Urine drug testing is commonly used in healthcare practices to ensure patients are compliant with their medication and not diverting or abusing medication and illicit substances. Many states have implemented drug testing requirements that providers must follow. Additionally, there has been increasing pressure by the Drug Enforcement Administration and Health and Human Services to frequently drug test patients. Failure to do so could result in investigations for unlawful drug diversion, state licensing action or even criminal charges under the Controlled Substance Act. As a result of this pressure, most providers who wish to be compliant have added a urine drug testing protocol or program to their practice to ensure patients are properly tested and to ensure compliance.
Seeing the increased expense of urine drug testing on the federal budget, the Department of Justice has initiated a rash of false claims cases against physicians under the false claims act for failing to properly risk stratify and bill urine drug testing. This is in part because providers have increased utilization of in-house labs to order drug testing for their patients which is a highly scrutinized activity by Health and Human Services (HHS). Failure to properly order urine drug tests and to document medical necessity could result in millions in civil monetary penalties, significant recoupment in audits, and perhaps be a business ending event for a healthcare practice.
In this article, we will walk you through typical mistakes and how you can correct them.
The False Claims Act
In order to receive Medicare reimbursement a service must be reasonable and necessary. 42 U.S.C. 1395y(a)(1)(A). Failure to ensure that a service is reasonable and necessary is a violation of the False Claims Act. The false claims act states that “any person who knowingly presents, or causes to be presented a false or fraudulent claim for payment or approval is liable to the United States for three times the amount of damages which the Government sustains, plus a civil penalty per violation”. 31 U.S.C. 3729(b).
Thus, in order to order urine drug testing for a patient the physician who orders the service must maintain documentation of the medical necessity in the patient’s medical record. 42 C.F.R. 410.32(d)(2).
Common Compliance Issues in Urine Drug Testing Programs
Medicare has specific requirements for what is considered eligible for payment. The most common areas of non-compliance seen by our healthcare compliance specialists are”
Not ensuring documentation of medical necessity of the specific urine drug test, Not properly risk stratifying patients before ordering frequent urine drug tests, Not specifically issuing a physicians order for a urine drug test, Implementing standing orders for urine drug tests, Testing for substances for which there is no reasonable probability of use, Running duplicative presumptive and confirmatory tests, Using unnecessarily large urine drug profiles.
Many practices in order to be compliant have implemented standing orders for drug testing. Patients may be tested two to four times per year based on a standing order. The problem with standing orders
are that they are not specific to the patient. If a provider is audited and the only proof of medical necessity is the standing order, they may risk large fines and civil monetary penalties for failure to properly document the medical necessity of the urine drug test. To make matters worse, many practices have utilized medical assistants or laboratory technicians to determine the frequency of testing based on this standing order. Again, the issue is that medical necessity is not determined specifically by the physician after consultation with the patient. Misuse of Reflexive Testing Protocols
In addition to standing orders, we are seeing the Department of Justice increasingly investigate the use of presumptive and qualitative testing. HHS has encouraged the use of presumptive testing as an initial screen to determine if more expensive confirmation is necessary. Here, a provider will utilize a point of care cup or chemistry analyzer to screen a patient’s sample to determine the presence of medication or drugs not prescribed and the absence of prescribed medication. When a potential aberrant screen is noted the provider will send the screen for confirmation utilizing an LCMS or GCMS to determine the presence or absence of metabolites.
Here at CCG we commonly see providers reflexively testing samples, meaning they are immediately confirming the result before analyzing the results of the point of care cup to determine issues.
In theory, this shouldn’t be considered a bad practice. Many providers believe the results of a point of care cup are essentially useless in determining the need for future testing because of the high error rate of presumptive tests. Unfortunately, insurers have insisted that patients be screened prior to a confirmation to lower costs.
The fix here is easy, prior to confirmation, a sample must be reviewed by a provider and a short entry into the patients medical record showing the need for confirmation is essential for good documentation. The point of care cup can be analyzed during the patient appointment and a conversation between the patient and the provider can occur. Once this happens, the sample can be sent for confirmation or tested in an in-house lab to determine the accuracy of the initial screen and a further discussion with the patient can occur at the next visit.
Providers are often concerned at how time consuming this may be. But remember, if the visit is more complex, a provider can bill a higher evaluation and management code for the visit.
Misuse of Drug Testing Panels
Many labs have a common “drugs of abuse” panel that tests for specific illicit and prescribed drugs. Providers who have contracted with labs are often informed by the lab that a custom panel is appropriate. The issue here is that in many cases the panel is too large and tests for too many substances thereby making it too expensive according to Medicare. Many providers correctly believe that utilizing a common drugs of abuse panel is appropriate because a provider cannot know specifically what medications a patient might be abusing before the test. This puts providers between a rock and a hard place. Test for too many and Medicare seeks recoupment. Test for too few and the patient may be at risk.
The solution here is to properly document the medical necessity of the panel chosen and specifically indicate on the requisition form and the patient documentation the panel chosen and the medical
necessity of the panel. It’s ok to test a large group of patients for the same substances as long as there is complete and clear documentation of the rationale for testing. How to Correct Compliance Issues in Your Drug Testing Program
Providers must properly assess compliance risks in their drug testing program and frequently review federal and state guidance to ensure compliance. This starts with a practice urine drug testing policy that informs staff and patients about the need for urine drug testing and specifically describes the risk stratification method used by the practice to test patients. This policy should also indicate that a provider must always document the medical necessity for the specific panel utilized and document the results of the test along with a conversation with the patient.
Once a clear policy is in place it must be trained and enforced to ensure providers are following the policy. Frequent checkups and reviews of provider documentation by a third party can ensure that your practice is in compliance and not engaging in unnecessary risks.
At CCG we provide comprehensive compliance reviews of drug testing programs and all other areas of your practice to ensure that you are compliant. Our experience compliance professionals can do a front door to back door assessment of your practice to ensure that your urine drug testing program is compliant with federal and state guidelines. This gives you the peace of mind to continue treating your patients without fear of government intervention. We utilize the most up-to-date federal guidance and train your staff on how to run a compliant practice.
Once you have implemented a urine drug testing policy and properly trained your staff, we can do periodic checkups to monitor the effectiveness of your program and to re-train staff where necessary. Contact us for a free compliance review today to determine if you require a compliance plan and an update to your policies and procedures.