Interview with Bryan Liang, M.D., Ph.D., J.D. and Arthur W. Grayson Professor of Law & Medicine, Southern Illinois University Schools of Law and Medicine
Interview with Bryan Liang, M.D., Ph.D., J.D. and Arthur W. Grayson Professor of Law & Medicine, Southern Illinois University Schools of Law and Medicine
Legal Issues & Ethics in Audiology
AO/Beck: Dr. Liang, please tell us a little about yourself. Frankly, I don't know too many people with three doctorates.
Liang: I was a science major and I wanted to be either a scientist or a physician. I actually decided rather late in my senior year at MIT to go to medical school. During medical school, I found I was more interested in following around the people in the suits, as opposed to following around the people in lab coats. Anyway, between my second and third years of medical school, I ended up getting my Ph.D at the University of Chicago in Health Policy. I returned to medical school and got my M.D. from Columbia in New York. Then, I applied to Harvard Law School and was lucky enough to get in; I was slated to do a combined residency-J.D. program between Yale and Harvard, but when the Clinton plan came out, I withdrew from my residency program and went directly to law school.
AO/Beck: So how do you combine all these skills, talents and knowledge areas into a day-to-day routine?
Liang: Since I've studied law, medicine, health care policy, physician financing mechanisms, and the Clinton health plan, I've been fortunate to have enough knowledge at just the right time to realize what a dangerous position we were and are in as a nation regarding health care, both from a patient and provider point of view. Fraud and abuse directly implicates these areas, as well as other areas. Thus, I try to use the perspectives I've gained to solve some of the more contentious problems in health care, and introduce the practical provider and patient perspectives into the debate.
AO/Beck: Before we get into specifics, what can you tell me generally about Law and Audiology?
Liang: The bottom line for all providers is that the law is arbitrary. Although there are rules written by attorneys, many of the issues we (as clinicians) are concerned about are not written in stone or don't have practical application for providers on the front lines. And the rules that do exist are interpreted by judges and juries who have little knowledge of health care, have biases of their own, and decide cases based on a lot of things apart from the legal rule. That's the way it really is.
AO/Beck: Let's discuss a few specifics. One issue that is foremost in the minds of many of my audiologic clinical colleagues is the issue of informed consent. In audiology, we rarely practice invasive protocols. Nonetheless, we are involved with Cerumen Management, Intraoperative Monitoring, taking ear impressions, vestibular diagnostics and clinical tests of cranial nerve function. Through all of these protocols, there is a professional risk . So the question becomes, at what point do we need to obtain informed consent from the patient? Additionally, if we do obtain a written or verbal consent, are we indeed becoming a 'lightening rod' when the risk of damage or injury to the patient is so amazingly small?
Liang: Those are tough questions. You are not becoming a lightening rod just because you do get informed consent; the basic issue is generally whether there's a significant injury; if so, you'll be likely sued regardless of informed consent. However, if you believe there is no material risk to the patient, you are not required to go through the formal process of getting informed consent, since such consent may be implied. But I emphasize that if you believe there is a material risk, you need to get informed consent. The question, of course, is what is 'material'? You should get that information from the published literature to determine what is considered a significant risk. If you assess it from the point of view, 'what would the case look to an uninformed jury in hindsight?', you'll have a better idea of when you should get informed consent.
AO/Beck: What about some specific instances -- For example, during electronystagmography testing, we indeed make the patients rather vertiginous via bithermal caloric stimulation. Should we obtain a written informed consent prior to the ENG test?
Liang: I would certainly tell the patient they may experience dizziness and to expect a certain level of discomfort. But, as long as the test is 'routine', and the literature indicates no permanent physical injury associated with the test, I think you probably don't need written informed consent. Of course, it's always good practice to tell the patient what's going to happen and what may happen; if you feel a written statement of the tests' diagnostic value and the discomfort issues is needed for a particular patient, it is probably a wise thing to do prior to the test.
AO/Beck: What about cerumen management? Is it necessary to obtain written informed consent prior to removing cerumen with a curette or irrigation?
Liang: The answer is based on the risk and the level of cerumen impaction. If the risk is a scratch in the ear canal, you may or may not feel it's necessary. However, if the risk is a perforated eardrum, yes, that's a signficant injury, and if there is a material risk of it, written informed consent is a good idea and probably very useful. Of course, if the adverse event has never happened to anyone, you can argue that the risk is not material. However, if the risk is real and damage happens on a regular or perhaps an irregular basis, material risk is there and written consent should be obtained.
AO/Beck: So the 'barometer' for informed consent might be; 1- What is the occurrence rate of the potential injury? And 2- What is the extent of the possible injury?
Liang: Yes, those are important factors in the decision as to whether or not to obtain informed consent. Basically, if you see reports of significant injury in the literature, you need to be cautious.
AO/Beck: Let's take an admittedly 'fringe' example. Suppose I see a patient for Bell's Palsy and I perform electroneuronography to help decide whether or not the patient has Bell's or has something else going on. Further, suppose we stimulate the patient's facial nerve with 20 or 30 milliamps at the stylomastoid foramen and we decide it's indeed a Bell's Palsy. OK, the patient regains animation and everything is fine for two years. At that time, the patient comes back with a hemi-facial spasm. If the patient says 'Judge and jury, I never had this problem until that audiologist zapped my face with all of that electricity', what is the legal risk to the audiologist with respect to this predicament?
Liang: You would have to look at the literature. If there is a history of this event as a possible outcome of an EnoG text, there should be informed consent. If it has never happened before, you probably don't need to be too concerned about it. Without any previous literature reports, it's probably not going to be a big concern to too many courts. But I should say that that's no guarantee; if it goes to a court and if it goes in front of a jury, who knows? The results are essentially unpredictable.
AO/Beck: Another factor which I've heard discussed is regardless of informed consent, if there is an injury, the patient can simply say 'I didn't understand what I was signing' and then the written informed consent goes out the window anyway.
Liang: Well, it's not as cut and dried as that, but yes, that's certainly within the realm of possibility.
AO/Beck: So basically, we need to be cautious and we need to be realistic, but despite informed consent and a great clinical outcome, anyone can be sued for anything?
Liang: Yes that's true. Despite fantastic clinical work and phenomenal outcomes, if the patient sustains an injury, and if other factors are involved, for example, the patient doesn't like you or didn't feel you communicated with him or her enough, he or she can and probably will sue you.
AO/Beck: All right, if you don't mind, let's discuss some other laws as they apply to the practice of audiology. Please tell me about fraud and abuse laws.
Liang: Basically there are three major federal laws which address fraud and abuse: the False Claims Act, the Antikickback Statute and the Stark Self-referral prohibitions. Basically, the False Claims Act deals with clinicians who submit claims for things which were not done, or things that were not necessary and so forth. More formally, the False Claims Act prohibits submission of false claims and fraudulent billing under any federal health care program, for any item or services, if it's provided by a person who 'knowingly and willfully' has made any false statement or representation in application for payment including claims for uncovered services; or has furnished services or supplies that are determined to be substantially in excess of those needed or is so lacking as to be worthless.
AO/Beck: Can you speak a little about the Stark laws?
Liang: The Stark Laws came into being as a result of many conflicts of interest and
self-referral situations. Some of the problem areas included self-referrals from physician-owners of clinical labs and radiology equipment (MRI and CT scanners) who wound-up referring enormous amounts of patients to their own labs and radiology centers which were arguably unnecessary. So the bottom line on Stark is, a physician cannot refer to an entity in which he or she or his or her spouse or a close relative (sons, daughters, brothers, sisters, mother, father) have a financial interest. More formally, if the physician or immediate family member has a financial relationship with an entity, then the physician may not make a referral to the entity to furnish 'designated health services' for which payment otherwise may be made by a federal health program, and the entity may not present a claim to a federal health program, or bill any individual, third party payor, or other entity for the service. Note that here, the statute is focused on physicians, and audiologists are not within the statute's definition of 'physician'; however, they can still be liable if they participate in 'the scheme'. One should also note that no actual referrals need to be made for a person to be within the Stark laws.
AO/Beck: What can you tell me about antikickback laws?
Liang: Basically, you cannot pay for referrals, even though referral arrangements in any other commercial sector allows for these kinds of activities. Thus, any conduct whereby you solicit referrals for a product or service which could or may be paid for by the federal government through any of the federal programs is a violation. Again, more formally, the Antikickback statute prohibits any 'knowing and willful' conduct involving the solicitation, receipt, offer, or payment of any kind of remuneration in return for referring an individual for services or recommending or arranging the purchase, lease, or ordering of any item that may be wholly or partly paid by a federal health care program. Note that no claim to the feds needs to be made here to be within the statute, just like the Stark laws.
Unfortunately, all of this sounds complex and legalistic because it is. As I mentioned in forums such as last year's AAA meeting in Miami, you need to be careful and closely assess all financial relationships.
AO/Beck: Suppose you're an audiologist in a busy private practice. Further, suppose a new ENT moves in across the hall. In order to get know the ENT, you invite him or her to lunch to learn more about him or her and to see if you can establish a 'working relationship' whereby you send this new ENT patients requiring ENT services and the ENT sends you patients who need audiologic services and/or hearing aids. At what point do we cross that line? It seems like buying lunch is a simple, innocent and benign way of getting to know someone. Is this potentially 'paying for a referral'?
Liang: Yes, absolutely it is. Technically, you're buying the lunch with the intent of eventually arranging for and getting referrals; in that sense, yes, it is a violation of the Antikickback statute.
AO/Beck: So in essence, just by setting up the lunch meeting and paying the tab, you are technically in violation of antikickback laws?
Liang: Yes, if the purpose is to arrange for referrals; it might seem pretty strange, but it does indeed meet the definition in the statute.
AO/Beck: What is the difference between Stark I and Stark II?
Liang: Stark I only applied to clinical laboratory services. Stark II extended this to designated health care services, which brings in virtually everybody on health care if they provide in-patient or out-patient services, occupational therapy services, as well as a slew of other services.
AO/Beck: One common employment scenario is where ENT physicians employ audiologists. The audiologist earns a salary and perhaps earns a commission based on total number of hearing aids sold, or a percentage of the special tests ordered etc. Is this a violation in that the ENT is referring to his employee to perform a task, of which the employee is incentivized to perform?
Liang: It might be. There is an 'employee safe harbor' exception in the Antikickback statute. The idea here is that if the audiologist is working for 'fair market value' it's probably OK. If the audiologist is way above and beyond the 'fair market value', or if the audiologist's income is somehow tied to the volume of referrals, there's potentially a problem. If the audiologist and the ENT each pay half of the costs for acquiring and dispensing the hearing aids, the 50-50 profit split is probably OK; if, however, the audiologist gets more than the cost split would indicate, then there may be a problem for a payment for referrals.
AO/Beck: Suppose an audiologist works on a straight salary for an ENT physician doing required routine audiometric tests and selling and servicing hearing aids. Further suppose, there are no commissions, no incentives to 'sell' hearing aids or special tests. However, at the end of the year, the audiologist has sold 150 hearing aids as an employee of the physician. Is that a violation of Stark? It seems that if the physician has referred to the audiologist he employs, in essence he is referring the patient to himself?
Liang: You have to watch out in that situation. There is a physician item and service purchase exception in Stark as long as fair market value is paid for the items and services. However, in the situation you mention, if there is an entity set up and Medicare or Medicaid pays for the services relating to the audiometric evaluations or the hearing aids as a designated health care service, Stark may be implicated. And if you as the audiologist are involved in the 'prohibited action', you are at risk.
