Clinical Practice Guidelines as “Safe Harbors” against Malpractice Claims

Health care costs too much in the United States. One key problem is gold-plating of services driven by physicians’ fears of lawsuit for failure to do everything possible for patients. A notable example of such overutilization is increasingly routine ordering of advanced imaging or other tests. Reliable, evidence-based clinical guidelines promise to address low-value utilization by authoritatively stating standards of good care in advance.

Some thought leaders among Democrats seek to use guidelines to side step the routinized political battles over malpractice reform. Republicans have been saying that defensiveness and other problems justify caps and other limits on medical liability. Belittling defensiveness as a problem, Democrats have defended and promoted liability as an incentive for good care.

Defensiveness is a problem, acknowledge proponents of guidelines to reform liability. But it can be fixed simply by legislating that adherence to reliable guidelines constitutes a “safe harbor” against lawsuits for failure to do more. Safe harbors would remove the motivation for defensiveness and also any need to accept Republicans’ caps and other limits. Given the political stalemate in Washington, the idea is worth thinking through.

Good guidelines are a good idea, especially to improve quality of care, which is their main policy driver. And, because guidelines hold promise for cutting wasteful defensiveness, they have superficial appeal as a liability reform. However, practical feasibility limits the reach of safe harbors, as explained in a recent policy brief from The Urban Institute for the Robert Wood Johnson Foundation.

One set of practical challenges comes from the difficulties of creating—and updating—enough reliable guidelines to change caregivers’ now reflexive defensiveness. Maine tried twenty years ago and gave up in large part because few guidelines were created or used. Another set of challenges arises in actually implementing guidelines in lawsuits. Among numerous examples, the targets of guidelines seem mismatched to the grounds of liability claims. And there will always be claims that a particular patient was an exception to the general rule of a guideline.

Moreover, no single silver bullet can cure defensive over-utilization because gold-plating of care is driven by many factors. Patients and jury members alike believe that more is better, insurance pays for it, and medical culture accepts it. Using guidelines for population-based targeting of outlier clinical practices seems much easier to effectuate than using them to reform liability’s case by case decisions in which judges and juries cannot take a broader perspective.

The legal influence of guidelines will grow naturally if changes in payment rules or responsibilities over time change provider or patient thinking about the desirability of additional procedures, and more advanced information technology may help. Meanwhile, crafting appropriateness guidelines that specifically target overutilization promise some reduction of specific defensive practices.

Malpractice fears remain a constant irritant, though far less so than when liability premiums were soaring a decade ago. As for many other policy conundrums today, there’s no lack of reasonable solutions for malpractice shortcomings, but partisan gridlock blocks them. Unlike other policy gridlocks, however, splitting the difference here would miss many of the best solutions. Both patients and caregivers suffer under the current malpractice “system,” but the parties claiming to represent their interests simply advocate for more or less of that same inadequate system. Both would be better served by some nonpartisan tweaking, including some appropriateness guidelines, or by a quite different system.

Randall R. Bovbjerg, J.D., is a senior fellow in the Health Policy Center of The Urban Institute. A policy analyst and lawyer, he specializes in health insurance and reform, reinsurance, the safety net for the uninsured, and legal issues in health care, notably relating to medical injury.

10 replies »

  1. Excellent description of our current system. Unfortunately, your point is lost on the vast majority of the public. People tend to have some blind faith that the system will get to the correct answer most of the time….and it probably does….but not before exacting a huge toll on the healthcare system. Money spent on malpractice is just passed along to consumers in one way or another.

    A prime example I use to show the general public that malpractice suits don’t have to do as much with bad doctors as it does with a bad system is to look at the different risks of lawsuits/payments associated with different specialties. OB/Gyn and neurosurgeons have a higher rate of lawsuits than primary care….does that mean they have a higher rate of bad doctors that commit more malpractice?

