September 2, 2004

The Honorable Tommy G. Thompson
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Thompson:

The National Committee on Vital and Health Statistics (NCVHS) has been
called upon by the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) to develop recommendations for uniform standards to enable
electronic prescribing (e-prescribing) in ambulatory care. E-prescribing should
enable significant improvements in patient safety, quality of care, and cost
effectiveness. Standards for e-prescribing must not only meet the requirements
of MMA but must also be compatible with all other standards that are becoming
part of the National Health Information Infrastructure (NHII). This includes
standards developed under the Health Insurance Portability and Accountability
Act of 1996 (HIPAA) and the Consolidated Health Informatics Initiative (CHI).

In order to expedite the development, implementation, and pilot testing of
e-prescribing standards by the Department of Health and Human Services (HHS),
NCVHS is providing this first set of recommendations. Additional
recommendations will be sent in March 2005.

Current Prescribing Environment

Today, prescribers (physicians and others who write prescriptions) make
their drug-prescribing decisions using whatever medical, medication, and
eligibility information is known or available to them. Typically they give a
handwritten prescription to the patient or fax it to the dispenser
(patient’s pharmacy of choice). At the dispenser, tasks are somewhat more
automated. Through internal and external electronic claims, eligibility, and
benefits verification processes, the dispensing pharmacist may identify
contraindications, lower cost alternatives, or the need for prior
authorization. At any of the steps in the process, the dispenser may need to
contact the prescriber by phone for clarification or approval of changes.
Dispensers also must frequently call the prescriber to obtain approval for
refills or renewals where they are not specified on the prescription or when
they have run out. According to some estimates, almost 30 percent of the 3
billion prescriptions written annually [1] require dispenser calls. [2] This equals 900 million prescription-related telephone calls

Many reports have identified that the current prescribing process is prone
to errors. Prescribers may not have access to the latest drug knowledge. They
often do not have a complete or accurate medication list or even medical
history for their patient, and, as a result, they can miss potential
contraindications or duplicate therapies. Dispensers often have difficulty
reading handwritten prescriptions and frequently have little or no information
about the patient’s condition for which the prescription is written.
Contacting the prescriber by phone to clarify what is ordered and to make
changes often results in delays for the patient, and it is time-consuming for
both the prescriber and the dispenser. There are disconnects between the
prescriber and patient in the medication process, with little or no feedback to
the prescriber on whether a prescription was filled or what generic
substitutions were made. Every year, more than 8 million Americans experience
outpatient adverse drug events (ADEs). Analysis shows that e-prescribing
systems can avoid more than 2 million ADEs annually, of which 130,000 are
life-threatening. [3]

Current E-Prescribing Capabilities

E-prescribing has the capability of addressing many of these issues. The
eHealth Initiative provided a helpful framework to conceptualize e-prescribing
systems. [4] It describes
graduated levels of functionality, producing differing sets of benefits. Today,
various levels of e-prescribing systems are being implemented. [5]   However, the lack of e-prescribing
standards has forced the industry to use workarounds to accomplish many aspects
of e-prescribing. The following describes levels of e-prescribing systems
derived from the eHealth Initiative framework and the extent of their use

  • Basic Reference Information. E-prescribing reference tools provide
    basic drug information, dosing calculation, and formulary information. Recent
    estimates suggest that about 15 percent to 17 percent of prescribers use such
    systems. [6] These systems may
    prevent errors by making appropriate reference information readily available.
    While there are several formulary reference products on the market, their
    content and format are not standardized. Some community projects have attempted
    to map the various formulary products to one another.
  • Standalone Prescription Writers. These e-prescribing applications
    produce a legible prescription and include dosage information. They do not
    provide access to any patient-specific information or connectivity with
  • Integrated E-Prescribing Systems. These systems are more
    sophisticated in several ways: Some products combine patient demographics,
    allergy, formulary, and plan information. Others can assist in medication
    management. Still others may connect the prescriber with the dispenser to
    transmit a prescription. To obtain patient demographics and allergy
    information, the products depend on either linking to a practice management
    system (PMS) or the re-entry of data. To receive formulary and plan
    information, prescribers may connect with third-party information exchange
    networks that integrate medication history and/or eligibility information from
    pharmacy benefits managers (PBMs). To route e-prescriptions to dispensers,
    prescribers often use electronic fax, which requires re-entry of the
    prescription information by the dispenser. Some prescribers with electronic
    data interchange (EDI) capability are routing prescriptions through a switching
    network. The National Council for Prescription Drug Programs (NCPDP) has
    developed a standard (SCRIPT) for communications between prescribers and
    dispensers. NCPDP estimates that 75 percent of pharmacies have the capability
    to receive messages using the SCRIPT Standard. However, fewer than 3 percent of
    all prescriptions are written by prescribers using an integrated e-prescribing
    system. [7]
  • Electronic Health Record Systems with E-Prescribing. Still further
    enhancements to quality and patient safety can be achieved by integrating the
    medication order into the overall process of medical care delivery. This level
    of e-prescribing requires an electronic health record (EHR) that integrates
    data from multiple sources, is used at the point of care, and provides
    evidence-based clinical decision support. EHR systems are deployed at an
    estimated 14 to 28 percent of practices. [8] It is unknown how many of these are comprehensive EHR
    systems and how many utilize standard industry protocols.

