In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks with Jennifer Michael, Member, Bass Berry & Sims, about OIG Advisory Opinion 22-14, which was released on June 29 and analyzes an ophthalmology practice's proposal to offer continuing education (CE) programs for local optometrists. They discuss the requestor’s four proposals for financing the CE programs, OIG’s analysis and the questions it raises, and advice for the drug and device industry. Jennifer is the former Head of OIG’s Industry Guidance Branch. She co-authored a PG Briefing on this subject. 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 with Jennifer Michael, Member, Bass Berry & Sims, about OIG Advisory Opinion 22-14, which was released on June 29 and analyzes an ophthalmology practice's proposal to offer continuing education (CE) programs for local optometrists. They discuss the requestor’s four proposals for financing the CE programs, OIG’s analysis and the questions it raises, and advice for the drug and device industry. Jennifer is the former Head of OIG’s Industry Guidance Branch. She co-authored a PG Briefing on this subject. 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 ALA is 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:Good morning. Good evening. Wherever you may be. This is Matt Wetzel host of the American health law association fraud abuse podcast. Today we're talking about OIG advisory opinion, 2214. Of course, OIG receives a significant amount of requests for guidance and for advice and are faced with some complex and complicated questions. OIGs advisory opinions, of course can only be relied upon by the requesters themselves. However, they do provide good direction and good insight for others about how they should structure their programs. And of course, while OIG grapples with difficult situations, sometimes we are left with questions, seeking more information and more clarification. Joining me today to talk about opinion 2214 and the impact on continuing education programs for providers that might be sponsored by drug and device companies is Jennifer Michael member of Berry and Sims based in Washington, DC and former head of the industry guidance branch at OIG. Jennifer. Welcome.
Speaker 3:Thanks Matt. I'm glad to be here.
Speaker 2:Well, it's nice to have you back and it's been an exciting, uh, I suppose couple of weeks, perhaps a month at OIG, of course, you know, earlier, uh, uh, uh, this month, last week, in fact, we had a new special fraud alert come out with respect to telemedicine. Um, we've had several OIG advisory opinions released and it does seem that OIG has not taken a break for the summer here. Uh, and today we want talk a little bit about OIG advisory opinion 2214 released at the end of June, in fact, June 29th, uh, in the opinion itself, Jennifer, as we both know, uh, uh, uh, addresses a proposal related to continuing education programs for in this instance, uh, optometrists. But I wonder if you might start, um, the conversation today by sharing a little bit about the facts of advisory opinion, 2214, who's the requester, the type of program that they were hoping to undertake?
Speaker 3:Sure. So the requester here is an ophthalmology practice that is comprised of one ophthalmologist and three optometrists. And this practice receives about half of its surgical referrals from local optometrists. And the requester here is proposing to offer continuing education or CE programs to the local optometrists. And those programs would address new technology, um, pharmaceutical practice treatment protocols that are related to the ophthalm ophthalmic surgeries, and the requester would seek approval from the relevant accreditation bodies to offer the attending optometrist CE credit. And in the facts here, the requester proposed essentially four variations of these CE programs. Um, each of the programs would involve, um, requester as one of the presenters and also, um, the, the day long program would involve external faculty and there would be an evening program as well.
Speaker 2:And you, you mentioned the four proposals, uh, you mentioned some of the, um, details around, uh, the programs themselves. I wonder if we might talk a little bit before we dive into each of the proposals, which as I understand it relates primarily to sort of the cost and expense of the program, registration fees, solic solicitation of grants from external parties. When we talk about these CE programs, Jennifer, um, you mentioned faculty, you mentioned sort of timeline. Um, what, what, what additional details do we know about these CE programs and in particular, how the practice itself is seeking to set these up?
Speaker 3:So one of the details that I think is important, but was not really explored in the opinion, is that requesters said that the accreditation council for continuing medical education standards for integrity and independence in accredited continuing education or that ACCME standards, um, would, would apply in cases where, um, there would be pharmaceutical or device manufacturer sponsors contributing funding to the CE programs. So, you know, like I said, before we delve into the arrangement under a couple of them requester, the practice is sponsoring the CE program on its own. And under two of them, um, pharmaceutical or device manufactured would be, um, would be sponsoring some of some or all of the expenses related to the programs.
Speaker 2:And with respect to the faculty, uh, my understanding is that the requester has included some information about who would be actually teaching and training at these continuing education programs. What do we know about the faculty here?
Speaker 3:Yeah, so requester the, the, um, physicians who, who work at the group practice would be faculty, and also there would be external faculty university faculty who would not be selected based on any referrals to requester or to, if there is an industry sponsor, um, not be selected based on any referrals to industry sponsors and they would receive a fair market value payment or honorary for their teaching services and with respect to the CE programs. Um, another important factor is that the requester would make these CE programs available to all optometrists within a certain geographic area. So any optometrist who is interested in attending the program may attend regardless of whether they ever refer a patient to requester or might refer a patient to requester.
Speaker 2:So it sounds like, you know, kind of at first glance, just the initial cursory review of the program, that the requester is intending to put some controls in place, um, to demonstrate, uh, you know, sort of, uh, uh, uh, uh, the, the fact that they're not seeking to, uh, provide this program as a, you know, a sweetener or remuneration to, uh, induce referrals, but rather there is faculty that's experienced, trained, uh, expert in the areas to be covered that the attendees themselves would not be selected based on their referral patterns. Rather it's sort of open in a more broad sense. Um, you know, I, then that then we get into sort of the proposals, the four proposals, um, related to financing the program. And I wonder if maybe we could talk about each of those a little bit in turn and, and OIG lays out, or perhaps the requester laces out as proposals a through D. So maybe if we could go through each of those Jennifer that would helpful audience to bit more the S program itself
Speaker 3:And I'll use the same references that OIG does in the opinion. So under proposed arrangement, a requester would charge attendees, attending optometrists, a fair market value registration fee to attend the CE programs. And with respect to all of the proposed arrangements, as you, as you just outlined that any local optometrist can attend. So under a proposed arrangement, a requester, um, charges, the fair market value fee, requester funds, any expenses and any, um, overages. So if, if the fair market value registrations fees exceed requested expenses, then requester would donate that, that Delta to an independent disinterested charity. So that's proposed arrangement, a under proposed arrangement, B requester would not charge the attending optometrist, any registration fee at all, and would cover the entire cost related to the programs on its own under proposed arrangement C um, again, requester would not charge attendees, any registration fee, but in this case, requester would solicit funding from industry sponsors, such as pharmaceutical manufacturers and device manufacturers to offset some or all of the program's costs. And then finally under proposed arrangement, D requester would charge attendees a registration fee. Um, but it would also get sponsorships from pharmaceutical or device manufacturers and use those sponsorships to subsidize some portion of the fee, um, unclear how much, but there would be, it would be, um, less than fair market value at, but not zero is, is what I intuitive from the opinion.
Speaker 2:So we've got a program with, you know, clear, uh, robust content. We have faculty that are selected based on their expertise, based on their knowledge of the area, paid at a fair market value, uh, uh, uh, honor area rate. Um, we have attendees that are not selected based on their referral patterns. Um, however, um, the, what the opinion then turns on these four proposals and just sort of, you know, kind of, um, reiterating here. So proposal a, as I understand it, the optometrist pay a fee it's intended to cover the costs, any excess that the, uh, the, um, uh, ophthalmologic practice receives, um, gets donated to a charity proposal B uh, there's no registration fee to attend again, it's open to all. Um, and, and the requester is simply covering the cost of the program. And then of course the item of value that could conceivably be provided to the attendees is the credit under the, as a CE program. Um, however, you know, with these proposals, we're talking about just sort of how, how are, uh, the attendees paying to attend or not paying proposal C you have the attendees not paying a fee. Um, the request covers the cost and seeks to, um, recoup those costs through grants from, uh, the device and drug industry, and then D uh, there is a fee to attend paid by the optometrist. And the requester also seeks that funding, uh, in the form of educational grants from drug and device companies. And you noted, um, Jennifer that it's unclear sort of how much the requester would be soliciting in, uh, proposal D from drug and device companies. My question is, do we know exactly what those funds would be used for obviously, um, to offset the cost of the program, but any sort of indication in the opinion, whether there would be excess funds that would be provided, whether there would be sort of a, you know, um, a dollar for dollar, uh, you know, expense to educational grant reconciliation, any concepts like that in the opinion,
Speaker 3:You know, the opinion is a little, um, that's, I, I could, I could not gather that from the opinion, it was unclear. Um, and I think, you know, a, a big part and, and we'll get into this more, what's, what's unusual about this particular opinion and I, what, what I think raises so many questions is, um, you know, typically when there's more than one stream of remuneration, OIG will separately analyze each remunerative stream. And so that would answer a lot of the questions we have here. Um, but OIG didn't do that in this opinion. And I think, you know, OIGs failure to do that and, and their, um, reference to the, the special fraud alert is, um, ends up creating more questions than it answers here.
