LCD Reference Article Response To Comments Article

Response to Comments: Urine Drug Testing

A59501

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Article ID
A59501
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Article Title
Response to Comments: Urine Drug Testing
Article Type
Response to Comments
Original Effective Date
08/24/2023
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The comment period for the Urine Drug Testing DL35724 Local Coverage Determination (LCD) began on 4/27/23 and ended on 6/10/23. The notice period for L35724 begins on 8/24/23 and will become effective on 10/8/23.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

We are pleased to submit our written comments on the Palmetto GBA (“Palmetto”) proposed local coverage determination, Urine Drug Testing (DL35724)(“dLCD”). We are the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

We would like to thank Palmetto for retiring the previous dLCD DL35724 posted on October 27, 2022. We are pleased to see that the proposals where we had significant concerns were not included in the current dLCD. We truly appreciate the opportunity to comment and engage with Palmetto during the LCD development process. We also commend Palmetto for developing a comprehensive overview of the various methodologies and indications for presumptive and definitive drug testing to ensure reasonable and necessary patient care.

We would like to provide 1 comment on the Coverage Indications, Limitations, and/or Medical Necessity section and the discussion about the use of an Opioid Risk Tool. We agree 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. 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 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 produced or is insufficient. Health care practitioners have no incentive to spend extra time and resources responding to requests from laboratories or from health plans for medical documentation. While we do not recommend any specific changes to the language in the dLCD, we look forward to working with Palmetto, 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.

Thank you for your consideration of our comments. We welcome the opportunity to work with Palmetto in support of policies to ensure appropriate access to necessary testing services for all Medicare beneficiaries.

Thank you for your comments. We understand your concerns regarding the difficulty in obtaining the required documentation from the provider, when needed, and continues to be available to collaborate in finding Medicare compliant resolutions to this concern. However, 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 the tests. While it is the laboratory's responsibility to obtain and submit medical documentation for the billed test(s) to 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

We are pleased to submit comments to Palmetto GBA (Palmetto) in response to the draft Local Coverage Determination (dLCD): Urine Drug Testing (DL35724). We would like to thank Palmetto for retiring the prior dLCD DL35724, posted on October 27, 2022, and appreciates the opportunity to provide comment and participate in the LCD development process.

We are a CLIA-certified, CAP-accredited specialty laboratory providing drug testing and data services to support improved clinical decision making as part of treatment for millions of Americans with chronic pain, mental illness, substance use disorders (SUDs), and other health conditions. Definitive drug testing is an important tool used to obtain objective information about patients’ recent use of prescription medications and/or illicit drugs and helps monitor the effectiveness of treatment plans. Our testing and lab results help guide critical decisions for thousands of individuals every day and, in aggregate with partners like the U.S. Department of Health & Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), help direct the public health response to the overdose crisis.

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 but 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). 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.

We thank you for the opportunity to submit comments and would be happy to discuss these issues further.

This LCD clearly states that ethanol is not a topic of discussion in this policy. 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
Related Local Coverage Documents
LCDs
L35724 - Urine Drug Testing
Related National Coverage Documents
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Updated On Effective Dates Status
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Keywords

  • Urine Drug Testing
  • UDT