Building CasesAcross State Lines April 10-12, 2012Walt Disney World Swan Resort
Learning Objectives:1) Evaluate the roles of practitioners, regulatory authorities, state and federal investigators and prosecutors in pharmaceutical drug crime cases, with an emphasis on how individuals and agencies can collaborate to achieve common goals.2) Describe the evolution of the prescription pill epidemic and outline the uses and limitations of prescription drug monitoring programs to aid in multi-state investigations.3) Identify problem areas and common roadblocks to effective multi-state investigations from a prosecutor’s perspective, with a discussion of the prosecutor’s role in working with the investigator in early case development.
Disclosure Statement• All presenters for this session, Agent Bruce DiVincenzo and AAG Vernon Stejskal, have disclosed no relevant, real or apparent personal or professional financial relationships.
Medical Practitioners• They are Law Enforcement partners, not adversaries, in most instances, such as in cases of doctor shopping and prescription fraud• Like lawyers and police, the worst 1% give the profession a bad reputation• On the front lines – first hand observation of addiction/drug- seeking, and first ones with the ability to do something• As an investigator, make friends with at least one pharmacist or medical provider who will take your calls and answer questions – don’t use that person as a witness, and don’t overload them
Medical Practitioners• One of the first things to do in every investigation is to determine who is the problem/target. Is it the doctor, someone working in the doctor’s office, or the “patient”?• That determination will effect how records are requested from a medical practitioner.
Medical PractitionersHIPPA does not prohibit sharing patientinformation with law enforcement• There are a number of exceptions that permit law enforcementofficials to access protected health information. These exceptionsbypass the requirement that the individual consent or be given anopportunity to decide whether his or her protected healthinformation will be disclosed.• Crime on premises: If a covered entity believes in good faith thatprotected health information is evidence of criminal conduct thatoccurred on the premises of the covered entity, it may disclosethe information to a law enforcement official.
Medical PractitionersMay require a subpoena to obtain patientinformationRestricted access for administrative requests: An administrativesubpoena may be used to obtain protected health information.In order to use an administrative subpoena, however, thefollowing criteria must be met:1) the information sought must be relevant and material to alegitimate investigation,2) the request must be specific and limited in scope to meet itsintended purpose, and3) information that does not reveal the individual’s identity couldnot reasonably be substituted for the information sought.
Medical Practitioners• Most medical practitioners are willing to cooperate with law enforcement as long as they won’t get into legal trouble over confidentiality• The ones that aren’t cooperative may have something to hide themselves
Medical PractitionersCheck the PDMP• Medical providers should check theControlled Substance Database tosee whether a patient is getting anycontrolled substances from any othersource before prescribing controlledsubstances to that person. Adatabase check is not a legalrequirement, but is stronglyencouraged.
Medical Practitioners• The second doctor is NOT prohibited from prescribing controlled substances. Rather the law is intended to allow doctors to make informed decisions on whether controlled substances are medically necessary, and to avoid unintentional overprescribing and/or addiction.• We are not in the business of making medical decisions.
Medical Practitioners • People starting out with legitimate injuries or pain issues become dependent or addicted and become doctor shoppers seeking more pills.• No informed consent to patients that controlled substances can be addictive and have unwanted side-effects. – Are unscrupulous or untrained doctors creating addicts?
Regulatory Authorities• In Utah, the Division of Professional Licensing (“DOPL”) investigates professionals and grants or denies, suspends, revokes, or places limitations on medical/ pharmacy professionals’ licenses• The Drug Enforcement Administration (“DEA”) grants or denies, revokes, suspends, or places limitations on controlled substance prescribing/dispensing registration
Regulatory Authorities• Even if a criminal charge cannot be filed, at times a licensing action, Controlled Substance registration restriction, or civil fine can be imposed on medical professionals who are in violation of the applicable requirements
State Investigators• Use State PDMP’s• Build partnerships with Pharmaceutical drug crime investigators in neighboring states• Assist other investigators within the limits of your state PDMP
State Prosecutors• Work with officers in the investigation stage – Don’t wait for a prosecution packet and then decline to prosecute because something is weak or missing.• Don’t be afraid to contact federal prosecutors if a case involves jurisdictional issues which make it difficult to prosecute in a state district court.
Federal Investigators• Concentrate on the cases involving large scale drug diversion, and cases that cannot be prosecuted in a single state or county because of jurisdiction/venue issues• If resources are limited, focus on the most egregious offenders. Successful prosecution may have a deterrent effect.
