The document discusses the current regulatory environment and auditing practices for urine drug testing. It provides an overview of the history of urine drug testing and the regulatory guidelines around coding, indications for services, and testing frequency requirements. It outlines best practices for compliance with billing codes and documentation requirements to pass audits. Key points include assigning patients a risk level, individualizing testing frequency based on risk, and documenting medical necessity for each test ordered.

1. The Current Regulatory
Environment and Auditing
of Urine Drug Testing
JENNIFER BRIDGEFORTH – PYA, P.C.
MBA, CPHT, CPC®, CPMA
SARAH BOWMAN – PYA, P.C.
MBA, RHIA, CHC
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2. About PYA
2
PYA, P.C. is a national healthcare advisory services firm
providing consulting, audit, and tax services including:
 Regulatory compliance
 Risk assessments
 IT advisory
 Mergers and
acquisitions due
diligence
 Fair market value
assessments
 Business valuations
 Strategic planning
 Operations
optimization
 Tax, audit, and
assurance

3. Agenda
 History of Urine Drug Testing (UDT)
 UDT coding guidelines
 Indications for services
 UDT frequency and provider documentation requirements
for Chronic Opioid Therapy (COT) treatment
 UDT best practice tips and audit checklist
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4. History of UDT
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5. History
5
Opioid epidemic
Increased demand for UDT
Increased lab revenue/payer cost
Increase in payer audits and denials
Concern for potential overuse of drug testing

6. UDT Continuum
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2.
Physician
orders
test(s)
3.
Lab receives
order and
performs test(s)
1.
Patient
sees
physician

7. UDT Coding Guidelines
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8. Presumptive vs. Definitive
Presumptive screens for drug classes rather than individual drugs:
 Usually performed in the office
 Results are immediate
 Since 2018 coding is the same for commercial and Medicare
Definitive identifies individual drugs:
 Performed in laboratory setting
 Since 2018 coding varies based on payer
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9. Presumptive UDT Coding: All Payers
Medicare and Commercial Plans
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Code Description
80305 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable
of being read by direct optical observation only (e.g., utilizing immunoassay [e.g., dipsticks, cups, cards,
or cartridges]), includes sample validation when performed, per date of service
80306 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; read by
instrument-assisted direct optical observation (e.g., utilizing immunoassay [e.g., dipsticks, cups, cards,
or cartridges]), includes sample validation when performed, per date of service
80307 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; by
instrument chemistry analyzers (e.g., utilizing immunoassay [e.g., EIA, ELISA, EMIT, FPIA, IA, KIMS,
RIA]), chromatography (e.g., GC, HPLC), and mass spectrometry either with or without
chromatography (e.g., DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF)
includes sample validation when performed, per date of service

10. Definitive UDT Coding: Medicare
The number of “drug classes” is used to select the correct code.
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Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and
distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to
GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays
(e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods [e.g., alcohol dehydrogenase]), (2) stable isotope
or other universally recognized internal standards in all samples (e.g., to control for matrix effects,
interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-
matched quality control material (e.g., to control for instrument variations and mass spectral drift);
qualitative or quantitative, all sources, includes specimen validity testing, per day:
HCPCS code G0480 1 – 7 drug class(es), including metabolite(s) if performed
HCPCS code G0481 8 – 14 drug class(es), including metabolite(s) if performed
HCPCS code G0482 15 – 21 drug class(es), including metabolite(s) if performed
HCPCS code G0483 22 or more drug class(es), including metabolite(s) if performed

11. Definitive UDT Coding: Commercial
Commercial Plan
 Check payer’s policy guidelines.
o If payer follows Medicare guidelines:
o Use Medicare coding method (G-codes)
o If payer follows CPT:
o Select CPT code per Definitive Drug Classes Listing
o CPT codes 80320 – 80377
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Source: CY 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determination

12. Drug Class: Defined
 Medicare = CPT
 Medicare’s classification of drug class is the same as the “Definitive
Drug Classes Listing” in the 2018 CPT Manual
 Total of 36 drug classes
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Source: CY 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determination

13. Drug Class: Defined (cont.)
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Source: CY 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determination

14. Drug Class: Defined (cont.)
What is the definition of “drug class?”
 Palmetto’s Local Coverage Determination (LCD) (L35724) could lead
providers to understate the number of drug classes
o Tramadol is listed under the drug class “opioids”
o In CPT, Tramadol is classified as a drug class
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15. Drug Class: Defined (cont.)
Example from Palmetto LCD L35724 – Controlled Substance
Monitoring and Drugs of Abuse:
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Source: L35724 - Controlled Substance Monitoring and Drugs of Abuse.
Opiates
Codeine Tylenol® 3
Hydrocodone Hycodan®, Lorcet®, Lortab®, Norco®,
Vicodin®, Vicoprofen®
Hydromorphone Dilaudid®, Exalgo®, Hymorphan
Morphine Avinza®, Kadian®, MS Contin®, MSER,
MSIR, Roxanol
Oxycodone OxyContin®, OxyIR®, Percocet®,
Percodan®, Roxicodone®, Tylox®
Oxymorphone Numorphan®, Opana® ER, Opana®
Opioids
Buprenorphine Buprenex®, Butrans®, Suboxone®,
Subutex®
Fentanyl Actiq®, Duragesic®, Fentora®, Onsolis®,
Sublimaze
Meperidine Demerol®, Mepergan®
Methadone Dolophine®, Methadose®
Propoxyphene Darvocet®, Darvon®
Tapentadol Nucynta®
Tramadol Rysolt®, Ultracet®, Ultram®, Tramadol

