Declaration of Compliance with California
Health & Safety Code §§ 119400 - 119402
Cue Health Inc. (“Cue ” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”) consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Cue ’s Compliance Program is intended to provide guidance for Company interactions with Health Care Professionals (“HCPs”), promote the prevention and resolution of actual or apparent conflicts of interest, ensure compliance with applicable laws and regulations, and provide processes for reporting of violations of the Company’s policies relating to the sale and marketing of Cue ’s products.
For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Cue has established a specific annual aggregate dollar limit of $2,000 on gifts, promotional materials, or items or activities that Cue may give or otherwise provide to an individual HCP in California on an annual basis from January 1st to December 31st. Such items or activities primarily include:
Educational material and other items that principally entail a patient benefit or are related to the HCP’s practice;
Modest meals associated with a substantive discussion of a Company product or a disease state; and
Other items or activities permitted under the AdvaMed Code of Ethics for interactions with Healthcare Professionals (“AdvaMed Code”) and/or the OIG Compliance Guidance.
These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for HCPs in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limited will be published in this section of the Company website. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician or other HCP may be substantially less than the cap amount.
The annual limits do not include the following:
Samples given to physicians and other HCPs;
Financial support for continuing medical education forums;
Financial support for health educational scholarships;
Payments for legitimate professional services, and any meals or expenses associated with the provision of such services; and
Patient educational materials provided to patients by their provider with the purpose of educating the patient.
As stated in its Compliance Program description, the Company is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, the Company has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. The Company has tailored its Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Compliance Program. Subject to the limitations described above, the Company declares that, based upon current tracking and monitoring systems, the Company is, in all materials respects, in compliance with the Compliance Program and with respective established annual spending limits for reporting period of January 1, 2021 through December 31, 2021.
As recognized by the OIG Compliance Guidance, an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.
For a written copy of the Compliance Program description or this declaration, please call 1-833-283-8378.