Standards Evaluation Process

Charged with the task of recommending standards for e-prescribing to promote
patient safety and quality health care, NCVHS scheduled testimony in 2004 to

  • Which standards are needed to support e-prescribing
  • How MMA requirements are supported or not supported by current standards
    (i.e., standards gaps and limitations)
  • What related issues exist that may affect the implementation or acceptance
    of e-prescribing

After this information was gathered, NCVHS then reviewed the standards gaps
and limitations with the standards developers. This dialogue helped NCVHS
determine what standards have adequate industry acceptance and what actions are
necessary to address gaps and limitations in standards for them to be available
for the MMA demonstration projects beginning January 2006. See Appendix A for
the NCVHS work plan.

The MMA provides that pilot testing of standards is not required where there
already is adequate industry experience with the standards. At the July 21,
2004, Health Information Technology Summit, HHS announced its intent to
accelerate the implementation of e-prescribing by proposing an initial set of
well-established standards for implementation by January 2006, when the
Medicare Part D benefit begins. Standards appropriate for inclusion in this
initial set are identified in the NCVHS recommendations below as
“foundation standards.”

Stakeholder Testimony

NCVHS received testimony from all stakeholder groups identified in the MMA
(i.e., standards setting organizations, practicing physicians, hospitals,
pharmacies, practicing pharmacists, pharmacy benefit managers, state boards of
pharmacy, state boards of medicine, experts on e-prescribing, other appropriate
Federal agencies). In addition, testimony was heard from e-prescribing
networks, demonstration projects, software developers, and consumer advocacy
organizations. (See Appendix B for list of testifiers.) In over 11 days of
deliberations from March to September 2004, NCVHS heard from 65 testifiers and
other industry experts.

Guiding Principles for Selecting Standards

In making its recommendations, NCVHS utilized the guiding principles and
requirements identified in the MMA for selecting e-prescribing standards [9] :

  • Improve patient safety
  • Improve quality of care
  • Improve efficiency (including cost savings)
  • Not present an undue administrative burden on prescribers and dispensers
  • Be compatible with other standards
  • Permit electronic exchange of drug labeling and drug listing information
    maintained by the Food and Drug Administration (FDA) and the National Library
    of Medicine (NLM)
  • Include quality assurance measures and systems
  • Permit patient designation of dispensing pharmacy
  • Comply with HIPAA Privacy regulations
  • Support interactive and real-time transactions

In addition, NCVHS believes the standards should be vendor neutral and
technology independent, preferably be developed by standards development
organizations accredited by the American National Standards Institute (ANSI),
and have suitable indications of market acceptance.

Types of Standards and Important Related Issues

There are three types of e-prescribing standards that NCVHS identified and
evaluated as being necessary to support e-prescribing. They are: message
format standards
that provide communication protocols and data content
requirements (including those to support medication decision making),
terminologies to ensure data comparability and interoperability, and
identifiers for all relevant entities within the e-prescribing process.

NCVHS notes there are privacy considerations uniquely related to
e-prescribing, which will be investigated in subsequent hearings and reflected
in the March 2005 recommendations.

