The Basics

To have an effective compliance program under this standard, you need:

• to know what laws and regulations apply to you organization and 
• to have robust mechanisms to assure that these laws and regulations are consistently obeyed by your employees and agents.

So, everybody involved in the organization's compliance program should keep both of these components in mind -- tracking and adherence to legal standards.

Management Tips

I was conducting reviews for URAC at the time this standard was adopted, and, at the request of my fellow reviewers, developed some guidelines to help flesh out the meaning behind this rather bare-bones standard. I leaned on the recently released revisions to the Federal Sentencing Guidelines, and came up with what you'll see in the Program Guide:

"Elements of a corporate compliance program include: 

• standards and procedures to detect non-compliant conduct by employees and agents;
• promotion of an organizational culture to encourage ethical conduct and a commitment to compliance with the law;
• reasonable oversight by the governing body of the compliance program;
• clear designation of individuals accountable for the organization’s compliance;
• systems for assuring that both hiring and compensation practices encourage the creation and maintenance of a compliant work force;
• the existence of appropriate reporting and disciplinary mechanisms for instances of misconduct;
• ongoing training of employees and managers on the organization’s standards;
• monitoring and auditing to detect misconduct;
• periodic evaluation of the organization’s compliance program;
• post hoc analyses of instances of misconduct to determine whether a systemic change is suggested by the problem; and
• periodic assessment of risk and establishment of compliance priorities

Pharm Core 19 applies to both state and federal regulations that are applicable to the program standards."

URAC Accreditation Tips

Both elements of the standard are mandatory.

In the application, all you need do is submit a coherent and comprehensive compliance plan as well as some evidence that you have a decent mechanism for tracking laws and regulations that apply to your organization.

The challenge is in the onsite interview. Typically, in a URAC review, the interview of the compliance officer is brief, usually less than one hour. How can you assure that this interview goes well? Well, if your compliance staff can answer these questions and produce the requested documentation, you'll probably do pretty well:

• How do you track the existing laws and regulations that apply to your company? By what process do you incorporate the requirements of such laws and regulations into the policies and procedures of the company? Please show records demonstrating this tracking mechanism. In addition, please show documentation demonstrating the incorporation of laws and regulations into corporate P&Ps.
• How do you track changes in or new laws and regulations (both state and federal) that apply to your company? By what process do you incorporate the requirements of such laws and regulations into the policies and procedures of the company? Please show records demonstrating this tracking mechanism. In addition, please show documentation demonstrating the incorporation of laws and regulations into corporate P&Ps.
• Please describe your company’s program, including any standards and procedures, to detect non-compliant conduct by employees and agents. Please produce documents that confirm that you implement such standards and procedures.
• What does your company do to promote an organizational culture to encourage ethical conduct and a commitment to compliance with the law? Please describe the role of your governing body in the oversight of the compliance program. Can you produce minutes of meetings of that governing body that would substantiate that it is involved in compliance oversight?
• Who is accountable for the organization’s compliance? Please describe, and produce supporting documentation, of your company’s systems for assuring that both hiring and compensation practices encourage the creation and maintenance of a compliant work force.
• How do you let employees and agents know of the existence of appropriate reporting and disciplinary mechanisms for instances of misconduct? Please produce documentary evidence of such notice to employees and agents, as well as any tracking mechanisms for such reporting. How do you track your company’s program of ongoing training of employees and managers on the organization’s standards? Please produce documentation showing those tracking processes.
• How does your organization monitor and audit to detect misconduct? Who conducts such monitoring and auditing activities? Please produce reports to support this. To whom do these people report the results of their monitoring and auditing activities? Does your organization engage in periodic evaluation of the organization’s compliance program? Who conducts such an assessment? Please produce documentation demonstrating that periodic evaluation.
• Does your organization conduct post hoc analyses of instances of misconduct to determine whether a systemic change is suggested by the problem? Please show records of such analyses. Please describe, and provide supporting documentation, of your organization’s periodic assessment of risk and establishment of compliance priorities.

One last thing -- if a URAC reviewer finds that you haven't complied with a standard that has regulatory ramifications (e.g., clinical licensure), you'll also lose points on this standard and probably find yourself in conditional accreditation -- if not worse.