AHLA's Speaking of Health Law

Acting IG Joanne Chiedi on AKS Reform, Technology, and the Future of Enforcement

November 21, 2019 AHLA Podcasts
AHLA's Speaking of Health Law
Acting IG Joanne Chiedi on AKS Reform, Technology, and the Future of Enforcement
Show Notes Transcript

Acting Inspector General Joanne Chiedi speaks to AHLA CEO David Cade about the OIG’s goals in proposing Anti-Kickback Statute reforms and how the agency plans to move forward in its enforcement efforts. Chiedi talks about emerging technology and the future of data analytics and how technology can improve health care. The podcast also discusses how OIG intends to address information blocking and interoperability. Sponsored by GlassRatner, a B. Riley Financial company.

To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Speaker 1:

Support for A H L A and the following message comes from Glass Rattner, A b Riley Financial Company, a national specialty advisory services firm, providing solutions to complex business problems.

Speaker 2:

Hello, this is David Cade, c e o of the American Health Lawyers Association. Today we're joined by Joanne Kedi, HHS, acting OIG G. Welcome, Joanne.

Speaker 3:

Thank you, David. Happy to be here.

Speaker 2:

The last time we spoke, um, you were presenting at our fraud and compliance form in September, and one of the things you said, and I totally agree with, is that it's an exciting time in healthcare. It's an exciting time in healthcare. Since that time, OIG and C m s issued regulations on Stark and n a kickback, and I can tell that OIG and CMS are really striving to harmonize their approach in this area. One of the things I'd like to start off with is sort of invite you to share with us, uh, some of the goals that you see, uh, as a result of issuing those regulations.

Speaker 3:

Okay. Thank you, David. Um, you know, we are extremely engaged, uh, in the concept of value-based care across our work and these regulations, you know, fit into our work and that work. Um, we gave tremendous amount of thought to, uh, to proposing rules that if finalized would allow for beneficial innovations in the healthcare delivery, and also ensure the safeguards against potential abuses and harm. And, you know, both are, are really important. Um, we were helped tremendously by course of thoughtful input from the public in response to our request for information. And to be exact, we received 359, uh, comments. Wow. Uh, and, uh, yeah, that was, that was pretty tremendous. And I actually, I wanna really thank your members, uh, who provide the comments for their time and thoughtfulness and expertise. And, uh, the, the current comment period, uh, closes on December 31st, so I'm giving you a New Year's gift. And, um,

Speaker 2:

Thank

Speaker 3:

You,<laugh>. You're welcome. And so we look forward, uh, to your further input. Clearly, um, the goals, you know, the goal was to design proposals that would be useful for a range of individuals and entities, including large systems and small practices, and for those serving rural and under underserved populations. And that's really important. Um, we also wanted to propose safe harbors that would not drive innovation to limit chan, limit limited channels that do not reflect, you know, up to date, up to date understandings and medicine and science and technology. So we thought a lot about the range of risks that can be, that can arise in a coordinated arrangements, especially when the same arrangement might involve parties getting both the traditional fee for service and other forms of payment. As you know, these risks include over utilization, but also sting on care and cherry picking patients and falsifying data to verify outcomes or performance. And that's backed up by what we've seen in our evaluation and audits in our law enforcement efforts. So, as always, we're, we're interested in ensuring that the government has tools, uh, to take action to protect patients and address fraud and abuse. And I'll give you an example. In many respects, OIGs proposed rules for value-based arrangements are more restricted, uh, than CMSs com comparable proposals. In those instances, the anti-kickback statute would serve as a backstop, uh, protection in case of arrangements that might be protected by a less restrictive exception to the physician self-referral law. Now we're adapting our oversight strategies to the new value-based world, and this will evolve new uses of data and data analytics, as well as new technologies like AI and blockchain. And the ways in which we detect and prevent fraud, waste, and abuse are going to change as well. So we are already using data and technology to be more efficient at our mission. Uh, we will get better at it over time, and this will help honest providers as well, because we will be better able to target the dishonest ones and leave the honest ones alone, uh, who are working hard to serve patients, um, themselves. So those focused on compliance will, uh, be doing the same thing. Getting better at using data and technology to promote their compliance mission. And compliance will need a seat at the innovation table and access to data as well. Uh, you know, we know that compliance plays a big part in getting innovation, right? In healthcare and those of us who have been around together, I mean, for a long time, yeah. Businesses that themselves plan to be around for more than 15 or 20 years, uh, embrace change, and they will have their compliance professionals, I'm confident working shoulder to shoulder with their disruptive innovators. It's a winning combination. So getting in early and often can avoid costly mistakes and retrofitting down the road. And compliance will especially be important for new players in healthcare who may not be familiar with all the complicated rules of the road in our industry. So that's our vision and that's our hope.

