Technologies to Reduce Diversion, Fraud and Abuse:Electronic Prescribing and Drug Deactivation

Presenters:• Sean P. Kelly, MD, Emergency Physician, Beth Israel Deaconess

Medical Center• Arthur F. Ream III, Chief Information Security Officer and Director

of Information Technology Applications, Cambridge Health Alliance• Hooshang Shanehsaz, RPh, Director of Pharmacy, Cardinal Health,

and Vice President, Delaware Board of Pharmacy

Pharmacy Track

Moderator: Jinhee J. Lee, PharmD, Senior Public Health Advisor, Division of Pharmacologic Therapies, SAMHSA, andMember, Rx and Heroin Summit National Advisory Board

Disclosures

• Arthur F. Ream III; Hooshang Shanehsaz, RPh; and Jinhee J. Lee, PharmD, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

• Sean P. Kelly, MD – Employment: Imprivata, Inc.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest:

Starfish Health (spouse)– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center

Learning Objectives

1. Explain how electronic prescribing of controlled substances reduces drug diversion and fraud and improves patient satisfaction.

2. Outline DEA requirements for electronic prescribing of controlled substances.

3. Describe the results of Delaware’s pilot program with an at-home drug deactivation system.

4. Provide accurate and appropriate counsel as part of the treatment team.

Technologies to Reduce Diversion, Fraud and Abuse: Electronic Prescribing and Drug

Deactivation

Sean P. Kelly, MD and Arthur F. Ream III

March 29, 2016

Arthur F. Ream III, BSCISO and Director of IT

Applications Cambridge Health Alliance

Sean P. Kelly, MDEmergency Physician

Beth Israel Deaconess Medical Center

1. Explain how electronic prescribing of controlled substances reduces drug diversion and fraud and improves patient satisfaction.

2. Outline DEA requirements for electronic prescribing of controlled substances.

3. Describe the results of Delaware’s pilot program with an at-home drug deactivation system.

4. Provide accurate and appropriate counsel as part of the treatment team.

Learning Objectives

Agenda

Why EPCS matters & drivers of adoption

Regulatory overview

EPCS: A real-life rollout

Discussion/Q&A

Why EPCS matters

New York I-STOP enabling technologyand pharmacy readiness nationally

Paper-based prescriptions create risk of fraud and DEA number theft

Combat a National Public Health Epidemic Improve Provider Workflows and Patient Safety

Dual workflows lead to provider and patient dissatisfaction

More deaths from prescription drugsthan cocaine and heroin combined

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

0

5,000

10,000

15,000

20,000

25,000

Deaths Involving Drug Overdoses

Prescription Drugs Cocaine & HeroinSource: CDC

eRx proposed as core objective forhospitals in Meaningful Use Stage 2MU

The challenge of dual prescribing workflows

• 38% of patient interactions in which prescriptions are written include mix of controlled & non-controlled substances

• What does this mean?

− Providers have to switch between electronic and paper, creating inefficiency and dissatisfaction

− Providers may revert to a single, paper-based workflow, which could impact Meaningful Use

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

41.4%

38.3%

20.3%

Physician Prescription Mix

Just controlled

Mix of both

Just non-controlled

Impact of hydrocodone reclassification• Hydrocodone combination drugs (i.e.,

Vicodin) now Schedule II, placing tighter controls on prescribing:

− No refills− No verbal/faxed orders

• Potential 68% increase in number of prescriptions written for controlled substances, exacerbating challenges of dual workflows

Before Reclassification After Reclassification0

5

10

15

20

25

30

15.6

26.3

Controlled Substance Prescriptions (physician/week)

Overview of EPCSDEA requirements for EPCS

Pharmacycertification

Adoption by state board of pharmacy

CII-V Allowed (all schedules)

Two-factor authentication

EMR certification

EPCS Workflow

Consider the Clinician’s Workflows

Technology should:

• Integrate directly into the EHR’s e-prescribing workflows

• Support DEA-approved 2FA modalities, to deliver flexibility for providers

• Present only the 2FA modalities that are available and allowed

Two-factor authentication offerings• Password

• Fingerprint biometrics

• Software and hardware OTP tokens

• Hands Free Authentication – Automatically retrieves and verifies a one-time

password (OTP) from provider’s mobile device– No need to carry, touch, or type a token code FIPS Compliant Readers

