This document outlines a conference for building cases across state lines related to pharmaceutical drug crimes. It discusses the roles of various practitioners, authorities, investigators and prosecutors involved in these types of cases. It also covers the evolution of the prescription drug epidemic and how prescription drug monitoring programs can aid in multi-state investigations. The document identifies common roadblocks to effective multi-state investigations and the prosecutor's role in working with investigators during early case development.
2. 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.
3. 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.
4. 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
5. 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.
6. Medical Practitioners
HIPPA does not prohibit sharing patient
information with law enforcement
• There are a number of exceptions that permit law enforcement
officials to access protected health information. These exceptions
bypass the requirement that the individual consent or be given an
opportunity to decide whether his or her protected health
information will be disclosed.
• Crime on premises: If a covered entity believes in good faith that
protected health information is evidence of criminal conduct that
occurred on the premises of the covered entity, it may disclose
the information to a law enforcement official.
7. Medical Practitioners
May require a subpoena to obtain patient
information
Restricted access for administrative requests: An administrative
subpoena may be used to obtain protected health information.
In order to use an administrative subpoena, however, the
following criteria must be met:
1) the information sought must be relevant and material to a
legitimate investigation,
2) the request must be specific and limited in scope to meet its
intended purpose, and
3) information that does not reveal the individual’s identity could
not reasonably be substituted for the information sought.
8. 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
9. Medical Practitioners
Check the PDMP
• Medical providers should check the
Controlled Substance Database to
see whether a patient is getting any
controlled substances from any other
source before prescribing controlled
substances to that person. A
database check is not a legal
requirement, but is strongly
encouraged.
10. 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.
11. 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?
12. 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
13. 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
14. 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
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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
21. 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
22. 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
23.
24. 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
25. 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
26. 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
27. 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
28. 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.
29. 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
30. Pill Mills
Model Policy for the Use of Controlled Substances
for the Treatment of Pain
• The Model Policy provides that: the prescribing of
controlled substances for pain will be considered to be for a
legitimate medical purpose if based on sound clinical
judgment. All such prescribing must be based on clear
documentation of unrelieved pain. To be within the usual
course of professional practice, a physician-patient
relationship must exist and the prescribing should be based
on a diagnosis and documentation of unrelieved pain.
Compliance with applicable state or federal law is required.
31. 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.)
32. Pill Mills
A regular regimen of controlled substances
without anything else is not a treatment plan.
• The Model Policy also provides that:
a medical history and physical examination must be
obtained, evaluated, and documented in the medical
record. The medical record should document the nature
and intensity of the pain, current and past treatments for
pain, underlying or coexisting diseases or conditions, the
effect of the pain on physical and psychological function,
and history of substance abuse. The medical record should
also document the presence of one or more recognized
medical indications for the use of a controlled substance.
33. 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.
34. 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)
35. 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)
36. Pharmacist’s Responsibility
“The responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription.” 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 otherwise
been obvious.
• U.S. v. Leal, 75 F.3d 219 (6th Cir. 1996)
37. 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)
38. 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.
39. 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)
40. 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
41. Prosecutor’s Role
Overcoming 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?
42. Roadblocks to Prosecution
1) 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.
43. Roadblocks to Prosecution
2) Getting Medical Professionals to give a
Statement and Testify in Court.
3) They should take the case in (another
jurisdiction).
4) Others??