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Appropriate Number

of Definitive Drug

Classes to Test in

Outpatient Settings

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Contents

How many different definitive drug

classes should be tested?

Drug Use in the United States

Trends in Prescriptions of Opioids in the

U.S.

Definitive Drug Testing

What is the average number of drug

classes prescribed per individual for

which definitive testing would be

indicated?

What proportion of definitive urine

drug tests rendered by providers

consists of more than 7 drug classes?

Guidelines

References

Appendices

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Appropriate Number of Definitive Drug Classes to Test in Outpatient Settings of 29

How many different drug classes should be tested definitively?

Urine drug testing (UDT) is an important patient monitoring tool designed to help with monitoring

prescription opioid therapy, screening for illicit drug use, and monitoring compliance with treatment

programs. Historically commonly abused drugs are known as SAMHSA-5, a group targeted in

federally regulated testing programs, including amphetamines, cannabinoids, cocaine, opiates, and

phencyclidine (PCP). Additional categories that may be screened for according to SAMHSA’s

(Substance Abuse and Mental Health Services Administration) website include benzodiazepines,

alcohol, opioids, and MDMA. Several national and state guidelines also exist to assist physicians with

prescribing and monitoring opioids. Often, such guidelines recommend that a presumptive urine

drug screen be performed first, and then, based on the results of the presumptive tests, additional

definitive urine drug testing should be performed to confirm the results of the screening results. Not

every presumptive urine drug test result needs to be confirmed since confirmation is needed only in

the face of unexpected screening results. In the specific case of chronic opioid therapy monitoring,

urine drug testing is just one of the available tools for patient management available to clinicians;

generally, urine drug testing results must be used in conjunction with professional judgement and

other opioid risk assessment tools (eg. Screener and Opioid Assessment for Patients in Pain, a 24-

item tool).

How large a panel of drugs to test for in

assessing a patient is a commonly asked

question. Use of too small a panel risks

missing clinically important exposures to

dangerous substances, yet too large a

panel leads to great unnecessary

expense, collection of information that is

not actionable, and other pitfalls

associated with over-testing, such as an

increasing risk of false-positive results.

Clearly, assessment of the more than one

thousand FDA-approved drugs or the

millions of known distinct chemical

entities is excessive, but less guidance

points one towards the correct number to

screen or confirm in any specific patient.

Basic clinical judgment, in combination with data from studies assessing patterns of abuse and

misuse, must therefore be employed in arriving at an answer to the question of the optimal size of

drug testing panels.

Use of too small a panel risks missing

clinically important exposures to

dangerous substances, yet too large a

panel leads to great unnecessary

expense, collection of information that is

not actionable, and other pitfalls

associated with over-testing, such as an

increasing risk of false-positive results.



Overall, in the clinical approach to assessing

potential misuse or abuse of substances,

barring specific medical/prescription

information about an individual patient, it is

highly unlikely that clinicians would need to

assess the presence or concentrations of more

than 7 different drug classes in their patients,

for three main reasons. First, very few patients

are prescribed more than 4 drug classes

simultaneously that require monitoring, such as

opioids. Second, patients tend to abuse or

misuse those drug classes with which they have

prior experience, addiction or dependence,

such as opiates or stimulants. Third and finally,

Bayesian interpretation of screening results

dictates that only those screening results that conflict with the initial clinical impression should be

confirmed with definitive testing. Thus, in a hypothetical patient who is being monitored during a

course of office-based opioid replacement therapy with buprenorphine, it would be most clinically

sound and efficient to screen for SAMHSA-5 drugs as well as relevant opioids, and only to confirm

with definitive testing those screening results that were unexpected; as the likely unexpected

findings would be opioids, benzodiazepines or

stimulants in these patients, definitive testing

confirmation of more than two or three drugs

would be rare, and certainly definitive testing

confirmation of more than 7 drug classes would be

difficult to support on clinical grounds. Very large

panels of definitive drug tests performed without

any prior screening tests are likewise lacking in a

clinical rationale, and there is a paucity of data

supporting such panels’ clinical superiority over

standard sequential screening-confirmation

strategies. Similar logic applies to testing for drugs

of abuse in the other clinical situations outlined

above, and it is for this reason that definitive

testing for over 7 drug classes in a single setting

does not meet criteria for medical necessity.

Drug Use in the United States

According to the 2016 National Survey on Drug Use and Health (NSDUH), as many as 28.6 million

Americans 12 or older used an illicit drug in the last 30 days, which corresponds to 10.6% of

Americans overall and 25% for young adults from 18 to 25. The 2016 NSDUH also states that 11.8

million misused opioids in the previous year, with 11.5 million misusing prescription pain relievers.

Approximately 8.2 million adults had a concurrent mental illness and substance abuse disorder in

the previous year (SAMHSA, 2017). A drug of abuse (DOA) may be defined as “a drug, chemical, or

plant product that is known to be misused for recreational purposes”, which can include drugs, such

It is highly unlikely that clinicians

would need to assess the

presence or concentrations of

more than 7 different drug

classes in their patients.

Large drug panel screening lacks

clinical superiority over standard

sequential screening-

confirmation strategies.



as pain relievers, that have legitimate prescriptions.

Drug testing may be performed for several reasons.

For example, patients in certain areas, including

pain management, substance abuse treatment, and

psychiatric treatment, have a higher propensity for

substance abuse and must be monitored as such

(Hoffman, 2018).

According to the CDC, in 2016, a 21.5% increase in

the number of age-adjusted rate of drug overdose

deaths occurred, and 66.4% of all drug overdose

deaths involved the use of opioids (CDC, 2017a).

