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.