Wade McFaul Healthcare Fraud Team Former HHS-OIG Assistant Special Agent-in-Charge
Health care providers that bill Medicare, Medicaid and other federally-funded programs are subject to numerous statutory requirements. One of the most important statutes in this area is the federal Anti-Kickback Statute. Providers that fail to maintain strict anti-kickback compliance can face steep penalties—up to and including criminal fines and prison time in some cases.
As a result, for all program-participating health care providers, anti-kickback compliance needs to be a priority. At Oberheiden P.C., we rely on extensive experience on both sides of federal health care fraud investigations to advise our clients in this complicated area. Our former federal health care fraud prosecutors help providers develop compliance programs that address all pertinent aspects of the Anti-Kickback Statute, and we work with our clients on an ongoing basis to help ensure that they avoid mistakes with potentially criminal implications.
5 Key Aspects of Anti-Kickback Compliance
When assisting health care providers with Anti-Kickback Statute compliance, we break the process down into five key aspects. By taking a structured and systematic approach, not only do we ensure that our clients’ compliance programs are both sufficiently comprehensive and custom-tailored, but we also help our clients gain a firm grasp of their compliance obligations so that they can become self-sufficient in many respects. When you choose Oberheiden P.C. for anti-kickback compliance, our lawyers and consultants will provide assistance with:
1. Understanding How the Anti-Kickback Statute Applies to a Facility or Practice
The Anti-Kickback Statute is broad, complex, and far from straightforward. As a result, when it comes to developing an effective compliance program, one of the first steps is simply to understand how the law applies to a particular health care facility or practice. In general terms, the Anti-Kickback Statute establishes two areas of prohibitions:
Offering, paying, soliciting, or accepting rebates or other compensation in connection with the purchase, sale, or recommendation of services, facilities, equipment, and supplies reimbursable under federal health care programs.
Offering, paying, soliciting, or accepting referral fees or other compensation in connection with referring patients for services or items covered under a federal health care program.
But, within each of these two areas, there are numerous specific prohibitions—all of which may or may not apply in various scenarios. As anti-kickback compliance counsel, we work closely with our clients to identify all relevant aspects of their operations, and then we focus on ensuring that our clients are able to maintain compliance in each aspect.
2. Developing a Custom-Tailored Anti-Kickback Compliance Program
Once we have a clear understanding of a health care provider’s specific needs, we then shift our focus to developing a custom-tailored anti-kickback compliance program. In broad strokes, this process involves addressing the following:
General Anti-Kickback Statute Compliance – The federal authorities that enforce the Anti-Kickback Statute expect all health care providers to have general anti-kickback compliance protections in place. Having represented hundreds of health care providers, and having previously worked for the federal government, our lawyers and consultants have a clear understanding of these authorities’ expectations.
Policies and Procedures for Establishing Financial Relationships – The main crux of anti-kickback compliance is avoiding financial relationships and transactions that can be categorized as involving prohibited rebates, referral fees, and other forms of remuneration. We help our clients implement policies and procedures designed to avoid these prohibited relationships and transactions in the ordinary course of business.
Utilizing the Anti-Kickback Statute’s Safe Harbors – The Anti-Kickback Statute’s broad prohibitions are subject to several “safe harbors.” If a financial relationship or transaction falls within one of these safe harbors, then it is legal even if it facially involves compensation paid out of federally reimbursed funds. For most health care providers, structuring key relationships and transactions to fall within specific safe harbors is a key aspect of anti-kickback compliance.
Establishing Documentation and Recordkeeping Protocols – To demonstrate Anti-Kickback Statute compliance when necessary, all health care providers should establish (and follow) documentation and recordkeeping protocols that confirm their good-faith compliance efforts.
Encouraging Internal Self-Reporting and Incentivizing Compliance – Along with adopting anti-kickback compliance programs, it is essential for health care providers to facilitate compliance on an ongoing basis. This includes encouraging internal self-reporting of potential violations and incentivizing compliance (among other measures).