The CDC monitors the number of deaths and

nonfatal overdoses of opioids in four categories

(CDC, 2017b):

Natural/semi-synthetic opioids, such as

morphine and oxycodone, respectively

Methadone

Synthetic opioids other than methadone

Heroin

Trends in Prescriptions of Opioids in the U.S.

The overall trend in annual opioid prescribing rates have been falling from the peak in 2012 of 81.3

prescriptions per 100 persons to 58.5 in the most recently reported year (2017) (CDC, 2017c).

Appendix A contains the map showing the relative rate of prescriptions of opioids by state in 2017

with the highest rate (107.2 per 100

persons) reported in Alabama and the

lowest rate in the District of Columbia

(28.5 per 100 persons) (CDC, 2017e). The

rate of prescriptions, however, does not

reflect the relative rate of reported deaths;

for example, Alabama reported an age-

adjusted rate of 16.2 deaths per 100,000

whereas the District of Columbia had a

significantly higher rate of 38.8 deaths per

100,000 (CDC, 2017a). Appendix B

contains the map of the U.S. with the age-

adjusted rate of drug overdose by state in

2017 as reported by the CDC (CDC, 2017a,

2018).

DOA screening varies in composition

between countries. In the U.S., the typical

DOA screening tests for amphetamine,

cocaine, marijuana/tetrahydrocannabinol

2016 NSDUH

25% of Americans 18-25

years old used an illicit substance

within the past 30 days

50

55

60

65

70

75

80

85

2006 2008 2010 2012 2014 2016

Opioid Prescriptions in the United StatesData from the 2018 CDC Annual Surveillance Report

of Drug-Related Risks and Outcomes

Year



(THC), opioids, and phencyclidine (PCP) as included in the United States’ Drug-Free Workplace Act of

1988; these DOA are often referred as the SAMHSA 5, named after the Substance Abuse and Mental

Health Services Administration (Hoffman, 2018; Phan, Yoshizuka, Murry, & Perry, 2012). Although

drug use trends have changed dramatically since 1988, these five have remained on the basic drug

screen used across the U.S. The U.S. Department of Defense (DOD) removed PCP from its routine

screening but added benzodiazepines, amphetamine derivatives, common barbiturates, synthetic

and semisynthetic opioids, lysergic acid diethylamide (LSD), and synthetic cannabinoids. Other

countries or regions, such as Australia and the European Union, also include testing for

benzodiazepines and a wider range of opioids (Hoffman, 2018).

Definitive Drug Testing

Drug testing can be described as qualitative, semi-quantitative or quantitative, and can also be

described as presumptive or definitive. Qualitative refers to testing for the presence of a given

analyte, semi-quantitative reports if the analyte is present above or below a certain threshold or set

of thresholds, and quantitative testing reports the concentration of an analyte (drug) numerically.

Presumptive drug testing is used to identify use or non-use of a drug or a drug class, but this type of

testing cannot distinguish between closely related chemicals or structural isomers, and as it is

usually based on immunoassay, it is subject to the normal interferences that affect immunoassays.

Definitive drug testing usually refers to a more definitive methodology, such as mass spectrometry

or chromatography, and most often the combination of chromatography and mass spectrometry,

because these methods can identify use or non-use of a specific drug and/or its associated

metabolites. Both types of drug testing can be either quantitative or qualitative (Jannetto &

Langman, 2018). The frequency of testing is ultimately up to the ordering provider; testing may be

random or scheduled depending on the provider’s objectives (Becker & Starrels, 2018).

Urine is the most common specimen type used in drug testing for several reasons. Unlike blood or

saliva, the window of detection of most drugs is longer in urine; moreover, urine tests are generally

inexpensive, noninvasive, and convenient to use while still maintaining acceptable statistical validity.

Salivary testing can provide a higher rate of false-negative results, especially for individuals who

smoke. Urine may provide more objective assessment of drug levels compared to purely clinical

evaluation or a patient self-report (Becker & Starrels, 2018). One disadvantage of urine testing is a

“risk of adulteration of the sample by the patient to avoid detection of non-compliance with the

therapeutic regimen (AACC, 2017),” but there are analytical strategies that can be employed to

detect such adulteration.

Even though single-site studies have shown the potential positive impact of direct-to-definitive drug

testing for monitoring compliance in pain management by decreasing the number of false-positive

results (Gencheva et al., 2018), the current standard of care approach in most circumstances is to

initially perform a presumptive drug screen followed by a definitive drug test of any positive results

(Hadland & Levy, 2016). Mandatory guidelines for federal workplace drug testing using urine

samples also establishes initial screening for the SAMHSA drugs, and in 2017 they removed MDEA

from the authorized drugs and added MDA as an initial test analyte. In section 3.4 of the mandate,

they list the following as initial analytes (with the initial test cutoff values given in parentheses):

marijuana metabolites (50 ng/mL)

cocaine (150 ng/mL)

codeine/morphine (2,000 ng/mL)



hydrocodone/hydromorphone (300 ng/mL)

oxycodone/oxymorphone (100 ng/mL)

6-acetylmorphine (10 ng/mL)

phencyclidine (25 ng/mL)

amphetamine/methamphetamine (500 ng/mL)

MDMA/MDA (500 ng/mL)

Again, positive initial screens are to be followed by definitive drug testing (HHS, 2017). However,

higher cutoff values may not truly indicate compliance in patients. One study shows “wide variation

in the false-negative rate, ranging from 1.5% to 94.3% across a range of prescribed and illicit drugs

(Krock et al., 2017).”

