Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

August 17-19, 2004

Washington, D.C.

Meeting Minutes

The Subcommittee on Standards and Security of the NCVHS was convened on August 17, 2004 at the Hubert H. Humphrey Building in Washingon, D.C. The meeting was open to the public. Present:

Subcommittee members

  • Simon P. Cohn, M.D., Chair
  • Jeffrey S. Blair, M.B.A., Vice Chair
  • Stanley M. Huff, M.D.
  • Harry Reynolds
  • Judith Warren Ph.D., R.N.

Staff and liaisons

  • Maria Friedman, D.B.A., CMS, lead staff
  • Vivian Auld, NLM
  • Suzie Burke-Bebee, ASPE
  • Jorge Ferrer, VA
  • J. Michael Fitzmaurice, Ph.D., AHRQ
  • Kathleen H. Fyffe
  • Gail Graham, DVA
  • Marjorie S. Greenberg, NCHS
  • Debbie Jackson, CDC
  • Randy Levin, FDA
  • Steve Steindel, Ph.D., CDC
  • Marietta Squire CDC, NCHS
  • Karen Trudel, CMS

Others

  • Margaret Amatayakul, independent consultant assisting the Committee
  • Eleni Anagnostiadis, Natl. Assn. of Boards of Pharmacy
  • Brian Bamberger, Medimedia
  • Patrice Bavoro, Medco Health Solutions
  • Carol Bickford, ANA
  • Laura Blom, Joint Commission on Accreditation of Healthcare Org.
  • Meryl Bloomrosen, FEHI
  • Jennifer Bordewick, EHI
  • G. F. Brown, Mayer, Brown, Rowe & Maw, LLP
  • Teri Byrne, RxHub
  • Anne Canfield, RX Benefits Coalition
  • Ahib Dable, SureScripts
  • Michael DeCarlo, Blue Cross/Blue Shield Association
  • Karen Eckert, Medi-Span, WoltersKluwer Health
  • Lynne Gilbertson, NCPDP
  • Emily Graham, ACCRS, ASOA
  • Jill Helm, Allscripts
  • Rebecca Hirschorn, CMS
  • Cynthia Howard, CMS
  • Andrew Kasper, FDC Reports
  • Lee Kerowski, FDC Reports
  • Ross Martin, Pfizer Global Pharmaceuticals
  • Lisa Miller, X12
  • Stuart Nelson, NLM
  • Richard Peters, Amer. Academy of Family Physicians
  • Helga Rippen, ASPE
  • Scott Robertson, HL7
  • Bill Robinick ExpressScripts
  • George Robinson, FirstDataBank
  • Phil Rothermich, ExpressScripts
  • Phillip Scott, NCPDP
  • Tony Schueth, Point-of-Care Partners
  • David Silke, The Health Strategies Consultancy
  • Mike Simko, Walgreens
  • Dana Sherwood, Pharmaceutical Care Management Association
  • Andrew Shelton, The Pink Sheet
  • Lee Ann Stember, NCPDP
  • Agee Tave, SureScripts.
  • Laura Vartain, Wexler & Walker
  • Elizabeth Walker, The Pink Sheet
  • Rachelle Wheatley, RxHub
  • Michelle Williamson, NCHS, CDC
  • Ken Whittemore, SureScripts
  • Rochelle Wooly, RxHub

EXECUTIVE SUMMARY

Messaging Standards

  • Scott Robertson, Co-Chair, HL7 Medication and Information Special Interest Group
  • Lisa Miller, Chair, X12 Convergence and Outreach Task Group; Steering Committee, X12
  • Lynne Gilbertson, Director, Standards Development, National Council for Prescription Drug Programs
  • Richard Peters, M.D., ASTM International

Mr. Robertson discussed Health Level Seven’s (HL7) established and developing standards contributions to electronic-prescribing (e-prescribing: versions 2 and 3 messaging, clinical document architecture (CDA), structured product labeling (SPL), and the electronic health record system (EHRS) functional model. He urged NCVHS to support National Council for Prescription Drug Programs (NCPDP)/ HL7 mapping with funding and resources. HL7 proposed v3 methodology and the reference information model (RIM) for ongoing mapping of clinical, administrative and other financial data. He asked NCVHS to endorse: existing implementations of HL7 and NCPDP standards for e-prescribing; HL7 v3 RIM and associated methodology; functional definitions of HL7 EHRS; and joint NCPDP HL7 mapping.

