Addressing the Opioid Crisis: Collaboration between a Medical Expert and Law Enforcement / Prosecutor –Case Study

Tim Munzing, M.D.Kaiser Permanente Family MedicineMedical Expert Consultant to DEA, FBI & Medical Board of CaliforniaNADDI – Norfolk, VA. 2018

Disclosure• Dr. Munzing has no relevant financial interests

to disclose

Goals & Objectives:Participants will be able to:• Identify Elements of Opioid Prescribing

Cases• Discuss Standards of Care for Controlled

Substance Prescribing• Identify “Red Flags” for Potential Controlled

Substance Abuse / Diversion• Describe How to Optimize the Use of a

Medical Expert

1. The DEA/FBI/HHS→ U.S. Attorney’s Office

2.Local Law Enforcement→ District Attorney’s Office

3.HQIU/MBC→ CA Office of the Attorney General

Investigation and

Enforcement to Stop Opioid

Epidemic

• Family members of addicts / patients who overdose or die

• Fellow physicians or ERs who see the inappropriately managed patients

• Pharmacists• Coroners• Medicare arrest or

conviction

How do Physicians come to the Attention of

law enforcement?

• Cases reviewed - ~150• Prison sentences – 75 years• Loss of medical license - >25• Administrative Probation -

>25• Added training - >50• Many cases pending

The Consequences?Heartache for

Others

• Dr. Kim Case –ABC News Clip

• 17 Felony Convictions

• Sentence – 3 years

Stranger than

Fiction:High

Profile and Salacious

Case

Soaring Towards Improved Outcomes and Patient Safety

• Dr. Edward RidgillCase

• Multiple UC patients• PDMP Review• Red flags everywhere

Example Case:

Illustrates so Many

of the Key Issues

Ridgill Investigation Origins

Gang Investigation – Local LE Gang Unit

Gang burglariesProfits – to obtain drugs to sellCapper scheme with gang members

DEA Added

SurveillanceUC patients

Medical Expert

UC ReviewPDMP Review

Medical Record

Reviews

Federal Court Testimony

UC & PDMP

Reviews

Medical Expert Involvement

Ridgill Case Origins• Investigation of targeted burglaries

– robberies• Victims – wealthier appearing

Asians• East Coast Crips identified• Social media postings of stolen

property

Ridgill Case• Office surveillance – many gang

members – monthly office visits• Cappers used – gang leader would direct• Front office – gang connection• Burglary “profits” used for medical visits

- to obtain drugs• Drugs results in greater profits – sold on

the streets

Ridgill Case• Younger patients• Some drove > 100 miles for appointment• Search warrant - >$70,000 cash• Torrance PD gang unit, LAPD, DEA,

HIDTA (High Intensity Drug Trafficking Area)

• 2 Physicians involved – 2nd physician charged – died of cancer

Ridgill Case• Undercover “patients”• “Pain and anxiety”• Minimal or no history or exams• Capper observed in the office

helping the front office staff

Ridgill Case• Cash business ($150)• Drugs prescribed as requested• Visits - few minutes• After 4 visits – pick up Rx

without appointment• Red flags ignored by Ridgill

Prescriptions Obtained• Norco (Hydrocodone) 10 mg• Xanax (Alprazolam) 2 mg• Soma (Carisoprodol) 350 mg• Nearly every prescription and visit

had non-controlled substance medications prescribed (less suspicious)

Additional Review• PDMP Review – high priority list

developed• Many selected – gang members• Search warrant – medical records –

reviewed• Multiple findings – similar to UC’s• Not medically legitimate• Not used in prosecution

• Excessive prescription of medications

• Prescribing without an appropriate exam

• Overall prescribing• Falsification of records

Dr. Munzing’sFindings in Ridgill

Case

Outcome• Federal prosecution – AUSA• 26 Felony counts – illegally

distributing controlled substances• Convicted on all counts (jury – 30

minute deliberation)• 5 year sentence – Federal Prison

1. Xxx2. Xxx3. Xxx4. Xxx5. Xxx6. Xxx

Illegal -Inappropriate

Rx – Why?

• Dr. Greed ($$$) / Dr. Sex• Dr. Addict• Dr. Underworld• Dr. Feelgood• Dr. Naïve• Dr. Running Late• Dr. Ill Prepared• Dr. Satisfaction Scores

Illegal -Inappropriate

Rx – Why?

