Randel Richner

Americans love technology—we will pay almost anything for something that makes communication faster, louder, brighter, or more colorful. We want quick changes and new models, new colors, new brands. In medicine, we demand the same—only the top doctors for our mothers, the best hospitals for our sons, the latest new treatments for our own shaky knees and leaky bladders. We expect it, we demand it. Yet, in medicine, we have a profound tension with balancing cost, risk and newness that translates into enormous policy and political challenges.

For medical technology innovators and physicians that invent and use these tools, we are in the middle of a “policy tug-of-war” that generally comes down to the level of risk we are willing to assume for new treatments. Further, the regulators of medicine assessing the level of risk to the public are besot with too much information vs. too little, with the politics of instant messaging and YouTube clearly influencing how they will ultimately disseminate and manage their decisions equitably.

Our appointed guardians of public safety and risk (the FDA) attempt to monitor new medical therapies and interventions and gather “evidence” knowing that their decisions will affect millions for years, as decisions are rarely intractable in health care. They carefully balance these decisions recognizing that practitioners must have some ability to freely practice to continue to encourage experimentation for the improvement of health in their individual patients.

Having said this, we are now finding that the purchaser is playing an extraordinary role in managing dissemination of care to control escalating costs of providing new innovative interventions. If managing risk through gathering patient evidence works, then of course the regulator (in both private and public sectors) assumes we should logically be able to control costs through the same process. Enter: Evidence-Based Medicine, Coverage with Evidence Requirements, Comparative Effectiveness, Outcomes Research, Cost-Effectiveness Studies, or whatever label you would like to apply to the same fundamental principle: Control Health Care Costs through managing access and volume of services.

As reported in USA Today, critics and proponents of “evidence-based medicine” agree on one thing: It is nearly impossible to remain current on all the latest evidence. Rapid medical innovations are often anecdotal, and when facing a life or death crisis we demand to have anything that would push the envelope to save a loved one. Nonetheless, the budget holders and regulators constantly struggle with maintaining a balance of enough information to allow rapid medical change while at the same time protecting the overall safety of the less-than-perfect medical solutions.

The true problem lies with the budget holder (The Centers for Medicare and Medicaid Services or private payers) using imperfect evidence as a process to control costs and access. Medical innovators are seen as attempting to quickly reach market commercialization at a “risk” to public safety if data are not provided without convincing results. By trying to move technology quickly to the marketplace, this is perceived as “cutting corners” as we negotiate based on the reality that no data will ever completely satisfy the answers related to risk once technology is available outside the investigational settings. We struggle with FDA safety requirements and then are further challenged by each budget stakeholder to provide more evidence as a ubiquitous means to control costs.

In my next post, I will write on Coverage with Too Many Conditions.

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