OneOme’s Code of Conduct governs the behavior and actions of employees, management, and agents in all business decisions and interactions with customers, vendors, partners, or other entities. If you need to report a violation of this Code of Conduct, you can do so anonymously by calling our integrity hotline at +1 612-852-4817.

General

The purpose of this Business Ethics and Code of Conduct Policy is to describe the process that OneOme, LLC uses to ensure compliance with ethical business practices, Federal Law, and AdvaMed Code of Conduct for interactions with healthcare professionals. (AdvaMed).

OneOme strives to foster a culture of honesty and accountability. Our commitment to the highest level of ethical conduct should be reflected in all of OneOme’s business activities including, but not limited to, relationships with employees, contractors, customers, suppliers, competitors, the government, the public, and our investors. All of our employees, contractors, agents, officers and directors must conduct themselves according to the spirit of this Code and avoid even the appearance of improper behavior. Even well-intentioned actions that violate the law or this Code may result in negative consequences for the OneOme and for the individuals involved.

Scope

The following policy manual describes and incorporates by reference the Standard Operating Procedures, the Employee Handbook published by OneOme and the Employee Business Ethics and Code of Conduct in use by OneOme.

Associated Documents and resources

Employment, Confidential Information and Invention Assignment Agreements

Reference Documents

  • OneOme Compliance Charter
  • OneOme Standard Operating Procedures and Policies
  • OneOme Employee Handbook
  • AdvaMed Code of Ethics on Interactions with Health Care Professionals

Responsibilities

OneOme Management and all employees, contractors and agents are responsible for ensuring that this procedure is followed. As a Medical Device retailer and Covered Entity Healthcare Provider, OneOme must comply with all Federal Regulations governing these business areas. Failure to comply with this policy or report suspected violations of this policy to OneOme Management is grounds for sanction, including termination, and may carry civil and criminal penalties for OneOme and the individual employee. In addition, if an employee, contractor or agent believes that following a OneOme policy or process would cause them to violate this Code they must act in a manner that is in compliance with this Code.

Reporting Issues and Seeking Guidance

All members of the OneOme community have a shared responsibility to maintain an environment of accountability and open communication and are encouraged to raise concerns regarding this Code and its enforcement. Illegal or unethical behavior, as well as any violation of the Code of Conduct or related policies should be reported. If someone does not feel comfortable raising an issue with management, concerns may also be raised to Human Resources, the legal department, Compliance Committee members, or through the Integrity Hotline which allows employees to report concerns confidentially. (US 1-612-852-4817).

OneOme handles inquiries and investigations confidentially. If a concern is substantiated, the situation will be resolved through appropriate corrective actions which may include among other things, clarification of a OneOme policy, additional training, process changes, and/or disciplinary action.

No Retaliation

OneOme values employee, contractor or agentassistance in uncovering possible misconduct and forbids retaliation against anyone who raises an issue or concern in good faith. Retaliation is defined as any action that would likely deter someone from reporting a Code concern or participating in a Code investigation. In fact, retaliation against an individual for a good faith report of a suspected violation, even if it turns out to be unfounded, constitutes a violation of the Code. This provision does not protect OneOme employees from disciplinary action for their own misconduct.

Policy

1. Compliance with Laws and Regulations

OneOme is strongly committed to conducting business affairs with honesty and integrity, and in full compliance with all applicable laws, rules and regulations. It is the personal responsibility of all employees, contractors and agents to acquaint themselves with the legal and policy standards and restrictions applicable to their assigned duties and responsibilities, and to conduct themselves accordingly. No employee, contractor, agent, officer or director shall commit an illegal or unethical act or instruct others to do so for any reason.

Healthcare is a highly regulated industry with numerous laws that apply to the work we do at OneOme. Following are examples of laws or regulations that impact OneOme. This is not intended to be an exhaustive list and other laws, rules and regulations may apply to OneOme, its contractors, employees and officers.

Federal Regulations via the Food and Drug Administration (FDA):

OneOme is committed to producing products that are safe and effective. OneOme will comply with standards that meet or exceed regulations promulgated by the FDA or the laws and regulations of the country of development and manufacture. In manufacturing its products, OneOme will comply with all applicable laws and regulations, including those relating to the environment and occupational health and safety. OneOme will represent its products and services accurately and will comply with applicable regulatory and legal requirements governing the marketing and sale of its products and services.

