Download Urine Drug Screening

Urine Drug Screening
I.
Policy
Urine Drug Screening (UDS, also known as Urine Drug Testing, or UDT) is performed to detect the
presence in the urine of prescription medications and illegal substances for the purpose of medical
treatment.
UHA recognizes the following definitions within this policy:
Presumptive/Qualitative testing to determine the presence or absence of drugs or drug classes as a Urine
Drug Test; results may be negative, positive, or numeric, and methods may be TLC or immunoassay.
Definitive/Quantitative testing identifies specific medications, illicit drugs, or metabolites [note these are
specific chemical entities, not classes], which are absent or present in ng/ml; and tested by GC-MS or LCMS methods.
Specimen validity testing does not test drugs (or classes) but pH, specific gravity, etc.
II. Criteria/Guidelines
University Health Alliance (UHA) will reimburse for Urine Drug Screening when determined to be medically
necessary and when it meets the medical criteria guidelines (subject to limitations and exclusions) indicated
below.
A. Within the scope of this policy, all Urine Drug Screening is considered medically necessary for the
conditions listed below only when treatment planning by the requesting provider is dependent upon the
test results:
1. Outpatient Pain Management, defined as the medical management of chronic opioid therapy
for non-cancer pain. This policy does not apply to palliative or end of life comfort care.
2. To assess and treat members with substance abuse disorders
B. Outpatient Pain Management:
1. In outpatient pain management, presumptive urine drug testing may be considered medically
necessary within the following limitations:
a. For baseline screening before initiating treatment or at the time treatment is initiated,
when the following conditions are met:
A. An adequate clinical assessment of patient history and risk of
substance abuse is performed;
B. Clinicians have knowledge of test interpretation;
C. There is a plan in place regarding how to use test findings clinically
b. Subsequent monitoring of treatment at a frequency appropriate for the risk level of
the individual patient. The risk-level for an individual patient should include a global
assessment of risk factors and monitoring for the presence of aberrant behavior.
Standardized risk assessment tools are available, such as the 5-item opioid risk tool
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(ORT) and should be used only by clinicians familiar with the inherent limitations of
such tools. UHA allows frequency of repeat UDS as follows:
A. All members on long term opioids: Up to 1 per year
B. Members showing signs of aberrant behavior or opioid dose >90
MED: Up to 4 times per year
A. Aberrant behavior is defined by one or more of the
following:
i.
ii.
iii.
iv.
v.
multiple lost prescriptions,
multiple requests for early refill,
obtained opioids from multiple providers,
unauthorized dose escalation,
Apparent intoxication during previous visits.
C. Testing on date of service when clinical evaluation of the patient
suggests noncompliance or use of non-prescribed medications or
illegal substances. Such testing is not subject to four times a year
limit, but specific, clear documentation of medical necessity is
required and must be available to UHA upon request.
ii.
Documentation must clearly show medical decision
making that supports medical necessity for more frequent
testing and how the results of this testing will impact
clinical treatment decisions.
iii.
In the absence of adequate documentation, payment for
UDS will be denied and may result in a significant financial
burden to the patient. The clinician should discuss the
potential cost with the patient at time of testing.
C. Outpatient substance abuse treatment
1. Urine Drug Testing for the outpatient management of substance abuse, including opioid
abuse, may be considered medically necessary under the following conditions:
a. Baseline screening before initiating treatment program or at the time treatment is
initiated, 1 time per program entry, when the following conditions are met:
i.
ii.
iii.
An adequate clinical assessment of patient history and risk of substance
abuse is performed;
Clinicians have knowledge of test interpretation;
There is a plan in place regarding how to use test findings clinically
2. After patient is established in a substance abuse treatment program, Urine Drug Screening
may be medically once every 1 to 3 months, up to eight random drug tests per year, per
patient.
a. In addition to random drug testing, testing on date of service may be medically
necessary when clinical evaluation of the patient suggests noncompliance or use of
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non-prescribed medications or illegal substances (not subject to eight times a year
limit, but documentation required)
3. Members being tested more often than 8 times a year require documentation in the medical
record of clinical reasoning that clearly shows a need for more frequent testing and how the
results of testing will impact/has impacted clinical treatment decisions.
a. Documentation above must be available to UHA upon request.
b. In the absence of adequate documentation, payment for UDS will be denied and may
result in a significant financial burden to the patient. The clinician should discuss the
potential cost with the patient at time of testing.
D. Definitive (confirmatory) urine drug testing
1. Definitive testing is considered medically necessary only in those instances when the results of
the initial drug screening require information that may result in a change in the evaluation
and/or treatment of patients.
a. In agreement with nationally accepted guidelines, it is the policy of UHA that every
urine drug screen does not require definitive (confirmatory) testing. The results of
presumptive drug screening are often all that is necessary to initiate the
conversations with patients that are an integral part of opioid therapy for treatment of
chronic pain or the treatment of substance abuse.
