Medicolegal Issues

CER: Friend or Foe?


A key engine of healthcare reform is poised to accelerate, with the potential to improve clinical decision-making and care quality, curtail inappropriate utilization of ineffective treatments, and lower costs. Comparative-effectiveness research (CER), until now, has received relatively meager funding and has occupied a relatively low profile among policymakers, clinicians, and the public.

With a $1.1 billion injection from the American Recovery and Reinvestment Act of 2009 (better known as the “stimulus”) and dedicated funding mandated by the Affordable Care Act, a new national center dedicated to CER—the Patient-Centered Outcomes Research Institute (PCORI)—has recently released a draft of its national priorities and is mobilizing a national research agenda for CER.1

Demonized by critics as a prelude to coverage denials, healthcare rationing, and intrusion upon physicians’ clinical autonomy, CER is reconstituting its reputation as a non-coercive yet powerful tool to reduce uncertainty about which healthcare options work best for which patients, and to encourage adoption of care practices that are truly effective.

“I practice on weekends as a pediatric hospitalist, and it is still far too common to encounter a case for which we don’t have good, evidence-based guidance—such as whether surgery or medical management is best for a neurologically impaired child presenting with aspiration and gastroesophageal reflux disease,” says Patrick Conway, MD, MSc, SFHM, chief medical officer of the Center for Medicare & Medicaid Services (CMS) and director of its Office of Clinical Standards and Quality.

SHM strongly supported the creation of PCORI during the health reform debate, and hospitalists have important opportunities to be part of the nation’s CER agenda, as well as key beneficiaries of its results, according to Dr. Conway.

Efficacy vs. Effectiveness

While the traditional “gold standard” of clinical research is the randomized controlled trial, its focus on efficacy typically involves comparing some treatment to no treatment at all (a placebo), and requires highly controlled, ideal conditions, often with narrow patient-inclusion criteria. All of those requirements sacrifice generalizability to patients whom physicians encounter daily in clinical settings who often have multiple chronic conditions and comorbidities and might require multiple therapies, Dr. Conway says.

CER studies larger, more representative patient populations treated in real-world clinical circumstances, explains SHM Research Committee chairman David Meltzer, MD, PhD, FHM, who is a member of the PCORI’s Methodology Committee. “One of the big initial tasks of the PCORI is to produce a translation table of what research study designs—randomized controlled trials, head-to-head, observational studies, and others—can best answer which kinds of questions,” he says.

The PCORI’s ultimate goal, says Dr. Conway, is to enable better-informed decision-making between physicians and their patients by allowing for the “right treatments to the right patients at the right time.”

The Case for CER

The unrelenting reality of an unsustainable healthcare cost spiral that threatens to bankrupt the national economy might be changing the conversation about CER (see “PCORI: Built to Reject the Myth of Coercive Rationing,” at left). Add to that increasing gravitation by government and private insurers toward reimbursement models that reward providers for better outcomes, more efficient care, and evidence-based practices (and penalizes the opposite), and CER makes a lot of sense.

An estimated $158 billion to $226 billion in wasteful healthcare spending last year came from “subjecting patients to care that, according to sound science and the patients’ own preferences, cannot possibly help them—care rooted in outmoded habits, supply-driven behaviors, and ignoring science,” wrote former CMS administrator Donald Berwick, MD, MPP, and RAND researcher Andrew Hackbarth, MPhil.2

It appears as though physicians are becoming more receptive to their role as responsible stewards of finite healthcare resources, and are willing to abandon some common clinical practices that add little value to patient care when given credible evidence. In the recent Choosing Wisely campaign (, for example, nine medical specialty societies worked with the ABIM Foundation and Consumer Reports to publicize 45 tests and procedures—five from each society—that are commonly used in their field, but which evidence suggests might be unnecessary and inappropriate for many patients.

