Electronic Prescribing of Controlled Substances: Future Opportunities & Real-Life Experience

Ken Whittemore, Jr. | SVP, Surescripts Rick Camp | Marketing Director, Surescripts Melissa Kotrys | CEO, AZ Health-e Connection

May 6, 2014

Presentation Description Electronic prescribing of controlled substances (EPCS) is legal in all but 2 states, and represents an opportunity to reduce fraud and abuse, improve care efficiency and support safety. Despite increasing adoption, gaps in awareness and education result in lost opportunities. Knowledge of the facts, real-life experience and effective approaches provide a roadmap for future adoption and success.

About NCPDP Founded in 1977, NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,600 members representing virtually every sector of the pharmacy services industry.

NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for e-Prescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry.

Our data products include dataQ®, a robust database of information on more than 76,000 pharmacies, and HCIdea®, a database of continually updated information on more than 2.3 million prescribers. NCPDP's RxReconn® is a legislative tracking product for real-time monitoring of pharmacy-related state and national legislative and regulatory activity. www.ncpdp.org

About Surescripts Surescripts is a nationwide health information network that connects, exchanges and activates health information between pharmacies, payers, pharmacy benefit managers, physicians, hospitals, health information exchanges and health technology firms. By providing information for routine, recurring and emergency care, Surescripts is committed to saving lives, improving efficiency and reducing the cost of health care for all.

For more information, go to www.surescripts.com and follow us at twitter.com/surescripts.

Today’s Speaker Ken Whittemore, Jr. R.Ph, MBA Senior Vice President, Professional & Regulatory Affairs Surescripts, LLC Ken Whittemore, Jr. is Senior Vice President, Professional & Regulatory Affairs at Surescripts. He works with federal and state laws and regulations pertaining to health information technology and serves as the liaison to pharmacy boards and associations. Formerly, Ken worked at the National Community Pharmacists Association and also co-owned a successful independent pharmacy in Maryland. Ken is a graduate of the University of Maryland School of Pharmacy, is licensed to practice pharmacy in Maryland, and holds an MBA degree from Mount Saint Mary’s University.

Today’s Speaker Rick Camp Director, Customer Marketing Surescripts, LLC Rick Camp, is Director, Customer Marketing at Surescripts. He has over 20 years of experience working in healthcare after receiving his BA in Economics & Business Administration from Ursinus College. Formerly, he was a brand director at Merck Pharmaceuticals, senior director of strategy & analytics consulting group at Epsilon and senior director of marketing strategy at Healthcare Resources Online.

Rick leads all e-prescribing related healthcare technology market strategies and identifies new opportunities to increase efficiency and innovation for physicians, pharmacies, PBMS and IT companies. In 2002, Rick’s work was featured in Pharmaceutical Executive and Product Management Today. In 2011, his team’s work won two eHealthcare Leadership Awards for overall website design and best healthcare content.

Today’s Speaker Melissa Kotrys, MPH Chief Executive Officer Arizona Health-e Connection Melissa (Rutala) Kotrys is Chief Executive Officer of Arizona Health-e Connection, the non-profit that advances the adoption and optimization of health IT and health information exchange in Arizona. AzHeC operates Arizona’s regional extension center and leads ePrescribing efforts, Arizona’s HIE marketplace, and recruitment for the statewide health information organization (HIO). Melissa serves as interim CEO for the Health Information Network of Arizona. Ms. Rutala holds a Masters in Public Health from The George Washington University with a concentration in health policy, and a Bachelor of Arts from The University of North Carolina at Chapel Hill.

Faculty Disclosures

• Ken Whittemore, Jr., Rick Camp, and Melissa Kotrys report no actual or potential conflicts of interest associated with this presentation, OR

• Ken Whittemore, Jr., Rick Camp, and Melissa Kotrys report no: » Grant/research support » Consultant Interest » Speaker’s bureau member compensation

Accreditation Statement

The Institute for Wellness and Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Attendees who participate in the interactive portion and submit the completed evaluation form at the conclusion of the program will have credit for 1.0 hour(s) of continuing pharmacy education (0.10 CEU(s)) uploaded to CPE Monitor within 60 days after the program date. ACPE program numbers are 0459-0000-14-033-L04-P&T. Initial release date is 05/06/2014.

