Some principles are important enough to our mission to be written down. Our shared principles enable us to provide patients with important information about diseases that could impact them or their children. Patients and customers provide us with sensitive health and financial information and rely on our results. That’s why it is so important that each of us earn their trust through a commitment to these shared principles. Ethical conduct and compliance is our shared responsibility.
Counsyl values integrity in clinical and business dealings. This Code describes the minimum standards of business conduct required by all Counsyl personnel, including employees, independent contractors, and agents. While this Code is an overview of key areas of risk and appropriate behavior, it does not address every potential situation you may encounter. We hope this Code will be useful to you as a tool to help make day-to-day decisions.
We are committed to putting patients first. We comply with relevant laws governing research and development and regularly develop laboratory protocols to improve screening procedures and ensure accuracy of results. We strive to improve every aspect of the patient and customer experience through innovations in provision of laboratory services, billing, test results and genetic counseling. Our services conform to superior clinical, safety and patient service standards. We are all responsible for performing our jobs with integrity and quality.
Respect for Others. We maintain a positive working environment to encourage respect both within the company and toward our patients and the business partners and healthcare providers with whom we work. We respect patients’ and employees’ rights and do not tolerate disrespectful, threatening or harassing conduct toward any person, including sexual, physical, verbal or other unlawful harassment or discrimination.
Safety in Our Workplace. We strive to protect the safety of our personnel through training, monitoring of workplace conditions and compliance with applicable law. All Counsyl personnel are expected to be aware of their environment and to comply with Counsyl’s policies regarding workplace safety. Counsyl personnel should also comply with all procedures and applicable laws governing the handling, storage, use and disposal of hazardous materials. Additionally, we endeavor to maintain a drug-free workplace. Use of illegal drugs, or legal drugs that interfere with your ability to perform your job, is strictly prohibited on Counsyl premises. Counsyl personnel should promptly report safety concerns to management, a member of the People Ops team or to our Compliance Officer.
Maintaining and Retaining Accurate Books and Records. Our books, records and accounts must accurately reflect Counsyl’s finances and business transactions. Counsyl personnel may not make, or cause to be made, a false or misleading statement, record or report regarding Counsyl finances or business transactions and no business record, including patient billing claims and medical records, should ever be improperly altered or falsified. All Counsyl personnel should strive to ensure any financial report or disclosure of the company is fair, accurate and transparent. In addition, Counsyl personnel will safely and securely store all confidential records, including medical, financial and employee records, for the period of time required by law and in such a manner to allow prompt retrieval as necessary. When appropriate, Counsyl personnel will properly dispose of or destroy records in accordance with applicable law. Billing Practices . We bill for our services according to guidelines established in conjunction with the various payers to which we submit claims. Counsyl personnel will submit accurate and complete claims for Counsyl’s services, will maintain appropriate documentation to support all claims, and will notify payers of payment errors and process refunds promptly and accurately.
Patient Privacy. We respect and protect the confidential nature of protected health information (“PHI”) and other confidential information we receive, whether in verbal, written or electronic form. Counsyl personnel must comply with laws and regulations governing the privacy and security of PHI, including the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act. We strive to limit use and disclosure of PHI by Counsyl personnel to the minimum amount necessary to accomplish their jobs. Generally, with the exception of use of PHI for purposes of treatment, payment for treatment, or healthcare operations, Counsyl personnel may not use or disclose PHI without authorization by a patient or representative. In addition, Counsyl enters into written business associate agreements with all parties that receive, use or access PHI on Counsyl’s behalf.
Confidential and Proprietary Information of Counsyl and Its Partners. We have developed sophisticated technology to improve all aspects of patient care, including proprietary and confidential information and methods related to laboratory services, billing, and delivery of patient results and genetic counseling. Confidential information includes any information that is not publicly available and that might be of use to competitors or cause harm to Counsyl if disclosed. Confidential information, whether originating from Counsyl or our partners, must be treated with strict confidence and may not be disclosed to or discussed with others outside of Counsyl, including family and friends, except as necessary to perform your job.
Conflicts of Interest. We all have a duty to put the interests of Counsyl before our own personal interests in all that we do in connection with our work. A conflict of interest may exist if you have an opportunity to pursue a personal benefit to you, your friends or family at the expense of Counsyl, our patients or our partners. Conflicts of interest may arise in a variety of situations, such as when Counsyl personnel take action that makes it difficult for them to perform their job duties objectively. Counsyl personnel must avoid engaging in any activity that creates an actual or perceived conflict with the interests of Counsyl and must do business with third parties on Counsyl’s behalf based solely on Counsyl’s best interests.
When faced with a potential conflict of interest, you should ask yourself if the activity would (i) create an incentive for you, or be perceived by others to create an incentive for you, to benefit yourself, your friends, or your family at the expense of Counsyl, (ii) harm your reputation, negatively impact your ability to do your job at Counsyl, or potentially harm Counsyl, or (iii) embarrass you or Counsyl if it showed up on the front page of a newspaper. If the answer is “yes,” a conflict of interest likely exists and you should avoid the activity.
Interactions with Healthcare Professionals and Gifts. We aim to maintain the highest ethical standards in our dealings with healthcare professionals. We operate under the understanding that patient care should be based on medical need as determined by healthcare professionals. Gifts of any type or value are never appropriate if offered, given, solicited or received from a potential or actual referral source (e.g., a physician or clinic) in exchange for, or as inducement for, business or referrals.