Medicare Program Requirements:

OneOme, through its Clinical Medical Laboratory, participates as a covered entity Medicare billing provider1. The rules and requirements of this program are numerous and change frequently. OneOme employees, contractors and agents are responsible for knowing and complying with the program requirements applicable to their individual role.

Healthcare Fraud, Waste and Abuse:

OneOme complies with all federal and state regulations to ensure the preparation and submission of accurate and complete claims to Medicare, and does not submit false, fraudulent or misleading information to the government or any third-party payer to obtain payment for a service. OneOme prohibits any employees, contractors, agents or representatives from knowingly presenting or causing to be presented claims for any payments that are false, fictitious, or fraudulent. All subcontractors that perform billing or coding services must have the appropriate skills, training, quality assurance processes, necessary procedures, and knowledge of federal and state regulations to ensure all billings are correct. OneOme only bills for services that are actually rendered.

False Claims Act2:

OneOme does not submit claims for payment to government payors that it knows, or should know, are false or fraudulent. OneOme will ensure that all orders, tests, procedures, documentation, coding and information submitted to the government or third-party payer is accurate and not misleading. If OneOme discovers an error in a claim that has already been submitted it will correct the error, including implementing appropriate corrective actions to return overpayments that may result in non-compliance with Section 6402 of the Affordable Care Act.

Anti-Kickback Statute3:

OneOme shall not solicit, receive or offer to give anything of value to anyone in exchange for referral of patients or federal healthcare program business. Contracts with referral sources and customers shall conform to all applicable laws and shall be reviewed by the Legal Department prior to being entered into.

Exclusion Statute4:

OneOme shall not accept payment from any Federal Health Care Program for referrals from excluded organizations or individuals. OneOme cannot employ, contract with, or have any services provided by an excluded organization or individual.

Health Insurance Portability and Accountability Act (HIPAA):

OneOme is a covered entity Healthcare Provider5 and complies with HIPAA regulations to protect the privacy and security of patient information. OneOme employees and subcontractors who have access to patient information must be thoroughly familiar with, and conform to, HIPAA regulations and OneOme privacy and data security policies and procedures. OneOme provides an avenue for employees to ask HIPAA related questions by contacting the OneOme Data and Privacy Officer at 651-407-7151 (Office) or 651-278-3895 (Mobile) or by reporting concerns to the Integrity Hotline.

2. Integrity

As a company, OneOme must earn and maintain a reputation as an honest and ethical organization by maintaining high standards in our relationships with customers, vendors, employees, distributors, investors, contractors, agents, and the general public. To ensure that OneOme continues to uphold these high standards, all officers, employees, contractors and agents of OneOme need to be aware of our policy regarding business ethics. Briefly stated, our basic principles are honesty and integrity. It is not feasible to list all of the various situations in which questions of business ethics might arise. In this Code we cite several areas where our policies are clear, and employees, contractors and agents are expected to comply fully with our policies, and with all applicable laws.

3. Confidentiality of OneOme Information

Employees must at all times, while employed and thereafter, keep in confidence all confidential information of or about OneOme. Confidential information refers to information of a confidential or proprietary nature related to OneOme or its business. All employees are expected to comply with OneOme’s Employee Handbook and must execute a Confidentiality Agreement. Employees may have access to non-public information or business practices, new product plans, objectives and strategies, records, databases, salary and benefits data, supplier lists, and pricing information, all of which are determined to be Confidential Information. Confidential Information also includes conversations with our team, customers, vendors, and clinicians. Proper handling and security of confidential information is the cornerstone of earning and maintaining a reputation as an honest and ethical organization.

4. Intellectual Property:

It is essential that OneOme employees, contractors and agents always use company trademarks and other intellectual property properly. OneOme’s intellectual property is an invaluable asset that must be protected at all times. Intellectual property includes trademarks, brands, logos, copyrights, inventions, patents, know-how, confidential business information, and trade secrets. OneOme employees, contractors and agents should never allow a third party to use our trademarks or other intellectual property without proper authorization and a license agreement that has been approved by Senior Management. Furthermore, our trademarks should never be used in a degrading, defamatory, or otherwise offensive manner.

Our intellectual property also includes employees’ work product. As a Company employee, any work you create, in whole or in part, in connection with your duties, and/or using Company time, resources, or information, belongs to OneOme. For example, inventions, ideas, discoveries, improvements, artwork, processes, designs, software, or any other materials you may help create or author in connection with your work for our Company belongs to OneOme and is considered a work for hire. Employees should promptly disclose any invention so that it may receive the same protection as other intellectual property of our Company.

