1. 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) Innovations in Recovery San Diego, CA March 30, 2015

2. 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.

3. 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

4. Policy Landscape 21.5 million Americans with SUDs 90 percent untreated 120 people die every day of overdoses Stigma Social Structural

5. 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

6. 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)

7. 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

8. 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

9. 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. O PIOID M ANAG. 89 (2015).

10. 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. O PIOID M ANAG. 89 (2015).

11. 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. O PIOID M ANAG. 89 (2015).

12. 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?

13. 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

14. 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

15. 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

16. 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

17. 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

18. Addiction Medicine Context

19. Terminology Preliminary QualitativeDefinitive Quantitative ImmunoassayChromatography – mass spectrometry PresumptiveConfirmatory QualitativeQuantitative Point-of-care / in-office / lab-basedIn-office / lab-based ScreenConfirmation Semi-quantitative / quasi-quantitativeAbsolute level, creatinine corrected Simple test (cup / strip / dip / cassette)Complex test Class or specific drug identificationSpecific drug identification

20. Methodology Comparison Preliminary QualitativeDefinitive 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. Screening & Diagnosis If...Then… Patient exhibits one or more indicators of riskDefinitive quantitative Patient exhibits evidence of useDefinitive quantitative Definitive quantitative test results indicate abstinenceTest again if risk or presentation changes; test no more than once per year if no change Definitive quantitative results indicate useIntervene and establish a treatment plan

28. Screening & Diagnosis 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

29. 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

30. Active Treatment *Testing may be conducted up to three times per week, based on clinical considerations. Duration of abstinenceFrequency of testing ≤30 daysOnce per week* One in every three should be definitive quantitative 31 to 90 daysOnce per week* No more than three definitive quantitative per month 91 days to 2 yearsOne to three times per month No more than three definitive quantitative per quarter

31. 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

32. 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

33. Chronic Care Management Duration of abstinenceFrequency of testing 2 to 5 yearsDefinitive quantitative no more than once per year >5 yearsDefinitive quantitative based on clinical considerations

34. 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

35. 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

36. Conclusion Thanks to Foundations Recovery Network and sponsors Contact LinkedIn.com/in/DrAndreaBarthwell @DrAGB LinkedIn.com/in/MichaelCBarnes @MCBtweets Thank you Questions and discussion