November 11, 2013
For the third blog in our series about the Controlled Substance Epidemic and Crisis, I’d like to talk about Electronic Prescribing of Controlled Substances (EPCS) and its importance in the healthcare market and the controlled substances epidemic.
Electronic Prescribing for Controlled Substances is a concept that has been discussed for many years although it was not until the Drug Enforcement Agency published the IFR (Interim Final Rule) in June 2010 that EPCS became legal at the federal level. Given the relative youth of e-prescribing of legend drugs, as well as the ingenious and troublesome ways in which fraud, abuse, and diversion have grown so widely, the DEA deliberated for approximately 10 years before issuing the IFR.
Since the mission of the DEA as part of the Department of Justice is primarily law enforcement, it’s no surprise that the medical management of addictive diseases, behavioral health, and pain as well as the complex coordination with providers and health plans, has taken a back seat in that agency over the past decade. However, the growing epidemic and crisis of prescription drug abuse, particularly the opioid and other psychoactive classes outlined in the first installment of this series has catalyzed action from all stakeholders.
In addition, similar to the situation with PDMPs–that each state has the authority to create and modify PDMP rules—EPCS is likewise subject to state variation with the proviso that the DEA’s strict requirements must be satisfied first. In other words, very much similar to HIPAA and other federal rules, the DEA IFR is a “floor” whereupon each individual state may build additional regulatory structures as it sees fit for its citizens and their environment. These state regulations usually are promulgated by the Department of Public Health, a Board of Pharmacy, or a combination of such statutory agencies.
Currently, only nine states do not permit EPCS but in several, legislation is pending and the status is unclear in a few states. Five states allow only Schedules III – V. The map s below illustrates this and it is changing from month to month.
New York is a special case due to the passage of the Internet System for Tracking Over-Prescribing Act (I-STOP) law passed in 2012, which mandates EPCS by March 27, 2015. I suspect other states will be considering this approach in the near future, depending on their own particular environment.
The single greatest benefit of EPCS to clinical prescribers is the ability to send all drugs electronically and have a single application that creates, manages, and stores every Rx, with detailed verification and safety checks at every step. Eliminating paper prescriptions entirely will also be a significant benefit for almost every stakeholder including pharmacists, drug companies, health plans, law enforcement agencies, and patients. However, EPCS places new responsibilities on EHR vendors, prescribers and pharmacies in terms of “Identity Proofing,” two factor authentication (e.g. using hard tokens such as those with one time passwords) and more robust audit trails as well as strict auditing procedures. In addition, to utilize Surescripts, the most widely accepted eRx network, there are other steps to their own certification. There are 14 vendors currently on the SureScripts EPCS certified list and DrFirst was the original member of this select group to actually send controlled substance scripts electronically.
Finally, despite the growing numbers of states passing EPCS enabling legislation, not all states have “turned on” their pharmacies, as this is a complex process involving both state regulatory agencies and individual as well as proprietary considerations with each and every pharmacy. The map below represents a recent status overview of the EPCS enabled Pharmacy distribution:
The next six to twelve months — looking ahead:
Since there are many competing priorities in healthcare clinical IT programs over the next year, e.g. managing costs, EHR adoption/upgrades, ICD-10 integration, ACO analytics, HIPAA/HITECH increased exposure and penalties, I suspect that EPCS rollouts will continue adoption at a slow to modest pace. The primary beneficiaries and thus early adopters are likely to be those who are high-volume controlled substance prescribers. These may include psychiatrists, pain management specialties, addiction specialists, oncologists, “end-of-life care” specialists, pediatricians who see large numbers of ADHD patients, selected surgeons who prescribe post-operative opioid analgesics and other physicians and “eligible prescribers” who must use controlled substances frequently to treat legitimate, relevant clinical disorders.
Their initial experience on how EPCS affects patient care and workflow will determine the speed of adoption among the remaining clinical community.
The next installment is: 4. Which one is more important…PDMP versus EPCS?