Doctors May Now Electronically Prescribe Schedule II Drugs
In May of this year, physicians across the country received the letter many have been waiting for—a letter from the Drug Enforcement Agency stating that as of June 1, 2010 all Federal restrictions against the use of electronic prescribing for controlled substances (Schedule II – Schedule V) would be lifted. Even though we witnessed a 181% increase in the use of e-prescribing nationwide from 2008 to 2009, the DEA’s outright ban on e-prescribing for controlled substances has been the last great barrier to electronic prescribing adoption over the last 10 years.
Although this notification was received by our country’s doctors with open arms, there were still countless questions left unanswered. What took so long to get this law lifted? Now that this is “legal,” is it “possible?” What do I need to do to ensure that I am ready to e-prescribe controlled substances as soon as possible?
Easing the minds of some skeptical physicians and reinforcing the DEA’s most recent announcement, Thursday, June 3, 2010 marked the beginning of a new era in e-prescribing with a public demonstration of the nation’s first end-to-end electronic controlled substance prescribing system at the 2010 AHRQ Annual Health IT Grantee and Contractor meeting in Washington, DC. This innovative pilot system has been operational in Berkshire County, Massachusetts since September 14, 2009 under the auspices and guidance of the Massachusetts Department of Public Health—the Principal Investigator for this AHRQ grant. Dr. Tom Sullivan, Chief Strategic Officer at DrFirst, conducted the demonstration to show the success of this pilot program and to present the culmination of years of hard work and perseverance from the many organizations involved.
History of Electronic Prescribing
Before diving into detail about this pilot program and the technological innovations that it spawned, it is important to understand the history of electronic prescribing and exactly why this issue was so pressing for so many people.
Over the past several years, doctors, payors, and patients have all begun to realize the patient safety, efficiency and financial benefits of adopting an electronic system for routing prescriptions to the pharmacy and for handling renewal and refill requests as they come in from the pharmacy. Renewals handled through e-prescribing systems drastically reduce phone calls and faxes by transforming this extremely time-consuming process into only a few clicks on their computer thus saving office staff hours every day otherwise spent handling phone calls and faxes from pharmacies. Additionally, modern systems are capable of checking a patient’s insurance information at the point of care to prevent them from paying an unnecessary cost at the pharmacy (and eliminating additional phone calls and faxes) as well as prevent countless adverse drug reactions.
To further catalyze the adoption of e-prescribing, Medicare implemented an incentive program in 2009 to provide financial reimbursements for those physicians that accurately documented their use of an e-prescribing system for their Medicare patients.
With these benefits driving the adoption of e-prescribing on a national level, the DEA’s ban on using this technology for controlled substances prevented a large segment of the market from being eligible to benefit. To provide a sense of scope to this market, controlled substances make up roughly 11% of all prescriptions written and controlled-substance prescriptions are written by roughly 90% of all providers. To make matters worse, some specialties such as pain management physicians write primarily controlled substance prescriptions. With this said, it is evident that this ban creates a problem for a majority of providers that wished to use an electronic system. The inability to sign and send a controlled drug electronically created the need for a provider to implement two office workflows: one for the controlled substances that must be dealt with by hand and one for all other electronic prescriptions. This inconsistency in workflow ultimately negated the benefits of electronic prescribing as a whole.
Until recently, the Drug Enforcement Agency had placed an outright ban on using this helpful technology for controlled substance prescribing fearing that the systems in place were not secure enough to be trusted with highly abused and addictive medications.
Industry leaders were aware that this absence of approved standards directly contributed to the delay in realizing the potential patient safety, risk reduction and clinical benefits that are made possible through the use of e-prescribing. It was known that in order for e-prescribing and healthcare IT as a whole to become the norm there must be a cooperative agreement between vendors, users, and the DEA to permit the e-prescribing of controlled substances. What everyone needed was a solution to this problem that would enable them to reap the benefits of an electronic system without slowing down their entire office.
The EPCS Project: Birth of ePrescribing
Following talks at a 2006 symposium held by the DEA, the spark was lit when industry leaders, including DrFirst, met with the DEA to discuss a safe and measureable way to enhance the security and accountability of the existing e-prescribing infrastructure to overcome the DEA’s concerns. This critical meeting and several that followed eventually led to a proposal from the Massachusetts Department of Public Health, DrFirst, BrandeisUniversity and Berkshire Health Systems. This Electronic Prescribing of Controlled Substances (EPCS) pilot program was funded by the Agency for Healthcare Research and Quality (AHRQ) and granted a waiver by the DEA to electronically sign and transmit controlled substance prescriptions.
The DEA identified a set of security concerns that had to be addressed by the solution created by the EPCS. The first and most pressing of these issues was authentication. It was imperative to have the ability to positively identify the signer of any prescription and to be able to correctly identify those that either send or receive all controlled substance prescription data. Non-repudiation was another concern as the system would have to ensure that any and all parties involved in a prescribing activity could not reasonably deny their participation. The DEA also stressed the need for a high level of record integrity to ensure that the prescription’s data and signature have not been tampered with or altered after the prescription has been signed. Due to the potential legal ramifications of this pilot program and the DEA’s concern with drug abuse, all systems in place had to have the legal sufficiency for the DEA to successfully prosecute if a misuse occurred—remember that the “E” in DEA stands for “Enforcement.” The DEA’s requirements were designed to prevent diversion to the maximum extent possible and to allow successful criminal investigation and prosecution of any diversion that does occur. The final DEA requirement was for all information to be confidential. Only authorized persons were allowed to have access to any of the data from the EPCS project.