Speaker 2:

Oh, I like, I appreciate the vision and, and in fact, it, it, it reminds me in, uh, or sometimes I, I hear folks say, well, um, you can't have compliance and value-based care one has to give or yield to the other. Um, yet, uh, the way you've structured it and the way you've described it through the lens of the ig, you can have both. So, one things I would delight you to speak to, uh, also is that how do you see compliance and integrity in the nature of the new regs? Um, supporting value-based care, where so often some people think that compliance and integrity is an afterthought. Mm-hmm.

Speaker 3:

<affirmative>

Speaker 2:

Mm-hmm.<affirmative>. And, and so I would imagine that one of the goals in the regulation is to harmonize that, to make sure that compliance and integrity are not an afterthought, but supportive. Mm-hmm.<affirmative>, um, could you share a little more about the, the vision there of, of how you all are bringing together and making sure that compliance and integrity are, are not that afterthought, but that our, our provider community are achieving both.

Speaker 3:

Well, certainly, you know, leveraging technology for enforcement and oversight clearly supports the compliance. And, you know, you have to integrate both. You can't have, uh, a CIO or the tech, you know, the IT department not harmonizing with your compliance department. And that's what I mean by, you know, you don't wanna sit there retrofitting later and, uh, you know, you're in an essence, your compliance department serves as your backstop. So, at oig, you know, as an example, what we're doing is we're putting technology in service of our important mission. So this means we're infusing data science and technology into our work to foster that collaboration, to improve effectiveness, and to prepare us to oversee the emerging use of data and technology in healthcare. And you can plant what we're doing in OIG and say, industry should be doing this with their compliance department as well as, as well as integrating their CIO's office. I mean, we want to continue finding new ways to use data and technology capabilities, uh, with our enforcement and oversight. Because if we use better data, it means better results for federal programs than for patients. You know, the sooner we catch that crooked physician who is provide, uh, prescribing opioids for no legitimate medical purpose, the more lives we can save. And the faster that we follow the money that's being stolen, the sooner we can recover it. Um, you know, the more precisely that we can spot trends in unsafe care, the sooner we can step in to be sure patients are protected. So with, with the patients and public we serve as our focus. We began investing in technology so that our OIG is at the forefront of using advanced data driven capabilities to fight fraud, waste, and abuse. So if you're a CEO in a company, you're chief operating officer or cfo, you have to make some hard decisions about how you're looking at the foundation that you're sitting on. And are you prepared for the future because the changes are coming fast and with serious consequences for those who don't keep up. So now, I mentioned in my speech at the ALA Fraud and Compliance Forum that we've invested back in 2015 in a chief data officer and a dedicated team of data experts who work across our organization, and they're developing user focused analytic tools. So we're putting this actionable data on demand at our employees fingertips through tools like cloud computing and mobile devices. Cause as you know, we're in nationwide organization, we're in 80 different locations across the country, and now in mere minutes, we are conducting the kind of data analysis David, that used to take us days or weeks or months. And this has been a, a game changer for us. And, you know, an example is theorist case, right? So you had an owner of a national nursing home chain who was engaged in a scheme, and we've seen this before, to bri doctors and hospital administrators, you know, just to refer patients to his facility. And this wasn't just about fraud for us and lost the government. This scheme placed patients at serious risk. And we know that some were harmed, but we were able to use billing data and claims data in investigations data to provide a folsom picture of the enormity and the egregiousness of this fraud. So much so that the prosecutor in the case said that the data jumped off the page, and it allowed the jurors to see both the magnitude and the harm to our healthcare program, and more importantly, to the people. You know, 10 years ago, that same case would've taken us months, if not, not years to reach conclusion. And in the business that we're in, it's so complicated. And to be able to, you know, bring to life the seriousness of these fraud schemes to jurors that, you know, we don't many, they all have different backgrounds, but the complication and, and that we're trying to, to articulate in our cases for it to basically the data to be present and, and state it very clearly. I mean, again, that's a game changer not only for federal government and ourselves, but for, for individuals. So we're really pleased about where we are, but it's going to take continued investments and vigilance. We cannot stay still. You have to be committed.

Speaker 2:

Well, for, for many of us, um, you know, to to hear you describe, uh, and I guess I wouldn't say, I wouldn't say this is an emerging use of technology. It's an explosion in the use of technology, um, right. To say for many of us who started our career without computers on our desk, uh, the next generation, you know, the generation that embraces your children who are basically born with a computer in their hand, uh, you said it's a game changer. Technology is a game changer. What do you, what do you see sort of on that next horizon? Um, you had commented once before about ai, which may be that next step, um, as in the game changer. I mean, after all, you're using the provider's own data, right? That they have. Uh, and so, uh, could you describe a little more about what you see in the future of where your data, their data analytic capabilities are going, uh, where the tools are allowing you, uh, to be able to reach and react in more real time? Sure. What do you think it's gonna look like in the next 10 to to 20 years?

