Transcript Improving Utilization and Outcomes of Urine Drug Testing

Innovations in Recovery
San Diego, CA
March 30, 2015
Improving Outcomes and
Preventing Practitioner Liability
in Urine Drug Testing
Andrea G. Barthwell, M.D., FASAM
Director, Two Dreams
(@DrAGB)
Michael C. Barnes, Esq.
Managing Partner, DCBA Law & Policy
(@MCBtweets)
Disclosures
Andrea G. Barthwell, M.D., FASAM
Michael C. Barnes, Esq.
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• 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.
Alvee Laboratories: Consultant
Braeburn Pharmaceuticals: Consultant
Caron Foundation: Collaborator
EMGlobal LLC: Partner
Encounter Medical Group, PC: Medical Director
GW Pharmaceuticals: Former Consultant
Millennium Laboratories: Consultant
The Parents Academy: Founder
Treatment Partners LLC: Managing Partner
Preview
• Policy landscape
• Responses
• Restrictions
• Enforcement
• Legal bases
• Factual bases
• Policy recommendations
• Terminology & Methodology
• Practice Recommendations
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General
Test Selection
Diagnosis
Active Treatment
Chronic Care
• 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
quantitative 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
Michael C. Barnes & Stacey L. Worthy, Evaluating Motives: Two Simple Tests to Identify and Avoid Entanglement in Legally Dubious Urine Drug Testing Schemes, 11 J.
OPIOID MANAG. 89 (2015).
Response: Enforcement
(Factual Bases)
• 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
Michael C. Barnes & Stacey L. Worthy, Evaluating Motives: Two Simple Tests to Identify and Avoid Entanglement in Legally Dubious Urine Drug Testing Schemes, 11 J.
OPIOID MANAG. 89 (2015).
Response: Enforcement
(Factual Bases)
• 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
Michael C. Barnes & Stacey L. Worthy, Evaluating Motives: Two Simple Tests to Identify and Avoid Entanglement in Legally Dubious Urine Drug Testing Schemes, 11 J.
OPIOID MANAG. 89 (2015).
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
• Enforcement
• Consensus on the need for change
• Outline of next steps
• New paradigms and literature
• Common terminology
• Stages of care: screening/diagnosis, active treatment, chronic care
management (2+ year continuum)
• Documentation of best practices
• Education of practitioners, law enforcement, payers, and policy
makers
Predictions
• Continued opposition based on confusion w/ forensic model
• Frequency of UDT relative to stage of care
• Rapid results to help stabilize (preliminary qualitative)
• Days of abstinence over 2+ year continuum (definitive quantitative)
• No blanket orders; individualized testing
• No “confirmation” of preliminary w/ preliminary
• Bundled services
• 40+ substances, including their analytes
• Definitive quantitative results
• Flat fee w/ single billing code
CMS Jurisdiction 11 Part B Controlled Substance Monitoring
and Drugs of Abuse Coding and Billing Guidelines
Clinical Value 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
Addiction Medicine Context
• 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
Addiction Medicine Context
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 Comparison
Preliminary Qualitative
Definitive Quantitative
Rapid (depending on location)
24 – 72 hours
Presumptive 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 – 165
False 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
Practice Recommendations
• Balance quality and cost
• Understand benefits of methods and frequency
• Inadequately informed attempts to reduce costs may worsen health and
increase costs
• Obtain proper training
• Test selection
• Administration
• Interpretation
• For greater clinical confidence, consult with lab toxicologists or obtain
expert medical review
Test Selection
• Individualized based on clinical evaluation
• Patient history
• Prescribed medications
• Trends
• Local community
• Patient population
• Circumstantial considerations, e.g., introduction of a substance into a
treatment facility
• Document in medical record
• Bases for decisions
• Medical response to result
Test Selection
• 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
Test Selection
• 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 history and physical (H&P) to narrow test selection
Screening & Diagnosis
• Early diagnosis can lead to improved outcomes
• Universal & routine clinical screening (not necessarily
testing)
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Primary care
Urgent care
Pain
Psychiatry
• Conduct a H&P
• Add testing as necessary
• Obstetrics
• Peri-operative
• Addiction
Screening & Diagnosis
• 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 & Diagnosis
If...
Then…
Patient exhibits one or more indicators of risk
Definitive quantitative
Patient exhibits evidence of use
Definitive quantitative
Definitive quantitative test results indicate abstinence
Test again if risk or presentation changes; test no
more than once per year if no change
Definitive quantitative results indicate use
Intervene and establish a treatment plan
Screening & Diagnosis
• Screening, Brief Intervention, and Referral to Treatment (SBIRT) has
numerous benefits
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Decreases stigma
Reduces profiling (including pregnant women)
Improves health outcomes
Reduces costs of untreated SUD
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
Active Treatment
Duration of abstinence
Frequency of testing
≤30 days
Once per week*
One in every three should be definitive quantitative
31 to 90 days
Once per week*
No more than three definitive quantitative per month
91 days to 2 years
One to three times per month
No more than three definitive quantitative per quarter
*Testing may be conducted up to three times per week, based on clinical considerations.
Active Treatment
• 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
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
Chronic Care Management
Duration of abstinence
Frequency of testing
2 to 5 years
Definitive quantitative no more than once per year
>5 years
Definitive quantitative based on clinical considerations
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
Consensus Project
• Pressing need
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Lack of clinical knowledge
No guidelines or recommendations
Unethical behaviors
Responsive payer restrictions
• 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 13+ mos.
• Work product forthcoming
Conclusion
• Thanks to Foundations Recovery Network and sponsors
• Contact
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LinkedIn.com/in/DrAndreaBarthwell
@DrAGB
LinkedIn.com/in/MichaelCBarnes
@MCBtweets
• Thank you
• Questions and discussion