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45th Annual Conference of the ACLM

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45th Annual Conference of the ACLM
The annual conference of the American College of Legal Medicine (ACLM) brought together well over 400 practitioners with dual degrees in law and medicine or dentistry to discuss the most current legal and legislative trends that impact the practice of medicine. Three themes were of particular interest: (1) the differing opinions on medical malpractice legislation at both the federal and state level, (2) the efforts of law makers to encourage a more benevolent healthcare environment by enacting legislation that safeguards apologies by physicians when errors are made, and (3) a bevy of high-tech devices that physicians use to expedite their work but that carry potential liabilities and infractions of security and privacy laws.

Considerable discussion focused on the fundamental differences in medical malpractice liability from the physician's vs the lawyer's perspective. Although the majority of attendees have degrees in both areas, they more commonly practice medicine over law. Miles J. Zaremski, attorney and chair of the American Bar Association (ABA) Standing Committee on Medical Professional Liability, presented a summary and analysis of the state laws that have been enacted to limit the amount an injured patient can recover for noneconomic damages in medical malpractice suits, ie, those damages awarded on the basis of pain and suffering. Supporters of this approach, including the American Medical Association (AMA), argue that placing caps on these awards will lead to a reduction in doctors' malpractice insurance premiums.

According to Zaremski, the ABA strongly refutes this contention and argues that "neither empirical data nor experience with tort reform efforts within the states in the past have shown any established link between limiting non-economic damages and the affordability of malpractice insurance policies." Furthermore, many of the states that the AMA has listed as "in crisis" have already enacted caps on noneconomic damage awards ( Table ), which Zaremski says challenges the AMA's contention that states are "in crisis" or "showing problem signs."

Proposed federal legislation introduced by Senators Ensign (R-NV) and Gregg (R-NH) would provide for comprehensive medical liability reform. The HEALTH Act of 2005 (S.354) – an acronym for Help Efficient, Accessible, Low Cost, Timely Healthcare – that saw discussion in the last Congress (2003-2004) with new legislation introducing in early 2005, offers comprehensive change. It would encourage a speedy resolution of claims by requiring that healthcare lawsuits be filed no later than 3 years after the date of injury. The bill applies to all healthcare providers, a healthcare organization, or the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product in which the claimant alleges a healthcare liability claim based upon the provision of, use of, or payment for (or failure to provide, use, or pay for) healthcare services or medical products.

The bill would set no limits on economic damages for the patient; however, noneconomic damages would set a hard cap at $250,000, a provision that would preempt existing state laws with specifications for damages. Punitive damages (those imposed as punishment for the acts) would be set at the greater of 2 times economic damages or $250,000. To prevail on an award for punitive damages, the claimant must prove by clear and convincing evidence that the acts of the defendant showed malicious intent to injure or there was a deliberate failure to act. Past or current healthcare expenses would be paid at the time of the judgment; however, future damages, if more than $50,000, could be paid over time.

The bill would also limit an attorney's contingency fee recovery. Customarily, plaintiffs' attorneys receive 30% to 40% of the award; however, the HEALTH Act of 2005 would apply a sliding scale as follows: 40% of the first $50,000; 33.3% of the next $50,000; 25% of the next $500,000; and then 15% of any amount over $600,000.

Unique to the legislation is the requirement of an "expert witness" rule whereby experts on both sides must be appropriately credentialed and experienced with the standard of care in the case. The standard of care varies to a modest degree by state law and practice area; however, establishing the standard of care and whether it has been breached in connection with the harm alleged is the central point in every medical negligence lawsuit.

Opinions by conference attendees varied considerably as to whether federal legislation for malpractice liability would be enacted this year, noting that considerable movement in this area is being made on the state level.

Every discussion of medical errors and malpractice liability includes, to some degree, at least a mention of the 1999 Institute of Medicine's (IOM) report, To Err is Human . In it, the IOM reported that 44,000-98,000 patients die each year as a result of "medical error" (eg, medication errors, surgical errors, missed diagnoses) at an estimated cost to the US economy of $17 - $29 billion.

