. 6. Antitrust and Competition Laws, Fair Dealing: Antitrust and competition laws protect free enterprise. These laws prohibit agreements that reduce competition, such as price-fixing and boycotting suppliers or customers. RLCCC believes in and intends to operate with fair and open competition. Under no circumstances should employees enter into arrangements with competitors affecting pricing or marketing policies. RLCCC representatives should avoid creating even the appearance of an improper agreement or understanding by keeping communications with competitors to a minimum and ensuring that there is a legitimate business reason for all such communications. 7. Conflict of Interest, Corporate Opportunities: Each of us is expected to deal with all matters related to RLCCC and persons doing business with RLCCC in an honest and ethical manner and in the best interests of RLCCC without favor or preference based on personal considerations. Employees, consultants and Board Members will therefore avoid any situation that does or may involve an actual or apparent conflict of interest between our personal interest and RLCCC s interest. In particular, none of us will: A. Serve as director, officer, employee or consultant of any concern which does substantial business with, or is a competitor of, RLCCC B. Use RLCCC s property or information or position for personal gain C. Compete with RLCCC, directly or indirectly, in the purchase or sale of property, property rights (including both tangible and intellectual property), products, services or other interests

19 D. Accept any personal loan or guarantee of obligations from RLCCC The extent such arrangements are legally permissible: E. Own, nor will any member of our household own, an interest in or participate in the profits of any concern that does business with or is a competitor of RLCCC, provided that, securities of publicly traded entities may be owned if (a) they are not purchased as a result of confidential information obtained as a result of being employed by RLCCC, and (b) ownership is less than 1% of any publicly owned RLCCC F. Accept, nor will any member of our household accept, gifts (of more than nominal value), loans, excessive entertainment, travel, services or other favors from any person or concern which does or is seeking to do business with, or is a competitor of, RLCCC, except where such gifts or favors are unavoidable because of local custom, in which case, they should be reported immediately to the CEO/Medical Director. In addition, none of us will enter into transactions or cause RLCCC to enter into transactions with related parties (individuals or entities) if there is a financial or personal relationship with or interest in the related party who would receive or would likely receive an improper benefit as a result 8. Confidentiality and Improper Use of Non-Public Information: From time to time, each of us may become aware of non-public information, both favorable and unfavorable, regarding RLCCC and its suppliers, customers, collaborators and competitors. RLCCC representatives will not disclose confidential information except when authorized by or required by law. Confidential information includes (but is not limited to): A. Information marked Confidential, Private, For Internal Use Only, or similar legends B. Technical or scientific information relating to current or future services or research C. Business or marketing plans or projections D. Earnings and other internal financial data that have not been publicly disclosed E. Personnel information

20 F. Supply and customer lists G. Other non-public information that, if disclosed, might be of use to RLCCC s competitors, or harmful to RLCCC or its suppliers, customers or collaborators; in addition, none of us may use confidential information to trade in RLCCC s securities or securities of its suppliers, customers, collaborators and competitors, prior to this information being released in the public domain; likewise, none of us may transmit this information to others with the intent of engaging in trading of financial instruments 9. Our Employees and Our Community: RLCCC is committed to treating all employees with honesty, fairness, safety and respect. In order to create this environment, RLCCC will provide equal treatment for employees, promote a positive work environment and protect the health and safety of all employees. RLCCC is also committed to participating actively in and improving the communities in which RLCCC conducts business. In building relationships with our community and the public, RLCCC will respect the welfare of animals, protect the environment and conduct political activity responsibly. 10. Communication, Open Door Policy: Any concerns relating to RLCCC s compliance with or knowledge or actual or potential violations of laws, regulations or this Policy must promptly be communicated to RLCCC s CEO/Medical Director or Compliance Officer. A failure to communicate knowledge of violations of this Policy is itself a violation of this Policy. Retaliation against anyone who raises a concern or reports misconduct is strictly prohibited and will not be tolerated. If for any reason you are uncomfortable speaking about your concerns with any of the individuals set forth above, you may communicate your concerns anonymously by calling the independently monitored hotline established for this purpose, or you may contact RLCCC's Compliance Officer or external legal counsel. 11. Investigation, Disciplinary Actions: RLCCC s Compliance Officer will investigate any reported violations and will oversee an appropriate response, including corrective action and preventative measures. Those who violate any laws, governmental regulations or this Policy will face appropriate, case specific disciplinary action, which may include oral warnings, suspension, demotion or discharge. RLCCC may take disciplinary action if such a violation occurs due to recklessness or negligence. In addition, disciplinary action, up to and including termination of one s relationship with RLCCC, may result for:

21 Conspiring with or directing others to violate the law, regulations or RLCCC policies Failing to cooperate in a RLCCC investigation of possible violations Retaliating against another employee for reporting a concern or violation Failing to effectively monitor the actions of subordinates RLCCC will assist in any investigation by any regulatory or law enforcement center. No RLCCC representative will conceal information from regulators or law enforcement personnel or from RLCCC s independent auditors or lawyers with respect to matters for which they have been engaged by RLCCC. 12. Waiver: The provisions of this Policy may be waived for directors or executive officers only by a resolution approved by a majority of the independent and disinterested members of RLCCC s Board of Trustees. Any change in or waiver of this Policy will be publicly disclosed in accordance with applicable law or regulation or as required.