  2. I am a big supporter of safe havens for evidence-based practice.

    The main problem with med mal law is that it is based on a lie. The lie is that doctors have to break a “standard of care” in order to be guilty of malpractice. Yet the ONLY way the courts have to decide a “standard” is two experts arguing technical details in a court full of people who have no clue what they are talking about. How can 2 people arguing accurately determine whether a “standard” has been broken?

    Standards, by definition, are not one expert’s opinion, yet that’s EXACTLY what the court’s use of a “standard” is. Standards are CONSENSUS GUIDELINES THAT THE MAJORITY OF DOCTORS follow. The courts wave this magic BS wand about breaking a “standard” yet they have NO WAY to determine if a standard was actually broken or not.

    What med mal law should say is not that you have to break a “standard” but that you have take a course of action that at least one doctor disagrees with. Thats REALLY what the med mal system makes judgments on. You dont have to break a “standard” you simply have to do something that another doctor disagrees with. Thats a VERY different thing, and for the law to claim this is a “standard” is an outrageous lie.

  3. Scott doesnt understand this issue at all. He stupidly says that overutilization has nothing to do with “defensive” medicine. So I guess he beleives that when an ER doctor orders a test, they get paid extra? Wrong. In fact, for most doctors, ordering extra tests means they make LESS money, not more. There are some exceptions in the procedural-based field, but they account for a very small percentage of spending.

    The VAST MAJORITY of testing is done by frontline primary care doctors or ER docs. Those guys get paid NOTHING for extra tests.

  4. When medical specialty societies develop standards of care, it’s likely that those standards incorporate the realities of the litigious society that we live in. In other developed countries where people are less likely and less inclined to sue when there is a bad outcome but no evidence of negligence, medical practice patterns can be more conservative and less costly. As I said earlier, defensive medicine pervades the medical culture but it’s impossible to quantify its effect on costs with any precision.

    As for cost differences among various healthcare systems, Princeton professor Dr. Uwe Reinhardt, published a paper in Health Affairs back in 2003 titled “It’s the Prices, Stupid.” Hospital based procedures, including outpatient care, are generally significantly more expensive in the U.S. than elsewhere. Brand name drugs are also more costly in the U.S. because other countries use a combination of price controls and limited formularies to keep costs down. Paradoxically, though, generic drugs are actually cheaper in the U.S. than elsewhere. Go figure.

  5. yes, tort reform may not have brought down costs(yet)….but a lot of that is because doctors aren’t confident enough yet that they have to be defensive. i think there is data showing that malpractice premiums(which get passed along to consumers) are not rising at the same ridiculous rates as before. and yes, there are many reasons for high costs including consumers not having any personal responsibility for their healthcare due to 3rd-party payer and fee-for-service which encourages providers to do more for money, but defensive medicine has a huge role.

    your argument against defensive medicine is not correct from a practical standpoint. i’ve heard time and time again how defensive medicine is not good medicine…and from an ivory tower, that is true. but determining the standard of care AFTER a bad outcome is the problem. if a test deemed “unnecessary” BEFORE a bad outcome was not ordered, then some expert somewhere may be found to deem it “necessary” in hindsight AFTER the bad outcome….and there you go!….the reason for defensive medicine!

  6. @ Pat S: You bring up some great points. I would just like to add, that over 30 States have some sort of Tort reform on the books. I would challenge anyone to point to data that shows overall healthcare costs have decreased as a result – or – at the very least utilization rates have gone down.

    @ PV: I have heard this statement countless times – “Doctors are ordering unnecessary procedures to protect themselves.” You have to understand one thing; defensive medicine is a deviation from the standards of care, period. So, how would ordering unnecessary tests protect physicians in a malpractice suit? It wouldn’t – it’s not the standard of care, therefore indefensible. Now, you can get into the nuanced discussion of what’s medically necessary or not, but that is a different argument. “Defensive medicine” has been a longtime cover for increased utilization rates in the ever decreasing reimbursement reality.

