All laboratory testing sites are regularly monitored to safeguard against unintentional violations of federal compliance guidelines. Monitoring activities are also aimed at raising awareness of federal guidelines and assisting in developing mechanisms for successfully meeting them.
Staying Reasonable with your Drug Screens and Testing. It has become increasingly common for practitioners of all specialties to routinely test for the presence of both legal and illegal substances before prescribing certain medications such as opiates for pain control and to monitor patients who are on chronic opiate therapy for long term pain management. CMS effectively killed this "cash cow" by code revisions and single unit billings and are now taking additional steps to combat abuses on testing that lacks actual necessity to manage the patient's treatment.
This discussion paper is a supplement to our March 2014 release and prompted by additional CMS carrier general audit policies on the frequency of testing and challenges to its "necessity". We must focus on their increased scrutiny and enforcement that coverage is dependent on proper documentation of your clinical decision-making and written test orders that are tailored to the individual patient's medical needs. Carriers frequently invoke 42 CFR Section 410.32 to deny testing based on an absence of a written order and/or lack of documentation that the testing and the results are reasonable and necessary for proper case management. For the most part, our members test prior to or during chronic pain management cases using opioid therapy of some type and therefore should be aware of the conditions specific to Treatment for patients on chronic opioid therapy (COT).
A Provider who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, efficacy, side effects, and patient safety in general.
In Keeping with these identified objectives, we suggest, at a minimum, you include in your documentation statements of necessity such as the ones provided below:
New Patient - Established Patient with initial New Order I am ordering baseline UDT prior to prescription of narcotics for pain to identify any undisclosed medications or substances that could potentially lead to adverse interactions or compromise efficacy of care. We will specifically screen for AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, TCA, THC using a CLIA waived UDT. Confirmatory, qualitative testing will be performed based on results.
Periodic Radom Testing: We are performing a random precautionary monitoring UDT today to assess the patient for presence of prescribed medications, non-prescribed medication and illicit substances that may pose a safety risk if taken with prescribed medications. We will specifically screen for AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MTD, OPI, OXY, TCA, THC using a CLIA waived UDT Confirmatory, qualitative testing will be performed based on results.
These statements are examples of justification statements for initial and periodic monitoring tests. They will vary by circumstance and should be modified by the test being used and, if applicable the substance analytes.
Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patient's medical record and minimally include the following elements:
National pain organizations, physician societies, and the Federation of State Medical Boards recommend a practical approach to definitive UDT for COT. Frequency of testing beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patient's medical record.
Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:
Initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or "designer" drugs.
Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, selfescalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern. The frequency of testing must be based on a complete clinical assessment of the individual's risk potential for abuse and diversion using a validated risk assessment interview or questionnaire and should include the patient's response to prescribed medications and the side effects of medications. The clinician should perform random UDT at random intervals, in order to properly monitor a patient. UDT testing does not have to be associated with an office visit. Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this document's guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.
UDT Frequency Based on Validated Risk Assessment and Stratification*: Testing must be based on clinician's documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.
|Risk Group||Baseline||Frequency of Testing|
|Low Risk||Prior to Initiation of COT||Random testing 1-2 times every 12 months for prescribed medications, non-prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.|
|Moderate Risk||Moderate Risk||Random testing 1-2 times every 6 months for prescription medications, non-prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.|
|High Risk||Prior to Initiation of COT||Random testing performed 1-3 times every 3 months for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.|
Monthly testing is NOT considered reasonable or necessary by Medicare and many other carriers and billing a monthly screen before you write the new prescription will probably trigger an audit or at least an additional documentation request.
Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical record in situations in which changes in prescribed medications may be needed, such as:
Most testing for any form of drug monitoring will fall to one of these new codes.
Z51.81 Encounter for therapeutic drug level monitoring
Z79.891 Long term (current) use of opiate analgesic
Z79.899 Other long term (current) drug therapy
Substance ABUSE is coded in the F10-F19 section of the ICD-10.F10. - Mental and behavioral disorders; due to use of alcohol
|F11.20||Opioid dependence, uncomplicated|
|F11.220||Opioid dependence with intoxication, uncomplicated|
|F11.221||Opioid dependence with intoxication delirium|
|F11.222||Opioid dependence with intoxication with perceptual disturbance|
|F11.229||Opioid dependence with intoxication, unspecified|
|F11.23||Opioid dependence with withdrawal|
|F11.24||Opioid dependence with opioid-induced mood disorder|
|F11.250||Opioid dependence with opioid-induced psychotic disorder with delusions|
|F11.251||Opioid dependence with opioid-induced psychotic disorder with hallucinations|
|F11.259||Opioid dependence with opioid-induced psychotic disorder, unspecified|
|F11.281||Opioid dependence with opioid-induced sexual dysfunction|
|F11.282||Opioid dependence with opioid-induced sleep disorder|
|F11.282||Opioid dependence with other opioid-induced disorder|
|F11.29||Opioid dependence with unspecified opioid-induced disorder|
|F19.20||Other psychoactive substance dependence, uncomplicated|
We suggest you look to carrier policies under; Drugs of Abuse Testing, Qualitative Drug Testing; Controlled Substance Monitoring and Drugs of Abuse Testing Or Urine Drug Screening.
Carrier publications and policies are often under different titles.
A signed and dated physician order for clinical drug screening and/or testing is a key element the medical record and the clinical decision-making based thereon. Documentation is important to the billing and claims for reimbursement of clinical laboratory services. Copies of the test results alone without a proper clinician order for the test are not sufficient documentation to support a claim for the testing services.
The physician order must specifically match the number, level, and complexity of the testing panel components performed. Orders for "custom profiles", "standing orders" or "orders to conduct additional testing as needed" are typically not sufficiently detailed and thus cannot be used to verify the medical necessity for the specific tests the ordering clinician intended to be performed.
From a post drug testing payment review prospective, an order from a non-qualified person (i.e. lab technician, front office personnel, sales rep), or one lacking the documentation required to verify that the billed tests were specifically ordered and medical necessary and reasonable may result in overpayment.
All documentation must be maintained in the patient's medical record and available to the contractor upon request. The following additional documentation requirements apply: