Just Say Yes: Helping Physicians Embrace eprescribing of Controlled Substances

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Simplifying the Business of Healthcare

An Emdeon

White Paper

A practical guide to help physicians get started

with ePrescribing of controlled substances

Just Say Yes: Helping Physicians

Embrace ePrescribing of

Controlled Substances

Introduction

While over 30 states have made it legal for physicians to electronically prescribe controlled substances, ePrescribing of controlled substances (EPCS) is not taking off. This white paper is intended to help physicians understand the value of EPCS, what it takes to get started and why their peers profiled in the paper prefer EPCS over paper controlled substance prescriptions.

Approximately 90 percent of prescribers write prescriptions for controlled substances and 11 percent of all prescriptions are for controlled substances. According to industry analysis, most prescribers are interested in electronically prescribing for controlled substances. And the ability to do so is now available. The United States Drug Enforcement Administration (DEA) recently began allowing the ePrescribing of controlled substances, provided that certain technical, security and other conditions are met.(1)

A safe, secure infrastructure is in place and more and more vendors are developing compliant systems that meet the DEA’s requirements.

Although the DEA has given the green light for EPCS, uptake has not yet begun to take off. Due to timing issues, technology, cost of certification and misconceptions about EPCS, many potential users have held back on implementation. This means that physician practices and their patients are missing out on the many benefits of EPCS.

Emdeon—a national leader in ePrescribing has been paving the way for physicians and other legal prescribers to begin using EPCS so that providers and patients can take advantage of its many clinical, safety and cost-benefit advantages.

Emdeon provides information on EPCS and other ePrescribing issues through its Resource Library, which may be accessed on its website at

http://www.emdeon.com/resourcelibrary/#122#282 (1)

Federal Register, Department of Justice Drug Enforcement Administration, 21 CFR Parts 1300, 1304, 1306 and 1311 Electronic Prescriptions for Controlled Substances; Final Rule, Wednesday, March 31, 2010.

“Once we got used to using it

(EPCS), which only took a couple

of weeks, it was effortless. And

we had never done any kind of

ePrescribing before.”

Jennifer Michaels, MD

Medical Director The Brien Center Pittsfield, MA

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What is EPCS? (continued)

With these requirements in mind, the pilot involved a number of collaborators: DrFirst, the ePrescribing vendor; the Massachusetts Department of Public Health; Berkshire Health Systems, Inc.; Brandeis University’s Heller School for Social Policy and Management; the Drug Enforcement Administration and Emdeon’s eRx Network, which provided the ePrescribing infrastructure and a secure and safe connection to the project’s nine participating pharmacies in Berkshire County, MA. This region was selected as the pilot site because its relatively small and secluded medical catchment area created a controlled and measurable environment. Results of the pilot, which ended in 2011, may be used by the DEA to see if additional changes to its existing EPCS requirements are warranted.

How does EPCS work?

ePrescribing of controlled substances is not a difficult process and can easily be managed within the physician’s office. “I highly encourage people to get on board with this,” urges internist Thomas Vaughn, MD, whose practice is Dalton Medical Associates LLP, in Dalton, MA. He also is an assistant professor of medicine at the UMass Medical Center at Berkshire Medical Center, Pittsfield, M A.

In fact, getting on board with EPCS is as easy as 1-2-3-4.

Step 1. Providers and pharmacies select an ePrescribing application that has been certified to manage controlled substance prescriptions electronically in accordance with the DEA’s requirements and the National Institute of Standards and Technology (NIST) requirements for physical security and processing integrity.

Step 2. The provider completes an identity proofing process. This proves that the prescriber is who they say they are and that they meet certain requirements, such as having a valid license to practice and a valid DEA number. This may be conducted remotely or in a face-to-face process by a credential service provider or certification authority approved by the federal government. Vendors can assist with the process.

Step 3. The prescriber must log into the ePrescribing system using “two factor” authentication to “digitally sign” the prescription. This means that the log-in must be completed by using two of the following: a token (such as a secure cryptokey that looks like a flash drive), unique password or biometric. The specific combination of factors to be used is decided up-front by the EPCS system vendor.

