Knowledge Base Article

“No payment may be made under (Medicare) part A or part B for any expenses incurred for items or services — which, …, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, …”Social Security Act 1862(a)(1)(A)

If your work involves knowledge of Medicare requirements, you are likely very familiar with the above statement that is the basis for the concept of “medical necessity” for covered healthcare services. But do you actually consider the implications of this statement when billing Medicare for services?

It appears a large number of providers did not assess their services against this statement before billing Medicare for specimen validity testing as a recent Office of Inspector General (OIG) report found $66.3 million in overpayments for this type of testing. Specimen validity testing is used to analyze urine specimens prior to drug testing to determine whether the specimens have been adulterated or tampered with. Although necessary to assure the legitimacy of the drug testing, these tests themselves are not used to provide a diagnosis or treatment to a patient.

As the OIG report explains, the requirements for laboratory testing are that tests meet the requirement for medical necessity as described above and more specifically, to be covered under Medicare Part B, clinical laboratory tests must:

• Be ordered by a physician who is treating a beneficiary for a specific medical problem;
• Be related to the patient’s illness, injury, symptom or complaint; and
• The results must be used in the management of the patient’s problem.

The overpayments occurred because the same tests used for specimen validity testing may be medically necessary if used to diagnose certain conditions. “For example, tests for urinary pH and specific gravity may be performed to diagnose diseases of the kidney and urinary system. If these tests are used for diagnosis, treatment, or management, they may be Medicare-covered services. However, when used for the purpose of determining whether a specimen is adulterated, the test results are not being used to manage a beneficiary’s specific medical problem. In these cases, specimen validity testing is not a separately billable Medicare-covered service.” 

Providers should have known this because, over the years, Medicare and their contractors have addressed this issue numerous times. Almost all the Medicare Administrative Contractors (MACs) have a Local Coverage Determination (LCD) for drug testing that includes direction that tests to validate urine specimens are not separately billable. The first such LCD instruction was in 2010 and in 2015 the Medicare National Correct Coding Initiative (NCCI) manual included the statement, “Providers performing validity testing on urine specimens utilized for drug testing should not separately bill the validity testing.” Beginning in 2016, new HCPCS codes for urine drug testing include specimen validity testing in their code descriptions and payments, regardless of whether specimen validity testing is performed or not. And in April 2016, NCCI edits were created to prevent payment for the type of lab tests performed for validity testing when billed on the same date of service as a urine drug test unless modified by the provider to indicate a “separate and distinct” service.

Although the number of overpayments dramatically decreased from 2014 to 2016, the OIG thinks further actions by CMS could reduce the risk of estimated overpayments of $12,146,760 over a 5-year period. The OIG recommends CMS “strengthen its system edits to prevent improper payments for specimen validity tests and instruct the Medicare contractors to educate providers on properly billing for specimen validity and urine drug tests.” Also, be warned that CMS may be recouping the overpayments identified in the OIG audit.

Now is a good time to investigate your billing practices for specimen validity testing with the understanding that if you have been separately billing these services, you owe the government some money back. Going forward, be sure to first apply the Social Security Act standard in determining whether to bill for services – i.e., to be paid under Medicare, a service must be reasonable and necessary for the diagnosis or treatment of illness or injury. After that, there are a lot more coverage rules that need to be considered, but it is a good place to start.