Learning Objectives 1. Define state regulatory status, requirements and anticipated changes

2. Describe EPCS benefits to patients, providers and technology vendors

3. Outline the national landscape trends and obstacles

4. Categorize opportunities for broad adoption for EPCS

5. Employ effective techniques to stimulate adoption

6. Explain real-life experience of EPCS and a vision for the future

Pre-Test Questions

1. What are the benefits of EPCS?

2. How many states have regulations allowing EPCS?

3. What is the national percentage of community pharmacies that are enabled for EPCS?

E-Prescribing for Controlled Substances: Regulatory Progress & Prognosis

Ken Whittemore, Jr. R.Ph, MBA Senior Vice President, Professional & Regulatory Affairs Surescripts, LLC

Controlled Substances are an Important Medication Option

• Narcotic and psychoactive medications

• Regulated according to 5 schedules of abuse potential

13% of all

prescriptions

1. National Association of Chain Drug Stores (NACDS) 2013 dispense data for all new prescriptions, refills, and renewals in the US.

Misuse of Controlled Substances: Epidemic and growing health threat

of the U.S. population has used an opioid pain reliever non-medically

Emergency Department visits related to substance abuse in 2009

increase in drug overdoses since 1995

4.8%

1 .2M

3X

• Laws are emerging to allow broad availability of opioid antidote

• Pharmacies and prescribers are intervention points, also subject to investigations and loss of license

Drug Overdose Death Rates

3% - 9% Of diverted drugs for abuse are tied to fraud and forgery of paper prescriptions¹

States MANY

Require special paper Rx pads and records²

Work DUAL

When both paper Rx pads and e-prescribing are used³

1. Butler SF, Budman SH, Licari A, et al. National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse. Pharmacoepidemiol Drug Saf 2008;17:1142–54. ALSO, Rosenblum A, Parrino M, Schnoll SH, et al. Prescription opioid abuse among enrollees into methadone maintenance treatment. Drug Alcohol Depend 2007; 90:64–71.

2. Agency for Healthcare Research and Quality (AHRQ), Reducing and Preventing Adverse Drug Events to Decrease Hospital Costs, Publication #01-0020 3. Economic Impact Analysis of the Interim Final Electronic Prescription Rule, DEA, U.S. Department of Justice, March 2010

Paper Prescriptions for Controlled Substances Add Additional Risk and Work

Electronic Prescribing of Controlled Substances (EPCS) Can Reduce Risks

• Reduced fraud and abuse

• Secure electronic records

• Improved safety and patient care

DEA, U.S. Department of Justice, Economic Impact Analysis of the Interim Final Prescription Rule, March 2010

DEA’s Interim Final Rule (IFR) for EPCS1

1 Drug Enforcement Administration (DEA) issued an interim final rule (IFR) allowing electronic prescribing of controlled substances (EPCS) on 03/31/2010, effective 06/01/2010

Aims to ensure secure and auditable EPCS transactions to reduce the risk for drug fraud, diversion and abuse • Establishes new security requirements for prescribers, pharmacies and

systems that support electronic transmission • Requires provider EHR and pharmacy management software updates

are independently certified as compliant • Allows prescribers the option of signing and transmitting, and

pharmacies to receive, dispense and archive, controlled substance prescriptions totally electronically

• However, the DEA’s EPCS rule does not preempt any state rules

EPCS Regulatory Status in 2010

Surescripts and NACDS Collaborated to Align State EPCS Rules with the DEA • Reviewed state rules related to EPCS

• NACDS’s state directors communicated with state authorities o Asked to validate resulting assessments with respect to their EPCS rules

• Found both positive and negative variances • Resulted in a roadmap for action - reliable, validated compilation of state EPCS rules

o Where necessary, urged local authorities to begin legislative and regulatory processes to bring their rules into alignment with those of the DEA

• Industry wide collaboration facilitated steady regulatory progress

Now in 2014, Only 2 States Do Not Yet Permit EPCS in Some Form

Data through April 2014

Special State Considerations - Georgia

Georgia Drugs and Narcotics Agency (GDNA) EPCS Policy*

• Application vendors must submit their Part 1311 EPCS audits to GDNA

• GDNA doesn’t evaluate said audits, but accepts at face value

• GDNA posts a list of all of the approved vendors on its website http://gdna.georgia.gov/