Step 4. The prescriber creates the ePrescription using the EPCS system. In an instant, the ePrescription can be securely sent electronically to the pharmacy using one of two optional methods selected by vendors for their ePrescribing systems. These two options have little impact on prescribers, as they are built into the ePrescribing system and have to do with how the ePrescribing infrastructure and pharmacy systems send and receive the EPCS. The expectation is that both options will be used in the future, but most will implement the option that more closely resembles the current electronic prescribing messaging done today for non-controlled substance prescriptions.

Who and what are covered by ePrescribing for

controlled substances?

In a regulation that became effective in June 2010, the DEA spelled out its requirements for voluntary electronic prescribing for Schedule II-V medications. The DEA’s requirements apply to physicians in offices and institutional settings, as well as to stand-alone ePrescribing systems and electronic health record systems with ePrescribing capabilities. They also apply to other health professionals—such as nurses and physician assistants—who may be permitted to prescribe controlled substances depending on the laws and regulations of the States where they practice. The DEA’s regulation also has special requirements for pharmacists, pharmacies and their software, which, after being certified, can receive, dispense and archive electronic prescriptions for controlled substances. The DEA’s requirements for ePrescribing do not apply to written, manually signed and oral

prescriptions for controlled substances. These still follow the existing requirements of both the DEA and the States, whose individual requirements can be more stringent than those at the Federal level.

What is EPCS?

With EPCS, prescribers can voluntarily manage all prescriptions electronically, rather than use electronic prescriptions for non-controlled substances and the time-consuming, separate paper-based process for controlled substance prescribing. In addition to separate record-keeping and workflows at the point of prescribing, the current paper-based system for prescribing usually involves an additional post-prescription process with several rounds of telephone-based and/or fax-based interchanges between prescribers (or their office staff) and pharmacies before the prescription is ready to be filled. Having a single process for both types of prescriptions improves prescription accuracy, increases patient safety and reduces costs,(2)(3)as well as enables secure, real-time electronic connectivity between

clinicians and pharmacies. It is based on the safe and secure infrastructure that has been in place for the last 15 years, which experts estimated handled some 326 million non-EPCS prescriptions safely, securely and accurately in 2010.(4)

For prescribers, the EPCS process is similar for electronically prescribing non-controlled and controlled substances, except for some important differences in prescriber authentication and security requirements, which are described below. “There is a quick learning curve, especially for physicians who have already been ePrescribing,” explains neurologist Alec S. Kloman, MD, whose practice is Green Mountain Neurology, Inc., in Pittsfield, MA. He is also Chief, Division of Neurology & Stroke Program Director at the Berkshire Medical Center and an Associate Professor of Neurology at the UMass Medical School. Dr. Kloman and his practice were among a number of small providers who recently participated in a Massachusetts pilot program for EPCS that was funded under a $1.99 million grant from the Federal Agency for Healthcare Research and Quality, with oversight from the DEA.(5)

The project was aimed at developing, implementing and verifying a system for the safe and secure electronic transmission of prescriptions for Federally controlled substances in an ambulatory care setting. A secondary goal was to develop and test how the EPCS system could be interfaced with the Massachusetts Prescription Monitoring Program.

(2)

Fischer MA, Vogeli C, et al (2008, Dec 8). Effect of Electronic Prescribing with Formulary Decision Support on Medication Use and Cost. Archives of Internal Medicine 168(22):2433-9.

(3)

Kaushal R, Kern LM, et al (2010, June). Electronic Prescribing Improves Medication Safety in Community-Based Office Practices. Journal of General Internal Medicine 25(6):530-6. Epub 2010 Feb 26.

(4)

Surescripts (2010). National Progress Report on ePrescribing and Interoperable Health Care. Accessed at: http://www.surescripts.com/about-e-prescribing/progress-reports/national-progress-reports.aspx.

(5)

Agency for Healthcare Quality and Research (2010). AHRQ Funded Research Studies: Enabling Electronic Prescribing and Enhanced Management of Controlled Medications: Massachusetts. Rockville, MD. Accessed at http://healthit.ahrq.gov/portal.

Provider selects approved EPCS system Prescriber completes Identity Proofing Prescriber logs onto EPCS system

using password, biometric and/or secure token Prescriber creates ePrescription and electronically sends it to pharmacy of patient’s choice

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EPCS: Myths vs Reality (continued)

Myth: ePrescribing of controlled substances is not secure.

Reality:ePrescribing is not transmitting raw patient information over the open Internet. ePrescriptions and other information, such as patient eligibility and formulary data, are encrypted and transmitted through secure networks, such as the one operated by Emdeon. Prescribers and pharmacies must be credentialed and approved before they can participate in the ePrescribing process. They also must securely log on before they can ePrescribe or receive a prescription. “We deliberately tried to fool the system by logging on with the wrong token or password. It didn’t work,” explains Dr. Vaughn.

Infrastructure technology partners, vendors and others are bound through strong contracts to ensure the authentication of users, the integrity of prescriptions and the privacy and security of personal health information as it passes through the secure networks. All must comply with applicable privacy and security standards for patient information required under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as State laws, which often are stricter. As of 2011, there were no known breaches of these networks.

Myth: ePrescribing of controlled substances is hard to do.

Reality:ePrescribing of controlled substances may require some minor changes in the physician workflow, such as up-front credentialing and logging in with a token, password or biometric system. However, many institutions are already requiring similar security measures, including steps to document physician authentication and credentials, such as verification of licensing and employment requirements. ePrescribing vendors and technology partners are working to make sure that the legal requirements of EPCS have minimal impact on physicians’ workflow. More importantly, EPCS creates a common workflow for all prescriptions, instead of time-consuming, separate paper-based, telephone-based and fax-based methods for controlled substance prescriptions. “Once we got used to using it, which only took a couple of weeks, it was effortless. And we had never done any kind of ePrescribing before. We went right from paper to using the EPCS system,” explains Jennifer Michaels, MD, a psychiatrist who is the medical director of the Brien Center, which is the largest community mental health program in Berkshire County, MA. It has a staff of 13 psychiatrists and clinical nurse specialists who provide mental health and substance abuse services to over 10,000 patients per year.

Benefits of EPCS

A paperless prescribing system is preferable to today’s paper world because it adds new dimensions of safety and efficiency to current practice, which are especially important given the heightened risks associated with controlled substances. Some of the benefits are described below:

EPCS can offer return on investment.EPCS can offer an effective return on investment, especially for those specialties—such as psychiatry and pain management—that write a significant number of controlled substance prescriptions. ePrescribing decreases time spent managing prescription renewals by reducing phone calls and faxes. It also minimizes issues related to formulary, generic substitution, dosage and legibility. A study by MGMA’s Group Practice Research Network estimated that the time spent managing unnecessary administrative complications related to prescriptions is approximately $15,700 annually for each full time physician.(8)

EPCS could also help Accountable Care Organizations meet their cost and quality targets.

(8)

Medical Group Management Association (MGMA) Center for Research (2004). Analyzing the Cost of Administrative Complexity in Group Practice. Accessed at: http://www.mgma.com/about/default.aspx?id=280.

EPCS: Myths vs Reality

Myth: ePrescribing of controlled substances can’t be done now because technology is not available.

Reality:The technology infrastructure is now available to make EPCS a reality. Pharmacies and payers/ PBMs have built a national infrastructure connecting their systems, which has been used successfully for the past decade for ePrescribing of non-controlled substances.(6)

It provides a very firm base that EPCS builds on. Technology partners, such as Emdeon, already have the infrastructure in place to safely and securely handle the EPCS transaction flow between the prescriber, payer and pharmacy. Pharmacies and ePrescribing systems typically must register with Emdeon and other networks to access their secure networks and ePrescribing infrastructure. There are built-in audit trails for each transaction. Furthermore, contracts are in place among the participating parties to ensure that

prescribers and pharmacies are credentialed and authorized to use the infrastructure. These infrastructure “pipelines” have built-in security, such as encryption of the data when it is sent as part of the ePrescription process. They use all the latest industry technology standards and meet all requirements of the federal government for ePrescribing under Medicare Part D and HIPAA.

Hardware and software are available for both prescribers and pharmacies for the secure electronic transmission of prescriptions for controlled substances that meet the DEA’s requirements and additional State regulations. Finally, the industry is constantly making changes to ensure that the infrastructure allows for new technology as it is introduced and can comply with Federal and State standards, laws and regulations.