Noting changes needed in ASC X12N 270/271 Health Care Eligibility Benefit Inquiry and Response transactions, Ms. Miller saw an opportunity for X12 to give providers verbose answers. X12 asked: to be included in the 2006 demo and ongoing discussions and for NCVHS to examine the business process and how, through NCPDP, clinical and e-prescribing systems fed the administrative process. She noted HL7 had presented a memo of understanding (MOU) and inquiry about revitalizing their relationship to X12, and she proposed Context Inspired Component Architecture (CICA) as a point of harmonization. Ms. Miller suggested using the demo as a way for X12 HIPAA to move to the next version.

Ms. Gilbertson assessed the completeness of e-prescribing standards and practices and gaps relative to the Medicare Prescription Drug Improvement and Modernization Act (MMA), and recommended a model e-prescribing environment. She called for supporting NCPDP SCRIPT Standard in applicable domains and relevant prescribing HL7 messaging standards. Ms. Gilbertson suggested CMS fund studies with participants with e-prescribing functionality to show return on investment (ROI) for prescribers, pharmacies and payers as well as for transactions and code sets not widely used. She suggested CMS might fund studies to verify that Medicare will provide sufficient eligibility and benefit information for electronic prescriber’s needs. She asked NCVHS to define success and how to measure pilots.

While not a messaging standard, Dr. Peters noted ASTM International’s (ASTM) continuity of care record (CCR) worked with such entities. Coordinated efforts ensured mapping with NCPDP SCRIPT, SureScripts and RxHub. A MOU underway with HL7 allowed integration with CDA and RIM. Administrative data was mapped to HCFA 1500 and UB92 claims; 271, 272, 278 preauthorization; and utilization review. He noted concern that the patient instructions (SIG) reflected the complex difference between prescriptions filled by a pharmacy and orders for administration of an IV or add mixture in inpatient, home health, long-term care or outpatient settings. A final standard will be under final ballot in October.

HL7/NCPDP Harmonization

  • Ross Martin, M.D., M.H.A., Senior Manager, Business Technology, Pfizer
  • Karen Eckert, RP.h., M.P.M., Medi-Span, WoltersKluwer Health

Dr. Martin and Dr. Eckert noted NCPDP and HL7 selected liaisons to facilitate communication. A group identified discussion points: scope, resources, deliverables and inversion. The project goal is to: (1) produce a guidance document outlining mapping requirements between HL7 and NCPDP SCRIPT standard messages, (2) conduct a working demonstration of mappings that result from this guidance, (3) develop a change management process to ensure guidance continues to be updated, (4) create a document of currently out-of-scope work for further collaborations. Dr. Martin said HHS and AHRQ could do much to facilitate these efforts.

Terminology Standards: Readiness for Adoption and Demo, Mapping to Drug Knowledge Bases

  • Randy Levin, M.D., Food & Drug Administration
  • Steve Brown, M.D., Department of Veterans Affairs
  • Stuart Nelson, M.D., National Library of Medicine

Dr. Levin noted FDA’s collaborations on medication identifiers and terminologies. National Drug Code (NDC) directory has most prescription drug products. FDA will harmonize manufactured dose form, administration route, strength and package type with others. Medication information, labeling section headings and related content are being standardized into a highly structured format. Some approved prescription drug products will be available this way late in 2005. All approved prescription products are expected by 2007; all marketed products are expected within three-to-four years. SPL is part of the drug description and provided as data elements to the National Library of Medicine (NLM) for distribution in Daily Med and support creating RxNorm.

