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Transcript for audio podcast: OIG Outlook 2013: Chief Counsel to the IG, Gregory E. Demske

From the Office of Inspector General of Department of Health and Human Services

http://www.oig.hhs.gov

[Roberta Baskin] As Chief Counsel, Greg Demske leads a full service in-house legal counsel to OIG. Let's just talk about a kind of overview of the programs that you do in terms of compliance and protecting health care programs.

[Greg Demske] Sure, we in the Office of Counsel to the IG provide all the legal services for OIG and we have a specialized role with respect to certain enforcement and compliance matters such as exclusions.

[Roberta Baskin] Talk about exclusions; that's a big part of what you do and it is what any provider doesn't want to hear.

[Greg Demske] Federal health care programs will not pay for any items or services furnished by an individual or entity, which is excluded. And so that has a very broad application because that applies to someone like a physician who's directly billing for their services, but also to a nurse who's employed at a hospital or other institution, and even to companies like pharmaceutical companies that sell items that are then billed by other entities. So, these-- this is very important for us as the government to protect our programs respectively, because we've banned that payment and it basically keeps those untrustworthy people out of our programs.

[Roberta Baskin] You also play a large role in large settlements with large companies, pharmaceutical companies. Tell us a little bit about how that works.

[Greg Demske] Well, whenever the Department of Justice is pursuing a False Claims Act case to recover money on behalf of the government, we work closely with them and advise them about our perspective about how the case should be resolved, and importantly, we decide how to resolve the exclusion issue in a case. Usually with entities, we decide that the programs and our beneficiaries are better off letting an entity participate in our programs if they agree to certain measures. We enter into agreements, called Corporate Integrity Agreements or CIAs that require these entities to have compliance programs and systems and controls, and hire an outside entity to monitor their dealings with our program; and then we monitor whether they are complying with those CIAs.

[Roberta Baskin] So, what's the intended impact of a CIA? And give us an example of a large one that you've had recently, how it works.

[Greg Demske] Sure. CIAs are designed to put the entity at the frontline of promoting compliance. What they have to do is put in certain steps and hopefully put in the culture of compliance that comes from the top of the company.

[Roberta Baskin] So, you're not really thinking about it in a punitive way?

[Greg Demske] No, not at all. The exclusion is a remedy to protect the programs going forward, and when we enter into a CIA it's the same idea. The punishment takes place with criminal and civil enforcement. Our job is to decide what's the best way to protect our programs going forward.

[Roberta Baskin] So, an example would be the GlaxoSmithKline recent case, and you also had strengthened provisions in your Corporate Integrity Agreement. So, talk a little bit about that.

[Greg Demske] Sure, the largest health care fraud settlement ever is the GlaxoSmithKline case. The company paid three billion dollars to resolve their civil and criminal allegations against them. We did a Corporate Integrity Agreement that had some innovative provisions; two in particular that relate to how individuals at the company are compensated. First of all, before the settlement was finalized, the company actually changed the way that they compensate their sales people, and severed the relationship between sales that are generated for a particular product, and compensation to sales people. So now-- the salaries and bonuses of these employees are based on their knowledge, scientific knowledge, and the job that they do imparting accurate information to physicians. We are requiring them to continue that for the next five years. The other provision is what we call, "Clawback", which allows for the clawing back of bonuses that have been made by executives, where they were engaged in wrongdoing or a part of the business that they were responsible for was engaged in wrongdoing.

[Roberta Baskin: Quality of care plays a growing role in the CIAs. Can you talk a little bit about how that works?

[Greg Demske] Yes, absolutely. When we have a case that involves not only financial fraud but also potential harm to our beneficiaries we do enhanced CIAs, and most importantly we require the entity to hire an independent monitor. It goes in on-site and looks at the services being provided to our beneficiaries, and systems and controls that the entity has in place, and we then monitor and take enforcement action based on that.

[Roberta Baskin] And finally educating providers is gaining importance, what are some examples?

[Greg Demske] OIG has always believed that it's important to give information to the provider community to promote voluntary compliance. And we do that through advisory opinions, compliance program guidance, fraud alerts. But also increasingly over the last couple of years, more and more resources on our website, for example, videos that talk about a variety of compliance steps that providers can take. So they can look at those videos and use those for training that fits the needs of that particular provider.

[Roberta Baskin] Greg Demske, Chief Counsel, thanks for giving us a glimpse of how OIG works to promote compliance and protect the public.

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