Comparative effectiveness research (CER) is definitely in the news. It may not be getting quite as much media coverage as meaningful use or insurance exchanges, but the Health Information Technology for Economic and Clinical Health (HITECH) Act and the Patient Protection and Affordable Care Act (PPACA) include more than $1 billion for future studies of different approaches to care for specific medical conditions. This level of new federal funding means that comparative effectiveness is intended to become serious business.
However, like other major initiatives of the economic stimulus and health reform laws, the evolution of CER is uncertain. Threats of Congressional defunding and judicial reversals will cast doubt over implementation for months to come. And although the Patient-Centered Outcomes Research Institute (PCORI)-the independent authority for implementing CER-is off to an impressively fast start in getting organized, it will need another year or two to develop a process for conducting research and disseminating results in a way that will create appropriate changes in clinical practice.
Should providers and their business partners adopt a wait-and-see attitude toward CER? I think not, for several reasons. The situation reminds me of “The Rest of the Story” features made famous by Paul Harvey, a legendary radio broadcaster, because headlines often mask important details that put a different spin on the news. The CER story is more complicated and more important than indicated by its coverage in the healthcare news. CER is here to stay, no matter what happens to its authorizing legislation, because it is an essential input to the performance improvement processes that will make the difference between success and failure for most providers and payers over the next few years.
ROADBLOCKS TO CER IMPLEMENTATION
As reporters and analysts rightly note, CER is not ready for widespread adoption because the foundations of valid research are not yet solid. Most of the existing scientific research on drugs and procedures compares a single intervention with a placebo. Controlled studies that compare the clinical effects of two or more approaches are rare, although they are becoming more common as researchers develop methodologies that appropriately incorporate the complexities of comparative research.
Of course, political pressures will be applied as good research begins to suggest that some clinical interventions are better than others, and many caregivers will continue traditional practices in spite of evidence that an alternative produces superior results. Ironically, the rapid and promising development of molecular medicine will give some credence to physicians who claim exemptions from evidence-based practices because “my patients are different.”
Indeed, comparative-effectiveness research is developing in parallel with a revolutionary shift from the 20th century clinical paradigm of one-size-fits-all to the more complex realm of personalized, predictive medicine that is significantly mediated by epigenetic factors. The underlying scientific challenges would be overwhelming-even if drug and device manufacturers were eager to “let the chips fall where they may” and clinicians were prepared to change practice patterns on the basis of solid new medical evidence.
THE CASE FOR CER IN SPITE OF REFORM
CER programs are solidly embedded in HITECH and PPACA because reform focused initially on reducing expenditures. Even a few Republicans joined Democrats in a quest to harness spending on medical services that did not measurably improve health. Comparative-effectiveness studies had bipartisan support as a tool for identifying and eliminating unproductive expenditures, giving clinicians the information they needed to make the best decisions. CER was also promoted as a valuable source of information that consumers could use to make intelligent choices when confronted with therapeutic options.
However, due to intense political battles that erupted in the summer of 2009-specifically, town hall meetings reacting to rumors of “federal death panels”-any cost-related applications of CER were explicitly prohibited as a price to be paid for passing the reform laws. PPACA states that the Centers for Medicare and Medicaid Services (CMS) cannot use any of PCORI's findings to make coverage decisions. If two treatments with different prices are equally effective, public health plans will not be allowed to favor the less-expensive therapy.