  7. although i don’t disagree with most of your points, i must strongly disagree with 15% defensive medicine cost. as you said, there are many other factors such as higher fees for more procedures(especially for cardiology). as an anecdotal example, i have a “friend” who works emergency medicine that orders 80% of his workup on patients simply so that some plaintiff’s expert can’t say later on that he SHOULD’VE ordered all those unnecessary tests if there is a bad outcome.

    i am a big fan of guidelines…and an even bigger fan of “loser pays” if guidelines were followed and a lawsuit was still filed.

  8. Fear of lawsuits have increased health care cost drastically. Doctors are ordering unnecessary procedures to protect themselves. The cost of malpractice insurance also contributes to increased cost, as it is past along.

  9. I often hear doctors comment that defensive medicine pervades their practice culture. When I asked my NYC based cardiologist a couple of years ago to estimate the percentage of his healthcare decisions (by cost) that are primarily driven by defensive medicine, his answer was about 15%. Moreover, he gave the same estimate for virtually every doctor he knows in the area. It’s obvious that defensive medicine does not lend itself to precise quantification because there are other factors that can drive medical decisions including the desire to make money under a fee for service payment model and patient demands and expectations.

    I think safe harbor protection from failure to diagnose lawsuits if evidence based guidelines are followed where they exist could mitigate a lot of this defensive medical practice but it won’t happen right away even if the appropriate laws are passed at either the state or federal level or both. To gain credibility, doctors would need to see very quick and clear dismissal of failure to diagnose lawsuits. Either they wouldn’t be able to get certified as meritorious or a judge would issue a summary judgment ruling for the defense thus saving doctors and their insurers not only defense costs but time needed for depositions and high emotional stress during the time the case is pending before it’s decided. If it happened in diverse geographies and, especially, in jurisdictions with reputations as plaintiff friendly venues, only then would it start to gain sufficient credibility to gain doctors’ trust and belief that the new rules are for real.

    In the meantime, as more doctors become employees of hospitals, those institutions would be in a better position to insist that their doctors follow more conservative practice guidelines where appropriate because the hospitals can better afford to take the litigation risk while they work for passage of appropriate legislation. If the payment model moves away from fee for service in favor of bundled payments and capitation, hospitals would also no longer have any incentive to compensate their physicians based on relative value units billed as so many do now. I think such a change in the payment model could be a cost control game changer.

  10. There are two important sets of well proven facts about malpractice and its impact on unnecessary care that deserve attention in any attempt to reduce the potential impact of malpractice litigation on health care costs.

    First, there are several American states that have passed tort reform laws, but none have seen any effect on the growth of health care costs. Texas, in particular, has a tort reform law that contains almost all of the conservative wish list — limits on non-monetary damages including pain and suffering, limits on fees for plaintiffs’ attorneys, and other features designed to be barriers to lawsuits. In the interval since Texas passed this reform, health care costs in Texas have continued to rise at rates ahead of national rates, and have risen much faster than many states without tort reform.

    Second, the experience of American anesthesiologists with using practice standards to decrease incidence of malpractice suits and awards has been illustrative of the potential of that approach. Anesthesia was once one of the worst specialties in terms of malpractice suits. The American Society of Anesthesiologists responded to this crisis by creating a well defined set practice guidelines for anesthesia and a team of defense experts to help any anesthesiologists who were sued for cases in which compliance with the standards was documented. Lawsuits plummeted and malpractice insurance rates quickly followed. An incidental effect was that the rate of complications for anesthesia also fell markedly, and implementation of well proven useful innovations was accelerated while ineffective practices disappeared or died, benefitting all surgical patients.

    These experiences are not conclusive, and application of standards to a highly technical field like anesthesia may be much easier than other specialties. The experiences do suggest that use of practice standards deserves more investigation and that tort reform aimed at limiting the value of lawsuits and decreasing access of potential plaintiffs to courts does not have the desired impact on growth of health care costs.