improving outcomes and preventing practitioner liability in urine drug testing andrea g. barthwell,...

Improving Outcomes and Preventing Practitioner

Liability in Urine Drug TestingAndrea G. Barthwell, M.D., FASAM

Director, Two Dreams (@DrAGB)

Michael C. Barnes, Esq.Managing Partner, DCBA Law & Policy

(@MCBtweets)

Innovations in RecoverySan Diego, CA

March 30, 2015

Disclosures

Andrea G. Barthwell, M.D., FASAM

• 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

Michael C. Barnes, Esq.

• 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

• Policy recommendations

• Terminology & Methodology• Practice Recommendations• 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


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


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

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

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

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

• 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 H&P• 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


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, 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

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

*Testing may be conducted up to three times per week, based on clinical considerations.

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 monthNo more than three definitive quantitative per quarter

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• 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• LinkedIn.com/in/DrAndreaBarthwell• @DrAGB• LinkedIn.com/in/MichaelCBarnes• @MCBtweets

• Thank you• Questions and discussion

improving outcomes and preventing practitioner liability in urine drug testing andrea g. barthwell,...

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