Federal standards for electronic prescribing (e-prescribing) proposed by
the Centers for Medicare and Medicaid Services (CMS) must be pilot tested
first, APA informed CMS Administrator Mark McClellan, M.D., M.P.H., in a
recent letter. Further, the deadline for compliance with the standards should
be moved from January 1, 2006, to the end of 2007.
Those are just a two of the recommendations expressed in a lengthy comment
letter signed by APA Medical Director James H. Scully, M.D., regarding the
agency's proposed final standards for e-prescribing.
The proposed e-prescribing regulations, issued at the beginning of the
year, are intended to hasten the adoption of e-prescribing by physicians. The
effort is part of a global effort to move medicine toward electronic medical
The regulations would establish standards for the following:
Under the Medicare Modernization Act of 2003 (MMA), the National Committee
on Vital and Health Statistics (NCVHS) was called upon to develop
recommendations to CMS for uniform standards for e-prescribing. From March to
September 2004, NCVHS heard testimony from 65 witnesses and industry experts
including all stakeholder groups identified in the MMA, as well as
e-prescribing networks, demonstration projects, software developers, and
consumer advocacy organizations.
The proposed e-prescribing foundation standards are based on the NCVHS's
recommendations to McClellan.
The letter from Scully outlined a series of concerns about the proposal
focused on protection of patient privacy, the need to minimize the cost burden
associated with acquiring technology for e-prescribing, development of
regulations to protect physicians who accept in-kind technological assistance
for e-prescribing, and policies to protect against manipulation of physician
All of these concerns found expression in Scully's request that CMS
reconsider the deadline for compliance and pilot test the standards in a
subgroup of physicians before adopting them as final standards.
"APA maintains that the goals and mission of effectuating widespread
adoption of e-prescribing with the physician community will be fraught with
barriers, unless CMS adopts a more judicious, cautious approach," Scully
wrote. "Pilot-testing of standards within their actual context of usage
is imperative, along with a more realistic, workable effective date for
"Only after evaluating the results of e-prescribing pilot projects
using different systems across a spectrum of clinical settings will it be
feasible to determine precisely which standards, process areas, or
technologies require adjustment. It will take some time to discover how to
perfect these systems, and CMS must not foreshorten this process or it will
prove ultimately to be at the expense of patients."
Specifically, APA urges CMS to take these actions: