H.R. 3372: An Innovative Proposal on How to Handle Medical Malpractice Litigation
By Dr. William Harvey, M.D.
On July 29, Representative Tom Price (Republican, GA, 6th District) introduces a remarkably short (13 pages!) yet insightful bill to create a strategy for improving health care and reducing the risk, cost and time spent in medical malpractice. There are no co-sponsors yet, and the Bill has been assigned to the House Ways and Means Committee as well as the Energy and Commerce Committee. The short title is the “Health Care OverUse Reform Today Act (HealthCOURT Act) of 2009”.
In the interest of transparency, I don’t live in Georgia, I’ve never met Mr. Price, and to be honest, I know very little else about him. However, reading his words and the underlying ideas, I really like the way he thinks.
This bill addresses three inter-related issues to create a smoothly functioning, logical, efficient system for dealing with the underlying issues in most medical litigation:
• To establish Medicare performance-based quality measures (Section 2);
• To establish an affirmative defense in medical malpractice actions based on compliance with best practices guidelines (Section 3); and
• To provide grants to States for administrative health care tribunals (Section 4).
This bill isn’t perfect, and it does have some items that will be a hard sell for AARP and many liberal organizations and legislators, but it does provide a solid basis for discussion. Let’s take it apart and see where the good, the bad and the ugly will be.
To establish Medicare performance-based quality measures
There’s a reason why we speak about the “art of medical practice” and not only the “science of medical practice”. Every one of us is an individual; our bodies have evolved differently, we react to drugs differently, and we have different mixes of diseases (and treatments). Each on of us constitutes a unique medical situation. It takes years of experience and learning to know when you can ignore a factor and when it’s critical to the outcome. Still, in many cases, the care of many conditions can be simplified to a set of guidelines.
You may think that each disease/disorder/complication has been studied to death (sorry for that choice of words) and that all those medical books and journals basically say “if the patient has this, do that.” Not so fast!
First, we have many doctors who learned from their mentors how to treat a condition, without the mentors having really done the comparison to other potential treatments to see which was best; this is the medical equivalent of “I do it this way because my grandma taught me to do it this way … and she learned from her grandma.” What we get is a variety of ways of treating the same condition. If we look at outcomes we can often determine that some methods clearly work better than others.
If you remember from a previous post, when we look at particular treatments for a given condition, in the setting of real people (with all their complications) in the real world, we call that “comparative effectiveness.” If we take the information we have from all the research we’ve done (randomized controlled trials; case studies; registries; etc.) and let a group of experts sift through it, we can get recommendations based on performance and on the quality of the results (outcomes) on what the best course of action is in a certain situation. These recommendations are guidelines and they are produced by a number of professional and scientific organizations.
If you’ve been unlucky enough to have a heart attack, you will notice that the EMTs who come in the ambulance have a standard routine they use; when you’re taken into the ER, the ER staff likewise have a standard set of routines. If you’ve had hip or knee replacement surgery, the same thing is true: your doctor had a standard routine for when to start blood thinners and how long to continue them. All of these are “guidelines” and following them is called practicing “evidence-based medicine.”
What Section 2 does is establish the basis for creating the standards “guidelines” that will be used to direct performance-based (“evidence based”) medicine. It requires the HHS Secretaryto find such standards and to make certain they are widely distributed.
Now, if you remember the discussion of the HIT part of the Stimulus Package, you’ll say, “Wait a minute, the Office of the National Coordinator of HIT is supposed to do that, so what’s the big deal?” The big deal is that in the Stimulus package, the government and its committees and administrators, working in with no public exposure or input, generate the guidance that the ONCHIT distributes. The process is as transparent and participatory as developing a new section of the IRS code.
In this bill, on the other hand, the development of the standards is done independently of the government, by medical and professional societies, with participation broadly based around the nation and, in many cases, internationally. When a standard has been developed by such a recognized independent body, the Secretary may promulgate it … a breath of fresh air.
This initially applies to diseases and procedures of interest to the Medicare population, but if the system functions well it could be easily expanded to cover common conditions in non-Medicare populations.
To establish an affirmative defense in medical malpractice actions based on compliance with best practices guidelines
Jeff (or a kind, legally-trained reader) will have to correct me here, but our medical malpractice system is based on tort law. This means that one party believes that a legal injury has occurred in a non-contractual relationship. In short, someone had to be “at fault” for what happened to the other party. A tremendous amount of time and money is spent in resolving the key questions of fault and extent of fault.
Section 3 of the HealthCourt Act attempts to simplify this process and reduce costs. First, once Best Practice Guidelines have been issued, if a physician has followed the Guidelines, that will constitute an affirmative defense against a malpractice action. In simple language, if you as a physician follow what the medical community has identified as the best way to handle a particular condition or disease, you have a positive defense. The part of this Section that people will have trouble with is the limitation (amounts not specified) on non-economic (“pain and suffering”) and punitive damages. Pages 4 and 5 cover this and are in reasonably clear language (at least for a Congressional Bill). Remember that if a physician has been negligent or has not followed the Practice Guidelines, none of the restrictions discussed above apply.
When you remember that administrative fees (to insurance companies and to attorneys) and damages amount to about $30 billion a year, any simplification of this process will remove a thorn in the relationship between doctors and their patients. The availability of Best Practice Guidelines will mean that a physician and patient can have a very clear and detailed discussion of what the patient’s treatment should be … and why.
To provide grants to States for administrative health care tribunals
When you read that title you imagine a dark chamber with secret meetings; Rep. Price should have come up with a better name. This Section actually establishes a hierarchical series of panels, appeal bodies, and then a transition to the Court system to handle allegations. What is particularly impressive is that the entire process is established and runs under the jurisdiction of the State governments, not the Federal government. Of equal importance is the way the make-up of the panels is described. These are heavily based on independent, specialist, expert healthcare practitioners (MDs, nurses, etc.) – individuals who can sort out the issues that are usually buried in today’s system by “expert witnesses” who contradict one another and leave a jury more confused than educated.
The system almost has the appearance of a mediation panel to handle the first few levels of the process. As much as possible, the intent is to provide a non-confrontational, objective process and evaluation. Clearly, in the real world, not all cases will be resolved in the first 1-2 levels, so there is a transition to the Courts. However, it is clear that the hope here is that most issues will be resolved early in the process.
As we’ve noted previously, healthcare reform without malpractice litigation reform is unlikely to succeed. This is the first Bill that addresses the litigation reform AND provides a better way than any other bill presented so far to provide practice standards. It also keeps the definition of standards of practice with the professional bodies involved (not the Federal Government) and keeps the litigation process at the State level (and not the Federal level).
Please read this bill … and if you like it, bring it to the attention of your Congressmen. It needs all the publicity and help it can get.
William Harvey is a physician with extensive experience in drug research and development. He began as an academic researcher but has been a pharmaceutical executive in the global development arena for almost two decades. His current position involves the strategic use of comparative effectiveness research to speed drug development and to educate healthcare stakeholders: government, payors, prescribers, and patients. He lives in the greater Philadelphia area.