Our federal criminal defense lawyer lays out the most crucial opioid-related High Court case in five decades and what prescribers need to know.
Doctors, pain management specialists, and other licensed healthcare professionals in the U.S. are in the midst of a impasse when it comes to safely prescribing opioids and other pain medication. The U.S. Department of Justice and the DEA are targeting doctors nationwide for allegedly prescribing unlawful amounts of opiates in a careless manner, and they are using prescription database records to fuel their indictments.
Instead of looking for signs of outright criminal behavior, these agencies are relying on signs of malpractice. Yet, without a deeper patient-by-patient investigation to analyze the context of a prescription pattern, a doctor’s behavior might not actually be malpractice at all.
At the same time, the controversial CDC guidelines for prescribing controlled substances are usurping federal criminal standards and state regulatory standards. This has left physicians with a hard choice: either prescribe fewer legal opioids and undercut what the patients truly need, and thus avoid government investigation; or do what they believe to be in the best interest of their patients — sometimes to the point of cycling in other opioids that the insurance company refused to approve.
Meanwhile, the real sources of the opioid epidemic — illicitly produced drugs like fentanyl and heroin — continue to provide an illegal, often deadly alternative for pain patients who can’t find relief any other way.
Ronald W. Chapman II, chair of Chapman Law Group’s White Collar Defense & Government Investigations practice group, spoke about this crisis with Dr. Stephen Zielger of the Center for Effective Regulatory Policy & Safe Access (CERPSA) on a recent edition of CERPSA’s “Pain Politics” podcast.
The full transcript of the podcast follows.
Dr. Stephen Ziegler: Today, doctors, nurses, and other healthcare professionals who prescribe drugs are at an increased risk of investigation and prosecution. Last year in a press release from the U.S. Department of Justice, they stated, “With opioid addiction ravaging communities across the nation, we are going to fight against doctors who are handing out prescriptions like candy. We are determined to stem the tide of the crisis and we will use all the legal authorities at our disposal — both criminal and civil.” They went on to say that, “The DEA has teams of investigators specialized in finding negligence when writing perilous prescription, which can cause a harmful addiction or potential overdose. The DEA will investigate the doctors who conduct this kind of practice and continue to combat the opioid crisis.”
Of course, what is missing from that statement about the opioid crisis is the fact that the primary cause of overdose in the United States involves the use of illicit opioids like counterfeit fentanyl or heroin, drugs that are made in someone’s garage or smuggled into the United States.
Putting these alarming statements aside for a moment, prescription drugs can treat disease and can help healthcare professionals reduce human suffering by treating pain and managing symptoms. Depending on the patient and their condition, pain can be treated and symptoms managed in a variety of ways. And often times, that treatment will involve the use of prescription drugs — legal drugs that are controlled by federal and state law.
While prescription pain medication has helped millions of people, like any intervention it carries risk to the individual. It also carries risk to healthcare professionals who prescribe drugs to treat pain, who are being investigated and prosecuted by various regulators or law enforcement agencies at the local, state, and federal level.
In earlier episodes, I discussed cases against prescribers that were clear-cut violations of law. Cases where healthcare professionals could easily be described as nothing more than illegal drug traffickers, or those who abuse their prescribing authority for their own selfish ends; trading prescription drugs for sex is but one example.
Today, our focus is different. Instead of focusing on doctors who clearly abuse their prescribing authority and end up placing people in pain and everyone else at risk, we focus on what could be described as “Politics by other means.” Where the government is trying to achieve some positive outcome, but instead of passing a law to achieve that result that helps everyone, they instead use the criminal justice system and its power to investigate and prosecute.
Joining us today is Mr. Ron Chapman. Mr. Chapman is a defense attorney with the Chapman Law Group, and their website for their organization is chapmanlawgroup.com. He also writes a healthcare defense blog that can be easily found online at healthcaredefenseblog.com. Mr. Chapman, thank you for coming on the show today.
Ronald Chapman II: Well, thank you very much for having me.
Dr. Stephen Ziegler: Can you tell us more about you and the work that you do?
Ronald Chapman II: I am, as you stated, a defense attorney, and I primarily defend physicians and other healthcare providers who have been accused of violations of the Controlled Substances Act and also healthcare fraud. I’ve handled cases across the United States, quite a few of them to trial acquittal, on behalf of physicians accused of unlawful prescribing of opiates and other types of medications.