The Centers for Medicare & Medicaid Services (CMS) in 2018 issued a statement reminding

laboratories and other providers to use correct coding for drug testing and screening. For

presumptive drug testing, codes 80305, 80306, and 80307 must be used; however, as part of the

National Correct Coding Initiative (effective January 1, 2016), HCPCS codes G0480-G0483 must be

used for definitive drug testing with only one code being allowed per date of service. G0480 is

defined as:

“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; 1-7 drug class(es), including metabolite(s) if

performed (CMS, 2018)”.

The CMS definitive drug testing codes G0480 – G0483 are summarized below in Table 1:

Table 1: CMS Definitive Drug Test Codes

CMS definitive drug testing code Number of drug classes tested

G0480 1 - 7

G0481 8 - 14

G0482 15 - 21

G0483 22 or more



CMS also requires that the billing codes used are based on medical necessity. They state that

medical necessity documents “may include clinical evaluations, physician evaluations, consultations,

progress notes, physician’s office records, hospital records, nursing home records, home health

agency records, records from other healthcare professionals and test reports. It is maintained by the

physician and/or provider (CMS, 2012).” CMS also reiterates the importance of medical necessity

and notes that reimbursement documentation can often be inadequate in justifying necessity.

“Physician/LCMPs [licensed/certified medical professional] should be aware that

templates designed to gather selected information focused primarily for reimbursement

purposes are often insufficient to demonstrate that all coverage and coding

requirements are met. This is often because these documents generally do not provide

sufficient information to adequately show that the medical necessity criteria for the

item/service are met… Certificates of Medical Necessity (CMN), DME Information Forms

(DIF), supplier prepared statements and physician attestations by themselves do NOT

provide sufficient documentation of medical necessity, even if signed by the signed by

the ordering physician (CMS, 2019).”

The CMS also states that the physician/LCMP, when ordering a service from an outside entity, is

required to provide “adequate documentation supporting medical necessity” to the outside facility

at the time the item or service is ordered. Failure to do so can result in a review of the physician or

LCMP (CMS, 2019).

A report by Kaiser Health News (KHN) and Mayo Clinic reviewing the billing data from 2011 to 2014

shows that the federal government “paid providers more to conduct urine drug tests in 2014 than it

spent on the four most recommended cancer screenings combined.” The researchers estimated the

yearly cost to private insurers and Medicare Advantage to be approximately $8.5 billion from 2011

to 2014—more than the annual budget of the Environmental Protection Agency—based on data

from Medicare’s fee-for-service program, the CMS’ Beneficiary Public Use File, and the Current

Population Survey of the U.S. Census (Schulte & Lucas, 2017).

What is the average number of drug classes prescribed per

individual for which definitive testing would be indicated?

To address this question, the records of individuals (n = 101137) within the 2015 calendar year from

a private insurance company were reviewed. The average number of drug classes (for which

definitive drug testing is applicable) prescribed per month per individual was calculated. These

definitive drug classes include drugs associated with a potential of abuse and/or associated with

definitive toxicology screening, such as amphetamines and opioids. For a list of the definitive drug

classes as defined by the AMA that are included in the calculation, please see Appendix C. The

overall average number of drug classes per month per individual was 1.26, and the highest average

number of drug classes per month calculated for any single individual was 8.83. The graph in Figure

1 shows the distribution of the average number of drug classes per month for 2015 (note

logarithmic y-axis). The red bar in Figure 1 indicates 7 drug classes, the limit of drug testing as

covered by code G0480. Only 44 individuals (out of the more than 100,000 total) have monthly

averages greater than 7.0. The overall median number of drug classes prescribed monthly per

individual was 1. Table 2 lists the numerical values in greater detail. More than 50% of individuals



are prescribed no more than 1 drug

class per month on average of the

definitive drug classes as listed in

Appendix C. Please note that this

does not include prescription drugs

not regarded as a drug of abuse or

associated with a toxicology screen,

i.e. statins. Although there is no

direct correlation between the

number of drug classes prescribed

and the number of definitive drug

classes required to be tested per

patient, these data suggest that the

number of definitive drug classes

that needs to be tested is probably

not large. Even if an individual was

only prescribed suboxone

(buprenorphine), one single drug

class, they would still need

additional drug classes tested, but

the number of definitive drug classes

needed to be tested definitively

would be unlikely to exceed seven.

Table 2: Monthly Average Number of Definitive Drug

Classes per Individual

Average Monthly

Number of Drug

Classes

Number of Individuals Percent of Total

Number of

Individuals

0 – 1 55022 54.4%

1.1 – 2 26181 25.9%

2.1 – 3 11894 11.8%

3.1 – 4 5098 5.0%

4.1 – 5 2001 2.0%

5.1 – 6 708 0.7%

6.1 – 7 189 0.2%

7.1 – 8 37 0.04%

8.1 – 9 7 0.007%



What proportion of definitive urine drug tests rendered by

providers consists of more than 7 drug classes?

The data from two private insurers for the calendar year 2018 was examined to determine the total

number of units of G0480, G0481, G0482, and G0483 ordered. These data consist of all units of

service, including those that were denied coverage. So as to not skew the results, a rendering

provider must have provided a minimum number of 30 units of service to be included in the data

analysis. Figure 2 displays the usage of definitive drug testing for more than 7 drug classes on a

single order (i.e. panel testing) for each

rendering provider. The percent of

screens with more than 7 drug classes was

calculated by adding the number of units

of G0481, G0482, G0483 and dividing by

the total number of units for each

provider. The individual values ranged

from 0% (i.e. 100% G0480 only) to 98.6%

(or 1.4% of claims contained 7 or fewer

drug classes). The identities of the

individual laboratories have been withheld

and assigned a letter (A – T) based on

ascending order of noncompliance.

