Journal Logo

At Your Defense

At Your Defense

Safe Harbor Law Could Help Defend Malpractice Claims

Reyes, Carlo MD; Fusaro, Angela M. MD

Author Information
doi: 10.1097/01.EEM.0000453167.70028.e4
    Watch the progress of HR 4106 at

    The threat of medical liability continues to pressure medical providers to practice defensive medicine, which drives them to order tests for fear of litigation. That means billions of health care dollars are spent yearly on medically unnecessary tests because providers wrongly believe that this practice will prevent lawsuits.

    Congress members Andy Barr (R-KY) and Ami Bera (D-CA) recently introduced HR 4106, the Saving Lives, Saving Costs Act, which will protect physicians from medical malpractice litigation if they adhere to evidence-based clinical guidelines. Ideally, the amount of unnecessary testing and ultimately unnecessary costs would decrease if providers make decisions based solely on evidence-based principles, not fear of litigation.

    A safe harbor is a legal provision that provides liability protection as long as good faith is demonstrated. This act would protect a physician from malpractice liability if providers demonstrate they followed the relevant clinical practice guideline. These clinical practice guidelines would be submitted, maintained, and periodically updated by eligible professional organizations on behalf of the Secretary of Health and Human Services. Providers would obtain access to the guidelines on the Internet through the National Guideline Clearinghouse.

    No financial incentive is provided to physicians who abide by the clinical practice guidelines endorsed through HR 4106, at least not in the way the Emergency Medical Treatment and Labor Act and other regulatory statutes mandate compliance through penalties or exclusion from federal health care programs. It provides only a safe harbor of malpractice protection, which does not incentivize providers to utilize clinical practice guidelines. The cost-saving measure of the statute remains to be proven, but the protections should compel providers to order responsibly.

    HR 4106 appears to be the first federal malpractice statute proposed in Congress. The bill proposes to set a federal mechanism by which national standards of care are established. EMTALA was never intended to be a federal malpractice statute, though few would argue that it has significantly influenced how providers deliver care. This federal mechanism includes clinical practice guidelines, eligible professional organizations, and an Independent Medical Review Panel. The Secretary of Health and Human Services would deem the professional organizations eligible to submit clinical practice guidelines if HR 4106 passed, and would certify those members qualified to serve on the panel.

    The panel is composed of three members selected by both parties who are experts in the relevant field of practice. Panel members must be board certified by the American Board of Medical Specialties, and must have been actively practicing, teaching, or conducting patient-care research within two years. Panel members must be approved by their specialty society, and, when reasonable, be from the region of the case in question to account for geographical variation. Members of the panel are protected from civil liability based on the scope of their duties while serving on the panel.

    The panel will determine if the provider met the standard of care, and if not, whether the provider's negligence proximately caused the patient's injury. If the panel finds that the provider adhered to the standard of care, those findings raise the standard of proof for the plaintiff from a reasonable probability standard (roughly 51% likelihood) to a clear and convincing standard (roughly 75% likelihood), making it more difficult for the plaintiff to win the case in court. If the panel finds the provider did not meet the standard of care, such preliminary findings will not automatically constitute negligence or conclusive evidence of liability, but the panel's findings and opinions are admissible as evidence before subsequent court proceedings.

    Moving a malpractice case from state to federal court has several strategic implications. HR 4106 will not preempt or supersede any state or federal law that imposes greater procedural or substantive protections for health care providers. If your defense attorney recommends that you remove your case from state to federal court under HR 4106 and utilize its safe harbor provision, for example, the federal court would enforce your state's procedural protections (e.g., peer review protections). Few states currently have safe harbor laws, so removal to federal court would afford physicians substantially more litigation protection, generally speaking.

    We hold ourselves to a high standard as providers and members of professional societies. That standard is recognized as a national standard already. It seems reasonable to envelop that standard with federal protections in the form of clinical practice guidelines that we choose. What we must now do is make sure that clinicians — not the government or nonproviders — form the clinical practice guidelines, and that each specialty is responsible for forming its own practice guidelines with reasonable input from other relevant overlapping specialties.

    Do you have any input into this bill? Please let me know by writing to [email protected]. More importantly, let your local representatives know. Find all Congress members listed by state at

    Access the linksin EMN by reading this on our website or in our free iPad app, both available Comments?Write to us at[email protected].

    © 2014 by Lippincott Williams & Wilkins