Something you are

Password

Something you know

FIPS Compliant Token or Smart Card

Something you have

Two-factor authentication considerations

Security AND Convenience

Imprivata ID USB receiver

1. Provider places EPCS order

3. Hands Free Authentication automatically retrieves token code from provider’s mobile phone

Second factor ✔

2. Provider scans fingerprint*

First factor ✔

Automatically completes one factor of the two-factor authentication

Provider simply enters order and scans fingerprint

Hands-free authentication runs on provider’s locked phone

4. EPCS ordercomplete ✔

* or enters password if biometric not available

EPCS: A real-life rollout

About Cambridge Health Alliance

• Three hospitals, 15 primary care practices in Boston’s Metro North region

• Serving about 140,000 patients• 4,323 employees (691 physicians)• HIMSS Stage 6 (pursuing

ambulatory Stage 7)• NCQA Level 3 Medical Home

recognition for seven CHA Primary Care Practices

Drivers for EPCS• Increase patient safety and satisfaction− Paper-based prescriptions inconvenient for patients− Risk of fraud and drug diversion

• Improve provider satisfaction and efficiency− Aim to give physicians the best tools available− Eliminate dual prescribing workflows

• EPCS is part of a robust strategy for addressing prescription drug abuse

EPCS team• Project driven by IT in conjunction with

Clinical Informatics

• Implementation Team:– EPIC application analysts– Systems Engineer– Server Engineer

Technology overview• EHR: Epic 2014 IU1• Two-factor authentication

o Hands Free Authentication (Imprivata)o Mobile one-time password tokens

• Syncing providers with Surescripts

Why Imprivata Confirm ID?

• Comprehensive functionality to meet DEA authentication requirements for EPCS

• Best solution for driving physician adoption− Hands Free Authentication− Seamless Epic integration

Hands Free Authentication at CHA• Solid technology base

• Seamless integration with desktops

• Where to implement?– Based on volume of prescriptions, particularly

for CII medications (i.e., ED)– Primary care clinics with high CII volumes

• Feedback from clinicians– Workflow streamlines patient visit– Keeps providers focused on the patient

Results• Since going live with EPCS and Imprivata Confirm ID, e-prescribing

rates have increased 40% for all medications

• Moving away from paper prescriptions has increased patient satisfaction

• Feedback from physicians:– Exceptionally easy workflow– Able to service patients more effectively – No need to travel to another location to physically sign a

prescription

EPCS with Epic: Tips for Success• Surescripts: Start the process early and make sure you

specify if you are already e-prescribing non-controlled substances

• Epic interfaces to Surescripts must be on latest's 10.6 version

• Epic turnaround time on build review is about two weeks

• Hold fairs to enroll providers into the system

Experience and Advice• Simplify the EPCS process with a single, robust

solution (vs. using disparate technologies and manual processes)

• EHR integration is essential!

• Think about multi-purpose solutions

EPCS

Questions/discussion

Appendix

Use Case/WorkflowExamples Password FIPS Compliant

Biometric

FIPS Compliant Token

Value/ Differentiation Relative Speed & ConvenienceHard/Soft Hands Free

Authentication

Physician prescribing in patient exam room (shared

workstation)

or

Physician prescribing in their office (dedicated

workstation)

X X• Fastest authentication – touch and done• No disruption to workflow

5

X X• Fast – type password and done• Minimal disruption to workflow

4

X X

• Fast – type password and touch finger • Slower than Hands Free Authentication, but

fastest workflow when it is not available

3

X X• Slow – type OTP code from token

and touch finger2

X X• Slowest– type password and type OTP code

from token • Most disruptive to workflow 1

Physician prescribing in hospital on Windows Tablet

(managed)

XTypically not

available on mobile devices

X• Fast – type password and done• Minimal disruption to workflow

4

X X• Slowest– type password and type OTP code

from token • Most disruptive to workflow

1

Two-factor authentication considerations

Identity proofing – institutional

Verifies practitioners are licensed and allowed to prescribe controlled substances

Medical Credentialing Office

Creates a list of practitioners that are allowed to electronically prescribe controlled substances

Creates a list of users that can approve EPCS access in the EMR

Creates a list of supervisors that are authorized to witness enrollment of practitioners in Imprivata Confirm ID

