IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target for government and private payers, along with federal investigators.
The news cycle of the past 60 days makes up the intelligence briefings in this issue. Our lead story deals with recent actions by the federal Food and Drug Administration (FDA) to put pharmacogenetics testing labs on notice that they must follow federal regulations and guidelines. You’ll read about the confusing elements of the agency’s actions and why some lab industry experts believe the FDA is overstepping its existing regulatory authority.
Many pathologists use companion diagnostic tests, particularly to diagnose cancer patients and guide physicians as they make treatment decisions. Thus, the FDA’s unexpected actions to warn labs performing pharmacogenetics (PGx) tests to comply with appropriate laws and regulations is a disruption to the PGx market. It also increases the risk that a lab and its pathologists can be investigated and sanctioned for non-compliance.
Another negative news story for pathology involves Anthem, Inc. and its plan to cut anatomic pathology professional component (PC) prices by 50% to 70% for many pathology CPT codes. Anthem is also shifting anatomic pathology (AP) contracts from its professional services division to its ancillary services division. Multiple pathology consultants interviewed by The Dark Report concur that this will disrupt long-standing local physician-pathologist relationships. They say these fee cuts also have the potential to affect patient care negatively.
Probably the most unusual bad news story for pathology recently is the arrest and indictment of an Arkansas pathologist who worked for a Veterans Administration hospital in that state. He now faces three counts of involuntary manslaughter, along with 28 other criminal counts. He is accused of working while under the influence of alcohol and drugs.
These different bad news stories also demonstrate that the pathology profession lacks effective public communications. There is no credible, recognized entity or individual who can speak on behalf of pathologists when reporters call.