Self-referral, live surgery raise ethical challenges

March 1, 2015

In this interview, Patrick H. McKenna, MD, former chairman of the AUA’s Judicial & Ethics Committee, discusses self-referral as well as the AUA expert witness program, conflicts of interest, and live surgical demonstrations.

Patrick H. McKenna, MDUrologist self-referral of services such as intensity-modulated radiation therapy and pathology has raised ethical questions that continue to be debated. In this interview,

 

Please discuss the AUA Judicial & Ethics Committee’s duties.

This committee has broad responsibilities in matters related to controversy with the association and its members, ethics of medical practice, education, and research. It serves in an advisory capacity to the AUA Board, allowing active membership input at the highest levels on these matters. Every section has two representatives that sit on the committee, along with senior leadership from the administrative side of the AUA and the AUA’s legal counsel.

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The main areas of focus are monitoring the organization’s conflict of interest policy, the expert witness policy and, more recently, the development of the expert witness voluntary registry. It covers a tremendous number of ethical issues and is also involved in writing and updating policy on these issues.

I strongly recommend members to check out the policy statements on the AUA web site. The work of this committee is often not recognized but represents one of the best member benefits.

 

How often does the committee meet?

Normally, we meet twice a year face to face, and then by phone in between when necessary. There is an executive committee of the Judicial & Ethics Committee that meets more frequently.

NEXT: Expert witness program

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Please discuss the expert witness program.

Over the last decade, the committee has developed one of the best expert witness programs of any medical organization.

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All members agree to abide by the expert witness affirmation statement (http://www.auanet.org/about/policy-statements/testimony-in-medical-liability-cases.cfm). There are key elements that our members agree to abide by that go above most state requirements for expert witnesses. Some of these areas include: only testifying on matters the members have recent and relevant substantive clinical experience, allowing the Judicial & Ethics committee to review any testimony, and being willing to provide testimony for both plaintiff and defendants.  You must be at least 5 years out of training to testify and have been clinically active in the area under question within at least 5 years.

Recently, the AUA Board approved the establishment of a voluntary Expert Witness Registry. Most urology malpractice cases result in upholding the defendant’s position, but even the process of a trial can be very disruptive to a urologist’s practice. The goal of the registry is to provide good expert witnesses in the hope that the number of cases that go to trial is diminished.

 

What can the committee do if it believes somebody acted inappropriately?

The committee follows a step-by-step policy when referred a malpractice case to review. That provides fair review for our members. Usually, two members who are not from the same section review the case, as does the entire executive committee.

The case is scored on a sheet that is based on the expert witness affirmation statement. The case and review are presented to the entire committee. The committee can decide to provide feedback to the member and have them review the affirmation statement or may recommend to the board that disciplinary action be taken against the member.

 

What is the most severe action that can be taken against a member?

The committee itself cannot take action, but we can recommend to the board that there be a formal rebuke of a member. The most severe action would be a recommendation for member expulsion from the AUA.

There have been rebukes and expulsions in the past; members can view rebukes and expulsions on the AUA members-only ­website.

NEXT: Self-referral of IMRT

 

Let’s discuss a study published in the New England Journal of Medicine (2013; 369:1629-37). Among self-referring urologists, the number of intensity-modulated radiation therapy procedures for prostate cancer rose from 80,000 to 366,000 from 2006 to 2010, and the article concluded that financial incentives for self-referring providers were likely a major factor driving the increase. Should we be surprised by these findings, especially given the cost of equipment and the higher reimbursements for IMRT? Isn’t this just human nature?

First, let me say that this is not an area of urology where I am an expert. I serve on the board of the American Association of Clinical Urologists and on other health policy committees, so I have participated in discussions about this article. As a pediatric urologist, I’m not involved with prostate cancer treatment, which may be an advantage in giving a fair evaluation of the current information.

