“It’s Broke. Fix It” by Alex Tabarrok, The Wall Street Journal, 8-12-2014 (book review for “Innovation Breakdown” by J.V. Gulfo, Post Hill, 2014)
Article: “70,000 Ways to Classify Ailments” by Melinda Beck. The Wall Street Journal, 9-27-2015
Summary prepared by Michael Lastinger for discussion on 11-03-16:
The first article, “It’s Broke. Fix it.” describes the difficulties companies often face when
seeking FDA approval of medical devices. The author makes an example of a company called MELA Sciences that created MelaFind, an optical device capable of scanning potential melanomas and determining whether or not they were cancerous. Under the leadership of Dr. Joseph Gulfo, the company gained FDA approval to conduct a clinical trial, which produced positive results. Unfortunately, the FDA’s Center for Devices and Radiological Health appointed a new director who raised various questions about MelaFind. After the release of a public review by the FDA saying that the device could cause harm, MELA Sciences lost many investors. Dr. Gulfo fought back and finally gained FDA approval for MelaFind. The process was surprisingly faster and easier in Europe with MelaFind gaining approval after just 5 months.
In the second article, “70,000 Ways to Classify Ailments,” the author discusses the pros and cons of the new set of diagnostic codes, called ICD-10, to be used by doctors and hospitals to describe illnesses and injuries. With rapid medical and technological advances over the last few decades, more specific codes were needed to differentiate diseases, injuries, and other ailments. This latest version of the International Classification of Diseases has expanded from 14,000 codes to 70,000. In order to get paid, doctors must submit these diagnostic codes along with separate procedure codes describing the services performed. Insurance companies and other healthcare providers use these codes to determine if procedures were medically necessary and whether or not reimbursements will be issued. Although the transition has been really expensive, the ICD-10 codes will provide more detailed patient data that will also be useful for research.