Synchronizes Imprivata Confirm ID with AD accounts of practitioners and enrollment supervisors

Information Technology

Synchronizes Imprivata Confirm ID with AD accounts of enrollment supervisors and assigns enrollment privileges

Supervisors do not have to be DEA registrants and can be individuals from IT, clinical or hospital administration

Enrollment Supervisors

Verifies photo IDs of practitioners match those on the list from the Medical Credentialing Office

Issues two-factor credentials to practitioners and supervises enrollment of credentials in Imprivata Confirm IDImprivata Confirm ID creates records of IDs verified and enrollment of credentials

EMR Administrators must be a different entity/group than the Medical Credentialing Office

EMR Administrator

Sets EPCS access for practitioners in an EMR that has been certified for EPCS

Approvers must be a different group than the EMR Administrators and do not have to be DEA registrants

EPCS Access Approvers

Approves EPCS access for practitioners in the EMR (does not require two factor authentication)

EPCS

Identity proofing – individual

Synchronizes Imprivata Confirm ID with AD accounts of practitioners

Information Technology

AD accounts must include the full legal name of practitioners and valid e-mail addresses

Imprivata Confirm ID performs NIST Level 3 identity-proofing of practitioners using social security number, date of birth, credit card information, valid e-mail address and mobile or home phone number

Credential Service Provider

Imprivata Confirm ID registers and issues tokens to practitioners via two channels

Practitioners can optionally self-enroll fingerprints with Imprivata Confirm ID

Imprivata Confirm ID automatically creates records of enrollment of credentials

EMR Administrators must be a different entity/group than the Credential Service Provider

EMR Administrator

Sets EPCS access for practitioners in an EMR that has been certified for EPCS

Approvers must be a different group than the EMR Administrators and are required to be DEA registrants

EPCS Access Approvers

Approves EPCS access for practitioners in the EMR using Imprivata Confirm ID two factor authentication

EPCS

• Full auditing capabilities of user and administrative activity

• User activity for signing transactions, including workflow, modality and device

• Administrative activity tracks policy changes and overrides

• Configurable audit record retention

Auditing and reporting

Technologies to Reduce Diversion, Fraud and Abuse: Electronic Prescribing and Drug Deactivation

Delaware’s Initial Pilot Program with an At-home Drug Deactivation System

March 29, 2016 Hooshang Shanehsaz, RPh

Presenter Information

Hooshang Shanehsaz, RPhDirector of Pharmacy, Cardinal Health, Vice President, Delaware Board of PharmacyPrescription Drug Action CommitteeControl Subcommittee, Chair“Has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.”No Financial Disclosures for Verde Technologies

Learning Objectives:

1. Describe the results of Delaware’s pilot program with an at-home drug deactivation system

The Urgent Problems

The USA consumes over 90% of the world’s prescribed opioids-

yet we’re less than 7% of the population

• Based on Delaware’s PDMP, 347,930 individuals filled prescriptions for controlled substances in 2013

• Approximately 12% (n=42,364) filled prescriptions for benzodiazepines and opioids in the same calendar quarter

• Most of those who filled prescriptions for both opioids and benzodiazepines were aged between 51-75 years old (47%), and more than two-thirds were male. Thus higher probability for having children within the age ranges most prone to abuse

Why Delaware for a Drug Deactivation Study?

• According to a 2012 CDC report, prescribing rates of opioids and benzodiazepines were higher than average in Delaware compared to other states:

• 90.8 opioid prescriptions per 100 persons (ranked 17th highest in the US)

• 21.7 prescriptions per 100 persons for long-acting / extended-release opioid pain relievers (ranked 2nd highest)

• 8.8 per 100 persons for high-dose opioid pain relievers (ranked highest)• 41.5 prescriptions per 100 persons for benzodiazepines

Why Delaware for a Drug Deactivation Study?

Six-month multiple-provider episode* rates† for state residents, Schedule II, III, and IV Drugs— Prescription Behavior

Surveillance System, eight states, 2013

California Delaware Florida Idaho Louisiana Maine Ohio West Virginia

0

10

20

30

40

50

60

70

80

8.9

45

52.9

20.9

4.4

20.7

66.8

18.4

* Multiple-provider episode is defined as a resident filling a controlled substance prescription from five or more prescribers at five or more pharmacies within 6 months.† Per 100,000 state residents; annual rate is based on the average of the two half-year rates.

