April 26, 2010

E-Prescribing Standards — More Clarity Needed
By Lindsey Getz
For The Record
Vol. 22 No. 8 P. 14

Experts say the lack of concise standards numbers chief among the issues confronting users who want to meet meaningful use requirements.

Along with EHR technology, e-prescribing, by most accounts, will be one of the most prominent tools at a provider's disposal as healthcare moves headlong into the digital age. In fact, the adoption of standards to help aid the e-prescribing process is part of the government's agenda in accelerating EHR adoption.

As part of that plan, the Medicare Modernization Act (MMA) created a new voluntary prescription drug benefit under Medicare Part D. And although e-prescribing will remain optional for pharmacies and physicians, the provision will require drug plans participating in the new prescription benefit to support e-prescribing. Those prescriptions and correlated information will need to comply with a set of uniform standards.

As the number of e-prescriber users grows, so does the need for a set of regulatory standards, something for which e-prescribing proponents have been backing for quite some time. A handful of foundational standards developed by the Centers for Medicare & Medicaid Services (CMS) became effective January 1, 2006. Then the MMA required the CMS to implement pilot programs to test additional standards. In June 2006, the CMS suggested the adoption of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard version 8.1—used between pharmacies and physicians—on a voluntary basis. Following the results of the pilot test, a final e-prescribing rule was published in April 2008. The standards that were recommended and approved for adoption include formulary and benefits information, exchange of medication history, and fill status notification.

Confusion Abounds
Despite the movement toward improved standards, adoption rates have remained low. However, government mandates and incentives appear to be making significant headway. In the “2009 National Progress Report on E-Prescribing,” Surescripts, which operates the country's largest e-prescribing network, reports that 18% of the prescriptions eligible for inclusion in the e-prescribing process were sent electronically, nearly three times that of 2008.

There are still many roadblocks in the way of more widespread adoption, perhaps the most significant being the confusion that continues to surround the process. Though there's been some argument that the existing standards are too lenient, the biggest problem currently seems to be a lack of understanding about what's expected of participating parties. To be eligible for the government incentives available for adopting EHRs, providers need to participate in the e-prescribing process. However, there are only a few requirements for this process, and they aren't clearly quantified yet, says Libby Sagara of Manatt Health Solutions, which is working with the California E-Prescribing Consortium. “Many providers aren't completely clear on how they're being measured and so they're participating in e-prescribing and just hoping they'll hit the mark and meet the criteria of meaningful use. There's still a lack of clarity,” she notes.

That need for clarity is felt on the pharmacy side as well, says John Klimek, RPh, vice president of industry IT for the NCPDP and chair of the Standards Charter Organization, who says standards need to be better defined to improve interoperability between physicians and pharmacists. But it's a bit of a catch-22. Being too lenient in what's required to meet the goals of meaningful use may prevent people from adopting standards quickly, says Klimek. However, at this early stage of adoption, enforcing too many rules and regulations may also impede the process as some stakeholders are still too unfamiliar with the technology.

According to Sagara, the California E-Prescribing Consortium is recommending that the CMS lower the aggressive threshold to encourage participation. They would like to see the percentage of prescriptions required to be delivered electronically either lowered or adjusted to measure threshold values as a group, acknowledging that although individual providers may not meet measures, they may still contribute to achieving these goals on an aggregated basis.

Adding to the uncertainty is the lack of a single messaging standard, says Todd Shores, senior manager with the healthcare providers practice at Deloitte Consulting.  While the first version of the SCRIPT standard was introduced more than a decade ago and has evolved to keep pace with technological and business changes, many of the standards’ early adopters have not followed suit. “Despite the rich capabilities available for prescriber-pharmacy interaction built into the current version of the standard, e-prescribing vendors are typically required to support only basic functionality to exchange transactions across the network,” he says. “As a result, much of the advanced functionality is available to a limited number of participants. Such disparity in functionality has resulted in inconsistent prescriber and pharmacy workflows or a 'least common denominator' approach that avoids the enhanced functionality all together.”

Shores adds that as new regulations and standards are developed, it is crucial that they include the primary business functions supported in the current release of the NCPDP SCRIPT standard. “Continued refinement and adoption of a single standard governing the messaging capabilities of EHR and e-prescribing software will be crucial to facilitating successful implementation of an enduring national EHR infrastructure,” he says.

In addition, a lack of CMS standards surrounding drug terminology and codified instruction standards contributes to confusion. Shores says this oversight can result in the use of proprietary information that can lead to errors in translating data between systems. “There is also an absence of standards for prior authorization approval messages from insurance companies, which causes cumbersome manual processes,” he continues. “Stakeholders will need to work closely with federal and state regulatory bodies to identify and encourage adoption of clear, concise standards for drug terminology, codified detailed medication instructions, prior authorization data exchange, and data transmission standards for other necessary information to support patient safety while preserving ease of use for end users.”

Additional Roadblocks
Clear and uniform standards will certainly help drive adoption rates, yet some say there are more important issues to address. “Besides [the development of] standards, there needs to be significant focus on addressing the implementation and operational issues which now plague e-prescribing,” says Glen Moy, a senior program officer with the California HealthCare Foundation's Better Chronic Disease Care program. “Otherwise, adoption of e-prescribing will be short-lived.”

While Moy agrees the standards will have an initial impact on adoption rates, he says any increase cannot sustain itself if other issues are not also addressed. “There's more to e-prescribing than simply generating the prescription and sending it to a pharmacy,” he says. “On the eligible provider side, it's a complex process involving health plans, pharmacy benefit managers, Surescripts, and chain and independent pharmacies. This process is not nearly as smooth as many believe, especially when it comes to the prescription renewal process, which many assert is where the greatest workflow efficiencies can be gained.”

Moy says the renewal process issues are due to the fact that benefit and medication history data are not always available in a timely manner and may also be of poor quality. “Because of data-matching issues,” he continues, “renewals are sent back to the practice via paper or fax, which perpetuates an inefficient paper-based process and causes all parties to maintain dual workflow. Unless these issues are addressed, the initial increased adoption rates will not be sustained because it's too difficult, inefficient, and expensive for all parties to live in dual worlds.”

Also creating these “dual worlds” is the fact that controlled substances cannot be included in the e-prescribing workflow due to Drug Enforcement Administration (DEA) regulations (see below). This amounts to up to 12% of all prescriptions. “Prescriptions for these drugs must be handwritten or printed, which creates a workflow challenge and reduces efficiency gains,” says Shores. “The DEA has proposed a rule change that would address the issue of submitting controlled substance prescriptions via e-prescribing, and there are many supporters of this change in the Senate. However, there is no clear timeline as to when this change may go into effect. The DEA is not a healthcare agency and has asked CMS to participate in the formulation of the final rule.”

In addition, the adoption of new technology, in general, continues to be an issue. It has been difficult for many providers to accept more in-depth standards when, until recently, they may have not even been on board with the technology. But with government incentives in place, including a stronger push toward EHR adoption, changes are in the works. That makes it even more important to develop a uniform set of standards that will help all parties embrace e-prescribing.

“Those that were operating under older versions [of standards] may have seen no reason to change, but part of that is because they may have never operated outside of the four walls of their facility,” says Klimek. “Now that we're seeing more people adopt EHRs, and along with that e-prescribing, they are beginning to communicate beyond the four walls of their facility. Now they have a need to accept new standards and there's a need for regulation that allows for advancement and creates structure for all entities to follow."

— Lindsey Getz is a freelance writer based in Royersford, Pa.