In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks to Jennifer Michael, Bass Berry & Sims, and Samantha Flanzer, OIG, about OIG’s September 24 Request for Information (RFI) on how to improve its guidance and “modernize the accessibility and usability of our publicly available resources.” They discuss what is prompting OIG’s modernization drive, what to expect from OIG during the process, and what the RFI is asking commenters to focus on. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks to Jennifer Michael, Bass Berry & Sims, and Samantha Flanzer, OIG, about OIG’s September 24 Request for Information (RFI) on how to improve its guidance and “modernize the accessibility and usability of our publicly available resources.” They discuss what is prompting OIG’s modernization drive, what to expect from OIG during the process, and what the RFI is asking commenters to focus on. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
The following message and support for AHLA has provided by Berkeley research group, a global consulting firm that helps organizations advance in the areas of disputes and investigations, corporate finance, and strategy and operations BRG helps clients stay ahead of what's next for more information, visit think brg.com
Speaker 2:From the American health law association in Washington, DC. Good morning. Good evening. Wherever you may be listening. Welcome to the AHLA fraud and abuse podcast. I'm your host, Matt Wetsel as the delivery of healthcare modernizes and as technological advancements accelerate dramatically. There's a lingering question. Can the federal agencies tasked with regulating the delivery of care, keep up the centers for Medicare and Medicaid services. The office of inspector general of HHS and a range of other healthcare focus. Federal agencies are tasked with making sure that all of the players know all of the rules, but what happens when the rules no longer make sense for the game? When the players have to develop capabilities that exceed the original scope, intent and definitional concepts of the rules, what can be done? The HHS office of inspector general may have an answer tasked with providing a variety of guidance to stakeholders about the applicability of the federal healthcare fraud laws. OIG for decades has regularly released both formal guidance and informal guidance. And to date, this guidance creates a patchwork quilt of do's and don'ts for the industry that can, with all due respect to the government, sometimes be confusing and conflicting. And her September, 2021 address to HLS fraud compliance forum and inspector general Christie grim spoke about the rapid advancements in healthcare and the dramatic impact of the COVID public health emergency. She noted that OIG seeks to help providers during this rapid time of industry change by tailoring guidance and resources to the industry's needs and making resources easier to use by making processes more efficient. And by prioritizing the quick release of available data for external stakeholders to this end on September 24th, 2021, OIG released a lengthy request for information from stakeholders, seeking feedback on how to improve its guidance and how the agency can work to quote, modernize the accessibility and usability of our publicly available resources. End quote OIGs request is a series of questions. So listening, candid feedback and input from stakeholders about how they use existing guidance, modalities, and other types of guidance that might be helpful. We're extremely fortunate to hear from two guests today who have unmatched insight into the OIGs guidance process. Jennifer Michael ABAs, Varian Sims in Washington, DC, and Samantha plans are an attorney with the HHS office of inspector general. Jennifer's a member of the healthcare practice at bass Berry Sims and is the former chief of the industry guidance branch at OIG. Her practice focuses on healthcare fraud and abuse and regulatory compliance in her former role. As the chief of the industry guidance branch, Jennifer led a team of attorneys responsible for interpreting and applying federal fraud and abuse statutes to a wide variety of arrangements across all segments of the healthcare industry under her watch the industry guidance branch issued dozens of advisory opinions, the first ever rescission of an advisory opinion, special fraud alerts, policy statements, and other guidance documents. Samantha planter is an attorney with the HHS office of inspector general. Her work involves drafting advisory opinions, providing technical assistance to various components of HHS on OIG authorities and drafting regulations for the federal anti-kickback statute and the civil monetary penalty provision prohibiting inducements to beneficiaries. Jennifer, Samantha, welcome. Thanks so much for joining us today on the podcast.
Speaker 3:Thanks for having us
Speaker 4:Not having to be
Speaker 2:Here. Absolutely. All right. Well, let's jump right in, uh, Jennifer, um, you know, maybe we can start by level setting or the listeners, what is sparking OIGs move to modernize its guidance here. And what would you say are the top goals for OIG for this process?
Speaker 3:So I think this is something that's kind of been percolating in OIG for awhile. Um, all of the guidance on OIGs website is good guidance, but many of the resources haven't been updated in decades and, you know, OIG has, um, there's been a very big push towards using data. And I think they've done a great job on the enforcement side, you know, using data to, for example, target outliers. Um, but now they want to try to use that data on the compliance side and have, you know, make it available to people to use, um, in their compliance programs. So, um, you know, advancements in technology, um, data at your fingertips is a, is a term they use a lot. And so I think, you know, that is what is driving this push
Speaker 2:And Samantha, same question, you know, from your perspective as a lawyer with OIG, um, what are the goals here and what do you see as sort of the spark or impetus for this move?
