Drug Testing

Title XVIII of the Social Security Act section 1862 (a) (1) (A). This section excludes coverage and payment of those items or services that are not considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act section 1862 (a) (1) (D). This section states that no Medicare payment may be made under part A or part B for any expenses incurred for items or services that are investigational or experimental.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations and services.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Code of Federal Regulations (CFR) Title 42, Part 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see section 411.15 (k) (1) of this chapter).
Medicare regulations at 42 CFR 410.32(a) state in part, that “…diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem.” Thus, except where other uses have been authorized by statute, Medicare does not cover diagnostic testing used for routine screening or surveillance.

CMS Pub 100-03 Medicare National Coverage Determination Manual, Chapter 1 – Coverage Determinations, Part 2, Sections 130.5 – Treatment of Alcoholism and Drug Abuse in a Freestanding Clinic and 130.6 – Treatment of Drug Abuse (Chemical Dependency).

CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.

Change Request 10901, Local Coverage Determinations (LCDs)

A qualitative/presumptive drug screen is used to detect the presence of a drug in the body. A blood or urine sample may be used. However, urine is the best specimen for broad screening, as blood is relatively insensitive for many common drugs, including psychotropic agents, opioids, and stimulants.
Common methods of drug analysis include chromatography, immunoassay, chemical ("spot") tests, and spectrometry.

Analysis is comparative, matching the properties or behavior of a substance with that of a valid reference compound (a laboratory must possess a valid reference agent for every substance that it identifies). Drugs or classes of drugs are commonly assayed by qualitative/presumptive testing. A test may be followed by confirmation with a second method, only if there is a positive or negative inconsistent finding from the qualitative/presumptive test in the setting of a symptomatic patient, as described below.

Examples of drugs or classes of drugs that are commonly assayed by qualitative/presumptive tests, followed by confirmation with a second method, are: alcohols, amphetamines, barbiturates/sedatives, benzodiazepines, cocaine and metabolites, methadone, antihistamines, stimulants, opioid analgesics, salicylates, cardiovascular drugs, antipsychotics, cyclic antidepressants, and others. Focused drug screens, most commonly for illicit drug use, may be more useful clinically.

Indications:

1. Although technology has provided the ability to measure many toxins, most toxicological diagnoses and therapeutic decisions are made based on historical or clinical considerations:
   1. Laboratory turnaround time can often be longer than the critical intervention time course of an overdose. 
   2. The cost and support of maintaining the instruments, staff training, and specialized labor involved in some analyses are prohibitive.
   3. For many toxins, there are no established cutoff levels of .toxicity, making interpretation of the results difficult.

   Although comprehensive screening is unlikely to affect emergency management, the results may assist the admitting physicians in evaluating the patient if the diagnosis remains unclear. Screening panels should be used when the results will alter patient management or disposition.

2. A qualitative/presumptive drug test may be indicated for a variety of reasons including the following:
   1. A symptomatic patient when the history is unreliable, when there has been a suspected multiple-drug ingestion, to determine the cause of delirium or coma, or for the identification of specific drugs that may indicate when antagonists may be used.
   2. For monitoring patient compliance during active treatment for substance abuse or dependence.
   3. To monitor for compliance/adherence to the treatment plan or illicit drug use in patients under treatment or seeking treatment for a chronic pain condition. The clinical utility of drug tests in the emergency setting may be limited because patient management decisions are unaffected, since most therapy for drug poisonings is symptom directed and supportive.
3. Medicare will consider performance of a qualitative/presumptive drug test reasonable and necessary when a patient presents with suspected drug overdose and one or more of the following conditions:
   1. Unexplained coma
   2. Unexplained altered mental status in the absence of a clinically defined toxic syndrome or toxidrome
   3. Severe or unexplained cardiovascular instability (cardiotoxicity)
   4. Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome
   5. Testing on neonates suspected of prenatal drug exposure
   6. Seizures with an undetermined history
4. Medicare will consider performance of a qualitative/presumptive drug test reasonable and necessary when a patient presents with one or more of the following conditions:
1. For monitoring patient compliance during active treatment for substance abuse or dependence.
2. A drug screen is considered medically reasonable and necessary in patients on chronic opioid therapy:
   - In whom illicit drug use, non-compliance, or a significant pre-test probability of non-adherence to the prescribed drug regimen is suspected and documented in the medical
   record; and/or
   - In those who are at high risk for medication abuse due to psychiatric issues, who have engaged in aberrant drug-related behaviors, or who have a history of substance abuse.
3. Medicare will consider performance of a drug test reasonable and necessary in patients with chronic pain to:
   - determine the presence of other substances prior to initiating pharmacologic treatment
   - detect the presence of illicit drugs
   - monitor adherence to the plan of care

Drugs, or drug classes for which testing is performed, should reflect only those likely to be present, based on the patient's medical history, current clinical presentation, and illicit drugs that are in common use. Drugs for which specimens are being tested must be indicated by the referring provider in a written order.

A drug test may be reasonable and necessary for patients with known substance abuse or dependence, only when the clinical presentation has changed unexpectedly and one of the above indications is met.

A drug test may be reasonable and necessary for patients with symptoms of schizophrenia suspected to be secondary to drug or substance intoxication.

Definitive drug testing is indicated when:

1. The results of the screen are presumptively positive.
2. Results of the screen are negative, and this negative finding is inconsistent with the patient's medical history.
3. This test may also be used, when the coverage criteria of the policy are met AND there is no presumptive test available, locally and/or commercially, as may be the case for certain synthetic or semi-synthetic opioids.

A positive screen often results in an inadequate result upon which to make a proper determination. A more specific method, such as gas or liquid chromatography coupled with mass spectrometry, may be needed to obtain a confirmed analytical result. In particular, screens are frequently inadequate for interpretation of opiate and benzodiazepine results. Therefore, quantitative testing may be needed in these instances. Confirmation testing is usually not required for drugs like methadone, wherein false positive results are rare. However, factors such as cross-reactivity with other similar compounds or interfering substances in the specimen may affect test results. Confirmatory testing eliminates the risk of false positives. Also, eliminated by confirmation, is the risk of a “pill scraper” slipping through. Patients diverting their drug, attempt to cheat the test by scraping a bit of drug from a pill into their urine sample. It would screen positive, but there would be no metabolite upon confirmation. Frequent use of this code will be monitored for appropriateness.

Limitations:
It is considered not reasonable or necessary to test for the same drug with both a blood and a urine specimen simultaneously.

Drug screening for medico-legal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a pre-requisite for employment or as a requirement for continuation of employment) are not covered.

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   doi: 10.1016/j.jpain.2008.10.008
3. Hughes, M. A., & et. al. Recommended opioid prescribing practices for use in chronic non-malignant pain: A systematic review of treatment guidelines. Journal of Managed Care Medicine, 14 (3): 52-58. Interagency guideline on opioid dosing for chronic noncancer pain: An educational aid to improve care and safety with opioid therapy. (2010).
4. Jackman RP, Purvis JM. Chronic nonmalignant pain in primary care. American Family Physician. 2009;78(10):1155-1162.
5. Melanson SEF, Baskin L, Magnani B, Kwong TC, Dizon A, Wu AHB. Interpretation and utility of drug of abuse immunoassays: lessons from laboratory drug testing surveys. Archives of Pathology and Laboratory Medicine. 2010;134(5):735-739.
   doi: 10.5858/134.5.735.
6. Paulozzi L, Baldwin G, Franklin G, et al. CDC grand rounds: prescription drug overdoses - a U.S. epidemic. JAMA. 2012;307(8):774-776.

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