Regardless of the recipient, gifts may create a conflict of interest depending on the parties involved and the purpose of the gift. As a general matter, Counsyl personnel may not offer or provide gifts unless the gift is modest in value and is not : (1) made in cash; (2) at risk of being viewed as a kickback or bribe; (3) given on a frequent basis to the same recipient; or (4) in violation of any state or federal laws. If you receive an offer of money or a gift of greater than nominal value or that you think may be intended to influence a business decision, you should report it immediately to your supervisor or the Compliance Officer.
Marketing of Counsyl’s Products and Services. We market our products and services through a variety of methods and media. Regardless of the method used, we communicate information about our products in a manner that is accurate and truthful and never false, misleading or deceptive. Information we provide must be supported by proper evidence, and all marketing and promotion, including information regarding the price of our products or services, must be approved by appropriate personnel and comply with applicable state and federal law.
As a clinical laboratory, Counsyl is subject to many state and federal laws and regulations. Counsyl is committed to compliance with all laws and regulations governing our business operations.
Anti-Kickback Statute. The federal Anti-kickback Statute (“AKS”) prohibits payment or receipt of anything of value that is intended to induce the recommendation or ordering of items or services that may be reimbursed under a government healthcare program, including Medicare or Medicaid. Certain Counsyl services may be reimbursed in whole or in part by such programs and anything of value offered by Counsyl to induce the purchase of our services could potentially violate the AKS. We strive to ensure our business transactions comply with the AKS and/or one of the “safe harbor” provisions that enable structuring of transactions in a manner that protects the parties from penalties under the AKS.
Many states, including California, have enacted similar prohibitions and we also comply with such state laws. Counsyl’s legal team will provide appropriate guidance with respect to any proposed transactions.
Federal Stark Law. The Stark Law prohibits physician referrals for “designated health services” payable by Medicare, including clinical lab services, to any entity if the referring physician or an immediate family member has a “financial relationship” with the entity receiving the referral. A “financial relationship” exists if the referring physician (or a family member) holds an ownership or investment interest in Counsyl or if there is an arrangement involving payment between the physician (or a family member) and Counsyl. A violation can occur regardless of the parties’ intent. The Stark Law includes exceptions whereby certain arrangements are deemed not to create a “financial relationship,” including personal service arrangements between the physician and the entity receiving the referral.
We do not accept referrals from a physician where the referral would violate the Stark Law. Counsyl’s legal team will provide appropriate guidance with respect to any proposed transactions.
Other Federal and State Laws, Regulations and Standards. Our laboratory is certified under the federal Clinical Laboratory Improvements Act (“CLIA”), licensed in California and several other states, and accredited by the College of American Pathologists (“CAP”). We are also required to comply with various state and federal laws, regulations and standards applicable to clinical laboratories, including state licensing laws, the federal False Claims Act, the Civil Monetary Penalties Law, and the Foreign Corrupt Practices Act. Counsyl personnel work to ensure compliance with our obligations under these laws and standards.
Reporting Violations. Counsyl personnel with knowledge of actual or possible wrongdoing or violations of law or Counsyl’s compliance policies and procedures, have a duty to immediately report the matter. Counsyl has an “open door” policy, and Counsyl personnel should report actual or suspected violations to either (1) their supervisor; (2) a People Ops representative; (3) the Compliance Officer; or (4) Counsyl’s legal team. If you’re not sure if a violation has occurred, you should seek advice from one of these sources.
Counsyl personnel may also confidentially report potential or actual misconduct 24 hours a day, 7 days a week through an independent anonymous telephone and web reporting hotline. You may make a report through the hotline by phone at (844) 258-2210 , or online at http://bit.ly/1KdBUYr.
If you report potential misconduct anonymously, no attempt will be made to trace your identity. If you choose to reveal your identity in reporting misconduct, confidentiality will be maintained to the extent practicable and allowed by law, but it may not be possible to preserve anonymity if you identify yourself, provide other information that identifies you, if the investigation reveals your identity, or if you inform others that you have reported a potential compliance issue. Counsyl is legally required to report certain types of crimes or potential crimes and infractions to external agencies.
Non-Retaliation. We do not tolerate retaliation against Counsyl personnel who have reported a violation of Counsyl’s policies and procedures, or state or federal law. Counsyl policy strictly prohibits such retaliation in any form.
Investigation and Resolution of Compliance Issues. In the event of a potential or actual compliance issue, the Compliance Officer (or a designee) will thoroughly review, investigate and respond to any related allegations. We will promptly investigate and resolve all reported compliance issues. Counsyl personnel are expected to cooperate with and assist in such investigations, as necessary.
Disciplinary Action. We all have an obligation to help ensure that Counsyl maintains the highest standards of ethical conduct. Compliance with this Code and with applicable laws and regulations is a condition of your employment with Counsyl. Personnel failing to comply with this Code or applicable law will be subject to appropriate disciplinary action, which may include termination of employment.
Updated April 2015
Counsyl has renamed its products effective July 19, 2017. The Family Prep Screen is now the Foresight Carrier Screen. The Informed Pregnancy Screen is now the Prelude Prenatal Screen. The Inherited Cancer Screen is now the Reliant Cancer Screen.
The new names now appear on all communications from Counsyl. If you have any questions, please contact Counsyl directly.