mitigating risk when prescribing opioids€¦ · 10/04/2019 · opioids 4/10/2019 8 source: doj,...

Mitigating Risk When Prescribing Opioids

4/10/2019

1

Mitigating Risk When Prescribing OpioidsPresented by:

John Bowman Chief Executive Officer Sure Med Compliance

The Epidemic

Types of Prescriber Liability

Civil Liability

Criminal Liability

Cases Against Doctors

Legitimate Medical Purpose

Key Takeaways to Mitigate Risk

Q & A

Overview


4/10/2019

2

The Epidemic

201664,000 unintentional

drug overdose deaths

20,000 Linked to non‐methadone synthetics (predominantly fentanyl)

16,000 Linked to heroin

71% Linked to an opioid and other substances

201772,000 unintentional

drug overdose deaths

29,000 Linked to non‐methadone synthetics (predominantly fentanyl)

16,000 Linked to heroin

Types of Prescriber Liability

CIVILMedical Malpractice Lawsuit “Medical standard of care” “Reasonable prudent physician” Can result in financial penalties

CRIMINAL Prosecuted under CSA, Code of Federal Regulations, FDCA and state homicide lawsMust prove criminal intent Can result in financial penalties and imprisonment

STATE BOARD SANCTIONS Initiated by a complaint Overprescribing is most common reason for complaint Can result in license revocation


4/10/2019

3

Civil Liability How are prescribers of opioids

found guilty of medical malpractice?

Elements of a Negligence (Medical

Professional Liability)

Claim

Duty

Breach of Duty

Proximate Cause

Injury


4/10/2019

4

Criminal Liability

How are physicians charged with a

prescription drug crime?

Criminal Liability: CSA

Title 21 United States Code (USC) Controlled Substances Act SUBCHAPTER I — CONTROL AND ENFORCEMENT

Part D — Offenses And Penalties

§841. Prohibited acts A

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—

(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

1. A prescription is written or dispensed2. It was done knowingly and intentionally


4/10/2019

5

Title 21 United States Code (USC) Controlled Substances Act SUBCHAPTER I — CONTROL AND ENFORCEMENT

Part C — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

§822. Persons required to register

(a) Period of registration

(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.

(b) Authorized activities

Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other provisions of this subchapter.

(c) Exceptions

The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:

(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.

3. It was not prescribed “acting in the usual course of business”

Criminal Liability Explained

Based on the CSA, in order to be found guilty of a prescription drug crime under 21 U.S.C. § 841(a)(1), a prescriber must

1. Write or dispense a prescription

2. Do it “knowingly” and “intentionally”

3. Do it while “acting outside the usual course of business or employment”


4/10/2019

6

Question

What is the definition of acting outside the course of business or employment?

Acting outside the course of business or employment

Not defined in the Code of Federal Regulations or Controlled Substance Act

Determined on a “case by case” basis


4/10/2019

7

DEA Cases Against Doctors

Source: DOJ, DEA Cases Against Doctors, Oct 2017

Name: AHLES, Peter, MDCity, State: Anaheim, CADate of Arrest: 06/14/2005Date of Conviction: 10/05/2006Judicial Status: Pled GuiltyConviction: Dispensing a controlled substance outside the scope of professional practiceDEA Registration: Revoked 09/25/2006Remarks:Peter Ahles, MD, age 67, of Anaheim, CA, pled guilty in United States District Court to one count of dispensinghydrocodone, a controlled substance, outside the scope of professional practice with no legitimate medical purposeAccording to court documents, Ahles dispensed 500 units of hydrocodone to confidential informants in exchange for $500.Ahles was placed on home detention for a period of six months and sentenced to three years probation.