Dr. Brown noted NDF-RT was a formal terminology with description logics based on the Department of Veterans Affair’s (VA) National Drug File (NDF) interlinked with terminologies and coding systems from other federal organizations, NLM, RxNorm and MESH. NDF-RT collaborated with National Cancer Institute and HL7 dose forms and was published in AB Metathesaurus. FRT was part of NCI’s browser. Terms and concepts related to pharmacogenomics have been added to NDF. Process integration included the new drug transaction, near-term rapid turnaround, NDF maintenance environment, and lab/pharmacy reengineering initiatives. VA focused on integration and implementation. MOA currently is 256 elements; P currently is 1,699. VA and FDA added roles and properties. Updates were from NDC databases. VA and NOM worked on RxNorms, drugs and components and NCI. VA will fix issues with devices and supplies in NDF.

Dr. Nelson said Daily Med will be browsable, downloadable and have SPL, RxNorm name, NDF-RT data, and links to other sources.  First SPL (late 2005) form the core of Daily Med. Built to facilitate interoperability between vocabularies and linked to unified medical language system (UMLS), RxNorm is a vehicle for interoperability needed for clinical vocabularies that might be the basis of an electronic patient record (EPR). RxNorm’s first updates apart from UMLS release fall 2004. RxNorm will have monthly, then weekly updates. Current content includes 110,000 concepts and 95 percent of prescription drugs available with RxNorm IDs. NLM will support special ingredients and reimbursable common supplies orderable with a prescription, and is considering addressing the level of equivalence between brand names and generics.

Identifier Standards

  • Karen Trudel, Acting Director, Office of HIPAA Standards, CMS
  • Lee Ann Stember, President, National Council for Prescription Drug Programs

Ms. Trudel identified health plans from the Medicare Part D perspective: Medicare Advantage plan drug programs, PDP plans, and fallbacks contracted to provide choice. All are under HIPAA and specifiable. Plans could be extensions of current process, but private sector contracts and benefit packages could impact NPRM. She urged the social security system (SSS) to recommend additional requirements for PlanID structure. The National Provider Identifier (NPI) compliance date is May 23, 2007; May 2005 is effective date for regulation and issuance of provider NPIs. System build and enumeration contract are underway. Pilot testing is scheduled May-August; identifiers will be issued August or September 2005. NPI will enumerate many providers, but not replace DEA, FEIN, provider enrollment or certification. Covered/non-covered providers and subparts can get NPIs. Ms. Trudel noted possibilities for addressing the location identifier dropped from the final rule.

Ms. Stember explained that NCPDP envisions HCIdea will mirror the success of NCPDP’s pharmacy enumerator. NCPDP will crosswalk between HCIdea identifier and NCPDP Provider ID to NPI. Data supplier arrangements facilitate supplying prescriber data to the National Health Information Network (NHIN) for validation and population of the HCIdea database. Multiple suppliers have passed all certifications: criteria are met and DOD and others receive this data. Implementation throughout Utah is expected in 2005. She said the HCIdea database (which contained 1.2 million or 86 percent of the records) can serve as enumerator for newly defined requirements of electronic prescriptions. NCPDP’s pharmacy identifier could be a way for prescribers to identify the patient’s choice of community pharmacies.

Standards for Formularies: Messages, Structure and Prior Authorization

  • Teri Byrne, Director, Trading Partner Integration, RxHub
  • Brian Bamberger, President, MediMedia Information Technologies

Ms. Byrne said RxHub planned to take their proprietary standards (used in production applications including EMR, point-of-care technology and electronic medical record vendor, Pharmacy Benefit manager [PBM], health plan, hospital and pharmacy networks) through NCPDP accreditation. Twelve participants use RxHub standards or present information to physicians. Ten others are certified and ready for production once physicians are enrolled. Eight more are certifying and others signed NDAs and are developing flow transactions. Ms. Byrne urged NCVHS to recommend utilization of RxHub standards currently in use for the demonstration. She recommended that NCVHS keep involved in NCPDP’s consideration of RxHub and that HHS adopt RxHub under MMA and NCVHS.

