By Jeffrey C. Lerner, PhD, President and Chief Executive Officer, ECRI Institute
Cancer will be diagnosed in a third of Americans at some point in their lifetimes. The largest cohort, Baby Boomers, is in or entering their "Medicare years." But children and younger adults, as well as the oldest populations share a concern about the effectiveness, quality, and cost of cancer care. It's not just demographics that drive the need to take stock now. Let's consider some of the issues.
Our basic understanding of what cancer is–or more accurately, what cancers are–is in flux. As the framework of believing that cancers arise in organs appears inadequate, we are looking more to molecular changes in our biological systems. But based on what we know now, should clinicians, health system providers and payers be adjusting their models of patient care, including how that care is paid for, or is it too early to do this? With over 40,000 genetic tests available, so many of which are for cancer, there is good reason to believe that the healthcare delivery system is changing regardless of whether that is justified by what we can do with the results of these tests.
So let's step back and ask some fundamental questions about how the healthcare delivery system addresses our changing understanding of the biology and epidemiology of cancers.
The U.S. Food and Drug Administration (FDA) has long been the guardian for determining the safety and effectiveness of the drugs, medical devices, and many of the tests that enter the marketplace, but they are not alone given the regulatory structure that also relies on the Clinical Laboratory Improvement Amendments (CLIA) for many tests. They are now tasked with determining how this applies to precision medicine, that often ill-defined term that implies we know what targets we wish to hit and why. This is a complex issue as FDA sorts through ever more intricate data and claims from manufacturers. And there are new pressures on those manufacturers, too, to design studies and provide the data to FDA, but also to CMS and the rest of the payer community.
One thing leads to another in cancer care delivery, just as it does in cancer itself. Payers rely on the research produced by public institutions, like the National Cancer Institute, as well as the vast network of researchers in cancer centers, academic and community hospitals, research institutes, and in industry as well. The emphasis on precision medicine is not the only change in the research paradigm. Just as basic research is changing, so is healthcare delivery system research, particularly as the Patient Centered Outcomes Research Institute (PCORI), social media services, and advocacy organizations exert their influence. Patients are evermore a part of the research teams. They are becoming less “subjects” and more participants. But some of this is still in the early stages. Other influences on cancer care delivery include payment incentives to treat the “whole patient” across the continuum of care as all constituencies see cancer, increasingly, as a chronic rather than acute disease. The trend will only accelerate as value-based payment progresses through concepts like the Centers for Medicare & Medicaid Services (CMS) oncology bundle and as health systems and Accountable Care Organizations (ACOs) assume responsibility for treating populations, not just patients. And these are very diverse populations with different needs and behaviors. Factored in must be differences based on race, ethnicity, religion, and economic status in our multicultural nation.
Even our ability to measure quality, which is often thought of as an underdeveloped field, is further challenged when this needed to encompass the continuum of care. At present these broader quality measures don't exist.
How challenging it is all of this? If you were the head of a cancer program in a provider system, or the Chief Executive Officer of that system, how would you balance our new biological understandings, new cost pressures and new demands for ever better care for a larger and larger cancer cohort?
There is no single, simple answer to these many questions. ECRI Institute is bringing together a range of government and private sector agencies and organizations to get a start on these questions in a free leadership conference November 17-18, 2015 at the Omni Shoreham Hotel in Washington, DC.
We invite you and your colleagues to join us—not just to listen to the experts from our multi-stakeholder panels, but rather to contribute to the discussion. By joining us, you’ll gain new understandings that are necessary to improve our healthcare system's approach to cancer at a time when so much is in flux.
Your time will be well spent.
Jeffrey C. Lerner, PhD, is president and chief executive officer of ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care. He played a key role in setting the course for ECRI Institute's transition from its origins as a medical device evaluation laboratory to a broader health research organization that assesses clinical procedures and drug therapies in addition to medical devices, worldwide. ECRI Institute is designated as an Evidence-based Practice Center (EPC) by the U.S. Agency for Healthcare Research and Quality (AHRQ) and is listed as a Patient Safety Organization (PSO) by the U.S. Department of Health and Human Services.
AcademyHealth is proud to be a co-sponsor of the leadership conference. The ECRI Institute is an Organizational affiliate member of AcademyHealth. Organizational affiliate benefits include many opportunities for organizational visibility and networking, money-saving discounts on conference registrations and subscriptions, and advocacy for funding to support the field of health services research. To learn more about AcademyHealth membership, please click here or email membership@academyhealth.org.