Specimen Validity Testing
Determine coverage and be sure to maintain documentation.
You may know it as adulteration, specimen validity, or specimen integrity testing; regardless of terminology, Medicare does not cover it, but other insurance plans do. The key to reimbursement is to understand the tests, determine if they are medically necessary, review payer policies for coverage parameters, and be sure your physician’s documentation is supportive.
Urine Evaluation and Report
Understanding how to evaluate urine drug screens for adulterations, substitutions, and potential false results is complex, but vital to interpreting their results. A detailed medication history — including prescription, nonprescription and herbal medications — and proper knowledge of medications that cross-react with urine drug screens are essential for assessing cross reactivity that may affect results. (Moeller 2008)
Urine tests can appear in a report as adulterated, substituted, or dilute. An adulterated urine specimen contains a substance that is not normally found in urine, or that normally is found, but is in abnormal concentrations. Adulterants work by interfering with immunoassay and/or confirmatory assay function, or they convert the target drug into compounds not detected by the test.
Synthetic urine products can be submitted when urine specimen collection is not observed; however, more commonly, water or saline solution is substituted. Diluting the urine sample to the point where the targeted drug is below the cutoff concentration is a way to get a negative result. (Substance Abuse and Mental Health Services Administration)
The National Correct Coding Initiative (NCCI) manual (chapter 10, section E) says:
Providers performing validity testing on urine specimens utilized for drug testing should not separately bill the validity testing. For example, if a laboratory performs a urinary pH, specific gravity, creatinine, nitrates, oxidants, or other tests to confirm that a urine specimen is not adulterated, this testing is not separately billed. … [a] laboratory test is a covered benefit only if the test result is utilized for management of the beneficiary’s specific medical problem. Testing to confirm that a urine specimen is unadulterated is an internal control process that is not separately reportable.
Treating physicians typically order specimen validity testing to make patient-specific therapeutic decisions, including those related to medication compliance and illicit drug use. In the absence of this validity testing, a patient may succeed in deceiving a physician through the submission of an adulterated urine specimen. This may have the unintentional effect of masking the presence of some underlying medical conditions by providing misleading urine drug test results. (Kirsh 2015)
Concerns of drug abuse and noncompliance are considerations pain management physicians routinely assess. Specimen validity testing provides evidence that, when taken into consideration with other indicators (e.g., incorrect pill counts, suspicious behaviors, clinical symptoms), may assist the medical management of the patient, including the initiation of a conversation regarding potential drug abuse, mismanagement of medications, or diversion of prescribed drugs. (Ko 2013)
Coverage Varies, but Is a No for Medicare
Palmetto Government Benefits Administrator states their position in policy M00024, consistent with the NCCI manual:
… a diagnostic laboratory test must be ordered by the treating physician and the test results must be used in the management of the beneficiary’s specific medical problem. Although some laboratory requisitions allow the ordering physician to designate specimen validity testing (e.g., creatinine, oxidant, pH, specific gravity) to ensure that a patient specimen has not been adulterated, the results of this testing are not used in the management of the beneficiary’s medical problem. Therefore, Palmetto GBA has determined that specimen validity testing is a statutorily excluded service.
Similarly, Florida Medicare administrative contractor First Coast Service Options does not cover specimen validity testing including, but not limited to pH, specific gravity, oxidants, and creatinine. (First Coast Service Options, Inc., 2014)
Cigna coverage policy 0512 regarding drug testing indicates routine tests to confirm specimen integrity are not covered because they are not considered medically necessary. (Cigna 2015) Because the phrase “routine tests” is used, you can argue that although routine integrity testing is not covered, integrity testing when specifically requested may be covered.
A federal employee health benefit plan for mail handlers (Mail Handlers Benefit Plan) on urine drug testing specifically indicates CPT® codes 81002 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy; 81003 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy; and 82570 Creatinine; other source as additional tests that may be appropriate to verify a urine sample was not adulterated when specifically ordered by the authorized requesting provider. Coventry Health Care, an Aetna company, has a urine drug testing policy with the same coverage wording.