• Pharmacies not required to maintain any audit reports o Instead, GDNA collects and is responsible for keeping and posting a list of approved vendors

• EPCS can begin when o Vendors email their audit reports to Mr. Rick Allen, Director, Georgia Drugs and Narcotics

Agency at rallen@gdna.ga.gov

* 09/16/13 edited

Special State Considerations - New York

Internet System for Tracking Over-Prescribing (I-STOP)* • Designed to address prescription drug abuse and diversion,

providing law enforcement and medical professionals tools to stop abuse and diversion before it occurs o Allowed EPCS in the state and makes e-prescribing mandatory for both

controlled and non-controlled substances as of 03/27/15 o Created a prescription drug monitoring program (PDMP) for New York

that requires real-time reporting of PDMP information o NY State Department of Health, Bureau of Narcotic Enforcement (BNE)

released required packets for pharmacies and prescribers to register their certified electronic prescribing applications

*I-STOP bill announced, introduced, passed and signed in 2012

In Spite of Tremendous Regulatory Progress, Many Still Think EPCS is Illegal

I wish I could electronically prescribe controlled substances.

I’m not sure if we are able to accept EPCS

E-Prescribing for Controlled Substances: National Landscape, Perspectives, Opportunities

Rick Camp Director, Customer Marketing Surescripts, LLC

Barriers Impeding EPCS Adoption

• Education o Low awareness of legality and availability of EPCS o Unclear requirements / credential verification & authentication o Uncertainty around on-going costs of compliance (third party audits)

• Competing Priorities o IT vendor workload for 10.6, MU2, ICD-10, etc. o Pharmacy /provider responsibilities limit time for EPCS training

• Lack of Critical Mass o Pharmacy vendors and EHRs waiting to see progress first o Geographic disparity of EPCS capable pharmacies and providers

Certified EPCS Software / Limited Rollout Ph

arm

acy

Com

pani

es

Prov

ider

EH

R Co

mpa

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0

EPCS Enabled Pharmacies: Nationwide Scale

More than 40% of total pharmacies are EPCS enabled o Five States over 60%: DE, MA,

NH, IL, RI o EPCS mail order enabled:

Express Scripts Home Delivery

March 2014 data

EPCS Enabled Providers: EHRs Trail Pharmacy

Provider Enablement

March 2014 data

More than 2% of providers are EPCS enabled o Top States: FL (23%), MI (10%),

CA, WY, AZ o Top EPCS volume: MA, CA,

MI, IL, AZ

Geographic Disparity Between Pharmacy / Provider Enablement Hinders EPCS Adoption

March 2014 data

Pharmacy enablement by NY county

Provider enablement by NY county

30% disparity between pharmacy and provider EPCS

enablement in NY

30% EPCS enabled 1352 locations 62 counties

<1% EPCS enabled 274 prescribers 13 counties

10 States Represent 50% of National Controlled Substance Volume: Greatest Need for EPCS

Top 10 States

40 Other States

National CS Prescription Volume

CALIFORNIA TEXAS FLORIDA NEW YORK PENNSYLVANIA OHIO TENNESSEE MICHIGAN NORTH CAROLINA GEORGIA

1. National Association of Chain Drug Stores (NACDS) 2013 dispense data for all new prescriptions, refills, and renewals in the US.

EPCS Utilization Potential Varies by Medical Specialty

Controlled substances as a percent of total prescriptions

1Suescripts 2010 Internal Survey of 1375 prescribers

0%

20%

40%

60%

80%

100%

Primary Care Pain Specialist Psychiatrist

1 - 20%

21 - 60% 21 - 60%

Providers Interested in EPCS

1 2010 Internal Survey of 1375 prescribers 2 2013 Black Book Survey of 80,000 e-prescribing doctors

Interest highest in practices with 40% or more of total Rx for controlled substances

87% expect to see reductions in o Doctor shopping o Prescription fraud o Drug overdoses2

80% say they are very much or extremely interested1

Providers Using EPCS Report Benefits

1 Journal Am Medical Info Assoc., June 2013, Early experience with electronic prescribing of controlled substances in a community setting 2 American Institutes for Research - CHCF Pilot , November 2013 http://www.chcf.org/projects/2013/epcs-pilot and Surescripts Experience