NCVHS further observed that deployment of e-prescribing may involve policy
or workflow issues that are outside the scope of standards but are important
related issues

Observations and Recommended Actions

NCVHS observes that the U.S. healthcare system has made considerable
progress in developing pragmatic solutions for e-prescribing. These solutions
provide an excellent foundation to build upon. The status of each e-prescribing
standard evaluated is described in detail in the working document in Appendix

Following is a list of observations and associated recommended actions. The
observations describe the purpose and extent of industry experience regarding a
standard or issue. The recommended actions under each observation recognize
first any foundation standards, then the actions to address additions,
development, and pilot testing necessary to meet the MMA requirements. While
foundation standards do not in themselves need to be pilot tested, they do need
to be tested with the expanded functionality required by MMA. The observations
and recommended actions are grouped as follows: general overarching items,
message format standards, terminologies, identifiers, and important related

Observation 1 (General Standards Compatibility): Many testifiers
emphasized to NCVHS how important it is that e-prescribing standards be
compatible with all HIPAA standards, CHI standards, and the clinical data
terminologies recommended by NCVHS in November 2003. This is to avoid dual
standards for Medicare Part D and all others. The testifiers’ observations
are consistent with the MMA requirements that e-prescribing standards should be
compatible with HIPAA standards and “general health information technology

Recommended Action 1.1: HHS should ensure that e-prescribing
standards are not only appropriate for Medicare Part D but also for all types
of prescribers, dispensers, and public and private sector payers.

Recommended Action 1.2: HHS should ensure that e-prescribing
standards are compatible with those adopted as HIPAA and CHI standards, and
with those recommended in November 2003 by NCVHS for clinical data

Observation 2 (General Standards Versioning): There are lessons
learned from HIPAA regarding both the value of standards and the need for
flexibility to respond to industry requirements and technology changes. There
are a number of approaches that could be considered to provide the industry
greater flexibility and ability to advance, while maintaining standardization
of messages and data. For example, the CHI has set precedence for this through
adopting a version of its clinical information standards as a baseline, from
which new versions may be adopted by the industry when ready; although this
process is different from the process required for standards adopted under

Recommended Action 2.1: HHS should work with the industry in its
rulemaking process to determine how best to afford flexibility in keeping
standards in pace with the industry, including standards for HIPAA and
e-prescribing. For example, HHS might consider recognizing new versions of
standards, without a separate regulation, if they are backward

Observation 3 (Prescription Messages):  The NCPDP SCRIPT
Standard provides for the exchange of new prescriptions, changes, renewals,
cancellations, and fill status notifications. Each function has varying degrees
of industry experience. The NCPDP SCRIPT new prescription function is most
widely used. The renewal function has good industry acceptance, represents an
easy transition, and provides the most immediately apparent return on
investment. The NCPDP SCRIPT Standard cancellation and change functions are
currently underutilized.

Testimony indicated that the fill status notification function is not used
today. Testimony also revealed that there were questions about the business
value and clinical utility of the fill status notification function, as well as
possible privacy issues.

The NCPDP SCRIPT Standard allows for both free text in certain fields and
choices of codes. It is critical to standardize on common, interoperable
terminologies to provide automated decision support required by portions of the
MMA that relate to patient safety and cost benefits. These items are
specifically addressed in later recommendations.

Recommended Action 3.1: HHS should recognize as a foundation standard
the most current version of NCPDP SCRIPT for new prescriptions, prescription
renewals, cancellations, and changes between prescribers and dispensers. The
NCPDP SCRIPT Standard would include its present code sets and various mailbox
and acknowledgement functions, as applicable.

Recommended Action 3.2: HHS should include the fill status
notification function of the NCPDP SCRIPT Standard in the 2006 pilot tests.
These pilot tests should assess the business value and clinical utility of the
fill status notification function, as well as evaluate privacy issues and
possible mitigation strategies.

Observation 4 (Coordination of Prescription Message Standards):
Health Level Seven (HL7) is commonly used to communicate medication orders
within a hospital and with clinical pharmacies within an enterprise.
Coordination of HL7 with NCPDP SCRIPT would result in functions being more
seamless across healthcare environments. This would remove a barrier to
adoption of electronic medication ordering and prescribing. HL7 and NCPDP have
already begun to map their standards that support common functions.

Recommended Action 4.1: HHS should financially support the
acceleration of coordination activities between HL7 and NCPDP for electronic
medication ordering and prescribing. HHS should also support ongoing
maintenance of the HL7 and NCPDP SCRIPT coordination.

Recommended Action 4.2: HHS should recognize the exchange of new
prescriptions, renewals, cancellations, changes, and fill status notification
within the same enterprise
as outside the scope of MMA e-prescribing standard

Recommended Action 4.3: HHS should require that any prescriber that
uses an HL7 message within an enterprise convert it to NCPDP SCRIPT if the
message is being transmitted to a dispenser outside of the enterprise. HHS also
should require that any retail pharmacy within an enterprise be able to receive
prescription transmittals via NCPDP SCRIPT from outside the enterprise.

