Elements of An Effective Compliance Program
Basic Elements of An Effective Compliance Program
Developing a compliance program that will be effective to reduce internal and external risk is a “practice specific activity.” There is no “one size fits all” compliance program and there is no good “off the shelf” form solution. There are certainly vendors, consultants and lawyers out there who would like you to believe that you can take a form, make a few changes and fill in a few blanks, and create an effective compliance program for your organization. This approach really misses the point of what is required in order to develop and effective program. Certainly the written plan is an important and necessary part of the compliance effort. However, even more important is the process that you go through to develop the compliance plan.
Establishing a compliance program requires you to perform a risk assessment on your specific organization and document the outcomes of that assessment. The risk assessment could take many forms. Compliance professionals talk about a “gap analysis” which is an approach to help determine the vulnerabilities of your organization. A lawyer or compliance professional that has specific training and background in performing legal risk analysis can help you design an appropriate risk analysis process. The primary point here is that this process needs to be organization specific rather than based on a pre-canned form. You need to score your areas of risk and provide emphasis to appropriate areas of risk that are identified through your risk assessment.
All compliance programs will have language regarding compliance with fraud and abuse, anti-kickback statutes, HIPAA and other health care laws. It means virtually nothing to simply adopt a pre-canned policy without backing the policy up with the process that the practice went through to identify the specific risks that it faces given the specific nature of its practices, size, and specific personalities involved in the operation.
As mentioned above, the Office of Inspector General has issued general industry guidance on compliance program development and one such guidance relates to physician practices. This guidance, plus the general requirements of the Federal Sentencing Guidelines, provide general elements that are necessary to make a compliance program effective. There are generally seven (7) basic core elements that are required of an effective compliance program including:
- Adoption of written guidelines and policies to promote the organization’s commitment to compliance;
- Identification and appointment of a high ranking individual within the organization to serve as compliance officer;
- Establishment of anonymous reporting systems, preferably through multiple pathways, to encourage individuals to make complaints regarding compliance items without fear of retaliation;
- Effective education and training programs for all levels of employees and others with close relationships to the organization;
- Ongoing auditing systems to assess the effectiveness of the compliance program and to provide input into areas that require additional emphasis;
- Mechanisms to enforce the requirements of the compliance program and to discipline employees for violations of the organization’s commitment to compliance; and
- An ongoing system of program modification based upon audit, feedback and experience that can further adapt the compliance policies to the specific issues faced by the organization.
Establishing Commitment From the Top of the Organization
An important and often overlooked aspect of developing a compliance program is the need to obtain commitment from the top of the organization. Many times in a physician practice this will mean the physician owners of the practice. It is important that the physician have a clear understanding of the need and benefit of establishing a focused compliance program. There will inevitably be initial expenditures involved with establishing a compliance system. In some cases it may even necessitate retaining additional staff. There will almost certainly be fees to outside attorneys and consultants if the organization is not large enough to hire the needed expertise internally. It is important that sufficient resources be allocated to compliance and that the physicians and administration understand that in the long term, these expenditures will pay off by reducing the risk of institutional compliance problems. The difficulty is that if the compliance program works to reduce risks, there will never be a serious event that proves the benefit of the expenditures. However, if an event occurs in the future and there is no compliance program in place, the regrets will be very deep because compliance issues are much more difficult to solve if there is no compliance plan in place.
As a practical matter, the institutional “buy-in” is often the most difficult hurdle to overcome. It is somewhat easier now that compliance plans are becoming mandatory. Yet there is still risks associated with under-funding compliance activities or providing enough resources to do the “bare minimum” when it comes to compliance due to a reluctant attitude on the part of physician leaders who are now being forced to develop compliance programs that they have not fully embraced.
Certain groups may be in a position that they have not been dependent upon institutions who have implemented compliance programs. Some practices completely reject policies and procedures of any kind that could bind the physicians in their practices. These organizations present the greatest challenges and unfortunately the greatest potential risk of violations of federal and state laws occurring due to the low level of leadership embracing appropriate compliance activities. Even as these groups are forced to adopt compliance programs, they present the greatest residual risk because of a low level of physician commitment.
We suggest that physician practices begin the process of implementing formal compliance programs immediately to provide more time to gain physician commitment and appropriately assess the risks associated with the specific practice. It takes a great deal of time to develop a system for establishing compliance programs, perform a “gap analysis” or other baseline analysis, perform employee interviews and take other steps to identify specific risk areas. Developing a compliance program is much more than simply adopting a form compliance program. Even though the precise effective date that compliance programs will become mandatory for physician practices has not yet been set, providers should consider this time a gift to permit them to develop appropriate policies rather than a reprieve.
About The Author
This article is part of a multiple part series by Health Care Attorney John Fisher, CHC on compliance programs for physician practices.
John Fisher, JD, CHC is a seasoned health care attorney and is certified in Health Care Compliance by the Health Care Compliance Association. Mr. Fisher is available to assist physician groups and other health care providers nationwide in the development and operation of Compliance Programs.
Mr. Fisher has significant experience in the various legal and regulatory matters that are faced by physicians including the Stark Law, Anti-Kickback Statute and Safe Harbors, Medicare and Medicaid reimbursement rules, HIPAA, False Claims Act, antitrust laws, employment laws, contract matters, business ventures and laws governing financial relationships between physicians, and others.
Mr. Fisher practices with the Ruder Ware law firm in Wausau, Wisconsin. His practice on compliance and Federal Law issues is nationwide.
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Tags: Compliance Programs, healthcare compliance, physician compliance