Saves time for provider and patient with less steps, less driving to office for renewal, less waiting at pharmacy2

Better prescription monitoring and pharmacy coordination1

70% Say o Easy to use from any

EPCS enabled computer

o Improved accuracy and less errors1 Eases security concerns

with improved records / tracking2

Saves Money with less use of watermarked paper and secure printers for wet signature2

“We want the prescription to be something people don’t question. When there is concern about misuse or improper medicines, it’s easy to just look into the electronic records. It’s all secure, and if it’s in there, it was prescribed by me. That’s 100 percent accountability for me and the patient. We all gain confidence”

Dr. Larry Sumner Family Practitioner Tahlequah Medical Associates

An Experienced EPCS Doctor Shares…

Dr. Sumner on E-Prescribing of Controlled Substances “It’s reliable. Once I send it electronically, I never have to visit it again. In other words, the pharmacist is not going to call me and ask what it says.”

“Convenience and accountability with EPCS is good, but the number one benefit of electronic prescribing is that it has helped us to reduce our medication errors to virtually zero. This safety benefit is the most important reason that lead us to begin e-prescribing in the first place.”

Positive Pharmacy EPCS Experience

• Stronger security reduces fraud risks of paper Rx

• Improves safety with more accuracy / less errors

• Saves time by eliminating rekeying and manual paper processes

• Lowers cost of call backs and paper record storage

• Easy to use, similar to regular e-prescribing

Collaborate Early for Success “We’ve had a lot of communication keeping each other informed…that has been very helpful.” - Pharmacist

Surescripts Experience and American Institutes for Research Pilot , November 2013 http://www.chcf.org/projects/2013/epcs-pilot

EPCS Enhances Medication Management for Providers, Pharmacies, Patients

1 DEA, U.S. Department of Justice, Economic Impact Analysis of the Interim Final Prescription Rule, March 2010 and Surescripts Analysis

FEWER Callbacks between pharmacy and providers with less risk of fraud1

ONE Workflow, secure and efficient for all prescriptions1

$700M Reduction in annual healthcare costs of calls and record keeping1

Up To

EHR Vendor / Provider IT Vendor / Pharmacy EHR Updates Software • EPCS Certification • Select Identify Proofing • Verified Audit

Key Steps for EPCS Transactions

Vendor Updates Software • EPCS Certification • Verified Audit

Step 1

Step 2

Systems connected to Surescripts network for

secure EPCS transactions

Enable Pharmacy Systems • Access Controls Set • Training

Enable Provider EHR Systems • ID Proofing Setup • Dual Authentication Device • Training

EHR

Prescriber ready to send EPCS

PMS

Pharmacist ready to receive EPCS Step 3

Know the Facts About EPCS Access Online Resources www.surescripts.com/epcs

Found 314 pharmacies within 50 miles of Scottsdale, AZ 85254

Find E-Prescribing Pharmacies Enabled for EPCS

Find E-Prescribing Healthcare Providers Enabled for EPCS

Collaborate to Realize the Full Value of EPCS

Collaboration Case Study: Driving EPCS Success in Arizona

Melissa Kotrys, MPH Chief Executive Officer Arizona Health-e Connection

Arizona Health-e Connection (AzHeC) exists to

Convene, Coordinate and Communicate

for health information infrastructure improvements that

affect every Arizonan.

AzHeC Programs & Initiatives

HIT HIE REC: Helping Arizona providers meet their health IT goals

HIE Marketplace : viable HIE solutions for providers

Policy development: leading legislative efforts

eRx Initiative: increasing adoption

Consumer Outreach: education, awareness & engagement

HINAz Provider Outreach: Recruitment & Enrollment

Arizona’s Health IT Roadmap 2.0: 2-3 year plan for HIT/HIE in Arizona

Arizona eRx Initiative - An Overview

Outreach, Education and

Resources EPCS Program

Provider & Pharmacy Technical

Assistance

Pharmacy Incentive Program

Arizona EPCS Initiative AzHeC established an advisory committee, conducted a needs assessment and implemented four key programs between May and December 2013

Key EPCS Program Strategies:

• Provider and pharmacist focused education and outreach

• Encouraged pharmacy chains to get EPCS-enabled

• Worked collaboratively with EHR vendors to support EPCS

• EPCS incentive program to reimburse providers for their identity proofing costs