In outpatient pain management or substance abuse treatment, definitive UDS may be
considered medically necessary under the following circumstances:
i.
There is a positive finding (e.g. presence of a substance not prescribed) on
the presumptive UDS; or
ii.
A negative finding when a positive result is expected on presumptive UDS
(e.g. absence of a prescribed medication); or
iii.
There is no immunoassay test commercially available.
A. When testing is required and meets criteria for medical necessity
for a drug not included in the initial presumptive drug screening
panel, as may be the case for certain synthetic or semi-synthetic
opioids
B. UHA recognizes that many drugs are not available on presumptive
UDS, however this exclusion is not an indication to allow coverage
for definitive testing unless there is a clinical rational for such
testing documented in the patient chart
iv.
Definitive testing should be ordered only after the results of preliminary
testing have been reviewed and, when appropriate, discussed with the
patient and the results of this discussion were not sufficient to answer the
clinical concerns that would make definitive testing unnecessary.
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b. Definitive (confirmatory) UDS must be ordered indicating the specific drug(s) requiring
further testing. (e.g., order the individual substance(s) in question) instead of a
comprehensive confirmatory panel.
NOTE:
This UHA payment policy is a guide to coverage, the need for prior authorization and other
administrative directives. It is not meant to provide instruction in the practice of medicine and it should
not deter a provider from expressing his/her judgment.
Even though this payment policy may indicate that a particular service or supply is considered covered,
specific provider contract terms and/or member’s individual benefit plans may apply, and this policy is
not a guarantee of payment. UHA reserves the right to apply this payment policy to all UHA companies
and subsidiaries.
UHA understands that opinions about and approaches to clinical problems may vary. Question
concerning medical necessity (see Hawaii Revised Statutes §432E-1.4) are welcome. A provider may
request that UHA reconsider the application of the medical necessity criteria in light of any supporting
documentation.
I.
Limitations/Exclusions
The following are not covered services within this policy:
1. Routine presumptive or definitive urine drug testing (e.g., frequent testing without
consideration for specific patient risk factors or without consideration for whether testing is
required for clinical decision making).
2. Unbundled tests when using a multi-test kit screening (e.g. strip, dip card, or cassette)
3. Definitive (confirmatory) testing instead of presumptive drug screening, or as a routine
supplement to presumptive drug screens
4. Any Urine Drug testing orders for "custom profile" or "conduct additional testing as
needed"
5. Definitive (confirmatory) testing that is indiscriminately carried out without a positive or
unexpected negative result on initial presumptive screening.
6. Definitive (confirmatory) testing ordered prior to clinician review of the results of initial
presumptive testing and, when appropriate, discussion of results with patient.
7. Testing ordered by third parties, such as school, courts, athletic programs, or employers
(as a pre-requisite for employment or as a requirement for continuation of employment);
or requested by a provider for the sole purpose of meeting the requirements of a third
party.
8. Testing for residential monitoring.
9. UHA will allow one unit of service for presumptive testing per patient encounter regardless
of the number of drug classes tested.
10. Definitive (confirmatory) testing is limited to four (4) units per date of service regardless of
the number of analytes tested.
11. Definitive (confirmatory) urine drug testing will be denied when no underlying preliminary
test has been performed
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12. UHA does not reimburse for UDS result interpretation or supplies; as such service is
considered a routine part of a patient care visit.
13. UHA does not reimburse for Specimen Validity Testing. (pH, specific gravity, creatinine,
urinalysis).
II. Administrative Guidelines
A. Prior Authorization is not required.
B. For presumptive urine drug screening, UHA recognizes (Codes) 80300, 80301 only
1. UHA will reimburse one unit with a flat fee for each code per date of service when the above
criteria are met.
C. Definitive (Confirmatory) Testing:
1. For Confirmatory Testing, UHA recognizes the codes for specific metabolites from the list
below.
a. Coverage is limited to four codes per date of service
b. Frequent use of this code will be monitored for appropriateness.
