Urine Drug Testing and Software Overview

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UDT typically detects the parent drug and/or its metabolite(s) and,

therefore, demonstrates recent use of prescription medications and illegal substances. Although other biologic specimens can be used in drug testing, urine is usually preferred for determining the presence or absence of drugs and is currently the most extensively validated biologic specimen for drug testing.

The 3 main types of UDT are:

1. Immunoassay Drug Testing

Either laboratory based or at point-of-care* (POC), eg, "rapid cup" testing 2. Laboratory-Based Specific Drug Identification eg, gas chromatography/mass spectrometry† (GC/MS) or liquid chromatography/mass spectrometry‡ (LC/MS) 3. Comprehensive Combination of Techniques eg, special applications for pain testing

What is Urine Drug Testing?

When used with an appropriate level of

understanding, UDT can improve a clinician's ability to manage therapy with prescription drugs (including controlled substances), to assist in the diagnosis of substance misuse or addiction to guide treatment, and to advocate for patients. The rationale for performing UDT will depend on the clinical question(s) to be answered; for example, to assist in medication adherence, seeking an initial diagnosis of drug misuse or addiction, as an adjunct to self-report of drug history, to encourage or reinforce healthy behavioral change, or as a requirement of continued treatment.

Why Should I Conduct a UDT on My Patients?

Identify Use of Illicit or Nonprescribed Licit Drugs UDT can aid the health care professional in detecting misuse or abuse of illicit or nonprescribed licit drugs.

Suspected Diversion Diversion is the intentional removal of a medication from legitimate distribution and dispensing channels for illicit sale or distribution.

Reduce Liability Knowledge of the illicit or licit medications in your patients system will prevent contraindications from your prescribed regimen that could impact liability.

ACOEM Guidelines Recommend UDT ACOEM guidelines recommend a prescription drug monitoring program for those physicians or clinics that prescribe or dispense controlled medications.

Why Should I Conduct a UDT on My Patients?

One Doctor. One Patient.

One Complete Way To Provide Better Care

There is a 6 or 12 panel testing option. The 6 panel covers all of the

non illicit drug classes (Barbiturates, Benzodiazepines, Methadone, Opiates, Oxycodone, Tri-Cyclic Antidepressants) and the 12 panel covers both the illicit and non-illicit drug classes. The complete 12 classes are listed below. Also, you have the ability to choose your desired drug classes for testing.

What Substances are Tested ?

• New Patients Already Receiving a Controlled Substance

• Patients Who Are Resistant to Full Evaluation

• Patients Who Request a Specific Drug

• Patients Who Display Aberrant Behavior

• Patients in Recovery

Whom to Test?

When Meeting a Patient for the First Time Substance-use disorders are not uncommon in the population (they may be more or less common in your practice depending on your demographics). UDT should be considered as a part of the evaluation of any new patient who is taking controlled substances.

When Starting Treatment With a Controlled Substance

Although only a minority of patients either misuse or become addicted to their prescribed medications, those who do generally have a current or past history of substance misuse or addiction.

When Making Major Changes in Treatment

If treatment objectives are not being achieved despite medication adjustments, UDT may assist with monitoring patient adherence before making further changes to the treatment plan.

Random Testing

Every 90 days to ensure compliance with prescribed regimen.

When to Test?

Identify Patients to be Tested

Obtain Urine Specimen

From Patient

Turn Cup on its side to view rapid

results

Record rapid results in ToxPlus

software Place cup in specimen bag and

prepare for shipping

Lab receives specimen

and performs confirmatory

testing

Lab sends test results to

ToxPlus software for

review

Billing and collections is performed in-house or by ToxPlus

ToxPlus Work Flow Process-Chart

MedeRx-ToxPlus Online Services ℠ make this valuable

information always available and easy to use, making it easier for you to integrate urine drug monitoring into your practice. MedeRx-ToxPlus Online Services allow you to submit lab requisitions, manage patient selection for monitoring and access a wide array of informative reports—24 hours a day, 7 days a week.

MEDeRx-ToxPlus Online Services

With MedeRx-ToxPlus Online Services ℠, our secure,

internet-based physician resource, you can submit lab requisitions, check patient results and manage the automatic selection of patients for urine drug monitoring.

Do I Need A CLIA Waiver For Rapid Screening?

What is a Waived Test? As defined by CLIA, waived tests are categorized as "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result". The Food and Drug Administration (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer's applications for test system waiver. A Certificate of Waiver is issued to a laboratory that performs only waived tests.

How Do I Apply for a CLIA Certificate of Waiver?

Our representatives will assist you in this process. The CLIA application (Form CMS-116) is available online at the CMS CLIA website. A CLIA certificate will be needed for each location where you perform testing

What is My CLIA Number?

You will receive a ten-digit number on the CLIA certificate. This number will be utilized to identify and track your laboratory throughout its entire history. You should use this number when making inquiries to the State Agency and CMS about your laboratory. Your CLIA number will also be required on all Medicare claims for laboratory tests.

Will My Laboratory be Inspected?

No, Certificate of Waiver Laboratories are not subject to routine surveys.

Reimbursements for UDT Testing and Review?

Is a Physician Entitled to Reimbursements for UDT Testing and Review?

1) In Office Rapid Test (12-panel or 6-panel)

2) Review of Records (ROR) - In eligible states, the physician/clinic may be able to create, prepare and bill for Review of Records. If so, these documents will be automatically generated and available via our software. ROR reimbursement is not available for Medicare and commercial insurance patients.

Billing

Upon request, ToxPlus will recommend billing and collection companies that have experience in billing and collecting for toxicology testing. Most claims are paid within 60 days. Normally, these billing and collection companies charge a billing/management fee based on collections.

Cost To Physician

Specimen cups and ToxPlus annual software fee. Invoices for supplies have 30 day terms, by which time the doctor will be generating income.

How To Begin

Contact your representative! Once the physician/clinic has decided to implement medication monitoring and has completed the paperwork, it takes only 5-7 days to get the account set up and ready to start testing.