What to Expect During a Visit from the Drug Enforcement Administration Consultant Drug Education Consulting Group 1 Drug Education Consulting Group Educate corporate/private groups on drug trafficking and its impact on society 25 years as Special Agent with the DEA (Retired in 2008) Served Assignments in Atlanta, Denver, El Paso, Los Angeles and Thailand Investigated global drug trafficking organizations Served in Washington, D.C. as Chief of DEA s International Intelligence Program 10 Years as a Police Officer in Cobb County, Georgia Served on multi-agency narcotics unit investigating regional and local narcotics issues, including diversion of prescription drugs Conducted numerous undercover assignments; taught undercover techniques at police academies. 2 Key Topics Common reasons for DEA Investigations Outcomes if issues are discovered in an investigation. Does an interview mean I am in trouble? Where can I expect the investigation go? What is prescribing for a legitimate medical purpose versus improper behavior. 3 August 7-9, 2015 1
Who or What is the Drug Enforcement Administration? The Drug Enforcement Administration was created by President Richard Nixon through an Executive Order in July 1973 in order to establish a single unified command to combat "an all-out global war on the drug menace." At its outset, DEA had 1,470 Special Agents and a budget of less than $75 million. Today, the DEA has nearly 5,000 Special Agents, 525 Diversion Investigators,700 Intelligence Research Specialists and a budget of $2.02 billion. http://www.justice.gov/dea/ops/diversion.shtml 4 Diversion of Controlled Pharmaceuticals Many of the narcotics, depressants, and stimulants manufactured for legitimate medical use are subject to abuse and have, therefore, been brought under legal control. Under federal law, all health professionals licensed to dispense, administer, or prescribe them must register with the DEA. Registrants must comply with regulatory requirements relating to drug security and record keeping. Diversion investigations involve, but are not limited to, physicians who sell prescriptions to drug dealers or abusers; pharmacists who falsify records and subsequently sell the drugs; employees who steal from inventory and falsify orders to cover illicit sales; prescription forgers; and individuals who commit armed robbery of pharmacies and drug distributors. http://www.justice.gov/dea/ops/diversion.shtml 5 Closed System of Distribution Investigations Established Schedules Record Keeping Requirements Registration Security Requirements ARCOS Established Quotas 6 August 7-9, 2015 2
DEA Mission To prevent, detect, and investigate the diversion of controlled substances from legitimate sources while Ensuring an adequate and uninterrupted supply for legitimate medical and scientific purposes. 7 DEA Authority to Investigate Diversion The DEA derives its authority to pursue its Diversion Control program from federal law. Specifically the Controlled Substances Act (CSA), 21 U.S.C. 801-971, and the corresponding regulations found at 21 CFR Part 1300-1321, give DEA the authority and responsibility to monitor and regulate pharmaceutical controlled substances. These same laws and regulations also set forth the requirements of physicians and other health care providers who have authority to prescribe, dispense and/or administer controlled substances. 8 Expectations of a DEA Visit to a Practice Drug Enforcement Administration (DEA), Diversion Investigators can make periodic unannounced inspection/audits to registrants. Always be prepared, a DEA visit could occur late in the afternoon or near holiday weekends. The purpose of inspection/audits is to ensure that the registrant is complying with the Controlled Substance Act and to bring them back into compliance if they are not. Investigators could also be looking for suspected criminal activity. Registrants must be aware that the DEA is a law enforcement agency. Upon arrival a DEA Diversion Investigator will present to the registrant their credentials and photo identification. Afterward, the DEA Diversion Investigators will request informed consent by having the registrant or authorized personnel sign a Notice of Inspection (DEA Form 82) or present a search warrant for items that are to be reviewed. 9 August 7-9, 2015 3
