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Identity proofing is often a roadblock
In healthcare, the famous line from the movie, “Field of Dreams,” should be amended to “If you build it, they will eventually come.”
Consider the biosimilar pathway created in March 2010 that has yet to be exercised in the United States.
The same fate is facing the Drug Enforcement Agency’s (DEA) Interim Final Rule for Electronic Prescriptions for Controlled Substances (EPCS) that became effective on June 1, 2010.
After years of deliberation, the DEA established a federal regulatory framework that applies to Schedule II-V controlled substances and to retail pharmacies, but not to inpatient prescriptions. The regulations allow pharmacies, hospitals and practitioners to use modern technology for prescribing controlled substances, while maintaining the closed system of controls on controlled substances dispensing.
The DEA believes that EPCS could save up to $700 million annually.
“Fate” might sound a bit ominous, but it appears that while 40% of retail pharmacies are certified for EPCS and it is legal in 48 states, prescribing controlled substances electronically is moving slowly. While Arkansas and Montana are outliers, Vermont and Kansas do not allow Schedule II drugs to be prescribed electronically, according to the Office of Diversion Control.
“We need to enable both prescribers and providers to send and receive,” says David Yakimischak, executive vice president and general manager, Medication Network Services, Arlington, Va.-based Surescripts, a national health information clearinghouse facilitating electronic communications between healthcare providers. “Growth has been slow initially but will increase with critical mass.”
“The DEA wants to ensure that providers are ready to deal with electronic prescribing for controlled substances versus using pen and ink,” Yakimischak says. “There are different concerns associated with EPCS, such as digital crime and wire fraud-different animals than providers faced with paper prescriptions.These could present a new risk factor.”
Individual states can establish more stringent rules than the DEA recommends. For example, starting March 27, 2015, all prescriptions issued in New York State must be electronically transmitted, with certain limited restrictions, according to the state’s I-STOP law passed in 2013.
Yakimischak says that when the non-mandatory rule was first issued, it raised the bar in identity proofing for providers who must acquire signing credentials and need to use approved authentication technologies when prescribing electronically.
One of the biggest challenges for physicians in generating controlled substance prescriptions electronically is the need for rigorous identity proofing and authentication. EPCS necessitates some changes on the part of prescribers and pharmacies, including using systems certified and audited by third-party vendors and two-factor authentication modalities-one of the three is a password-identity proofing; registration and training.
Identity proofing is completed by a third-party that verifies prescribers are who they say they are, either face-to-face or remotely. Once achieved, prescribers receive a credential that authenticates each e-prescription (e-Rx) of a controlled substance.
The DEA requires that prescribers satisfy two out of three of the following to secure authentication and permission to electronically prescribe controlled substances: 1) something they know (knowledge factor); 2) something they have, such as a hard token, which can be a digital signature or a one-time password generator that is stored separately from the computer being accessed, such as in a PDA, cell phone, smart card or USB drive; and 3) something they are (biometric information).
Vendors such as DrFirst, a Rockville, Md.-based provider of electronic healthcare solutions for physicians and hospitals, have developed compliant systems that meet all of the DEA’s requirements as well as Surescripts’ strict certification processes.
Although Peter Kaufman, M.D., chief medical officer of DrFirst, says that approximately 90% of prescribers are able to complete the authentication process entirely online, Scott Kruger, M.D., a hematologist/oncologist with Virginia Oncology Associates, says that most doctors in Virginia, including himself, are not yet able to complete the authentication process due to older technology.
Virginia Oncology Associates is part of The U.S. Oncology Network, which McKesson Corporation acquired to create McKesson Specialty Health.
Dr. Kruger says that many computers in practitioners’ offices are older laptops that are not yet ready to accommodate the second password for authentication, including his own. As physicians move into phase 2 of meaningful use, he anticipates that many will update their computers and be able to achieve certification.
In addition, pharmacies have to be willing to accept prescriber authentication and complete their own according to standards.
Yakimischak says that some physicians are waiting until they need to send both controlled and non-controlled prescriptions before signing on to electronic prescribing to bundle them into one process.
Another challenge, Yakimischak says, is the work demand placed on electronic health record vendors to ensure quality and safety measures and to determine how controlled substances fit in.
“EPCS has not been a priority for e-Rx vendors to adjust their submissions to meet the standards due to other priorities, such as developing the new ICD-10 codes and helping clients achieve meaningful use,” says Edmund Pezalla, M.D., vice president and national medical director for pharmaceutical policy and strategy at Aetna.
Dr. Kaufman points out that prescribers are also focused on conforming to meaningful use and to National Council for Prescription Drug Programs’ SCRIPT Standard version 10.6 for e-prescribing. The latter, which also affects pharmacies, is a voluntary rule established by the Centers for Medicare and Medicaid Services in July 2010.
Although Dr. Kaufman says the industry has passed the tipping point, he believes that if more physicians signed on to e-prescribe controlled substances, more pharmacies would set themselves up to receive the prescriptions
On the other hand, he praises the pharmacies’ uptake, 50% of which are certified to use EPCS, including the three industry leaders-Walgreens, Rite-Aid and CVS. (Some states don’t allow CVS pharmacies to prescribe controlled substances, however.)
Initiating EPCS requires updating technology, educating prescribers and, most importantly, ensuring that both prescribers and pharmacies are certified to generate controlled substances electronically.
Many stakeholders, however, say the effort would be worth it.
“The e-Rx platform can be used for all prescriptions helping to make a complete medical record, and it also allows for enhanced auditing of prescriptions that is not easily possible with paper,” says Dr. Pezalla. “The impact of e-Rx makes the workflow on both the prescriber and the dispensing sides more consistent with the International Standards Organization (ISO). This way, our information matches with the information from ISO.”
He adds, “The dosage information built into the electronic medical record helps reduce the chance for errors and increases patient safety.”
Dr. Pezalla does not foresee EPCS contributing to abuse and overprescribing of controlled substances.
“Many states have introduced a registry of controlled substance prescriptions. The state’s database can be checked by any prescribing provider or dispensing pharmacy,” he says.
Dr. Kaufman attributes the advantages of EPCS to those accrued by e-Rx of non-controlled substances: eliminating mistakes emanating from illegible handwriting; checking for clinical alerts; and offering convenience for the patient, potentially leading to more compliance. He also points out that EPCS can automatically create an electronic record, link into a state’s prescription monitoring database to reveal multiple prescriptions from different doctors and create one workflow system.
Yakimischak says that EPCS ensures non-repudiation, in which anyone involved in the development, transmission, receipt or storage of an electronic prescription cannot deny participation in the process.
Mari Edlin is a freelance writer based in Sonoma, Calif.