Robert M. Wachter, MD, Professor of Medicine, Chief of the Medical Service at University of California, San Francisco, and national leader in the field of medical errors and patient safety, believes the report provides opportunities for change, but that much remains to be done. He compares the IOM report to the discovery of AIDS in 1981 and the SARS epidemic in 2003 and poses the question, "How did medical care get so unsafe?" According to Wachter, as progress in healthcare rendered care more dangerous, 4 main forces limited the ability to answer the challenge: (1) an outdated mental model for medical mistakes, (2) collective inattention to patient safety, (3) a reimbursement system that provided no incentives for safety, and (4) a fragmented organizational structure. "There was no incentive to talk about errors, there were no hospitals with billboards that said, 'we kill fewer patients than the hospitals down the road,'" says Wachter. "The discussion of medical errors essentially went under radar until the IOM report."

Wachter provides a "report card" of what's been done to reduce medical errors, with regulations receiving the highest grade of A-minus. Wachter believes the most important driver in patient safety is the Joint Commission On Accreditation of Hospital Organizations (JCAHO) because the regulations cut through a lot of debate that would still be going on. "When the Chinese restaurant reads back your order to make sure they got it correctly, yet I can call up and order drugs that can kill someone and a nurse doesn't read it back to me for accuracy, you have to stop and think if you're taking all the steps you can to ensure patient safety." Alternatively, he gives error-reporting systems a grade of C primarily because there are few efforts to actually turn what is learned from the reports into something that educates people. "Reporting systems are fine," says Wachter, "just figure out something useful to do with the information."

Of all the efforts reviewed, Wachter gives the malpractice system and other vehicles for accountability a grade of D+, the lowest grade of all. He believes the legal system does a poor job of compensating patients, punishing the negligent, and protecting the innocent. Furthermore, a system that constantly applies blame and finger-pointing leaves physicians demoralized and distrustful. This often leads to access problems in many areas of the country. "While there are some bad doctors," says Wachter, "we haven't really figured out how to deal with poor performers."

Finally, on work force issues, to which he assigns a grade of B, Wachter feels some progress has been made. "In nursing, there are some data that support the premise that the nurse-to-patient ratio does matter and there is legislation that addresses this, which should lead to some important new policies." He also points to enforcement of limiting residents' duty hours as a measure that will ultimately improve safety by decreasing fatigue among trainees.

Ila S. Rothschild, MA, JD, adjunct professor at Loyola University School of Law, presented an overview of new federal legislation related to patient safety. One, the Patient Safety and Quality Improvement Act (S.720), saw passage in the last Congress with new legislation introduced in early 2005. The legislation encourages healthcare providers to voluntarily report errors and "near misses" to patient safety organizations (PSO) that would in turn use the data to develop recommendations and promote standards to avoid future medical errors. PSOs will either be private or public organizations that are tasked with analyzing reported data and developing strategic guidance to give back to providers on how to improve patient safety and quality of care.

According to Rothschild, the legislation would establish a federal evidentiary privilege and confidentiality protection to promote the voluntary reporting of medical errors. The belief is that this nonpunitive environment will foster the sharing of medical errors because healthcare providers will be less concerned about their admission of wrongdoing being used in court against them. This was welcomed news, according to David M. Benjamin, PhD, Adjunct Assistant Professor, Department of Pharmacology & Experimental Therapeutics at Tufts University School of Medicine, an expert in reducing medical errors. He advocates for a conscious shift from the blame game to one of corrective knowledge.

Under the Patient Safety and Quality Improvement Act, Benjamin says the "most promising initiative is the legal privilege of the reporting of medical errors to a PSO. You can report to a PSO and you don't have to worry about having any of that information stuck under your nose at trial as evidence of liability. It will unlock the system and enable us to find the root of the problem and assure that it doesn't happen again. You've got to come out of the closet and tell the patient actually what happened."

According to Benjamin, patients sue their physicians primarily because of communication issues. "Patients feel deserted by their physicians or devalued," say Benjamin. Some of the risk management strategies Benjamin suggests for preventing lawsuits are good documentation ("never alter a patient's chart; once you do, you're credibility becomes zero"), be professional and courteous at all times, provide an adequate informed consent and instructions to be contacted at the first signs of an adverse event, and project a realistic outcome ("don't say it won't hurt when you know it will; tell the patient that it may hurt and we will manage the pain").

"Develop a philosophy of patient safety," says Benjamin. To do this, his advice is to recognize the patient's needs, be alert for better ways of administering care, investigate all instances of "near misses," re-engineer faulty medication delivery systems to reduce the risk of errors, and focus on the system, not the person who has committed an error. "The focus should be on doing it correctly and setting up systems that do not promote errors."

