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Internal & External Scope

Pamela Brown

Director, Safety & SecurityPark Nicollet Health Services

Sept., 2013

Objectives

� Define Drug Diversion

� Review the impact of the staff diverter/user.

� Review the impact of the patient “Dr. Shopper”

� Legal referrences

Diversion is defined as the transfer of a controlled substance from a lawful to an unlawful change of distribution or use.

� Uniform Controlled Substances Act (1994)

OR

Any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient.

▪ This can include the outright theft of the drugs, or it can take the

form of a variety of deceptions such as diversion by direct patient care-givers, doctor shopping, forged prescriptions, counterfeit

drugs and international smuggling.

2

Absolutely not.

Is this a fast growing problem?

Definitely.

Where Can Diversion Occur?

• Hospitals, Clinics & Nursing Homes • Private homes - Family/Visitor of patients• Pharmacies, retail and institutions• Via stolen scripts and forged prescriptions

• Theft of shipment or CS in transit within facility• Waste Stream

Anywhere controlled substances are found

by anyone intent on diverting!

� Prescribed opioids was the equivalent of 96 mg of morphine per

person in 1997 and approximately 700 mg per person in 2007, an increase of >600%!

� In 2007, approximately 27,000 unintentional drug overdose deaths

occurred in the United States…one death every 19 minutes.

� Prescription drug abuse, driven by the increased use of opioid

analgesics, is the fastest growing drug problem in the United States

� Overall, rates of opioid analgesic misuse and overdose death are highest among men, persons aged 20–64 years, non-Hispanic whites,

and poor and rural populations.

� Individuals with a mental illness are overrepresented among both

those who are prescribed opioids and those who overdose on them.

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Fig

5.1

Numbers in Thousands

Marijuana Heroin

Pain

Relievers

Inhalants

LSDTranquilizers PCPEcstasyCocaine

Stimulants Sedatives

Diversion by direct patient care-

givers, pharmacy staff, prescribers and other staff with access to pharmaceuticals through ordering,

procurement, transfer, dispensing and the waste stream.

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� We have an ongoing epidemic of prescription drug

diversion and abuse in America

� Some of those addicted work in the healthcare

setting

� Some of these addicted health care workers divert

(steal) drugs from their patients and their employers

to support their addiction

While some call addiction a “victimless crime,” supportingthat addiction by drug diversion from the heath careworkplace is a multi-victim crime.

� It puts at risk the patient� It puts at risk the addict

� It puts at risk their co-workers� It puts at risk the their employer� It puts at risk society in general

By its nature, diversion is a clandestine activity, and

methods in place in many institutions leave casesundiscovered or unreported.

Drug diversion by health care providers is universalamong institutions in the United States. If yourinstitution is not finding and reporting drug

diversion, review your program with the goal ofidentifying its weak points.

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Medical Staff Specifics:

� High achiever� Significant (trigger) stress in personal life� Night shift, Critical care or other Float where

staff have increased autonomy� Agency or traveler� Past or current legitimate prescription for drug

being diverted� Smoker

Why? � Suppression of feelings and emotions� Vicarious trauma

� Physical demands of job� Legitimate use and chronic pain� Ease of access to prescriptions and medication

� Knowledge and sense of control

The major factors impacting the incidence of drug misuse by healthcare professionals are access and availability of controlled substances.

Bell DM, McDonough JP, Ellison JS, Fitzhugh ED. Controlled drug misuse by Certified Registered

Nurse Anesthetists. AANA J 1999;67(2):133-140.

