LCD Reference Article Response To Comments Article

Response to Comments: Urine Drug Testing

A59459

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Source Article ID
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Article ID
A59459
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Urine Drug Testing
Article Type
Response to Comments
Original Effective Date
10/08/2023
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The comment period for the Urine Drug Testing Local Coverage Determination (LCD) began on 04/27/023 and ended on 06/12/2023. The notice period for L36668 begins on 08/24/2023 and will become effective on 10/08/2023. 

Response To Comments

Number Comment Response
1

ACLA would like to provide one comment on the Coverage Indications, Limitations, and/or Medical Necessity section and the discussion about the use of an Opioid Risk Tool. ACLA agrees that orders for urine drug testing should be based on specific patient information that supports an indication for testing. While we fully support a practitioner’s use of any of several evidence-based risk tools when prescribing/renewing a controlled substance, specific documentation requirements often lead to inefficiencies and difficulties in obtaining this information from the ordering practitioner. The commenter-member laboratories make significant efforts to educate ordering clinicians on coverage requirements and comply with records requests related to the adjudication of claims. However, laboratories often struggle to obtain medical documentation from health care practitioners to support the medical necessity of tests that they perform in pursuant to the health care practitioners’ orders and for which the laboratories submit claims.

The ordering health care provider creates and maintains the documentation about a patient encounter that supports the medical necessity of a test, yet the performing laboratory’s reimbursement is at stake when the documentation is not provided or is insufficient. Health care practitioners have no incentive to spend extra time and resources responding to requests from laboratories or from health care plans for medical documentation. While ACLA does not recommend any specific changes to the language in the dLCDs, we look forward to working with Noridian, other Medicare Administrative Contractors, and the Centers for Medicare & Medicaid Services to find solutions to the ongoing difficulties in obtaining and transmitting appropriate medical documentation.

For clinical laboratory tests to be covered by Medicare, the medical record must contain enough information about the patient's condition to support the medical necessity of tests. The clinical laboratory must attempt to obtain the medical order at the time the beneficiary appears at the facility to receive the test(s). They can do this by asking the beneficiary to submit the medical order that includes the related diagnosis. While it is the laboratory's responsibility to obtain and submit medical documentation for the billed test(s) to Noridian or other Medicare contractors when requested, they are often unable to provide this important documentation from the medical records because the information is with the ordering doctor's office or practice. In these cases, for the laboratory to receive payment, they must request the information from the doctor ordering the test(s). Without the order or documentation such as progress notes indicating the intent to order the test(s), as well as supporting medical necessity, payment for the service(s) will be denied. 

2

Although the dLCD makes clear that ethanol is not a topic of discussion in the dLCD, the dLCD goes on to state as follows:

“Ethanol is a known drug of abuse by is routinely tested in blood, not urine. In addition, the Drug Enforcement Administration (DEA) Resource Guide states that alcohol is exempt from control by the Controlled Substances Act (CSA).”

While ethanol may be tested in blood, that should not limit the availability of testing for ethanol via urine. Testing for alcohol use via urine specimens is a necessary tool for clinicians monitoring patients in numerous settings and may be more accessible and useful than blood testing, especially for those being treated and monitored in a clinical setting for an alcohol addiction or disorder. Blood alcohol testing can be useful when levels of acute use are needed, but this method has limitations that do not align with clinical settings where abstinence is being monitored.

Aside from being an invasive test requiring a blood draw (something many clinical offices do not have skilled staff to perform), the detection windows for use are much lower for ethanol in blood (~6-12 hours window of detection) than in urine (~80 hours window of detection when monitoring urine levels of alcohol metabolites). So, as an example, patients can avoid detection when monitored via blood testing by simply avoiding alcohol the prior evening, whereas urine testing gives a more accurate indication of alcohol use.

Given the above stated clinical advantages of monitoring for alcohol use in urine vs. blood, we believe that access to this testing in urine, when deemed medically necessary by a treating clinician, is important and should be considered in any future policymaking.

This dLCD clearly states that ethanol is not a topic of discussion in this dLCD. Therefore, there is no restriction for billing ethanol by whatever means tested and payment will be based on criteria of Reasonable and Necessary, benefit category, etc.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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