Observation 5 (Formulary Messages): Formulary and benefit coverage
information, including information on the availability of lower cost,
therapeutically appropriate alternative drugs (if any), from payers/PBMs to
prescribers currently is communicated with proprietary messages. RxHub [11] has communicated its intent
to submit its proprietary Formulary and Benefit Information File Transfer
protocol to NCPDP to establish industry consensus and ensure the protections
for the industry afforded by becoming an ANSI-accredited standard. Development
of an ANSI-accredited standard appears to be possible in an accelerated
timeframe. This process will accommodate any specific requirements affecting
the implementation of Medicare’s new Part D prescription drug program.

Recommended Action 5.1: HHS should actively participate in and
support the rapid development of an NCPDP standard for formulary and benefit
information file transfer, using the RxHub protocol as a basis.

Recommended Action 5.2: NCVHS will closely monitor the progress of
NCPDP’s developing a standard for a formulary and benefit information file
transfer protocol, and provide advice to the Secretary in time for adoption as
a foundation standard and/or readiness for the 2006 pilot tests.

Observation 6 (Eligibility and Benefits Messages): Eligibility
inquiry and response are HIPAA transactions, and standards have been adopted
for their use in retail pharmacy and other sectors.  The HIPAA standard
for eligibility communications between retail pharmacy dispensers and
payers/PBMs is the NCPDP Telecommunication Standard. [12] The HIPAA standard for eligibility and
benefits communications between dentists, professionals, institutions, and
health plans is the Accredited Standards Committee (ASC) X12N 270/271. [13]   There is good
industry experience in using the ASC X12N 270/271 standard for general drug
benefit functions. ASC X12 has identified workarounds for some of the gaps in
ASC X12N 270/271 with respect to drug listings and step therapy. ASC X12
reports that version 4050 addresses some of these workarounds more directly,
and that version 5010 is under development and can more tightly address
industry needs for e-prescribing. Because Medicare’s Part D prescription
drug program is new, specific requirements are not known at this time and new
requirements may emerge.

Recommended Action 6.1: HHS should recognize the ASC X12N 270/271
Health Care Eligibility Inquiry and Response Standard Version 004010X092A1 as a
foundation standard for conducting eligibility inquiries from prescribers to

Recommended Action 6.2: HHS should support NCPDP’s efforts to create
a guidance document to map the pharmacy information on the Medicare Part D
Pharmacy ID Card to the appropriate fields on the ASC X12N 270/271 in further
support of its use in e-prescribing.

Recommended Action 6.3: HHS should work with ASC X12 to determine if
there are any requirements under MMA with respect to how situational data
elements are used in the ASC X12N 270/271, especially concerning the quality of
information needed for real-time drug benefits. Use of these situational data
elements could be addressed in trading partner agreements. Specifications of
use of situational data elements, as well as proper usage of the functional
acknowledgments, should be included in the 2006 pilot tests.

Recommended Action 6.4: HHS should ensure that the functionality of
the ASC X12N 270/271, as adopted under HIPAA, keeps pace with requirements for
e-prescribing and that new versions to the Standard be pilot tested.

Observation 7 (Prior Authorization Messages): Under HIPAA, claims,
eligibility, and benefits information between dispensers and payers/PBMs are
communicated using the NCPDP Telecommunication Standard. [14] The need for prior authorization for a
drug is identified between the payer/PBM and the dispenser through this
process. The formulary and benefit file transfer protocol being developed by
NCPDP provides information from the payer/PBM to the prescriber about the need
to obtain prior authorization of a drug. The NCPDP SCRIPT Standard may be used
between the dispenser and prescriber to communicate the prior authorization
approval for a drug. However, the request for a prior authorization for a drug
from the prescriber to the payer/PBM is now conducted in a manual mode. This is
due, in part, to the complexity of the decision making involved in ensuring
that the use of a drug considers cost, patient safety, special handling or
administration procedures, and other pre-authorization requirements. It is
estimated that 2 percent of prescriptions now require prior authorization, and
that there is a higher rate for Medicaid payers. This provides a natural body
of experience from which to draw data for study of economic and quality of care

The ASC X12N 278 [15] is a
HIPAA standard that provides for prior authorization inquiry and response in
general. It provides very limited support for prior authorization of drugs and
is not widely used.