To determine if the usage of codes G0481

– G0483 is related to the total number of

tests performed by any particular

laboratory (i.e. is it possible that a

laboratory with minimal number of tests

has a higher proportion of panels with

more than 7 drug classes tested as

compared to a laboratory that renders a

large quantity of tests), the total number of units provided by each lab is provided for comparison in

Figure 3. Here, the lab providing the highest number of definitive drug screening tests (32607 units),

lab B within the figure, has the second-highest degree of usage of G0480 (only 0.5% of units

submitted were G0481 – G0483); however, the next highest lab provider, lab R (with 29943 units)

has the third highest percentage of panel screens with greater than 7 drug classes (69%). In fact,

this single lab comprised 68.7% of all units of G0481 – G0483 submitted by all labs combined (20531

units by lab R out of 29902 total units of G0481 – G0483). The next highest use of non-G0480 codes

ordered was by lab T with only 9.44%. All other labs with at least a minimum of 30 units of G0480 –

G0483 combined accounted for 21.9% as depicted in Figure 4. In summary, no correlation exists

between the number of units ordered and the rate of appropriately using the correct code for

definitive drug testing.



Conclusion

Urine drug testing is an important tool in monitoring

prescription opioid therapy, illicit drug use, and drug

abuse treatment compliance. In definitive drug

testing, the size of the toxicology panel is important

since a panel with too few analytes tested may

result in drugs missed and a panel with too many

analytes tested can result in over-testing and

possible false-positives. The CMS lists the G0480 –

G0483 coding series for definitive drug testing based

on the number of drug classes being tested rather



than by the testing methodology (i.e. immunoassays, spectroscopic assays, and so on). By reviewing

the records of more than 100,000 individuals over the course of a year, we determined the average

number of drug classes prescribed per individual per month. 99.96% of individuals were prescribed

7 drug classes or less on average (Figure 1), and the overall median number of drug classes

prescribed monthly is 1. These individuals fall within the scope of the G0480 code. These findings

do not preclude a two-tiered, sequential screening-confirmation strategy. The bulk (68.7%) of panel

tests containing more than 7 drug classes were rendered by a single laboratory (Figure 4). It appears

that large panels of definitive drug tests, using codes other than G0480, performed without any

prior screening tests are lacking in clinical rationale and that standard sequential screening-

confirmation strategies can be used to effectively monitor the patients in these populations.

Contact

The website for Avalon Healthcare Solutions is located at https://www.avalonhcs.com/. For

additional information, please contact Barry Davis, Avalon Chief Growth Officer, at

[email protected].

Guidelines

1. Centers for Disease Control and Prevention (CDC)

In the 2016 CDC guidelines, they recommend an evaluation of the benefits and harms of

continuing opioid-based therapy with the patient every three months or more

frequently; moreover, “for patients with opioid use disorder, clinicians should offer or

arrange evidence-based treatment, such as medication-assisted treatment with

buprenorphine or methadone (Dowell et al., 2016).”

Within the guidelines, the CDC recommends that clinicians should consider urine drug

testing prior to discontinuing opioids to determine possibility of withdrawal. The CDC

also recommends that “when prescribing opioids for chronic pain, clinicians should use

urine drug testing before starting opioid therapy and consider urine drug testing at least

annually to assess for prescribed medications as well as other controlled prescription

drugs and illicit drugs (recommendation category: B, evidence type: 4).” The CDC states

that “urine drug tests can provide information about drug use that is not reported by

the patient. In addition, urine drug tests can assist clinicians in identifying when patients

are not taking opioids prescribed for them, which might in some cases indicate diversion

or other clinically important issues such as difficulties with adverse effects (Dowell,

Haegerich, & Chou, 2016).”

Concerning the frequency of urine drug testing, they state, “While experts agreed that

clinicians should use urine drug testing before initiating opioid therapy for chronic pain,

they disagreed on how frequently urine drug testing should be conducted during long-

term opioid therapy. Most experts agreed that urine drug testing at least annually for all



patients was reasonable. Some experts noted that this interval might be too long in

some cases and too short in others, and that the follow-up interval should be left to the

discretion of the clinician. Previous guidelines have recommended more frequent urine

drug testing in patients thought to be at higher risk for substance use disorder.

However, experts thought that predicting risk prior to urine drug testing is challenging

and that currently available tools do not allow clinicians to reliably identify patients who

are at low risk for substance use disorder (Dowell et al., 2016).”

2. American Association in Clinical Chemistry (AACC)

AACC have published Laboratory Practice Guidelines: Using Clinical Laboratory Tests to

Monitor Drug Therapy in Pain Management in 2017. The main goal of their guidelines

was to provide evidence-based recommendations for the use of laboratory and point-of-

care (POC) urine drug tests for detection of drugs. AACC’s guidelines include 26

recommendations and 7 expert opinions.

AACC lists no recommendations for the frequency of testing but states that “more

frequent laboratory testing is recommended for patients with a personal or family

history of substance abuse, mental illness, evidence of aberrant behavior, or other high-

risk characteristics.” (Evidence A, II). Authors recommend using other tools available to

physicians in addition to urine drug screening for monitoring compliance. Urine drug

testing is recommended for detection of drugs in pain management patients (Evidence

B, II). POC qualitative presumptive tests offer similar performance characteristics to

laboratory-based immunoassays and therefore AACC recommends that physicians use

package inserts or consult laboratory personnel to accurately interpret lab results

(Evidence B, II). They recommend the use of qualitative immunoassays before

prescribing controlled substances to identify illicit drug use in pain management

patients (Evidence B, II). They also recommend confirming with definitive testing any

immunoassays that are not consistent with clinical presentation of the patient (A, III).