I got into this practice about eight years ago after I came out of the United States Marine Corps. While I was there, I was a prosecutor. I was prosecuting cases, including drug cases, on behalf of the United States. When I finished with the Marine Corps, I decided I wanted to be on the defense side after seeing what I was seeing in the prosecutor’s office, and since then I’ve been fighting on behalf of doctors and pain patients, to disrupt the government’s efforts at attacking pain.
Dr. Stephen Ziegler: I have worked as both a prosecutor and defense attorney myself. Although prosecutors and defense attorneys have adversarial roles, they should share the common goal of justice and fairness. Defense attorneys, for example, protect the rights of the accused but end up protecting all of us in the process by asserting the rights of others and ensuring that the Constitution continues to protect us from government overreach; whereas a prosecutors’ job, in my view, is really to seek justice, not merely convict. But when prosecutors are elected or they are connected somehow to the political process, that is easier said than done. What do you think?
Ronald Chapman II: Well, the statement in your opening remarks, “politics by other means,” I think it was spot on. We’ve seen the Department of Justice and most federal prosecutors’ offices or U.S. Attorney’s offices, utilize the tools available to prosecute doctors as a political tool in order to stem what they believe is the cause of the opioid epidemic.
As a result, we’ve seen many politically fueled prosecutions against doctors, and the way that we know these prosecutions are politically fueled, it’s because the Department of Justice ignores the facts related to the opioid epidemic and the causes. Illicit fentanyl is actually a leading cause of drug overdoses.
Despite that fact, the majority of the Department of Justice’s efforts to combat the opioid epidemic, and the DEA’s efforts, have been through targeting physicians accused of overprescribing, as if the prescription of controlled substances is the cause of the opioid epidemic.
The reality here is that prosecutions of physicians do two things for the Department of Justice. First, they give highly publicized results for not a lot of effort. Second, they put a lot of money back in the coffers of the United States and allow federal prosecutors to say to Congress, and other lawmakers, that they’ve done a good job in stopping the opioid epidemic and healthcare fraud through collection of millions of dollars from prosecuted physicians.
Dr. Stephen Ziegler: You know, there’s this idea that so much addiction — addiction is a complex psychosocial phenomenon — as well as the so-called opioid crisis is a completely and extremely complex area. And it’s almost as if … it’s kind of like the police arresting only one person and then no longer investigating, when actually four other people are involved, and those four other people are other participants in the opioid crisis.
For example, what role does the insurance industry play in this? It seems like a myopic approach to arrest physicians or investigate physicians, etc., while ignoring all the other complex matters associated with this crisis.
Ronald Chapman II: That’s absolutely right. And I think that what we’re seeing is the tail wagging the dog.
Listen, with PMP [Prescription Monitoring Program] requirements, and what I mean by PMP is the databases that track prescription drugs and prescriptions issued by doctors under the Controlled Substances Act, [they] allow federal prosecutors a significant amount of data related to how doctors are prescribing controlled substances. The use of Medicare for a large amount of this country’s healthcare insurance has also allowed federal prosecutors to have large databases filled with Medicare data related to patients, which also gives them a glimpse into how doctors are prescribing.
Utilizing that data, it’s been very easy for federal prosecutors to get quick, snap convictions against doctors by leveraging large datasets. That’s a lot easier to do than chasing after drug cartels. That’s a lot easier to do than chasing after illicit fentanyl dealers. And they get more bang for their buck, and that’s why we’ve seen this myopic view of prosecutions. Not to mention the fact that forfeitures — getting money back from doctors related to convictions and related to illicit drug activity — is much easier to do than it is against drug cartels and other drug dealers who hold most of their assets in cash in hidden locations.
Simply put, the Department of Justice brags about the bang for the buck they get when they decide to target physicians, and that’s one of the reasons they’ve done it so much. One of the tools that they’ve used to do that is the now hotly contested CDC guidelines, by essentially changing the lay of the land for how a physician should analyze a prescription to a government-created standard of care.
Dr. Stephen Ziegler: Yes, the CDC prescribing guidelines creates an enormous amount of difficulty and problems associated with the practice of medicine and the prescribing of drugs.
