Our Health Care Conundrum: Innovation vs. Access

Medical innovation advances while access to medical care declines. How can the U.S. drive innovation and expand access?

To me, a first step might be to get the government's purveyors of advancement and access working together. 

The Food and Drug Administration (FDA) evaluates the efficacy and safety of new interventions, but not their effectiveness in alternative clinical settings or cost implications.

The Centers for Medicare & Medicaid Services (CMS) has a mission "to ensure effective, up-to-date healthcare coverage and promote quality care for beneficiaries."

Why can't the FDA and CMS collaborate early on to ensure the clinical and reimbursement viability of new diagnostics and treatments?

I posed that question to Dr. Steven Gutman, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA, at a recent conference. He confirmed that the agencies currently work completely separately and that past efforts for collaboration have not been successful. Another overture is taking place currently, but he is unsure what the outcome might be.

As usual, the wheels of bureaucracy turn slowly, even in the face of evidence for change.

To fund biomedical innovation in 2007, the U.S. government provided $28 billion to the National Institutes of Health and $593 million to the National Science Foundation. 

At the same time, 47 million Americans, almost 16 percent of the population, did not have any healthcare coverage—which means they could not directly reap the benefits of medical advancements. 

Innovation is essential, but the high cost of new interventions is not always covered by a Medicare system that struggles for solvency.

Back in 1999, the RAND Corporation corporation recommended that "it would be beneficial, then, for policymakers to consider how their decisions may effect medical innovation indirectly through the effects of those decisions on private technology adoption, along with the more obvious direct effects of their decisions about coverage and payment under public health insurance programs."

A decade later, we're still not getting there. What's the answer?

Dr. Gutman provided a candid assessment at the conference. He said, "I have a perverse view that the health system will explode in three to four years and that will fix it."

No one, including Dr. Gutman, truly wants to see an explosion. But we could use a little fireworks. Maybe then our health system can break down more silos and reach a more acceptable equilibrium between innovation and access.

—Tom DeSanto