D. UHA does not pay for testing for Specimen Validity Testing (i.e. pH, Creatinine, specific gravity)
CPT
80300
80301
CPT
80184
80299
80320
80321
80323
80324
80327
80329
80332
80335
Presumptive Urine Drug Screening Codes
Description
Drug screen, any number of drug classes from Drug Class List A; any number of non-TLC devices or
procedures, (eg, immunoassay) capable of being read by direct optical observation, including
instrumented-assisted when performed (eg, dipsticks, cups, cards, cartridges), per date of service
Drug screen, any number of drug classes from Drug Class List A; single drug class method, by
instrumented test systems (eg, discrete multichannel chemistry analyzers utilizing immunoassay or
enzyme assay), per date of service
Definitive (Confirmatory) Testing Codes
Description
Phenobarbital
Quantitation of therapeutic drug, not elsewhere specified
Alcohols
Alcohol biomarkers; 1 or 2
Alkaloids, not otherwise specified
Amphetamines; 1 or 2
Anabolic steroids; 1 or 2
Analgesics, non-opioid; 1 or 2
Antidepressants, serotonergic class; 1 or 2
Antidepressants, tricyclic and other cyclicals; 1 or 2
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80338
80339
80342
80345
80346
80348
80349
80350
80353
80354
80355
80356
80357
80358
80359
80360
80361
80362
80365
80366
80367
80368
80369
80371
80372
80373
80374
80375
83789
83986
83992
84311
Antidepressants, not otherwise specified
Antiepileptics, not otherwise specified; 1-3
Antipsychotics, not otherwise specified; 1-3
Barbiturates
Benzodiazepines; 1-12
Buprenorphine
Cannabinoids, natural
Cannabinoids, synthetic; 1-3
Cocaine
Fentanyl
Gabapentin, non-blood
Heroin metabolite
Ketamine and norketamine
Methadone
Methylenedioxyamphetamines (MDA, MDEA, MDMA)
Methylphenidate
Opiates, 1 or more
Opioids and opiate analogs; 1 or 2
Oxycodone
Pregabalin
Propoxyphene
Sedative hypnotics (non-benzodiazepines)
Skeletal muscle relaxants; 1 or 2
Stimulants, synthetic
Tapentadol
Tramadol
Stereoisomer (enantiomer) analysis, single drug class
Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3
Mass spectrometry and tandem mass spectrometry (eg, MS, MS/MS, MALDI, MS-TOF, QTOF), nondrug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen
pH; body fluid, not otherwise specified
Phencyclidine (PCP)
Spectrophotometry, analyte not elsewhere specified
III. Policy History
Policy Number: M.DIA.05.140715
Current Effective Date: 02/01/2016
Original Document Effective Date: 07/15/2014
Previous Revision Dates: 11/07/2014, 11/15/2014, 02/01/2016
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2015 CPT® Presumptive Drug Class Screening
2015 CPT® Definitive Drug Testing
Includes immunoassays, enzymatic methods,
chromatographic methods without mass spectrometry,
mass spectrometry without adequate drug resolution by
chromatography, etc.
Includes methods such as:GC with mass spectrometry (any type). Any metabolites of the tested drugs
Process must be able to identify individual drugs
Process that distinguishes between structural isomers
80300-80304
80320-80377
CPT® 80301 reports single drug classes included with Drug Class List A using direct optical observation or an instrumented system such as a multichannel
chemistry analyzer/enzyme assay (e.g., EIA, KIMS, CEDIA immunoassays). Code 80301 is reported once per date of service, regardless of the number of
procedures performed, number of classes analyzed, or results obtained. (Generally this would be the type of testing performed in a hospital-based laboratory.)
CPT® 80302 is used for presumptive, single drug classes other than those in Drug Class List A, (i.e., Drug Class List B). CPT® 80302 does not use direct optical
observation or thin layer chromatography (TLC). Code 80302 does require the use of immunoassays or chromatography without mass spectrometry. It’s reported
for each drug class or procedure performed.
CPT® 80303 is used for presumptive, single or multiple drug class method; thin layer chromatography (TLC) procedures (e.g., acid, neutral, alkaloid plate), per
date of service.
CPT® 80304 reports single or multiple drug screenings not specified elsewhere. Examples include: TOF, MALDI, LDTD, etc. See the CPT® codebook for
additional examples.
CPT® 80300 reports single or multiple drug class process
using dipsticks, cups, or cassettes – with or without the
use of an instrument to complete the interpretation. Code
80300 is reported one time, regardless of the number of
direct observation done/obtained on any date.
For example, 80320 class of drugs is Alcohol(s). Drugs included are acetone, ethanol, ethchlovynol,
ethylene glycol, isopropyl alcohol, and methanol.Codes 80324-80326 class of drugs are
Amphetamines. Drugs included are amphetamine, ephedrinelisdexamphetamine, methamphetamine,
phentermine, phenylpropanolamine, and pseudoephedrine.For a complete listing of the 59 codes in
the Definitive Drug Classes Listing, refer to the 2015 Professional Edition CPT® codebook (beginning
on page 474).