Recommended Action 7.1: HHS should support ASC X12 in their efforts
to incorporate functionality for real-time prior authorization messages for
drugs in the ASC X12N 278 Health Care Services Review Standard Version
004010X094A1for use between the prescriber and payer/PBM.

Recommended Action 7.2: HHS should support standards development
organizations and other industry participants in developing prior authorization
work flow scenarios to contribute to the design of the 2006 pilot tests.

Recommended Action 7.3: HHS should evaluate the economic and quality
of care impacts of automating prior authorization communications between
dispensers and prescribers and between payers and prescribers in its 2006 pilot

Recommended Action 7.4: HHS should ensure that the functionality of
the ASC X12N 278, as adopted under HIPAA, keeps pace with requirements for
e-prescribing and that new versions to the Standard be pilot tested.

Observation 8 (Medication History Messages from Payer/PBM to
: The exchange of medication history may occur at multiple
points: among prescribers, between patients and prescribers, between payers and
prescribers, and between prescribers and dispensers. MMA indicates that
medication history should be provided to prescribers and dispensers but does
not explicitly identify the source(s) or actual intended use of the medication

Medication history from payers/PBMs to prescribers is currently communicated
primarily with proprietary messages. RxHub has communicated its intent to
submit its proprietary medication history message to NCPDP to establish
industry consensus and ensure the protection for the industry afforded by
becoming an ANSI-accredited standard. Development of an ANSI-accredited
standard for medication history messages between payers/PBMs and prescribers
appears to be possible in an accelerated timeframe.

The following recommended actions address only exchange of medication
history from payers/PBMs to prescribers. NCVHS plans to address other
medication history communications in its March 2005 recommendations.

Recommended Action 8.1: HHS should actively participate in and
support rapid development of an NCPDP standard for a medication history message
for communication from a payer/PBM to a prescriber, using the RxHub protocol as
a basis.

Recommended Action 8.2: NCVHS will closely monitor the progress of
NCPDP’s developing a standard medication history message for communication
from a payer/PBM to a prescriber, and provide advice to the Secretary in time
for adoption as a foundation standard and/or readiness for the 2006 pilot

Observation 9 (Clinical Drug Terminology): Today’s e-prescribing
systems support free text entry of a clinical drug and/or selection of a
clinical drug code from one of several proprietary terminology systems. A
standard terminology [16] for
clinical drugs facilitates automated drug utilization review (DUR) and decision
support for patient safety. It is also necessary for interoperability among
different e-prescribing systems. However, it is recognized that not every item
ordered by a prescription will always be included in a terminology (e.g.,
compounded drugs, devices, and supplies). This means that the ability to enter
free text in an e-prescribing system must be preserved.

The National Drug Code (NDC) is used by dispensers to identify packaged
drugs. However, NDC is not appropriate for use by prescribers in describing the
clinical drug. To address this need, the NLM has produced a clinical drug
terminology, RxNorm. [17]
RxNorm provides links from clinical drugs to their active ingredients, drug
components, and most related brand names. Preliminary analysis of the
prescriptions written by the Department of Defense (DOD) found that of the
1,000 most commonly written prescriptions, the NLM matched 974 to RxNorm
codes. [18] Fully
comprehensive RxNorm terminology for all marketed drug products, including
generics, repackaged products, and over-the-counter medications, will not be
available until structured product labels (SPL) [19] become available to the NLM from the FDA.
The RxNorm contains sufficient codes to be included in the 2006 pilot tests.
When the SPLs become available, it is the intent of the NLM to update the
repository of drug information on a daily basis (as the DailyMed).
Additionally, until the full set of brand names is included in RxNorm, some
“dispense as written” prescriptions cannot be accommodated through

NCVHS further observes that the FDA is looking to the Department of Veterans
Affairs (VA) National Drug File-Reference Terminology (NDF-RT) to provide drug
classifications for use in the SPL. In addition, the MMA directed HHS to
request the United States Pharmacopoeia (USP) to develop model guidelines for
drug categories and classes that the prescription drug program sponsors
participating in Medicare Part D can use in structuring their formularies.