1. Removal too frequently

2. Gets an extra dose in3. Removal of medication without order4. Medication override frequently used

5. Falsification of “verbal order”6. Giving less than ordered more frequently7. Use from inconspicuous vessel

8. Failure to waste9. Medication intended for waste is kept for self

(proper waste procedure is to waste & witness

upon removing whenever possible)

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� Tardiness, unscheduled absences and an

excessive number of sick days used;� Frequent disappearances from the work site and

taking frequent or long trips to the bathroom or

to the stockroom where drugs are kept;� Volunteers for overtime and is at work when not

scheduled to be there;

� Arrives at work early and stay late;� Pattern of removal of controlled substances near

or at end of shift

� Over or Under Medicated

� Impairment and addiction put patients at risk� Strong likelihood of denying patients

appropriate pain relief

� Potential to expose patients to blood borne pathogens

� Falsification of records (fraud)

� Theft (Felony)

� Liability-civil, regulatory

� Negative publicity� License and participation in Medicare/Medicaid

in jeopardyHospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment.

State Operations Manual Appendix A – Survey Protocol,

Regulations and Interpretive Guidelines for Hospitals.

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� Must report to DEA when we know of “theft” or

“substantial loss”. (Form 106)

� Applicable State Licensure Board and/or

Professional Assistance

� Department of Health (patient harm event)

� Law Enforcement - crimes, issues of

abuse/neglect/reckless endangerment,

vulnerability, fraud

� Pharmacy, Medical and Nursing Boards

� FDA/OCI (tampering cases)

� OIG as applicable

Why Many Staff Don’t Report

� Lack of awareness� Uncertainty or disbelief

� Turning a blind eye to signs

and symptoms (surely I was

mistaken)

� Hoping the problem will go

away-this is an isolated event

� Concern about what getting

involved will mean for them

Reporting Suspicion

� Once an employee suspects impairment or

diversion, patient safety

concerns require that it be

reported immediately

� Certainty is not required -

just a good faith concern� Employees should know

their concerns will be taken

seriously and confidentially

� Failing to report is not the

compassionate approach

Enabling by Practitioners

Some well intended

practitioners may enable by:

� Signing verbal orders without

confirming details

� Writing prescriptions for staff

� Failing to address a pattern of

requesting orders for the same controlled substance or

requesting inappropriate

orders, especially

evening/night shifts

� Not coming forward with

concerns

Enabling

Some well intended staff may

enable by:

� Ignoring what is going on

� Trying to protect their

colleague by taking

responsibility for his/her

actions (it’s my fault-I didn’t train him properly)

� Covering up and making

excuses or minimizing what

is happening Doing their

colleague’s work for them

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Organizations need to identify staff training and education plans at all levels of an organization.

� All Staff to the topic and awareness

� Administrators, Prescribers, Nursing, Front Line, Pharmacists, Security specific to their

roles and access

� Develop internal control processes

� Develop a “Best Practices” utilization of the PMP

� Develop internal reporting requirements and processes

DR. SHOPPING

When individuals, or teams, admit to healthcare

facilities (fraudulently), with the intent of procuring controlled substances (fraudulently) .

� Fraudulent Indicators: Presenting under a false name, address and/or other demographics.

Using injury, symptom and/or disease falsification to guide how the prescriber will treat and prescribe for the patient.

Commonly sought narcotics are;

� Hydromorphone (Dilaudid) � Hydrocodone (Vicodin)

� Percocet� Oxycontin � Oxycodone� Xanax / Ambien� Promethazine w/Codeine

� Purple juice- prescription strength cough syrup containing codeine and promethazine. [Robitussin with Codeine used to be desired in 80’s- early 90’s]

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Adverse Misuse or Abuse Misuse or

AbuseReactions* of Pharmaceuticals of Illicit Drugs

2004 * 626,472 991,6402005 1,250,377 765,314 922,0132006 1,526,010 859,136 958,864

2007 1,908,928 984,894 974,6312008 2,157,128 1,126,407 994,5082009 2,287,273 1,243,633 974,384

2010 2,329,221 1,345,645 1,171,024

� ED visits involving misuse or abuse of pharmaceuticals increased

115 percent between 2004 and 2010.

Why should we care?

� One patient can be presenting as 3-30-60 patients, with multiple

visits to multiple corporate sites and multiple healthcare systems.

� Increasing addiction = increasing admissions = increased $$ impact.

