View From the Hill: The Administration Takes a Step Forward on E-Prescribing


May / June 2005

View From the Hill

The Administration Takes a Step Forward on E-Prescribing

Many industry observers believe that electronic prescribing (e-prescribing) is one of the key steps for reaching our president’s 2004 goal of “most Americans having an electronic health record within the next decade.” Congress also shares this goal that electronic prescribing is very important to patient safety and quality healthcare and included specific legislative provisions in the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) on this topic. One provision in this legislation asked the Centers for Medicare and Medicaid Services (CMS) to adopt regulatory standards for an electronic prescription drug program under Title I of the MMA.

In order for the administration to issue e-prescribing regulatory standards, it is required to go through an official government process to ensure that all interested stakeholders have an opportunity to comment on the proposed regulation. This review began when the federal government issued a Proposed Notice for Rule-Making where everybody has an opportunity to provide official comments back to the administration on their proposed new regulation. A request was issued by the administration for comments on its proposed new e-prescribing standards with input due by April 5, 2005.

So what did the administration propose in its first e-prescribing rule? First, the rule stated that these proposed standards would be the Foundation Standards or the first set of final uniform standards for an electronic prescription drug program under the MMA, and represent the first step in an incremental approach to adopting final uniform standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care.

It should be noted that Section 1860D—4(e) of MMA specified that initial standards, which are to be used in a pilot project that is to be conducted in calendar year 2006, must be adopted not later than September 1, 2005. However, pilot testing is not required for those standards for which the secretary of the Department of Health & Human Services (HHS), after consultation with affected standard-setting organizations and industry users, determines there is “adequate industry experience.” However, the secretary is required to provide a report to the Congress on its findings not later than April 1, 2007.

Final e-prescribing standards may be adopted by the secretary as a result of the pilot project. However, if the secretary, after consultations with stakeholders, determines that pilot testing is not required because there is adequate industry experience with the proposed standards, those standards may be adopted as final without pilot testing.

Early Concerns
Because many believe that e-prescribing is one of the integral steps to achieving broad deployment of electronic health records (EHRs), there was much interest in this proposed e-prescribing rule. However, some in industry identified several concerns with this proposed rule that I thought I would share with you. (To read a complete review of the proposed new regulation, please go to: Most significantly, some felt that the Foundation Standards identified in the proposed e-prescribing rule may not be adequately tested, and some have recommended a pilot program to determine understanding and use of the Foundation Standards in real-world settings. Also, the proposed standards allow so many options that a system may be perfectly compliant in the standard, but not capable of supporting Part D e-prescribing, let alone a uniform means of conducting e-prescribing.

Another concern raised with the proposed new regulation was that the proposed National Provider Identifier (NPI) has two essential limitations that need to be addressed by both the government and industry. First, NPIs will enumerate legal entities, but it may be more useful to identify physical locations in e-prescribing systems and processing. And second, the National Council for Prescription Drug Programs’ Provider Identifier Number enumerates the dispenser’s physical location, but a broader consideration of healthcare location enumeration may be warranted.

Finally, I thought that it is important to note that there has been public discussion recently that CMS is considering exemptions for the Anti Kickback Act and Stark Regulations for healthcare information technology (HIT) efforts between various entities. There has also been discussion with both the administration and the Congress on the need for establishing a Standards and Policy Entity that would provide the means of assessing the need for safe harbors as information-sharing networks are created, especially in meeting the needs of rural and underserved communities. In order to be successful, CMS must work closely with the Office of the National Coordinator for Health Information Technology to continue to move the process for the Standards and Policy Entity into an implementation phase of development.

Patient safety and quality healthcare have truly caught policy-makers’ attention in Washington, D.C. This proposed e-prescribing rule is another step down the long road to making the electronic health record a reality.

Dave Roberts ( is HIMSS director of public policy. Formerly a professional staff member for both the U.S. House Appropriations Committee and the U.S. Senate Health Subcommittee on the Handicapped, and a civilian financial analyst for the U.S. Air Force, Roberts now resides with his family in Solana Beach, California, where he is an elected member of the City Council and maintains a HIMSS office in Alexandria, Virginia.