California Compliance Declaration

Preventice Comprehensive Compliance Program

Introduction

Preventice is committed to fully complying with all applicable laws, regulations, guidelines and company policies. As such, Preventice implemented and maintains a robust Comprehensive Compliance Program founded upon the seven essential elements of an effective compliance program as promulgated by the U.S. Department of Health and Human Services Office of the Inspector General (OIG) and in compliance with the provisions of the Code of Ethics on Interactions with Healthcare Professionals created by the Advanced Medical Technology Association (the “AdvaMed Code”), which is consistent with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Providers ("PhRMA Code").  This program applies to Preventice Solutions, Inc. and its wholly owned subsidiaries, Preventice Services, LLC and Preventice Technologies, Inc. (collectively, “Preventice”).

Preventice’s Compliance Program is comprised of the following:

Compliance Officer and Committee

Preventice’s Compliance Manager and Privacy Officer is responsible for developing, operating and monitoring the Compliance Program, including supporting company-wide compliance activities and initiatives and providing guidance and oversight for the processes, training and implementation necessary to fully comply with all applicable laws, regulations and guidelines. 

Preventice has a Compliance Committee that partners with the Compliance Department to (1) identify key enterprise compliance risks, (2) implement and oversee the performance of the Compliance Program, and (3) foster a culture of compliance throughout Preventice. Pursuant to its charter, the Compliance Committee meets on a quarterly basis. 

The Compliance Department makes regular reports to Preventice’s executive leadership and the Audit Committee to facilitate appropriate strategic direction and oversight relating to the management of compliance risks for the company.

Compliance Policies, Procedures and Standards of Conduct

Preventice has adopted Standards of Conduct and policies, procedures and guidelines to ensure that Preventice meets regulatory and legal requirements, organizational expectations and ethical standards. Such policies include, but are not limited to, the:
• Preventice Compliance Program Policy;
• Preventice Privacy and Security Policies;
• Preventice Certifications and Place of Service Policy; 
• Preventice Interactions with Healthcare Providers Policy;
• Preventice Conflict of Interest Policy; and
• Preventice Quality/Regulatory Standard Operating Procedures.

Additionally, as required by California Health & Safety Code §§ 119400-119402 (the “Statute”), Preventice has established an annual dollar limit on educational or practice-related items, items of minimal value and meals which Preventice Field Based Employees are permitted to provide to medical or health professionals in California under Preventice policy. As of January 1, 2019 the annual limit of $2,000 applies prospectively to educational or practice-related items, items of minimal value, and meals associated with informational presentations or discussions provided to individual medical or health professionals in California; and incorporates the limitations and definitions contained in the Statute. Most California medical or health care professionals receive much less than $2,000 worth of educational items, product literature and related items from us. However, out of abundance of caution and to fully comply with the Statute, we have established $2,000 as our maximum amount.

Training and Education

To foster cultural awareness and understanding of compliance topics, relevant laws and regulations, internal policies, procedures and reporting guidelines, Preventice requires that employees and contractors complete training upon hire or contract implementation and annually thereafter. Compliance also provides tailored compliance training for specific groups, such as the Commercial and Revenue Cycle teams. Attendance at these training sessions is mandatory.

Open Lines of Communication

Preventice is committed to fostering open lines of communication for asking compliance questions and reporting compliance concerns. As such, Preventice has a strict confidentiality and non-retaliation policy to protect individuals that report concerns in good faith. 

Preventice contracts with a compliance hotline vendor to provide employees, contractors and partners with an anonymous option to report compliance concerns. The hotline reporting option is available in multiple languages 24 hours a day, 7 days a week, 365 days a year. 

Preventice also provides employees with an opportunity to report concerns during each employee’s exit interview.

The Compliance Department promptly and thoroughly investigates all reported concerns in collaboration with relevant leadership and implements corrective measures, as appropriate.

Reported question and concern metrics are tracked and reported to the Compliance Committee and Executive leadership on a regular basis.

Internal Reviews and Risk Assessments

Preventice conducts routine internal monitoring, auditing and risk assessments to ensure compliance with the Standards of Conduct, internal policies and procedures, and relevant laws, regulations and guidelines.

Prompt Responses to Detected Deficiencies

Preventice responds promptly and appropriately to all potential compliance issues. Upon notice of a potential compliance issue, the Compliance Department ensures that a documented investigation is carried out in an appropriately prompt, thorough and efficient manner. If a potential issue is substantiated, Preventice takes prompt and appropriate remedial actions, including but not limited to, root cause analysis, the implementation of policies and/or procedures, education and training, process enhancements, and voluntary self-disclosure and/or the timely return of overpayments, if an overpayment is identified.
 

Enforcement of Disciplinary Standards

Preventice enforces its compliance and ethical standards through well-publicized Standards of Conduct and policies that outline the compliance and ethical responsibilities of employees and contractors and communicate the consequences of non-compliant, unethical or illegal behaviors. Preventice evaluates each potential compliance concern on a case-by-case basis, taking into account all relevant factors, to address inappropriate conduct and deter future wrong-doing.
 

Availability of Information

For a copy of Preventice’s Comprehensive Compliance Program call 888-400-3522.
 

Declaration of Compliance

To the best of its knowledge, Preventice is, in all material respects, in compliance with its Comprehensive Compliance Program, and its good faith understanding of the requirements of California Health and Safety Code §§ 119400-119402 as it may apply to device manufacturers, based on an assessment as of February 21, 2019.