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Treatment Track:Optimizing Utilization and

Outcomes of Urine Drug Testing

Presenters:• Louis E. Baxter, Sr., MD, FASAM, President and CEO,

Professional Assistance Program of New Jersey, Inc.• Michael C. Barnes, JD, Executive Director, Center for

Lawful Access and Abuse Deterrence (CLAAD), and Member, Rx Summit National Advisory Board

• Elaine Jeter, MD, MolDx Medical Director, Palmetto GBA• Kenneth L. Kirsh, PhD, Vice President, Clinical Research

and Advocacy, Millenium Health

Moderator: Andrea Grubb Barthwell, MD, FASAM, President, Two Dreams Outer Banks

Disclosures

• Louis E. Baxter, Sr., MD, FASAM; Michael C. Barnes, JD; and Elaine Jeter, MD, have disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Kenneth L. Kirsh, PhD – Employment: Millennium Health

• Andrea Grubb Barthwell, MD, FASAM – Advisory Boards: Caron Foundation, Alvee Laboratories; Consulting Fees: Millennium Laboratories, Braeburn Pharmaceuticals, GW Pharmaceuticals; Partner: Treatment Partners, LLC, Encounter Medical Group, PC; Stock Ownership: Hythian

Learning Objectives

1. Identify the obstacles currently related to appropriate use of UDT in substance use management.

2. Describe a research-based clinical approach for employing UDT in management of substance use disorders.

3. Explain civil and criminal liability for practitioners related to waste, fraud and abuse in UDT.

4. Advocate state and federal policy responses to UDT liability concerns.

Optimizing Utilization and Outcomes of Urine Drug Testing:

Statements of Consensus

Louis E. Baxter, Sr., MD, FASAM

Disclosure Statement

• No relevant real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services

Preview

• Consensus project• Background

– Terminology– Methodology

• Consensus– General– Test Selection– Diagnosis– Active Treatment– Chronic Care

Need for Consensus

• Lack of clinical knowledge

• No guidelines or recommendations

• Unethical behaviors

• Responsive payer restrictions

Consensus Development

• Nine independent panelists met on 2/21/14 for 8-hour discussion

– Hosted by NAATP

– Assisted by ASAM and CLAAD

• Debated and revised paper over 12 mos.

Overview of Substance Use Testing

• To identify presence/absence or concentration of specific substances & metabolites

• Should be exclusively for therapeutic purposes in addiction medicine

– Prevent or deter use

– Identify or diagnose use

– Support abstinence in active treatment & chronic care management

Pain & Addiction

• Pain guidelines are inadequate for addiction medicine (see next slide)

– Do not address overlap of people in pain who also have SUDs

– Do not support testing frequently enough

Risk Stratified UDT for Pain & Addiction Care

Pain Addiction

Pain Clinical Guidelines1

Low Risk 1-2/year + targeted

Moderate Risk 2-4/year + targeted

High Risk 4/year + targeted

Assessment & DiagnosisDuration of period determined by clinician, clinical setting, presentation

**Phase of Active TreatmentPhase I – Early engagement <30 daysPhase II – Middle stabilization > 30 day < 90 daysPhase III – Late Consolidation > 91 days < 2 yrs

**Phases of RecoveryPhase I – Early recovery > 2 yrs < x < 5 yrsPhase II – Moderate/Stable Recovery > 5 yrs < 10 yrsPhase III – Mature Recovery > 10 yrs

1. Multiple national guidelines2. ASAM policy

Addiction – with new pain syndrome

R/O reactivation of addiction through common

reward pathwaysmanage addiction

*Pain & AddictionPain –

critical incident in active pain treatment

R/O addiction

•Clinician determines: Then a) return to pain pool or, b) continue in active addiction treatment

Step 1 – Assessment/Diagnosis – to characterize disease

Step 2 – Early Stabilization – (Role of UDT – detect issues & deter

progression) – until 30 days without unexpected results

Manage risk of exposure & addiction to

determine which pool a client returns to

Terminology

Preliminary Qualitative Definitive Quantitative

Immunoassay Chromatography – mass spectrometry

Presumptive Confirmatory

Qualitative Quantitative

Point-of-care / in-office / lab-based In-office / lab-based

Screen Confirmation

Semi-quantitative / quasi-quantitative Absolute level, creatinine corrected

Simple test (cup / strip / dip / cassette) Complex test

Class or specific drug identification Specific drug identification

Methodology ComparisonPreliminary Qualitative Definitive Quantitative

Rapid (depending on location) 24 – 72 hoursPresumptive screen (presence / absence)

Concentration of parent drugs & metabolites

Low specificity (substance class)High specificity (can detect specific substance and metabolites)

Low sensitivity (high cut-off value)High sensitivity (can detect low concentrations)

$25 $66 – 165False positives / negatives, inaccuracies more likely

False positives / negatives unlikely

Cannot detect all drugs or illicit substances

Provides reports of all drugs, metabolites, and substances present

Consensus: General

• Urine is the specimen of choice (except for alcohol)

– Easy to collect

– Minimally invasive

– Relatively affordable

– Wide selection of analytes

Consensus: General

• Balance quality and cost

– Understand benefits of methods and frequency

– Inadequately informed attempts to reduce costs may worsen health and increase costs

Consensus: General

• Clinicians should obtain proper training

– Test selection

– Administration

– Interpretation

• If not possible, collaborate and consult with lab toxicologists or obtain expert medical review

Consensus: Test Selection

• Testing decisions should be individualized based on clinical evaluation – Patient history

– Community trends

– Prescribed medications

– Circumstantial considerations

• Document in medical record– Bases for decisions

– Medical response to result


• Utilize preliminary qualitative tests when rapid result is necessary– Point-of-care/cup test

– Rapidity and cost savings are lost if sample must be sent to lab

• Utilize definitive quantitative tests when accurate information is necessary

• Sample integrity checks can help identify deceptive behaviors


• Use comprehensive-definitive drug panel (CDDP) for most thorough and accurate results

• In case access to CDDP is restricted, carefully select definitive quantitative analytes

– Collaborate w/ lab to account for trends in community & population

– Use H&P to narrow test selection

Consensus: Diagnosis

– Primary care

– Urgent care

– Pain

– Psychiatry

– Obstetrics

– Peri-operative

– Addiction

• Early diagnosis can lead to improved outcomes

• Universal & routine clinical screening (not necessarily testing)

• Conduct a history & physical (H&P), and add testing as necessary


• Review patients for substance use during first consult and periodically thereafter

• Clinical considerations in choosing when and how to test– Indicators of risk (e.g., family history or legitimate

Rx for a controlled substance)

– Evidence of use (e.g., self-report or needle marks)

– Information necessary to direct care

– Cost constraints


• Substance use alone is insufficient to substantiate presence of SUD

• Screening, Brief Intervention, and Referral to Treatment (SBIRT) has numerous benefits

– Decreases stigma

– Reduces profiling (including pregnant women)

– Improves health outcomes

– Reduces costs of untreated SUD

Consensus: Active Treatment

• Test on regular basis and at random intervals

• Collection process: aim to reduce patient’s ability to undermine test results

• Give same quality of care to:

– Patients in MAT/not in MAT

– Patients in office-based setting, methadone clinic, elsewhere


• If evidence of use after period of abstinence

– Consider testing to ascertain nature & extent of use

– Resume testing schedule for abstinence of 30 days

• May need to intensify treatment

Consensus: Chronic Care Management

• Patients with >2 years of abstinence

– Often self-directed in recovery

– Testing is less prescriptive and may be driven by individual’s self-identified need

• Test on regular basis & at random intervals

• If test is positive, establish an active treatment plan appropriate to recent use

Consensus: Chronic Care Management

Summary

• Decisions should be individualized

• Preliminary qualitative (point-of-care/cup) for rapid result

• Definitive quantitative for accuracy

• Document in medical record

– Bases for decisions

– Medical response to result

Conclusion

• Thank you

Optimizing Utilization and Outcomes of Urine Drug Testing

Michael C. Barnes

April 7, 2015

Conflict of Interest Disclosure

The Center for Lawful Access and Abuse Deterrence (CLAAD) receives funding from businesses in the health care industry that share CLAAD’s mission to reduce prescription drug fraud, diversion, misuse, and abuse while advancing consumer access to high-quality health care. CLAAD’s funders include pharmaceutical companies, treatment centers, and laboratories, and are disclosed on its website, www.claad.org.

CLAAD is managed by DCBA Law & Policy. DCBA also provides legal and policy counsel to professionals and businesses whose activities align with CLAAD’s mission. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct §§ 1.7-1.9.

