Urine Drug Test Policy

Mako Medical Laboratories and its affiliated laboratories (“Mako”) is dedicated to serving the laboratory needs of its health care provider clients as efficiently and effectively as possible. At the same time, Mako is devoted to complying strictly with federal and state law regarding reimbursement for its lab services, as well as with the reimbursement policies and contracts that govern its relationship with commercial health plans and insurers.

Mako generally is reimbursed only for performing tests that payors, whether government or commercial, deem to be reasonable and necessary.  As a clinical laboratory, Mako’s ability to be reimbursed for any test is dependent on the ordering provider making and documenting sound decisions regarding the medical necessity of any laboratory test they order from us in accordance with applicable health plan guidelines and coding standards, including by properly and fully completing the test requisition or order to include a diagnosis code that supports the tests ordered.  It is ultimately the providers’ responsibility to sign and date the laboratory test requisition where reasonably possible and to document in their system of record (patient chart, EMR, PMS, etc.) why they ordered the test and how they will use the test to provide care to the subject patient.

In recent years, urine drug testing (“UDT”) has become a clinically important and high volume type of laboratory assay.  UDT encompasses a wide variety of different tests that can be especially useful in patient management.  For example, UDT can be used to document adherence to the agreed-upon pain medication treatment plans, to aid in the diagnosis of drug addiction, or to detect improper or illegal diversion of controlled substances. Notwithstanding the efficacy and importance of UDT, any lab orders for it must be supported by patient-specific medical necessity determinations that are appropriately documented in the ordering provider’s medical record.  This policy is intended to provide our provider clients with general guidance on ordering UDT from Mako and Mako’s oversight process regarding UDT test orders. 

Any UDT, whether an individual test or panel, should be ordered by a provider only if deemed to be reasonable and necessary under the facts and circumstances presented with respect to an individual patient. Specifically,

• Presumptive, qualitative, or screening-based UDT should be ordered from Mako only when a patient’s signs and symptoms, clinical history and specific risk assessment warrant evaluating the patient for the presence of each and every drug tested for, including when presumptive UDT is ordered as a multi-analyte panel or profile.

• Definitive, quantitative or confirmatory UDT should be ordered based on provider assessment of a patient’s historical drug use and specific clinical findings. The decision to order definitive UDT may be influenced by, but not based exclusively on, community, population or practice wide trends, including when ordered as multi-analyte panel or profile. 

• The medical necessity determination supporting orders for both presumptive and definitive UDT must be documented in the subject patient’s medical record and made available to Mako for review upon request.

• Mako must receive a written order from an authorized person for UDT that includes a diagnosis code that supports each test requested in the subject order.

Many professional organizations, such as the American Society of Addiction Medicine and the America Academy of Pain Medicine, have published guidance on clinical indications for presumptive and definitive UDT. Similarly, many third-party payors, including the Center for Medicare and Medicaid Services (“CMS”), have issued guidance on when UDT is reasonable and necessary for patients. The following are links to various resources that provide direction on assessing and documenting the medical necessity supporting UDT, including with respect to ordering UDT in profiles or panels.  Mako encourages you to familiarize yourself with these resources, particularly any that may apply directly to your patient population:

CMS UDT Revised NCD:  CMS Revised NCD

CMS LCDs:  CMS LCD

CMS Local Coverage Article:  CMS UDT LCD Article

Anthem BlueCross Blue Shield Policy:  Anthem UDT Policy

Aetna UDT Policy:  Aetna UDT Policy

United Health Policy:  United UDT Policy

Harvard Pilgrim UDT Policy:  Harvard Pilgrim UDT Policy

Mako understands that there may be times when the ordering provider deems it necessary to order testing that does not meet the patient or members medical coverage policy or plan policy guidelines. In such circumstances, the provider should obtain an Advanced Beneficiary Notice of Non-Coverage (ABN) if required by the patient’s health plan.  As noted below, Mako generally will not process UDT orders that do not include a supporting diagnosis code or an ABN signed by the patient.   

Mako clients may wish to order UDT on a panel or profile basis. Panel testing groups together tests for multiple analytes. Some UDT panels or profiles are assigned their own individual CPT codes, but provider clients may ask Mako to group together individual UDTs, each with its own CPT code, into custom profiles with a single Mako test name or number to facilitate ordering efficiency and practice-specific lab ordering needs. Mako will not create custom UDT profiles for clients as it believes the creation of these panels too frequently will not or cannot be supported by medical necessity.

As with panel and profile-based orders, standing orders for recurring laboratory tests, including UDTs, must be specific to the medical and clinical needs of each individual patient to which they relate.  Mako will not rely on standing orders for UDT based solely on patient demographics or a patient’s membership in a specified group or population.