Although quantitative definitive urine testing is not more useful than qualitative

definitive testing, according to AACC there are advantages to use quantitative definitive

testing in certain situations such as: “…quantitative urine definitive testing is

recommended to identify variant drug metabolism, detect pharmaceutical impurities, or

metabolism through minor routes. Quantitative results may also be useful in complex

cases to determine the use of multiple opioids, confirm spiked samples, and/or rule out

other sources of exposure (e.g. morphine from poppy seeds) (AACC, 2017)” (Evidence A,

II).

AACC experts recommend ordering amphetamines, barbiturates, benzodiazepines,

cannabinoids, cocaine, opiates/opioids for a routine pain patient monitoring. They

suggest that additional substances could be tested for patients considered “high-risk

with known history of abuse for this medication prevalence of drug use is endemic to

local region, risky polypharmacy, multiple providers, or if prescribed and patient shows

lack of efficacy or toxicity”. Substances listed in this category include alcohol,

anticonvulsants, antidepressants, synthetic cathinones, antitussive, dissociative



anesthetic, hallucinogens and muscle relaxants (AACC, 2017).

3. Federation of State Medical Boards (FSMB)

Federation of State Medical Boards (FSMB) indicates in their Guidelines for Chronic Use

of Opioid Analgesics policy that for patients being prescribed opioids for chronic pain

management that “… the initial work-up should include a system review and relevant

physical examination, as well as laboratory investigations as indicated”(FSMB, 2017).

They also note the utility of periodic testing for monitoring adherence to the patient’s

treatment plan and to detect non-prescribed drugs. Regarding frequency of testing,

“Patients being treated for addiction should be tested as frequently as necessary to

ensure therapeutic adherence, but for patients being treated for pain, clinical judgment

trumps recommendations for frequency of testing (FSMB, 2017).”

Additionally, relative to how testing should be performed, the Federation of State

Medical Boards notes that POC tests have significant limitations in both sensitivity and

specificity, and therefore “the use of point of care testing for the making of more long

term and permanent changes in management of people with the disease of addiction

and other clinical situations may not be justified until the results of confirmatory testing

with more accurate methods … are obtained.” They also note that initial testing could

be done using immunoassays and followed up by a more specific technique such as

GC/MS or other chromatography-based technique. They highlight the importance of

knowing specific drug and metabolites, “not just the class of drug” for the pain

management.

4. American Society of Interventional Pain Physicians (ASIPP)

“Despite limited evidence for reliability and accuracy, screening for opioid use is

recommended, as it will identify opioid abusers and reduce opioid abuse. (Evidence:

limited)… UDT [urine drug testing] must be implemented from initiation along with

subsequent adherence monitoring, in an in-office setting with immunoassay and

confirmation for accuracy with chromatography in select cases, to identify patients who

are non-compliant or abusing prescription drugs or illicit drugs, and UDT may decrease

prescription drug abuse or illicit drug use when patients are in chronic pain

management therapy (Evidence: good) (Manchikanti et al., 2012a)”. In Part 1 of their

recommendations, ASIPP states that, “in a systematic review of treatment agreements

and UDT to reduce opioid misuse in patients with chronic pain, the evidence was

relatively weak in supporting the effectiveness of opioid treatment agreements and UDT

in reducing opioid misuse by patients with chronic pain (Manchikanti et al., 2012b).”

They note that a large percentage of testing requires follow-up confirmatory testing; in

fact, one study reports that approximately 36% of specimens required confirmation

testing, but that reference testing improves the accuracy of UDT for benzodiazepines to

83.2% (Manchikanti, Malla, Wargo, & Fellows, 2011). ASIPP also notes the limitations of

confirmation testing and POC testing. “UDT has become the standard of care for

patients on controlled substances; however, the relative value of in-office screening and



laboratory confirmation of those tests is sometimes unclear or controversial for

physicians. The POC manufacturers recommend that their test needs to be confirmed;

however, advantages and cost benefits have not been independently evaluated and

confirmed (Manchikanti et al., 2012b).”

5. Texas Pain Society

The Texas Pain Society released detailed guidelines concerning urine drug testing (UDT)

and its use in the practice of pain management. They do not recommend a prescribed

regimen of UDT but rather leave it to the discretion of the physician. They do

recommend random UDT over scheduled UDT. Concerning what should be included in a

UDT, “Elements of UDT may include specific gravity, temperature at the time of sample

collection, pH, creatinine concentration, and mass spectroscopic confirmatory testing

for the following agents: opioids (fentanyl, oxycodone, oxymorphone, tramadol,

methadone, hydrocodone, hydromorphone, morphine, codeine, propoxyphene,

meperidine, buprenorphine, tapentadol, 6-mono-acetyl morphine [6-MAM])…”(Owen,

Burton, Schade, & Passik, 2012). For the extensive list of possible drugs, in addition to

opioids, please review the attached table in Appendix D.

6. Annals of Internal Medicine Review

In 2014 Nuckols and colleagues released an extensive review of guidelines on

prescribing and monitoring opioids from more than ten different societies and

organizations in the Annals of Internal Medicine. No consensus concerning urine drug

monitoring or testing was noted across all guidelines; in fact, the APS-AAPM noted to

use UDT only “if risk is high; consider otherwise”. The NOUGG recommends that, if UDT

is used, to consider pros and cons (expert consensus). The Colorado Division of Workers

Compensation requires mandatory UDT. The VA/DoD and ASIPP uses UDT to establish a

baseline followed by random testing during treatment whereas the ACOEM and UMHS

uses UDT to establish a baseline followed by either a minimum of quarterly testing or

annual testing, respectively (Nuckols et al., 2014). The detailed table is included in

Appendix E.