According to Benjamin, the JCAHO has also been very instrumental in promoting patient safety. JCAHO requires that accredited hospitals report sentinel events. Why sentinel events? Because, according to Benjamin, they signal the need for immediate investigation and response. The JCAHO's definition of a sentinel event is ". . . any patient death, paralysis, coma or other major loss of function associated with a medication error" (original definition in January 1996), and then later, ". . . an unexpected occurrence involving death or serious physical or psychological injury or risk thereof." A critical corrective step is the performance of a "Root Cause Analysis," a system that "does not point fingers but rather identifies the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event" says Benjamin.

Benjamin also stated that the US Pharmacopoeia (USP) has established a nationwide program for reporting medication errors -- the MedMARx System -- where errors are categorized according to severity and outcome. The lowest level of severity is Category A, signifying that "circumstances can cause an error," and the highest is Category I -- "resulted in patient death." Hospitals pay a fee to join the reporting program.

Medical informatics is a growing field and partly represents the growing trend and usage of high-tech devices and computer systems to aid in healthcare delivery. The primary concern with new technologies is maintaining the privacy and accuracy of information. Jack W. Synder, MD, JD, PhD, Associate Director of the National Library of Medicine of the National Institutes of Health, spoke on the federal government's goals and strategies for furthering the use of important technologies while maintaining confidentiality and security of data, especially as it applies to the now familiar Health Insurance Portability and Accountability Act (HIPAA).

According to Synder, from the federal government's perspective, the goals and strategies for the use of medical information in cyberspace are to avoid errors, improve use of resources, accelerate infusion of knowledge, strengthen private and public protection, and promote public health and preparedness. Medical informatics involves a consensus between the federal government and the private sector. The belief, and there are "some data to support this contention," says Synder, is that standardizing the electronic use of medical data and information "would save about 5% annually of the $1.66 trillion spent on healthcare delivery in this country in 2003."

Although few studies have looked at clinicians' actual satisfaction with the use of electronic medical records (EMR), Synder points to 1 small study that provides a starting point. In a study of emergency department physicians and nurses at a large urban teaching hospital after implementation of an EMR system, clinicians were questioned as to: (1) computer background and experience, (2) perceptions regarding EMR use, and (3) concerns about impact upon quality of patient care. Those who responded to the study reported finding that the EMR system was easy to use, and they were generally satisfied with the impact on their work. The respondents, however, noted that it did not appear that the EMR system had any impact on the quality of patient care. Some of the concerns they voiced were confusion with the flow through data screens and concerns about patient confidentiality and the time it took to complete the entries. Nurses, but not doctors, reported that they were able to complete their work much more quickly.

According to Synder, the barriers to the use of EMR are many. First, Congress decided not to fund legislation calling for $50 million to establish a new federal office to oversee medical informatics and the use of EMR. "There's still a perception out there that sufficient compatibility with systems does not exist," says Synder. Another very real barrier is the concern of practitioners with limited, small or specialized practices who fear obsolescence -- the idea that any device or technology they learn today will be outdated in the near future and they cannot budget for ever-changing technology. A concern for safeguarding patient information has been voiced with some concession that there are "many difficulties with preventing manipulation" of the medical records. There are no real incentives to use EMR, including financial incentives.

Closer to the home front, hand-held medical computers appear to be "taking the medical scene by storm," says Kenneth A. De Ville, JD, PhD, of counsel to a law firm in Raleigh, North Carolina and published expert in the area of medical malpractice and bioethics. According to American Medical News , in January 2001, 20% of the country's physicians used personal hand-held computers (commonly referred to as PDAs), whereas by January 2005, the rate had climbed to 40%. A wide range of software is being used, including scheduling programs, billing and charge-capture programs, medical reference software, data management programs, and decision support programs. According to De Ville, some opine that the use of medical technology to support the physician's day-to-day practice will have a bigger impact on the delivery of healthcare than managed care.

Of the software available, the most problematic are the decision support programs. These programs provide diagnosis and treatment recommendations using medication algorithms, decision trees, outcomes data, and evidence-based guidelines. Their usage is fairly straightforward: the physician enters the pertinent patient data and the program generates a diagnosis. Many argue that it is impossible to develop a computerized system that could even approach the diagnostic ability of the human physician; however, De Ville emphasizes that the devices need "not be infallible to provide benefit to patient and society if they serve to guide a clinician's thinking through a problem or momentarily spur a physician to recall a set of details about a diagnosis or set of symptoms." Of all the devices and software available, the decision support programs pose the greatest liability if relied upon erroneously.

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