Do you hate policies and procedures?
If you do, you’re not alone! While we don’t enjoy drafting them, health care Compliance professionals are all too aware that policies and procedures (or policies) are a critical element of a successful Compliance Program, as emphasized in the newly released OIG “General Compliance Program Guidance” (“Guidance”). The Guidance makes it crystal clear that your policies and procedures must address 2 specific areas: regulatory risk associated with your specific business as it relates to federal and State laws and, and the operations of your Compliance Program itself, i.e., the 7 Elements of a Compliance Program as recommended by the OIG. As the Guidance states:
“Compliance policies and procedures should encompass...the implementation and operation of the entity’s compliance program, including the seven elements.”
Does the thought of drafting these policies and procedures sound horrible? For so many, it is extremely stressful! As a Compliance Officer for over 20 years, and once dubbed the “Policy and Procedure Queen,” I have witnessed this TERROR countless times!
So, why are policies and procedures so important?
As the Guidance notes, they are, simply, PROOF – verification to the government and other stakeholders of your intent to comply with a requirement, and your explanation of how you are going to do that.
Policies and procedures evidence the decisions your organization has made about a particular topic – you are acknowledging your obligation to implement one of the 7 Elements of a Compliance Program (your policy), and then how you are going to make that happen (your procedure). Policies and procedures outline consistent processes and approaches and help to protect your organization from the significant financial and reputation risks of non-compliance. In an industry as sophisticated and complex as health care, regulatory compliance requires focused awareness and consideration. Policies and procedures also define and communicate performance expectations for employees, which is absolutely critical to a successful Compliance Program. Absent the decisions your policy conveys - absent a written policy and procedure - there is nothing that communicates to stakeholders, or to your employees, the organization’s intent of meeting your regulatory obligations. For further assistance or templates for Compliance Program policies and procedures click here.
Further, Compliance policies and procedures define your entire Compliance Program. The exercise of drafting and implementing the policies, and making necessary revisions, generally enhances comprehension of the structures and processes necessary to build an EFFECTIVE COMPLIANCE PROGRAM and promotes a detailed understanding of how to operationalize the 7 Elements as recommended by the OIG. Often it serves as an educational experience for all those involved - for you, the Compliance Committee, and other members of leadership. You can learn and make solid decisions regarding your Compliance Program as a team.
But, why is drafting written policies and procedures so dreadful?
Often the struggle with the development of policies and procedures is because we are not sure exactly “what” we need to do, or “how” we are supposed to do it. If the detail of the subject matter is not clear, or we are not sure of what must be done to ensure the policies and procedures promote compliance and are accurate, they are extremely difficult to draft. It can also be uncomfortable to admit that you are unfamiliar or inexperienced with a topic about which you have been tasked to explain and define. If you have not been working in compliance for very long, it is even more difficult to draft complex and detailed policies and procedures. And, let’s face it, writing any policies and procedures is just plain hard!
Remember that you should not have to draft these alone. Your COMPLIANCE COMMITTEE and other members of the leadership team should be available to assist and work through the process with you. Templates from professional organizations, or colleagues can be extremely helpful in getting started. Don’t be afraid to reach out. Additionally, the process for the development of policies and procedures should be flexible and adaptable. If a draft turns out not quite right or unclear, it can be revised! You don’t always get it right the first time! After I draft and finalize a policy and procedure, I immediately open a new draft in a “Versions” folder and turn on “track changes” in Word. Then, as time goes on and I realize I need to revise something in the policy, I make the change right away in the new version. After there are enough changes to warrant re-review and approval, I submit it to the Compliance Committee for consideration, even if it is before the organization’s required deadline for policy renewal. Change is inevitable. Policies and procedures are always a work in progress!
It is also valuable to ask for feedback and input from employees who are expected to comply with the policy and procedure. Do they understand the intent of the policy? Is it clear what they are expected to do? For example, in writing your “Hotline” or “Effective Lines of Communication” policy and procedure, ask employees, after they read it, if they know “what” they should report, and “how” they go about doing that, etc. Revise what is not clear based on their recommendations. Keep the dialogue open and it will help you to develop accurate and meaningful policies and procedures.