7. American Society of Addictive Medicine (ASAM)

Concerning what drugs should be included in a UDT, ASAM states, “Drug testing panels

identify the use of only the specific drugs, drug classes, or drug metabolites built into

the particular test panel. However, clinicians should have the choice of what drugs to

test for each patient based on their assessment of that patient and risk history. Unlike

forensic testing, clinical testing should be individualized to each patient situation and

not determined by a forced panel of drugs. The most common immunoassay drug test

panel includes the SAMHSA-5: amphetamines (various stimulant drugs as a drug class),

marijuana metabolites (THC), cocaine metabolites, opiates (natural opiates such as

codeine and morphine, a metabolite of heroin but not other opioids such as oxycodone,

hydrocodone, buprenorphine and methadone), and phencyclidine (PCP) (ASAM, 2013).”



8. American Academy of Family Physicians (AAFP)

The AAFP published in 2019 recommendations concerning ordering and interpreting

urine drug tests. They state, “Several federal and state regulations have been enacted

that recommend or require urine drug testing in patients receiving long-term opioid

therapy. Similar guidance may apply to patients receiving long-term benzodiazepine or

stimulant therapy. (Kale, 2019).” They state that the frequency of urine drug testing

depends on individual risk factors and is ultimately left to the attending physician;

however, they do state a recommended frequency for urine drug testing given in the

Table 3 below:

Table 3: Recommended Frequency for Urine Drug Testing (Kale, 2019)

Level of misuse risk Frequency of testing

Low (no risk factors) Every 6 to 12 months

Moderate Every 3 to 6 months

High (mental health disorder, substance

use disorder, prior opioid misuse, aberrant

behavior*) or opioid dosage >120

morphine milligram equivalents

Every 1 to 3 months

*Aberrant behavior includes, but is not limited to, lost prescriptions, multiple requests for

early refills, opioid prescriptions from multiple physicians, unauthorized dose escalation, and

apparent intoxication.

They state the following clinical recommendation: “Urine drug testing can be used to

monitor compliance with prescribed therapy and detect the use of nonprescribed and

illicit substances, especially opioids, benzodiazepines, and heroin (Kale, 2019).”

9. American Pain Society/American Academy of Pain Medicine

The American Pain Society and American Academy of Pain Medicine joint guidelines

panel released their opioid treatment guidelines titled Clinical Guidelines for the Use of

Chronic Opioid Therapy in Chronic Non-cancer Pain in 2009. They addressed the

monitoring of controlled substances use via UDT as part of a chronic opioid treatment

(COT) program. The authors recommend periodic urine drug screening and suggest that

random urine drug screens may be more informative than scheduled or routine testing.

The guideline section on monitoring (Section 5) states:

“5.1: Clinicians should reassess patients on COT periodically and as warranted by

changing circumstances. Monitoring should include documentation of pain

intensity and level of functioning, assessments of progress toward achieving

therapeutic goals, presence of adverse events, and adherence to prescribed

therapies (strong recommendation, low-quality evidence).

5.2: In patients on COT who are at high risk or who have engaged in aberrant

drug-related behaviors, clinicians should periodically obtain urine drug screens



or other information to confirm adherence to the COT plan of care (strong

recommendation, low-quality evidence).

5.3: In patients on COT not at high risk and not known to have engaged in

aberrant drug-related behaviors, clinicians should consider periodically obtaining

urine drug screens or other information to confirm adherence to the COT plan of

care (weak recommendation, low-quality evidence). Clinicians should

periodically reassess all patients on COT. Regular monitoring of patients once

COT is initiated is critical because therapeutic risks and benefits do not remain

static” (Chou et al., 2009).

The American Pain Society guidelines state that for individuals at low-risk for adverse

outcomes, quarterly or semi-annual monitoring is sufficient. The risk for abuse may be

measured using standard tools, such as the Screener and Opioid Assessment for Patients

with Pain (SOAPP) and the Opioid Risk Tool. These types of tools may help clinicians

assess the suitability of long-term opioid therapy for chronic pain patients and may help

differentiate those patients who require more clinician monitoring while on long-term

opioid therapy. Both tools may be self-administered at or prior to an office visit, or

completed as part of an interview with a nurse, physician or psychologist (Chou et al.,

2009).

10. Washington State Agency Medical Directors’ Group (AMDG)

The AMDG published an Interagency Guideline on opioid dosing for chronic non-cancer

pain. This guideline and related expert commentary support low-risk individuals having

UDT up to once per year, moderate risk up to 2 per year, high risk individuals up to 3-4

tests per year, and individuals exhibiting aberrant behaviors should be tested at the

time of the office visit. They list the following as examples of aberrant behavior: “lost

prescriptions, multiple requests for early refills, opioids from multiple providers,

unauthorized dose escalation, apparent intoxication, etc. (AMDG, 2015).”

11. South Carolina Pain Management Guidelines

South Carolina’s guidelines have several statements and recommendations for clinicians

to help them with prescription and monitoring of controlled substances.

