Category: Michael J. Young

Capturing Value in Advanced Medical Imaging

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On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Ethics and Oversight in Recombinant Genetic Research

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By Michael Young

In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule.  These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules.  Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974.  The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).

Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”

The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Read More

Medical Advice and the Limits of Therapeutic Influence

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By Michael Young

It is estimated that 500,000 patients are discharged from U.S. hospitals against the recommendations of medical staff each year.  This category of discharges, dubbed discharges against medical advice (DAMA), encompasses cases in which patients request to be discharged in spite of countervailing medical counsel to remain hospitalized.  Despite safeguards that exist to ensure that patients are adequately informed and competent to make such decisions, these cases can be ethically challenging for practitioners who may struggle to balance their commitments to patient-centered care with their impulse to accomplish what is in their view best for a patient’s health.

Writing in the most recent issue of JAMA, Alfandre et al. contend that “the term [‘discharge against medical advice’] is an anachronism that has outlived its usefulness in an era of patient-centered care.”  They argue that the concept and category of DAMA “sends the undesirable message that physicians discount patients’ values in clinical decision making.  Accepting an informed patient’s values and preferences, even when they do not appear to coincide with commonly accepted notions of good decisions about health, is always part of patient-centered care.”  The driving assumption here seems to be that if physicians genuinely include patients’ interests and values in their assessments, then the possibility of “discharge against medical advice” is ruled out ab initio, since any medical advice issued would necessarily encapsulate and reflect patients’ preferences.  They therefore propose that “[f]or a profession accountable to the public and committed to patient-centered care, continued use of the discharged against medical advice designation is clinically and ethically problematic.”

While abandoning DAMA procedures may well augment patients’ sense of acceptance among medical providers and reduce deleterious effects on therapeutic relationships that may stem from having to sign DAMA forms, it leaves relatively unaddressed the broader question of how to mitigate health risks patients may experience following medically premature or unplanned discharge.  Alfandre and Schumann’s robust interpretation of patient-centeredness also raises the question of how to handle situations in which patients refuse medically appropriate discharge.  On this interpretation, can the ideal of patient-centered care be squared with concerns for optimizing the equity and efficiency of resource allocations more broadly?

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Disruptive Innovation and the Rise of the Retail Clinic

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By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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Mental Health in the Intensive Care Unit: The Need for Early Intervention

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By Michael J. Young

A prospective cohort study recently published in the New England Journal of Medicine adds to a growing body of research illuminating the neurocognitive sequelae of critical illness requiring intensive care.  Researchers reported that “one out of four patients [treated in the ICU] had cognitive impairment 12 months after critical illness that was similar in severity to that of patients with mild Alzheimer’s disease, and one out of three had impairment typically associated with moderate traumatic brain injury.”  They underscore the possible role of delirium – a syndrome of disturbed consciousness commonly seen in critically ill patients treated in the ICU – in contributing to downstream cognitive impairments.  More broadly, these findings prompt intensivists to rethink the relative priority assigned to the mental health needs of patients during ICU stays.

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Improving Outcomes by Empowering Patients: The Empirical Case for Patient-Centered Care

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By Michael Young

As healthcare institutions work to meet the triple aim of reducing healthcare costs while improving quality of care and population-wide health, efforts to expand the role of patient involvement in clinical decision making have gained appreciable momentum.  Interest in increasing patient participation in clinical decision making and goal setting is premised in large part on the notion that greater patient involvement can improve health outcomes by ensuring that treatment plans align with patients’ interests, abilities and sociocultural contexts.  A recent study published in the Journal of Personality and Social Psychology adds to the growing body of empirical research supporting these efforts, suggesting that the very act of allowing patients to choose between treatment alternatives can augment the efficacy of treatment by enhancing patients’ sense of personal control.  By giving patients more opportunities to exercise autonomy at times when many are inclined to perceive their circumstances as well beyond their influence, healthcare providers can help to restore patients’ sense of self-governance and optimize patients’ perceptions of their situations and the medical care they receive.

The idea that empowering patients to choose between treatment options might itself contribute to better health outcomes invites clinicians to rethink how to approach formulating and conveying treatment plans to patients.  Whereas traditionally some clinicians might have conceptualized their roles as experts whose responsibility is to design therapeutic plans on behalf of their patients, the principle of patient-centered care encourages providers to regard patients as associates in developing shared plans to advance and sustain health.  This paradigm of care and the distinctive stance that it demands of clinicians is poetically captured by a letter penned by novelist John Steinbeck to his personal physician, in which he incisively relates “What do I want in a doctor? Perhaps more than anything else—a friend with special knowledge.”

Effectively transitioning to this horizontal model of therapeutic relationships will require careful planning and implementation.  Indeed, boosting patient involvement in clinical decision making may prove increasingly elusive as medical knowledge continues to grow exponentially complex in substance and scope.  As such, to realize the promises of patient-centered care, clinicians should work to develop concrete plans and quantifiable measures to operationalize the ideal of patient engagement within the context of day-to-day practice.  As a first step in this direction, healthcare providers might consider ways to deliver complex biomedical knowledge to patients and surrogates in ways that are more accessible, timely and actionable.  By coupling enhancements in patient education with efforts to promote patient involvement in clinical decision making, clinicians can play a pivotal role in maximizing the efficacy of healthcare innovations and delivery systems of the future.

Coupling Genetic Counseling to Test Coverage

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By Michael Young

As debates surrounding genetic patent rights begin to settle, new questions and disputes have started to emerge around insurance coverage for genetic testing.  For the first time, a U.S. health insurance provider (Cigna) has decided to require evaluation by an American Board of Medical Genetics or American Board of Genetic Counseling certified counselor before covering the costs of genetic testing, including genetic tests for susceptibility to breast and ovarian cancer (e.g., BRCA1 and BRCA2).  Cigna specifies in its new coverage policy statement, which goes into effect on September 15, 2013, that coverage for such testing will require recommendation by a certified genetic counselor based on pre-test individual evaluation, pedigree analysis, and intent to engage in post-test counseling.

By mandating genetic counseling prior to testing, this requirement aims to reduce unnecessary tests and to increase the efficiency and efficacy of health risk management and service delivery. Earlier this week, however, the American Society of Clinical Oncology (ASCO) took aim at Cigna’s policy, claiming that it can “negatively impact the care of cancer patients by serving as a barrier to the appropriate use of genetic testing services.”  At least four key considerations appear to underpin ASCO’s apprehensions about Cigna’s new policy.

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