DEALING WITH GOVERNMENT SCRUTINY OF PAIN MANAGEMENT BY PRIMARY CARE PHYSICIANS How To Anticipate And Avoid Government Interference With This Crucial Area Of Medical Care By Alan I. Kaplan, Attorney at Law

Introduction-Origins of Opiophobia Food and Drug Act of 1906 Food and Drug Act of 1906 Harrison Act of 1914 Harrison Act of 1914 Webb (1919) Moy (1920), Behrman (1921) Webb (1919) Moy (1920), Behrman (1921) –The Doctor’s Dilemma-purpose of pain meds Controlled Substances Act (1972) Controlled Substances Act (1972) DEA Reassurances 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 End of Life Pain-Hospitalized Patient Chronic Intractable Pain 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

DEA REASSURANCES 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. 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. 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. 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. 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. 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 relationship Distortion of the doctor-patient relationship –E.g. selecting less effective, more toxic non- controlled 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” “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) 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 Over 10% of Chronic Opioid treaters face DEA investigation

Strategies to Combat the Undertreatment of Pain End of Life Pain End of Life Pain Principle of double effect recognizes the difference between 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 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 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 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 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 Documenting balancing decisions Use of Institutional Resources to manage relationships with family Use of Institutional Resources to manage relationships with family Documenting response to pain management Documenting response to pain management Visual Analogue Scale Visual Analogue Scale Pain as the 5 th Vital Sign Pain as the 5 th Vital Sign

Strategies to Combat the Undertreatment of Pain-Outpatient Identifying the areas of outpatient pain management most subject to greatest scrutiny 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 Identify Agencies that have the most interest in the area and understand how they target physicians –DEA, Medical Board, Medicare, MediCal –Data Mining-CURES/ARCOS –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 Risk management strategies to minimize the likelihood of being targeted –EHR –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 detox. –Pain contracts and surveys DO NOT SURRENDER YOUR REGISTRATION DO NOT SURRENDER YOUR REGISTRATION