Preview

• Policy landscape• Responses

– Restrictions– Enforcement

• Legal bases• Factual bases

• Recommendations– Practice– Policy

• Progress• Predictions• Conclusion

Policy Landscape

• 21.5 million Americans with SUDs

• 90 percent untreated

• 120 people die every day of overdoses

• Stigma

– Social

– Structural

Policy Landscape

• Therapeutic approaches reduce costs and recidivism• Need to expand non-punitive interventions and

referrals to treatment– Education– Employment– Criminal justice

• Knee-jerk opposition to testing for substance use (confusion w/ forensic model)

• Kick “up”, not “out” (health care and social safety net programs)

• Sentencing reform and voting-rights restoration

Policy Landscape

• Significant UDT expenditures

– Medicare paid $457 million for 16 million tests (2012)

– Sales at UDT labs reached an estimated $2 billion (2013)

• Unethical practitioners have seized on the surge in spending

• Aggressive federal action to reduce healthcare waste, fraud, and abuse: $4.3 billion recovered (2013)

Response: Restrictive Coverage Policies

• BCBS of Alabama proposed to deny coverage of any definitive testing

• Medicaid per-member limits on testing: GA: 25 per year, NY: 2 per week, VT: 8 per month, NJ: 2 per month

• What contributes to ill-advised testing coverage policy?– Lack of knowledge about the practice of addiction

medicine

– Lack of understanding about current testing technology

– Confusion w/ forensic model

Response: Enforcement (Legal Bases)

• Stark law: prohibits referrals of Medicare/Medicaid patients if physician or family member has financial interest

• Anti-kickback statute: prohibits exchange of value to induce/reward a referral of federal health care program business

• Criminal health care fraud statute: prohibits schemes to defraud health benefit programs, including private plans

• False Claims Act: prohibits claims for payment/approval to gov’t known to be false

• Bank, mail, wire fraud: prohibits schemes to defraud using a financial institution, postal service, or wire

Response: Enforcement(Factual Bases)

• Physician-owned or family-owned labs

– Includes management firms

• Physician owns firm

• Firm owns lab

– Includes requiring employees to refer

• Leasing

– Office space to lab

– Lab equipment to physician

Evaluating Motives: Two Simple Tests to Identify and Avoid Entanglement in Legally Dubious Urine Drug Testing Schemes, JOURNAL

OF OPIOID MANAGEMENT (Forthcoming 2015)


• Clinical trials and registry arrangements: paying to submit patient data, answer patient questions, or review registry report

• Free supplies or services to a referral source, including labs reviewing doctors’ orders and determining whether there is a need for UDT




• Improper markups, coding, and billing

– Interpretation of results that a lab performed but for which the practitioner bills

– Using codes to circumnavigate prohibitions against more expensive tests

• Medically unnecessary tests, including results not reviewed by a physician



Practice Recommendations: Evaluating UDT Proposals

• Does the patient’s health depend on the service?

• Will my decisions be influenced by the potential for profit?

• Does the proposal appear to avoid the spirit of the law while possibly complying with the letter of the law?

– Circumvention schemes are disfavored if not expressly illegal

– Do you want to serve as the test case?

Policy Recommendations

• Employ UDT to expand interventions and treatment• Educate the uninformed

– Identify and avoid participating in legally dubious UDT schemes– Follow best practices

• Isolate and enforce against bad actors• Advance ethics, efficiency, and transparency

– Eliminate wasteful practices and payment policies• Inaccurate technology• Duplicative testing

– Document medical necessity and the bases of UDT selections– Help appeal unjust denials of care

Progress

• New paradigms and literature

– Common terminology

– Stages of care: screening/diagnosis, active treatment, chronic care management (2+ year continuum)

– Documentation of best practices

– Education and enforcement on waste, fraud, and abuse

• Consensus on the need for change

• Outline of next steps

Predictions

• Continued opposition based on confusion w/ forensic model

• Frequency of UDT relative to stage of care– Rapid results to help stabilize (presumptive)– Days of abstinence over 2+ year continuum (definitive)

• No blanket orders; individualized testing • No “confirmation” of presumptive w/ presumptive• Bundled services

– 40+ substances, including their analytes – Quantitative results– Flat fee w/ single billing code

CMS Jurisdiction 11 Part B Controlled Substance Monitoring and Drugs of Abuse

Coding and Billing Guidelines

Conclusion

• Thanks to Cindy Lackey, Nancy Hale, Karen Kelly, and co-presenters

• Questions and discussion at end of session

• Contact– LinkedIn.com/in/michaelcbarnes

– @mcbtweets

– www.claad.org

– @claad_coalition

• Thank you


Elaine K Jeter, MD

Palmetto GBA

Disclosures

Elaine Jeter, MD, has disclosed no relevant, real

or apparent personal or professional financial

relationships with proprietary entities that

produce health care goods and services.