Methods of Diversion Illegal sales Internet Employee theft Prescription rings Doctor shopping Inappropriate prescribing Fraudulent prescriptions Pharmacy theft Foreign diversion and smuggling into the U.S. 10 DEA s Role in Prescribing Controlled Substances DEA's role under the Controlled Substances Act (CSA) is to ensure that controlled substances are prescribed, administered, and dispensed only for legitimate medical purposes by DEA-registered practitioners acting in the usual course of professional practice and otherwise in accordance with the CSA and DEA regulations. Each State also has its own laws (administered by State agencies) requiring that a prescription for a controlled substance be issued only for a legitimate medical purpose by State-licensed practitioners acting in the usual course of professional practice. http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm 11 DEA Published Position Federal Register, Vol. 71, No. 172, 9-6-2006 Prevent abuse and diversion without adversely impacting the legitimate need of patients to have full access to pain relief prescribed by their physician The entirety of the circumstance is considered The cases in which physicians have been found to have prescribed improperly typically involve blatant criminal conduct The percentage of physicians who prescribe improperly (or are investigated for doing so) is extremely small http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm 12 August 7-9, 2015 4
A Valid Prescription A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (for example, an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription). A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient s full name and address, and the practitioner s full name, address, and DEA registration number. The prescription must also include: drug name strength dosage form quantity prescribed directions for use number of refills (if any) authorized A prescription for a controlled substance must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (secretary or nurse) may be designated by the practitioner to prepare prescriptions for the practitioner s signature. The practitioner is responsible for ensuring that the prescription conforms to all requirements of the law and regulations, both federal and state. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm 13 Legitimate Medical Purpose Usual Course of Professional Practice This requirement has been construed by the courts to mean that the Rx must be issued in accordance with a standard of medical practice generally recognized and accepted in the United States. United States v. Moore 423 U.S. 122 (1975) 14 Inspections Versus Investigations Is There a Difference? During a typical audit/inspection, DEA Investigators will verify security practices and compare the records of controlled substances prescribed or dispensed. According to the Code of Federal Regulations, there is no acceptable discrepancy range for DEA purposes. The inspection could also be searching for elements of criminal activity. Keep in mind that just because investigators want to interview you, doesn t always mean you are the target of their inquiry, but it also doesn t mean you aren t. Preliminary background and data base checks have already been done and there may be specific questions to ask you. There has more than likely been a complaint that has led to the visit. The more specific the complaint the more thorough the actions. 15 August 7-9, 2015 5
Does Consent Have to Given During an Inspection If consent is not given or withdrawn, Diversion Investigators and/or Special Agents can make application for an Administrative Warrant signed by any judge of the United States or of a State court of record, or any United States magistrate judge. The warrant shall identify the items or types of property to be seized, if any and: Note who is authorized to serve the warrant What may be seized pursuant to the warrant What authority the warrant return must be made http://www.deadiversion.usdoj.gov/21cfr/21usc/880.htm 16 Criminal Investigations 17 Factors Leading to an Investigation DEA document contained in the Federal Register states: This does not mean that the existence of any of the foregoing factors will automatically lead to the conclusion that the physician acted improperly. Rather, each case must be evaluated based on its own merits in view of the totality of circumstances particular to the physician and patient. Rather than focusing on any particular factor, it is critical to bear in mind that (i) the entirety of circumstances must be considered, (ii) the cases in which physicians have been found to have prescribed controlled substances improperly typically involve facts that demonstrate blatant criminal conduct, and (iii) the percentage of physicians who prescribe controlled substances improperly (or are investigated for doing so) is extremely small. FR Doc. E6-14517 582 F.2d 1032 UNITED STATES of America, Plaintiff- Appellee,v. Isadore I.ROSEN, Defendant-Appellant http://bulk.resource.org/courts.gov/c/f2/582/582.f2d.1032.78-5025.html 18 August 7-9, 2015 6
Legitimate Medical Purpose (What the Courts say) (1)An inordinately large quantity of controlled substances was prescribed. United States v. Behrman, 258 U.S. 280, 42 S.Ct. 303, 66 L.Ed. 619 (1922); United States v. Warren, 453 F.2d 738 (2nd Cir.), Cert. denied, 406 U.S. 944, 92 S.Ct. 2040, 32 L.Ed.2d 331 (1972); United States v. Brandenburg, 155 F.2d 110 (3rd Cir. 1946). (2) Large numbers of prescriptions were issued. United States v. Abdallah, 149 F.2d 219 (2nd Cir.), Cert. denied, 326 U.S. 724, 66 S.Ct. 29, 90 L.Ed. 429 (1945). (3) No physical examination was given. United States v. Warren, supra; White v. United States, 399 F.2d 813 (8th Cir. 1968); Brown v. United States, 250 F.2d 745 (5th Cir.), Cert. denied, 356 U.S. 938, 78 S.Ct. 779, 2 L.Ed.2d 812 (1958); United States v. Brandenburg, supra. (4) The physician warned the patient to fill prescriptions at different drug stores. United States v. Abdallah, supra. http://law.justia.com/cases/federal/appellate-courts/f2/582/1032/401088/ 582 F.2d 1032 UNITED STATES of America, Plaintiff- Appellee,v. Isadore I.ROSEN, Defendant-Appellant http://bulk.resource.org/courts.gov/c/f2/582/582.f2d.1032.78-5025.html 19 Legitimate Medical Purpose (What the Courts say) (5) The physician issued prescriptions to a patient known to be delivering the drugs to others. United States v. Warren, supra. (6) The physician prescribed controlled drugs at intervals inconsistent with legitimate medical treatment. United States v. Brandenburg, supra. (7) The physician involved used street slang rather than medical terminology for the drugs prescribed. United States v. Larson, 507 F.2d 385 (9th Cir. 1974). (8) There was no logical relationship between the drugs prescribed and treatment of the condition allegedly existing. See United States v. Behrman, supra; Webb v. United States, 249 U.S. 96, 39 S.Ct. 217, 63 L.Ed. 497 (1919); United States v. Warren, supra; White v. United States, supra; United States v. Brandenburg, supra. (9) The physician wrote more than one prescription on occasions in order to spread them out. United States v. Bartee, 479 F.2d 484 (10th Cir. 1973); United States v. Larson, supra. http://law.justia.com/cases/federal/appellate-courts/f2/582/1032/401088/ 582 F.2d 1032 UNITED STATES of America, Plaintiff- Appellee,v. Isadore I.ROSEN, Defendant-Appellant http://bulk.resource.org/courts.gov/c/f2/582/582.f2d.1032.78-5025.html 20 What About Patient Charts? Your patient files and charts should be complete and accurate, clearly legible, fully articulate and document each patient medical history, your thorough physical examination conducted, medical diagnosis and justification for writing any controlled substance prescription being issued to a patient for a legitimate medical purpose as well as any authorization for refills. The files and charts should be absent of red flags that will require further investigation by DEA. When appropriate your files and charts should include results of blood work, electronic imaging such as: x-rays, scans and/or MRI testing, additional physician consults and opinions and your follow-up with the patient. Some doctors have included the results of random urinalysis drug screening for patients who regularly receive controlled substance prescriptions to assure they are legitimately using the medication and not diverting the drugs. www.deadiversion.usdoj.gov 21 August 7-9, 2015 7
Purpose for Issuing a Prescription To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. In addition, a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription within the meaning and intent of the Controlled Substances Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm 22 Tactical Diversion Squads The Tactical Diversion Squads combine DEA resources with those of federal, state and local law enforcement agencies in an innovative effort to investigate, disrupt and dismantle those suspected of violating the Controlled Substances Act or other appropriate federal, state or local statutes pertaining to the diversion of licit pharmaceutical controlled substances or listed chemicals. The Tactical Diversion Squads : Allow for the unification of separate and sometimes disparate federal, state, and local information, authorities, and enforcement programs Help coordinate with various judicial districts to maximize the effectiveness of multiple investigations and prosecutions of those involved in the diversion of controlled substances or listed chemicals Support traditional Diversion Groups when law enforcement authority is required (i.e., making arrests, purchase of evidence, payment of information, conducting surveillance, executing a search warrant) http://www.deadiversion.usdoj.gov/offices_n_dirs/tac_squad.htm 23 Applying criminal sanctions to doctors Registered physicians can be prosecuted under [21 U.S.C.] 841 when their activities fall outside the usual course of professional practice. United States v. Moore 423 U.S. 122 (1975) 24 August 7-9, 2015 8
