In this episode of On Record PR, Gina Rubel goes on record with Kathleen Fisher Enyeart, Counsel at Lathrop GPM, to discuss the challenges of complying with health care regulations in a complex and rapidly changing industry. Kathleen is a seasoned litigator and a former in-house attorney. While she has represented companies in many industries and handles white-collar and government investigative or regulatory matters, she is also engaged in health care regulatory work.
What issues do providers need to be aware of with the increased use of AI tools in health care and medicine?
One of the interesting things is there’s so much discussion about the future of AI, but most electronic health record systems already have a number of tools that rely on algorithms and artificial intelligence for various patient alerts for things like blood matching.
Many of those tools are already in place and as clinicians have become more accustomed to having that clinical decision support available to them, they have started to rely on it and perhaps not do their own clinical check of whether the tool is accurate in a particular case with a patient.
One of the areas where we see this happen sometimes is with sepsis alerts, which several of the electronic health vendors provide. When you see a sepsis alert as a clinician, you can’t just rely on the algorithm, nor can you rely on it if it hasn’t alerted that this patient is at risk. You still have to be responsible as the clinician for that standard of care.
That’s an area where clinicians have to become increasingly vigilant that they’re not relying too heavily on these tools and certainly for new clinicians that are being trained. They still are responsible. One of the ways I’ve heard this explained is – if you have the auto-driving car, but you’re behind the wheel, you still have responsibility for the car. You can’t just take a nap and say, “Well, it’s a self-driving car and whatever happens, happens.” You still are the one sitting there. You can use the technology as a tool, but you still have the ultimate responsibility as the clinician for patient care.
In your practice, do you tend to work with the general counsel or are you working directly with the providers?
It depends on the case. If we’re working with a large hospital system, for example, we’re probably working with their general counsel or in-house legal department. We also represent smaller clinics and in some cases physicians directly who may have a legal issue they’re facing. Maybe they have a False Claims Act matter or some other patient issue beyond just a medical malpractice issue. It may be a disciplinary issue. In those cases, you’re often working directly with the provider as well as sometimes different fields like nursing or dentistry.
Gina Rubel: The reason I asked that is to have a better understanding of not only who you represent. I was also thinking about the regulatory world as you were talking about AI tools and their use in medicine. Do their malpractice insurance policies address the use of AI tools?
Kathleen Fisher Enyeart: That’s a great question. In general, if you look at the legal standard, you’re looking at the standard of care. On the one hand, we’re saying, “Yes, don’t be too reliant on the AI tool because you as the clinician ultimately have the standard of care and you’re directly responsible.” On the other hand, you could find a scenario where you’re not following an alert or you’re not utilizing an AI tool that’s available to you.
For example, in a lot of the imaging areas, they’re starting to see advances in AI being able to spot cancers or other things in an image that are very difficult to see with the human eye. If you are not availing yourself of those technologies, is that potentially going to evolve into a substandard of care? I think you have to keep in mind that the standard of care evolves, but it’s ultimately always going to be the clinician’s responsibility to ensure that patient is receiving that standard of care.
Gina Rubel: What I’m hearing you say is that providers also have to maintain and stay up on the standard of care and technologies, much like we do as lawyers.
Kathleen Fisher Enyeart: I agree. Medicine evolves very rapidly. New clinical trials come out. Research finds that with medications we thought had beneficial long-term effects, maybe the long-term effects aren’t as beneficial as we thought. Some things we try to do as preventative medicine may be less effective than we thought at ultimately preventing death or cancer. For clinicians, it’s important that they stay abreast of all the evolving developments, whether that’s from research or technology, so that they can provide the best standard of care that’s up to date.
One of the things we’re also seeing is the consolidation of health plans and medical practices. How does that impact patients and providers?
I think that’s going to become increasingly challenging. As we talk about clinical studies that come out, we’re seeing more areas of medicine where medical necessity is being called into question. One area we’ve seen a lot is that recently there have been a lot of back surgeries to alleviate back pain. But there have been several studies that have come out that say it’s not clinically been proven effective. Insurance companies are starting to scrutinize those surgeries, which are very costly.
Another area where there have been prosecutions is in angioplasty and coronary stent placements – whether there’s sufficient stenosis. Some recent studies have said if there’s less than 70%, a stent is not effective in preventing a future heart attack or furtherance of heart disease. Those standards have changed pretty dramatically.
As we have more consolidation of these health plans, we’re going to see that there’s less independent judgment for practitioners. More and more physician groups are owned by hospitals or by these health plans that are looking to maximize profit. We’re going to see that what will be covered is going to be less a choice for the patient to decide with their doctor looking at the evidence and more what the health plan or larger hospital system has decided ultimately makes sense.