NCVHS documented deficiencies in the NDC that must be overcome to support
many clinical applications, including e-prescribing, in its Report to the
Secretary on Uniform Standards for Patient Medical Record Information, dated
July 6, 2000. NCVHS recommended adoption of the RxNorm in the core set of
clinical data terminologies in its Letter to the Secretary on Recommendations
for Patient Medical Record Information Terminology Standards, dated November 5,

Recommended Action 9.1: HHS should include in the 2006 pilot tests
the RxNorm terminology in the NCPDP SCRIPT Standard for new prescriptions,
renewals, and changes. RxNorm is being included in the 2006 pilot tests to
determine how well the RxNorm clinical drug, strength, and dosage information
can be translated from the prescriber’s system into an NDC at the
dispenser’s system that represents the prescriber’s intent. This
translation will require the participation of intermediary drug knowledge base
vendors until the RxNorm is fully mapped.

Recommended Action 9.2: HHS should accelerate the promulgation of
FDA’s Drug Listing rule and hence the ability to support the correlation of NDC
with RxNorm (e.g., for passing daily updates of the SPL to NLM for inclusion in
the DailyMed). Timely rulemaking is critical to sustain the daily use of RxNorm
beyond the 2006 pilot tests.

Recommended Action 9.3: HHS should ensure that, if the Medicare Part
D Model Guidelines and NDF-RT differ, an accurate mapping exists so they both
can be used successfully.

Observation 10 (Structured and Codified SIG): Patient instructions
for taking medications are placed at the end of a prescription. These are
called the signatura, commonly abbreviated SIG. Structured and codified
SIGs will enhance patient safety, although it is also recognized that free text
capability must be preserved for special circumstances. NCPDP, HL7, and others
are working on addressing structured SIG components and plan to seek broad
industry participation.

Recommended Action 10.1: HHS should support NCPDP, HL7, and others
(especially including the prescriber community) in addressing SIG components in
their standards. This should include preserving the ability to incorporate free
text whenever necessary (e.g., for complex dosing instructions, and to address
special cultural sensitivities, language, and literacy requirements).

Recommended Action 10.2: HHS should include in the 2006 pilot tests
the structured and codified SIGs as developed through standards development
organization efforts.

Observation 11 (Dispenser Identifier): The NCPDP Provider Identifier
Number has been in use for a number of years and is widely accepted as the
dispenser (pharmacy) identifier. Its database contains information to support
various claims processing functions, and it needs to continue to be available
for this purpose. The NCPDP database can accommodate the National Provider
Identifier (NPI) as a reference field. HIPAA requires the NPI, when it becomes
available, to be used in the NCPDP Telecommunication Standard for claims
processing. The National Provider System (NPS) enumerates pharmacy
organizations, subparts of organizations at a particular address, and

Recommended Action 11.1: HHS should ensure that the NPI, when it
becomes available, is incorporated as the primary identifier for dispensers in
the NCPDP SCRIPT and other e-prescribing standards.

Recommended Action 11.2: HHS should accelerate the enumeration of all
dispensers to support transition to the NPI for e-prescribing.

Recommended Action 11.3: HHS should permit the industry to use the
NCPDP Provider Identifier Number in the event that the NPS cannot enumerate
dispensers in time for Medicare Part D implementation.

Recommended Action 11.4: HHS should evaluate how mass enumeration of
dispensers for the NPI can occur using the NCPDP Provider Identifier Number

Recommended Action 11.5: HHS, when requiring the NPI as the primary
identifier for dispensers, should protect the ability to maintain linkages to
the NCPDP Provider Identifier Number database for current claims processing

Observation 12 (Prescriber Identifier): There is no single identifier
for prescribers. The Drug Enforcement Administration (DEA) Number is widely
used as a proxy. Although testimony is expected to be heard from the DEA
between now and March 2005, others indicated that the DEA prefers the number to
be reserved for use only on prescriptions for controlled substances. NCPDP
created HCIdea for the purpose of enumerating prescribers in order to eliminate
usage of the DEA on prescription claims when transmitted between dispensers and
payers/PBMs. It is not currently made available directly to prescribers. The
HCIdea database supports all of a prescriber’s DEA numbers, practice
locations, and the National Provider Identifier (NPI), when it becomes
available.  The NPI is the HIPAA standard for identifying all providers,
including prescribers, on all HIPAA transactions. The NPI database could
accommodate a bulk load from HCIdea to include missing elements, if efficient
and valid to do so.

It is further noted that the DEA is anticipated to produce an electronic
signature standard to ensure the protection of messages containing
prescriptions for controlled substances. Electronic signatures will also be
addressed by NCVHS in subsequent recommendations.

Recommended Action 12.1:  HHS should ensure that the NPI, when
it becomes available, is incorporated as the primary identifier for prescribers
in the NCPDP SCRIPT and other e-prescribing standards.  It should be noted
that the NPI must be at the individual prescriber level, because a prescription
cannot be written at a group level.