Prescription Requirements 21 CFR 1306.03 A controlled substance prescription may only be issued by a duly licensed and (DEA) registered practitioner. 21 CFR 1306.04 A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. (Pharmacies have a responsibility to ensure prescriptions adhere to this directive.) http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html 25 Legitimate Medical Purpose Usual Course of Professional Practice (One More Time) This requirement has been construed by the courts to mean that the Rx must be issued in accordance with a standard of medical practice generally recognized and accepted in the United States. United States v. Moore 423 U.S. 122 (1975) 26 Personnel Precautions The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term "for cause" means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances. http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_76.htm 27 August 7-9, 2015 9
Employee Screening DEA recommends that inquiries concerning employees' criminal records be made as follows: Local inquiries. Inquiries should be made by name, date and place of birth, and other identifying information, to local courts and law enforcement agencies for records of pending charges and convictions. Local practice may require such inquiries to be made in person, rather than by mail, and a copy of an authorization from the employee may be required by certain law enforcement agencies. Inquiries supplying identifying information should also be furnished to DEA Field Division Offices along with written consent from the concerned individual for a check of DEA files for records of convictions. The regional check will result in a national check being made by the Field Division Office. http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_93.htm 28 Advice for a Practice During an Inspection Since inspections may occur at any time during typical business hours, the registrant must have an action plan that is reviewed by all authorized personnel on how to immediately retrieve the necessary documentation required for a DEA inspection. Review the DEA Diversion Inspectors credentials and obtain their contact information. Inquire the reason for the inspection. Have all documentation readily available. Take notes of all recommendations and observations made by the DEA Diversion Investigators. Obtain a location in the office to allow the investigators to review records and policies. Ask any questions you may have regarding their findings so corrective actions can be implemented. Be polite and cordial. Do not argue or debate with the investigators. 29 No Finding Possible Outcomes of DEA Investigation Letter of Admonishment Criminal Charges Memo of Agreement Could limit prescribing Could include voluntary surrender of DEA # 30 August 7-9, 2015 10
Valuable Law Enforcement Resources DEA Office of Diversion www.deadiversion.usdoj.gov www.dea.gov Office of National Drug Control Policy www.whitehousedrugpolicy.gov National Association of Drug Diversion Investigators - NADDI http://www.naddi.org 31 Protecting Prescribing Practices This program is NOT intended to discourage the prescribing or dispensing of appropriate medication for legitimate medical purposes. Physicians and other authorized prescribers should not allow those who divert or misuse prescription drugs to influence the legitimate prescribing and dispensing of controlled substances. The material presented in this presentation is made with the understanding and agreement that Richard Tucker d/b/a Drug Education Consulting Group is not engaged in rendering legal or other professional services by presenting said material. The material is presented as educational material only. The services of a competent professional should be sought if legal or other specific expert assistance is required. 32 DISCLAIMER The material presented in this presentation is made with the understanding and agreement that Richard Tucker d/b/a Drug Education Consulting Group is not engaged in rendering legal or other professional services by presenting said material. The material is presented as educational material only. The services of a competent professional should be sought if legal or other specific expert assistance is required. 33 August 7-9, 2015 11
The Drug Education Consulting Group Telephone: 630-809-0770 Email: richard.tucker@drugeducationgroup.com 34 August 7-9, 2015 12