2026 OIG Advisory Opinions: What Healthcare, Life Sciences, and Medtech Companies Need to Know

Transcript

The following transcript of this discussion was edited for clarity.

Dustin Schaefer: Hi, my name is Dustin Schaefer, counsel in Goodwin’s healthcare group. I’m here with my colleagues, healthcare partners Matt Wetzel and Greg Demske. There have been a number of notable developments coming out of the U.S. Department of Health and Human Services Office of Inspector General (OIG). So today, we wanted to take a step back and do a 2026 look back on some of the key themes in the recent OIG advisory opinions we are seeing thus far. Before we dive into the advisory opinions themselves — Greg, maybe you can start us off with some background on the current healthcare fraud and abuse enforcement climate more broadly, including what you’re seeing from both the OIG and DOJ.

Greg Demske: I think it’s just important as we talk about these types of issues to understand that we are in a heightened atmosphere of enforcement from the federal government. We had record recoveries under the False Claims Act last year — almost $7 billion, of which almost $6 billion were healthcare and life sciences companies that were paying out a record number of whistleblower or qui tam False Claims Act actions filed last year. And also the most extensive criminal healthcare fraud enforcement action by the Department of Justice.

So those are historical, and we have the government establishing a DOJ–HHS False Claims Act working group for coordination on these types of cases and setting out as one of their priorities kickbacks for drugs, medical devices, and other products paid for by federal healthcare programs.

We also have the establishment of a new division at the Department of Justice focused solely on fraud. That’s the first time that’s ever been in place. And there are only a limited number of divisions at the Department of Justice. And it’s very important to note that the government is explicitly and repeatedly encouraging private whistleblowers to file qui tam suits under the False Claims Act, which means even if you’re not on the government’s radar screen, anybody is at risk of being a defendant in a federal case brought by an individual or an entity.

So that’s the context we’re in. There’s a lot of risk, particularly around the anti-kickback statute.

Dustin Schaefer: Let’s dive into the advisory opinions. Of the 10 opinions this year, nine are favorable and one is unfavorable. And they involve a range of stakeholders, including two opinions for medtech life science industry stakeholders, in both the ophthalmology and cardiology space. Matt, let’s dive into these two opinions.

Matt Wetzel: There’s been a lot of developments, as you mentioned, Dustin. I think there’s 26-05 and 26-03 — those are sort of the recent ones we’ve been doing a lot of thinking about. But each opinion addresses two separate issues that medical technology companies face in the industry. First, 26-05, here you have a medical device company that’s asking the federal government, “Are we able to cover the out-of-pocket cost for Medicare beneficiaries who enroll in a clinical trial?”

So basically, money is no longer a barrier to their participation. And here, the device in question, 26-05, was an implantable heart failure treatment device. The trial was registered with FDA, and CMS approved. The manufacturer here had proposed covering the cost-sharing obligations so Medicare enrollees wouldn’t have any of out-of-pocket expense related to their purchase or patient but would still receive the benefit of the device in the research context. This would also allow the manufacturer to continue to collect information about Medicare patients, in particular.

And so the OIG here concluded that, yes, the subsidies at stake would have some degree of prohibited remuneration under the kickback statute and the beneficiary inducement law. In other words, it’s an item of value. It’s a transfer of value. And it could appear to be some form of improper payment on paper.

But the OIG saw, on the whole, key safeguards. It’s a one-time treatment. There’s no downstream product utilization over time. There’s no hidden or obscure hook for patients or providers for future purchases. Study had rigorous oversight, informed consent, IRB approval — the standard controls around clinical research. And so OIG concluded that covering the copays by the medical device manufacturer itself would be permissible and would not give rise to an enforcement action.

Dustin Schaefer: With respect to OIG opinions in the clinical trial space, is there anything unique about this particular opinion?

Matt Wetzel: I think that the scale here is larger than the previous places where OIG has gone into cost waivers for these sorts of IDE studies. In previous opinions — 22-05, 23-11 — participants there were 260 and 1500, respectively. Here, we’ve got 2,500 randomized participants across 200 sites. So it’s a large-scale research project here. And so I think what we’re seeing is that OIG has concluded, at least in this most recent opinion, that the same guardrails that could work for a small 260-person trial are conceivably as effective as they are for a research program that’s 10 times larger.

And so I think the key guardrails are, of course, don’t advertise the subsidy, formal enrollment criteria, informed consent, IRB oversight, CMS pre-approval. This study is positive, too. So the advisory opinions don’t necessarily apply to other parties, but they do allow stakeholders to glean good compliance controls.

So I think focusing in that space when establishing or designing a research program for medical technology and looking at this opinion and the other opinions in this line is important in understanding what are the best guardrails to put in place.

Dustin Schaefer: That’s super helpful context. And the opinion really does show OIG applying a fairly consistent framework in the clinical trial context. And I think here, too, in addition to the strong safeguards that you mentioned and the limited downstream utilization concerns that they noted for this particular product, helped these factors were consistent with other opinions.

Shifting gears a little bit to 26-03 — that opinion involved a medical technology manufacturer and distributor with products across a number of specialties, including ophthalmology and microsurgery. In this context, for the Advisory Opinion, they analyzed a proposed discount arrangement tied to its commercial contracting practices. Can you provide a little background here?

Matt Wetzel: As a longtime medical technology industry participant, it’s been nice to see medical devices getting some spotlight and recent opinions. 26-03 is in the ophthalmic space. And this is a company that makes cataract surgery supplies, lenses, surgical packs, and software — because obviously, medical technology now involves more than just the physical product.

There’s always some manor, degree, or scope of software involved here. And so the proposal was pretty straightforward: A physician practice would buy the company software full price, and the affiliated surgery center would get some manner of discount on supplies, IOLs, that kind of thing. And OIG said this doesn’t necessarily fit into any safe harbor cleanly — and most notably, the discount safe harbor, I think, comes to mind for everybody when hearing the very brief fact pattern.