Universal Precautions for Opioid Prescribing• Evaluate the need• Assess risk• Select the specific treatment - opioid not first choice• Discuss – informed consent – risk / benefit – written

agreement• Monitor closely• Trust but verify• Document thoroughly

CDC Prescribing Guidelines (2016)- Published JAMA – March 15, 2016

• Avoid benzodiazepines with opioids [increases risk of overdose death ten-fold versus only opioid use]

• Periodic benefit / risk evaluation, including PDMP and Urine Drug Screen

• Non-pharmacologic and non-opioid tx – first line

• Chronic pain – avoid opioids – risk outweighs benefits for most

2016 CDC Guidelines

for Controlled Substances

• Discuss risk / benefits with patients and document

• Establish realistic goals – prior to opioid starts

• Start immediate release – avoid Methadone as first line – higher risk

• Additional precautions if dose exceeds 50 MME mg /day

2016 CDC Guidelines

for Controlled Substances

Con’t

CDC Prescribing Guidelines (2016)- Published JAMA – March 15, 2016

• “Generally avoid increasing the dosage >= 90 MME mg/day

• Should only give 3 days max for acute pain for most non-traumatic, non-surgical pain

• Avoid combinations – short and long acting opioids

• Concerns – may limit opioids for some for whom they may benefit

2016 CDC Guidelines

for Controlled Substances

Con’t

CDC Prescribing Guidelines (2016)- Published JAMA – March 15, 2016

29

PeriodicReview –

Monitoring

InformedConsent

Treatment Plan & Objectives

Medical History

Physical Exam

STANDARD OF CAREGuidelines

Controlled Substance Prescribing

Adapted from the Medical Board of California; American Academy of Pain Medicine; American Pain Society

STANDARD OF CAREGuidelines

Medical

Prescribing to Addicts

Compliancewith Laws & Regulations

RecordsConsulta-tion

Controlled Substance Prescribing

• Analgesia: rating of average pain, worst pain, and pain relief

• Activity: progress in patient’s functional goals

• Adverse Effects: nausea, dizziness, drowsiness, other forms of impairment, etc.

• Affect: impacts to mood, anxiety, depression, ability to be happy, etc.

• Aberrant behaviors: taking meds as prescribed, illicit drug use

The 5 A’s Plus

(Monitoring Pearls)

• Reference: 1. Executive Committee of the Federation of State Medical Boards of the United States, Inc. Model policy on the use of opioid analgesics in the treatment of chronic pain. July 2013. (Sourced 25/2/14) www.fsmb.org/pdf/pain_policy_july2013

• Prescription Drug Monitoring Program (PDMP)

• Urine Drug Screening (UDS)• Updated History, Exam, and

Assessment• Taper medications when possible• Include the Morphine Equiv Dosing

– Every visit

The 5 A’s Plus

(Monitoring Pearls)

• Reference: 1. Executive Committee of the Federation of State Medical Boards of the United States, Inc. Model policy on the use of opioid analgesics in the treatment of chronic pain. July 2013. (Sourced 25/2/14) www.fsmb.org/pdf/pain_policy_july2013

Phases of a Case with a Medical Expert

Phase – Pre Med Expert• Initial Investigation• Surveillance• Undercover visits (when

possible)• Additional materials as available

and pertinent

Phase 1• Review Undercover (if any)• CURES / PDMP Review (to

identify red flags, select ~10 – 20 patients with potentially suspicious prescribing profiles)

• Initial Report – List of Patients Files to Get at Search Warrant

Phase 2• Review Search Warrant

Materials• Opinion and Detailed Report

Generation

Phase 3• ISO – Suspension Order (if

needed) – Washington, D.C. DEA

• Phase 4Grand Jury vs Preliminary Hearing - Testify (as needed)

Phase 5Criminal Prosecution –AUSA vs Deputy DA -Plea bargain vs trial –

Testify (as needed)

Phases of a Case with a Medical Expert Continued

Morphine Equivalent Dosing (mg/day)

Drug Brand Relative Strength

100 mg/d MED Equiv

Morphine 1 100

Hydrocodone Norco, Vicodin 1 100

Oxycodone OxyCodoneRoxycodone

1.5 66

Hydromorphone Dilaudid 4 25

Oxymorphone Opana 5 20

Methadone 10 + 10

Fentanyl Duragesic 100 42

Adapted from Opioid Calculator - Available at http://agencymeddirectors.wa.gov/mobile.html

Physician Drug Monitoring Program (PDMP) –[Example]

Date Med Strength Amount PhysicianPharmacy

A. Opioid MED > 250 mg/day

B. Early refills of medsC. Using multiple doctors\D. Driving a long distance

to be seenE. All of the aboveF. None of the above

Question-Red Flag(s) that confirm

abuse / diversion

include???:

37October 7, 2018

1. Xxx2. Xxx3. Xxx4. Xxx5. Xxx

List Red Flags for Abuse /

Diversion

38October 7, 2018

Identify Potential Red Flags in PDMP• Early Refills• MED > 100 mg / day• Multiple concurrent prescribers• Multiple pharmacies• Combinations (i.e. Opioid,

Benzodiazepine (e.g. Alprazolam (Xanax)), Carisoprodol (Soma))

• Prescriptions at maximum strength

Dr. Tim Munzing SCPMG

Additional Potential Red Flags • Inconsistent UDT results• Patients driving a long distance for

care• Multiple family members – identical

or similar meds• Drug overdoses• Buy/ give / sell meds• Use of THC – even with Marijuana

Card

Dr. Tim Munzing SCPMG

How does Administrative action differ from a Criminal trial?