Physicians who in the past might have resisted traditional evidence-based guidelines as “cookie cutter” algorithms that “don’t apply to my particular patient” will find it harder to dismiss CER findings on that basis, Dr. Meltzer notes, because CER is designed at the outset to be relevant to specific subsets of patients in actual clinical settings.

Nevertheless, incentives will be required to drive rapid and widespread adoption of CER findings, Dr. Conway believes.

“Just creating evidence doesn’t create change,” he says. “Cycle time from research finding to implementation matters, and the typical 17 years [time lag from bench to bedside] is not going to cut it. We need to work with clinicians and patients to take new findings and implement them sooner.”

CMS already has selected some evidence-based process and outcome metrics for its value-based purchasing program. “As CER identifies new evidence-based process and outcome metrics, we could incorporate them,” Dr. Conway adds.

Private insurers could use CER findings when making coverage decisions for their health plans. By law, CMS is obligated to provide coverage to Medicare beneficiaries for healthcare services that are “reasonable and necessary,” and cannot exclude coverage based on the cost of services.

“CMS could use CER findings to make coverage determinations based on ineffectiveness, when there is compelling evidence that a service is ‘not reasonable and necessary,’” Dr. Conway states.

HM Opportunity

Dr. Conway says hospitalists are uniquely poised to seek funding for CER that builds upon several critically important topics, such as examining the best discharge planning processes and transition-of-care protocols for certain types of patients. Dr. Meltzer, who is chief of the section of hospital medicine at University of Chicago, says he is seeking funding for a study of alternative transfusion thresholds for older patients with anemia across different levels of patients’ functional status.

“That’s the type of patient-centered study that CER is especially equipped to handle,” Dr. Meltzer says.

CER promises to produce important evidence for clinical questions that hospitalists struggle with day to day, Dr. Conway says. “Hospitalists should take the lead in developing effective ways to disseminate those findings, to teach medical trainees about them, and to spearhead CER-based QI [quality improvement] implementation and tracking efforts at their institutions,” he adds.

Christopher Guadagnino is a freelance medical writer in Philadelphia.

PCORI: Built to Reject the Myth of Coercive Rationing

The Patient-Centered Outcome Research Institute, or PCORI, has been carefully designed as an independent body with its own board to allay concerns over it becoming a rationing board that dictates treatment options or denies care that is too costly.

Unlike in Great Britain, whose National Institute for Health and Clinical Excellence (NICE) factors cost-effectiveness into its recommendations whether the National Health Service should cover new therapies, PCORI is proscribed by law from developing or employing such a measure, or from permitting its funded research to mandate coverage or reimbursement policies for any public or private payor.

“One of the things that the PCORI has to do is simply promote the notion that comparative-effectiveness research is a good model for research,” PCORI executive director Joe V. Selby, MD, MPH, told Health Affairs.3 Even with overt cost-effectiveness analysis left out of the equation, he noted, “It’s much better for us to generate good comparative evidence on outcomes, and let others think about the findings.”

As further evidence of “CER, American-style,” PCORI’s agenda is set by private stakeholders with input from physicians and other clinicians, researchers, hospitals, consumers, industry, payors, and governmental agencies. It will focus on common and widespread conditions, particularly chronic disease, and will pay close attention to reducing disparities in health outcomes among patient subpopulations.

The agency deliberately was named and structured to reflect the importance of patient preferences—toward the nature of research that will be conducted, the outcomes that are most important to them, and in the manner in which they can discuss the best treatment decisions with their physicians.


  1. Patient-Centered Outcome Research Institute. Draft National Priorities for Research and Research Agenda, Version 1. Patient-Centered Outcome Research Institute website. Available at: Accessed April 15, 2012.
  2. Berwick DM, Hackbarth AD. Eliminating waste in U.S. health care. Journal of the American Medical Association website. Available at: Accessed April 15, 2012.
  3. Selby JV. The researcher-in-chief at the Patient-Centered Outcomes Research Institute. Inverview by Susan Dentzer. Health Aff (Millwood). 2011;30(12):2252-2258.

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