ACEP board members, council officers, executive leaders weigh in on this potential solution to regulatory pressure around reducing health care delivery costs

This article was discovered by Michael Baldyga, ACEP public relations manager, and forwarded to Dean Wilkerson, ACEP Executive Director; Alexander Rosenau, ACEP President; and Michael Gerardi, ACEP President-Elect. The “think tank” erupted with a fury of interaction and communication over a 96-hour period.

It is important to recognize the raw nature of this work and see this for what it is: issue identification, rapid dissemination, and brainstorming. It is not a completed work and includes most, but not all, comments submitted. In the coming months, solutions will be investigated to support the interests and needs of emergency physicians and our patients.

Kevin M. Klauer, DO, EJD, FACEP, is director of the Center for Emergency Medical Education (CEME) and chief medical officer for Emergency Medicine Physicians, Ltd., Canton, Ohio; on the Board of Directors for Physicians Specialty Limited Risk Retention Group; assistant clinical professor at Michigan State University College of Osteopathic Medicine; and medical editor in chief of ACEP Now.

The work of the ACEP Board of Directors is often messy, frequently goes unnoticed, and is always productive. The following is a recent email discussion between the ACEP Board Members, Council Officers, and ACEP executive leadership. The issue of safe harbor protections for following clinical guidelines was raised as a potential solution in response to regulatory pressure to reduce the cost of care delivery. ACEP started to feel the squeeze after an article published on February 23, 2014, in the lay press, “A Push for Less Testing in Emergency Rooms: Heavy Use of Imaging Scans May Drive Up Costs—and Risks,” by Barbara Sadick of The Wall Street Journal.

Dean,

Thanks for forwarding…unfortunate that medial liability reform/safe harbors got no mentions…the take home seems to be: “If only these ED docs could do a physical exam.”

—Mark L. Mackey, MD, MBA, FACEP, ACEP Board Member

Yes, and we can’t seem to shake the title “ER physician” instead of emergency physician. We haven’t been holed up in a “room” for a long time.

—Rebecca B. Parker, MD, FACEP, ACEP Board Member

Unfortunately, no professional liability discussion. What is the acceptable miss rate? Where are the safe harbors, etc., etc.? We should draft a thoughtful editorial comment. We have been working hard on making progress on utilization issues.

—Andrew E. Sama, MD, FACEP, ACEP Chair of the Board and Immediate Past President

I think it would be interesting to pose this question to the trial attorneys whether the Choosing Wisely recommendations constitute safe harbors. Let’s have somebody else debate this issue rather than us trying to make a statement that may appear to be self-serving. I wonder what the president of ATLA [the Association of Trial Lawyers of America] would say.

—Paul D. Kivela, MD, FACEP, ACEP Secretary-Treasurer

As per my reply to Dean, this is all about risk benefit continuum or spectrum—in other words, how much certainty for how many dollars cost for the patient and how much risk for doing or not doing the test or procedure, which entails health risk for the patient and medical liability and career risk for the physician.

Medical liability must be addressed. Agree with Sama, a letter to the editor that clarifies that issue would be appropriate.

—Alexander M. Rosenau, DO, FACEP, ACEP President

Let’s move forward and try something different. Let’s establish safe harbors and advertise that this will save waste from the system … Safe harbors to improve patient safety and decrease health care costs.

— ACEP Secretary-Treasurer Paul D. Kivela, MD, FACEP

My question is perhaps a philosophical one. It doesn’t seem to matter if it’s right or if it’s wrong but how it is perceived. So why do we continue to self-advocate as it rarely seems to be effective in changing public opinion? I think we need to go and try something different from time to time. It seems like we are writing too many letters to editors to clarify misperceptions.

I would rather have articles written in our favor the first time around. What about pitching this to the LA Times if not The Wall Street Journal and having them ask the trial attorneys how they feel about safe harbors for Choosing Wisely measures. For balance, they can ask the insurance companies and the regulators.

—Paul D. Kivela, MD, FACEP, ACEP Secretary-Treasurer

Think Paul has struck a nerve.