And that’s for two reasons. First, OIG said the arrangement isn’t a typical bundle discount. It involves two discrete parties and requires one party here, the ophthalmology practice, to make a full-price purchase in order for a different party, the ASC, to qualify for a discount on products. And then second, OIG said the arrangement required the ASC to secure participation of a practice with at least one common owner in order to purchase the software. In other words, this requires some degree of additional actions similar to a services agreement, and that itself would fall outside of the discount safe harbor protection.

And so OIG said that although, as a whole, this doesn’t fit within the safe harbor, they thought that it would be a permissible activity for the following reasons: the typical prudential factor; review of the program; it wouldn’t really increase cost to the federal healthcare programs or utilization; the IOL products are reimbursed as part of a predetermined global payment; the software isn’t reimbursed at all; and it’s unlikely to influence clinical decision making, because the software could also be used with competitor products, so it wasn’t steering toward one manufacturer over another.

The direction of the financial flow also was instructive for OIG here. The money moved from the referral source to the referral recipient, not the other way around. And so the physician practice paid full price for the software and the surgery center got the discount. Had it been reversed — in other words, the surgery center had gotten something of value that flowed back to the referring physician — the OIG signaled the outcome could have been different. And so the lesson here is that it’s another example of what falls outside of OIG’s narrow view of what constitutes a permissible, bundled arrangement — something that we’ve all struggled with and debated for many years.

But then it’s also a reminder about who pays and who benefits and in which direction those funds and remuneration and money flow, which is what’s most significant — or at least a huge determinant in how these decisions can be made. And so, again, I think it’s positive that OIG looked at what was conceivably a very straightforward issue — they recognize the complexities, especially in the medical technology space — and applied a practical reasoning to it. And so I think it’s a positive step with this advisory opinion.

Dustin Schaefer: Taken together, it sounds like these opinions are a good reminder that the advisory opinion process is highly fact-specific and often depends on the particular safeguards and risk profile of the arrangement. Greg, given your experience both inside and outside the government, maybe this is a good opportunity to take a step back and talk a bit more broadly about the OIG advisory opinion process itself, including the timing, cost, strategic considerations, and when stakeholders should be thinking about pursuing an opinion in the first place.

Greg Demske: There are a lot of things to think about. A big part of our job is counseling clients on the risk of arrangements that may fall within the broad scope of the anti-kickback statute, and it’s hard to fit within the safe harbors often. And there are usually circumstances where clients are making a risk analysis, with our guidance, on whether they’re going to go ahead with an arrangement. And very few arrangements, relatively, are ones that are submitted to the OIG for an advisory opinion.

But we do think that there are certain circumstances where that makes sense. So, as far as timing, the statute says that OIG should issue these within 60 days. Realistically, that never happens. I would say six months is a good benchmark. That is probably the minimum in most circumstances. There’s two pieces of good news there: First, if you have the time to wait to go through that, there’s really a dialog with OIG, and you’ll get feedback from OIG as part of that process. It’s not just an up or down decision. And that dialog alone can be very helpful. And OIG will allow an arrangement to be tweaked and change based on that feedback during that process. So that’s very helpful.

And second, you can always withdraw your request for an advisory opinion at any point before it is published. So you have the ability to walk away, having had that dialog with OIG and informing your analysis of your risk. But if you can get to a favorable opinion, then it’s always in your benefit to get that, and then that protects you in a way that you’re not protected if you don’t have that. Because as we’ve mentioned, it only applies to the requesting entity.

OIG does charge for its time, but it’s a very minimal amount, relatively; it’s usually under $10,000. And they will let you know if it’s going over their estimate that you can ask for. Overall, I think that there are circumstances where a client doesn’t feel comfortable going forward without the certainty of an advisory opinion, and it may be because of their own risk tolerance, or it may be because of business partners. For example, a big pharmaceutical company — if you’re entering into a business arrangement with them, sometimes they they’re pretty conservative on some of these questions and will not feel comfortable with a novel or new type of arrangement unless there’s certainty from OIG.

So those are circumstances where I think it should at least be considered. I also think that you should work up front on developing what the arrangement is and crafting the request in a way that makes it easy for OIG to get to “yes.” It can reduce the pain and the time involved in the process. And that’s something that experience working with OIG helps in crafting that approach.

The last thing I’ll mention is that sometimes we’ve seen a growing trend of entities seeking a negative advisory opinion where they believe a competitor’s engaged in risky activity. And they want to go into OIG and get a negative opinion. You’re required to certify that you intend to enter into the arrangement that you’re asking for advice on. But with that consideration in mind, it’s something that is at least a tool in the arsenal — that we’ve seen some people use this process as a sword rather than a shield. But for the most part, for our client base, we’re looking at this as a tool to get the best protection one can get for novel arrangements that raise risk under the anti-kickback statute.

Dustin Schaefer: To wrap things up, these recent advisory opinions reinforce a broader point that even in today’s aggressive enforcement environment, the OIG continues to recognize that innovative arrangements can move forward when they’re thoughtfully structured and supported by meaningful safeguards. And at the same time, they’re a reminder that the analysis remains highly fact-specific, and even small differences in structure or financial flow can materially affect the outcome.

So for stakeholders navigating novel or complex business arrangements in the healthcare industry, the advisory opinion process remains an important strategic tool.

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The Goodwin Healthcare team will continue to monitor activity from OIG, including its issuance of new advisory opinions. For more information on the issues discussed in this alert, please contact the authors or reach out to Goodwin’s Healthcare Regulatory and Compliance group or the Goodwin lawyer whom you typically consult.

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