Speaker 2:I, I, I couldn't agree with you more, Jennifer. And in fact, my next question is about the reference to the special fraud alert. I mean, I think, you know, we'll, we'll go into the analysis's analysis on each of the proposals and where it comes out. Of course, you know, there's, uh, you know, at least one, uh, uh, proposal that OIG blesses for lack of a better expression. Um, however it starts the analysis by turning to the November 20, 20 special fraud alert on speaker programs. Tell me a little bit about why OIG did that, uh, and sort of, you know, why that may or may not necessarily make sense in the context of this opinion.
Speaker 3:Yeah. Um, well, certainly I, I can't say I, I'm not there anymore. I'm not sure why OIG did that. It seems a little bit like a square peg round hole situation. Um, you know, as you know, many of our listeners may know this, that special fraud alert related to company sponsored speaking programs. So, um, this here, the, the proposed arrangements here are continuing education, so a different, um, a totally different arrangement. Um, the special fraud alert was designed to address, um, circumstances where companies such as, you know, pharmaceutical manufacturers or device manufacturers pay a speaker, an honorarium to, um, speak on behalf of their product, provide educational content on behalf of their product. Here, you have, um, an ophthalmology practice providing continuing education that would get the requisite, um, accreditation and comply with the ACCME standard. So, um, you know, it's, I, you know, OIG characterized the special fraud alert as instructive, and they acknowledged that the scope was different. Um, it might have been an easy way for them, and to quickly dispense with a number of, um, uh, big part of their analysis. Um, I'm not sure, but, you know, they, they went through the, what they thought were the, the primary, um, concerns listed in the special fraud alert and what they saw as the safeguards here that applied to that. They claimed applied to all of the proposed arrangements. And that was, um, you know, the concerns are that the company sponsors a speaker program where there's little or no substantive information, alcohol is available, or an, a meal exceeding, um, modest value is provided to attendees. The program is held at a location that is not conducive to the exchange of educational information. Um, a company selects speakers or attendees based on their past or expected referrals. And a company pays speakers more than fair market value for speaking, or in a manner that takes into account the volume or value of their referrals. And so OIG was able to conclude that none of the, or the CE the CE programs would not exhibit any of these suspect features. So, um, you know, they were able to dispense with it, but a again, it, it, doesn't not all of these suspect characteristics are present in all of the proposed arrangements. And so that's where I think, you know, OIGs failure to separately analyze each stream of remuneration, um, you know, kind of creates some confusion because if they had looked at and addressed each separate stream, and, and I believe that there's five streams, um, and we can touch on that in a minute. Um, I think, you know, then they could have been more precise about which safeguard apply to which remunerative streams and, you know, if there is a break in the chain there where that break is, and, you know, and analyze each stream to say, well, this stream would have been okay, except the other stream made it not okay. Kind of thing.
Speaker 2:Absolutely. Absolutely. I, I, I, I read it the same way and the idea that, um, OIG included this reference to the special fraud alert as a way to quickly dispense with. And I love that expression to quickly dispense with the analysis on that sort of, you know, the sort of, uh, um, underlying facts of the program that we just went through, the faculty they're expert, they're, you know, paid fair market value attendees aren't selected based on referrals, et cetera. Uh, however, you know, my, my take my own personal opinion, um, is a lawyer in the space is that, uh, you know, the use of the fraud alert in reference to this continuing education program, muddies the water a little bit, uh, when it comes to, uh, when it comes to support for educational programs, the other piece of it as well from my perspective is that the special fraud alert like you note is about drug and device companies, education and training programs on their products. And what we are talking about at heart is one provider's effort, uh, to provide educational resources for other providers and, you know, but for that touchpoint with the drug and device grant solicitation, uh, that's referenced in the advisory opinion 2214, uh, there they're really, you know, those, those two are different things. And, um, and so it sounds like, you know, yes, perhaps a shorthand way to dispense with, uh, the analysis on what otherwise would be, uh, you know, an acceptable program in order to get to the heart of OIGs concerns here. You mentioned five streams of remuneration let's dig in. Um, and let's talk about, um, each of the proposals, Jennifer, and, and, and, and the fifth stream of remuneration that you reference. Um, so, uh, you know, kind of walking through OIGs analysis. So after they reference the special fraud alert, they say, uh, you know, okay, we've, you know, we we're, we're, we're, we're comfortable that the program at heart faculty selection, et cetera, is okay. Um, when it goes into the, each of the four proposals, where does OIG come out?
Speaker 3:So OIG, um, noted all five streams of remuneration in the opening paragraph of their analysis, because they, they start off by, by explaining that the anti kickback statute is implicated, um, by each of the proposed arrangements, because under each of them requester would give something of value, which is the CE programs to local optometrists who are in a position to refer federal healthcare program PA uh, patients to requester. And then they said, in addition, under proposed arrangements, C and D, um, the sponsors would provide remuneration to requester, external faculty members and attendees, and those persons or entities may in turn, um, refer or make purchases from the sponsors. So if you break that down, the five potential direct or indirect remunerative streams are requester to the local optometrist attendees, requester to external faculty sponsors to requester sponsors, to attendees and sponsors to external faculty. So starting with proposed region a that one involves only two remunerative streams, and that is requester to the local optometrist attendees and requester to external faculty. And one thing that surprised me about OIGs analysis of this, um, of this arrangement, and, and just as a reminder, this is the arrangement where requester would charge fair market value fees for the CE programs is that OIG did not analyze it under the personal services, safe Harbor. Um, you know, it seems to check all of the big boxes, their requester would charge fair market value. Um, the, you know, the attendees wouldn't be selected based on the, the volume or value of their referrals, um, that it's for a commercially reasonable business purpose because the optometrists need these, um, CE credits. And, um, so, you know, it seems to check all the major boxes with respect to the optometrists attendees. And presumably it would also check all the major boxes with respect to the faculty. Um, you know, requester would pay the faculty a fair market value honor area that would not take into account any faculty members, referral patterns. So, um, you know, I kind of scratching my head as to why this arrangement wouldn't be safe harbored, or at least why OIG didn't walk us through the reason why it, why it's not safe harbored. Um, but instead OIG says, so the, the, the anti kickback statute is limit is, um, implicated, but this is low risk, um, because of the factors we cited in our analysis of the special fraud alert, and because it, um, the attendees would pay fair market value and they're not selected based on their referral patterns. So they, they quickly dispensed with that, but even the easiest, um, arrangement. Oh, so that one is the only favorable one that, that OIG approved. Um, so, you know, they, they discussed with it quickly, but even that, um, I think even that arrangement or analysis of the arrangement raises some questions.
Speaker 2:And how about, um, how about the other streams, Jennifer? You know, I'm almost thinking, um, as you're, as you're sharing this insight, which obviously is based on your significant experience in the area that OIG might have been, um, well suited to kind of analyze instead of analyzing each proposal B C, D, but rather to analyze the five independent compensation streams, and then to match up against the, the four proposals to say, you know, well, this proposal, you know, meets all of the standards that we would expect, um, for all five remuneration streams, some proposals may not have the, you know, the, the, the problematic remuneration streams. Um, it seems as if there's a little bit, um, there's a little bit too much detail, uh, with the special fraud alert reference and not enough detail, um, from the actual analysis under the kickback statute, personal surfaces, uh, safe Harbor C
Speaker 3:Agreed. Agreed. Yeah. So, yeah, I think OIG could have taken the approach that you just outlined Matt, or they could have, you know, analyzed each proposed arrangement as they did in the special fraud alert. And, you know, oftentimes OIG will say, you know, this stream of remuneration is low risk for the reasons outlined above and, you know, then they could have analyzed each proposed arrangement separately and independently to further eliminate any confusion.
Speaker 2:Absolutely, absolutely. Well, let's talk a little bit then about, so we talked about a, a, a proposed arrangement, a this is the arrangement that OIG says presents the, you know, sort of sufficiently low risk under the kickback statute that it would be permissible. Um, but when we talk about a, one of the unique attributes of proposal a is this concept of the donation, um, if, to the extent that expenses under the program, um, you know, uh, are entirely covered by revenue from the registration fee, if there's an excess in revenue that's received, the requester will donate that excess, uh, to a, a, a, a relevant charity. What factor did that play in the OIGs analysis, if any, at all,
Speaker 3:Um, great question, you know, so OIG cited that concern that requesters potential expenses, um, may exceed the fair market value registrations that collects, or, you know, the, um, the fair market value registration may exceed its expenses. And, but, and, you know, and so requester may make a donation to the charity or may subsidize, but OIG doesn't explain how or why that concern relates to whether the CE programs are intended to induce referrals or how that concern relates to whether the, the amount, the registration fees are consistent with fair market value in an arms length transaction. So it is a bit of a head scratcher for, for me and, um, a colleague and, and I were discussing, you know, take, you could take this analysis to its logical extreme. Um, if a hospital, for example, were to offer a donut for sale in its cafeteria to a community surgeon, um, would that sale of the donut implicate the anti kickback statute, even if the hospital charges fair market value for the donut. And so, like, you know, under this, um, under this advisory opinion is a little unclear how OIG would analyze that arrangement and, and whether, how the hospital treats the proceeds from the sale of that donut, would that factor into OIGs analysis? So, yeah. Great question. I agree. It's, it was kind of an unusual addition.
Speaker 2:I, I love it. Although I have to say, I hope we don't have any donuts based, uh, advisory opinions coming out soon, but it's a great, a great analogy, uh, and really kind of emphasizes that, uh, you know, when it comes to, uh, the kickback analysis, it's so important to really focus on the specific remuneration stream at issue and understanding, you know, the ins and outs of that remuneration in order to analyze it. And, you know, it's, it's, it's easy to be sort of distracted by other aspects of a program. Uh, but when you, you know, get down to brass tax, when you get down to the actual remuneration streams, um, the analysis, you know, should become a little bit clearer when we talk about proposals B, C and D. So these are the four, these are the three of the four proposals that OIG says are sufficiently high risk, that it will not, um, for lack of a better expression, sort of bless these proposals. Talk to talk to us a little bit about each of the, each of the, you know, BC and D Jennifer and, and OIGs conclusions about each.