Speaker 4:Yeah. So just turning to sort of the spark and impetus as a follow-up to Jennifer's. Um, I agree on the technology. Absolutely. Um, I also want to highlight the public health emergency as a driver of the RFI it's, you know, absolutely made us rethink how we work best. Um, we have had to push out time sensitive information to stakeholders regarding the application of our authorities, and we want to think creatively about how to continue to do so moving forward, um, regarding our, you know, at, at bottom, you know, we want to provide the health care industry and stakeholders with the best information and tools possible so that individuals and entities can take steps to reduce fraud and abuse. Now, the RFI is a way for us to seek the industry's feedback on how best to do so. And I, Jennifer, I loved how you were talking about data and wanting to think about data as a way to, um, not only from an enforcement perspective, but also push out and allow that as a tool for compliance. I think that's a really great summary of how we're thinking about data in this RFI.
Speaker 2:So, you know, this is interesting because, um, you know, as we think about data, as we think about what we're, you know, we've just gone through with COVID and are still going through, right. I mean, you know, the end may not necessarily be insight just yet. So maybe if I wonder if you could tell us a little bit about that experience that OIG had, um, during sort of the, you know, the, the real heavy throws of the public health emergency and how this is, you know, this experience is affecting or impacting the, uh, push for modernized guidance.
Speaker 4:Yeah. So I think Jennifer alluded to, um, some of our, some of our guidance may not be the most up, or it might not be the most recent in terms of publication date. Um, and historically we've taken a very deliberate approach to issuing guidance and advisory opinions. Um, and that can take a lot of time and that that framework obviously did not work in the public health emergency. Um, we recognize the need to pivot and promote more timely information to industry stakeholders. For example, you've seen this in our COVID-19 FAQ's and certain policy statements. Um, so that is not to say our work will not continue to be measured and deliberate. Um, but with this RFI, we're really, really looking for feedback on how to think creatively, to think through potential ways where we can push out guidance or advisory opinions and a more time-sensitive manner. Um, and to that point, we have a few questions in the RFI and for the potential for a short form advisory opinion, a potential FAQ process, similar to the COVID-19 FAQ process.
Speaker 2:Yeah. I ha I have to say just as a, as a practitioner, uh, you know, the FAQ's from OIG during the public health emergency had been really helpful and really demonstrated, um, the pivot, like you said to me, I think that's a great word to use the pivot that the agency has been able to undertake. Um, Jennifer, I don't know if you have any thoughts on that or response to that, your own experience at OIG prior to the public health emergency, um, certainly is so deep and informative. Um, what was your reaction to OIGs um, you know, COVID response and how the agency pivoted?
Speaker 3:I thought it was great. I know, you know, we in private practice loved the FAQ process. Um, I don't think it's quite fair to describe them as many advisory opinions. I think Sam would take issue with that, but they are super helpful because it provided the industry with insight into how OIG would analyze the specific set of facts and circumstances. And, you know, they don't, they don't give that prospective immunity that Bulletproof immunity that you would get in an advisory opinion context. But, you know, if someone were to look at the FAQ, even if it wasn't the person who submitted it and structure an arrangement, relying on that same facts and circumstances, that would really help from an intent perspective because of course the kickback is an intent-based statute. And so I think the industry found those to be incredibly helpful, um, and kind of struck that balance between, you know, the deep analysis and perspective immunity offered by advisory opinions and the requirement to be nimble and fast in during the public health emergency. So I thought that was great.
Speaker 2:So you use the word nimble, we've talked about pivot. Um, I've been thinking, you know, just from, um, Christy grim statements just a few weeks ago at the fraud and compliance forum, you know, for the rapid change, the modernization acceleration their speed here, that's the real kind of issue. And, you know, um, when we're thinking about this concept, um, the OIG notes that it wants to, you know, really modernize its guidance through what they say is a multi-step multi-year process, which, you know, might make some of us think, oh, is this going to be, you know, sort of slower than, than what we can anticipate, but, you know, Jennifer, you know, just based on your own experience, um, at OIG and sort of, you know, knowing who the stakeholders are, do you think the agency will be able to keep up, uh, it, you know, what can we expect from the agency with respect to this process?