193 More Arizona Pharmacies Became EPCS Enabled Through the Campaign

March 2014 data

262

455

0

50

100

150

200

250

300

350

400

450

500

May 2013 March 2014

EPCS Enabled Pharmacies

74% Growth

209 Arizona providers Were EPCS Enabled Through the Campaign

March 2014 data

16

225

0

50

100

150

200

250

May 2013 March 2014

EPCS Enabled Providers

1306% Growth

119

7812

4

4

7

1

AZ EPCS Program Grew Provider Enablement and Transaction Volume

20 14 11 494

2,718

3,113 3,311

3,546

4,070

3,454 3,723

49 54

96 119

144

215 218 220 223 225 225

40

90

140

190

240

290

340

390

440

490

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000

May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14

# of

Act

ive

EPCS

Pre

scrib

ers

New

RX E

PCS

Volu

me

NewRx EPCS Volume # of Enabled EPCS Prescribers

AZ EPCS Prescriber (EHR) Vendor Progress

March 2014 data

3

70

42

5

48 57

225

3 0

19

2 12

49

85

0

50

100

150

200

250

Allscripts Cerner DrFirst NewCrop NextGen RxNT Total

AZ Enabled and Active EPCS Prescribers

EnabledPrescribers

ActivePrescribers

AZ State Pharmacy EPCS Connectivity Pharmacy EPCS Enabled

Stores eRX Enabled Stores

% EPCS Enablement

Chain Pharmacies 403 888 45%

Independent Pharmacies 52 113 46%

Total 455 1001 45%

Arizona (45%) is above the national average of 40% EPCS enablement

March 2014 data

Considerations & Next Steps for AZ What we learned: What we can do:

Many prescribers and pharmacists still believe EPCS is not legal!

Continue educational efforts • Keep the subject alive in newsletters, AzHeC

speaking opportunities, forums, etc.

EPCS remains a low priority for many provider vendors

Maintain software vendor relationships to help them understand how EPCS benefits them • Encourage certification for Tier 1 endorsement

Prescriber and pharmacy communities have strong interest in doing EPCS

Keep EPCS in front of providers and pharmacies • Attend meetings, invite them to contact us with

questions or concerns, etc.

Considerations & Next Steps for AZ (cont.)

What we learned: What we can do:

Additional training needed for pharmacy staff after pharmacy is certified for EPCS

Maintain relationships with corporate pharmacy contacts. • Encourage ongoing training with staff and solicit

their help in addressing store by store problems.

Prescribers need a place to go for issue resolution or they may drop the use of the technology

Continue to work with DTAPS to keep them involved and helping with EPCS related issues. • Use the AzHeC website, meetings , etc., to

continue offering help.

EPCS is part of the bigger need for prescribers to adopt ePrescribing technology

In efforts to increase Arizona’s status for SafeRx, incorporate the benefits of EPCS as part of the rationale for using ePrecribing systems.

2014 Arizona eRx and EPCS Efforts

• Continue to track EPCS adoption – both by providers and pharmacies

• Develop proposal to have Medicaid health plans support ongoing eRx and EPCS promotion and adoption

• Continued online education for EPCS at www.azhec.org

Summary: Realize the Full Value of EPCS

• Efficiency

• Safety

• Accountability

• Minimize fraud and abuse

Collaborate for Successful Adoption

2. What are the key benefits EPCS can provide for patient care management? Reduced fraud and abuse of paper prescriptions One streamlined electronic workflow for all e-prescriptions Improved safety and patient care All of the above

Post-Test Questions

1. What is the estimated annual cost savings potential to U.S. pharmacies based on EPCS reduction on callbacks and paper record keeping? $50 million $500 million $700 million

4. In general, to e-prescribe controlled substances, a prescriber must? Have E-Prescribing software certified for EPCS Have ID proofing set up Use a two factor authentication method (ie. FOB, mobile app, biometric) Have pharmacies ready for EPCS All of the above

3. How many states have legislation for EPCS? 34 states 40 states 48 plus DC

Post-Test Questions

6. Once pharmacy software is certified for EPCS, is staff education needed? Yes No

Post-Test Questions

5. Obstacles preventing prescribers use of EPCS include? Unclear on legality Pharmacy and EHR software readiness Confusion around credentialing and authentication All of the above

Q & A