The AUA has responded to this article, as has the AACU and the Large Urology Group Practice Association. There are specific problems with the study that have been pointed out by these organizations; specifically, the study design and patient selection. Several publications, including the AUA News, have also identified problems with this study. A recent OncLive summary by Drs. Judd Moul and Deepak Kapoor succinctly summarizes that urology practices are prescribing IMRT appropriately (www.onclive.com/.../at-issue-imrt-self-referral/2). In addition, two other articles (J Urol 2011; 186:860-4,Brachytherapy 2014; 13:157-62) pointed out that three-dimensional conformal radiation therapy decreased during the time that IMRT saw an increase and the pattern of IMRT use saw similar increases in physician office and hospital facilities.

We need good data to know whether any of these accusations are true. I’m not sure we have all of the necessary data, but the two articles suggest that new technologies such as robotics and IMRT are rising more rapidly, as some of the previous treatments are declining because people are gravitating toward new technology.

 

Shouldn’t the burden of proof rest with those doing the self-referrals, because your gut instinct is that ownership is obviously going to make a difference?

I agree some may have that gut instinct, but the data does not exist to support that finding. The AUA has good guiding principles for self-referral. You need to follow state and federal regulations pertaining to care. For example, with standard radiology, you have to provide patients with information on alternative sites.

The most important thing is to have a complete discussion with the patient about what their disease process is and what the options are for their treatment. They should be advised that they are entitled to seek a second opinion, and treatment should be based on objective, medically acceptable and supported recommendations. Provision of ancillary services should be transparent and in the patient’s best interest. Patients’ urologic care should not be disrupted if they obtain their ancillary services from a different supplier.

Something else to note when talking about these services is that they are integrated, giving patients, particularly older patients, the ability to get these services in one place. It’s important to point out the benefits of integrated services. In addition to obtaining the services in one center, patients also benefit from close interaction between specialists. Close interaction between specialists may limit the number of studies done and allows close working relationships; for example, urologists and radiation oncologists can determine the boundaries of radiation treatment together.

 

I can see advantages to this if it were a competitive market where people were setting their own prices and it wasn’t mandated by insurance companies, but when it’s the same price no matter where you do it, it doesn’t seem like there is any major advantage to the patient being treated in the same center.

It’s important to be procedure specific when discussing this. For example, there are significant differences with outpatient surgery reimbursement. Hospital-connected outpatient surgery centers receive significantly higher reimbursement than freestanding centers.

IMRT is one of those exceptions where there isn’t a significant difference in reimbursement. We have two journal articles that come to different conclusions. The New England Journal study has significant flaws, and the Journal of Urology article suggests that use of IMRT is increasing at a similar rate in physician offices and at hospitals.

Last year, I was invited as visiting professor to a large urology group practice and saw how these integrated services worked. I was quite impressed. I saw in action some of the benefits of having a large integrated group; for example, having a single EMR is a big advantage when studying patient care. Not only can the guidelines be implemented throughout the whole practice very quickly, but the practice has a fairly robust EMR, so they can document that the guidelines are being followed.

I saw urologists talk to their robotic surgeon about a case and then go downstairs and talk to their radiation oncologist. It is clearly an advantage to have the different specialists in the same building.

Having served on the Judicial & Ethics Committee for over a decade, it is clear to me that we have a highly ethical membership that is focused on improving patient care. I feel confident that integrated independent practices bring added value to patient care and may decrease costs in some areas.

One way the AUA will help us make these decisions is the new realignment that’s happening in the areas of health policy and quality. At the 2014 AUA annual meeting, we voted on moving health policy and quality into two separate groups, and the new Science & Quality Council will oversee guidelines, a new data center, and patient safety issues. I think the development of the AUA Quality Registry (AQUA), our new quality patient database, will allow better patient data collection to evaluate treatment decisions. I think it will support my belief that we are providing good patient-focused care in our practices.

 

Do you think that disclosure of conflict of interest sufficiently mitigates the problem for the patient?

I’m not sure. The patient makes a connection with the physician and facility. My guess is the patient is more likely to stay there than go somewhere else no matter what disclosure is given. What we need is to confirm whether the treatment follows guidelines and to confirm a good outcome from treatment. This is why the AUA approach is on target by providing a resource to obtain that data.

NEXT: Self-referral for prostate biopsy

 

The practice of physician self-referral for imaging and pathology services has been criticized, because it can lead to increased use and escalating health care expenditures with little or no benefit to the patient. Jean M. Mitchell, PhD, looked at Medicare claims for men to determine how the in-office ancillary services exception affected the use of surgical pathology services and cancer detection rates associated with prostate biopsies (Health Affairs 2012; 31:741-9). Self-referring urologists billed Medicare for 4.3 more specimens per prostate biopsy than the adjusted mean of six specimens per biopsy than non-self-referring urologists sent to independent pathology providers, a 72% difference. The regression-adjusted cancer detection rate in 2007 was 12 percentage points higher for men treated by urologists who did not self-refer, indicating unnecessary biopsies. What is the AUA position on this?

The AUA has responded to this article, and interestingly, Dr. Mitchell was also the author of the New England Journal article we discussed earlier. Funding for the pathology study is from the group that stands to gain the most by her allegations-similar to the previous article. When this paper came out, I asked an oncologist at my institution how many biopsy samples he routinely does, and his answer was 12.

This paper covered a period of time when there was transition between six and 10-12 cores. The mean of six specimens reported in this paper is probably wrong, and subsequent to this article, two papers were published that supported the fact that a higher number of biopsy samples will have a higher detection rate (J Urol 2013; 189:2039-46,Rev Urol 2013; 15:137-44). I think most urologists are following the AUA guidelines, which recommend 10 to 12 samples.

At our institution, we recently standardized the whole prostate biopsy process. This is a high-volume procedure with easy-to-monitor complications. We have decided on a standardized process, determined what antibiotic we will utilize, decided against rectal swabs for bacterial culture, and agreed to the number of biopsies and how to manage the specimens.

 

What is the AUA’s position regarding the in-office ancillary services exception?

The AUA’s position on this was one of the key points taken up at the 2014 Joint Advocacy Conference in Washington. The AUA policy states that there is benefit in having integrated services and providing care in one site for the patient where there is interaction among specialists, as long as urologists follow the guidelines we talked about earlier.

NEXT: Pharmaceutical research

 

Should an academic physician who is consulting with a pharmaceutical or device manufacturer be a principal investigator on one of their studies, or is this an inherent conflict of interest? How does the AUA view this issue?

The AUA doesn’t have a specific guideline related to pharmaceutical research, but our Code of Ethics specifically states that research needs to be in the patient’s best interest. There needs to be full disclosure of any conflicts of interest that you have as a researcher. If you are the chairman or on the board of a pharmaceutical company making urologic medications, you couldn’t serve as a guideline chairman in an area that the company has a product or hold other key positions for the AUA. Speaking personally, if a paper were published about a drug in which one of the physician authors serves on the board for the drug’s developer, I would scrutinize the paper closely and certainly that relationship should be disclosed.

 

Let’s talk about live surgical demonstrations at meetings like the AUA. What’s the advantage of a live demonstration versus a recorded demonstration with the surgeon taking real-time questions from the audience? Are there ethical or patient safety issues with live surgical demonstrations?

That’s a great question. When I was secretary of the North Central Section, I advocated strongly for live surgical presentations and expanded its use at our annual meeting. There are strong opinions about this held by prominent members of our organization. The AUA has specific standard operating practices for live surgery.

If live surgery is utilized as a teaching method, it needs to be well organized and follow specific guidelines. To begin with, the patient who is having the surgery needs to know that they are going to be a part of a live surgical performance. The facility where the patient is being treated also needs to be aware. The decision to do a procedure must meet acceptable indications. I believe the person overseeing the planned educational event should review the case in advance. It is very important to have a sophisticated company handling the broadcast, because you need to be able to control the live feed and stop it immediately if any issues arise. I like to sit right at the control table. I like having more than one facility when doing these so we can switch between cases if necessary.

