CLIA-Waived Testing Explained

“Just What The Doctor Ordered”

Market Growth and Contributing Factors:

According to an article (#3104 “Drugs of Abuse Testing”) that appeared in Repertoire magazine (Edition: January 2009 – Vol 17 Number 01), pain management is one of the fastest growing users for Drugs of Abuse Point of Care Tests. With an increasing number of internists and anesthesiologists opening pain clinics and primary care and family practice physicians opting to treat patient pain in house instead of referring out the pain management opportunity is ever increasing. Pharmaceutical companies, feeling federal pressure, are even going so far as to encourage physicians to perform drug tests to monitor prescription compliance and aid in risk management. Point of Care tests are now also being seen as a revenue generator for physicians due to their high reimbursement potential. For further information please visit the source article http://www.repertoiremag.com/Article.asp?Id=3104

In a recent IVD Technology WebCast (held Thursday, March 26, 2009) James H. Nichols, PhD, DABCC, FACB and Professor of Pathology at Tufts University School of Medicine and Director, Clinical Chemistry at Baystate Health System indicated that the number of Waived labs increased from 20% to 63% of the 200,000 CLIA laboratories. Of these Waived labs, 45% were POL’s. According to his data, POCT is growing faster than any other segment of the diagnostic industry with an average growth rate of 14% a year. In 2007 POCT Immunoassay sales were at $1.6 Billion and they are estimated to hit $2.8 Billion by 2012. Of this, CLIA Waived is the fastest growing segment of this market due to its minimal lab regulations (i.e. exempt from many of the lab regulations that mandate device validation, operator training/competency, and continuous quality management and documentation, etc.).

In 2008, a study conducted by the Worldwide Marketing Research and Strategic Consultancy (WWMR, Inc.), indicated that with the increasingly chronic nature of many diseases the need for pain management has grown as well. With that the number of free-standing and university-based clinics in the US alone has increased from just 500 in 1998 to 2000 in 2008. Each of those clinics on average treats approximately 400 chronic pain patients per month. Over 70% of these patients are prescribed some form of opiate medication.

With the U.S. FDA (Food and Drug Administration) cracking down on the over-prescription or inappropriate use of at least 24 popular narcotics (such as various brand name opiates), physicians are coming under additional scrutiny. According to an article in the New York Times (“FDA to Place New Limits on Prescriptions of Narcotics”, February 9, 2009) in 2007 these 24 drugs had 21 million prescriptions written for them to 3.7 million patients. While these medications have been highly effective in the use of pain management, it is felt that doctors are also prescribing them far too heedlessly – for minor issues such as sprained ankles or wrists. There are several factors contributing to this: pharmaceutical marketing, doctors unfamiliar in recognizing potential for drug abuse, and physicians not being specialized in pain management.

 Why Are Doctor’s Testing?

 Simply put the main reason behind it is self-perseverance or a more direct way of putting it – CYA.

With an increase in drug abuse and overdoses, doctors are being considered also to blame. Disciplinary actions at state medical boards are being taken when prescriptions are given to patients who either clearly show signs of addiction or for whom the drugs are obviously inappropriate. Deaths caused by overdose of prescriptions drugs are on the rise and as a result one of the prescribing guidelines, indicated by the National Pain Foundation, is to evaluate patients for the risk of abuse before starting opioid therapy.

Physicians treating pain patients with opioids (i.e. morphine, oxycodone, oxymorphone, and fentanyl) are now following recommendations laid out by the American Academy of Pain Management (AAPM) who endorses the use of an Opioid Agreement and Contract with a patient. Drug testing is usually called for. Drug testing helps the doctor in evaluating the patient’s drug history as well as aide them in avoiding or minimizing a possible reaction to other medications or narcotics. The AAPM also published a comprehensive clinical practice guideline to assist physicians in prescribing opiate pain medications. In it, clinicians are advised to conduct a thorough medical history and assess the potential risk for substance abuse, misuse, or addiction. Regular physician visits, random drug tests, and written conditions, etc are among some of the recommendations. Running these inexpensive urine drug screens is an effective way for physicians to “document” that they are thinking about their patient’s potential for use of illicit substances PRIOR to writing the prescription.

In studies conducted among patients in a pain management setting, those considered to be non-abusers of prescriptions substances with prescription opioid agreements were still found to demonstrate significant use of illicit drugs such as marijuana and cocaine through random drug testing. Therefore, not demonstrating signs of abuse is not enough to warrant not testing prior to prescribing narcotics.

Physicians, not necessarily skilled in recognizing the signs for drug abuse or addiction and want to play it safe, are also being proactive and instituting drug testing as a regular part of their patient evaluation.

The tests are even used to monitor patients and their adherence to a pain management protocol of narcotics prescribed. Some patients sell off their prescriptions. Testing is sometimes used to determine if in fact the patient is taking their prescribed medications. It is suggested that regular monitoring is recommended for patients with chronic opioid therapy because the benefits of the medications are affected by changes in the underlying pain condition, coexisting disease, psychological or social circumstances, etc. Monitoring every 3 to 6 months is sufficient for those with a lower risk for adverse outcomes whereas patients that are at a risk for adverse events or a high risk for abuse should be monitored on a weekly basis.

Apart from the legal aspects of it all, doctors are now seeing this as a very profitable revenue generator for them with the reimbursements. 

What Is CLIA?

 Often we are asked by distributors why it is important for a test to be CLIA-Waived. Well to answer that question it is first best to explain what CLIA stands for. The Clinical Laboratory Improvement Amendments of 1988 specifies that laboratory requirements must be based on the complexity of the test performed. As a result they established provisions for categorizing a test as Waived.

If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.

Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.

 Do I Need A CLIA-Waived Test?

CLIA requirements do apply to entities that perform test on …”materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program. In these instances, the advantage of using a “CLIA Waived” test is that it “waives” you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).

CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets. However CLIA-Waived tests can still be sold to them as if they were not Waived at all. As distributors typically sell to multiple end user markets, having a selection of CLIA-Waived tests is advantageous as it avoids limiting their sales avenues.

Additional information on CLIA can be found at http://www.fda.gov/cdrh/clia/cliaWaived.html.

For state by state reimbursement fee schedule go to www.cms.hhs.gov.

How ALFA Can Help

At Alfa Scientific, our key area of focus is in Drugs of Abuse Testing.  As such, we have several “novel” products which would be of interest to any distributor competing in the Drugs of Abuse market. View our CLIA-Waived Products.

© Copyright  July 2009. This article may not be reproduced without prior written authorization from Alfa Scientific Designs, Inc.