Recommendation #10 on page 23 states:

“When prescribing opioids for chronic pain, clinicians should use urine drug

testing before starting opioid therapy and consider urine drug testing at least

annually to assess for prescribed medications as well as other controlled

prescription drugs and illicit drugs”. In the discussion on pages 23 through 24,

this guideline explains to physicians on how to use urine drug testing during

patient monitoring. They explain that opioid pain medication used in

combination with other nonprescribed opioid pain medications,

benzodiazepines or heroin has potential to cause overdose, and, therefore,



patients must be assessed for those drugs during urine drug testing. There was

no consensus on the frequency of urine drug testing among experts. Experts

suggested that initial urine drug testing can be performed with an

immunoassay panel for commonly prescribed opioids and illicit drugs. For

those patients on less commonly used opioids, a more specific test was

recommended. In addition, they specified that confirmatory testing “should be

based on the need to detect specific opioids that cannot be identified on

standard immunoassays or on the presence of unexpected urine drug test

results”. This guideline explicitly states that clinicians must be familiar with

drugs included in urine drug testing panels and must know how to interpret

results. They encourage clinicians to consult a toxicologist or clinical pathologist

to help them with results interpretation and to directly confront patients about

unexpected results. This guideline discourages clinicians testing for substances

for which there will either be no patient management needed or it is unclear.

And, confirmatory testing must be restricted “to situations and substances for

which results can reasonably be expected to affect patient management

(SCBME, 2017).”

12. Wisconsin Worker’s Compensation Patient Care

Wisconsin’s Worker’s Compensation program recommends for any worker’s

compensation patient who will need opioid treatment for a period of more than 90

days, that the treating physician should follow these guidelines and or consider referral

to a Pain Management specialist. In their document, they state that “urine drug

screening before starting chronic opioid therapy is imperative” to verify that patient is

not using illegal substances. In addition, according to their guidelines, compliance

monitoring is mandatory for all patients on chronic opioid therapy with several tools

including urine drug screen for the first visit and with aberrant behavior and

unannounced urine drug screens thereafter (DWD, 2013).

13. American Society of Addictive Medicine (ASAM)

ASAM states quantification (assessing specific concentration of a drug) should not be

used to determine adherence with a specific dosage or formulation regimen. There are,

however, specific reasons for obtaining quantitative data. For example, quantification

can help a clinician decide why the other opioids are present. Serial creatinine-corrected

quantitative values can help the clinician distinguish cessation of drug use from

continued drug excretion from ongoing drug use. Finally, the guidelines note that state

laws may also guide testing decisions (ASAM, 2013).

14. Substance Abuse and Mental Health Services Administration (SAMHSA)

These guidelines are for certification for opioid treatment programs (OTPs). OTPs

require certification before they can dispense opioids to treat opioid addiction. SAMHSA

recommends benzodiazepines and amphetamines at a minimum be tested before



admission to any opioid treatment program. Barbiturates are also strongly

recommended to be tested at regular intervals during the program. Testing is not

limited to these classes of drugs and may vary from individual to individual (SAMHSA,

2007).

15. Institute for Clinical Systems Improvement (ICSI)

The ICSI in their guidelines concerning pain management released in 2017 recommend

that “routine random urine drug screens (UDS) for all patients on chronic opioid therapy

for pain should be done at least once per year. UDS should be done if there is concern of

aberrant behavior based on a prescriber’s assessments and clinical judgment (Hooten et

al., 2017).”

16. American Association for the Treatment of Opioid Dependence Inc. (AATOD)

The AATOD recommends cessation of benzodiazepines before admission to an opioid

treatment program (OTP). Gradually tapering off to a lower dose is also acceptable, but

benzodiazepine use must be addressed prior to an OTP admission. The AATOD

recommends toxicology screening for benzodiazepines, as well as routine checks of each

state’s Prescription Monitoring Drug Program. Confirmatory testing may also be used

(AATOD, 2017).

17. American Academy of Child and Adolescent Psychiatry (AACAP)

AACAP notes, “Toxicology screens are indicated for acute onset or exacerbations of

psychosis when exposure to drugs of abuse cannot otherwise be ruled out. Genetic

testing is indicated if there are associated dysmorphic or syndromic features (McClellan

& Stock, 2013).”

18. World Federation of Societies of Biological Psychiatry (WFSBP)

The WFSBP states that drug screening (urine and blood) should be sought for

schizophrenia patients as “presence of substance abuse or dependence is often not

recognized and systematically assessed, especially if such a patient is seen during an

acute psychotic episode” (WFSBP, 2015).

19. American Academy of Neurology (AAN)

The AAN states that “toxicology testing may be considered in children with status

epilepticus, when no apparent etiology is immediately identified” (AAN, 2018).

20. Department of Veterans Affairs/Department of Defense (VA/DOD)

These joint guidelines state “We recommend screening for use of tobacco, alcohol, illicit

drugs, and unauthorized use of prescription medication because their use is common

and can result in adverse outcomes” (strong recommendation) (DOD, 2018).



21. World Health Organization (WHO)

The WHO released an intervention guideline for mental, neurological, and substance use

disorder in non-specialized health settings. The WHO states that urine testing may be

considered to confirm abstinence and to “consider occasional urine testing to confirm

non-use”. Under the section concerning the investigation of chronic drug use, they state

to consider using urine drug screens “for emergency cases, a urine drug screen should

be conducted whenever intoxication, withdrawal, or overdose is suspected, especially in

cases when the person is unable to convey what they have ingested (WHO, 2016).” The

WHO lists the following substances as psychoactive substances: alcohol,

benzodiazepines, opioids, tobacco, cocaine, methamphetamines, amphetamine-type

stimulants, khat, cannabis, tramadol, “volatile” solvents, MDMA, and hallucinogens.