I’ve noted on many lectures I’ve given is that we know that the CDC prescribing guideline was based on weak evidence. We know that it was largely created in secret. And we know that when they sought initial public feedback, they never provided a copy of the draft in the first place. They could have posted it on their website in advance so people could be prepared to be able to give feedback, but they did not do that. And the only way people could actually comment on the CDC prescribing guideline was to get a golden ticket to a webinar that was more like the code of silence. And you could ask questions during the webinar, but they would not answer any of them. And then finally, when the webinar was done … they only provided 24 hours of an open window to respond and to reply.
When I see that the draft is not provided in advance for professionals and everyone else to review before the actual feedback occurs, and when I see only 24 hours was the original time for that feedback, that comes across as nothing more than window dressing. And subsequently what is happening is, states throughout the United States have not questioned the CDC prescribing guideline, and have adopted it, whole or in part, without questioning.
So that raises a variety of concerns, and every lawyer knows that in any type of litigation, it’s necessary to be able to point to one standard, or, excuse me, several standards if you can. And using the CDC’s prescribing guideline as a standard raises significant concern, because the federal government does not regulate medicine — the states do.
Ronald Chapman II: You’re absolutely right. The implementation of the CDC guidelines and their subsequent use as a standard of care was one of the worst things to happen to United States healthcare in a very long time.
We feel that those guidelines were snuck into place and then widely touted as a standard. The issue with the CDC guidelines being looked at as a standard for care or a standard for prescribing is that, traditionally, the practice of medicine, through the Constitution and other federal statutes, is left to the states to decide. That means state medical boards should have exclusive control over how medicine should be practiced in their states, and standards of care should mostly be state specific.
The reason for this is a very good reason: different states need to have the ability to operate differently, and one large federal standard for how we practice medicine in this country might miss the needs of certain states or certain populations. So when the CDC guidelines started popping up in state statutes and rules and regulations, and when adherence to those guidelines started popping up in state statutes and rules and regulations, we started seeing federal prosecutors use those guidelines as a standard for conduct.
Now just to sort of take the audience on a brief, legal detour without all the legalese, a physician can only be prosecuted for overprescribing a controlled substance if the federal prosecutor is able to show a jury, beyond a reasonable doubt, that that physician intended not to practice medicine, but to prescribe a drug for some other means. And that was decided back in 1975, very early on in the Controlled Substances Act.
Through CDC guidelines and the use of other standards as guidelines, when physicians depart from those guidelines, prosecutors have been arguing to juries that the doctor must have been intending not to practice medicine and instead engage in drug dealing, because they have simply failed to follow the guidelines.
Of course, and I think your audience can probably hear this coming, but the critical issue with this is that the guidelines and their implementation were shady at best to begin with, and not really how physicians should practice medicine.
So it created two groups of physicians and other prescribers. One, those physicians that cut off their patient population who was above a certain dosing restriction put forward by the guidelines, those physicians who decided to strictly follow and adhere to the guidelines and do lots of damage to their patients.
And it created a second group of physicians, the physicians that still believed in their Hippocratic oath and still believed that the practice of medicine was a relationship between a physician and a patient: the physician caring about the patient and the patient providing truthful information. And those physicians have largely been targeted, simply because they didn’t adhere to the arbitrary guidelines that shouldn’t have been created in the first place.
However, help is on the way: the AMA just released a recent paper, which was very informative, on the misuse of the guidelines and how the prescribing standard really should be looked at. And it appears as if almost, I think, four years after the guidelines were implemented, we’re starting to see them rolled back and not used as much.
That being said, I have cases to this day, probably 15 or 20 of them, where I believe a prosecutor intends to offer that standard — the CDC guidelines — into evidence against a physician and try to argue that that physician committed a crime by failing to adhere to this arbitrary standard.
Dr. Stephen Ziegler: The primary purpose of the state is to protect the health, safety, and welfare of its citizens. And the regulation of medicine as a profession is very much a state matter, not a federal one. But those are administrative approaches to regulation as opposed to criminal regulation, vis a vis the federal Controlled Substances Act.
But it’s interesting to note that an awful lot of physicians, for example, are not only just being prosecuted criminally, but they’re also being sanctioned at the state level for arguably the same conduct, which, arguably, is consistent with good medical practice.