4/10/2019

8


Name: AHMAD, Salahuddin, MDCity, State: Ferndale, MIDate of Arrest: 05/13/2008Date of Conviction: 09/24/2009Judicial Status: Pled GuiltyConviction: Conspiracy to Possess with Intent to Distribute and to Distribute OxycodoneDEA Registration: Surrendered 10/03/2008Remarks:Salahuddin S. Ahmad, MD, of Ferndale, MI, pled guilty in U.S. District Court, Eastern District of Michigan, to one count ofConspiracy to Possess with Intent to Distribute and to Distribute Oxycodone.According to court documents, on May 13, 2008, Ahmad, outside the scope of his legitimate practice of medicine, plannedto sell (and possessed with the intent to sell) over 2,400 OxyContin tablets.Ahmad was sentenced to 36 months incarceration, followed by 36 months supervised release. Ahmad was also orderedto pay a $50,000 fine.


Name: ASTIN, Phil III, MDCity, State: Carrollton, GADate of Arrest: 07/02/2007Date of Conviction: 01/29/2009Judicial Status: Pled GuiltyConviction: Unlawful drug distributionDEA Registration: Retired 07/09/2007Remarks:Phil Astin III, MD, age 54, of Carrollton, GA, pled guilty in U.S. District Court for the Northern District of Georgia to 175counts of illegal distribution of controlled substances.According to the indictment, Astin distributed and dispensed a quantity of controlled substances for other than a legitimatemedical purpose and not in the usual course of professional practice. The controlled substances included Schedule IIpharmaceuticals Percocet and Adderall; Schedule III pharmaceuticals Vicoprofenand Lorcet; and the Schedule IVpharmaceutical Xanax. In the plea agreement, Astin admitted that he knowingly violated federal law by illegally writingprescriptions for 19 patients.Astin was sentenced to 10 years imprisonment, followed by 3 years supervised release and 250 hours communityservice. He was ordered to pay a special assessment of $17,500.


4/10/2019

9

Source: DOJ, DEA Cases Against Doctors, Oct 2017Name: ALEXANDERIAN, Harry, MDCity, State: West Pittston, PADate of Arrest: 10/4/2004Date of Conviction: 5/24/2005Judicial Status: Pled GuiltyConviction: Dispensing controlled substances with no legitimate medical purposeDEA Registration: Surrendered 3/30/2004Remarks:Harry Alexanderian, MD, age 80, of West Pittston, PA, pled guilty in state court to dispensing controlled substancesoutside of the scope of professional practice with no legitimate medical purpose. He also pled guilty to Medicaid fraudand unlicensed treatment of drug addiction.Alexanderian was sentenced to six months house arrest to be followed by two years probation.

According to case law, “Outside the Course of Business or Employment” can be loosely defined as illegal distribution i.e., selling prescriptions for money, favors, etc.

18


4/10/2019

10

Question

If a physician prescribes an opioid, “knowingly and Intentionally” and “in the usual course of business or employment”, are they safe from criminal prosecution?

There’s a Catch


4/10/2019

11

Criminal Liability: CFR

4. It was not prescribed for a “legitimate medical purpose”

Title 21 Code of Federal Regulations PART 1306 — PRESCRIPTIONS

GENERAL INFORMATION

§1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. 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. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Criminal Liability: CSA


4/10/2019

12

Criminal Liability

Based on the CSA/CFR, in order to be found guilty of a prescription drug crime a prescriber must 1. Write or dispense a prescription 2. Do it “knowingly” and “intentionally”3. Do it while “acting outside the usual course of

business or employment” AND/OR

4. Do it for anything other than a “legitimate medical purpose”(CFR,CSA)

Question

What is the definition of legitimate medical purpose?


4/10/2019

13

Question

How does the DEA define it?

Legitimate Medical Purpose mate Medical Purpose

Not defined in the Code of Federal Regulations or Controlled Substance Act

Legitimate Medical Purpose is determined by the States not the DOJ (DEA) (Gonzales vs. Oregon, 74 U.S.L.W. 4068 2006 Jan 17)

Determined on a “case by case” basis


4/10/2019

14


In fact, this opinion goes as far back as the 1980s


Associate Chief Counsel, DEA, 1983

“Acts of prescribing or dispensing of controlled substances which are done within the course of the registrant’s professional practice are, for purposes of the Controlled Substances Act, lawful. It matters not that such acts might constitute terrible medicine or malpractice. They may reflect the grossest form of medical misconduct or negligence. They are never the

less legal.”