Each UDT ordered and performed in reliance upon the standing order must be appropriate and necessary to address the individual patient's unique medical status, illness or injury. The frequency and number of repeat tests shall be medically necessary for the management of the individual patient’s clinical circumstances, as determined when the standing order is placed and on an on-going basis.

Initial standing orders must be in writing and must include:

• The name of the individual patient,
• The sex and age or date of birth of the patient,
• The test(s) to be performed pursuant to the standing order,
• The diagnosis (ICD-10) code/or a description of the condition warranting each test included in the order, the frequency of such test(s),
• The start or effective date for the order,
• The end date for the order (not longer than 6 months after start date), and
• The name, title, address and signature of the authorized physician or qualified nonphysician practitioner who is ordering the test(s).

Duration of Standing Orders

• Standing orders for recurring laboratory tests will be considered valid for a maximum of 180days or 6 months from the dates of their issuance.
• At the expiration of the standing order, or at the end of 180 days or 6 months, the subject patient’s physician or authorized practitioner must complete a new initial standing order if recurrent testing remains necessary and desired.
• Where state law or regulation, or the guidance or policy of any controlling Medicare Administrative Contractor (“MAC”), sets the maximum duration of standing orders to a time period of less than that specified in this Policy, then the state law or MAC guidance must be followed.

Generally, reflex or automatic confirmatory or quantitative UDTs are not reasonable or necessary and orders for such cannot be honored. Because independent laboratories do not have full access to patient-specific data, Mako deems reflex or automatic quantitative testing ordered under the following specific circumstances to be reasonable and necessary and it will perform such reflex or definitive tests as ordered:

• To verify a presumptive positive UDT using definitive methods that include but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician;
• To confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication identified by the ordering clinician in the test order;
• When medical record documentation that is individualized for a particular patient satisfies medical necessity requirements, direct to definitive UDT without a presumptive UDT may be reasonable and necessary;
• Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary when there is an unexpected negative presumptive UDT result, and it is clinically imperative to know if it is truly positive or negative (the medical record should state such);
• Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result to the extent one is indicated in the relevant order;
• Definitive testing following a positive enzyme immunoassay (EIA) screen when the FDA-approved package insert for the EIA test requires the performance of a definitive test to confirm the preliminary positive result and the provider orders the confirmatory reflect test.

To reinforce the concepts advanced in this Policy, Mako provides the following non-exhaustive list of examples or circumstances when UDT may be deemed unnecessary by third party payors:

• Blanket UDT orders, especially for a panels or profiles, (i.e., routine orders that are not individualized to the member's history and clinical presentation); 
• Concurrent performance of presumptive and definitive tests for the same drugs or metabolites at the same time (Definitive testing should be guided by the results of presumptive testing);
• Same-day testing of the same drug or metabolites from two different specimen types (e.g., both a blood and a urine specimen);
• Broad panels of drug tests (to be considered medically necessary, the specific drugs being tested should be supported by the person's clinical presentation (e.g., drug abuse history, symptoms, physical findings); 
• Reflex definitive testing of point-of-care presumptive urine drug tests.  Definitive testing ordered after presumptive POC testing is typically in order only when the treating provider determines that he or she lacks sufficient information to treat the patient, in which case the physician should order targeted follow-up testing based on the patient’s signs, symptoms and history; or
• Performance of definitive tests of excessive frequency are often not justified by medical necessity (for example, routine weekly ordering of definitive testing to confirm buprenorphine/norbuprenorphine levels without change in member status).

Mako will use various mechanism and processes to assess client adherence with this Policy. By submitting UDT test orders to Mako, provider clients understand and agree that Mako may, at its sole discretion:

• Review the client’s medical records relating to any patient to assess the documentation regarding the medical necessity of a UDT ordered for the patient;
• Require the client’s personnel to attend training on ordering UDT from Mako;
• Access and review any client policies on determining or documenting the medical necessity of any UDT ordered from Mako;
• Perform periodic audits of a reasonable number of patient medical records relating to UDT orders from Mako to determine whether they support the medical necessity of the UDT or ask client to conduct self-audits and report the results to Mako;
• Request the client to implement improved policies or procedures regarding assessing and documenting the medical necessity for UDT ordered from Mako;
• Suspend, temporarily or permanently, the ability of the client to order any or all UDT from Mako if the rate of claims denied due to lack of medical necessary for such tests becomes unreasonably high.  

DISCLAIMER: NOTHING IN THIS POLICY IS INTENDED TO, AND SHOULD NOT BE CONTRUED AS LEGAL ADVICE OR ADVICE ON THE APPROPRIATE PRACTICE OF MEDICINCE GENERALLY OR WITH REPSECT TO ANY PARTICULAR PATIENTS.