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Compliance Program Best Practices Mandatory Compliance Programs

Mandatory Compliance Programs Under the Affordable care Act

Now Is The Time To Re-Examine Compliance “Best Practices” In Your Organization

Historically, compliance programs have not been per se mandatory.  However, most larger health care organizations have established formal compliance programs to foster an atmosphere of compliance and to take advantage of possible benefits under the Federal Sentencing Guidelines.  The Patient Protection and Affordable Care Act of 2010 has made compliance programs mandatory for many providers.  The exact scope of what type of provider will be required to establish formal compliance programs has not yet been set in stone by the Office of Inspector General.  However, it can probably be expected that most providers will be required to formalize their compliance efforts.

Institutional health care compliance has been growing for well over a decade now.  Compliance is becoming of major importance to health care providers of all nature and size.  The OIG has promoted compliance programs by releasing compliance guidance covering a number of industries, including billing companies, physician practices, hospitals, home health agencies, long term care facilities, ambulatory surgery centers and others.  Smaller providers who have previously not had the establishment of formal compliance programs on their radar will now be required to adopt formal plans.

It is not enough to simply adopt a compliance plan, place it on a shelf, and let it collect dust.  A compliance program requires active monitoring.  There are seven basic elements that are necessary for a compliance program to meet regulatory requirements and the requirements under the Federal Sentencing Guidelines.  The seven primary elements of an effective compliance program include:

1)      The establishment of written compliance policies and procedures;

2)      The designation of a high ranking individual within the organization to serve as compliance officer;

3)      The establishment of an effective training and education program for all levels of personnel;

4)      The establishment of effective lines of communication, such as a compliance hotline,  to enable individuals within the organization to report compliance breaches;

5)      Performing ongoing internal auditing and monitoring

6)      The creation of a system that enforces breaches of the compliance program including appropriate discipline and corrective measures

7)      The establishment of effective measures to respond to compliance problems that are detected.

 An effective compliance program establishes an atmosphere of compliance that permeates the entire organization.  A compliance program should be tailored to the specific circumstances of the provider.  The program should also feed and grow on itself.  As problems are detected appropriate changes should be made to the program and related policies and procedures.

 Mandatory compliance programs also highlight the importance of compliance on larger institutions who may have already adopted formal programs.  These institutions should take the signal that compliance is of growing importance.   Providers who have already adopted compliance plans should take the opportunity to dust them off and re-examine the role of compliance within their organization.  Now is the time to increase the focus on compliance and assure that compliance is an active system rather than a written plan that is sitting on the shelf.

Best Practices In Compliance Program Operation

 Given the increased importance of compliance, it is helpful to for providers to get a feel for what constitutes “best practice” when operating a compliance program.  “Best Practices” is a term that is thrown around all of the time in the business world.  It is used in many contexts and takes on a variety of meanings depending on who is using it and for what purpose.  Wikipedia defines “best practices” as follows:

Best practices are generally-accepted, informally-standardized techniques, methods or processes that have proven themselves over time to accomplish given tasks. Often based upon common sense, these practices are commonly used where no specific formal methodology is in place or the existing methodology does not sufficiently address the issue. The idea is that with proper processes, checks and testing, a desired outcome can be delivered more effectively with fewer problems and unforeseen complications. In addition, a “best” practice can evolve to become better as improvements are discovered.  Best practice is considered by some as a business buzzword, used to describe the process of developing and following a standard way of doing things that multiple organizations can use.

As I was thinking about the concept of “best practices” in health care compliance, the Wikipedia definition seems to fall al little bit short of what I would have in mind when discussing “best practices” in health care compliance programs.

The Miriam-Webster Dictionary defines “Best” as the superlative form of “good.”  “Best” means “excelling all others” and “offering or producing the greatest advantage, utility, or satisfaction.”  I believe that the definition from Wikipedia is an accurate depiction of what the term “best practices” has become in the business world.  The term has been thrown around loosely to the  point that is no longer carries the meaning of the plain words that make up the two word “buzzword.”

In the health care compliance context, I believe that it is not advisable to direct you efforts toward the standard “buzzword” meaning of “best practices.”  Instead, you should focus toward attempting to achieve the meaning of “best practices” that is tied to the superlative form of the word “good.”  You should not focus on the “we are doing what everyone else is doing” or the “what we are doing will pass by in most cases” version of best practices when looking at your compliance plan.  The consequences of that approach could easily come back to bite you in the superlative.

 In reality, you may never be able to meet the truly “best” standard.  However, the point of the compliance program requirement is that you are trying to make your compliance program and your organization “the best” when it comes to compliance.  Here are a few tips to help you attempt to meet the “best practices” standard:

 1.         Act as if you are under a Corporate Integrity Agreement.  Always assume that the government is looking over your shoulder and that you will be called upon at some point to justify the effectiveness of your compliance program.

2.         Follow the government guidelines to the tee.  Familiarize yourself with the Federal Sentencing Guidelines and OIG Industry Guidance and integrate these requirements into your compliance plan.

3.         Keep up with government releases, speeches, regulations, comments, advisory opinions, and all other communication that help to define your obligations.

4.         Make your compliance plan a “living and breathing” documents that is continually up for revision based on specific things that you learn about your specific organizations.

5.         Make sure your compliance officer focuses on compliance and does not wear other hats that compete for time, attention or perspective.

6.         Make certain that sufficient resources are devoted to compliance.  Adopt the view that it is better to spend money on compliance that to pay for mistakes down the road.

 If there is any area where you are not able to achieve “best practices” for financial or other reasons, be prepared to justify your shortcomings.  Key to all of this is to operate as if you will someday be required to defend the effectiveness of your compliance program.  In all likelihood you will someday be in exactly that position given the current state of the health care industry and mentality of the governmental agencies that are charged with enforcement.

 These are just a few tips to get you thinking about your compliance approach.  Health care reform has made compliance programs mandatory for the first time.  There are also multiple indications that the government wants organizations to devote more to compliance as a way to save health care costs.  It is clearly time for organizations of all types and sizes to re-focus their efforts on compliance within their organizations.

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John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
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Wausau, WI 54402-8050

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