4/10/2019

15

How does our state board define it?

Question


ALBME (Alabama Board of Medical Examiners)THE BOARD WILL CONSIDER PRESCRIBING, ORDERING, ADMINISTERING OR DISPENSING CONTROLLED SUBSTANCES FOR PAIN TO BE FOR A LEGITIMATE MEDICAL PURPOSE IF BASED ON ACCEPTED MEDICAL KNOWLEDGE OF THE TREATMENT OF PAIN . ALL SUCH PRESCRIBING MUST BE BASED ON CLEAR DOCUMENTATION AND IN COMPLIANCE WITH APPLICABLE STATE OR FEDERAL LAW.(f) The Board will judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation. The goal is to reduce pain and/or improve patients’ function.(g) Physicians are referred to the Federation of State Medical Boards’ Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain, July 2013, as amended from time to time, and the Drug Enforcement Administration Office of Diversion Control manual, Narcotic Treatment Programs Best Practice Guidelines, as amended from time to time.


4/10/2019

16


But wait…..

We just saw case law that showed the DEA prosecutors referring to “legitimate medical purpose” in their cases against doctors.

And

Why is it mentioned in both the Code of Federal Regulations and the Controlled Substance Act if it cannot be defined by the Department of Justice?

Confused Yet?


4/10/2019

17

Eli D. Stutsman Author of the Oregon Death with Dignity Act

“Drug diversion cases (i.e., prescribing or dispensing “without a legitimate medical purpose”) are complicated cases to defend, with each case presenting the intersection between law, medicine and, sometimes, politics, with the occasional involvement of the media. When mounting an adequate defense against the DEA, lawyers face divergent tasks, and it is difficult for one lawyer to do it all.”

“ If a case is not well‐defended, the DEA will criminalize some aspects of the practice of medicine by confusing the civil standard of care with the criminal conviction standard.”

Substantiating Legitimate Medical Purpose can involve considering, assessing and documenting over 20 unique data points prior to prescribing.

IndicationAcute, moderate – severe pain (determined each episode/injury)Chronic, moderate – severe pain, failure on alt treatment (determined upon initiation. Expectation of seeing improvement on follow‐up visits, not indication)

Active VerificationMultiple risk assessments Aberrant behavior

Best interest of patient safetyMMEBenzo/Opioid Short‐actingLowest dose

Patient Education/contract/Informed consent Treatment Goals/Treatment PlanBenefit/Risk with continuation


4/10/2019

18


Document “intent”Have well established treatment goals

Patient educated on and agreed toReasonable/achievableSpecific to patient’s actual ADLsBad: “Improve ADLs”, “Reduce Pain”Good: “Allow patient to sleep minimum of 6 hours of uninterrupted sleep and perform moderate exercise for 30 minutes, 3 days a week. Patient educated on treatment goals and agrees to plan.”

Patient‐specific documentation (no generic notes)Bad: “ADLs Normal”Good: “Good improvement in ADLs. Patient able to sleep minimum of 6 hours of uninterrupted sleep and perform moderate exercise for 30 minutes, 3 days a week.”


Document tapering goals and successBad: “Patient being tapered”Good: “Tapering Xanax with goal for discontinuation by 12/23/2018”Bad: “Instructed patient to stop taking benzodiazepine”Good: “Instructed patient to taper and discontinue Xanax from physiatrist by 12/23/2018 or I will begin tapering and discontinuing opioid. Will confirm with UDT.”

Document aberrant behavior and patient explanationBad: “Inconsistent UDT”Good: “Inconsistent for prescribed medication/Norco. Patient said they ran out a few days early due to taking more than instructed. Patient was instructed to take as instructed and if they begin running out early again, to call our office when they have a week of medication left. Will perform pill count and UDT.”


4/10/2019

19

Q&AJohn Bowman

Chief Executive Officer

Sure Med Compliance

[email protected]

mitigating risk when prescribing opioids€¦ · 10/04/2019 · opioids 4/10/2019 8 source: doj,...

Documents