16. Indications for Services
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17. Indications for Services
 Majority of LCDs are broken down by Groups
o Group A
o Symptomatic patients
o Multiple drug ingestion
o Patients with unreliable history
o Group B
o Diagnosis and treatment for substance abuse or dependence
o Group C
o Treatment for patients on COT
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18. Indications for Services (cont.)
 Group A: Symptomatic patients, multiple drug ingestion and/or
patients with unreliable history
o Coma
o Altered mental status in absence of clinically defined toxic syndrome or
toxidrome
o Severe or unexplained cardiovascular instability (cardiotoxicity)
o Unexplained metabolic or respiratory acidosis in the absence of a clinically
defined toxic syndrome or toxidrome
o Seizures with an undetermined history
o To provide antagonist to specific drug
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19. Indications for Services (cont.)
 Group B: Diagnosis and treatment for substance abuse or dependence
o Patient in active treatment for substance use disorder (SUD) or monitoring
across different phases of recovery
o Provider is writing prescriptions for medications to treat SUD or other
conditions may need to know if patient is taking substances which can interact
with prescribed medications or taking medications as expected
o UDT is medically necessary and useful for treatment
o UDT frequency is based on number of consecutive days of abstinence
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20. Indications for Services (cont.)
 Group C: Treatment for patients on COT
o Provider is writing prescriptions for medications to treat chronic pain
o Denials for UDT services related to this category are common
o COT UDT Testing Objectives include:
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o Identifies absence of prescribed
medication and potential for abuse,
misuse, and diversion
o Identifies undisclosed substances, such
as alcohol, unsanctioned prescription
medication, or illicit substances
o Identifies substances that contribute to
adverse events or drug-drug interactions
o Provides objectivity to the treatment plan
o Provides additional documentation
demonstrating compliance with patient
evaluation and monitoring
o Provides diagnostic information to help
assess individual patient response to
medications (e.g., metabolism, side-effects,
drug-drug interaction, etc.) over time for
ongoing management of prescribed
medications

21. UDT Frequency and
Provider Documentation
Requirements for COT Treatment
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22. Medical Necessity Guidance
 Must be based on patient-specific elements identified during the
clinical assessment
 Must be documented by clinician in patient’s medical record and
minimally include:
o Patient history, physical exam, and previous laboratory findings
o Current treatment plan
o Prescribed medication(s)
o Risk assessment plan, using a validated risk assessment and stratification tool
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23. Medical Necessity Guidance (cont.)
 Best Practice Tip: Assign patients to a Low, Moderate, or High-Risk
Category based on results
o This approach is in line with six out of eight Medicare Administrative Contractors
(MACs) LCDs for UDT services and provides frequency guidance based on risk
category assignment
o Recommend that each encounter note reflect risk level assignment and indicate
criteria for placing in assigned risk category
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24. Medical Necessity Guidance (cont.)
 Risk level assignment is ultimately based on the clinician's
interpretation of results listed on previous “best practice tips” slides
 Documentation example:
o Patient assigned to Moderate Risk Group due to:
o Results from Opioid Risk Tool (ORT) – validated risk assessment tool
o Heavy tobacco use
o Receiving treatment for depression
o Prescription regimen consist of concurrent use of opioids and benzodiazepines
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25. Medical Necessity Guidance (cont.)
 Examples of validated risk assessment tools and risk factors include
the following:
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3200070/

26. UDT Frequency Associated with Risk
 All payers depend on documentation to support medical necessity
 Baseline UDT is standard practice
o Predicts future compliance and illicit drug use problems
 Ongoing testing frequency varies between payers as well as MACs
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Source: https://www.painphysicianjournal.com/2012/july/2012;15;ES119-ES133.pdf
https://www.nhms.org/sites/default/files/Pdfs/UrineDrugTestingguide.pdf

27. UDT Frequency
Associated with Risk (cont.)
 Subsequent testing is allowed (as shown in the following slide) for the
MACs listed below:
o CGS Administrators
o First Coast Service Options
o Palmetto GBA
o Noridian Healthcare Solutions
o National Government Services (NGS)
 Confirm payer guidelines
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28. UDT Frequency
Associated with Risk (cont.)
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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
Random testing 1 – 2 times every 6 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
Random testing 1 – 3 times every 3 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