Myth: ePrescribing of controlled substances is not legal.

Reality:Since June 2010, the Drug Enforcement Administration has allowed ePrescribing of controlled substances, provided that certain authentication and security requirements are met. Since then, many State legislatures and Boards of Pharmacy have proactively adjusted their laws and regulations so they are in compliance with the DEA’s requirements. EPCS currently is legal in 33 States, either by permitting EPCS for all controlled substances or generally permitting EPCS (either CII-CV or some variation), in accordance with Federal regulations.(7)

The remaining States do not currently allow EPCS and some will need new statutes. Many of these States are currently addressing these needed changes, but providers and pharmacists can encourage the wider-spread adoption of EPCS in their localities by talking to State associations, State authorities for controlled substances and State legislators. Vendors and Boards of Pharmacy can help providers know the status of their States’ adoption of EPCS.

(6)

eHealth Initiative and the Center for Improving Medication Management (2008, June). Electronic Prescribing: Becoming Mainstream Practice.

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Source: Point-of-Care Partners, LLC.

Figure 1. State Board Progress on EPCS

Source: Point-of-Care Partners analysis of state Board of Pharmacy (BOP) rules and regulations and relevant statute, (January 2012).

States that allow CII-V*

States that allow CII with hard copy; no CIII-V

States that allow CIII-V; no CII

States that do not allow EPCS

*Note that there are requirements and restrictions that vary by state, and this situation is dynamic. Consistent, on-going monitoring is critically important.

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Benefits of EPCS (continued)

EPCS is a tool that can help prescribers gain important data-driven insights about non-adherent patients. Medication history from pharmacies, health plans and pharmacy benefit managers—for controlled and non-controlled substance prescriptions—are sent to prescribers through the EPCS process. A growing number of ePrescribing applications are beginning to use medication history to calculate adherence and alert prescribers during the patient visit.(13)

This allows the prescriber to initiate a dialog with the patient about the importance of adhering to their prescribed therapies and determine why they are noncompliant. Studies have shown that patients fail to stick to their regimens for a wide array of reasons, ranging from out-of-pocket costs and side effects to poor understanding of their medicines or illnesses. The fragmentation of the healthcare system, literacy issues, cultural issues and lack of knowledge about healthcare compound the problem.(14)

Pharmacy organizations are reporting that they are also beginning to use their own electronic prescribing resources to identify non-adherent patients and to support a dialogue between patients and pharmacists.(15)

EPCS provides convenience.EPCS is quicker and more convenient for patients and providers. Patients can have their controlled substance prescriptions filled at the pharmacy of their choice. With EPCS, prescriptions are sent directly to the pharmacy, minimizing the chance that patients will lose prescriptions or forget about them. And, the prescriptions are usually ready when patients arrive. “Some patients needed to be educated about how EPCS works,” explains Dr. Michaels. “But once they understood (how prescriptions were sent to the pharmacy), it worked quite well and they were very happy.”

The convenience of EPCS is a major benefit for all patients, but especially for those with debilitating, chronic conditions. “EPCS is safer and more convenient for us and for our patients,” notes Dr. Vaughn.

EPCS helps stop drug diversion.Federal and State officials are struggling to keep pace with the growing epidemic of drug diversion related to controlled substance prescriptions and its deadly consequences. Prescription drug abuse spans all age groups, with the elderly becoming a rapidly growing group of unintentional drug abusers.(16)

Overdoses, deaths and injuries continue growing at an alarming rate. Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to a recent analysis by the Los Angeles Times.(17)

The drug death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety.(18)

According to the National Institute on Drug Abuse, abuse of prescription drugs kills more people accidentally than heroin or cocaine.(19)

(11)

O’Reilly, Kevin B. (2007, September 10). Report seeks more action on medication noncompliance. Amednews.com. Accessed at http://www.ama-assn.org/amednews/2007/09/10/prsd0910.htm.

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Ibid.

(13)

eHealth Initiative and Center for Improving Medication Management, op cit.

(14)

National Council on Patient Information and Education (2007, August). Enhancing Prescription Medicine Adherence: A National Action Plan. Accessed at http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf.

(15)

eHealth Initiative and Center for Improving Medication Management, op cit.