� If we don’t, we allow their addiction through disinterest and

inattention.

� They leave our facilities driving vehicles on our roads.

� They have families; parents, sisters, brothers, husbands, wives,

children.

� They make bad or desperate decisions in order to procure.

� Because dead by pharmaceuticals is the same as dead by cocaine,

heroin, meth and alcohol abuse.

With one visit we see immediate business impact;

Bad debt is added to the corporate bottom line

Increased wait times for legitimate patients

Use of medical resources such as lab, radiology and other diagnosing equipment, supplies and services

The use of our medical care teams time spent on diagnosis, care and treatment of fraudulent claims of injury or illness

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Elements of visit which may raise suspicions;

• No photo ID available (Esp. if she has a purse/he has a wallet)

• Repeated visits between Primary Care and UC/EC

• Moving between clinic sites, not sticking with one primary care provider

• Patient is not specific about pain, injury, history.

• Allergies include penicillin, acetaminophen, anti-inflammatory

• Refuses or delay’s diagnosing tests (i.e. MRI/CT)

• Physical Therapy is not desired or “is not effective”.

• Physical examination does not clearly support patient complaint

• Reports travel or past care from out of state in recent weeks/months

• Can’t recall MD name, healthcare system, etc..

• Details can’t be confirmed.

• Patient came in w/another patient (teams) with similar complaints

• PMP shows multiple care givers or more than one healthcare organization

< Sources of Complaint / Discovery >

Risk ManagementPatient Financial

ServicesOther

NotificationsPharmacy

Patient CareStaff

Investigation results

indicate follow-up required.Results Do Not Support

Concerns Raised

Case Open / Inactive for future review as needed

Security

Action

Patient

Terminated

Chart

Flagged

w/Alert

Recommendations communicated when

complete and appropriate.

Final results to be provided to Risk Mgt. for

conclusive & approved action.

Investigation Assignments

• Physician – Consult w/Risk Mgr.

• RM Chart Reviewer – Data Search & Comparison

• Security – External & Criminal Activity Search• Patient Financial Services– Account Review

Communication of summary to

Appropriate department; Risk Management,

Business Services or Data Integrity.

Close

Ticket

Risk Management Security &

Law EnforcementEPIC & Risk Mgt

Data

Co-mingle

RISK MANAGEMENT TRIAGES REPORTS

3/13

• Provider reports incident

• State Agency reports anomaly

• Risk Mgt. requests investigation

• Lawsuits

• Billing address returns

• Name as multiples• Creditor company

provides names• Outstanding bills tied

to multiple names & addresses

• HIM system matches multiple AKA’s

• HIM staff placing charts recognize similarities

• Front line sees same patient w/different name, reports event

• MD / RN identify seeking behavior

• On suspicion, requests patient review or Security response

• ID altered scripts• ID inappropriate

information on scripts

• Phoned in scripts checked

• Suspicious behavior of individuals reported.

• Outside Pharmacies

• State Agencies• Law Enforcement• Patient’s Family

Health Information Management

On-Site Care Options

1. Treat for complaint regardless

2. Treat for complaint, restrict medications (CII’s) received

3. Refuse Treatment entirely

4. Call Security (where available) for evaluation support,

possible criminal activity identification and ID of

individual

• LE response if no on-site Security, or if refuses to

provide ID (Don’t have it, it’s in my car, etc…)

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Post Visit Care Options

� Identify the Level of Diversion -

� 1x = Clinician Intervention

� Patterned & long-term = Initiate full investigation

� Outcome desired by Physician(s) & Risk Management

� Increased management of patient

� Letter to patient restricting care or access

� Termination of patient care

Options

� Control of future access

o ALERT in chart-Restrict narcotics to issuance by one

primary care provider within the health system.

o Confront the patient about discrepancies and medical

concerns.

o MN Restricted Recipient Program (MRRP) referral

o Pain Clinic referral

o In/Out-Patient Treatment referral

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Mistakes made;

� Registering these patients without seeing a photo ID

� Not notifying the medical staff when no ID is provided.