In a document published on the Anthem Blue Cross Blue Shield website titled “Urine Drug Screening – A Practical Guide for Clinicians,” laboratory tests are specifically specified, indicating contamination should be considered if test results for pH, specific gravity, urine creatinine, or urine nitrite levels are outside predetermined levels. (CARES Alliance 2010)
Specimen validity testing is mandatory for the Department of Transportation workplace drug and alcohol testing programs. (Section 40.89(b) 2008) The U.S. Department of Health & Human Services drug testing standards were first published in 1988. In 2004, significant revisions requiring specimen validity testing on federal employee donor urine specimens were included. (Bush 2008)
Although specimen validity testing is arguably medically necessary, routine use fits into Medicare’s definition. This does not, however, take into account conditions where there may be medical value in the tests. Check the relevant coverage policies to determine whether this testing is covered and what documentation to maintain.
Bush, Donna M., “The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: Current status and future considerations,” Forensic Science International 174 (2-3): 111-119, 2008.
CARES Alliance, “Urine Drug Screening – A Practical Guide for Clinicians,” 2010:
Center for Substance Abuse Treatment, “Medication-Assisted Treatment for Opioid
Addiction in Opioid Treatment Programs,” Treatment Improvement Protocol (TIP) Series
43 (Substance Abuse and Mental Health Services Administration):
Cigna, “Cigna Medical Coverage Policy – Drug Testing,” October 15, 2015:
The Centers for Medicare & Medicaid Services (CMS), NCCI Policy Manual for Medicare Services, chapter 10, section E.
Coventry Health Care, “Urine Drug Testing Coverage,” American Foreign Service Protective Association: www.afspa.org/home/pdfs/FEHBP-Urine-Drug-Testing-Coverage.pdf.
First Coast Service Options, Inc., “Controlled Substance Monitoring and Drugs of
Abuse Testing,” First Coast Service Options. November 15, 2014:
K.E. Moeller, Lee, K.C., and Kissack, J.C., “Urine Drug Screening: Practical Guide for Clinicians.” Mayo Clinic Proceedings 83 (1): 66-76.
Kenneth L. Kirsh, Christo, P.J., Heit, H., Steffel, K., and Passik, S.D., “Specimen validity testing in urine drug monitoring of medications and illicit drugs: Clinical implications,” Journal of Opioid Management, 11 (1): 53-59.
Mail Handlers Benefit Plan, “FEHBP Urine Drug Testing.” www.mhbp.com/web/groups/public/@cvty_mailhandlers_mhbp/documents/document/c075890.pdf
Mancia Ko, Merritt, P., and Dawson, E., “Specimen Validity Testing – Focus on Screens looks at interpreting urine drug assay results.” Practical Pain Management. June 1, 2013:
Palmetto GBA, “Specimen Validity Testing (M00024),” MolDX. September 4, 2014.
Section 40.89(b), 49 CFR, June 25, 2008.
Substance Abuse and Mental Health Services Administration, “Clinical Drug Testing in Primary Care (TAP 32),” chapter 4, page 43.
Substance Abuse and Mental Health Services Administration, “Clinical Drug Testing in Primary Care (Technical Assistance Publication Series – TAP 32),” chapter 5, pages 52-54.
Tellioglu, Tahir, “The Use of Urine Drug Testing To Monitor Patients Receiving Chronic Opioid Therapy for Persistent Pain Conditions,” Medicine and Health Rhode Island 91 (9), pages 279-80, 282.
Frank Mesaros, MPA, MT(ASCP), CPC, is CEO of Trusent Solutions, LLC, a management consulting firm specializing in the laboratory industry. Trusent provides revenue stream integrity services to regional laboratories, hospital based laboratories, and physician office based laboratories. He is a member of the Harrisburg, Pa., local chapter.