AO/Beck: What can you tell me about 'free hearing screenings'? This is an area many of us are concerned about as we sometimes offer free hearing screenings at health fairs, open houses and related venues. Additionally, some of our national organizations are promoting 'free hearing screenings' to help raise the awareness of hearing loss and treatment options.
Liang: This is a very, very difficult and important issue and audiologists are justified in being concerned about it. In fact, because of all the questions I've gotten about it, I've written a Viewpoint Essay for Audiology Today that will be coming out in the fall talking about it. At the outset, let me emphasize that free hearing screenings are not a per se a violation of fraud and abuse laws; it's just that they might be. One thing I think is clear, however: if it's a public health situation where you are not trying to induce referrals to yourself, and if Medicare, Medicaid and other federal health programs are not involved, youíre probably OK. If the free screenings become tied to or eventually involve Medicaid or Medicare or the VA program, there may be a problem.
AO/Beck: Suppose you have a patient who comes in for a free screening. The free screening reveals an asymmetric SN loss and the patient complains of unilateral tinnitus in the worse ear. When you review the findings with the patient, you explain there is a potentially serious issue here and you refer the patient to their primary care physician (PCP). The PCP bills Medicare for his/her evaluation and refers the patient back to you for a full diagnostic evaluation. At this point the PCP and the audiologist have billed the federal government via Medicare. Could the feds turn around and say both bills were in violation (to say nothing of the otologist who did the translabyrinthine surgery to remove the acoustic neuroma) as they were induced based on a free screening?
Liang: You're OK if you referred the patient to the PCP and you had no financial relationship with him or her; in other words, it's okay if you had no previous arrangement regarding the referrals to each other. But if you did, say you did the free hearing screenings and it was prearranged that all patients who needed medical attention would go to that PCP in exchange for a referral back, the Antikickback statue raises its ugly head.
AO/Beck: Tell me about what happens when an audiologist accepts free trips from a manufacturer? Some of my colleagues have said they will accept a trip now and then, but because it does not influence their buying patterns or decision making, they believe it's all right.
Liang: Again, you cannot be involved in a payment for referrals, and that includes arranging for and/or recommending the purchase, lease or ordering of any item that could be paid for by a federal health care program. Therefore, if you take any kind of benefit from a manufacturer or anyone else and its something that a federal health care program covers, you're in violation of the statute. You must avoid not only the actual occurrence of a conflict, but you must avoid the appearance of a conflict of interest. If a reasonable third party could possibly interpret your 'free' trip to exotic locations as having even the appearance of a conflict of interest, that's all it takes. You cannot do it. Of course, this perspective is consistent with organized audiology's code of ethics and provisions on conflict of interest.
AO/Beck: If the readers want to learn more about this topic and find some references relating to this discussion, where can they find information on this topic?
Liang: Certainly the internet, the library and the state licensing offices have a wealth of information. The audiologist should also review the ethical guidelines from AAA and ASHA to be certain they are practicing within the accepted and published norms. I also recommend they speak with their attorney on all of these issues to make sure they are in compliance with any kind of financial relationships. I think audiologists should also ask their professional organizations to set out some guidelines as to acceptable, and perhaps more important, unacceptable financial and referral arrangements.
AO/Beck: I know you recently published a book on this, informed consent, and related topics. If the readers wanted to get a copy of it for their personal library, what is the title and who is the publisher?
Liang: The title is 'Health, Law and Policy: A Survival Guide to MedicoLegal Issues for Practitioners'. The book is published by Butterworth—Heinemann in Woburn, Massachusetts. All proceeds go to my fund to pay off my student loans.
AO/Beck: Dr. Liang, thanks for your time and knowledge, I certainly appreciate the discussion and your insight on these fascinating issues.
Liang: Thanks very much for the opportunity.