� Medical staff not using resources.

� Checking the PMP

� Reviewing patient history

� Providing “some” narcotics just to get the patient out of the

office/EC/UC.

� Not trusting your instincts as a care-giver or prescriber.

� Most patients are valid and honest. You “know” when you aren’t

hearing what you should be hearing.

This information does not constitute legal advice

The HIPAA Privacy Rule has two prongs:1. First, it “provides federal protections for personal health

information held by covered entities and gives patients an array of rights with respect to that information, while at the same time…”

2. The rule is “balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.”

www.hhs.gov/ocer/privacy/hipaa/undertanding

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“The Privacy Rule (HIPAA) is balanced to protect an

individual’s privacy while allowing important law

enforcement functions to continue. The Rule permits

covered entities to disclose protected health information

(PHI) to law enforcement officials, without the

individual’s written authorization, under specific

circumstances.”

www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html

POSSIBLE RISKS� Minnesota Health

Records Act Liability� HIPAA Liability� Public Relations� Professional Sanctions� Other Tort Liability

(OIG Reference)

BENEFITS� Do the right thing

� Strengthen relationship with law

enforcement

� Decrease in drug diversions =

decreased costs

� Public relations benefit

� Professional sanctions

� Assist patients with addiction

� Avoid liability. 21 U.S.C. § 856

(Controlled Substance Act); 18 U.S.C. § 1518 (Obstructing

Health Care Fraud Investigation)

� Confidentiality

� Doctor/patient privilege ends when patient deceives doctor

� It does not protect false, fictitious, or fraudulent

information.

� HIPAA only applies to covered entities

� Health Plans

� Health care providers

� Health care clearinghouses: entities that process

nonstandard information they receive from another entity

into a standard (i.e., standard format or data content), or

vice versa

� It does not cover individuals that are non-patients

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� Theft of a Controlled Substance in the fifth degree

152.025 Subd. 2 (2) (i, ii)

� Definitions: “controlled substance” means a drug, substance, or immediate

precursor in Schedules I through V of section 152.02.

(2) the person procures, attempts to procure, possesses, or has control

over a controlled substance by any of the following means:

(i) fraud, deceit, misrepresentation, or subterfuge;

(ii) using a false name or giving false credit

� Symptom falsification defines how the prescriber will treat the patient. False

name, demographics, or symptoms used to lead prescriber to provide narcotics is fraud, deceit and subterfuge.

� Identity Theft 609.527 Subd. 1 (d) (1)

(d) “Identity” means any name, number or data transmission that may

be used, alone or in conjunction with any other information, to identify a

specific individual or entity, including any o f the following;

(1) a name, Social Security number, date of birth, official government-issued driver’s license or identification number, government passport

number, or employer or taxpayer identification number.

Subd. 2

A person who transfers, possesses or uses an identity that is not the

person’s own, with the intent to commit, aid or abet any unlawful activity is guilty of identify theft and may be punished as provided in Subd. 3.

�DEA number use is an element in Identity Theft; it is issued by a government agency and it is specific to the prescriber.

�Forgery 609.63 Subd. 1 (1) (5)

(1) Uses false writing, knowing it to be false, for the purpose of identification or recommendation.

(5) Destroys, mutilates or by alteration, false entry or omission falsifies a record, account or other document relating to a private business.

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� Swindle (Theft of Service)

609.52 Subd. 2 (4) and 609.52 Subd. 3

� Whoever does the following commits theft, and may be sentenced as provided in Subd. 3:

(4) By swindling, whether by artifice, trick, device or any other

means, obtains property or services from another person.

� Narcotics do not need to be received, the medical exam and treatment is the service swindled.

� Use of false information (name/address) = failed billing and no payment for

services received.

� Many of these patient register as “self-pay”. No insurance recorded, no

reimbursement, no correct address. Primary intent may not be to defraud but it is a result.