3. Conducting Anti-Kickback Compliance Training
Another key aspect of anti-kickback compliance is internal compliance training. We offer various training programs that we custom-tailor to specific audiences including physicians, billing administrators, and business development personnel.
4. Managing Anti-Kickback Compliance On an Ongoing Basis
In addition to helping our clients establish effective Anti-Kickback Statute compliance programs, we also help our clients manage compliance on an ongoing basis. Our lawyers and consultants are available to answer questions and provide advice as needed, and we can provide emergency response services for federal compliance audits and health care fraud investigations as well.
5. Auditing for Anti-Kickback Compliance
Another key aspect of ongoing anti-kickback compliance management is internal auditing. Health care providers need to know if their compliance programs are functioning as intended—and the only way to do this is by auditing their records on a periodic basis. We conduct and oversee internal anti-kickback compliance audits for our clients, and we guide our clients through all necessary post-audit compliance measures (i.e., updating their compliance programs or providing additional compliance training) as well.
Anti-Kickback Compliance Is Not Health Care Providers’ Only Concern
While anti-kickback compliance is essential for health care providers, it is ultimately just one of several areas of concern. As the U.S. Department of Health and Human Services’ Office of Inspector General (DHHS OIG) explains, “The five most important Federal fraud and abuse laws that apply to physicians are the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law (CMPL).”
As a result, when addressing anti-kickback compliance, healthcare providers must address compliance with these other laws as well. Even if a financial relationship or transaction complies with the Anti-Kickback Statute, it could still give rise to liability under the Stark Law or one of these other federal health care statutes. At Oberheiden P.C., we provide comprehensive health care compliance services to our clients, and our lawyers and consultants can work with you to develop policies, procedures, and protocols that are designed to protect your business or practice regardless of the focus of a federal compliance audit or health care fraud investigation.
FAQs: Maintaining Anti-Kickback Compliance (and Understanding the Risks of Non-Compliance)
How Important is Anti-Kickback Compliance for Health Care Providers?
Anti-kickback compliance is extremely important for health care providers. Enforcing the Anti-Kickback Statute is a top priority for several federal agencies, and providers suspected of violating the law can face audits or investigations leading to civil or criminal penalties.
How Do I Know if My Health Care Practice is Anti-Kickback Compliant?
Determining whether a health care practice is anti-kickback compliance involves conducting a comprehensive internal audit. The audit should examine the provider’s relevant policies and procedures, billing practices, and relationships with other entities in the health care realm. Even if a provider has a compliance program, this does not necessarily mean that the program is effective. Assessing the program’s effectiveness is critical for making informed decisions about what updates and modifications (if any) are necessary.
Does the Federal Government Enforce Anti-Kickback Statute Compliance?
Yes. Several federal agencies enforce Anti-Kickback Statute compliance. This includes the DHHS OIG and U.S. Department of Justice (DOJ), among others. Fee-for-service auditors working with the Centers for Medicare and Medicaid Services (CMS) will examine providers’ records for potential Anti-Kickback Statute violations as well; and, if auditors uncover evidence of prohibited financial relationships or transactions, they can (and typically will) turn this evidence over to federal authorities.
What Are Some Examples of Safe Harbors Under the Anti-Kickback Statute?
There are several safe harbors under the Anti-Kickback Statute that allow health care providers to engage in transactions that would otherwise be prohibited under the law’s primary provisions. Some examples of these safe harbors include protections for transactions involving investments, facility and equipment rentals, personal services, management contracts, physician recruitment, and payments to bona fide employees. Generally, when seeking to establish safe harbor protection, health care providers must structure transactions with a specific safe harbor in mind, and they must carefully address each of the safe harbor’s detailed requirements.
Do Health Care Providers Need a Law Firm for Anti-Kickback Compliance?
Health care providers should not try to manage anti-kickback compliance on their own. It is simply too complicated, and the risks are simply too great. We strongly recommend that all providers engage a law firm for compliance, and that providers work closely with their law firms to develop and implement comprehensive and custom-tailored anti-kickback compliance programs.
Speak with an Anti-Kickback Compliance Lawyer or Consultant in Confidence
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