Speaker 3:Uh, I think we'll see layers, you know, like the, the agency recognizes that, um, you know, that practitioners and private practice really did like the FAQ. And I think that's something perhaps that they could move along more quickly. Whereas, you know, some of the questions they posed about the advisory opinion process and, and potential changes to that process would require notice and comment rulemaking. And so that obviously is an extended process. Um, you know, they ask questions about CPGs, the compliance program, guidance documents, uh, historically they've been published in the federal register, um, you know, and, and through they get notice and comment, and that also takes quite a while, but maybe there's a way that they could supplement that. You know, we all know what the, you know, the steps for that, the OIG compliance guidance, you know, the seven essential elements, um, so that doesn't need to be repeated, but maybe, you know, they could have some sort of, I think proposed in the RFI was, was a website that updates like, Hey, here are the new risk factors we're seeing.
Speaker 2:Absolutely Samantha want to turn to you. Um, you're currently with OIG, tell us a little bit about what's on the table and this RFI, what's the rule really asking us to provide insight on and, and feedback about.
Speaker 4:Yeah. So I do want to emphasize the RFI is about how best to improve usability, accessibility, and process. So it's, it's not about the substance of our resource documents or advisory opinions for the most part. Um, so this isn't our annual solicitation where we request comments on potential new safe harbors, for example. Um, so when you approach, when you approach the questions in the RFI, I think that's really important to keep in the back of your mind. And, you know, as Jennifer highlighted this, this RFI covers a lot of ground, right? It's not just the bread and butter of the industry, guidance branch, like advisory opinion, special fraud alerts, et cetera. It's, you know, OIG work plan, it's audits and evaluations. So I think it's, um, this is really simple, but just, just respond to the questions that we ask you. And don't, don't tell us how much you want a new safe Harbor or some other wishlist. I mean, you can, but it's really outside of the scope of the RFI.
Speaker 2:Yeah. I, it's such a, such a great observation and you must've been reading my mind to me at the, my next question is what's not on the table when it comes to potential changes. So, you know, um, should comment or stick just to the suggestions for, um, you know, sort of the basics format, function rules around process, or is there room for specific substantive updates and requests? And it sounds like really, you know, there isn't, this is focused entirely on format and process.
Speaker 4:I mean, I will say that there are a couple of areas, um, you know, in the, in the first section of the RFI where we have general questions, we say, you know, what types of arrangements or practices topical areas or industry segments should OIG consider addressing and future resources. So to the extent you feel like there's a comp like a gaping compliance hole, or not even gaping like a sizable hole that we should address, you know, we, we want to hear from you. Um, so it's, it's not that substance is totally off the table, but you, where you're injecting substance into your response, you want to make sure it's very, um, tailored and responsive to what we're throwing out there in the RFI.
Speaker 2:Yeah. So for example, if we're talking about the compliance program, guidance documents that as we've noted, some of which are, you know, a couple of decades old almost now, but it's still very usable, but maybe there's some substantive gaps in there. So it could be something like, you know, we would request that you update the compliance program, guidance to account for the following topics. That might be something that's worthwhile, but not necessarily digging into the analysis for each of those topics.
Speaker 4:Yes, exactly. Yeah. And I mean, to the extent you feel like there is a topical area that warrants, um, our focus, you know, um, context, the framework around that is helpful as well. So I realized it's like a fine line between processes, substance that we're asking folks to walk. Um, but I think if, if you keep in mind sort of the, the overarching goals of the RFI, um, I think that can be, that can be helpful in orienting your responses,
Speaker 2:Jennifer, how are you advising clients with respect to the RFI and, you know, what, w we're our clients, um, indicating they've got some interest in perhaps submitting comments if you want to share.
Speaker 3:So I think the most interesting areas are with respect to advisory opinions. Um, the proposed changes there, and I think clients will be very receptive to the proposed changes to the L E I E. Um, you know, a lot of, a lot of my clients contract that out. And so, and that costs money, right? And because it's such a manual process and the stakes are so high when it comes to employing excluded individuals. And so I think developments and improvements there will be very welcome and could save clients potentially time or, and or money, um, the, the advisory opinion, um, proposed or questions and, and potential changes, you know, terminating advisory opinions after a certain amount of time or, or the short form advisory opinions, um, are very interesting, especially in light of recent developments in the Southern district of New York and, you know, the lawsuit against OIG. So, um, you know, asking clients what they think about that and how that might impact, you know, like I said, there's such a hunger for, um, more guidance and more timely guidance. Um, but you know, quite query whether, um, whether an FAQ type process would be, um, more effective or whether these changes to the advisory opinion would be more effective. I, I do think, you know, there's, there's frustration, I think on both sides about the advisory opinion process from the private practice perspective, you know, it is slow and cumbersome and expensive because you, you develop these requests and they're comprehensive, and then you submit, and sometimes they get rejected or, um, you're expecting possibly to get a favorable opinion, and it doesn't go your way, but it also is, is challenging. And at times frustrating from the government side, because it's such a one-sided process, you know, the requesters present the facts that they want OIG to see an OIG has to figure out what questions to ask, to determine whether they can give this arrangement prospective immunity. So that just by its nature is it is a time consuming and challenging process.
