City of Hope Presentation - The Law Offices of Alan I. Kaplan

How To Anticipate And Avoid Government
Interference With This Crucial Area Of
Medical Care
By Alan I. Kaplan, Attorney at Law
310 420 6961
[email protected]
Introduction-Origins of Opiophobia
• Food and Drug Act of 1906
• Harrison Act of 1914
• Webb (1919) Moy (1920), Behrman (1921)
– The Doctor’s Dilemma-purpose of pain meds
• Controlled Substances Act (1972)
• DEA Reassurances
– 2002 Asa Hutchinson speech to American Pain
Society: “We never want to deny deserving patients
access to drugs that relieve suffering and improve the
quality of life”
Type of Patient at Issue
• End of Life Pain-Hospitalized Patient
• Chronic Intractable Pain
– Other sanctioned treatment has run its course
– E.g. workers compensation system
– Needs pain management to work
– Financial Limitations
– Treating with PCP
The Myth of the "Chilling Effect"
Doctors Operating Within Bounds of Accepted Medical
Practice Have Nothing to Fear From DEA
Drug Enforcement Administration (DEA) statistics show that the vast majority of
practitioners registered with DEA comply with the requirements of the Controlled
Substances Act (CSA) and prescribe controlled substances in a responsible manner in
treating their patients' medical needs.
One of the missions of the Drug Enforcement Administration (DEA), Diversion Control
Program (DCP), is to prevent, detect and investigate the diversion of legitimately
manufactured controlled substances. The Controlled Substances Act (CSA) requires
doctors to become registered with DEA in order to prescribe, dispense or administer
controlled drugs to their patients for legitimate medical reasons.
The DEA may initiate an investigation of a practitioner upon receipt of information of
an alleged violation of the provisions of the CSA and may pursue sanctions against
the practitioner based upon the facts determined from that investigation.
Since FY 1999 the DEA registrant population has continually increased reaching
almost 1 million doctors (as of June 30, 2003). During this same time, DEA has
pursued sanctions on less than one tenth of one percent of the registered doctors.
The pie charts pictured put this in graphic perspective.
DEA Reassurances
The Chilling Effect
• Doctors who, faced with a patient in pain,
fearing being targeted by the DEA, modify
their treatment in an attempt to avoid
regulatory attention.
• Distortion of the doctor-patient
– E.g. selecting less effective, more toxic noncontrolled medications when a trial of opioid
analgesics would be in patient’s best interest
Statistical Realities
• “963,385 total registrants in 2003, only
557 investigations initiated, 441 actions
against M.D.s, 34 arrests..<.1% of
registered doctors”
• Estimated that only 5000 registrants are
engaged in chronic opioid therapy
(Hochman, Nat. Fnd. For Trtmt. Of Pain)
• Over 10% of Chronic Opioid treaters face
DEA investigation
Strategies to Combat the
Undertreatment of Pain
• End of Life Pain
• Principle of double effect recognizes
the difference between
– Provision of adequate treatment that
unintentionally hastens death
• Provision of medication that intentionally
causes a patient’s death
Strategies to Combat the
Undertreatment of End of Life Pain
• Physicians have responsibility to be aware of
realistic risks associated with treatments (e.g.,
the minimal risk of death associated with opioids
when prescribed appropriately for pain relief)
Physicians should feel comfortable providing
medication, including opioids
– Using accepted dosing guidelines to alleviate a
patient’s pain and suffering
• Even if unintended secondary effect might risk
hastening patient’s death
Strategies to Avoid Scrutiny of Care
Decisions-End of Life Pain
• Documenting balancing decisions
• Use of Institutional Resources to manage
relationships with family
• Documenting response to pain
• Visual Analogue Scale
• Pain as the 5th Vital Sign
Strategies to Combat the
Undertreatment of Pain-Outpatient
• Identifying the areas of outpatient pain
management most subject to greatest scrutiny
Long term opioid use for chronic pain states
Pain regimens where other family members object
Operating an office dispensary
Government databases that tabulate prescribing
and purchasing patterns- CURES and ARCOS
Older Physicians
Strategies to Combat the
Undertreatment of Pain
• Identify Agencies that have the most
interest in the area and understand how
they target physicians
DEA, Medical Board, Medicare, MediCal
Reports from other agencies
“Joint Task Forces”
Use of undercover operatives
Strategies to Combat the
Undertreatment of Pain-Outpatient
• Risk management strategies to minimize the
likelihood of being targeted
Use of CURES data
Second opinions and the Intractable Pain Relief Act
Office staff issues
Urine tests and other methods to expose
malingering and drug seeking behavior
Documenting decision making with patients who
have developed a tolerance or who have undergone
Pain contracts and surveys