5. Data Privacy and Security

OneOme and its employees, contractors and agents have access to the personal information of our customers, website users, providers, and their patients. OneOme must comply with all US federal and state laws and regulations regarding the obligation to maintain the privacy of personal identifying information obtained from data subjects. In addition, OneOme must also comply with the privacy laws and regulations of all countries in which it conducts business operations and/or offer products and services. This includes, without limitation, the GDPR in the European Union, the Privacy Act of 1988 in Australia, and PIPEDA in Canada.

6. Protected Health Information

Pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the California Consumer Protection Act (CCPA) and the European Union General Data Protection Regulation (GDPR), OneOme is required to protect and ensure the lawful use of personal data and Protected Health Information (PHI). All employees must be trained on data privacy and must ensure PHI held by OneOme is maintained, kept confidential and used only for legitimate business purposes based on OneOme policies and procedures and according to all laws. At no time should any OneOme employee access data for which they have no operational responsibilities; misuse of access to OneOme data or stored PHI will subject the individual to disciplinary action and / or immediate termination.

7. Equal Employment Opportunity and Harassment Policies

As emphasized in OneOme’s Employee Handbook, it is our policy to employ, retain, promote, terminate and otherwise treat any and all employees and job applicants on the basis of merit, qualifications and competence. The company engages contractors and agents on the basis of merit, qualifications and competence. No person shall be illegally discriminated against with respect to the terms of employment due to age, color, race, religion, disability, sex or national origin, or any other category protected by law.

OneOme does not condone and will not tolerate the harassment of its employees, contractors, agents, customers or vendors by any person. Degrading jokes, slurs, intimidation, or other harassing conduct is unacceptable. OneOme will not tolerate a hostile work environment under any circumstances regardless of whether the behavior takes place before, during or after normal working hours or inside or outside of the workplace. OneOme will not permit unwelcome sexual advances, requests for sexual favors, or other verbal or physical conduct of a sexual nature, or harassment of anyone because of his or her age, color, race, religion, disability, gender, national origin, marital status or other protected class.

8. Protection and Proper Use of OneOme Assets

Protecting OneOme Assets against loss, theft or other misuse is the responsibility of every contractor, employee, agent, officer and director. OneOme Assets can be tangible items such as office equipment, facilities and OneOme funds, as well as intangible items like information or data. We must maintain technical systems to safeguard our information systems so that they are kept secure from unauthorized use, damage or diversion. This means protecting computers, mobile devices, building access cards and information systems by complying with security and privacy policies. The sole purpose of OneOme’s equipment, supplies, funds, and technology is the conduct of our business. They may only be used for OneOme business consistent with OneOme guidelines.

9. Integrity of Records and Accounting Practices

All OneOme business transactions must be properly authorized and be accurately recorded on OneOme’s books and records in accordance with generally accepted accounting principles and established OneOme financial policy. Compliance with accounting procedures and internal control procedures is required at all times. OneOme employees should never participate in the misstatement of OneOme’s accounts, or the misstatement of the representations and certifications disclosures provided in OneOme’s filings.

10. Conflict of Interest

It is OneOme’s policy that every employee, contractor, or agent must avoid any interest, activity or relationship that conflicts with OneOme’s interest; these individuals owe a duty of loyalty to OneOme and should take care to avoid situations in which there is an appearance theirchoices and actions are for reasons other than the benefit of OneOme. Personal interests must not conflict with OneOme interests. No employee, officer or director may enter into a business arrangement or advisory capacity which causes them to compete with OneOme. Employees, contractors, agents, officers and directors are prohibited from taking for themselves business opportunities that are discovered through the use of corporate property, information or position.

11. Fair Dealing

Every employee, contractor or agent should endeavor to deal fairly with OneOme’s customers, patients, suppliers, competitors, the public, and employees. No employee, contractor or agent should take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts or any other unfair dealing practice. No bribes, kickbacks, or other similar payments in any form shall be made directly or indirectly to or for anyone for the purposes of obtaining or retaining business or any other favorable action. Business practices that would likely result in a feeling or expectation of personal obligation on the part of either party to the transaction should not be extended or accepted.

Business practices that are acceptable in a commercial business environment may still be against the law or the policies governing federal, state or local government employees, including Healthcare Professionals. Except in certain limited circumstances, the Foreign Corrupt Practices Act (FCPA) prohibits giving anything of value directly or indirectly to any “foreign official” for the purposes of obtaining or retaining business.

