Compliance Forms for Physician Practices

Physician Compliance Program FormsAlthough it is true that a compliance program should be tailored for the specific company, there are many elements of a standard compliance program that are relatively uniform from plan to plan. Speaking generally, a compliance program contains a few distinct parts.  First, every compliance program must include the 7 central elements of an effective corporate compliance program.  The 7 compliance elements were derived from the Federal Sentencing Guidelines, which give cooperation credit based on a number of factors, one of which operation of an effective corporate compliance program.  The 7 elements of an effective compliance program represent the absolute minimum that every compliance program must have in place.   The 7 elements is by no means everything that must be done to implement and operate your compliance program.  Rather, the 7 elements are the very basic things.  The things that if you do not have them in place and a compliance issue arises, you will have some explaining to do.

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Forms for the 7 Core Elements of an Effective Compliance Program.  The reason I am focusing on the 7 elements here is to make a simple point.  Even though you should not look at a compliance program as a group of forms that apply to all types of organizations, the documents and policies that are needed to establish the core 7 elements of an effective compliance program are relatively amenable to use by most organizations with relatively little adaptation.  Other areas such as risk area identification might differ across specialty areas.

Physician Specialty Specific Packages.  Compliance Forms also offers specific risk area packages based on provider specialty in order to enhance the specificity of coverage that is required to adequately create compliance coverage of the most significant risk areas faced by various practice and specialty type.  So if you represent a physician practice, you should choose the general 7 elements package for health care providers, unless we offer a package covering your area of specialty practice.  Packages that cover a specific specialty or license area will include some policies and/ore documents covering some of the specific risk areas that apply in that practice area.  Just for example, an Anesthesia Practice Compliance Program specialty practice will contain the core 7 elements package as well as a supervision policy that addresses the regulatory requirements surrounding the risk area involving supervision of multiple Certified Registered Nurse Anesthetists.   The specialty packages will also include the general “Risk Identification Process” document package.  The Risk Identification Process document package includes a variety of tools to assist a physician practice to identify the most critical risk areas that are applicable to the practice.

What Are the 7 Elements of Compliance?  I have seen the 7 elements described a little differently here and there.  But basically, the 7 elements of an effective compliance program include the following in some some form or another:

  1. Compliance Program Policies.  Compliance program policies, procedures, and standards of conduct have been prepared, validly adopted, and consistently followed.
  2. Designated Compliance Officer.  A compliance officer and compliance committee should be established.  The compliance officer should be appointed by the Board of Directors.  The Board of Directors should likewise establish a compliance committee.  A formal compliance committee charter is probably a good idea to reinforce the importance of the committee, to clarify its goals and objectives, and to standardize the rules that pertain to its governance and operation.
  3. Compliance Training.  Policies should be adopted that set the requirements for the contents of training as well as the various types of training that a staff member may be required to comply.  Documentary evidence should be maintained to demonstrate that training is consistently conducted, that employees meet their training obligations, that records of training and attendance are maintained, and that training has been effective to teach the concepts that employees must know to maintain compliance.
  4. Lines of Communication.  Internal reporting of compliance issues is the central fuel that maintains the compliance function.  Every compliance program must establish clear compliance reporting systems that staff members feel comfortable using to report compliance concerns.  Staff must be free of fear that they will be retaliated against for reporting a possible compliance concern.  One extremely critical compliance element is a strong anti-retaliation policy.  But more than a strong policy is needed to comply.  There must be evidence that employees feel free to use the reporting structure without fear of reprisal.  Evidence that the reporting system is actually used by employees is good evidence of this element.
  5. Internal Monitoring and Auditing.  An effective compliance program needs to have a system of self-checking to be sure that noncompliance is not occurring.  It is not enough to adopt policies and then sit back and assume that there is complete organization-wide compliance.  The organization needs to decide what its biggest areas of risk are and it must allocate assets to monitoring and/or auditing, as deemed appropriate, to assure that there is not evidence of fraud or noncompliance.
  6. Compliance Disciplinary Policies.  Every organization needs to establish and publicize within the organization, the disciplinary guidelines that will be applied to instances of noncompliance with compliance program requirements.  There should be evidence that disciplinary guidelines have been enacted and that they have been consistently applied across all levels of the corporate hierarchy.  Evidence that employees have been disciplined for failure to comply with requirements of the compliance plan can be the best proof that an effective compliance disciplinary program exists and has been operated.
  7. Response to Detected Offenses.  The organization’s ability to accept and respond promptly to internal and/or external complaints about possible compliance infractions with appropriate investigation, taken through conclusion.  There should be evidence indicating that corrective action is taken where appropriate to remediate the consequences of a compliance infraction.  Responding promptly to detected offenses and undertaking corrective action.

It is safe to say that most physician practices are going to be able to utilize the same, or nearly the same set of 7 element policies and documents.  The specialty or type of practice is not going to impact what those 7 key core elements of a physician compliance program are going to look like.  But if there is a package offered in your specific license area or specialty, you will need to have the more specific package to provide you with broader scope of coverage that includes some risk areas that are specific to the license area/specialty.

Now, the same is not true, or at least AS true, with respect to the other categories of compliance program documentary coverage.  For example, beyond the 7 elements, it is critical that every compliance program include a process by which the organization organizes the various compliance risks to which it is exposed.  The risk identification process will normally start out with identifying the universe of possible compliance risks.  The second portion of risk assessment involves using a standard process to prioritize identified risk areas so that higher priority areas can, at least theoretically, receive higher allocations of resources.  Identified risk can receive a risk area score that is based on the potential severity of the consequences of a violation in the area of identified risk.  An element of probability should also be considered as part of the process to score areas of compliance risk.  A risk area that has even the highest of potential risk exposure, such as high potential civil penalties or possible criminal liability, might not be of much concern to an organization that has a low risk of ever being subject to prosecution.  In this area it can be important to have a good understanding of enforcement activity in the identified area of risk as well as the enforcement policy of the governmental agency that is responsible for the area.  The annual Work Plan of the Office of Inspector General can be of great assistance by giving providers a glimpse into the stated priorities of the federal enforcement agency.