Integrating Clinical Labs into the Substance Abuse Treatment Program: Lots of Clamor Over Urinating in Cups

These programs yearn for ways to restore the revenue stream generated by urinalysis. For a conscious living program, lost income often means the difference between profitability and breakeven. For more comprehensive programs, lost income can hamper their ability to expand or provide scholarships to those who cannot afford medical expenses. Regardless of their specific goals, our clients are amazed and anxious in the regulating minefields that await them; especially because their lab consultants (read "reagent salespeople") make the process sound very simple.

Until about ten months ago, many drug use programs and the conscious living program provided relief under the Clinical Laboratory Improvement Amendment ("CLIA") and generated significant income from urinalysis given right in the program office or a drunken living facility. Providers who carry out tests that are released by CLIA must only comply with the recommendations of the test manufacturers, and are free of CLIA regulations and the need for clinical laboratory licenses under Florida law. These days the urinals released by CLIA don't generate much income.

To replace their lost income, many programs try to provide urinalysis with moderate and high complexity that is not released from CLIA, and for this the program requires a clinical laboratory license. There are two basic types of laboratory licenses under Florida law: "exclusive use" and "independent."

The "exclusive use" license is for laboratories operated by doctors, osteopaths, chiropractors, podiatrists, naturopaths, or dentists specifically for the use of patient operators. Exclusive use laboratories cannot accept specimens from providers other than operators, and are subject to regulatory requirements that are less stringent than independent laboratories.

"Independent lab" licenses are far more difficult to obtain than exclusive use licenses; and independent laboratories have greater requirements regarding their operations and personnel. Independent laboratories can accept specimens from providers other than their operators.

Many drug use treatment programs are more interested in establishing exclusive use laboratories, but sulfur analyzer indonesia they are not the types of providers listed in the law (ie medical doctors, osteopaths, chiropractors, podiatrists, naturopaths or dentists). So what should the treatment program do? Arguably, providers in exclusive use law can assess and adopt each patient from a program, order a patient's urinalysis, and that urinalysis can be carried out by a laboratory operated by the ordering provider. The laboratory can then collect and collect for urinalysis. The hard part is how providers who operate exclusive use labs, programs, and lab owners share the revenue generated by urinalysis.

Florida is very suspicious of bribery arrangements and the distribution of costs involving clinical laboratories. Not only are there laws specifically prohibiting bribery and cost sharing involving clinical laboratories, but there are also regulations that accommodate the same prohibition. In addition to the kickback ban and the separation of this lab-specific fee, the kickback ban that is more commonly found in Florida law, as well as the Florida and Federal bans on self-referral for clinical laboratory services make the integration of clinical laboratories into the organization including providers of ordering and / or treatment programs abuse of regulatory substances must be handled with care.

There is no structure for such integrated arrangements that is completely free of regulatory risk, but there are things that integrated companies can do to help reduce the risk. Any care or life program that is consciously thinking about integrating clinical laboratories into its company must consult with a bona fide lawyer or health care consultant.