Speaker 3:Sure. Well, I'll, I'll talk about B and C together. Um, that one, I think no surprise there. And as a reminder, those are the proposed arrangements under which the requester would not charge any registration fee to the local optometrist. So what OIG found there is that there was a heightened risk that, that remuneration being that the free CE programs could induce the attending optometrists, um, and, and the external faculty to refer surgical patients to requester. Um, so it totally makes sense with respect to the attending optometrists, um, not as clear why the external faculty was lumped in with that conclusion. Um, and then OIG went on with respect to arrangement C, which that's the one where requester would seek funding from industry sponsors. OIG concluded that there is heightened risk that, that remuneration could induce requester, external faculty and the optometrist attendees to prescribe or order a sponsoring company's products. And that's where I think, you know, going, going back to what I mentioned earlier, analyzing each remunerative stream, would've been very helpful to the reader because, um, you know, it's, it's a little unclear how that in it's, and it's an indirect remuneration, right? Because the sponsors are providing the funding to requester and then requester is using that funding, um, to, to reduce its expenses related to the program. And, and, you know, I mentioned earlier, the ACCME standard OIG did not make any reference to those standards in its analysis, which again, I think if they had analyzed the Ramirez to stream from the sponsors to requester the sponsors, to external faculty and sponsors to the optometrist attendees, that probably would have become an important factor because those, um, those standards are, are designed to really put a firewall between continuing education and marketing. And so it's unclear whether the attendees or, and, or the, the faculty would even have any idea that there was the sponsorship. And so if they didn't, weren't didn't know, or weren't aware of the sponsorship, how is that going to influence their referrals or change their prescribing or ordering habits? So, um, again, it was a very high level conclusion. And, and with respect to C wanted to just put a, wanted to highlight that, um, OIG said there's heightened risk that the Remar and from the sponsors to requesters could induce requester, external faculty and the optometrist to, um, order products from the sponsors. The reason put a point on that is respect to proposed arrangement D um, of all OIG only analyzed the remuneration from the sponsors to requester it didn't analyze, um, or tell or tell the reader how much of the registration fee might be subsidized. Um, and, and how that, how that would work. So, and the other thing is that OIG with respect to proposed arrangement D and, and I'm stumbling a little here because it's, it's, it's a head scratcher, they didn't mention heightened risk and proposed arrangement D even though proposed arrangement D included that same sponsorship from the sponsors to requesters and the same, um, stream of remuneration from requesters to the optometrist. Just not quite as much though. So there's a subsidy of the registration fee, but it's not free. Um, so OIG didn't mention heightened risk in proposed arrangement D um, they said it was, um, not low enough risk. It, it did not pose a sufficiently low risk of fraud and abuse for them to, to approve because requester is a direct referral source for the sponsors and the sponsors. Um, the sponsorships would relieve requester of expenses, requester, otherwise would incur. So you've got this mishmash of, of analysis here, and it's, it's unclear what OIG thinks presents a heightened risk to whom.
Speaker 2:And also, I, you know, one, as I read through the opinion as well, Jennifer, my take was that OIGs conclusions are based on an assumption, um, a couple of assumptions that are probably, um, you know, not well formed. I mean, first the idea that, um, an attendee or faculty, or, you know, even, you know, the requester itself could be swayed, uh, in its, uh, medical decisions in their medical decisions for patients based solely on this sort of, you know, potential indirect remuneration that could come from say a drug company that submits an educational grant to sponsor the conference. And that funding is then in turn filtered through request, or to cover the attendees registration fees, or to cover the faculty expenses. You know, there's an assumption that the attendees or the faculty will be able to track kind of dollar for a dollar, uh, you know, that while it was drug company, A's dollar that paid for this portion of my registration fee. And therefore I'm beholden to, uh, to this, to drug company a, uh, to write scripts for their product. You know, that seems to be, um, a little bit of an, you know, maybe academic and academic suspicious view of, uh, of the marketplace here now under, you know, understandably, you know, if you're taking this sort of academic review of the anti kickback statute, you know, clearly that is a remuneration stream, however, to your point, um, OIG seems to kind of gloss pass or gloss over the ACCME guidelines and the standards that are put in place to preserve impartiality, um, to protect independent, uh, medical judgment, to put a wall between sort of advertising and promotional activities on behalf of, uh, uh, grant funders or sponsors and the HCPs and providers who are attendees and faculty at one of these conferences. It just seems like you said, like you say, Jennifer, a mish of, of, uh, of guidance here that, you know, while, you know, looking at things, um, you know, at a, at a 30,000 foot view probably are not incorrect technically, uh, you know, when you get down to the details, there's probably a little bit cleaner, um, and more understandable way to write this analysis.
