Psychiatric News August 19, 2005
Volume 40 Number 16
© 2005 American Psychiatric Association
p. 6
APA Warns of Dangers In Rush to E-Prescribe
Mark Moran
Adoption of e-prescribing by the physician community will be fraught
with barriers unless CMS adopts a more cautious approach, according to APA
Medical Director James H. Scully Jr., M.D.
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
record keeping.
The regulations would establish standards for the following:
- Transactions between prescribers and dispensers for new prescriptions,
prescription refill requests and responses, prescription change requests and
responses, prescription cancellation requests and responses, and related
messaging and administrative transactions.
- Eligibility and benefit inquiries and responses between drug prescribers
and prescription drug plans.
- Eligibility and benefit inquiries and responses between dispensers and
sponsors of the new Medicare prescription drug benefit under Part D.
- Formulary and benefit coverage information, including information on the
availability of lower-cost, therapeutically appropriate alternative drugs, if
certain characteristics are met.
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
prescribing choices.
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
e-prescribing compliance....
"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:
- Work with the Office of the Inspector General to draft a new "safe
harbor" regulation for physicians to accept nonmonetary assistance
freely to implement their e-prescribing infrastructure and to establish an
effective temporary exemption from prosecution under the "Stark
II" federal law. (That law regulates transactions between physicians and
various other designated health services and entities).
- Establish clear policies prohibiting design bias in software and hardware
for e-prescribing systems, as well as for streaming commercials and other
superfluous information into e-prescribing systems.
- Adopt proposed standards as initial, rather than final, to determine their
functionality and interoperability and pilot test all initial standards,
preferably using several technology systems for comparative data.
- Move the effective date for e-prescribing rules to the end of 2007 to ease
the burden of the transition into Medicare Part D of those beneficiaries who
are "dually eligible" for Medicare and Medicaid. This will provide
more time to issue national prescriber identifier numbers for physicians to
obtain and implement grants and to finalize new laws protecting physicians
from prosecution for accepting assistance with e-prescribing systems.
The CMS standards are posted online at
<www.cms.hhs.gov/medicarereform/E-Prescribing.pdf>.
The text of APA's comments to CMS is posted at
<www.psych.org/members/advocacy_policy/reg_comments/APACommentsERxg.pdf>.
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