Recommended Action 12.2: HHS should accelerate the enumeration of all
prescribers to support transition to the NPI for e-prescribing.

Recommended Action 12.3: HHS should permit the industry to use the
NCPDP HCIdea in the event that the NPS cannot enumerate prescribers in time for
Medicare Part D implementation.

Recommended Action 12.4: HHS should work with the industry to
identify issues and possible solutions that deal with all elements of the
prescriber location and include those solutions in the 2006 pilot tests.

Recommended Action 12.5: HHS should evaluate how mass enumeration of prescribers for the NPI can occur using the NCPDP HCIdea database.

Recommended Action 12.6: HHS, when requiring the NPI as the primary
identifier for prescribers, should protect the ability to maintain linkages to
the NCPDP HCIdea database for e-prescribing routing functions.

Observation 13 (Pilot Test Objectives): NCVHS has observed that there
were many impediments to full adoption and implementation of the HIPAA
transactions and code sets standards. With the requirements for pilot testing
in e-prescribing, HHS has the opportunity to address any similar impediments
that might arise with e-prescribing standards implementations. As previously
noted, while the foundation standards being recommended here are suitable for
early industry adoption, there are several areas in the foundation standards
that do not support all the MMA requirements. In addition, there are a number
of patient and prescriber-specific issues which must be studied and addressed,
for example, acceptance and satisfaction. It must also be recognized that the
success of the pilots will require much work by the vendors to incorporate new
standards and functionality into their applications before they can be pilot

Recommended Action 13:1: HHS should support the efforts of
standards development organizations to incorporate in the foundation standards
as many as possible of the additional functions required for MMA, as identified
in these recommendations.

Recommended Action 13.2: HHS should include foundation standards with
as many as possible of the additional functions required for MMA in the 2006
pilot tests.

Recommended Action 13.3: HHS should immediately begin to work with
the vendors to ensure readiness for the pilot tests on January 1, 2006.

Recommended Action 13.4: HHS should identify and widely publicize
specific goals, objectives, timelines, and metrics to guide the design and
assessment and increase industry awareness of the 2006 pilot tests. HHS should
include metrics that address economic, quality of care, patient safety, and
patient and prescriber satisfaction factors. .

Recommended Action 13.5: After the pilot tests, HHS should develop
and widely disseminate information concerning any economic and quality of care
benefits of e-prescribing, provide comprehensive education on implementation
strategies, describe how e-prescribing can be implemented consistent with the
privacy protections under HIPAA, and address other elements that contribute to
successful and widespread prescriber adoption and patient acceptance.

Observation 14 (Support for Standards Collaboration): A significant
level of collaboration is occurring among standards development organizations
and with vendors who have proprietary solutions as there is growing momentum
for e-prescribing and other components of the National Health Information
Infrastructure (NHII). It is important to support the open, consensus-based,
and voluntary nature of standards development organizations, while accelerating
the process of standards development and coordination.

Recommended Action 14.1: HHS should financially support standards
coordination activities to ensure a seamless e-prescribing process across
provider domains (e.g., physician office, hospital, long term care),
dispensers, and payers/PBMs.

Recommended Action 14.2: HHS should encourage standards development
organizations to adopt a change management process that permits versions to
maintain interoperability.

Observation 15 (Policies to Remove Barriers): Testimony identified
widespread industry concerns relating to safe harbor, preservation of
provider/patient choice, and freedom from commercial bias in messages received
through e-prescribing applications

Recommended Action 15.1: HHS should ensure that regulations define
the parameters of safe harbor, ensure preservation of provider/patient choice,
and require that e-prescribing messages received through e-prescribing
applications be free from commercial bias.

Observation 16 (Conformance Testing and Certification): Testimony
identified the need for testing conformance to standards and certification of
e-prescribing systems (i.e., standards conformance, functionality, and
interoperability). While conformance testing and certification are two
distinct, but interrelated, concepts, it should be recognized that some parts
of the industry use the term “certification” in the limited sense of
passing a conformance test.

Recommended Action 16.1: HHS should support standards development
organizations in their development of conformance tests for the e-prescribing
standards and their implementation guides.

Recommended Action 16.2: HHS should require that e-prescribing system
vendors validate the conformance of their e-prescribing messages.

Recommended Action 16.3: The HHS Office of the National Coordinator
for Health Information Technology should investigate how e-prescribing
applications might best be certified.