And I’ve spoken with physicians and healthcare providers, where the insurance company has notified the state medical board or the state regulatory authority and said, “This prescriber is not following the CDC guideline.” Well, the CDC guideline is a federal advisory document. It has no control over medicine. Yet, insurance companies are essentially targeting other prescribers and saying that they’re not following the CDC guideline. As a result, these prescribers are getting in trouble.
Ronald Chapman II: We’re seeing that on the exact same level, states arguing that the providers are not following the guideline. As a result, what this effectively is, is a merging of the federal criminal standard and the state regulatory standard, which is very concerning for physicians.
I wrote an article some time ago called “Jailing Hippocrates,” and in that I argued, what we’re seeing is essentially prosecutions and loss of licensure through state boards for failing to adhere to the appropriate standard of care, essentially malpractice. And what we really are seeing is that the federal criminal standard for prescribing, which requires that a doctor cease practicing medicine in order to be convicted, and then the state standard, which usually requires that a doctor’s conduct amount to carelessness or negligence, something below simple malpractice, and the malpractice standard, have really become one. And that one standard is, did you or did you not comply with the CDC guidelines or state regulations related to opiate prescribing.
The problem with all of this is, professionals do not agree unanimously on the practice of pain management and the use of opiates. There’s much disagreement, and in fact, and I think Justice Potter Stewart said it best in oral argument in the first case related to a doctor prescribing, who was prosecuted under the Controlled Substances Act [U.S. v. Moore, 423 U.S. 122, 96 S. Ct. 335 (1975)]. I think he basically said, “Was this man not a doctor, or was he a seller of wares?” And I think what Potter Stewart was trying to say was that, because the physician was a physician, some deference is required in order to allow them to practice both the art and the science of medicine.
And that’s really the issue we’re talking about here today, those people who show up in a doctor’s office, and sit down, and seek to have an honest conversation with their physician, aren’t really having a conversation with their physician anymore. They’re having a conversation with the CDC guidelines. They’re having a conversation with state regulations. They’re having a conversation with all the rules that have been put into the doctor’s office. And until that patient can satisfy all of those hurdles, a doctor will not be prescribing medication that controls the pain. And that, right there, is the cause of the opioid epidemic.
Dr. Stephen Ziegler: Is there a way that people can obtain a copy of the article “Defending Hippocrates,” that 2019 article that you wrote for the National Association for Criminal Defense Lawyers?
Ronald Chapman II: Yes, absolutely. If they go to HealthcareDefenseBlog.com, and click on “Resources,” the article is located in the “Resources” page for a free download.
Dr. Stephen Ziegler: If we go back to the quote from the U.S. Department of Justice, “the DEA has teams of investigators specialized in finding negligence” Well, negligence is a complex legal standard. What it essentially is is where someone should have known, but they did not. Would you like to elaborate on that?
Ronald Chapman II: To a hammer, everything looks like a nail. And what the Department of Justice did is spend a lot of money and buy a lot of hammers. The problem is that they’re short on nails, so they had to go create some. And that’s one of the reasons why these task forces, these agents, are trained to look for signs of malpractice instead of signs of outright criminal behavior. That’s what I mean when I say it appears the tail is wagging the dog a bit.
So with respect to the manner and means of these federal investigations against these physicians, we have quite a few problems. First, in the olden days, and I’m talking about maybe prior to 2007, an undercover visit showing very clear criminal conduct is usually required before a physician would be prosecuted, before a federal prosecutor would decide to indict a physician.
However, we’re seeing in more recent cases, prosecutions are data driven. Prosecutions are initiated before an investigator has even looked at a medical record, before an investigator has even interviewed a patient. And in many cases, even though patients are clearly suffering from severe medical issues, the fact that a patient may have exhibited some signs of diversion or may have had a prior history of diversion is enough for federal prosecutors to move forward and indict that doctor.
I’ll give you an example. I have a case in an indictment that was recently unsealed. When you look at the face of the indictment, the only thing that it says about the physician’s conduct is that they were a statistically high prescriber of controlled substances relative to his peers. The other facts in the indictment are boilerplate language related to healthcare fraud, related to prescribing regulations and rules.
