In years past, the healthcare industry has seen audit outcomes resulting in multi-million dollar fines for noncompliant billing of drug testing procedures. In some instances, the findings were even more severe, with reports of exorbitant fines for fraudulent billing. On Oct. 19, 2015, news broke of the $256 million payment by Millennium Health to resolve allegations of unnecessary drug and genetic testing, coupled with a practice of illegal remuneration to physicians. Approximately 89 percent of that sum was attributable to False Claims Act allegations that were outlined in a complaint filed by the United States. The government had identified a pattern of excessive and unnecessary urine drug testing that occurred from Jan. 1, 2008, through May 20, 2015.

Per a U.S. Department of Justice (DOJ) news release, “the False Claims Act allegations resolved were originally brought in lawsuits filed by whistleblowers under the qui tam provisions of the False Claims Act, which allow private parties to sue on behalf of the government and to share in any recovery. “

Regardless of the publicity that placed a spotlight on a lack of compliance among drug testing laboratories, physician practices, and hospitals, the bad behavior continues. 

In January of this year, news broke of UnitedHealthcare’s lawsuit against a Dallas-based laboratory network, Next Health, over alleged bribes and kickbacks to doctors for overpriced and unnecessary drug and genetic tests billed to the insurer between 2011 and 2016. 

In what has been touted as the “largest ever healthcare fraud enforcement action” by the Medicare Fraud Strike Force, 412 individuals, including 115 doctors, nurses, and other licensed medical professionals nationwide, recently were criminally charged by the DOJ. There was reference to a Palm Beach, Fla. rehabilitation facility that is alleged to have used trips to strip clubs, gift cards, and drugs to recruit addicts, and then billed over $58 million for false treatments and drug abuse monitoring tests.

Last month, news broke of Carolinas HealthCare’s agreement to pay $6.5 million to settle a lawsuit that began as a whistleblower case and subsequently saw participation of state and federal prosecutors. This lawsuit was filed by the laboratory director of operations at the Carolinas Medical Center in Charlotte, who alleged that the hospital system was over-billing the federal government for urine screening tests.

While the above examples represent extreme cases, the fact is that coding and billing of urine drug tests is complex. Coding and billing guidelines governing these tests have been in flux for several years, and it seems that for some providers, this has created compliance issues that has placed revenue at risk. 

According to court documents, from 2011 to 2015, Carolinas HealthCare performed urine drug tests categorized by the Food and Drug Administration (FDA) as being of “moderate complexity,” but it submitted claims indicating that the company had conducted “high-complexity” tests. Based on statements by Carolinas Healthcare, between 2013 and 2014 the hospital’s coding processes were reviewed by two separate consultants and the coding selections were confirmed.

This cost the healthcare system $6.5 million in fines. 

Essentially, drug abuse testing is broken down into two categories – the request is either for presumptive testing or for confirmatory analysis (previously referred to as either qualitative or quantitative analysis).

Presumptive testing is medically indicated when it is necessary to screen for the presence or absence of drugs or drug classes in a urine sample. The technology for presumptive testing ranges from use of test strips that are easily interpreted by direct optical observation (visual) to more complex immunoassay procedures that use random access analyzers. 

The challenge for many laboratories and other billing providers that relied on Centers for Medicare & Medicaid Services (CMS) coding guidelines for the various HCPCS codes issued between 2010 and 2016 was that they were easily misled by code definitions that referred to CLIA complexity levels. The confusion was generated by the lack of clarity as to whether the complexity level was the FDA categorization of the test system or the testing laboratory’s CLIA certificate of waiver, provider performed microscopy (PPM), or accreditation as a moderate complexity or high complexity. Consider the following codes:

  • G0431 Drug screen, qualitative; multiple drug classes by high complexity test method (for example, immunoassay, enzyme assay), per patient encounter
  • G0434 Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter

A hospital laboratory holding a high complexity certificate could interpret the HCPCS G0431 as being applicable to the immunoassay procedures performed on the random access chemistry analyzer present in just about any chemistry laboratory. The problem is that none of the presumptive methods are categorized by the FDA as being of high complexity. 

A key point for presumptive drug testing is that the reported value may be qualitative, semi-quantitative, or quantitative. The American Medical Association (AMA) specifically states that methods that cannot distinguish between structural isomers (such as morphine and hydromorphone or methamphetamine and phentermine) are considered presumptive. The list of drug classes as well as the methodology are to be considered when coding for presumptive procedures. All immunoassays – regardless of drug class — are considered presumptive, whether qualitative, semi-quantitative, or quantitative values are provided.

Accurate coding requires, at minimum, a basic understanding of the test methodology and the drugs or drug classes that are to be analyzed. Again, in 2017, the AMA and CMS revised coding for presumptive analysis. The new set of CPT codes are specific to presumptive testing and are based on the method (such as dipstick) used, whether by direct optical observation or an immunoassay performed on an instrumented analyzer. Hopefully this coding change will help alleviate coding challenges of the past.

Regardless of the number of drug classes or number of devices or procedures performed for the presumptive analysis, only one CPT may be billed per date of service. There is no ability to bypass the per-unit limitation by appending a modifier. 

Billing departments should remember that the QW modifier is reserved for use by a laboratory holding a certificate of waiver. This modifier communicates to the payors that the testing platform being used is a CLIA waived technology. A laboratory holding a moderate or high-complexity CLIA certificate will not append the QW modifier when billing.

When determining if high-complexity confirmation testing is necessary, it is suggested that providers consider whether the result from the presumptive test was expected. Confirmation of unexpected results from a presumptive test would be appropriate, for example when a patient that has been prescribed an opiate-based drug tests negative for opiates. The negative result would be unexpected and therefore confirmation of the negative result would be indicated. 

High-complexity definitive testing will provide a quantitated value that not only identifies the specific medication or illicit drug, but will typically provide the physician with the concentration or amount of drug that is present. Gas chromatography combined with mass spectrometry or liquid chromatography, as well as tandem mass spectrometry, is frequently used for confirmation testing.

Scheduling of sequential drug testing is typically based on risk stratification. While the laboratory is not responsible for documenting the risk level and tracking frequency of testing, it would be good laboratory practice to understand the clinical guidelines that aid in the medical decision-making of the treating physician or practitioner.

Testing must be based on clinicians’ documented medical necessity and reviewed by the clinician in the management of patient care. Coverage of the testing will vary, with a low-risk patient tested one to two times over a 12-month period while it may be appropriate to test a high-risk patient once per month. A patient with a moderate level of risk would be tested one to two times in a six-month period for a maximum of four times annually.

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