If you are truly struggling to draft a specific Compliance Program policy and procedure, you might have to become more familiar with that particular Compliance Program Element and what is necessary for your organization to comply. As far as Compliance Program policies and procedures go, the new Guidance, and previous OIG guidance, can be extremely helpful. Try to concentrate on drafting the policy and procedure for one Element at a time or it can be over-whelming. Don’t try to boil the ocean or get them all completed at once – it takes time!
For more information:
Kirsten Ruzic Wild, RN, BSN, MBA, CHC
Wild Consulting, Inc.
262.993.4747
Are you the Compliance Lone Ranger?
I often encounter individuals who ask me how to get their Compliance Program off the ground, or they’re in a position in which their organization has bits and pieces of a Compliance Program in place, or someone started to develop a Program years ago, and somehow the ball got dropped. Regardless, this individual has been given the responsibility of ensuring their Compliance Program is implemented and they don’t know where to begin. If you are in this camp – read on!!
First, you must be sure you are not the Lone Ranger. I see this all too often and have also ridden in that saddle. It is truly a lonely ride through the wilderness! (Can you hear the William Tell Overture?”)
So, first consider that other departments or functions within your organization are not managed by a singular individual, alone, and with no support. Even in small organizations, there is more than 1 individual in a department, or there is a committee, or division meetings, etc., in which you discuss and receive support regarding objectives, initiatives, or various projects. No one can be effective and successful if they work in a vacuum. Even the Lone Ranger had Tonto.
It is no different for Compliance. In order to initiate, or move your Compliance Program forward, you will need to make decisions, get feedback on a myriad of documents, and generally collaborate with other leaders in your organization. You must ensure that you have that requisite support – that support is your Compliance Committee.
The membership of your Compliance Committee is entirely your organization’s decision. It should be comprised of individuals who will “aid and support the compliance officer in implementing, operating, and monitoring the Compliance Program.”** Specifically, members of the Committee should assist in analyzing your legal and regulatory requirements, review policies and procedures, help to monitor internal controls, review training materials, etc. If your Compliance Committee is just being formed, members will likely need a bit of education to understand their role and the expectations placed on them. Be careful, Kemosabe - the Compliance Officer does not report to the Compliance Committee; the Compliance Committee is there to bolster the Compliance Officer. You, as the Compliance Officer, are still responsible for leading this Committee. All of this – the Committee objectives, membership, expectations and responsibilities, etc., must be captured in a documented Compliance Committee Charter. For a template of a Compliance Committee Charter, click Policy & Procedures — Wild Consulting, Inc. (wildconsultinginc.net). Other detailed recommendations, expectations, and suggested structure of your Compliance Committee can be found in the OIG’s “General Compliance Program Guidance” released last November. **
So, how do you ensure Compliance Committee members will accept their role on the committee, be actively and meaningfully engaged, and support the Compliance Officer? The very first thing a Compliance Officer must do is to garner the support of your Board of Directors! This is your silver bullet - the governing body! Without their acknowledgment and validation of the organization’s Compliance Program, you will be very challenged to implement a successful Program. Most often formal support from the Board of Directors takes the form of a written resolution, brought to the Board of Directors by the Compliance Officer. The resolution officially documents the Board’s directive that the organization establishes (or strengthens) a Compliance Program, appoints a Compliance Officer, provides an adequate budget and resources, establishes a Compliance Committee, and requires regular status reports from the Compliance Officer. For a template of a Board of Directors Resolution, go to Policy & Procedures — Wild Consulting, Inc. (wildconsultinginc.net).
Once your Board of Directors passes a formal resolution directing the organization to form a Compliance Committee, it is very difficult for senior leadership, including the CEO, or the Compliance Committee, to act in any other manner than to help champion compliance. With an approved Board Resolution and Compliance Committee Charter, you are on your way! Hi’yo Silver!!
For more information:
Kirsten Ruzic Wild, RN, BSN, MBA, CHC
Wild Consulting, Inc.
262.993.4747