Compliance Risk Assessment

In today's ever-changing regulatory environment, pharmaceutical companies must establish a true "Culture of Compliance," where compliance is integrated throughout the organization, is effectively part of the daily operations, and is not a barrier to conducting business.

The purpose behind the Compliance Risk Assessment is two-fold. First, it enables an organization to be proactive, identifying key risk areas before they become unmanageable problems. Second, it enables organizations to minimize potential losses associated with fines and penalties. As a result, these two functions ultimately lead to greater efficiency and profit.

Pharmaceutical manufacturers come in many shapes and sizes, but they all face similar challenges related to compliance. CIS is committed to providing an efficient and affordable means of compliance and risk management that is scaleable to the needs and priorities of your organization. The Compliance Risk Assessment is a low cost means of identifying potential risks and thus saving your organization from fines and penalties. During the Risk Assessment, CIS will perform a 5 Point Diagnostic Evaluation.

 
The 5 Point Diagnostic Evaluation:

  • Documentation: CIS will review your existing documentation: corporate policies and procedures, departmental policies and procedures, and departmental SOP's and analyze it with respect to current applicable authoritative guidance. Additionally, CIS will review corporate communications policies and procedures.
  • Policy and Methodology: CIS will evaluate your policies and methodologies related to Federal program participation, including Medicaid, Medicare Part B, the VA program and PHS program participation.
  • Systems: CIS will review and evaluate the Information Technology infrastructure used to support government program compliance, including calculations and pricing, PDMA, Expense tracking and aggregate spend.
  • Organizational Structure and Training: CIS will detail organizational accountabilities, structure and staffing, as well as the appropriate utilization of resources and staff training, by interviewing employees in various functional roles.
  • Monitoring: The ongoing management review and monitoring of compliance
Scope of the Evaluation

The evaluation can cover the following areas, depending on the needs of your organization:

  • Corporate Compliance Infrastructure and Accountabilities
  • Document Management and Records Retention
  • Government Programs and Statutory Pricing (including assessing your preparation for the CMS proposed rule for Medicaid AMP and BP)
  • Managed Care
  • Gifts and Entertainment
  • Medical Education
  • Patient Assistance Programs
  • Off-Label Promotion
  • PDMA and Sample Accountability
  • State Programs and Reporting Requirements
  • Compliance Training



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