(16)

Korper, SP and Raskin, I ( 2008). The Impact of Substance Use and Abuse by the Elderly: The Next 20 to 30 Years. In Substance in Abuse by Older Adults: Estimates of Future Impact on the Treatment System. Rockville, MD. Substance Abuse and Mental Health Services Administration. Accessed at: http://www.oas.samhsa.gov/aging/chap1.htm.

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Girion, L et al (2011, September 17). Drug deaths now outnumber traffic fatalities in U.S., data show Los Angeles Times. Accessed at http://articles.latimes.com/2011/sep/17/local/la-me-drugs-epidemic-20110918

.

(18)

Harmon, Katherine (2010, April 6). Prescription Drug Deaths Increase Dramatically. Scientific American. Accessed at http://www.scientificamerican.com/article.cfm?id=prescription-drug-deaths.

(19)

Volkow, N (2011, October) Prescription Drugs: Abuse and Addiction. Rockville, MD. National Institute on Drug Abuse. Accessed at http://drugabuse.gov/ResearchReports/Prescription/prescription.html.

Benefits of EPCS (continued)

EPCS can improve office workflow and productivity.EPCS creates one electronic workflow for prescriptions, instead of time-consuming, separate paper-based, telephone-based and fax-based processes for controlled substance prescriptions.(9)

In the beginning, this may add time to tasks like creating new prescriptions. However, EPCS works easily into the physician and office work flows after a brief learning curve. “EPCS is easy to learn and maintain,” explains Dr. Kloman.

In addition, EPCS can improve office productivity. Nurses and office staff are freed up from the numerous faxes and phone calls with the pharmacy to clarify quantities, dosing, appropriateness of the controlled substance and insurance benefit compatibility.(10)

EPCS also assures the legality of the prescription itself because paper prescriptions can be forged or altered. EPCS eliminates the need for the patient to handle paper prescriptions, which can be easily lost, stolen or diverted. “One of the best things about EPCS is the electronic record keeping,” notes Dr. Kloman.

EPCS may provide many quality and safety benefits for providers and patients.This helps improve the quality and safety of patient care. EPCS helps improve the quality of care in two ways: It helps reduce the errors inherent in the paper-based process that can lead to adverse drug events and can enhance clinical decision support.

EPCS is safer than paper-based prescriptions.A paperless prescribing system is preferable to today’s paper world because it adds new dimensions of safety and efficiency to current practice, which are especially important given the heightened risks associated with controlled substances. Errors can occur at many points in the paper-based controlled substance medication prescribing and delivery system, which are mitigated or eliminated with EPCS. These potential points of error in the traditional manual prescribing processes for controlled substances include:

• Miscommunication due to illegible handwriting • Unclear abbreviations and dose designations • Unclear or ambiguous telephone, fax or verbal orders

EPCS helps improve the quality of care.EPCS can give the prescriber access to real-time patient clinical decision support information at the point of care, which could improve quality and safety. It also allows the clinician to select the most therapeutically appropriate and cost-effective medications for the patient. Some of the available information includes:

• Patient pharmacy benefit eligibility and coverage • Formulary information

• Medication history information for controlled and non-controlled substances • Checks for drug-drug interactions and allergies to medications prescribed

EPCS helps improve medication compliance.By having the patient’s medication history and clinical decision support available at the point of care, prescribers can avoid adverse drug events and help improve medication compliance. Patients commonly fail to take their medications as directed or do not take them at all, leading to unnecessary hospital admissions, reduced productivity and even death. This costs the healthcare system as much as $177 billion a year.(11)

Medication non-adherence “…is America’s newest drug problem,” said Carolyn M. Clancy, MD, who is the director of the Federal Agency for Healthcare Research and Quality.(12)

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MGMA (2008, September 25). Comments on DEA Proposed EPCS Rule The Drug Enforcement Administration proposed rule on the Electronic Prescriptions for Controlled Substances, 21 CFR Parts 1300, 1304, et al. (June 27, 2008). Docket No. DEA 218. Accessed at http://www.mgma.com/WorkArea/DownloadAsset.aspx?id=33603.

