1. Groups of stakeholders to testify (From MMA)
2. Criteria for Selection of Standards (From MMA)
3. Schedule of hearings
4. Copy of e-prescribing standards section of MMA
September 2, 2004
The Honorable Tommy G. Thompson
Secretary
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 annually.
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 today:
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 learn:
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] :
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 C.
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 issues.
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 standards.”
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 terminologies.
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 HIPAA.
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 compatible.
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 [10] as outside the scope of MMA e-prescribing standard specifications.
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 payers/PBMs.
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 impacts.
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 tests.
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 Prescriber): 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 history.
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 tests.
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 e-prescribing.
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, 2003.
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 pharmacists.
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 database.
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 purposes.
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 tested.
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 [20] .
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:
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,
/s/
John R. Lumpkin, M.D., M.P.H.
Chairman, National Committee on Vital and Health Statistics
Cc: HHS Data Council Co-Chairs
Enclosures
A. The E-Prescribing Standards Work Plan.
1. Groups of stakeholders to testify (From MMA)
2. Criteria for Selection of Standards (From
MMA)
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)
[1] Agency for Healthcare Research and Quality. MEPS Highlight #11: distribution of health care expenses, 1999.
[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 (www.ehealthinitiative.org/initiatives/erx/document.aspx?Category=249&Document=270)
[5] See also: Bell, DS, et al. “Recommendations For Comparing Electronic Prescribing Systems: Results Of An Expert Consensus Process,” Health Affairs, 0.1277/hlthaff.w4.305.
[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
[16] “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)