Article Review (4): ICD-10 Classification and FDA approval

“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.

2 thoughts on “Article Review (4): ICD-10 Classification and FDA approval

  1. In response to “It’s Broke. Fix it,” the class discussed whether or not we believed the government should review medical devices directly. Since the FDA is a government agency under the Executive Branch, it is controlled by a system of checks and balances not found in European countries. While the independent, certified groups that review medical devices in Europe may compete with each other, they still carefully review the devices to avoid harming patients and welcoming lawsuits. We also discussed whether or not we thought the regulatory burden in the U.S. is hindering us from developing revolutionary devices. An example was given regarding horse medication that is not FDA approved but is still commonly used because of its effectiveness. The process of gaining FDA approval is not actively pursued for this medication because of the price increase that would follow.

    In response to “70,000 Ways to Classify Ailments,” the class discussed the large amount of codes added to the ICD-10 code set and whether or not there are too many. We concluded that some of the codes, for instance “forced landing of spacecraft, injuring occupant,” would not be used often enough to be relevant. We also discussed the concept of a value-based payment system where clinicians would get paid differently based on the complexity of their cases. We agreed that this would be unfair and difficult to determine/regulate. Finally, we talked about the possibility of the ICD-10 codes being used by robots/AI to successfully diagnose patients. While this would be a revolutionary breakthrough, the technology is nowhere close to this caliber yet. Computers can contribute to a diagnosis and make it easier, but they cannot do so on their own.

  2. The one item I was wondering about (not sure I understood the student’s comment correctly myself) — I think the comment was more that the European system is more subject to checks and balances, since the independent contractors need to compete against each other. Conversely, the FDA is not subject to checks and balances, because who checks the FDA?

    Did I misunderstand this? Anybody care to comment?

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