CCS 2025: Minimizing risk in comanagement as an optometrist or ophthalmologist

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

Lori Wright, JD:

So we spoke about comanagement, generally, between ophthalmologists and optometrists, comanagement of refractive care and comanagement of cataract surgery postop care. It was a discussion of risk under federal statutes and how to minimize that risk as an optometrist or an [ophthalmic] practice. At the end of our presentation, we talk about the 4 pillars of a compliant comanagement program. So I think those are a really good way to sort of frame up the most important components of a compliant comanagement program that's going to comply with the law. Those pillars start with patient choice, informed patient choice: the patient needs to understand comanagement and make the decision themselves to engage in comanagement. The second pillar is fair market value rates, which are separately set. The third pillar is related to that one: it's typically payment separation, so that the optometrist and the ophthalmologists are charging separate rates independently from one another. And then the last one is an add on: it's no exchange of value. So often with these comanagement programs, they can sometimes be used as a tool. The issue is that they should not be used as a tool to induce referrals between the parties, and sometimes they can be packaged with perks and things that go between the ophthalmologist and the optometrist, and those perks should be avoided, because those are things of value that federal regulators consider to be inducements for referrals, which are prohibited by federal law.

So one of the pieces of our presentation is going through these 3 enforcement cases that all happened in 2023, all within a few months of each other. That in itself is really informative to the public. Here are 3 examples of what federal regulators believe is not a compliant program. Here's how you shouldn't be doing it. And they did it all at once as a sign to the public, that this is an area of enforcement for them, a trending concern. There are some themes through those 3 enforcement actions that we pick out in the presentation to see which kinds of things might raise the risk. Some of the common perks that might be provided are continuing education, free continuing education programs, sometimes speaker engagements, free entertainment and expensive meals. Those sorts of things are the kinds of perks that the Office of Inspector General is looking for when they're trying to determine if there might be a problematic arrangement.

How often is the legal landscape changing, and how can ECPs best stay compliant?

That's really good question, and interestingly, the answer is no, it's not constantly changing. Another piece of the presentation is tracing the regulatory and legal history. This started all the way back in the early 1980s when comanagement really took off, and the general principles have remained the same since then. I put up on the screen some of the language from Senate hearings back in the 1980s that sound really similar to some of the language the OIG has used in the 2023 enforcement action. So this is really something that hasn't changed a lot. I mean, the practice has changed, you know, optometry and ophthalmology has changed. So now we have LASIK. Now we have IOLs, premium IOLs, that we didn't have when this first started. But that's really just a change in the way the comanagement arrangement, the clinical components of the comanagement arrangement. But the basic components of what makes them legally problematic still remains the same. It's that exchange of value, a problematic arrangement doesn't have real patient choice. They're not setting real fair market rates for the services that are actually rendered. Those concepts still remain the same as what they were back in the 1980s even though the clinical components have changed.

How does AI change the dynamics of risk regarding patient confidentiality?

As so many answers around AI are right now, it's kind of in flux. We don't know what we don't know yet. I would encourage clinicians to think carefully about the issues that you've raised: patient privacy. Large language models often use the input in order to train future large language models. So you do have to be careful about HIPAA. You have to be careful about state privacy laws, which can be more restrictive than HIPAA in some cases. And there are some states now that are implementing AI specific laws. There's only a few of them, but that is something that you want to stay up to date on, just keep an eye on your state and see what specific restrictions might apply to your practice. I've heard there's a lot of efforts about medical scribe using AI, and I think you should be cautious about that at this stage. I can certainly see how that might be useful in the future, but at this point, I have not seen AI scribe materials performance that's really 100% accurate. And as we all know, you've got to have accurate medical records in order to make legitimate medical decisions. So I would just be cautious at this stage, make sure you're vetting any kind of AI tools that you're using to ensure that they are up to professional standards that apply in your practice, and just think about it carefully right now, while we're still in this transitional stage.

What do you hope MDs and ODs took away from the presentation to bring home to their respective practices?

That's an interesting question, in part because we have not seen enforcement yet against an optometric practice in the federal anti-kickback statute space in comanagement. What's interesting about that is that there is nothing in the text of the anti-kickback statute or the legal application of its concepts that would prevent enforcement against an optometrist. The anti-kickback statute prohibits both providing and receiving any kind of something of value in exchange for referrals. So either side of that equation should theoretically be equally guilty of a violation if they have an issue. Both sides then, I think, from my perspective as a counselor, should be adhering to the same standards, the same 4 pillars of a compliant comanagement program. I think ophthalmologists continue to be at a slightly higher risk. Just speculating on why they might be the focus of enforcement to date is probably because they are the ones who own the surgery centers. They have slightly deeper pockets. And what I would say is the takeaway for an ophthalmologist should be that there is a present risk, that there are enforcement actions ongoing, and they should be structuring their programs to comply. And then optometrists, on the flip side, should think about both potential risk for themselves in their practice, because there is no legal distinction between the 2 in this area and also partnering well with ophthalmologists, so they can understand where ophthalmologists are coming from when they're asking for a certain component of the program to be implemented, and why both sides should really be using those 4 pillars of compliant program.