Recently, an ACEP leader gave a talk about “What I learned in Washington.” It was illuminating. He says no one cares what we think. If we say it, then it is automatically seen as being self-serving and not to be trusted. [Politicians] want recommendations and data from impartial sources.

There were several other things he learned about how they think, how they view physicians, how they make decisions, etc. I’ve asked him to put his observations down as a report to the ACEP Board of Directors. Hope he does.

—John J. Rogers, MD, FACEP, ACEP Board Member

Great point, Paul, and good feedback, John.

Is there a way to change the conversation back to patient advocacy? Most patients want to see the system get better/improve (eg, heparin and Dennis Quaid’s twins). Any studies out there that safe harbors allow for more error reporting, error reduction efforts, and open conversations when issues occur? It represents an agreement with physicians and patients that we commit to following evidence-based decision making whenever possible, understanding the risks.

—Rebecca B. Parker, MD, FACEP, ACEP Board Member

My understanding is there are safe harbors in just about any other field, from construction to accounting. Why don’t we establish safe harbors and say that ACEP recommends the following safe harbors? Reality is that there’s no such thing as a medical malpractice case, or any malpractice case, without an expert witness saying that something has deviated from the standard of care.

Let’s move forward and try something different. Let’s establish safe harbors and advertise that this will save waste from the system. I say we just establish that ACEP determines the standard of care consensus-wise for emergency medicine. We need to come up with the campaign slogan and go with it and see what happens. Doesn’t mean you can’t do more, but you will be protected if you do what is the recommendation. I don’t think it needs to be any more complex or complicated than this, and I don’t think we have to ask for anybody’s approval. Let’s be bold.

Safe harbors to improve patient safety and decrease health care costs.

Safe harbors is smart and informed medicine.

—Paul D. Kivela, MD, FACEP, ACEP Secretary-Treasurer

I like the approach of creating safe harbors to give emergency physicians the confidence to practice evidence-based medicine without fear of litigation. This has to be patient-centered so that we are not viewed as self-serving when promoting safe harbors. As a practical matter, could we refer this to the medicolegal committee?

—Robert E. O’Connor, MD, FACEP, ACEP Vice President

I agree with moving forward with creation of safe harbors with appropriate efforts to approach it from a quality perspective with careful attention to not appear speaking from a self-serving perspective. The medicolegal committee might be a good place to start with this.

—Debra G. Perina, MD, FACEP, ACEP Board Member

How do we ensure it does not appear to only be about protecting physicians?

Who would need to recognize the safe harbor? The courts? In every state?

Feds have seemed very uninterested in addressing liability concerns. Then again, if it was a matter of saving them money, they may take more interest.

—John J. Rogers, MD, FACEP, ACEP Board Member

Defensive medicine is an expensive and unnecessary part of medical practice that does not benefit patients. But doctors have to do it because of the unreasonable and out-of-control liability environment.

— ACEP Executive Director Dean Wilkerson, JD, MBA, CAE

I’d like to see the first five EM safe harbors introduced this fall at ACEP14. In being good partners in the house of medicine, I’d like to invite the other specialties to similarly submit safe harbors that improve patient safety and decrease health care costs. Consumer Reports partnered with Internal Medicine. I wonder if The Wall Street Journal, USA Today, or someone else representing consumers, even [the Pacific Business Group on Health] or the Institute of Medicine, might want to jump in and partner with us. It might be nice to ask [former Secretary of State] Hillary Clinton and [NJ Governor] Chris Christie to be honorary board members. Now that would be interesting to see what they say to being on a panel that has the serious potential to decrease health care costs.

I think we should push forward the “Safe Harbors Are Smart Medicine” campaign or whatever it ends up being called.

I think if we find the right partner(s), we can accomplish this to everyone’s benefit, other than the trial attorneys. Government wins with less costs, employers win with less costs, health care plans win with less costs, patients win with low-yield tests not being done, and physicians win by decreased anxiety, decreased time doing tests, being able to treat more patients, and improved access.