 

I also believe the surgery should not be any different than if the patient was not participating in a demonstration. I don’t like the idea of the physician stopping at key points and waiting until we come back to the scene. If we miss a key point, we miss a key point. The surgery should proceed as it normally would. I believe it is wrong for an urologist to do a live case from another institution. It should be done at their home institution with their own team.

There are some other key components. The audience shouldn’t be able to call in questions. They need to go through a moderator. I prepare the moderator beforehand to make sure that they are comfortable with the case.

From a learning point of view, a live surgery case results in better attention by participants. There seems to be higher retention and more interest in a case when it is done live. Some people refer to this as a “crash” mentality; the audience is wondering what the next step is and if something will go wrong. This is the same reason why some argue against live surgery. If the above steps are followed, there should not be a higher complication rate. If there is a problem, the person overseeing the course should discontinue the transmission.

NEXT: Should the AUA get away from lobbying on economic issues?

 

Should the AUA get away from lobbying on economic issues and leave that to other urology organizations and restrict itself to issues related to research, patient safety and well-being, and optimal care? It seems like a potential ethical conflict for one organization to have both of those functions.

Medicine has changed significantly, and the direction is to connect reimbursement with quality outcomes, patient safety, and costs. Even tort reform on a national level incorporates the concept of patient quality with the recommendation of safe havens provided if physicians follow established guidelines. The government is looking at specific monitors of quality in discussions about reimbursement. As we go forward, more and more reimbursement is not going to be based just on the volume of what we do, but on the quality of outcomes.

The AUA has taken the correct stance, particularly by putting a lot of emphasis on guidelines. Guidelines are going to be important not only for reimbursement and patient safety, but also for tort reform. In the future, if you follow guidelines, you will likely be in a safe haven as far as tort litigation. All these things are coming together, and the AUA’s readjustment of its quality and health policy is right in line with what the future has to bring. We can’t disconnect from the economic part, because the government is connecting economics to quality.

 

I understand. It just seems like the AUA shouldn’t be the organization that’s protecting the economic interest of urologists; that should be handled by a different organization. The AUA should be more concerned with quality of care, outcomes, and guidelines.

I think we really are focused primarily on patient-related factors. I don’t think our organization is focused on the economic part of practice, but those elements are connected. Our focus really is on education, quality, and ethics, but the government is connecting all of this, so that reimbursement is going to be tied to quality. The AUA is in the best position to help urologists learn how to practice medicine in a quality-conscious way. We also need to work and maintain our specialty by helping to define our areas of expertise. In many of the areas that we manage patients, other specialties overlap or compete. This clearly has an economic aspect, but it is important to maintain the integrity of our specialty.

I think there is going to be a total change in how we think about quality. Separate physician/nurse quality committees will give way to institutional quality committees that incorporate all aspects of the institution. For example, right now, we focus on central line infections, catheter-related urinary tract infections, ventilator-associated infections, and C. difficile infections. These are really measures of effective hand washing, type of equipment, education, room cleaning, etc. What is the best hand washing solution to use? What is the cost? Where are the hand washing stations placed? What is the best cleaning solution for hospital cleaning staff to use?

In the future, we need to connect the entire facility to the quality initiatives and understand the cost along with the most effective methods to improve patient care. Future committees need to be broad based. It’s going to be an exciting time, but we have to rethink how we function. It’s not going to be the typical quality of the old days.

 

Is there anything else you’d like to discuss?

Yes. Three years ago, I did not understand completely the importance of being involved in health policy. Like many academic urologists, I did not think there was any need to be involved in health policy issues. I have come to understand that academic urologists need to be more involved in this area. More and more educational programs are being driven and supported by clinical dollars. This cannot be sustained. We need to rethink how the costs of graduate medical education are being covered.

There was a recent report from the Institute of Medicine recommending major changes in how graduate medical education will be funded in the future. There are work force issues and research support issues. These are areas where academic urologists need to become involved. Our academic institutions are often the largest employers in a region and carry significant weight with local and national political leaders. I encourage more academic urologists to become active in this area because as an organized group, we can have a significant impact.