• Administrative Law Judge• No jury• Rules of evidence are relaxed (somewhat)• Decision is written by ALJ and issued some

time after the hearing—not like jury trial where result is announced immediately at end of deliberations

Frequently Identified Issues: A Medical Expert’s Findings• Minimal/missing documentation• Minimal or no history – no past medical history• No verification of a patient’s history of pain /

controlled substance medications• No inquiry of mental health and potential addiction

issues• Exam – missing, minimal, or too much - unbelievable• No customization of treatment

Frequently Identified Issues: A Medical Expert’s Findings

• Appropriate monitoring missing• Lack of consultation, re-evaluation • High dose (MED > 100 mg/d) without intensive

management• Same Rx for all patients• Lots of young patients• All cash business

Frequently Identified Issues: A Medical Expert’s Findings

• Multiple family members with similar medications• Patients drive long distances for care• Minimal to too much lab testing (?fraud involved)• Long gaps in care or appointments• Deaths• Patient doctor or pharmacy shopping

Pertinent State and Federal Regulation/Potential Charges• Business and Professions Code 725 – Excess treatment or over-prescribing• Business and Professions Code 2242 – Prescribing without medical indication• Business and Professions Code 2234 – Unprofessional conduct• Business and Professions Code 2234 (b) – Gross negligence• Business and Professions Code 2234 (d) – Incompetence• Business and Professions Code 2241 – Prescribing to or treating an addict• Business and Professions Code 11153 (a) – Illegal Prescriptions• DEA Regulation 21 C.F.R. 1306.04 – Purpose of issue of prescription

- medically legitimate, usual course of professional practice• Business and Professions Code Section 2242 (a): Furnishing dangerous drugs

without an examination: Prescribing, dispensing, or furnishing dangerous drugs as defines in Section 4022 without an appropriate prior examination and a medical indication, constitutes unprofessional conduct

• FRAUD involved???• [The decision as to which of these or other charges apply

specifically in this case is under the knowledge and decision of law enforcement and/or legal prosecutors.]

Improving Patient Safety and Outcomes

References• Medical Board of California Guidelines for Prescribing Controlled Substances for Pain – 1994,

2003, 2007, and 2014

• “Physician Guide to Appropriate Opioid Prescribing for Noncancer Pain”; Permanente Journal, Timothy Munzing; 2017

• DEA Regulation 21 C.F.R. 1306.04 – Purpose of issue of prescription

• “Opioid Prescriptions for Chronic Pain and Overdose: A Cohort Study”; Annals of Internal Medicine, Kate Dunn, PhD, et al; January 19, 2010 [MED dosing information / risks]

• “Use of Opioids for the Treatment of Chronic Pain” – American Academy of Pain Medicine, http://www.painmed.org/files/use-of-opioids-for-the-treatment-of-chronic-pain.pdf

• Washington State Agency Medical Directors’ Group – in conjunction with the Interagency Guideline on Opioid Dosing for Non-cancer Pain

References

• Drug Enforcement Administration• Centers for Disease Control - Overdose and Overdose death statistics• “Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic

Noncancer Pain”, American Pain Society – American Academy of Pain Medicine Opioids Guideline Panel – February 2009 – Journal of Pain -http://www.jpain.org/article/S1526-5900(08)00831-6/fulltext

• National Forensic Laboratory Information System (NFLIS) data – found at: http://www.deadiversion.usdoj.gov/mtgs/pharm_awareness/conf_2012/sept_2012/houston/drug_trends_1002.pdf

• Dreamland: The True Talk of America’s Opiate Epidemic; Author: Sam Quinones

• American Pain: How a Young Felon and His Ring of Doctors Unleashed America’s Deadliest Epidemic; Author: John Temple

• Drug Dealer, MD: How Doctors were Duped, Patients Got Hooked, and Why It’s So Hard to Stop; Author: Anna Lembke

Books

50

Physician Guide to Appropriate Opioid Prescribing for Noncancer Pain (Dr. Tim Munzing SCPMG) May 1, 2017

Opioid Prescribing Review

• “Physician Guide to Appropriate Opioid Prescribing for Noncancer Pain”, The Permanente Journal

• Author – Timothy Munzing, MD• https://doi.org/10.7812/TPP/16-169

• Tim.a.munzing@kp.org• Kaiser Permanente

• 1900 E. 4th Street• Santa Ana, CA. 92705

• Medical Expert Reviewer• Medical Board of California• DEA, FBI• Multiple other law enforcement

agencies

Tim Munzing,

M.D.