Having ACEP establish safe harbors may be an actual solution rather than just PR. ACEP has been pushing the envelope since before our inception. Let’s be bold.

—Paul D. Kivela, MD, FACEP, ACEP Secretary-Treasurer Dean, et al.

Perhaps the article has served us well by driving our attention to this issue.

With respect to safe harbors, the Choosing Wisely recommendations are a good start, as you must have an evidence-based recommendation to create the safe harbor of professional liability protection around. In addition, safe harbors must be drafted by intent and not implied via common sense. For instance, it makes perfect sense to avoid unnecessary head CTs per our recommendation. However, the Choosing Wisely recommendation would provide an excellent platform for defense but is a far cry from a safe harbor, which should be crafted to avoid all liability if followed. The plaintiff’s burden would then be to prove that the safe harbor does not apply or is not applicable to the facts in question. The policy would need a safe harbor provision, and that policy would have to become law, from my perspective. The tort of negligence is handled at the state level. However, I do believe that preemption is possible if this were tied to a federal program such as the ACA [Affordable Care Act] (ie, value-based payment modifier).

I agree with everyone that firing back in our own defense is most likely to be perceived as self-preservation. However, I would like for such an article to spark an ACEP-led debate on shared decision making. Serving our patients is always the best road to travel. In addition, shared decision making, in my opinion, functions as a bedside safe harbor. I avoid the provision of more unnecessary tests in this way and serve my patients better while also reducing my liability by informed discussions and documenting patient preferences.

I included this concept in a chapter in the new edition of Jim Adam’s management text, Emergency Medicine: Clinical Essentials, 2nd ed.

I have considered addressing this concept in ACEP Now. Following this article, I’m certain that I will.

Thank you.

—Kevin M. Klauer, DO, EJD, FACEP, ACEP Council Speaker

Alex, I like [ACEP public relations director Laura Gore’s] opinion. Editorial boards will want to know what we intend to discuss that is new. At root, this remains an argument we have been making for years. Defensive medicine is an expensive and unnecessary part of medical practice that does not benefit patients. But doctors have to do it because of the unreasonable and out-of-control liability environment. Advocating for safe harbors for practicing evidence-based medicine (which is cheaper for society and better for patients), and thereby allowing doctors to be exempt from medical liability if there is the unexpected bad outcome, is not a new concept. Insurers and hospitals will support it along with doctors, but trial lawyers, some consumer groups, and many Democrats will fight it to the death. We can try to get meetings and be more proactive and raise our voice on this, but I think Kevin Klauer’s analysis is correct. Unless there is legislation, or perhaps some hardwired regulation, establishing the safe harbor, it will not be a true safe harbor insulating from liability. Without the legislative or regulatory underpinning, ACEP can say what is the standard of care, but it will then be litigated in each case. I think we might want to get some legal advice from [former CMS administrator and ACA regulatory law expert] Tom Scully’s firm or [association and health care law expert] Rob Portman on any angle there may be for us to truly establish safe harbors either through legislation or regulation under the ACA.

—Dean Wilkerson, JD, MBA, CAE, ACEP Executive Director

After thinking about this, and I do appreciate Kevin’s insight as well as Laura’s and the rest of the staff’s, what about the simple strategy of stating that ACEP has developed five proposed safe harbors and then submitting those to the media? We would certainly need Laura to craft a great message about how safe harbors are the right thing to do, and we let the other people shoot them down. The worst thing that could happen is that ACEP was proposing cost-saving measures that benefit patients and eliminate unnecessary tests. I think it might be hard politically for ATLA and even consumer groups to say that safe harbor should not exist, particularly if we pick something very simple and straightforward. Emergency physicians determine the standard of care, and there’s no reason why we should not be able to determine what safe harbors should exist in our field. If we can determine what is unethical and egregious testimony, certainly we should be able to agree on some straightforward, simple safe harbors. Jay [Kaplan’s] list and some of our Choosing Wisely submissions might be a good start, but I’d like to do something with chest pain and POLST [Physician Orders for Life-Sustaining Treatment]. I don’t think we do need to make this too complicated. Legislation will take forever and get bogged down, and if it gets close, they may even filibuster it.