Medicare AdministrativeContractors (MACs)

• 10 Jurisdictions – multiple states

• 8 Contractors • Palmetto

• Noridian

• Novitas

• NGS -

• WPS

• First Coast

• CGS

• Cahaba

Problems

• Blanket UDT orders

• Absent medical record documentation of tests ordered, results of cup or IA, clinical history

• Self-referral testing to maximize reimbursement

• Semi-quant IA billed with specific quant codes

• Cup testing, followed by IA, referral to partnered lab arrangement with change of DOS repeat IA and definitive testing

UDT Policy

• L35105 – Controlled Substances Monitoring and Drugs of Abuse Testing

• Provides covered indications and testing frequency for:

– Symptomatic patients, multiple drug ingestions and/or patients with unreliable history

– Patients with substance abuse or dependence

– Patients on chronic opioid therapy

“G” Code Proposal

• HCPCS – quarterly update

• Gxxxx – Definitive drug testing by mass spectroscopy, with confirmation when indicated, >40 drugs, metabolites and illicits; per encounter; includes specimen validity testing (pH, specific gravity, oxidants, creatinine)

• Asked CMS not to recognize existing 21 quant codes and 58 new codes

What Happened to Comprehensive “G” code?

• 2015 CPT drug codes – not adopted by CMS

• Palmetto’s G code proposal – not adopted by CMS

• CMS cross-walked 2014 CPT codes to “G” codes

• Palmetto issued Coding/Billing Guidelines

• Requires short text string in SV101-7 claim field

• Created CSPAN text string with # of drugs > 8

• Tiered reimbursement: 8-14; 15-34; >35

Questions?

[email protected]


Kenneth L. Kirsh, PhDVice President, Clinical Research and Advocacy

Millennium Health

Principal InvestigatorMillennium Research Institute

Disclosure Statement

• Kenneth L. Kirsh, PhD wishes to disclose he is employed as Vice President of Clinical Research and Advocacy for Millennium Health and Principal Investigator at Millennium Research Institute.

• He will present the following content in a fair and balanced manner.

Learning Objectives

1. Identify the obstacles currently related to appropriate use of UDT in substance use management.

2. Describe a research-based clinical approach for employing UDT in management of substance use disorders.

3. Explain civil and criminal liability for practitioners related to waste, fraud and abuse in UDT.

4. Advocate state and federal policy responses to UDT liability concerns.

Urine Drug Testing (UDT) Rationale

•

• Prescription medications?

• Non-prescription medications?

• Illicit substances?

Gourlay DL, Heit HA, Caplan YH. Urine Drug Testing in Clinical Practice: the Art and Science of Patient Care. 2010. Stamford, CT: PharmaCom Group, Inc.

UDT provides objective information regarding medication use and patient risk

for substance abuse or misuse

UDT should be used in conjunction with other monitoring tools to optimize outcomes

UDT Results in SUD Patients: Results From a National Profile

Passik SD, et al. Trends in drug & illicit use from urine drug testing from addiction treatment clients. Poster #3. International Conference on Opioids (ICOO): Basic Science, Clinical Applications & Compliance, Annual Meeting, Boston, MA. June 9-11, 2013.

Study on UDT National Profile: Results

Condition/Category Occurrence% of Total Specimens

Millennium Average

1: Specimens in full agreement with reported medications2082 48.5% 39.7%

2: Specimens with unreported prescription medication(s) detected 1097 25.6% 34.0%

3: Specimens with reported prescription medication(s) not detected 291 6.8% 10.6%

4: Specimens with unreported prescription medication(s) detected & reported prescription medication(s) not detected 119 2.8% 7.7%

5: Specimens with illicit substance(s) detected241 5.6% 2.0%

6: Specimens with illicit substance(s) & unreported medication(s) detected 399 9.3% 3.8%

7: Specimens with illicit substance(s) detected & reported medication(s) not detected 28 0.7% 1.1%

8: Specimens with illicit substance(s) detected & unreported medication detected & reported medication(s) not detected 32 0.7% 1.0%


