CLIA Waived Drugs of Abuse Screening

Edition: November 2005 - Vol 13 Number 11
Article#: 2259
Author: Repertoire

Simplicity is key. Physicians appreciate ease-of-use features and quick test results. In addition, using a test that not only offers these features, but also comes with a CLIA waived status, makes the product that much more accessible. Instant Technologies’ iCassette™, a rapid diagnostic screening test for drugs of abuse has recently been Clinical Laboratory Improvement Act (CLIA) waived.

Previously, drugs of abuse tests have been scarce in the medical supply community. Although the test itself is easy to demonstrate and administer; the puzzling series of CLIA exempt, moderately complex, and over the counter (OTC) labels attached to these tests have made them somewhat taboo.

Physician office and hospital settings have been dependent upon traditional laboratory analysis for drugs of abuse testing. The iCassette and other rapid drug screens offer a simple and fast method of screening. In addition to the obvious benefits of rapid testing, the use of CLIA waived drug screens allow the physician the opportunity to bill for these services, creating an important new revenue stream for the fiscally challenged physician office.

Drug screening for occupational reasons, such as pre-employment and random employee screening, has been CLIA exempt for many years. The clinical-use setting when using the tests to make a medical determination had been labeled as moderately complex until recently. As a result, the use of rapid tests in the physician, clinic and hospital market was minimized.

It’s no wonder distributor sales reps have not reached heavily into the drugs of abuse testing market. Aside from grasping the various levels of waived status for DOA testing (all situation dependent), selling physicians moderate tests can be an uphill battle in the current market.



CLIA waived drug screen

An exciting new entry into this CLIA waived market is the one-step iCassette. The iCassette is a FDA-cleared device that provides accurate results within five minutes, and requires a minimal urine specimen. Currently, the following six drug panels have CLIA waived status:

• Amphetamine (AMP)

• Cocaine (COC)

• Methamphetamine (mAMP)

• Opiate (2,000) (OPI)

• Marijuana (THC)

• Phencyclidine (PCP)



These six drugs can be combined into a wide variety of configurations from a single test cassette to a six-panel including all the drugs on one test.

The CLIA waived iCassette allows medical facilities and physicians the opportunity to administer a rapid point-of-care test as well as bill for reimbursement for the six waived drug tests.



New customers and market opportunities

New business opportunities aren’t far from home. Most distributor reps call on customers that would be interested in performing in-office drug screening using a CLIA waived test or are currently doing drug screening, but are sending it off to a reference lab, which can be expensive and take a long time to get results. “As sales reps become more comfortable with drug screening, they quickly find their sales increase,” says Scott A. Taillie, director of national accounts, Instant Technologies. Now that drug screens are becoming CLIA waived, the opportunities for reps should grow substantially.

Target customers for the iCassette drug test include many familiar settings:

• Pain Management Practices

• OB-GYN Practices and Clinics, especially high risk OB

• Emergency Rooms and Urgent Care Centers

• Internal Medicine, Family Practice and many others.




The CLIA waived iCassette provides these specialists with an invaluablesource of information about their patients. With the confusion of CLIA status removed, physicians are quick to bring this inexpensive time saving test in house. Knowing the drug or drug-free status of a patient can make a critical difference in effective treatment. It’s easy to see the many positive facets that the CLIA waived iCassette offers. This innovative product will facilitate quality patient care in a financially viable, fiscally responsible physician or hospital setting.