Speaker 3:

Well, first I'll say this is, and, and this is truly a statement that we, uh, you know, at work we talk about all the time as far as, as a motivator to keep us, you know, in the forefront is, you know, you can't oversee what you don't understand. Okay? So that's a basic premise. And I think in all of our heads, we have to keep that on the forefront that we can't, we, we just can't do it. And so, first, you know, I recognize that just about any time you read an article these days about the future of healthcare, it, it probably mentions artificial intelligence or machine learning. And there's a lot of hype around AI and how it's going to change healthcare. And even at a time when many providers are still using that fax machine to send healthcare, health, healthcare records to other providers. So you sit there scratching your head, now, how is this all gonna work? But there are innovations and new healthcare technology being tested right now at this very moment that will impact how, where and when patients will get care, who's gonna provide it, who's gonna pay for it. And, you know, many of these innovations will improve care. They're gonna, uh, you know, ease clinician burden and decrease costs, and some will not. And that's the, the nature of innovation. And sometimes you make investments and you have nothing to show for it. Um, but digital health technology that can lead to better coordinated care and health outcomes is not only possible, but it's emerging all around us. So improving healthcare with technology might be as simple as getting rid of the fax machines and doctor's offices, or as complex as we've seen using artificial intelligence to diagnose disease or to code claims. Um, and the changes are coming fast and with serious consequences for those who don't keep up. And that's why OIG has, you know, we've cultivated a resiliency that has enabled us to adapt our oversight work to many of the transformations in the healthcare system like ai, uh, that are hard to predict, you know, the exact type of impact they're gonna have on our system. So regardless of how AI is used in in the healthcare system, I am confident that we will be ready. Um, but it isn't just about oig, you know, ensuring that any new technology or innovation in healthcare system works, right? It's gonna require the vision and talents of healthcare professionals, scientists, engineers, and men investors and vendors and regulators. But, and this gets back to your compliance question. It, it also is going to be, you know, the focus effort of healthcare attorneys and compliance professionals. We all need to be at that table. And AI is great. It's a great example where, uh, it can, it, you know, it can be an example where about just about engineers and it, it, and providers implementing AI without other input, but fraud and compliance. Attorneys and professionals can help ask the right questions and put the right safeguards in place so that the opportunities of the technology can be realized without having to retrofit later. And having, you know, fraud and compliance attorneys and professionals involved before an AI product is deployed can help ensure that AI has, uh, or is working as intended. And another example, you know, of questions is asking developers and, uh, vendors questions like, how was the, how was the AI trained? You know, what data did you use? Um, were any steps taken to validate or audit the ai, uh, being, you know, that's, that's being performed. These questions might help providers in assessing the potential compliance issues raised by AI that can be addressed before deployment within their organization. So it's all about prevention. Do things before, do the smart work upfront. Don't do it later when, you know, government's knocking at your door,

Speaker 2:

Right? Seems like one of the major takeaways is bring the team together, bring compliance, bring legal, bring risk managers, have a multidisciplinary approach to understanding the technology and how it'll be deployed. Um, that's a very, very strong message. I'm, I'm hopeful that folks who will be listening to this podcast will definitely take that message back into the boardroom.

Speaker 3:

I mean, I would, I would have the image of working shoulder to shoulder. If you're not working shoulder to shoulder, then you need to get there to be successful.

Speaker 2:

Powerful message. One of the things you shared in September was that information blocking is, is one of oig G'S main areas of focus. And I, I don't know if folks, uh, who weren't in the room, uh, know what that is and know how important it is and, and understand why it is one of oig G'S main areas of focus. So, so could you share a little bit about what the agency plans to do to address this issue? And, and really what is this issue?

Speaker 3:

Well, it's not about football that I will tell you,

Speaker 2:

<laugh>. Thank you.