Based on the latest information from Medicare, providers may be required to use these CPT® codes for commercial payers, and
Medicare G codes to report qualitative and quantitative drug screens for Medicare beneficiaries. At the November 2014
American Medical Association (AMA) CPT® 2015 Symposium, Centers for Medicare & Medicaid Services (CMS) officials
presented numerous G codes created for 2015. CMS’ overall position is that when the timing of a CPT® code creation precludes
adequate time for consideration of comments and Relative Value Update Committee valuation, they will implement or default to
using a G code(s). In the 2015 Medicare Physician Fee Schedule (MPFS) final rule, CMS indicated they would also create a G
code if the revisions and/or deletions to CPT® may affect the code’s relative value units. CMS said they would also add a G code
whenever AMA separated a single CPT® code into two CPT® codes.
In the 2015 MPFS final rule, CMS said:
These codes represent various drug screening codes, many of which are specific to individual drug testing. While we appreciate
the recommendations for these tests, we are concerned about the potential for overpayment when billing for each individual drug
test rather than a single code that pays the same regardless of the number of drugs that are being tested for. Therefore, it is our
recommendation to delay pricing for these codes at this time, until further information and education is obtained.
As of late December 2014, CMS had not yet released the clinical lab fee schedule for 2015. Stay tuned for additional updates as
we learn more on how Medicare and other payers plan to respond to these extensive changes. Because Addendum B of the final
Medicare rule contains the established urine drug screen codes (G0434 Drug screen, other than chromatographic; any number
of drug classes, by CLIA waived test or moderate complexity test, per patient encounter and G0431 Drug screen, qualitative;
multiple drug classes by high complexity test method (eg, immunoassay, enzyme assay), per patient encounter), plus 28 new
HCPCS Level II codes for drug assay and confirmation, such as G6031 Benzodiazepines, G6045 Dihydrocodeinone, and
G6058 Drug confirmation, each procedure, it’s likely that CMS will default to using G codes for drug screening/testing in 2015.
For commercial payers, use the 2015 CPT® codes unless advised otherwise.
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According to Barthwell, Palmetto, a CMS claims processing contractor overseeing one of the 10 CMS jurisdictions, has adopted
a new urine-testing reimbursement model for its region, which she predicts will ultimately become the nationwide standard. The
model does not allow for additional reimbursement when an immunoassay test at a lab is used to confirm a test from the point of
care.
“What drug treatment programs must be aware of is that the guidance from Palmetto does not allow the use of a presumptive
test to confirm a presumptive test,” Barthwell tells Behavioral Healthcare.
For example, if at the point of care, a clinician processes a dipstick type of test and a lab also completes a test to confirm that
result, both testing providers cannot bill for that service.
“It’s been written into the regulation now that that would be disallowed,” she says. “We have indications that it’s going to be
adopted across the country.”
She believes the Palmetto model is being viewed as guidance that all the other CMS jurisdictions will follow in how they
reimburse for urine drug testing. And it’s the lab’s jurisdiction that determines the rules the provider would need to follow.
Barthwell advises that treatment centers confirm with their lab partners whether or when the new guidance will be adopted. It's
already policy in the Palmetto jurisdiction.
“You are responsible for knowing how to be in compliance with the laws you operate under,” she says. “For the folks I’m working
with, I advise to err on side of caution and act as if this policy is adopted.”
At this point, the regulations can only be enforced for Medicare and Medicaid claims, however, Barthwell cautions that
commercial payers tend to ride on the coattails of CMS and adopt the same policies.
“The trend always is that CMS sets the standard and then commercials tend to follow, which is why we pay attention to what
CMS is doing,” she says.
Four tiers
In her testimony, Barthwell also recommended that CMS adopt Palmetto’s tiered structure for testing:

Tier I permits testing for up to 7 drugs, and prices are determined by individual drug testing codes (CPT/G-codes);

Tier II allows testing for 8 to 15 drugs at a flat rate of $180;

Tier III permits testing for 16 to 34 drugs for approximately $215;

Tier IV allows testing for 35 or more drugs at a capped rate of $250. Adoption of this code would allow a laboratory to
report all available information when ordered.
“Pricing should correlate with the value of the service provided to ensure that clinicians use drug testing appropriately in the
treatment of their patients and valuable healthcare dollars are efficiently allocated,” she said at the hearing.
The new CPT codes are divided into 3 classifications: Therapeutic Drug Assay, Drug Assay and
Chemistry. The Drug Assay codes are further differentiated into two categories. The Presumptive Drug
Class codes are used to identify possible use or non-use of a drug. The Definitive Drug Class describes
qualitative or quantitative tests to identify possible use or non-use of a drug. The Definitive Drug Class
codes describe specific drugs and their associated metabolite(s).
The Presumptive Drug Class Screening codes (80300-80304) are based on a List of Drugs that is
included in CPT. Definitive Drug Testing codes (80320-80377) and common analytes are noted in a
separate table in CPT for easy identification. The Therapeutic Drug Assays (80150-80299) are used to
monitor clinical response to a known prescribed medication. These codes are specific to the medication.
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