Healthcare Regulatory & Compliance Lawyers

The development and implementation of an effective compliance program is like a dose of “preventive medicine” for health care providers because it identifies problems before they can grow and significantly impact the organization or practice. In the current audit landscape, a compliance program helps providers to self-identify and correct deficiencies before outside auditors can do so.

Our firm can help you to develop an effective compliance program to help keep your organization out of trouble. We have been involved in the development of compliance programs for a broad spectrum of health care providers for many years. When the Office of the Inspector General (OIG) began issuing compliance guidance for various health care industry sectors beginning in 1998, Mr. Wachler, the principal of our firm, was invited to analyze the guidance for hospice organizations, Medicare + Choice entities and physician practices for the American Bar Association Health Law Section’s publication, The Health Lawyer.

We view compliance as the process of identifying appreciable risks within a health care organization or practice and reducing those risks through the development and implementation of a compliance plan involving practical policies and procedures and continuing education. The policies and procedures are drafted to address billing, documentation and related requirements of Medicare and other applicable third party payors.

The compliance process can create legal dilemmas that require seasoned judgment from experienced health care counsel. For example, recent amendments to the false claims act as well as new obligations to repay identified overpayments can create legal and ethical dilemmas related to the repayment process. Our firm can help you understand and navigate the various legal requirements related to the identification of overpayments and guide you through the process of determining when and how to repay overpayments.

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Compliance programs are currently “voluntary” although they are strongly encouraged based upon the favorable treatment that the Federal Sentencing guidelines give to entities with an effective compliance program in place. Further, the recently passed health care reform legislation directs the Department of Health and Human Services to make compliance programs mandatory for certain providers. While the required content of the mandatory compliance programs will be determined by regulation, the Department of Health and Human Services has suggested that the required plans will follow the guidance issued by the OIG. We generally use the OIG’s compliance guidance as a framework for compliance, utilizing the seven essential elements: (1) conducting internal auditing and monitoring; (2) designation of a compliance officer and compliance committee; (3) conducting appropriate training and education; (4) responding appropriately to detected offenses and developing corrective action; (5) developing open lines of communication; (6) enforcing disciplinary standards through well-publicized guidelines; and (7) implementing compliance and practice standards (i.e., policies).

The first step in developing a compliance plan is to identify the areas needing attention in your practice or organization. This is done through communication with key personnel to get an understanding of how services are being provided, documented, and billed and to understand the current systems and procedures in place. We also identify those areas to be addressed in the policies and procedures by reviewing applicable third party payor policies and information pertinent to your operation. In addition, our attorneys review the applicable OIG compliance guidance and fraud alerts relevant to your specialty. Our significant experience with the representation of providers in the Medicare appeals process is also helpful in determining risk areas.

After we have identified areas needing attention, we draft the compliance program and policies to assist you in enhancing compliance with various legal and third party payor requirements. After the documents are approved and finalized, the next step is the implementation of the compliance program including staff education. The goal of education is to enhance compliance with policies prospectively and enhance uniformity of billing and documentation procedures. We encourage our clients to maintain the effectiveness of their programs by monitoring to ensure that policies are being followed and that policies are updated based on changes in payor requirements and the law.

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Frequently Asked Questions

Who Should Perform an Internal Compliance Audit?

We recommend that all internal audits are conducted under direction of attorneys. This allows us to assert attorney client and/or work product privilege to the extent possible. We ask that all initial drafts are provided to us for review. While someone within your organization or practice with specific coding or billing expertise could do the compliance audit, in many cases we recommend bringing in an outside auditor for a “fresh look” and confirmation that services are being billed correctly.

Why is an Internal Reporting System Important?

When implementing a compliance program, we suggest that clients set up a hotline, drop box, or other anonymous method for internal reporting. This reporting mechanism is emphasized during employee training and all employees are asked to sign a statement that they agree to report all compliance matters. This provides some protection for the organization or practice because employees are required to bring compliance matters to the attention of the compliance officer rather than discuss such matters with outside entities.

What Pitfalls Should Providers Watch Out for When Developing Compliance Policies?

It is important that providers develop achievable goals within policies and procedures. The development of policy and procedure goals that are later not met by the organization can increase risks for the organization.

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Outside Resources

OIG Compliance Guidance Page:

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If you have any questions regarding the implementation of a voluntary compliance program, please contact Andrew Wachler at 248-544-0888 or through our website.

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Wachler & Associates has written extensively on compliance programs and related issues. For a complete list of Wachler & Associates articles, please click here.


The attorneys of Wachler & Associates have spoken frequently on compliance issues. For a complete list of Wachler & Associates speaking engagements, please click here.

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