Speaker 3:

So, um, you know, there's an important issue. This is an important issue for OIG because information blocking and interoperability are essential to a more effective and efficient healthcare system. You know, and primarily it's, it's a patient safety issue. If you think about it. If the patient's record doesn't have the latest test results, because providers can't share the data, how can a provider ensure that treatment is appropriate? So information blocking just undermines efforts to coordinate a care and improves outcomes for patients. So it's, these are all strings that we're pulling at the same time, you know, we are committed, uh, to using our new authorities to take action against those who intentionally engage in information blocking. And we're working closely with the office of the National Coordinator for Health Information Technology. And, um, we are gonna be ready to bring enforcement actions, uh, when the conduct warrants, uh, when the department's rules about information block and go into effect. And, and we expect that many companies and providers, we know that, you know, there's, they'll, they're gonna need some time to bring their practice into compliance. Uh, but we really do expect them to do so pro promptly. Um, we know that there's gonna be a learning curve for some, but this is not new, David. So people need to really pay attention to this and, and again, get their, uh, get their business in order. Um, now this is, this will be a new enforcement area for us. Uh, but as always, we will investigate the facts, including the intent of the parties, and then of course, exercise appropriate discretion in determining the right outcome. You know, for our, for the healthcare system to deliver better value and be better coordinated, entities of all types will have to decide that improperly blocking data is no longer in their best interest. And that's, that's very important for everyone to understand. Data will have to flow, and technology will need to be interoperable, period. Uh, af you know, and, and really just think about it. Don't we all want the choice to have our healthcare records seamlessly follow us throughout our lifetimes as we're all using our iPhones and apps to gather and, and look at that data. So it just, it's common sense. Uh, this is not a new conversation, and we're hopeful, and certainly we, we understand, we know that industry is looking at this, and they will get their house in order.

Speaker 2:

Again, another powerful theme. I mean, I, I, you know, what's, what's coming to me, and I'm hoping coming to the listening audience is consistency and enforcement. You know, assertive and objective. I mean, these are some of the words that you shared in, in September. You know, you will be bold, uh, in the pursuit of those who cheat, uh, or hurt our programs and, and, and hurt the people serve by our programs. And so, I'm, I'm hoping that folks understand that, and as you said, you know, get their house in order or maintain an orderly household.

Speaker 3:

Yeah. And, and let me, let me just say this. You know, patients are re-imagining. They really are. They're re-imagining how and where they wanna receive their healthcare. It's not necessarily at a doctor's office or facility. You know, I would say those walls are thinning and patients are becoming those empowered consumers. And, you know, they're, they're making decisions right now based on data and using technology to find, you know, and receive services. This is a generational thing as well. Think about, think about the, the different generations today that are on their phones every day, and, and they want, they want things immediately, but we need to give them the right things. And patients are going to have better access to their, their own medical records. They will. And new sources of that, uh, of health related data, like I said, through wearables and apps. It, it's, like I said earlier, it's emerging all around us. It's happening now. Big leaders, big thinkers are, are providing that. We just make, we need to make sure that the data is accurate and timely and actionable for individuals. That's the important part.

Speaker 2:

I'm gonna ask you one last question. I wanna invite you to look into the future. I'm gonna assume for this, that the reg does in fact, get finalized, so sometime soon. That being the case. What does success look like to you? What does the healthcare environment look like in the next 10 plus years? Um, you know, with the impact of a finalized regulation,

Speaker 3:

Okay, so let's 10, let's think 10 years, 10, 15 years. Cause it seems like in healthcare, it gives, in these chunks of every 25 years, there's like major changes. But I truly believe, you know, if I keep the, keeping the theme of my kids, that they're gonna be able to call up, uh, their doctor on a hologram, you know, and some of the technology exists today. Uh, they're gonna be able to, to receive certain services in their home because homes will be built with a proper infrastructure. And most importantly, they're going to know that the provider on, you know, through the hologram or even telegraph to uh, uh, telemedicine, there's going to be assurance that they know that it is their provider. So the thing that concerns me a little bit is how are we gonna know who's on the other end of that technology that's creating the hologram or who's on the el other end of that telemedicine call? So I believe that, uh, through program integrity and having the right guardrails in place that will allow this transformation to occur. You know, I am hopeful that it's going to happen, uh, for the, you know, that we know the population of providers who want to do the good things, and for the small percentage of those that we're gonna have the tools and technology to zero in with laser, laser vision and quickness to prevent and detect and then come in with our enforcement authority. So we can't change, we can't stop innovation train has left the station, but we can certainly sharpen our tools so that, so that our children and grandchildren can realize the benefits of it.

Speaker 2:

Well, I share your dream, uh, for the future. Uh, as you said early on, it's an exciting time to be in healthcare. Uh, with that, Joanne, I wanna thank you very much for your time today and remind the listening audience, uh, that you have until December 31st to get your comments in on the proposed regulations. Again, thank you, Joanne. I've really appreciated the time you shared with us today.

Speaker 3:

Well, it's always a pleasure to spend time with you. And we, you know, for over two decades, we've enjoyed a great partnership, uh, with A H L A and we will continue i together as partners to continue to provide outreach and training to our community. And we look forward to

Speaker 2:

That. Absolutely. Absolutely. Thank you so much.

Speaker 3:

Take care, David.

Speaker 2:

You too. Bye now.

Speaker 3:

Bye.