Next Steps

There are several other message format, terminology, and identifier
standards and important related issues that were identified by NCVHS but that
are not addressed in this initial set of recommendations. NCVHS plans to
receive testimony on as many of these topics as possible between now and March
2005; and make further recommendations in March 2005. The topics include:

  • Electronic signature for use in e-prescribing.
  • Issues relating to privacy and security with respect to e-prescribing.
  • A directory that would identify prescribers, nursing facilities, and
    pharmacies that are able to accept e-prescribing transactions.
  • Codification of allergens, drug interactions, and other adverse reactions
    to drugs.
  • Incorporation of indications for drug therapy into e-prescribing messages.
  • A standard for units of measure.
  • Methods for patient identification for e-prescribing.
  • Use of the National Health Plan ID for e-prescribing.
  • Formulary identifier.
  • Exchange of medication history among all participants in the e-prescribing
  • Exchange of medical history within the e-prescribing process.
  • How best to ensure the interoperability among e-prescribing
  • Standard codes for orderable items (such as insulin supplies).
  • Exchange of drug labeling and drug listing.
  • Clinical decision support in e-prescribing.

NCVHS wishes to thank you for the opportunity to make these recommendations.
NCVHS would be pleased to review and comment on plans for the 2006 pilot tests.

Sincerely yours,


John R. Lumpkin, M.D., M.P.H.

Chairman, National Committee on Vital and Health Statistics

Cc:  HHS Data Council Co-Chairs



A. The E-Prescribing Standards Work Plan.
1. Groups of stakeholders to testify (From MMA)
2. Criteria for Selection of Standards (FromMMA)
3. Schedule of hearings
4. Copy of e-prescribing standards section of MMA

B. Observations and Findings from Testifiers on Status of E-Prescribing Standards (Working Document)

C. List of Testifiers

D. Glossary of Terms

[1] Agency for Healthcare
Research and Quality. MEPS Highlight #11: distribution of health care expenses,

[2] Hutchinson, Kevin,
SureScripts. Testimony before NCVHS Subcommittee on Standards and Security, May
25, 2004.

[3] Center for Information
Technology Leadership. The value of computerized order entry in ambulatory
settings. 2003.

[4] eHealth Initiative,
“Electronic Prescribing: Toward Maximum Value and Rapid Adoption,”
April 14, 2004, p. 26

[5] See also: Bell, DS, et
al. “Recommendations For Comparing Electronic Prescribing Systems: Results
Of An Expert Consensus Process,” Health Affairs,

[6] eHealth Initiative,
“Electronic Prescribing: Toward Maximum Value and Rapid Adoption,”
April 14, 2004, p. 33.

[7] NCPDP Testimony, March
30, 2004, p. 21.

[8] Thompson TG and DJ
Brailer, “Framework for Strategic Action,” U.S. DHHS, July 21, 2004,
p. 10

[9]   These elements
also align with the dimensions of care identified by the Institute of Medicine,
Crossing the Quality Chasm; that care be: safe, effective, efficient, timely,
patient-centered, and equitable.

[10] NCVHS recognizes that
properly defining “enterprise” may be complex. NCVHS encourages the
Secretary to clarify the definition in rulemaking.

[11] A national electronic
formulary and pharmacy benefits information exchange

[12] Implementation Guide,
Version 5 Release 1

[13] Health Care
Eligibility Benefit Inquiry and Response Version 004010X092A1

[14] Implementation Guide,
Version 5 Release 1

[15] Health Care Services
Review Standard Version 004010X094A1

“Terminology” includes codes, classification, and vocabulary

[17] RxNorm was developed
by the NLM, in consultation with the Food and Drug Administration (FDA), the
Department of Veterans Affairs (VA) relative to its National Drug
File-Reference Terminology (NDF-RT), and HL7 (for standards specification).

[18] The remaining 26
prescribed items that did not match to RxNorm codes were primarily medical
supplies, which RxNorm does not include, and drug delivery devices (e.g.,
steroid tapering dose packs and oral contraceptives), which RxNorm is just
starting to include.

[19] The SPL provides
computer-readable information that is to accompany dispensed medications.

[20] The report of the
Conference Agreement on MMA notes that conferees intend for electronic
prescribing to serve as a vehicle to reduce medical errors and improve
efficiencies in the health care system, but not for it to be used as a
marketing platform or other mechanism to unduly influence the clinical
decisions of physicians. (page 28)