29. UDT Frequency
Associated with Risk (cont.)
 Novitas Solutions and WPS Health Solution (WPS) are not as detailed
regarding UDT Frequency compared to other MACs
 Testing frequency must be based on clinician’s documented medical
necessity
 If UDT services are denied, then APPEAL to prove medical necessity
o Very common for these services to be denied
o Second level appeal (Reconsideration) is often necessary
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30. Non-Routine Indications for UDT
 Frequency should not exceed MAC’s recommended guidance
unless other reasons are identified and documented such as:
o Patient response to prescribed medication suddenly changes
o Patient side effect profile changes
o To assess for possible drug-drug interactions
o Sudden change in patient’s medical condition
o Patient admits to use of illicit or non-prescribed controlled substance
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31. UDT Best Practice Tips
and Audit Checklist
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32. UDT Best Practice Tips:
Billing Compliance
 Perform risk screening and assign individual risk level prior to initiation
of treatment
 Individualize UDT frequency based on patient’s risk level
 Document patient’s risk level and reason patient is assigned to risk level.
 Review/create a workflow process for random testing
 Do not order a UDT on every patient at every visit
 Only order UDT for baseline testing, random testing based on risk level
assignment, or if patient is exhibiting aberrant behavior
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33. UDT Audit Checklist
This checklist is not intended to be all-inclusive; each claim is given individual consideration
for coverage
The following basic documentation requirements are easily identifiable:
 Beneficiary name on ALL documentation, including cover letters explaining medical necessity
 Date of service
 Medical record reflects the CPT/HCPCS code(s) billed
 Legible signature of ordering/rendering provider (send signature log or attestation if not legible)
 The covered indication is easily identifiable (additional requirements to follow based on selection)
 Group A - Symptomatic patients, multiple drug ingestion, and/or patients with unreliable history
 Group B - Diagnosis and treatment for substance abuse or dependence
 Group C - Treatment for patients on COT
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34. UDT Audit Checklist – Group A
Group A – Symptomatic patients, multiple drug ingestion, and/or patients with unreliable
history
Patient presented with one of the following:
 Coma
 Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome
 Severe or unexplained cardiovascular instability (cardiotoxicity)
Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome
or toxidrome
 Seizures with an undetermined history
 To provide antagonist to specific drug
Patient’s medical record must include:
 The presumptive findings, definitive drug tests ordered and reasons for the testing
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35. UDT Audit Checklist – Group B
Group B – Diagnosis and treatment for substance abuse or dependence
Patient is:
 In active treatment for SUD or monitoring across different phases of recovery
Patient’s medical record must include:
 Appropriate testing frequency based on the stage of screening, treatment, or recovery
 Recommend documenting the number of days that patient has remained abstinent from drugs since
the above is based on this number
 Rationale for the drugs/drug classes ordered
 Results must be documented in the medical record and used to direct care
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36. UDT Audit Checklist – Group C
Group C – Treatment for patients on COT
Patient presented for:
 Treatment of chronic pain
Patient’s medical record should minimally include the following elements:
 Patient history, physical examination, and previous laboratory findings
 Current treatment plan
 Prescribed medications
 Risk assessment plan
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37. LCD References
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MAC LCD # LCD Name
CGS L36029 Controlled Substance Monitoring and Drugs of Abuse Testing
First Coast L36393 Controlled Substance Monitoring and Drugs of Abuse Testing
Novitas L35006 Controlled Substance Monitoring and Drugs of Abuse Testing
WPS L34645 Drug Testing
Palmetto L35724 Lab: Controlled Substance Monitoring and Drugs of Abuse Testing
Noridian - JF L36668 Lab: Controlled Substance Monitoring and Drugs of Abuse Testing
Noridian - JE L36707 Lab: Controlled Substance Monitoring and Drugs of Abuse Testing
NGS L36037 Urine Drug Testing

38. References
All LCDs for UDT Services: https://www.cms.gov/medicare-coverage-database
CY 2016 Clinical Laboratory Fee Schedule (CLFS) Final Determination (confirms
Medicare’s definition of drug class): https://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.htm
CMS: Opioids CDC Online Training Series (CDC’s recommendations in clinical
setting): https://www.cms.gov/Outreach-and-
Education/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2018-04-
05-eNews.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending#_Toc510531379
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39. Questions?
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40. Thank You!
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Jennifer Bridgeforth
MBA, CPhT, CPC®, CPMA®
Senior Consultant
PYA
jbridgeforth@pyapc.com
Sarah Bowman
MBA, RHIA, CHC
Senior Manager
PYA
sbowman@pyapc.com

41. SAVE THE DATES!
41
September 20-23, 2020
AHIA 39th
Annual
Conference
Sheraton Seattle Hotel