Federal Prosecutors• Break down state boundaries, like we do in other drug cases. Charge a conspiracy when applicable.• Work with officers on the investigation, making sure everything necessary for prosecution is obtained.
Prescription Drug Monitoring Programs (PDMP’s)• According to the Alliance of States with Prescription Monitoring Programs, (www.pmpalliance.org) as of October 16, 2011, 37 states have operational PDMPs that have the capacity to receive and distribute controlled substance prescription information to authorized users. States with operational programs include: – Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, and Wyoming.
Prescription Drug Monitoring Programs (PDMP’s) – Eleven states (Alaska, Arkansas, Delaware, Georgia, Maryland, Montana, Nebraska, New Jersey, South Dakota, Washington, and Wisconsin) and one U.S. territory (Guam), have enacted legislation to establish a PDMP, but are not fully operational. – If your state doesn’t have one, make it priority #1 to get one.• Each state designates a state agency to oversee its PDMP, which may include health departments, pharmacy boards, or state law enforcement. The Alliance of States with Prescription Monitoring Programs www.pmpalliance.org maintains a list of state contacts.
UTAH’s PDMP• Anyone licensed to prescribe a controlled substance is required to register with DOPL to use the database• Failure to comply is grounds for refusal to issue or renew a license, or to revoke, suspend, restrict, or place on probation, any license
UTAH’s PDMP• Access is given to: – DOPL investigators – Dept. of Health – Licensed Practitioners with CS privileges (and designated employees) – Licensed Pharmacists – Law Enforcement (and Prosecutors) o Assigned to investigate drug crimes o Insurance Fraud + Medicaid/Medicare Fraud
UTAH’s PDMP• Pharmacies are required to report information to the database every 7 days• Patient name and address• Prescribing physician• Dispensing Pharmacy & Date Filled• Drug, # of pills, and duration of Prescription
PDMP Uses• All of the information for each state is compiled in an easily accessible place• Can track multi-state activity using your computer, fax, and telephone• No prohibitions on sharing information with other law enforcement working jointly on a case
PDMP Limitations• Each state maintains their own info and imposes different restrictions on access – know the rules• Information in PDMP’s is not evidence – Investigators must obtain the prescriptions from the reporting pharmacies
Jurisdictional Issues• Have drug enforcement agents conducted multi-state investigations involving other drugs?• What makes pharmaceutical drug crimes different?• No PDMP database for meth, heroin, or cocaine• Old fashioned investigation – Physical surveillance – GPS tracking – Telephone interception – Confidential Sources/Cooperators – Confessions
Jurisdictional Issues• Any offense begun in one jurisdiction and completed in another, or committed in more than one jurisdiction, may be inquired of and prosecuted in any jurisdiction in which such offense was begun, continued, or completed• 18 U.S.C. § 3237• Look for federal charges such as Conspiracy or Medicaid/Medicare Fraud which can be charged in any state where some of the charged activity occurred
Jurisdictional Issues• Cooperate with law enforcement partners in other states• Help them, they’ll help you. Stone wall them, guess what you can expect in return.• Use DEA Diversion as a resource. They have expertise on Internet cases and have a form on their website.
Pill Mills• In order to be legal, a controlled substance prescription must: – Be issued by a registered practitioner – Be for a legitimate medical purpose – Be issued in the usual course of professional practice
Pill MillsModel Policy for the Use of Controlled Substancesfor the Treatment of Pain• The Model Policy provides that: the prescribing ofcontrolled substances for pain will be considered to be for alegitimate medical purpose if based on sound clinicaljudgment. All such prescribing must be based on cleardocumentation of unrelieved pain. To be within the usualcourse of professional practice, a physician-patientrelationship must exist and the prescribing should be basedon a diagnosis and documentation of unrelieved pain.Compliance with applicable state or federal law is required.
Pill Mills• Look for documentation in a patient’s medical record of tests conducted to – diagnose the source of pain or injury; – a specific diagnosis; and – a treatment plan designed to address the pain.• The offender records I have looked at frequently have no tests, or in some cases an x-ray at the beginning, but nothing but controlled substances for many years after that.• There is always some diagnosis, but that diagnosis is often not supported by any tests, documentation, or clinical notes. There may also be a pattern where multiple controlled substance-receiving patients have the exact same diagnosis. (Lumbar Degenerative Disc is popular.)
Pill MillsA regular regimen of controlled substanceswithout anything else is not a treatment plan.• The Model Policy also provides that: a medical history and physical examination must beobtained, evaluated, and documented in the medicalrecord. The medical record should document the natureand intensity of the pain, current and past treatments forpain, underlying or coexisting diseases or conditions, theeffect of the pain on physical and psychological function,and history of substance abuse. The medical record shouldalso document the presence of one or more recognizedmedical indications for the use of a controlled substance.
Pill Mills• A treatment plan is required to: state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. [The physician should also] periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health.
Pill Mills• Doctor guilty if he dispensed “other than in good faith for detoxification” of patients. Doctor not guilty if he “merely made an ‘honest effort’ to prescribe . . . In compliance with an accepted standard of medical practice.”• Good faith exception protects physicians who dispense prescriptions in good faith in the course of reasonable legitimate medical practice. “Some latitude must be given to doctors trying to determine the current boundaries of accepted medical practice.”• U.S. v. Hurwitz, 459 F.3d 463 (4th Cir. 2006)
Pill Mills• “Evidence regarding the applicable standard of care is not offered to establish malpractice, but rather to support the absence of any legitimate medical purpose.”• “Knowing how doctors generally ought to act is essential for a jury to determine whether a practitioner has acted not as a doctor, or even a bad doctor, but as a ‘pusher’ whose conduct is without legitimate medical justification.”• U.S. v. Feingold, 454 F.3d 1001, 1007 (9th Cir. 2006)• U.S. v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005)
Pharmacist’s Responsibility“The responsibility for the proper prescribing and dispensing ofcontrolled substances is upon the prescribing practitioner, but acorresponding responsibility rests with the pharmacist who fills theprescription.” 21 C.F.R. § 1306.04(a).• Government needs to show that : 1) the prescription filled by pharmacist was not issued for a legitimate medical purpose; and 2) pharmacist knew the prescription was invalid OR• pharmacist should have known that the prescription was invalid,but deliberately closed his eyes to what would have otherwisebeen obvious.• U.S. v. Leal, 75 F.3d 219 (6th Cir. 1996)
Pharmacist’s Responsibility• Pharmacist argued that he did not have any reasonable means to fulfill duty of establishing that doctor who issued the prescription did so in the usual course of medical treatment; that the most he could do to verify the bona fides of a prescription is to check with the issuing physician.• “The pharmacist is not required to have a ‘corresponding responsibility’ to practice medicine. . . a pharmacist can know that prescriptions are issued for no legitimate medical purpose without his needing to know anything about medical science.”• U.S. v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)
Deliberate Ignorance• “The key element of knowledge may be shown by proof that the defendant deliberately closed his eyes to the true nature of the prescription.”• “Lawson willingly ignored every signal that he should question the volume of controlled drugs being dispensed from his pharmacies.” U.S. v. Lawson, 682 F.2d 480, 482-3 (4th Cir. 1982)• New or clarifying law in CVS pharmacy case in Florida.
Clinic Owner • Owner was intimately involved in virtually every facet of administering the clinic, including the hiring and firing of the doctors and the staff, the recording of the receipts and the prescriptions, and the supervision of the employees who actually handed out the prescriptions and received the payments. Guilty of aiding and abetting the doctor.• U.S. v. Johnson, 831 F.2d 124 (6th Cir. 1987)• U.S. v. Armstrong, 2007 U.S. Dist. LEXIS 18023 (E.D. La., Mar. 14, 2007)
Prosecutor’s Role• Engages qualified expert to review doctor cases• Coordinates between investigators and prosecutors in multi-jurisdiction cases (Like SOD)• Cross-designation as state/federal prosecutor when available
Prosecutor’s RoleOvercoming defenses:• Just trying to help people in pain.• I just took the patient’s word for it. Why would they lie to me?• Just a sloppy record keeper.• Maybe malpractice, but not criminal.• Look at all of my “good patients”.• How dare you second guess my medical judgment.• I guess I didn’t keep up on the latest pain management techniques.• Somebody has to be the highest prescriber.• I seem to get all of the chronic pain patients.• What else could I have done?
Roadblocks to Prosecution1) ID offender. (Element is “acquired or obtained possession of” the controlled substance.) To prove who “acquired or obtained possession of” the controlled substance, we can look to several things. 1) Sometimes pharmacies have video recordings of the counter showing who picked up controlled substances from that pharmacy. 2) Occasionally pharmacy employees can ID the receiver of the controlled substance from memory. 3) Insurance billing may provide evidence of who obtained the controlled substance. 4) Suspects may also admit to prescription fraud when confronted. Ask for ID when interviewing. 5) Utah statute requires a D.L. # and a signature.
Roadblocks to Prosecution2) Getting Medical Professionals to give a Statement and Testify in Court.3) They should take the case in (another jurisdiction).4) Others??