The indictment merely says the number of drugs or the amount of drugs that the physician prescribed, it says the rank of the physician among his peers, and it also gives the initials of a few patients who the government believes he unlawfully prescribed to. It doesn’t say anything about bad behavior, like sex for drugs, as you indicated, or that the physician clearly intended to prescribe for some other means. It merely questions the way that physician prescribed.
That’s really what it’s come to, that when a physician isn’t prescribing the way that the federal investigators or the DOJ wants him or her to prescribe, they tend to indict. And that’s a big problem, because physicians don’t, right now, know where the standard lies.
So data-driven prosecutions are very problematic, because data is only maybe a reason to look a little further and perform good investigative work, but typically they’ve stopped short of that good investigative work. In fact, I think you may have interviewed somebody on one of your prior podcasts that explained a better way of doing things; unfortunately, we haven’t seen that repeated throughout other prosecutors’ offices and investigators’ offices.
The other issue that we’ve seen is the use of patients as sort of undercover informants and the use of agents as undercover informants when the government does decide to send an agent or an individual into the doctor’s office. Typically, what the government decides to do is they look up the criminal history using PMP data of a physician’s patient population, and then when they find somebody who has a prior drug conviction, they tend to roll up on that patient by using a fictitious traffic stop or showing up at their house. And what they say is, “Listen, we know you’re going to Dr. So-and-So, and we’re prepared to prosecute you for drug dealing,” which scares many people because they think that they might end up in jail. “But if you agree to wear a wire and go inside the doctor’s office, then we may forgive that or we may work out a deal with you.”
The problem is that many of these patients have underlying diseases or issues that may cause them pain anyway. So when they go into the doctor’s office, and the doctor has had a long treatment history with that patient, knows the treatment history, doesn’t spend too much time with the patient, and prescribes a controlled substance anyway, federal investigators say, “We gotcha. You didn’t do a physical exam, you didn’t thoroughly look over the medical records, you didn’t ask for a new MRI or X-ray, you didn’t update the patient history.” And, of course, the doctor didn’t, because the doctor may have been seeing the patient for six, eight, 10 months prior, and already knows the history.
So it’s through that lens that the government looks at a physician’s conduct without appreciating the entirety of the physician/patient experience. They tend to look at a single treatment visit as one single exercise in the standard of care, as opposed to looking at outcomes, treatment decisions, prior history, and prior medical records.
Dr. Stephen Ziegler: One of the challenges in treating pain is that you do not have unlimited resources. We do not have universal healthcare. We have folks who do not even have insurance. We have folks that have high deductibles. So this idea that almost anything is permissible is just simply not true.
Essentially, at times, you have a limited number of tools in the toolbox, and you have to work with what you’ve got. Pain care needs to be individualized — to that particular patient, their particular condition, and what they bring to the table. You know, it’s interesting that what we are essentially experiencing here is the criminalization of medical practice.
Going back to an earlier comment, the DEA or whatever regulator or investigator is involved, starts looking at the prescription drug monitoring program. Now, these are essentially keeping track of various drugs that are prescribed. They’re not universal across the United States; some are housed in law enforcement, some of them are housed in public health. And so earlier studies essentially have provided evidence of a race to the bottom. If the person that is at most risk is the one that prescribes the most, well, the goal, then, is if I prescribe less, that means less likely I’ll be investigated by the government.
Ronald Chapman II: Well, that’s exactly right. Going back to one of your prior points, listen, oxycodone is cheap, and that’s one of the reasons why health insurance companies routinely only authorize oxycodone as an opioid treatment for a patient.
I had a case down in Ohio some years ago, maybe four or five years ago, where a physician was prosecuted, and the argument that was made in the indictment, the statement that was made in the indictment was that he prescribed oxycodone for 80% or so of his patients. One of the issues is, this particular doctor attempted to cycle other opioid medications in there, like a newer drug at the time called Nucynta.
The issue with that drug, and many other drugs, is that insurance companies simply won’t approve those drugs. Nucynta is very expensive. Just about any other opiate with proper addiction controls or maybe less addictive alternative to opiates is very expensive in its experimental stage. And oxycodone has been very cheap because basically it’s been mass produced by, I think it was Purdue [Pharma], and it’s very readily available.