22. American College of Obstetricians and Gynecologists (ACOG)

ACOG states that additional research is needed to better understand the effects of

universal urine screening on clinical outcomes and recommend validated verbal

screening tools instead. ACOG acknowledges that urine drug testing has been used to

identify substance abuse and should only be performed in compliance with state’s laws

and with patient consent. ACOG also lists the following recommendations:

“Screening for substance use should be part of comprehensive obstetric care and

should be done at the first prenatal visit in partnership with pregnant woman.

Screening based only on factors, such as poor adherence to prenatal care or

prior adverse pregnancy outcome, can lead to missed cases and may add to

stereotyping and stigma. Therefore, it is essential that screening be universal.”

“Routine screening should rely on validated screening tools, such as

questionnaires, including 4Ps, NIDA, Quick Screen, and CRAFFT (for women 26

years or younger) (ACOG, 2017).

ACOG explicitly states, “Routine urine drug screening is controversial for several

reasons. A positive drug test result is not in itself diagnostic of opioid use disorder or its

severity. Urine drug testing only assesses for current or recent substance use; therefore,

a negative test does not rule out sporadic substance use… Health care providers should

be aware of their laboratory’s test characteristics and request that confirmatory testing

with mass spectrometry and liquid or gas chromatography be performed as appropriate

(ACOG, 2017).”

23. Society of Obstetricians and Gynaecologists of Canada (SOGC)

The SOGC recommends periodic drug screening for all pregnant women and all women

of childbearing age (III-A). The recommended method of drug screening is a urine

toxicology screen (II-2A); however, they state that prior to maternal drug toxicology

testing is ordered that informed consent be obtained (III-B) (Wong, Ordean, & Kahan,

2011).



24. American Psychiatric Association (APA)

The APA released their third edition of the Practice Guidelines for the Psychiatric

Evaluation of Adults in 2016. Within it, they acknowledge that urine toxicology may

provide clues to substance abuse during an initial psychiatric evaluation (APA, 2016).

25. Anxiety Disorders Association of Canada (ADAC)

The ADAC recommends urine toxicology as part of the patient’s baseline investigations if

warranted. This urine toxicology assessment applies to anxiety and other related

disorders, which include “panic disorder, agoraphobia, GAD, selective mutism,

separation anxiety disorder, SAD (social phobia), specific phobia, substance/medication-

induced anxiety disorder, as well as anxiety disorder due to another medical condition

or not elsewhere classified” (Katzman et al., 2014).

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Appendix A: 2017 U.S. Prescribing Rate Map (CDC, 2017d)

This map depicts the 2017 rate per 100 persons for retail opioid prescriptions dispensed in the U.S. at a

state level. Alabama had the highest rate (107.2) whereas the District of Columbia had the lowest rate

28.5). The CDC reports that the national average prescribing rate in 2017 was 58.7, the lowest rate in

more than ten years (CDC, 2017d).



Appendix B: 2017 U.S. Rate of Drug Overdose Deaths (CDC,

2017a)

This map depicts the number of age-adjusted rates of drug overdose deaths (per 100,000) in the U.S. by

state in 2017 as reported by the CDC. The lowest rate reported is in Nebraska (8.1) with the highest rate

reported in West Virginia (57.8) (CDC, 2017a).



Appendix C: Drug Classes Used in Determining the Average

Number of Prescribed Drug Classes per Month per Individual

The following drug classes were used in determining the average number of prescribed drug classes

per month per individual:

NULLǂ

Alcohol(s)

Alkaloids, not otherwise specified (NOS)

Amphetamines

Analgesics, non-opioid

Antidepressants, NOS

Antidepressants, serotonergic

Antidepressants, tricyclic

Antiepileptics, NOS

Antipsychotics, NOS

Barbiturates

Benzodiazepines

Buprenorphine

Cocaine

Fentanyls

Gabapentin

Hypnotics, sedative (non-benzodiazepines)

Methadone

Methylphenidate

Opiates

Opioids and opiate analogs

Oxycodone

Pregabalin

Skeletal muscle relaxants

Tapentadol

Tramadol

ǂNULL indicates a drug not included in the cross walk (i.e. a drug, such as prednisone, that

is typically not associated with a toxicology screen).



Appendix D: Agents in UDT (Owen et al., 2012) with assigned

2018 CPT Definitive Drug Class Code

2018 CPT Definitive Drug Class Code

Opioids

buprenorphine 80348 buprenorphine

fentanyl 80354 fentanyls

6-mono-acetyl morphine (6-

MAM) 80356 heroin metabolite

methadone 80358 methadone

hydrocodone 80361 opiates

hydromorphone 80361 opiates

morphine 80361 opiates

codeine 80361 opiates

oxycodone 80365 oxycodone

oxymorphone 80365 oxycodone

propoxyphene 80367 propoxyphene

tapentadol 80372 tapentadol

tramadol 80373 tramadol

meperidine 80362-80364 opioids & opiates analogs

benzodiazepines

nordiazepam 80346, 80347 benzodiazepines

oxazepam 80346, 80347 benzodiazepines

temazepam 80346, 80347 benzodiazepines

barbiturates

phenobarbital 80345 barbiturates

secobarbital 80345 barbiturates

miscellaneous

ethanol or ethyl glucuronide 80320-80322 alcohol(s) (or alcohol biomarker)

amphetamine 80324-80326 amphetamines

methamphetamine 80324-80326 amphetamines

methylphenidate 80360 methylphenidate

cocaine 80353 cocaine

MDMA 80359 methylenedioxyamphetamines

phencyclidine 83992 phencyclidine

tetrahydrocannabinol (THC) 80349 cannabinoids, natural

carisoprodol and/or

meprobamate 80369, 80370 skeletal muscle relaxants



Appendix E Selected Guideline Recommendations from

(Nuckols et al., 2014)

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