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Op#mizing U#liza#on and Outcomes of Urine Drug Tes#ng 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 prescrip#on drug fraud, diversion, misuse, and abuse while advancing consumer access to high-‐quality health care. CLAAD’s funders include pharmaceu#cal 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 ac#vi#es 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 –  Restric#ons –  Enforcement •  Legal bases •  Factual bases •  Recommenda#ons –  Prac#ce –  Policy •  Progress •  Predic#ons •  Conclusion Policy Landscape •  21.5 million Americans with SUDs; 90 percent untreated •  120 people die every day of overdoses •  S#gma –  Social –  Structural (need for parity) •  Outmoded, inaccurate technology •  Duplica#on and waste –  Access to accurate tests dictated by suspicion –  Errors yield life and death consequences Policy Landscape •  Evolu#on of the Rx abuse epidemic –  Heroin use and buprenorphine abuse –  Shi[ing tac#cs of dirty docs •  Black market biologics (recent KY enforcement cases) •  “Liquid gold” urine tes#ng labs •  Therapeu#c approaches reduce costs and recidivism •  Expand non-‐puni#ve interven#ons and referrals to treatment –  Educa#on –  Employment –  Criminal jus#ce •  Opposi#on to tes#ng for substance use (confusion w/ forensic model) –  Indiana –  Wisconsin •  Kick “up”, not “out” (health care and social safety net programs) •  Sentencing reform and vo#ng-‐rights restora#on Policy Landscape •  Signiﬁcant UDT expenditures –  Medicare paid $457 million for 16 million tests (2012) –  Sales at UDT labs es#mated at $4 billion •  Unethical prac##oners have seized on the surge in spending •  Aggressive federal ac#on to reduce healthcare waste, fraud, and abuse: $4.3 billion recovered (2013) Response: Restric#ve Coverage Policies •  BCBS of Alabama proposed to deny coverage of any deﬁni#ve tes#ng •  Medicaid per-‐member, per-‐year limits on tes#ng –  NJ: 24 –  NY: 104 •  What contributes to ill-‐advised tes#ng coverage policy? –  Inadequate knowledge of addic#on medicine –  No guidelines in addic#on medicine –  Lack of understanding about current tes#ng technology –  Confusion w/ forensic model Response: Enforcement (Legal Bases) •  Stark law: prohibits referrals of Medicare/Medicaid pa#ents if physician or family member has ﬁnancial interest •  An+-‐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 ins#tu#on, 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 Evalua&ng Mo&ves: Two Simple Tests to Iden&fy and Avoid Entanglement in Legally Dubious Urine Drug Tes&ng Schemes, JOURNAL OF OPIOID MANAGEMENT (Forthcoming 2015) Response: Enforcement (Factual Bases) •  Clinical trials and registry arrangements: paying to submit pa#ent data, answer pa#ent ques#ons, 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 Evalua&ng Mo&ves: Two Simple Tests to Iden&fy and Avoid Entanglement in Legally Dubious Urine Drug Tes&ng Schemes, JOURNAL OF OPIOID MANAGEMENT (Forthcoming 2015) Response: Enforcement (Factual Bases) •  Improper markups, coding, and billing –  Interpreta#on of results that a lab performed but for which the prac##oner bills –  Using codes to circumnavigate prohibi#ons against more expensive tests •  Medically unnecessary tests, including results not reviewed by a physician (MA state auditor) Evalua&ng Mo&ves: Two Simple Tests to Iden&fy and Avoid Entanglement in Legally Dubious Urine Drug Tes&ng Schemes, JOURNAL OF OPIOID MANAGEMENT (Forthcoming 2015) Prac#ce Recommenda#ons: Evalua#ng UDT Proposals •  Does the pa#ent’s health depend on the service? •  Will my decisions be inﬂuenced by the poten#al for proﬁt? •  Does the proposal appear to avoid the spirit of the law while possibly complying with the leoer of the law? –  Circumven#on schemes are disfavored if not expressly illegal –  Do you want to serve as the test case? Policy Recommenda#ons •  Employ UDT to expand interven#ons and treatment •  Educate the uninformed –  Iden#fy and avoid par#cipa#ng in legally dubious UDT schemes –  Follow best prac#ces •  Isolate and enforce against bad actors •  Advance ethics, eﬃciency, and transparency –  Eliminate wasteful prac#ces and payment policies •  Outmoded, inaccurate technology •  Duplica#on and waste –  Document medical necessity and the bases of UDT selec#ons –  Help appeal unjust denials of care Progress •  New paradigms and literature –  Common terminology (Dr. Baxter to discuss) –  Stages of care: screening/diagnosis, ac#ve treatment, chronic care management (2+ year con#nuum) –  Documenta#on of best prac#ces –  Educa#on and enforcement on waste, fraud, and abuse •  Consensus on the need for change •  Outline of next steps Predic#ons •  Con#nued opposi#on based on confusion w/ forensic model •  Frequency of UDT rela#ve to stage of care –  Rapid results to help stabilize (presump#ve) –  Days of abs#nence over 2+ year con#nuum (deﬁni#ve) •  No blanket orders; individualized tes#ng •  No “conﬁrma#on” of presump#ve w/ presump#ve •  Bundled services (Dr. Jeter to discuss) –  40+ substances, including their analytes –  Quan#ta#ve results –  Flat fee w/ single billing code CMS Jurisdic#on 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 •  Ques#ons and discussion at end of session •  Contact –  LinkedIn.com/in/michaelcbarnes –  @mcbtweets –  www.claad.org –  @claad_coali#on •  Thank you