Law Enforcement and the Prescriber Enforcement Action Protocol

Law Enforcement and the Prescriber Enforcement Action Protocol Ken Clark U.S. Department of Justice United States Attorney s Office District of Maryland

Opioid Abuse Approx 2.6 fatal overdoses per day in Baltimore City. Unofficial heroin/fentanyl 2018 data (through 10/19/18)

Opioid Abuse Approx 6.9 fatal overdoses per day in the State of Maryland. Unofficial 2018 data (through 10/19/18)

Opioid Abuse Every 3 ½ Hours Unofficial heroin/fentanyl 2018 data (through 10/19/18)

Roadmap

Who Are We?

USAO Maryland More than 80 Assistant US Attorneys Northern and Southern Divisions

USAO Maryland

USAO Maryland Fraud and Public Corruption Major Crimes National Security Violent Crimes Narcotics Asset Forfeiture Civil Greenbelt

Opioid Abuse

USAO Maryland - Narcotics

Isn t This Supposed To Be About Prescribers?

Providers

Target: Drug Diverters

Opioid Abuse Four out of five (heroin) addicts say they came to the drug from prescription pain killers. M. Calabresi Time Magazine, June 2015 The Price of Relief, Why America Can t Kick Its Painkiller Problem

PROVIDERS

The Violations: Potential Criminal Charges Drug Distribution (21 U.S.C. 841 et al.) Ultimate issue: Prescription must be issued for a legitimate medical purpose by an individual acting in the usual course of professional practice. 21 C.F.R. 1306.04(a) If not, they are DRUG DEALERS and same criminal penalties apply Healthcare Fraud (18 U.S.C. 1347) Evidence of: 1) Fraudulent billing under National Provider Identifier (NPI); 2) Fraudulent up-coding for examinations; 3) Unnecessary procedures or tests for the purpose of generating revenue Also can charge Mail & Wire Fraud (18 U.S.C. 1341, 1343) Anti-Kickback Statute (42 U.S.C. 1320a-7b) Knowingly and willfully offering, paying, soliciting or receiving ANY remuneration (does not have to be $) AT LEAST IN PART to induce, or in exchange for, some medical good or service that is PAID FOR AT LEAST IN PART by a federal healthcare program Money Laundering (18 U.S.C. 1956, 1957) Hiding the $$

Target: Drug Diverters Diversion of pharmaceutical drugs for financial gain. Pharmacies, physicians, health professionals Script mills to manufacture fraudulent prescriptions used to obtain pharmaceutical products Pharmacies filling known bogus scripts Physicians writing prescriptions with no legitimate medical reasons writers Doctor/ER Shopping drug seekers

Target: Pill Mills Operators Common Traits/Red Flags A doctor or prescriber who: Writes an unusually high amount of certain prescriptions. Doesn t ask a lot of questions. Does not subject patients to urinalysis testing. Does not discharge patients despite multiple abuses or signs of abuse. See patients for very short amounts of time (30 seconds). Accepts cash in exchange for prescriptions. Is willing to write multiple prescriptions at one visit and/or writes a dangerous combination of scheduled narcotics. Has patients lined up outside the practice each day. Has groups of patients showing up in vans, and often coming from long distances. Has a high number of patient overdoses and/or intoxication deaths.

Target: Pill Mill Operators

Wire Taps OWNER said, I messed up the first time because I thought that only one would do that for me, now I know it wouldn t so I m opening multiple ones to make a lot of money really fast ASSOCIATE said, all stems from them doctors writin people out shit that they don t really need it s s**t that they don t really need. ASSOCIATE said, people in these day and age dog are just lookin at as like you know all these pills are just f***in killin people and it s destroyin lives and s**t OWNER said, I will make you a promise when I say I m openin more, It s not to be forever, it, it s just gonna be for a couple years, save up the money I need cause it the more clinics I have, the more money I can stack up

Providers Investigate gather the data Search Warrants documents and computer systems Arrests providers, employees, dealers DEA / Medical licenses

Issue: Disruption of Practice

Solution: Prescriber Enforcement Action Protocol

Disclaimer

Fran

Overview of Protocol

Framework

Living Document

Resource

Purpose

Notice Varies What? Where? When? Goal: Information Sharing

Example Notice

What Next?

Problem: Identifying Scope

Problem: Identifying Scope Aggregate PDMP data Potentially specific PDMP data Doctor s office files

Goal: Address Urgent Medical Issues

Framework

Living Document

Resource

Complicated problem

Do no harm

Questions If you have questions, please contact: Ken Clark Maryland Opioid Fraud and Abuse Initiative Coordinator U.S. Department of Justice United State s Attorney s Office Kenneth.Clark@usdoj.gov (410) 209-4800