—Paul D. Kivela, MD, FACEP, ACEP Secretary-Treasurer

Maybe not safe harbors, but could we have more transparency around what following the guidelines means in terms of risk? For instance, following PECARN [the Pediatric Applied Research Network Head Injury/Trauma Algorithm], 1 in 2,000 kids will have clinically significant traumatic brain injury that will not have been CT’d initially. The “cost” of trying to be perfect is the cost of 1,999 CTs and the subsequent radiation exposure versus the cost of defense/settlement/verdict for the one “miss.”

—William Jaquis, MD, FACEP, ACEP Board Member

Bill,

Excellent points. I think an important educational point for the layperson is that reducing utilization and cost is the right thing to do, but there are two sides of the equation. Albeit a small percentage, some patients who are exempted by the guideline will have a bad outcome due to missed or delayed diagnoses from not ordering the test. When looking at population data, most, if not all, agree that this is the right thing to do. However, applying this to the individual patient encounter is a very different application of the concept. In other words, most laypersons agree this is the right thing to do. However, their opinions may change when they personally will not receive the test and particularly if they ultimately suffer a bad outcome.

We can reduce cost with a simple pen stroke (oversimplification), but why should the medical legal burden created by following a guideline fit squarely on the shoulders of the providers just trying to follow it?

I think this is an important question that could be posed in the lay press and to legislators.

—Kevin M. Klauer, DO, EJD, FACEP, ACEP Council Speaker

Hence the need for fair compensation with shared risk and shared payout by all of society, not just the provider.

—Alexander M. Rosenau, DO, FACEP, ACEP President

Could this be a case where we seek a cap for non-economic damages?

—Rebecca B. Parker, MD, FACEP, ACEP Board Member

Cogent points, absolutely agree! This conversation needs to be aired. It’s time for an honest debate about what is appropriate and needed, what is not, and how clinical providers can be free to strike that balance for the overall good of society. Answer: Choosing Wisely and Safe Harbors!

—James M. Cusick, MD, FACEP, ACEP Council Vice Speaker

Becky,

It could. However, the medical legal community’s acceptance of such caps is lukewarm, and their effectiveness is debatable. In addition, economic damages (special damages) come from hospital bills, lost future earnings, etc., and they can be huge. So I would not limit our protection to non-economic damages (ie, severe pain, disfigurement, loss of consortium, etc.). I think we really are entitled to true indemnification when we follow such clinical policies correctly and a bad outcome occurs.

—Kevin M. Klauer, DO, EJD, FACEP, ACEP Council Speaker

I think the problem is even more basic than this.

Society does not fathom the actual cost of not having safe harbors; most people just think it is doctors whining and wanting a better deal for ourselves.

They do not realize that the cost of medical tort to society is at least $300 billion a year (8 percent of what we spend on health care, between direct and indirect costs).

There is an economic argument that needs to be made since every one of those dollars is paid by consumers of health care.

This is true cost savings, not just making it easier for physicians to practice.

—Vidor E. Friedman, MD, FACEP, ACEP Board Member

Apropos to this week’s discussion about safe harbors, I wanted to let you know that two members of the U.S. House of Representatives, Rep. Ami Bera (D-CA) and Rep. Andy Barr (R-KY), have introduced legislation in the House that would establish safe harbors for physicians “who can demonstrate they followed the recommended best practices….” Those recommended best practices will be developed by the physician community based on the best available scientific evidence. The bill, HR 4106, was introduced yesterday and has been referred to the House Energy & Commerce Committee and the House Judiciary Committee.

We will be discussing this bipartisan bill on next week’s Federal Government Affairs Committee monthly conference call and will presumably recommend that Dr. Rosenau send a letter of support. There will be other opportunities to work with the bill’s sponsors in the coming weeks and months.

—Gordon B. Wheeler, ACEP Associate Executive Director for Public Affairs