One of the things I think about is some of the preventative cancer steps. Think of a scenario where a woman has breast cancer and clinically, she’s not being recommended to have a mastectomy. But in her mind, that’s going to give her more peace of mind. She doesn’t want to worry about a recurrence. She understands that there’s some research that suggests it’s not necessary, but that would be her preference.
I think we’re going to see that patients and their doctors have less ability to make those decisions on an independent basis based on the patients’ preferences and their view because I think we’re going to have more large health plans. As these practices are purchased by hospitals and there’s less independent practice, there’s going to be less independent judgment that patients are going to be able to exercise.
What other trends do providers need to be aware of, like the False Claims Act enforcement?
In the False Claims Act enforcement, we have been seeing several interesting trends in recent years. One is that as we see more Medicare Advantage plans taking a larger role in health care, there have been a lot of False Claims cases against those plans. One of the areas that’s interesting and implicates AI is a lot of these groups have utilized chart reviews to look for areas where perhaps they could have built a higher-level code for a higher reimbursement rate. There have been several prosecutions where it’s been found that that was done improperly or the algorithm only was looking for where they could increase the billing, but it was turning a blind eye to areas where maybe it was overcharging, and it should have been reduced. I think those Medicare Advantage plans are just going to come under increasing scrutiny as they play a bigger role in our overall Medicare and health care systems as we have an aging population. Another area that’s interesting for providers is the increased scrutiny around cybersecurity standards.
When you think about patient health data and HIPAA, if you see providers that don’t have sufficient cybersecurity standards or don’t have the standards that they are representing they have – to be compliant with HIPAA, that could result in False Claims charges. In addition to all the other data privacy concerns that providers have to consider, there’s a False Claims angle that they could face as well.
Another area that’s interesting is they’re starting to target private equity groups that are investing in health care and look at how they’re working to maximize profits and whether that’s being done in a compliant way where they’re following Centers for Medicare & Medicaid Services (CMS) standards, where they’re not increasing rates for unnecessary medical procedures or increasing billing codes in a way that’s improper. I think the government has a lot of scrutiny around private equity’s involvement in health care. We’re going to continue to see that as a target for the government.
Can we talk about the trend of private equity groups? Also, what are CMS standards, and why do they matter?
Private equity is investing more heavily in health care. Sometimes this is through health plans that are backed by private equity and are looking to reduce the overall cost of health care but also maximize profit. It’s difficult to do both of those things. You have to look at how is that happening? Are they failing to provide medical care that really should be provided to patients? Or are they increasing medical spend on procedures, medications, or visits that have a higher reimbursement rate but perhaps aren’t needed? I think we’re going to see more of that as well. The reimbursement and overall business structure of health care is very different because of the Stark law and the Anti-Kickback Statute.
As private equity investors come into this highly regulated space, the way they would normally try to incentivize referrals is not legal in health care. Are they following those rules and are they avoiding any types of kickbacks for referral plans? As they’re buying medical practices, are they doing that in a compliant way, and is the compensation being offered to doctors or practices compliant with Stark? I think we’re going to continue to see more scrutiny in that area.
CMS decides what will be reimbursed by Medicare and Medicaid, as far as what’s considered medically necessary. Going back to the discussion on coronary stents – under CMS standards, you have to have 70% blockage for a coronary stent to be considered medically necessary. Now there’s some nuance to that, but that’s a shorthand rule. The health plans often will adopt those CMS standards as well for what they will cover and what they will consider medically necessary.
As we have an aging population and we’re going to have more of our population utilizing either Medicare or Medicaid, I think the government is going to have much more control over what doctors are able to do and what they’re able to provide for their patients based on the standards that they set. Sometimes these evolve as new clinical studies come out.
We’re talking about whether stenting’s necessary. There’s a recent study that questions whether statins actually help long-term with preventing heart attacks or heart disease. They look at areas where there’s a lot of health care spending to scrutinize and say, “Is this really appropriate in all cases? Should we be targeting this to a more specific audience?”
Sometimes those clinical studies are designed in a way that they are looking to try to find areas that medicine and medical interventions, whether that’s through pharmaceuticals or surgeries, are not necessary or don’t have a long-term effect even if it might be considered to be the right thing in the short term. If we go out 10 or 20 years and look at people on statins, for example, are we actually seeing a difference in life expectancy or the number of heart attacks?
As we see the government being more active and trying to scrutinize and control health care spending, we’re going to start seeing more standards set by CMS to limit what will be covered by Medicare, and then health plans will frequently adopt the same.
Do concierge groups like the VIP doctors have all the same regulatory issues as every other doctor, or is there anything different in that space because the patients are paying them directly?