Speaker 3:Yeah, totally agree. I think, you know, the, the one other thing I'd mentioned is that I think there's a missed opportunity here for OIG to, um, provide guidance or, or at least explain if it departs from the pharma code and me code. Um, the pharma code specifically allows companies to provide subsidies to CME providers and to allow those providers in turn to use that money, to reduce the overall CME registration fees for all participants. And so, you know, it, it's unclear whether, um, you know, the primary problem here was the fact that, you know, requester is an ophthalmology practice. It is not really in the business of putting on CE. And if this had been an independent, you know, entity providing CE whether this all would be fine, um, that would be helpful to know that if, if that's the position that OIG would take, um, you know, OIG is never gonna put their stamp of approval on the pharma code or the me code, but, um, it has, it does occasionally reference them. And I, I know it references them in the physician roadmap. So I think, you know, even, even if it didn't mention the codes by name, just to walk through that analysis and explain where the, where the tipping point was from low risk to more than a minimal risk of fraud and abuse, would've been really helpful guidance for the industry.
Speaker 2:I, I think that's absolutely right. I mean, you know, two things come to mind, Jennifer, when you say that first, um, the special fraud alert for speaker programs also makes reference to the industry codes. And, uh, and so I, I, I do think that there is an acknowledgement by OIG that the, in, you know, the various industries here, the drug and device industries have certainly taken steps to, um, you know, encourage and direct their membership, uh, memberships to establish internal controls in this regard and to sort of, you know, make sure that there are those cut and dry lines. I think a second MIS opportunity here might be to articulate why this particular program might raise some concerns. In other words, what is it about this requester, um, that could be different or that could, um, or, or that could, uh, you know, encourage OIG to lead to a different conclusion? Are there controls the requester could put in place? Are there requirements that the requester could put in place? Is there something about the size and sophistication of the requester, um, that comes into play here? Uh, you know, I certainly, uh, have clients in the provider space who are quite large, uh, and put on their own continuing education programs similar to, uh, you know, what, I'm, what I'm reading about in 20, uh, 2214. Um, and, you know, they, they work very hard to put controls in place to make sure that that independent medical decision making is not, um, corrupted, uh, that there's a distinction between the, you know, grant funding and, um, and, uh, the, you know, substantive content of the program, et cetera, just like any standard, um, CME program that's put on by say, you know, a, uh, association of, uh, physicians or a specialty society, where does this leave the drug and device industry? I think that's what a lot of companies are asking. Can we still, um, as, as a drug company or device company fund, continuing education programs, what should we think about in terms of controls to put in place, you know, where, where, where should, where should, um, drug and device companies see themselves coming out of this opinion?
Speaker 3:Yeah, well, I, I think, you know, continuing edge pro continuing education programs can, and should continue and sponsoring manufacturers can, you know, continue to, um, provide funding to those programs. The remember the anti kickback statute is a criminal intent based statute. So if a sponsor is following the pharma code or the Avik code, um, I think, you know, there's pretty good evidence that their intent that they did not have the requisite intent there. Um, I think, you know, they might wanna ask some of the questions that, um, or ask questions to get at some of the concerns OIG outlined in this opinion, from the special fraud alert, you know, what does the venue look like? Are you providing alcohol? How are you going to use our funding? So, um, and, and also, you know, think about who is putting on the CE program. And, you know, if, if it is, if it isn't an independent, you know, CE provider, um, make sure that that provider is complying with the factors you just went through Matt.
Speaker 2:Well, Jennifer, Michael BA from Berry, thank you so much for joining us today. This has been so, uh, insightful and your experience, uh, having led the industry guidance branch at OIG of course, is certainly so informative here. And we really appreciate your insights. Thanks again for joining us today.
Speaker 3:Thank you, Matt. It was a pleasure.
Speaker 2:Thank you again for joining us for the American health law association fraud abuse podcast on your host, Matt Wetzel will be back next month with another edition.
Speaker 4:Thank you for listening. If you enjoy this episode, be sure to subscribe to a HLA, speaking of health law, wherever you get your podcasts to learn more about ALA and the educational resources available to the health law community, visit American health law.