Proper Utilization of Urine Testing in Identifying and Treating Substance Use Disorders

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1 CCSAD 27 th National Conference Hyannis, MA September 11 14, 2014 Proper Utilization of Urine Testing in Identifying and Treating Substance Use Disorders Michael C. Barnes Executive Director

2 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, 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

3 Preview Standard of Care in Testing for Substance Use UDT Under Scrutiny Enforcement Activity Case of Veritas Laboratories Cross-referrals/Fractional Ownership Limitations on Testing for Substance Use Payer Responses to Improper Utilization Lack of Knowledge Policy Recommendations

4 Standard of Care in Testing for Substance Use Medical necessity determined largely by standard of care. Practice customs (peers in the professional community). Reasonable, prudent practitioner. Not determined by the average practitioner. 99/100 could ascribe to a certain theory or technique that is not in the best interest of the patient. Inadequate documentation on the appropriate methodology and frequency for UDT in identifying substance use in the addiction medicine context.

5 UDT Under Scrutiny Mass. State Auditor: improper drug testing cost Mass. millions. Major cost issues: ordering tests too frequently, using multiple procedure codes for procedures that are supposed to be billed together ( unbundling ), and ordering tests that were not medically necessary (no medical review of results). Carolina Chemistries: FBI raid on testing equipment maker. FBI: Co. claimed its bench top analyzer could perform a quantitative review of drug levels, eliminating the need to send samples to a lab. Analyzer only performed a qualitative analysis; payers were overbilled. No FDA-approved, bench top quantitative UDT system on the market.

6 UDT Under Scrutiny: Veritas Labs Veritas Labs allegedly paid doctors cash rebates for testing. Physicians referring to Veritas reported earnings of $400 per sample. Cash-back arrangement applied only to commercial insurers. Veritas asserts that the arrangement is outsourcing, not referring. Our Take: the reimbursement scheme implicates: Federal Anti-Kickback Laws, which criminally prohibit offering, paying, soliciting, or receiving anything of value to induce or reward referrals or generate Federal health care program business. OIG: Anti-kickback laws apply even to referrals of commercially insured patients if the arrangement increases the likelihood that physicians will refer gov t-insured patients.

7 UDT Under Scrutiny: Veritas Labs Our Take: the reimbursement scheme implicates: Federal Self-Referral Law (Stark Law), which prohibits a physician from referring Medicare and Medicaid patients to an entity with which the physician (or immediate family member) has a financial relationship. Even if the services are ultimately paid for by a third party or commercial insurer, Stark law prohibits referrals of Medicare/Medicaid patients if the services are payable under those programs. Also Implicated: state Anti-Kickback & Patient Brokering laws, state Rebate prohibitions, federal False Claims Act, federal Criminal Health Care Fraud Statute.

8 Cross-Referrals/Fractional Ownership Referral CLINIC A LAB A LAB B CLINIC B Financial Relationship Financial Relationship Referral

9 Cross-Referrals/Fractional Ownership Likely problematic under Anti-Kickback & Stark Law. Implicates Stark law if Medicare/Medicaid patients are referred to an entity w/ which the physician (or family) has a financial relationship. Ex. Clinic A physician is a co-owner of Lab, Clinic B has made a capital loan to lab. A shares in Lab s net revenues in an amount that varies with the volume of Lab business generated by Clinic A for Clinic B. (MassMed, Making Sense of Stark Law, 13 (2005)) Implicates anti-kickback laws if any incentive is offered to induce referral for services paid for by Medicare/Medicaid. Ex. Lab offers Clinic A rebates on lab services if Clinic A refers to Clinic B.

10 Payer Response: Limitations on Testing Across-the-board policy responses to extreme cases of waste, fraud and abuse. MassHealth severely restricts testing for addiction treatment monitoring, despite contrary American Society for Addiction Medicine (ASAM) recommendations. Mass. Auditor proposed eliminating coverage for sample integrity tests ( not routinely necessary SAMSHA), even though they can be essential to identifying efforts to conceal use.

11 Limitations on Testing for Substance Use Medicare, most Medicaid plans, and most private insurance will only cover definitive testing in very limited circumstances, fostering duplication and waste. Some Medicaid programs established arbitrary 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 with the forensic model.

12 Policy Recommendations Education of Practitioners. Federal and state laws governing financial relationships, proper billing practices. Consequences of violations: not worth the risk. Enforcement. Rehabilitate negligent actors. Prosecute bad actors.

13 Policy Recommendations Balance access, quality, and cost. Eliminate wasteful spending. Foster new technology and ensure a competitive market. New paradigms in practice and in billing. Expand interventions and referrals to treatment. Health care: general, pain, addiction, obstetrics, psychiatry, peri-operative. Education, employment, criminal justice systems.

14 Law Review Articles Applying Lessons from the Opioid Abuse Epidemic to Protect Consumers from Gray Market Biologics, NOTRE DAME J.L. ETHICS & PUB. POL Y (Forthcoming 2014). Active Verification and Vigilance: A Method To Avoid Civil and Criminal Liability When Prescribing Controlled Substances, DEPAUL J. HEALTH CARE L. (2013). The Best of Both Worlds: Applying Federal Commerce and State Police Powers To Reduce Prescription Drug Abuse. MD. J. HEALTH CARE L. & POL Y (2013).

15 Conclusion Thanks to fellow panel members, C4 Recovery Solutions and staff. LinkedIn.com/in/michaelcbarnes. Thank you. Questions and discussion at the conclusion of the session.