That’s a great question, and those are becoming more popular for a lot of the reasons we’re discussing, which is you get more customized medical care in many cases, and you have more freedom to work with your doctor to decide what’s best for you in your circumstance. The trick is they do have to avoid taking Medicare Advantage or any of those kinds of payments. If they’re taking any kind of commercial insurance, there’s also a lot of limitations there. The percentage of the population that can afford that is relatively small.
What those doctors are going to be able to provide is somewhat limited too, because you might be able to afford a concierge physician for regular checkups, but then if you have to have surgery and you’re in a hospital, you’re right back in the regulatory mix, unless the doctor owns an ambulatory surgery center and you’re able to do all of that outside of the scope of any of your insurance. That’s very difficult to do, but it’s not impossible.
If you think of areas like plastic surgery, that’s almost wholly privately paid. There are some very limited areas of health care like that, but as you get into more complex medical problems, you’re still ultimately probably going to be involved in the regulated health care system.
Gina Rubel: It makes me wonder if concierge groups have a duty to the patient to explain that while this covers the doctor’s visits or the consultations, if you end up in the hospital, that has to go through your insurance. Is there any regulatory requirement for them to disclose that?
Kathleen Fisher Enyeart: Not that I’m aware of. I think the thing to keep in mind is, even if it’s a concierge medical practice, they still have to be licensed by the state, so they still have whatever the state licensing requirements are. They still have to meet the standard of care, and they still have liability if there’s an adverse patient event. While they may be able to avoid some of the additional regulations that Medicare puts on to physicians or that an insurance plan will cover or not cover certain things, there are still a lot of rules and restrictions, which are necessary to protect patients, of course. There’s still a lot of regulation to follow, even if they’re able to avoid some of the more difficult limitations that insurance companies set on providers.
It’s now mid-2024, and in recent years, weight loss drugs have skyrocketed in popularity. Do you see risks for providers related to the current surge in that popularity of weight loss drugs like Ozempic and some of the others?
I do. When I look at Ozempic and other glucagon-like peptide 1s (GLP-1s), I see a lot of parallels with the opioid crisis. There is a huge surge in popularity. There’s a huge push to make profit by the pharmaceutical companies involved. There’s a lot of marketing going on for these drugs, and in some cases, they are medically necessary and appropriate, but the population that is being targeted is much broader than those that truly need this.
I think providers, pharmacists, and anyone involved in this should be very cautious that they need to understand when these drugs are appropriate and medically necessary. They need to be documenting that when they’re prescribing this to patients. It’s not just an overweight patient who comes in and says, “I’ve tried dieting and exercise, and it hasn’t worked. I think I’d like to try Ozempic.” Do they have diabetes or prediabetes? Do they have other health risks associated with their weight that would justify some of the unknown risks of these drugs?
As we’re seeing more of the population use these, the long-term risks are very unknown. You have to keep in mind that there may be significant long-term risks. Are you justified in prescribing this by the patient’s medical need and the risk they have of whatever the excess weight is they’re trying to address? We’re also seeing some short-term effects. We’re seeing people who are having stomach issues and gastrointestinal issues related to taking these drugs and having some more acute issues.
I think providers need to be cautious that even though they’re going to have lots of patients coming in their offices wanting these drugs and pharmacies are probably seeing huge numbers of increased prescriptions which helps their bottom line, that they are being responsible. As we’ve seen through all the opioid prosecutions, they’ve cast a very wide net on everyone in that system who was involved – the pharmaceutical companies, the providers, the pharmacist – in that overprescribing.
I think the same thing could happen here, particularly if we see longer-term effects that are difficult. The other thing is there’s not much evidence that these work as a weight loss tool longer-term. People lose weight while they’re on them, but then when they quit taking them, are they able to maintain any of that? If not, then what’s the effect on the body of having taken a drug like this and then not staying on it long-term? That is not the intent and certainly not what the insurance companies want to happen because they are so costly. Is that putting the patient in a better position, a year or two or three years after they’re off of the drug if they’re not able to maintain the weight loss?
Is there anything else I should have asked you that you would have liked me to ask?
The health care system in the United States is incredibly complex and evolving, and the regulations are trying to rein in this system we have, which is such a strange mix of commercial and government-run health care here. There are a lot of interesting things evolving, and I hope what doesn’t get lost in all of this is the patient’s needs for good medical care and being able to work with a physician to have a healthy life.
I think a lot of these regulations are in the right spirit, but I also think we need to give providers some freedom to work with their patients and use their medical judgment. That’s something I think all of us value, when you find a provider whose judgment you trust to be able to work with patients and figure out the best solutions for their lives. I hope that as all these regulations come out, providers can inform themselves, protect themselves, and be in a position where they feel like they can still focus on doing what’s most important, which is caring for patients.
Kathleen Fisher Enyeart
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