Source: MMWR. Controlled Substance Prescribing Patterns — Prescription Behavior Surveillance System, Eight States, 2013. Surveillance Summaries October 16, 2015 / 64(SS09);1-14

Percent receiving >100 MMEs daily, 2013* - Prescription Behavior Surveillance System, eight states, 2013

Cali-fornia

Delaware Florida Idaho Louisiana Maine Ohio West Virginia

0

2

4

6

8

10

12

14

16

18

10.3

16

13.212

9.2

15

8.1

10.3

*The percentage of patients receiving >100 MMEs per day for all opioids used by the patient calculated as an average of four quarters

Source: MMWR. Controlled Substance Prescribing Patterns — Prescription Behavior Surveillance System, Eight States, 2013. Surveillance Summaries October 16, 2015 / 64(SS09);1-14

The White House

• National Drug Control Strategy was revised in 2015• Pillar 3: Disposal1. Supports DEA Takeback2. Drug Deactivation Systems

a) 2013 NIDA Researchb) “Exemplifies how the drug control interagency work

together with small business to address public health and safety needs.”

Collaborative Delaware Pilot Program

Delaware Prescription Action Committee (PDAC)The PDAC is a public-private partnership started by the State of Delaware’s Division of Public Health and the Medical Society of Delaware to enable multiple stakeholders to work collaboratively to address the prescription drug abuse problem in Delaware.

Delaware Public Health (DPH)DPH, a division of the Department of Health and Social Services, urges Delawareans to make healthier choices.

Pilot Program OutlineScope

1. To provide specific, pre-identified independent pharmacies with Deterra-SP Drug Deactivation Systems in an effort to promote at-home drug deactivation and collect end-user feedback; the pharmacies will provide the Deterra-SP with each qualifying prescription

2. The end goal is to create awareness, educate communities/pharmacists and provide a tangible solution for eliminating prescription medications from the pool of available abusable drugs

Locationsa. 2 pharmacies in New Castle b. 2 pharmacies in Kentc. 2 pharmacies in Sussex

MetricsCreate and implement a web-based survey tool to collect end-user feedback regarding ease-of-use and actual use.

Participating Delaware Pharmacies PHARMACY NAME COUNTY MARKET STREET PHARMACY 1914 N MARKET ST WILMINGTON, DE 19802 PHONE: (302) 421-9200

New Castle

FIRST STATE PHARMACY1707 FOULK ROAD, WILMINGTON DE. PHONE (302) 468-4300

New Castle

CAPE PHARMACY17252 N VILLAGE MAIN BLVD.,UNIT 3 LEWES, DE 19558 PHONE: (302) 645-0090

Sussex

BAYARD PHARMACY 202 W. LOCKERMAN ST. DOVER, DE 19904 PHONE: (302) 724-4497

Kent

ATLANTIC APOTHECARY100 S.MAIN ST SUIT 104 SMYRNA, DE 19977 PHONE: (302)653-9355

Kent

GEORGETOWN PHARMACY432 E MARKET ST UNIT 101, GEORGETOWN, DE 19947 PHONE: (302) 856-2828

Sussex

Comparison of Disposal for Model DrugsPresented at AAPS 2014:- Oxycontin/APAP- Hydrocodone/

APAP- Naproxen

- Ibuprofen- Diphenhydrami

ne- Dexamethason

e

- Amoxicillin- Ketoprophen- Venlafaxine

% o

f Dru

g De

activ

ated

(ave

rage

)

Deterra

100

50

25

75

Coffee15%

Cat Litter

21%

Sawdust

23%

98%

FDA Recommended

IngredientsSmartRX

Ingredient

Adsorption Technology

(deactivation)

Absorption Technology

(non-deactivation)

Challenges to Other Limited Disposal Methods

Pharmacy Drop Boxes:• Pharmacists are concerned and/or not interested in having the boxes in

stores, many cite the DEA data regarding increased robberies along with the burden and added work it places on the employees

Take-Back Programs:• The True Costs and Effectiveness are Unknown, According to a Recent

Study by Carnevale Associates (2014)• Wake Forest and Eastern Tennessee Data presented at the National Rx

Drug Abuse Summit in April 2015:Study Results:• They found that 1%- 5% of available drugs are returned• People won’t drive more than 5 miles to drop off• Include PSA and marketing through radio, TC and ads

Prescription Drug Drop Box1. Selbyville Police Department 302-436-5085 68 W. Church St.

Selbyville, DE 19975 Directions

2. Greenwood Police Department 302-349-4822 100 W. Market St.

Greenwood, DE 19950

3. Dover Police Department 302-736-7111 400 S. Queen St., Dover,

DE 19904 Directions

4. Smyrna Police Department 302-653-9217 325 W. Glenwood Ave.,

Smyrna, DE 19977 Directions

5. Camden Police Department Phone 1783 Friends Way

Camden, DE 19934 Directions

6. Harrington Police Department 302-398-4493 20 Mechanic St.

Harrington, DE 19952

7. Newark Police Department 302-366-7111 220 S. Main St., Newark,

DE 19711 Directions

8. New Castle County Police Department 302-573-2800 3601 N. DuPont Hwy.,

New Castle, DE 19720

Related Pharmacy and Healthcare Examples

Over 4,000 independent pharmacies, healthcare organizations and law enforcement partners

Survey Tool

• Total Responses: 1.5% • Estimate 1,000 Deterra provided

Delaware Pilot ProgramInitial Results

Q1: Which county do you live in?Answered: 15 Skipped: 0

Q2: Where did you receive the Deterra Drug Deactivation System?

Answered: 15 Skipped: 0

within 24 hours

within 4 weeks

longer than 1 month

I will Not use it

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00%

Q3: Upon receipt of the product, how quickly did you use it to destroy unwanted prescription drugs?

Answered: 15 Skipped: 0

Q4: Were the instructions clear and easy to understand?

Answered: 15 Skipped: 0

All respondents answered “yes”

Q5: Did you have any trouble using the product?

Answered: 14 Skipped: 1

All Respondents Answered “No”

Q6: Please check all that apply:Answered: 15 Skipped: 0

I would use this product again

I would recommend it to others

0% 20% 40% 60% 80% 100% 120%

Q7: Why did you use the product? Please check all that apply:

Answered: 15 Skipped: 0

To lower the risk of abuse and diversion

To lower the risk of accidental poisoning

To help the quality of the water supplu by not adding more drugs to the environement

To remove presciption drugs from my home without causing environmental damage

Other

Participating Pharmacists’ Comments“This product is a no-brainer.” Everyone should use

it. Kevin, Rph Atlantic Pharmacy

“The customers that were asked, appreciated the product and did use it to destroy old medications they had around the

home. I believe with heavy advertisement and really pushing the product it could be a success.” Sheila, Rph , Market Street Pharmacy

“I've used the product here in the pharmacy and it is so simple and convenient to use. I truly believe this is an excellent product to get into the

hands of the general public to help protect our environment and water supply.”

-Erik, Rph, Bayard Pharmacy

- Drug abuse is a multipronged problem which requires a multi faceted approach in resolving- Education has to be the main pillar; educating the prescribers in more responsive diagnosing, recognizing risk factors and prescribing- Patients in being more educated consumers and guardians - Creating tools to help consumer be more of an advocate; these tools have to be convenient, easy to use, renewable, cost effective, environmentally friendly, and offer scientific solution- Drug Drop Off Boxes offer an option however they are often being seen as inconvenient, carry high risk and hard to maintain

Drug Deactivation Bags offer:- Easy convenient way for medication disposal at home, in institution or in medical office- A reliable, very cost effective solution for getting unused medications out of the medicine cabinets and keeping them out of water supply- No need for constant expensive monitoring, collection and destruction- No hazardous waste by product - Minimal training

Lessons Learned and Conclusions

Thank You

Technologies to Reduce Diversion, Fraud and Abuse:Electronic Prescribing and Drug Deactivation

Presenters:• Sean P. Kelly, MD, Emergency Physician, Beth Israel Deaconess

Medical Center• Arthur F. Ream III, Chief Information Security Officer and Director

of Information Technology Applications, Cambridge Health Alliance• Hooshang Shanehsaz, RPh, Director of Pharmacy, Cardinal Health,

and Vice President, Delaware Board of Pharmacy

Pharmacy Track

Moderator: Jinhee J. Lee, PharmD, Senior Public Health Advisor, Division of Pharmacologic Therapies, SAMHSA, andMember, Rx and Heroin Summit National Advisory Board