Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

Jurisdiction

Type

• Title
• ID Number
• Medicare Administrative Contractors (MACs)
• Applicable States/Territories

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LCD

• Drug Testing
• L34645
• J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service
• | IA, KS, MO, NE IN, MI

Urine Drug Testing

• L36037
• Insurance Corporation J6 - National Government Services, Inc. JF - Noridian Healthcare Solutions, LLC JK - National Government Services, Inc.
• IL, MN, WI AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY CT, NY, ME, MA, NH, RI, VT

• L36029
• J15 - CGS Administrators, LLC
• KY, OH

• L36668
• r-nonton Healthcare Solutions, LLC
• Guam, Northern Mariana Islands

Controlled Substance Monitoring and Drugs of Abuse Testing

• 135006
• Solutions, Inc.
• AR, CO, NM, OK, TX, LA, MS

• JL - Novitas ; Solutions, Inc.
• DE, D.C., MD, NJ, PA

Urine Drug Testing

• L35724
• JJ- Palmetto GBA |
• AL, GA, TN

• JM Palmetto GBA
• NC, SC, VA, WV

LCDControlled Substance Monitoring and Drugs of Abuse TestingL36393JN - First Coast Service Options, Inc.FL, PR, U.S. VI

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Description

Drug testing is laboratory analysis which aids in the detection of prescription, recreational or illicit substances in an individual. Drug testing is performed for various reasons including, but may not be limited to: evaluation of therapeutic compliance, evaluation for drug aberrant behavior such as abuse or diversion, to evaluate for child or elder abuse or based on state mandate requirements. Drug testing can include analysis for most drugs, chemicals or plant products.

Although drug analysis may be performed on a variety of sample types (blood, saliva, sweat, hair and urine), urine drug testing (UDT) is most commonly utilized. UDT is widely available and has a longer period of potential detection. It is generally the least invasive sample type and least expensive method for drug detection and monitoring.

Types of drug testing:

• Qualitative/Presumptive/Screening – An initial test, commonly performed utilizing qualitative analysis on urine. Qualitative analysis is used to identify the presence or absence of one or more drugs or drug classes
• Quantitative/Definitive/Confirmatory – A follow-up test performed on a separate portion of the original specimen, utilizing quantitative analysis to validate the identity and quantity of a specific drug or drug metabolite (performed on the same urine specimen to confirm a positive result following qualitative testing)

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Genetic tests must demonstrate clinical utility, analytical and clinical validity and fulfill the CMS “reasonable and necessary” criteria.

Analytic validity (test accurately identifies the gene variant), clinical validity (test identifies or predicts the clinically defined disorder) and clinical utility (test measurably improves clinical outcomes) of the genetic test is supported by generally accepted standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, specialty society recommendations, and views of physicians practicing in relevant clinical areas. The test must be ordered by a physician who is treating the beneficiary and the results will be used in the management of a beneficiary’s specific medical problem.

For jurisdictions with no Medicare guidance for a particular test, Humana will utilize the MolDX program and Technical Assessments for molecular assays as the standard to evaluate clinical utility, analytical and clinical validity in conjunction with adhering to Medicare’s reasonable and necessary requirement.

Please refer to the above CMS guidance for drug testing.

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In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria. When referring to L36037 – Urine Drug Testing be advised that Humana follows guidance that adopts coverage for additional drug classes. 23-25

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

• Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law; OR
• Tests that confirm a diagnosis or known information; OR
• Tests to determine risk for developing a disease or condition; OR
• Tests performed to measure the quality of a process; OR
• Tests without diagnosis specific indications; OR
• Tests identified as investigational by available literature and/or the literature supplied by the developer and are not a part of a clinical trial

These treatments and services fall within the Medicare program’s statutory exclusion that prohibits payment for items and services that have not been demonstrated to be reasonable and necessary for the diagnosis and treatment of illness or injury (§1862(a)(1) of the Act). Other services/items fall within the Medicare program’s statutory exclusion at 1862(a)(12), which prohibits payment.