June 20, 2016

Overview

What is Urine Drug Testing?

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 types of UDT are:

  1. Immunoassay Drug Testing – either laboratory based or at point-of-care* (POC), eg, “rapid cup” testing
  1. Laboratory-Based Specific Drug Identification – eg, gas chromatography/mass spectrometry† (GC/MS) or liquid chromatography/mass spectrometry‡ (LC/MS)
  1. Comprehensive Combination of Techniques – eg, special applications for pain testing

Why Should I Conduct a UDT on My Patients?

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 non-prescribed 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.

What Substances are Tested?

There is a 6 or 12 panel testing option. The 6 panel covers all of the non-illicit drug classes (Barbiturates, Benxodiazepines, 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.

12 panel test

Whom to Test?

  • 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

When 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 – 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.

Coast Diagnostics Work Flow Process-Chart

flowchart

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, Coast Diagnostics 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 Coast Diagnostics 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.