For at least since the 1950s, clinical drug testing has been used as a diagnostic technique to detect the presence and/or absence of substances in the human body, providing law and health officials with valuable clinical information. Such uses included illicit drug screening in the military, federal and state crime lab-run death investigations, workplace drug testing, and in hospital emergency room settings/poison control. Blood was the primary matrix being tested for during this era, but the science of urine drug testing (UDTs) really only became feasible and practical in a lab setting after the discoveries of two very important test methods: thin layer chromatography in the 1960s and automated immunoassay in the 1970s.

Two notable events that helped introduce clinical drug testing to the private and government sectors were the military’s use of a UDT protocol in Vietnam and after a 1981 USS Nimitz aircraft crash, which exposed a prevalent illicit drug abuse problem in the U.S young military and mandated the use of a prevention protocol using UDT. These developments helped pave the way for a private toxicology lab industry now worth more than $3 billion that purports to provide health care practitioners with a prescription drug monitoring protocol and illicit drug deterrent. With opiate prescription drug abuse soaring to epidemic levels in the United States, and with both government and private insurance programs reimbursing labs well for their services, the private drug testing industry boomed exponentially over the past decade.

How Big Players shaped today’s market

This astronomical market growth begged a closer look by state OIG’s offices, Medicaid and Medicare fraud divisions. The results of the investigations into large players showed that much of the specimen volume from patients with government-funded health insurance was acquired through physician kickback schemes, clear violations of the Stark Law and Anti-kickback Statute.

Is there a need for a $3 billion/year industry to provide ancillary services you ask? Take a look at some of the facts that have helped keep this industry afloat.

• In 2012, physicians wrote 259 million prescriptions for painkillers, enough for every American adult to have a bottle of pills.
• Currently, 46 people die every day in the United States from a prescription painkiller overdose.
• Painkillers have turned into a $7.3 billion-per-year business.
• Pain pill overdose “epidemic” that cost 15,000 lives in the United States in 2008, up from 4,000 in 1999.
• Nearly half a million emergency department visits in 2009 were because of people misusing or abusing prescription painkillers.
• Non-medical use of prescription painkillers costs health insurers up to $72.5 billion annually.
• According to new data from the U.S. Centers for Disease Control and Prevention, painkiller overdoses accounted for almost 17,000 deaths in 2011.
• Opioid overdoses killed 9,869 Americans in 2012.

Unfortunately, today’s market has seen a huge discrepancy and decline in most state Medicaid programs as well as the private/commercial insurance sectors. The Center for Medicare and Medicaid Services (CMS) has evened the playing field for labs in the space by preventing free cups for physicians to perform and bill point-of-care testing, capping the amount of EIA testing that can be billed per UDT sample, and making stringent changes to their fee schedule. The net effect of all of the CMS changes is a lower reimbursement from the payers and far more stringent rules to prevent redundant and medically unnecessary testing from being performed by any given lab.

The noticeable reimbursement decline for these private labs is likely due to several factors, but most notable are Medicaid and/or Medicare fraud/kickback schemes, changes in the physician billing model, and a complete saturation of the toxicology lab space. CMS continues to severely restrict how much a lab can bill for a UDT test and how many tests can be ordered.

In my upcoming blog entries, I will take a closer look at what makes this industry so important and yet precarious and how the major players came to be, rise, and fall. I’ll also delve into some ways drug testing can still be utilized in a way that is financially rewarding for the private labs doing the work and yet still medically necessary and compliant for physicians who utilize drug testing protocols.

Samuel A. Thomas holds a medical school degree (M.B.B.S) and a master’s degree in Health Communication (MsHC) and is an active toxicology consultant on the GLG council. In the past 10 years, he has worked as a medical consultant, technical representative, chief certifying officer, and most recently as a sales director in the private toxicology market. Samuel deals with the business and sales side of toxicology lab testing day to day but also serves as a health communicator dealing with sociological and epidemiological impacts of prescription drug abuse. Samuel has an insider’s look at both the science and technology of drug testing, as well as it’s societal effects as a growing epidemic in the United States.