12. Conduct requirements associated with interactions with Healthcare Providers

OneOme is committed to ethical and transparent interactions with Healthcare Providers (HCPs) with whom we work, whether it be to support the effective use of our products, to improve patient care, or support medical research and education. HCP interactions could include meetings, speaking events, symposia, product promotion and training, research and education initiatives, or consulting agreements. OneOme employees, contractors, and agents must conduct themselves with the highest degree of integrity and honesty to facilitate ethical interactions with Health Care Professionals to ensure medical decisions are based on the best interests of the patient. In all such interactions OneOme employees,consultants and agents must be aware and comply with all applicable laws and regulations that govern relationships with HCPs in the countries in which we do business.

OneOme forbids the improper inducement to a HCP in the form of a payment or anything else of value to incentivize or reward the recommendation or use of OneOme products or services. OneOme will align its Corporate Expense Policy with applicable laws and the AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). Employees, contractors and agents’s financial interactions with Health Care Providers are limited, according to OneOme policy and under the AdvaMed Code, to promotional activities such as meals and business courtesies provided in the context of a business meeting. These legitimate promotional activities are allowed provided they: are permitted under local law; are reasonable and bona fide; are directly related to the product sales or service of a contract; in an amount that covers only the costs actually incurred; and are properly recorded in books and records.

Gifts to, and entertainment of, HCPs is prohibited.

13. Environment, Health and Safety

OneOme strives to provide each employee with a safe and healthy work environment. Each officer and employee has responsibility for maintaining a safe and healthy workplace for all employees by reporting accidents, injuries, and unsafe equipment, practices, or conditions and developing corrective and preventive actions, as appropriate. Contractors and agents who observe any unsafe work area or practice have a responsibility to report these observations to OneOme management.

Those with authorized lab access must take all reasonable precautions when handling hazardous materials. Those persons not specifically authorized to do so are prohibited from going into the lab.

14. Substance Abuse

Working while impaired from the use of drugs or alcohol may pose an unacceptable risk to yourself and others. OneOmetherefore prohibits employees, contractors or agents from:

  • working while impaired by alcohol, illegal drugs, or controlled substances on or off OneOme premises;
  • possessing, selling, using, transferring, or distributing illegal drugs or controlled substances while working for or on the behalf of OneOme;
  • working while impaired by a lawful prescription medication or over-the-counter drug;
  • operating a motorized vehicle while impaired by alcohol, illegal drugs, controlled substances or by a lawful prescription or over-the-counter drug.

OneOme employees who are concerned they may have a drug or alcohol problem are encouraged to seek assistance.

(See also Drug-Free Workplace and Alcohol Use Policy in the Employee Handbook)

15. External Communication and Social Media

Press: An employee who is contacted and asked to discuss Company business with any member of the press,investors, or market analysts, may not provide any information. Instead, the employee must politely advise the outside party that they are not authorized to discuss the subject and should refer them to OneOme Press Relations.

Social media: Employees, contractors, agents, officers, and directors may not post on social networking sites and blogs sensitive, proprietary, confidential, or unpublished financial information about the Company, or any Protected Health Information (PHI).

Employees, contractors and agents may not use social networking to promote or advertise on behalf of OneOme or its subsidiaryCompanies without Company approval. This includes any promotional content or statements intended to endorse, promote, sell, advertise, or otherwise support the Company and its products and services.

If you are a OneOme employee, contractor or agent, when using social media, you should be clear that you do not speak on behalf of the Company. You should always:

  • state that the materials and opinions you are posting are yours and not the Company’s;
  • take every possible precaution to protect confidential information from disclosure;
  • refrain from using any third-party logos or trademarks without express permission.

Executives, officers, directors, and managers have a special responsibility when posting communications since their opinions may still be deemed to express the position of OneOme.

(See also Conference, Panels, Social Events, Social Media and PR in the Employee Handbook)

17. Training and Education:

Continuing education and training of employees helps OneOme comply with the complex series of laws, rules and regulations that govern our business. Accordingly, all employees and contractors must complete on-going training to, among other things, ensure compliance with the Code of Conduct, OneOme policies, and applicable legal requirements where we do business. Failure to certify or complete required and mandatory training in a timely manner may result in disciplinary action

References:

  1. 45 C.F.R. §160.103
  2. 31 U.S.C.§§ 3729-3733; 18 U.S.C. § 287
  3. 42 U.S.C. § 1320a-7b(b)
  4. 42 U.S.C. § 1320a-7
  5. 45 C.F.R. §160.103