Mr. Bamberger urged NCVHS to recommend CAQH submission formats as a starting point. He said the submission format should be developed and maintained by an American National Standards Institute (ANSI)-accredited SDO (e.g., NCPDP or HL7) and allow for the plan’s maximum flexibility and creativity. He advised NCVHS to consider need for a wider data set and adequate time frames for vendors to reconfigure software (content and breadth of formularies varied by plans, making difficulties for application vendors). Plans (e.g., AMCP) and an ANSI-accredited SDO should lead in developing formulary and messaging standards. Identifying plans and numbers on their cards would facilitate at an individual card level the linking of plan and individual benefit to formulary.

Open Microphone

Noting physicians and pharmacies lack of unbiased, sound data on ROI boost reluctance to adopt the technology, Mr. Whittemore urged CMS to provide financial incentives to providers.

Dr. Eckert cautioned NCVHS not to use the umbrella “RxNorm” in recommendations.

Emphasizing the lengthy HIPAA modification process Jeff Brown, outside counsel to the Subcommittee, cautioned about implementing any standard for prior authorization other than the HIPAA-mandated X12 278 Implementation Guide and NCPDP T Standard telecommunications. He noted HIPAA taught that well-publicized pilots helped implementation.

George Robinson, FirstDataBank, clarified that the semantic clinical drug was the only concept RxNorm linked to NDC and SPL. Drug knowledge base vendors will have to link branded representation directly to NDC or name base concept.

Tony Schueth, Point-of-Care Partners, noted e-prescribing business models call for each individual receiving value from e-prescribing to pay a corresponding amount. Some sources had stronger negotiating positions; reimbursements were not always equitable. He suggested funding to help companies adopt a formulary standard.

DETAILED SUMMARY

The details of all presentations and letters drafted can be found in the meeting transcript posted on the NCVHS Web site, ncvhs.hhs.gov

-DAY ONE-

Subcommittee Discussion, Draft Recommendation Letter – Simon Cohn M.D., Jeff Blair, Margaret Amatayakul

The Subcommittee reviewed key observations relative to messages, terminology, identifiers, important related issues and other policy considerations, then considered observations regarding standards, issues and associated recommended actions recognizing identified standards and actions to address additions, development, and pilot testing necessary to meet MMA requirements. During an August 24 12:00 EST conference call, members will review and hopefully finalize a draft version eleven of the letter to the Secretary, conveying that industry had adequate experience with some standards, others needed piloting, and numerous process elements had to be put in place, then present the draft to the full Committee September 1. A joint hearing between the Subcommittee and Privacy and Confidentiality on security, e-prescribing and privacy and confidentiality issues is scheduled November 18 and 19. Hearings December 8 and 9 will deal with additional e-prescribing issues. Other hearings are scheduled January 19 and 20. Time is held open in early February for an additional meeting.

DETAILED SUMMARY

The details of all presentations and letters drafted can be found in the meeting transcript posted on the NCVHS Web site, ncvhs.hhs.gov

-DAY ONE-

INTRODUCTORY COMMENTS, Jeff Blair

Mr. Blair noted MMA directed NCVHS to evaluate and make recommendations on e-prescribing standards. Version ten of the work plan was posted on the NCVHS Web site. NCVHS was accelerating these hearings to provide information to HHS and CMS as quickly as possible. NCVHS aimed to give their initial set of e-prescribing recommendations to the Secretary in September, a second set in March. The strategy was to hear from all stakeholders identified in the MMA law as well as consumer groups and other unidentified users.

Messaging Standards

  • Scott Robertson, Co-Chair, HL7 Medication and Information Special Interest Group

Mr. Robertson discussed five of HL7’s established and developing standards contributions to e-prescribing: v2 and v3 messaging, CDA, SPL, and EHRS functional model.

