Compliance FAQs: Anti-Kickbacks and CIA’s

Compliance FAQs: Anti-Kickbacks and CIA’s

Posted by CJ Wolf
Nov 1, 2021 1:44:23 PM

If you’re like the rest of us, you probably have compliance questions that have gone unanswered until now. There’s so much to know and only so many hours in the day. So here’s a roundup of frequently asked compliance questions to help you get the nuanced tidbits you need to keep your organization safe and grow into the masterful compliance superstar we’ve known you are all along.

FAQ: Anti-Kickback Statute

Uncovering the Anti-Kickback Threats Hiding In Your Organization (Watch On-Demand for Free)

Despite the Anti-Kickback Statute being around since the seventies, folks are still found non-compliant all the time. Luckily, there are so many things that we can do as compliance professionals to protect our organizations from AKS and False Claims Act non-compliance.

QUESTION: Does anyone still participate in the professional courtesy copay waiver? We don't do this any longer. We decided it is not worth it anymore.

ANSWER: What I’ve personally seen is that organizations don't allow personal courtesy anymore. If you do, you might be an outlier.

QUESTION: Very curious about who determines FMV and how it is evaluated. I know the OIG provides guidelines but is it necessary to pay an outside company to determine FMV?

ANSWER: There are companies out there that just do fair market evaluations for you. If you’re using those companies, and they’re trustworthy, you’re probably on safer ground because you can say, look, we paid this company for the information they provided.

QUESTION: Is there an issue when a copay is waived as a professional courtesy or because of a professional or personal relationship?

ANSWER: Yes, there is a concern there. The OIG guidance docs talk about that and the importance of having some guardrails there. It shouldn’t have anything to do with who you know; it has to do with did you follow a process to apply for financial needs. Have you developed a thoughtful process? Yes, professional courtesy can be an issue?

QUESTION: How do copay assistance programs from drug companies fit in with the anti-kickback statute?

ANSWER: The key is that co-pay assistance has to be fair. The OIG gives opinions, you can submit a scenario to the OIG, and they can deliver a written opinion. If you read some of them, you can see that many of them have to do with pharmaceutical waivers for co-pays.

QUESTION: Does FMV only apply to physician arrangements? For example, should the Compliance Officer be concerned about arrangements with Nurse Practitioners and other non-physician providers?

ANSWER: Yes, they should be. It’s not limited to only physicians; it’s any provider and any service that can be reimbursed in part or in whole. PA or NP are all included.

FAQ: Corporate Integrity Agreements

Why You Should Be Leveraging CIAs to Improve Your Compliance Program (Watch On-Demand For Free)

CIA’s provide so much insight into what the OIG expects of a healthcare organization’s compliance program. And armed with all of that insight, we can better protect our organizations from noncompliance and the cascading disaster that could follow.

QUESTION: What does a compliance officer do when the elements are not present (i.e., no governing board, reporting to chief legal counsel, no board training, etc.)

ANSWER: It’s tough. There’s probably no one correct answer. If you can convince the board or the executive to let you get an outside opinion, sometimes people have an easier time buying into that because an expert tells them what to do. Usually, those are done through a compliance effectiveness review. You hire someone to come in and look at the program structure itself to see how effective it is. Sometimes if a competitor is hit with a CIA, you can use that to bring attention to the issue.

QUESTION: What does the OIG mean by senior management? Do they mean c-suite and part of the executive team? Or is there a separate executive team?

ANSWER: The corporate compliance officer or chief compliance officer is a member of the c-suite. From what I see, it’s folks who have a seat at the table.

QUESTION: Can you define non-employee for the board?  Would paid board members who don't work at the facility (for example, retired executives) meet the definition of non-employee?

ANSWER: In my opinion, it’s a person who does not hold a working position at the organization.

QUESTION: Is it normal practice for a non-prosecution agreement to accompany a CIA?

ANSWER: A non-prosecution agreement is similar to a CIA; they’re saying, look, we’re going to withhold our next step of prosecution, assuming your organization is willing to do the following. Often you see it instead of the CIA; usually, when I’ve seen them, it’s for an entity that might not have oversight by the OIG. An industry not overseen by the OIG.

QUESTION: Are there additional resources you suggest to support the necessity of having a CCO that does not report or serve as General Counsel?

ANSWER: In almost every CIA, they say that. Outside of that, the OIG has published guidelines stating that the compliance officer should not be the chief legal counsel. Is there a law? No. But the OIG and DOJ say that best practices are that the CO should not be part of legal counsel.

Have a question you didn’t see here about these topics? Put them in the comments below, and either one of our compliance experts or an expert from our fantastic community will answer it for you. Until then, stay tuned for the next installment.


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