Study on UDT National Profile: Results

Drug or Drug Class Negative Office Results Positive Office Results

*Based on laboratory testing results

True Negatives (TN)*

False Negatives

(FN)*

% of Positives Missed by

POCT

True Positives

(TP)*

Clinically False

Positives (FP)*

% of POCT Positives That Were Incorrect

Opiates 2590 182 29.9 427 123 22.4

Oxycodone/Oxymorphone 2933 81 31.3 178 125 41.3

Methadone 2924 29 27.9 75 62 45.3

Benzodiazepines 2323 349 36.5 606 78 11.4

Amphetamines 3036 112 43.9 143 39 21.4

Barbiturates 2632 34 40.0 51 14 21.5

Tricyclic Antidepressants 1479 24 34.8 45 144 76.2

Cocaine 3211 38 40.0 57 8 12.3

Marijuana 2579 140 20.7 536 145 21.3

MDMA 3147 1 50.0 1 182 99.5

PCP 2275 0 0.0 0 32 100.0


CASE VIGNETTES: Clinical Lessons Learned From SUD Counselors and Definitive Testing

Rzetelny A, et al. Clinical drug testing in substance-use treatment: A qualitative study of counselors’ use of definitive drug testing results in their work with clients. Submitted for publication.

Case Vignettes From Counselors

• Impact of UDT Transition on Therapy:

The relationships “worsened for a little while because people were upset that they were being tested at their treatment court and then by us, and we were the ones that were finding that they were using and their treatment court wasn’t finding that. It kind of made us the bad guys, but after you educated them about how much more sensitive the testing is that we were doing, they kind of got the message.”


• UDT as a Clinical Tool:

• Definitive drug testing could provide an opportunity to: “Foster healthy conversations with clients about their drug use. You can kind of catch people when they are not telling the truth or when they are in denial. So if someone is in denial you can kind of work on helping them in another way.”



The Model of Sobriety Case:

• Client consistently tested negative on IA prior to LC-MS/MS testing

– The counselor explained being surprised that: “she was not ready to stop using…we were able to pick up on that after we caught her relapses...she was probably doing it before, but because of the [previous IA-lab] testing we were unable to pick it up. Whatever games she played before it didn’t work [any more].”

• Initial denials were dramatic but eventually she entered one of her first true periods of abstinence, as suggested by consistently negative LC-MS/MS test results

• Nevertheless, during a weekend pass she died tragically following a relapse associated with marital discord

– Counselor explained, “her peers look at her and see her and see that they might have learned a lesson. They think ‘wow, I thought she was doing good (sic) but she continued to relapse.’ …knowing that she was continuing to use …they probably learned a lesson because there is a saying in the room that some of us will die for others to live…”



Legal Ramification Case:

• Woman with hx of crack cocaine use

– Criminal justice IA tests negative weekly, but treatment center found cocaine positive with LC-MS/MS

– Initial denial gave way to greater honesty and making further progress with her recovery

• Counselor stated, the positive cocaine result with LC-MS/MS was: “a catalyst therapeutically as far as acknowledging that there was a recent relapse and figuring out what we now had to do to move forward. …I think that she maybe opened up a little bit more about guilt and disappointment in herself. I think there was a vulnerability that happened but it was therapeutically useful.”

• Criminal justice system added 2 months to treatment mandate but she did not return to prison

• She was given more structure and monitored more closely



The Catch Me Please Case:• Client UDT positive for clonazepam after more than a year of treatment and

consistently negative IA results

• No denial, instead “…there was a deep sense of shame and failure …she was tearful and crying and saying the moment that she [relapsed] she wanted to go straight to her staff counselor and tell him but she couldn’t bring herself to disappoint him in that way. …it was kind of like she was waiting for [the positive LC-MS/MS result] to happen so she could say it.”

• Entered a new level of progress in her therapy, revealing old sources of emotional pain she related to SUD– Monitored more closely and tested negative for several months

– Recently experienced a new relapse, but remarkably, this time, she did not wait for the positive toxicology to report it

– Her previous experience had helped to build a new level of confidence and trust, this new relapse was much shorter and less intense.



Summary• Prescription drugs, and the opioid class in

particular, have wide ranging impact on society

• UDT can be an important tool in SUD treatment

• Differences exist between UDT technologies, impacting rates of false positives and false negatives

• Understanding these differences is important to avoid misjudging patients and harming therapeutic relationships

Treatment Track:Optimizing Utilization and

Outcomes of Urine Drug Testing

Presenters:• Louis E. Baxter, Sr., MD, FASAM, President and CEO,

Professional Assistance Program of New Jersey, Inc.• Michael C. Barnes, JD, Executive Director, Center for

Lawful Access and Abuse Deterrence (CLAAD), and Member, Rx Summit National Advisory Board

• Elaine Jeter, MD, MolDx Medical Director, Palmetto GBA• Kenneth L. Kirsh, PhD, Vice President, Clinical Research

and Advocacy, Millenium Health

Moderator: Andrea Grubb Barthwell, MD, FASAM, President, Two Dreams Outer Banks

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