HL7 v2 offered flexibility through optionality, supported a full range of health care factors, and was widely implemented in inpatient clinical and outpatient environments. V2 used a bottom-up approach addressing individual needs through emerging ad hoc methodology. Optionality and ad hoc development presented difficulties in implementation: v2 lacked a consistent view of the data HL7 moved or relationships to other data. Implementers had to analyze and plan interfaces to ensure both parties similarly used optional features. Interoperability between applications was achievable but not inherently guaranteed with v2 X-messaging.

V3 methodology brought object-oriented analysis/design and formal modeling to the standards development process. Core to v3’s development was establishment of RIM. Backbone classes (entity, role, participation and act) provide a way to conceptualize. Entities were persons, organizations, manufactured materials, and places. Role class applied context. Participation class represented performance. Act class represents what was, had or could be done or requested. Backbone classes could be placed into narrative form. By replicating, cloning and specializing classes, information objects and attributes in health care interactions could be represented. V3 vocabulary was a tightly controlled terminology allowing realization of RIM’s potential. But both versions could produce divergent models and messages without strict process methodology. V3 methodology was based on conceptual modeling of actors, triggers, interactions and data concepts. The resulting conceptual model derived from RIM the refined message information model or RMIM. Message specifications derived from RMIM supported specific interactions. Implementations used v2 messages for pharmacy orders and dispense reporting

Projects requiring large-scale integration employed v3 messaging. The HL7 EHRS functional model draft standard was a tool for clinicians and vendors seeking common language to describe functional capabilities supporting clinical care. Associations were planned between EHRS functions and messages/APIs supporting them. An HL7 EHR committee task group was reviewing the EHRS functional specification, identifying functions relating to e-prescribing, and would propose changes supporting e-prescribing requirements.

CDA, an early application of v3 concepts and methodologies approved as an HL7 standard, provided an exchange model for clinical documents (e.g., discharge summaries, progress notes). CDA leveraged use of XML, RIM and current vocabularies to make documents easily retrievable, parsed, and used. CDA was a basis for the structured document and representation for SPL. HL7 worked with FDA to apply CDA to regulated product information pharmaceutical manufacturers must supply to FDA and health care professionals.

Noting strong motivation for NCPDP/HL7 mapping was essential to successful e-prescribing between clinical provider and community pharmacy applications, Mr. Robertson urged NCVHS to support this mapping with funding and resources. HL7 proposed v3 methodology and RIM for ongoing mapping which could include clinical, administrative and other financial data.

Numerous HL7 committees collaborated to: ensure business processes, interactions and data elements were supported in 2.X and clearly defined under HL7 RIM and its pharmacy models; address identification/development of appropriate terminologies; and bring the CCR forward as a CDA implementation. HL7 pharmacy messages employed SNOMED, LOINC and NDC. Identification of ordered medication and associated attributes were among the terminologies addressed.

HL7 focused, near-term, on joint mapping with NCPDP and sought mid-term consensus on terminology issues. Mr. Robertson recommended that NCVHS endorse: existing implementations of HL7 and NCPDP standards for use in e-prescribing; HL7 v3 RIM and associated methodology as an overarching information model for health care messaging and process standards; functional definitions of HL7 EHRS related to functional aspects of e-prescribing; and facilitate joint NCPDP HL7 mapping.

Messaging Standards

  • Lisa Miller, Chair, X12 Convergence and Outreach Task Group; Steering Committee, X12

Ms. Miller noted changes had to occur in the 270/271 and 278 request/response transactions. Pointing out that the 270/271 eligibility transaction was not implemented to the detail reflected in the spreadsheet and the Subcommittee’s questions, she proposed this as an opportunity for X12 to push forward so provider communities had the benefit of verbose answers. She noted that clinical information asked for on the 270/271 transactions were outside of the administrative process that X12 considered currently appropriate.

She noted the 278 prior authorization transaction provided limited support for drugs and that X12’s work-around might not be cost effective or in the community’s best interest. X12 had to look for ROI. Codification and an additional segment were needed. She said X12 was committed long-term to those changes and assisting the community.

