Safe harbors: Liability reform for patients and physicians

Practicing physicians may be unsettled by the fact that over the course of their careers, more than 75 percent of all physicians are likely to be named in a liability claim.¹ Moreover, not all claims are resolved as expected, with one study estimating that one in four claims may not be resolved in accord with the claim’s merit.² The high lifetime claims rate and the incomplete overlap between the merit of a claim and its disposition have left many physicians feeling that the medical liability environment is unpredictable.

The unpredictability is readily illustrated during the claims resolution process. Because of the ambiguity that can exist as to what constitutes reasonable (for example, non-negligent) care, many liability claims often lead to a “battle of the experts” that occurs when both the plaintiff and defendant bring in qualified experts to support their side of the case. If the experts on both sides are well-qualified and equally convincing, adjudicators (for example, judges and juries) trying to decide the merits of the claim may be left without clear guidance on how to resolve the dispute.

In fact, some experts argue that the ambiguity of the claims resolution process and the desire to avoid being named in a liability suit altogether could have potentiated the practice of defensive medicine. The very existence of defensive medicine—which includes the ordering of tests or procedures primarily to reduce legal risk—clearly demonstrates how the legal system may at times be causing physicians to divert their focus away from cost-effective and high-quality care. To introduce better predictability and reliability into the existing litigation system while promoting more evidence-based standardized care (and less unnecessary utilization), many health policy experts have advocated for the creation of “safe harbors.”

Definitions and aims

Safe harbors are designed to protect physicians from liability risk if they provide care that follows approved clinical practice standards. If an adverse event occurs and a liability claim is asserted, safe harbors operate by establishing a presumption of non-negligence if the named physician adhered to the applicable, approved standards. This presumption can be either rebuttable or non-rebuttable via introduction of evidence. However, safe harbors can potentially offer additional benefits.

By providing direct guidance for negligence determinations, safe harbors may help ameliorate some of the current ambiguities in today’s litigation system for both patients and providers. At any stage in litigation, safe harbors can be a mechanism to facilitate rapid and accurate evaluation of claims for their merit. Due to the fact that they are described and documented in advance of a case, safe harbors may actually help patients (and their attorneys) better evaluate whether a claim is worth bringing forward. The availability of liability protection for following approved standards may lead to greater standardization in care and better patient outcomes as well.

Of note, safe harbors can also be deployed not only to provide liability protection, but also to help define the appropriate standard of care. This would mean that in addition to being available to physicians merely as a defense, safe harbors could also be used by injured patients to presumptively establish negligence if an approved and applicable standard was not followed.³ This use of safe harbors would further bolster the incentives for physicians to adhere to approved evidence-based standards.

Previous experimentation

Though safe harbors are receiving greater attention today, they are not new concepts in medical liability reform. In the 1990s, a handful of states conducted demonstration projects to test the implementation of safe harbors. However, due to their limited design or use, very little was learned from these trial implementations.

The Maine Medical Liability Demonstration Project, created by the state legislature in 1990, was a five-year safe harbor program in which implementation was limited to four clinical areas: obstetrics and gynecology, anesthesia, emergency medicine, and radiology.^4,5 The safe harbor standards were selected from national medical association guidelines and were modified by a physician committee to reflect local practice.⁴ The program noted high rates of physician opt-in. However, in the five years that the program was in place, only once were the guidelines used as a defense.⁶

Florida conducted a Cesarean Demonstration Project in safe harbors from 1994 to 1998. The project enabled obstetricians to use evidence of compliance with practice standards as a defense in liability claims. And while there was a 20 percent participation rate among obstetricians in this project, it was not renewed. However the final report recommended further experimentation and evaluation.⁷

In Minnesota, legislation enacted in 1992 allowed the state health commissioner to designate clinical guidelines. No outcomes data emerged from the project, and the programs were not renewed. Current Minnesota law now forbids admission of guidelines issued by external review organizations into evidence.⁸

A recent study funded by the Agency for Healthcare Research and Quality (AHRQ) sought to determine whether safe harbors could improve both patient safety and liability system performance.⁹ State of Oregon investigators reviewed 266 closed claims for commonly occurring diagnostic or medical management issues for which guidelines were likely to apply.⁹ In claims in which guidelines were applicable, reviewers found that injury might possibly have been avoided in 30 percent of the claims had the provider adhered to a guideline, demonstrating a considerable potential for safety improvement. Some possible benefits in the claims resolution process were also suggested. Reviewers found that up to 32 percent of the cases might have been resolved more quickly had safe harbor protection been applied. However, safe harbors did not appear to provide much protection from incorrectly adjudicated claims, as only a small percentage of paid claims would not have been paid under safe harbor protection.

Oregon’s retrospective application of safe harbor guidelines underscored the potential benefits and uncertainties regarding their use. Safe harbors appear to have the potential to prevent harms, and therefore, resultant claims. Furthermore, the faster resolution of claims could decrease the emotional burden that prolonged cases can have on providers and patients and, in the process, reduce administrative and legal costs as well. However, the exact extent of the benefits and how much they will affect overall compensation payouts remains unknown.

