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EDITOR'S PAGE

It wouldn’t be surprising to learn that more than a few IVD manufacturers were a bit disconcerted by an article that appeared recently on the Web site of the Wall Street Journal. The article was written by Forrest, IL, physician Benjamin Brewer, MD, in which he explained that many of his patients avoid getting recommended screening tests primarily because they know very little about IVDs and do not see the benefits that IVDs can offer to their health.

Unfortunately, the patient complaints and misconceptions described by Brewer are all too common. According to the WSJ article, patients avoid getting tested because of the expense, inconvenience, and perceived discomfort they associate with IVDs. Some patients think that early detection of diseases does not work, while others avoid tests because of their frustration with and fear of false positives.

Brewer also described the challenges that he faces in educating his patients about IVDs and encouraging them to get tested, equating his efforts to being a salesman. Brewer says that the absence of proper insurance coverage for IVD testing is also an incentive for patients to avoid getting tested.

As discouraging as this single physician’s experiences might seem, certain legislative developments have emerged, which may eventually lead to changes in how patients view IVDs. Last month in the U.S. House of Representatives, Rep. Michael Ferguson (R–NJ), Rep. Phil English (R–PA), Rep. Mike Thompson (D–IL), and Rep. Bobby Rush (D–IL) introduced the bipartisan Advanced Laboratory Diagnostics Act of 2006. This bill proposes major reforms to Medicare reimbursement policies for IVDs that currently discourage the development and adoption of new clinical IVDs.

For example, the bill aims to establish a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests. This project is designed to reflect more appropriately the value of molecular diagnostics to patient care management, their potential to reduce long-term healthcare costs, and their ability to improve overall healthcare efficiencies. The bill also intends to improve current processes for obtaining adequate reimbursement for new clinical IVDs, provide more transparency with respect to Medicare reimbursement decisions, and afford timely correction of historic payment errors that often lead to inadequate payment. (The full text of the bill can be accessed via the following Web site: http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=109_cong_bills&docid=f:h5369ih.txt.pdf.)

IVD manufacturers should not stand on the sidelines and hope that this bill passes. For starters, manufacturers should make concerted efforts to lobby their congressmen to support and pass the aforementioned act. With such potential changes on the horizon that may affect the future of the IVD industry, the industry has an opportunity to dictate the direction and extent of such changes, but only if it gets actively involved in making them happen.