United States

CA Declaration of Compliance

Corporate Compliance

As part of OraSure's ongoing efforts in the area of compliance, we have developed and implemented a comprehensive Corporate Compliance Program (the "Compliance Program") designed to comply with all applicable federal, state, and industry guidelines, relating to the marketing and promotion of our products to healthcare professionals, including the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (the "HHS-OIG Guidance"), the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (the "AdvaMed Code"), and the California Health & Safety Code §§ 119400-119402 (SB 1765).

Overview of the Comprehensive Compliance Program

The Compliance Program, described in further detail below, contains policies, procedures and processes to address risk areas identified in the HHS-OIG Guidance and the AdvaMed Code. As recommended by the HHS-OIG Guidance, the OraSure Compliance Program has been designed to fit the specific compliance needs of the company. OraSure will regularly review and evaluate its Compliance Program to ensure it continues to meet the evolving needs of the company.

OraSure has established a program designed to help ensure: (1) ethical interactions with healthcare providers, and (2) promotion and marketing practices that are in compliance with applicable federal and state laws and industry standards, as described above.

Acting Compliance Officer and Compliance Committee

OraSure has designated Stefano Taucer to act as its Compliance Officer for purposes of this compliance program. The Compliance Officer is charged with the responsibility of developing, implementing, monitoring and updating the Compliance Program. The Compliance Officer has the authority to effectuate change and exercise independent judgment within the company. The Compliance Officer reports directly to the Chief Executive Officer and provides periodic updates to the Board of Directors.

OraSure is also in the process of establishing a Compliance Committee comprised of senior management personnel from a variety of business units, as well as legal counsel. The Compliance Committee advises and assists the Compliance Officer in the development, maintenance and updating of the Corporate Compliance Program.

Written Standards

Consistent with the HHS-OIG Guidance, OraSure has established written policies and procedures to ensure compliance with the AdvaMed Code and other complementary policies that outline the company’s commitment to compliance and corporate accountability. The standards set forth in the policies apply to all OraSure employees, contractors and agents, and failure to comply with such policies and procedures may result in disciplinary action, up to and including termination.

Education and Training

All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the Compliance Program and relevant OraSure policies. In addition, further specialized training may be provided where a need for additional training has been identified. OraSure regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.

Effective Lines of Communication

OraSure is committed to open dialogue between management and employees. OraSure's goal is to foster an open-door policy to encourage employees to ask questions or report potential instances of inappropriate activity without fear of retaliation. The company has established a confidential and anonymous Compliance Hotline number that is available 24 hours a day, seven days a week for making good faith reports of known or suspected violations. Any such report relating to this Compliance Program may be directed to the Compliance Officer or designated Compliance staff through any of the following means:

  • Email, (non-anonymous)
  • Telephone (anonymous), toll-free and available 24 hours a day, 7 days a week, at:
    • U.S. and Canada: (844) 860-0008
    • All Other Countries: (800) 603-2869*

      Must dial country access code first

  • Internet (anonymous)

Employees may also report potential violations to their supervisor or Human Resources.

Auditing and Monitoring

OraSure recognizes that a comprehensive auditing and monitoring plan is critical to maintaining the effectiveness of a Compliance Program. The nature of OraSure's reviews as well as the extent and frequency of the Company's compliance monitoring, auditing and evaluation may vary according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations. As appropriate, auditing and monitoring results will be reported to senior management in order to help guide the OraSure risk-assessment process.

Responding to Potential Violations

A key purpose of the OraSure Compliance Program is to prevent and detect violations of law or company policy. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is OraSure's expectation that all employees will comply with the Compliance Program, and the policies established in support of such program. All OraSure employees have a duty to promptly report any violation of the Compliance Program or any company policies using any of the available company resources. In the event that OraSure becomes aware of violations of law or company policy, it will promptly investigate the matter and take appropriate corrective action to ensure the integrity of the Compliance Program and prevent future violations. Personnel who violate OraSure's policies and procedures and applicable state and federal laws may be subject to disciplinary action, up to and including termination.

Annual Aggregate Dollar Limit in California

OraSure does not permit gifts, promotional materials, items, or activities that are prohibited by the AdvaMed Code, HHS-OIG Guidance, or related federal or state laws or regulations. For items and activities that are not prohibited, OraSure has set an annual aggregate spending limit of $2,500 per medical or healthcare professional in California, as required by California Health and Safety Code §119402. This amount represents an upper limit rather than a spending goal or a usual, customary or typical amount for medical or healthcare professionals. This limit excludes amounts attributable to product samples, financial support for continuing medical education that conforms to OIG Guidance and the AdvaMed Code, and payment at fair market value for legitimate professional services. In setting this limit, OraSure has taken into account the size of the company and its portfolio and may revise this limit as the company and/or product portfolio changes.

OraSure Declaration of Compliance

OraSure declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, that as of September 15, 2023, it is in compliance with its Corporate Compliance Program, including its established annual aggregate spend limit of $2,500 per California medical or healthcare professional and the requirements of California Health and Safety Code §§ 119400-119402. This declaration is based upon an analysis of information available as of the date of this declaration.

Effective: September 15, 2023

This is a summary document and does not include all the policies and procedures that comprise the OraSure Corporate Compliance Program. OraSure is committed to conduct the ongoing assessment that is necessary to ensure an effective Corporate Compliance Program. The Corporate Compliance Program thus may be amended, altered or revised from time to time as needed and without prior notice.

To obtain a printed copy of this document please call (610) 882-1820.

© OraSure Technologies Inc., 2024