Ms. Miller reported that, in looking at these transactions from the viewpoint of administrative simplification and process, X12 realized the impact of other X12 transactions (e.g., the 275 transaction) and the entire continuum and administrative process model had to be evaluated. Other X12 transactions not mandated by HIPAA (e.g., the 274 provider roster) might be beneficial in the e-prescribing continuum.

X12 asked to be included in the 2006 demonstration and ongoing discussions and for NCVHS to look at the business process and how the administrative process was fed by clinical and e-prescribing systems through NCPDP. Noting everyone heard a lot about NCPDP/HL7 interoperability, Ms. Miller suggested X12 was also needed at the table. She noted in June HL7 presented to X12 a MOU and inquiry about revitalizing their relationship.

Ms. Miller introduced CICA, an XML effort divorcing X12 in the standards process from their business process and syntax, protecting the effort X12 put into formulating their business messages. She proposed CICA as a point of harmonization in interoperability that could cover all industries. Ms. Miller suggested using the demo as a way for X12 to move forward to the next version.

Messaging Standards

  • Lynne Gilbertson, Director, Standards Development, National Council for Prescription Drug Programs

Ms. Gilbertson testified on the e-prescribing process in general ambulatory settings applicable to the acute care environment for prescribing discharge medications electronically and in long-term care settings. She noted NCPDP members had created a recommendations document showing existing e-prescribing standards and practices, assessing their completeness and gaps relative to MMA, and recommending a model e-prescribing environment reflecting all stakeholders, MMA’s recommendations/ requirements, the marketplace, and e-prescribing’s anticipated advances and adoption.

NCPDP recommended continuing to support NCPDP SCRIPT Standard and relevant prescribing HL7 messaging standards in applicable domains. The committee supported:

  • HL7/NCPDP’s collaborative effort to map their standards in business functions.
  • Utilizing the X-12 270/271 eligibility request response between prescribing system and PBM or payer system. NCPDP will create a guidance document to map the pharmacy ID card to the appropriate field in the 270/271. Work will begin by November 2004.
  • Industry’s approval of a new standard allowing the prescribing application to download and use in real-time mode during the prescribing process formulary/benefit coverage information. Work was beginning. Estimated completion: two years.
  • Bringing industry together to approve modifications to NCPDP SCRIPT Standard supporting transfer of medication history from payers for treatment of patients. Work was beginning. Estimated completion: one year.
  • Continuing to support use of HL7 messages for transferring medication history as applicable.
  • CMS conducting a pilot testing existing and new standards and identifying gaps in the e-prescribing process to request, obtain and communicate prior authorization.
  • Industry modifying SCRIPT Standard to support a provider directory and prescribers, nursing facilities and pharmacies communicating electronically. Work was underway. Estimated completion: one year.
  • CMS evaluating functionality of the X12 274 health care provider directory transaction.
  • CMS considering utilizing HCIdea as a standard identifier for prescribers and analyzing the feasibility of NPI to meet the prescribing industry’s needs
  • NCPDP facilitating industry coming together to standardize SIG, focusing on both low-hanging fruit and what could be done long term.
  • Use of fields on the SCRIPT from the prescriber with NDC, HRI, and UPC identifiers for pharmacies. NLM and industry should determine RxNorm readiness for 2006 pilots.
  • Studies of RxNorm’s effectiveness and ROI in current e-prescribing environment
  • Engaging industry participation to address the special needs of long-term care settings,

Ms. Gilbertson suggested that CMS fund studies with industry participants with existing e-prescribing functionality to show: ROI of current transaction implementations for prescribers, pharmacies and payers as well as for transactions and code sets available but not widely used by them. Studies also could be funded to verify operationally that Medicare as a payer would provide sufficient eligibility and benefit information for electronic prescriber’s needs. ROI information could be used in educational material.