(10)

Tennant, R. (2006, July 11). Statement of the Medical Group Management Association to the Departments of Justice and Health and Human Services, Electronic Prescribing of Controlled Substances: Practitioner Perspective Panel. EPCS Public Meeting, Arlington, VA, Presentation accessed at : http://www.deadiversion.usdoj.gov/ecomm/e_rx/mtgs/july2006/rtennant_written.pdf.

“One of the best things about

EPCS is the electronic record

keeping.”

Alec S. Kloman, MD

Green Mountain Neurology, Inc.; Chief, Division of Neurology & Stroke Program Director at Berkshire Medical Center; Associate Professor of Neurology at UMass Medical School

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© 2012 Emdeon Business Services LLC. All rights reserved. EMDA1040184 rev 2.12

Emdeon is a leading provider of revenue and payment cycle management and clinical information exchange solutions, connecting payers, providers and patients in the U.S. healthcare system. To learn more, visit our website at www.emdeon.com.

3055 Lebanon Pike, Suite 1000

Nashville, TN 37214 USA

877.EMDEON.6 (877.363.3666)

Benefits of EPCS (continued)

Prescription drug abusers often end up in emergency departments, with some one million visits in 2009 attributable to prescription drug abuse, according to the latest data available.(20)

ePrescribing of controlled substances offers potential solutions to this growing and deadly epidemic by:

EPCS designed to be more secure than paper.ePrescribing of controlled substances is far more secure than today’s paper world, in which prescription pads are stolen, home computers easily can print out counterfeit prescriptions, signatures can be easily forged and drug quantities can be altered manually by patients before prescriptions are delivered to the pharmacy.(21)

In contrast, EPCS removes the “paper” from the hands of patients, which eliminates the opportunity for them to create bogus prescriptions for controlled substances or alter genuine ones. “Until we had EPCS, we had several instances per year where clients forged prescriptions or changed genuine, paper prescriptions,” explains Dr. Michaels, whose Center provides substance abuse and mental health services. “We had none during the year we participated in the EPCS pilot. It was a very quiet year.” Physicians and pharmacies must be credentialed and approved before they can participate in the ePrescribing process. They also must securely log on before they can create, send or receive an EPCS prescription.

EPCS helps control prescription drug abuse.ePrescribing of controlled substances can help providers recognize abuse through refill request monitoring, identification of multiple prescriptions of controlled substances by different providers for the same patient as indicated in the medication history. Through EPCS, they also can ensure that dosing instructions (Sig) are clear and correct.

EPCS helps eliminate “doctor shopping.”Paper-based prescriptions currently offer a major avenue for substance abuse and illegal drug diversion, including doctor shopping. Since ePrescribing does not require the patient to deliver the prescription to the pharmacy, there is no opportunity for abuse or diversion by the patient. EPCS can, therefore, help to quickly identify patients who doctor shop and garner multiple prescriptions for controlled substances. Through the medication history that is provided through the ePrescription process, physicians can see the history of which physicians have prescribed controlled substances for the patient, and where prescriptions have been filled—whether in the pharmacy next door, a nearby locality and States across the country. Patterns of doctor shopping and substance abuse become readily apparent. In addition, many States are looking at enhancing Prescription Monitoring Programs that can be tied into the electronic prescribing process to identify and report potential abuse and diversion prior to dispensing.

Ready to embrace EPCS?

There are a number of actions physicians can take to determine their readiness for adoption of EPCS systems and their use. Here are some examples: • Review your technology acquisition plans, whether for ePrescribing systems or electronic health records with ePrescribing capabilities. See where EPCS

fits in with potential purchasing decisions.

• Follow up with your current ePrescribing vendor to determine their readiness for EPCS and go-live timeline • Ask your local pharmacists how they plan to support their customers by offering EPCS as a benefit to improving care

• Ask vendors about their identity proofing process, and what is required to meet State and DEA requirements. Ask for assistance if need be. • Ask about training. Many vendors offer on-site training to help ease the transition of EPCS into the office work flow.

• Encourage the wider-spread adoption of EPCS in your locality by talking to State associations, State authorities for controlled substances and State legislators

(20)

National Institute on Drug Abuse. Trends In Prescription Drug Abuse. Accessed at http://drugabuse.gov/ResearchReports/Prescription/prescription5.html.

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