DRUG-TESTING – Are You Compliant with the Billing Procedures?
The article discusses the need for avoiding non-compliance when billing for drug testing and developing an effective and compliant plan for the same. www.outsourcestrategies.com
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Drug testing is used to detect prescribed, therapeutic drugs, prescription drugs of abuse, illicit drugs, and/or other substances. The healthcare industry, in the recent past has witnessed several audit outcomes resulting in multi-million dollar fines for non-compliant billing of drug-testing procedures. A recent report from Credence Research, Inc. predicts that the Drug of Abuse Testing/ Screening Market will reach USD 4,555.9 mn by 2022, expanding at a CAGR of 4.6% from 2016 to 2022. Managing and complying with the numerous federal regulations surrounding drug testing is one of the most complex challenges faced by medical centers and the healthcare community in general. Building an accurate and consistent medical billing compliance process requires tremendous effort to coordinate operations and to appropriately mitigate compliance risks.
Legal & Regulatory Issues – Fines for Improper Billing Procedures •
In October 2015, Millennium Health, the largest drug-testing lab in the United States ended up paying $256 million in fines for billing the government for unnecessary Medicare testing. The allegations against the company were that they performed unnecessary drug and genetic tests on patients (including conducting a cheap standard test and then re-testing with a more expensive test—even when the re-test was not warranted) coupled with a practice of illegal remuneration to physicians. This federal investigation, which involves the Department of Justice (DOJ), the Department of Health and Human Services (DHHS), the Office of the Inspector General (OIG), as well as the Centers for Medicare and Medicaid Services (CMS), has been ongoing for three years. They identified a pattern of excessive and unnecessary urine drug testing that occurred from January 1, 2008 through May 20, 2015.
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In January 2017, United Healthcare filed a lawsuit against a Dallas-based laboratory network, Next Health, alleging bribes and rewards to physicians for overpriced and unnecessary drug and genetic tests billed to the insurer between the period 2011 and 2016. In this episode which was advertised as the “largest ever healthcare fraud enforcement action” by the Medicare Fraud Strike Force, about 412 individuals (including 115 doctors, nurses and other licensed medical professionals) nationwide were criminally charged by the Department of Justice (DOJ).
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In another case, Palm Beach, Fla., a rehabilitation facility was 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.
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In another lawsuit of overbilling filed by the laboratory director of operations at the Carolinas Medical Center in Charlotte, it was alleged that the hospital system was over-billing the federal government for urine screening tests. The court documents (from 2011-2015) reveal that Carolinas Medical Center 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. This cost the healthcare system $6.5 million in fines.
Even though all the above cases of overbilling garnered publicity and highlighted the lack of compliance of physician practices, hospitals and laboratories, the same practice continues.
Drugs-of-Abuse Testing – Billing and Compliance Drugs-of-abuse testing is done to detect the presence of illegal drugs or prescription medicines in a sample of urine, blood or hair. Regular screening allows the person to be referred for treatment or monitored for drug abuse/misuse. Urine drug testing (UDT) is an important tool in pain management. Accurate, complete, and legible documentation of the services provided is crucial for success with pain management medical billing. While all the above examples represent extreme cases of non-compliance, it signifies the fact that medical billing and coding for drug testing is complex. For several years, the medical billing and coding guidelines governing these tests have been changing and this in turn has created compliance issues for several providers. Basically, the drugs-of-abuse testing is classified into two main categories – presumptive tests and confirmatory tests (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 this category of testing uses test strips that are easily interpreted by direct optical observation (visual) to more complex immunoassay procedures that use random access analyzers. Presumptive tests are less precise and indicate that an illegal substance may be present. Confirmatory tests provide a positive identification of the substance in question. Laboratories and other billing providers that relied on CMS coding guidelines for the various HCPCS codes (issued between 2010 and 2016) were confused by code definitions that referred to CLIA complexity levels. The confusion was generated as to whether the complexity level was the FDA categorization of the test system or the testing laboratory’s
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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
For instance, a hospital laboratory holding a high complexity certificate could possibly interpret the HCPCS G0431 code as being applicable to immunoassay procedures performed on the random access chemistry analyzer present in just about any chemistry laboratory. But, none of the presumptive methods are categorized by the FDA as being of high complexity. Another key consideration for presumptive drug testing is that the reported value may be qualitative,
semi-quantitative,
or
quantitative.
According
to
the
American
Medical
Association (AMA) the methods that cannot distinguish between structural isomers (such as morphine and hydromorphone or methamphetamine and phentermine) are considered presumptive. When coding for presumptive procedures, it is important to consider the list of drug classes and methodology. All immunoassays, regardless of drug class are considered presumptive, whether qualitative, semi-quantitative, or quantitative values are provided. A basic understanding about the test methodology and analysis of drugs and drug classes is crucial for accurate coding. In 2017, the CMS and AMA revised coding rules for presumptive analysis. The new set of CPT codes are specific to presumptive testing as they particularly based on the method (such as dipstick) used, whether by direct optical observation or an immunoassay performed on an instrumented analyzer. For presumptive analysis, only one CPT code may be billed as per date of service, regardless of the number of drug classes or number of services performed. It is not possible to bypass the per-unit limitation by appending a modifier. In the light of these revised coding changes, the support of an experienced and reliable medical billing company can be valuable to ensure precise claim submission for positive substance monitoring and drugs-of-abuse testing. Expert teams in reliable outsourcing companies keep regular track of changing billing and coding guidelines and help physicians submit error-free claims to maximize reimbursement.
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Need for High-complexity Definitive Testing While determining the need or necessity for high-complexity testing, it is important that healthcare providers check whether the result of presumptive analysis is correct or expected. For example, if a patient prescribed for an opiate-based drug tests negative for opiates. The negative test result would be quite unexpected and hence timely confirmation of unexpected or negative results from a presumptive test would be appropriate. High-complexity definitive testing will provide a quantified value that not only identifies the specific medication or illicit drug, but also provide the physician about the amount of drug that is present. In most cases, gas chromatography combined with mass spectrometry or liquid chromatography, as well as tandem mass spectrometry, is used for confirmation testing. Typically, scheduling of sequential drug testing is based on risk stratification. Although, the medical laboratory is not directly responsible for documenting the level of risk and tracking frequency of testing, it would be ideal for a laboratory practice to understand the basic clinical guidelines that help with medical decision making of the treating physician. Drug testing must be based on the clinician’s documented medical necessity and must be reviewed by the clinician in the management of patient care. Coverage related to testing will vary from low-risk patients to high risk patients. A low-risk patient will be tested one to two times over a 12-month period whereas a high-risk patient will be tested once a 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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