Speaker 2:Absolutely. You mentioned the Southern district of New York and, uh, the Pfizer, uh, matter involving copay assistance. And, you know, one of the questions there at least, you know, some of the, some of the concepts that were questioned in that matter was, you know, the guidance that OIG issues and the formality of that guidance and whether it be carries the weight, um, that, um, oftentimes we placed in it. I don't know, Jennifer, do you have any just sort of, you know, um, pontifications about that, uh, that matter or, um, anything to add coming out of the Southern district's decision? I think it's, um, you know, quite timely given, um, OIGs, um, modernization push, uh, and the court's decision there. So I don't know if you have any thoughts on that
Speaker 3:Is, and I wonder, you know, how that will impact OIGs decision, whether to offer some sort of short form advisory opinion, particularly with respect to unfavorable opinions, because it appears that, you know, the Southern district of New York potentially open the door, we'll see what happens with the case, but it's potentially opened the door to challenges of at least unfavorable advisory opinions. And, and the court said that, you know, these interpretations of law are entitled to respect to the extent that they have the power to persuade, and it's not going to be very persuasive if there's no analysis included. So, um, you know, the timing, I believe that RFI came out before the decision. So that might be something that factors into OIG decision, you know, do we offer this short form? And if so, um, just for favorables or for everything. And I think one of the, one of the questions they asked is should we allow request to make that decision? Um, and I think that's another area, you know, we talked about the process being very one-sided, um, would, would that requesters, um, requests be given deference? Where would it really be, um, up to OIG to determine whether or not, you know, a short form is appropriate in every instance,
Speaker 2:Absolutely. And stakeholders, um, you know, may want to have that analysis. I know I myself rely on that analysis regularly when I'm advising clients about, you know, good directional content from the government and, um, you know, uh, guidance, although, you know, not something that can be relied upon exclusively, obviously, but, you know, at least it's a compass, um, to help clients move in the right direction, Samantha winter comments due to the OIG. And maybe if you could share with us a little bit about what listeners can expect in terms of timing, when do you think, you know, maybe we'll see something coming out of this
Speaker 4:Is it, December is, uh, January 1st, the
Speaker 2:Comments are doing, I've got the rule right here, uh, January 31st. So there's a little bit of time,
Speaker 4:Matt. Thank you. That was a total gotcha question too.
Speaker 2:I know. That's what, that's what this podcast is about.
Speaker 4:Okay. So as far as timing goes again, Jennifer already, already spoke to this point about, um, how there may be areas. We are more likely to focus on coming out of the RFI. And the one thing I want to tag onto that is that's where comments are really gonna come into play for us, right? So we want to hear from you, what areas should we prioritize? Um, what is the most time-sensitive, um, area of focus for you and your clients for the public? Um, because again, we are covering a lot of ground in this RFI. We're talking about a lot of different aspects of OAGS work. And so the comments will help us think through about, um, what's the most time sensitive,
Speaker 2:Jennifer Michael Samantha plans, or this is really exciting from the OIG. A lot of us have been, you know, uh, using the CPGs and the advisory opinions and the CIA's for years and years. And it will be so interesting and exciting to see the developments here. Thanks for the time today. Any final thoughts or insights before we leave?
Speaker 4:I think it's very exciting that you think this RFI is exciting. I'm just going to say
Speaker 5:Agreed. We are very eager to see what OIG does.
Speaker 2:Absolutely. Well, if you can't be an excited health lawyer, you know what, well, thank you so much for the time both of you. We really appreciate it. And we'll look forward to more from, uh, OIG in this RFI. And thanks so much, uh, for the time today, our guests today have been Jennifer Michael ABAs, Berrien sins, and Samantha plans are of the HHS office of inspector general. This has been another edition of the American health law associations for wannabes podcast. I'm your host, Matt Wetsel and we'll be back next month with another edition.
Speaker 5:Thank you for listening. If you enjoy this episode, be sure to subscribe to AHLA, speaking of health law, wherever you get your podcasts to learn more about AHLA and the educational resources available to the health law community, visit American health law at org.