Perspectives on implementation

The various stakeholders in medical liability reform—specifically physicians, patients, and policymakers—each have their own interests in and concerns about the implementation of safe harbors. Some physicians worry that the introduction of prescribed practice standards will lead to “over-standardization” and cookbook medicine. However, clinical judgment will still be required to determine whether such standards are applicable to a certain case or clinical scenario. Moreover, the potential for standardization to increase patient safety should not be overlooked.

When adverse events occur, systematic standards for adjudication can also provide greater clarity of what constitutes reasonable care, possibly also decreasing defensive practices. This improved consistency in claims resolution may also restore faith in the self-regulatory ability of the medical profession and in the fairness of the legal system. These cultural benefits should not be overlooked in evaluating the impact of safe harbor guidelines.

The Oregon results demonstrate a potential for safe harbors to improve patient safety. This may be the greatest benefit from safe harbors, for patients and providers alike. In addition, if safe harbor rules are used to define the standard of care, many claims for injury that have gone unpaid may ultimately result in patient compensation. Nevertheless, it remains an open question as to whether safe harbor protection will provide enough encouragement to result in standardized care that translates to safety improvements.

Incorporation of evidence-based medicine to clinical practice standards has already become essential to medical practice today. The Choosing Wisely campaign provides a precedent for the fair and unbiased compilation of guidelines. In this initiative, specialty physician groups partnered with the American Board of Internal Medicine and Consumer Reports, an independent not-for-profit consumer organization, to release guidelines on 45 common tests and procedures that might be overused or unnecessary.¹⁰ It provides an example of the dissemination of guidelines to providers and patients via professional organizations and consumer organizations, respectively, for the facilitation of conversations about the guidelines and their implication on care.

However, the selection of the applicable standards for safe harbors—especially given the effect they may have—may be a highly debated issue. It will be critical to determine who will be responsible for selecting the standards, how standards will be chosen, and how they will be kept current and appropriate.¹¹ This includes the frequency and mechanism by which these guidelines will undergo continuing review and revision to reflect current medical science and local variations in medical practice.⁸ Reliance on an expert committee composed largely of physicians, such as that which helped to launch the Choosing Wisely campaign, may be best suited to ensuring medical soundness, but may also be perceived as being biased toward physicians.¹² Nevertheless, designation of eligible standards can have many downstream benefits, such as the resolution of disputes between conflicting best practices, heading off potential sources of contention in litigation, and improved administrative efficiency.

Conclusion

The creation of safe harbors may improve both patient safety and medical liability system performance. Safe harbors have many potential benefits, which include discouraging nonmeritorious liability claims, mitigating the unpredictability of settlements and verdicts, reducing defensive practices, and bolstering the integration of evidence-based care into clinical practice to improve patient safety. Previous experimentation has been limited in scope. The current political will and professional interest in generating standards of care, coupled with the need for liability reform, makes this an appropriate time to further investigate the effects of safe harbors.

---

References

1. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.
2. Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006;354(19):2024-2033.
3. Mello MM. Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation. Univ of Penn Law Review. 2001;149(3):645-710.
4. Begel J. Maine physician practice guidelines: Implications for medical malpractice litigation. Maine Law Review. 1995;47:69-103.
5. Smith GH. A case study in progress: Practice guidelines and the affirmative defense in Maine. Jt Comm J Qual Improv. 1993;19:355‐362.
6. Hyams AL, Shapiro DW, Brennan TA. Medical practice guidelines in malpractice litigation: An early retrospective. J Health Polit Policy Law. 1996;21(2): 289-313.
7. Matthews JR. Practice guidelines and tort reform: The legal system confronts the technocratic wish. J Health Polit Policy Law. 1999;24(2):275-304.
8. Mello MM, Kachalia A. Evaluation of Options for Medical Malpractice System Reform. A Report to the Medicare Payment Advisory Commission (MedPAC). 2010. Available at: www.medpac.gov/documents/Apr10_MedicalMalpractice_CONTRACTOR.pdf. Accessed January 16, 2013.
9. Agency for Healthcare Research and Quality. AHRQ Medical Liability & Patient Safety Planning Grant: Final Progress Report. Available at: www.oregon.gov/oha/OHPR/PSDM/AHRQ_MLPS_Report.pdf. Accessed February 19, 2013.
10. Cassel CK, Guest JA. Choosing Wisely: Helping physicians and patients make smart decisions about their care. JAMA. 2012;307(17):1801-1802.
11. Hall MA. The defensive effect of medical practice policies in malpractice litigation. Law Contemp Probl. 1991;54:119-145.
12. Rosoff AJ. Evidence-based medicine and the law: The courts confront clinical practice guidelines. J Health Polit Policy Law. 2001;26(2):645-710.