Long-Awaited DEA Rule on Controlled Substances Could Boost E-Rx Rates

by Kate Ackerman, iHealthBeat Senior Editor

Last week, the Drug Enforcement Agency took a major step in alleviating what many see as a significant barrier to electronic prescribing adoption.

In some ways, the federal government has been sending health care providers contradictory messages when it comes to e-prescribing.

CMS has said e-prescribing can help prevent medication errors and adverse events, as well as reduce prescription drug costs. The Medicare Improvements for Patients and Providers Act of 2008 provides physicians who e-prescribe with a 2% increase in their Medicare payments in 2009 and 2010, a 1% increase in 2011 and 2012, and a 0.5% increase in 2013. Beginning in 2012, health care providers who do not e-prescribe will face penalties.

However, because of abuse and security concerns, federal regulations prohibit the use of e-prescribing for controlled substances. Those regulations have created a major hurdle in e-prescribing adoption.

Studies estimate that controlled substances account for 10% to 20% of all prescriptions. Because of the current federal regulations, health care providers who e-prescribe also have to maintain a paper-based system for controlled substances. Some physicians have delayed adoption of e-prescribing systems all together because of the inefficiency of maintaining two separate prescribing systems.

Jennifer Covich Bordenick, CEO of the eHealth Initiative, said, "The need for two separate processes has undermined the overall adoption of electronic prescribing. A paper process may be less efficient and more time consuming, but utilizing two different methods is even more cumbersome."

On March 31, DEA published in the Federal Register a long-awaited Interim Final Rule that would allow the electronic prescribing of controlled substances. The IFR comes nearly two years after DEA published a Notice of Proposed Rulemaking on e-prescribing of controlled substances. DEA received more than 200 comments on its June 2008 NPRM, as well as several letters from lawmakers that urged the agency to take swift action.

DEA's action wasn't exactly swift, but e-prescribing advocates generally are lauding the new IFR as a critical step in realizing the cost saving and quality benefits of e-prescribing.

Rule Details

According to DEA, the new regulations "are in addition to, not a replacement of, the existing rules."

The IFR states, "The regulations will provide pharmacies, hospitals and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the close system of controls on controlled substances dispensing."

Numerous stakeholders took issue with the two-factor authentication requirement included in DEA's June 2008 NPRM. The new IFR maintains the two-factor authentication requirement but expands the options for authenticating the identity of the e-prescriber to allow the use of biometric identifiers, such as fingerprints or iris scans. Under the IFR, e-prescribers must prove their identities using two of the three following factors:

  • Something you know, such as a password or response to a challenge question;
  • Something you have, such as a hard token or device separate from the computer; or
  • Something you are, such as biometric data.

In a blog post, John Halamka -- CIO of Beth Israel Deaconess Medical Center and Harvard Medical School; chair of the Health IT Standards Panel; and co-chair of the Health IT Standards Committee -- said, "Although there will be some burden/inconvenience imposed on clinicians through the use of two factor authentication, I believe it will ultimately save time."

Stakeholders also raised concerns about DEA's earlier identity proofing requirements. State pharmacy boards "generally objected to being asked to conduct identity proofing, asserting that they did not have the staff or resources to do so," according to the IFR. Meanwhile, some stakeholders expressed doubt that hospitals or law enforcement agencies would be willing to conduct the identity check, while others raised concerns about the cost of traveling to a third-party organization.

In response to those comments, DEA has revised its identify proofing requirements. According to the IFR, for individual private practice providers, "DEA will use existing certification authorities and similar credential service providers that have been approved by a Federal authority."

After a 60-day public comment period, the IFR allowing e-prescribing for controlled substances will take effect on June 1. 

However, because the rule has been classified as a "major rule," it is subject to congressional review and, therefore, its effective date could be pushed back.

Industry Reaction

In general, the health care industry, as well as policymakers and patient advocates, applauded DEA's IFR on e-prescribing of controlled substances.

Covich Bordenick said, "Overall I think the industry is excited that this is finally changing. There will be a transition period, but this is good news." She added, "Most importantly, it will improve patient safety by offering the consistency needed to spur adoption of e-prescribing across the board."

Harry Totonis, president and CEO of Surescripts, said, "The DEA's interim final rule attempts to balance the legitimate and important interests of law enforcement, private industry and the federal government while producing an approach that is secure, workable and scalable for physicians and other prescribers." He noted that although the requirements "may impose particular challenges for prescribers and pharmacies," he believes "the ruling will help encourage more physician offices to adopt e-prescribing technology."

In a statement, Sen. Sheldon Whitehouse (D-R.I.) said, "Allowing for electronic prescribing of controlled substances -- while maintaining rigorous controls to prevent illegal diversion and protect privacy -- is key to unleashing the vast cost saving and quality improvement potential of health information technology."

Halamka said, "I look forward to our controlled substance e-prescribing pilots. Ultimately, it will be a win/win/win for patients, providers and pharmacies."

Remaining Barriers

While most industry experts agree that allowing e-prescribing of controlled substances will remove a major barrier in e-prescribing adoption, other hurdles still remain.

Covich Bordenick said the remaining barriers to e-prescribing adoption include:

  • Financial burdens, including the cost of implementation, training and maintenance of e-prescribing systems;
  • Workflow changes and change management;
  • Continued needs for greater connectivity; and
  • The need for tools to adequately reconcile medication histories from multiple sources.

Totonis noted that while e-prescribing adoption has increased significantly in the past year, adoption gaps remain in the following areas:

  • Independently owned pharmacies;
  • State Medicaid programs; and
  • Small physician practices.

to share your thoughts on this article.