The prior authorization requirements for experimental drugs are very, very high and very onerous on doctors who are receiving low reimbursement anyway. So the reality is that most physicians who are seeking to treat the pain of a patient have one tool in their toolkit, and that’s oxycodone. Simultaneously, the government, while looking at prescriptions issued by physicians to patients, is criticizing those doctors for using that single tool that’s available in their toolkit. That creates a particular race to the bottom, as you indicated.
Physicians now have the choice to prescribe nothing or oxycodone, and if they prescribe too much oxycodone more than their peers, they will be heavily criticized. Not to mention the fact that with the CDC guidelines in place, and PMP audits being authorized by prosecutors’ offices and state regulators, the number or the amount of oxycodone prescriptions a physician writes is heavily scrutinized. The result has been a class of physicians who simply refuse to prescribe oxycodone to patients.
I mean, we’ve all had this story. I had my wisdom teeth taken out and I was only given Tylenol 3. I personally went into an urgent care in North Carolina while I was on vacation because I tore a ligament in my shoulder, and not that I was seeking anything stronger, but I was quite amazed that the only thing they prescribed to me that day was a muscle relaxer, despite the fact that I was in very, very severe pain. That’s the reality of what we’re dealing with these days; that race to the bottom has caused prescribing decisions to be so constrictive that it leaves people in pain, and that really is a problem.
Dr. Stephen Ziegler: We cannot ignore the economics associated with this. For example, I published a paper on pain medicine several years ago that focused on the morbidity and mortality associated with dosage levels. One of the things that I raised in the article is the Washington state approach as it related to methadone being used to treat pain. Washington state — a state I very much love; it’s where I obtained my Ph.D., in fact, and grateful to that state for that — they placed methadone on the formulary, the preferred list for treating pain. Well, methadone was attractive because of its cost, and just think of all the money it would save taxpayers. Pennies on the dollar.
But at the same time, though, methadone is very complex, pharmacologically. The concern here is, instead of focusing on, perhaps, what would be the safest drug, they focused at this particular policy on the least expensive one. And some state officials tried to defend themselves by saying, “It’s dosage, dosage, dosage.” Well, no, it’s not simply dosage; it’s far more complex than that.
And The Seattle Times actually did an expose about the number of times that this policy — the preference for methadone, which is a very complex drug, it’s unlike other opioids — has resulted in an enormous number of overdoses, particularly among a very susceptible and at-risk population, the Medicaid population.
So it wasn’t until The Seattle Times raised this concern — I think the article’s something along the lines of “The Politics of Pain” — did the state all of a sudden say, “Well, maybe we need to give this a second look.” But we in the pain community knew this was a bad policy to begin with. So to fixate and simply focus entirely on this idea of dosage level is just wrong.
Ronald Chapman II: Well, yeah, I agree with you 100%. And I guess going back to my earlier comment, the only thing cheaper than oxycodone is methadone, and I think that’s one of the reasons why it was prescribed and approved by insurance companies largely until overdoses related to methadone started becoming more prevalent and certainly more apparent as a result of that study.
One of the issues with insurance reimbursement and the finance related to the practice of medicine is that we are absolutely kidding ourselves if we think that doctors don’t make treatment and dosing decisions related to the finance available by the insurance company, or the ability to pay by the patient or the insurance company. With drug co-pays being incredibly high, we can’t ask or demand that our doctors prescribe other alternatives to patients who lack the financial resources in order to fill them.
And I think what we really need to do in order to solve this opioid epidemic is take a hard look at insurance reimbursement and take a hard look at authorizing payments for experimental treatments related to pain.
Dr. Stephen Ziegler: I can see having you on the show for several more episodes in the future, and I really appreciate your time today. Is there anything else you would like add before we go?
Ronald Chapman II: No, that’s it. Thank you very much for your time today, thank you very much for an interesting discussion related pain treatment and prosecutions related to the opioid epidemic. And I look forward to hopefully appearing again sometime.
To find out more about the “Pain Politics” podcast and support CERPSA’s campaign to improve lives and reduce unnecessary human suffering, visit here.
As this podcast shows, the CDC guidelines are leaving doctors, pain management specialists, chiropractors, and other licensed healthcare professionals conflicted. But the national healthcare attorneys at Chapman Law Group are here to advise and defend healthcare practitioners across the U.S. who are involved in these kinds of Controlled Substances Act matters.
Contact us today for a consultation.
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