Ms. Gilbertson reported on NCPDP’s and NLM’s discussions outlining preliminary tasks for walking some currently prescribed medications through the RxNorm process to determine RxNorm’s level of functionality that supported prescribers’ requests and how that information could be carried in the SCRIPT Standard. Mapping tying RxNorm code to pharmacy systems and drug databases would provide guidance to industry.  She asked NCVHS to define success and how pilot programs should be measured.

Messaging Standards

  • Richard Peters, M.D., ASTM International

Dr. Peters clarified that ASTM CCR was not a messaging standard but worked integrally with messaging standard organizations. Coordinated efforts ensured full mapping with NCPDP SCRIPT, SureScripts and RxHub. A MOU underway with HL7 allowed integration with CDA, RIM and their approach to messaging. Administrative data was mapped to HCFA 1500 and UB92 claims; 271, 272, 278 preauthorization; and utilization review. Dr. Peters described CCR as an XML map enabling detailed summaries of patient data for doctors’ and nurses’ real-time decision-making in long-term care and inpatient facilities.

ASTM CCR’s focus in e-prescribing was on: a detailed, comprehensive medication history; adverse reaction allergy history; medication history; and medical history. Viewed as an integrated whole from the practice setting, medication management was NCPDP, SureScripts, RxHub, eligibility, pharmacy, Drug Utilization review (DUR) and interaction with PBMs. EHR vendors looked to XML to provide uniformity of order entry in the EHR world. HL7 was key to inpatient order entry from the office setting. Continuing and long-term care were still dependent on paper. Home health, also depended on paper, but provided opportunities for automation. Referral and medication management were primarily EHR-to-EHR. Dr. Peters noted a need to look at preauthorization, generation of claims (i.e., in subspecialties dealing with administration of medication in the outpatient setting), and a way to generate from EHRs some uniformity in a paper or electronic personal health record (PHR). He noted concern that the SIG segment reflected the complexity of the difference between a prescription written to be filled by a pharmacy versus an order for administration of a drug used as an IV or other add mixture in the inpatient or home health, long-term care or outpatient setting. The system and tagging had to allow for the prescription refill as well as the administration of medications. CCR also focused on medication and medical history, linking drug-drug, drug allergy, drug adverse event, drug procedure and drug diagnosis or drug problem within that medication segment, the indication for the medication or restrictions on its use or factors defining when and how to administer it. Another focus was on pediatrics and dose calculation on a real-time basis.

Dr. Peters emphasized that physician specialty societies, e-prescribing vendors, and long-term care organizations drove ASTM CCR and the focus was on complete, uniform content and working integrally to generate messages that went through the correct messaging standards to the correct sources (e.g., inpatient, outpatient, prescribing pharmacy, TBM). Vendors were adamant that the CCR standard be locked down with a uniform implementation guide and tagging approach. Trials were held at the January HIMS and May Tepper conventions. A final standard will be under final ballot in October. Demonstrations will be conducted again at both conferences in 2005.

Discussion

Mr. Robertson said the point of mapping and harmonizing standards was not to allow multiple things to happen between trading partners, but to ensure they could communicate if the two did not use the same standard. Ms. Miller noted the difficulty for implementers if NCVHS sent a mixed message. Communities implementing waited to be told which method to use. She recommended sticking with one standard, even though it might not be perfect. Progress was perfecting that standard. From an X12 perspective, she urged NCVHS to give a clear pact for implementation and stronger wording around some transactions (e.g., eligibility). She posed this as an opportunity to increase progress and ROI to providers.

Dr. Peters said CCR’s experience suggested any standard would be a benefit to the industry so long as: (1) NCVHS and HHS were explicit about what the standard applied to and was meant to do, and (2) the SDO, NCVHS, and HHS required the whole food chain to implement without variation.

Noting problems because changes with the HIPAA process called for the regulatory process, Mr. Steindel asked how “closed” e-prescribing should be.           Ms. Gilbertson contended it had to be more open than HIPAA. Personally, she believed the industry had to declare what they wanted to do and that they did not need to be regulated. Speaking from an X12 perspective, Ms. Miller noted “accept” and “reject” were the hardest words to define within HIPAA. Recommending a gentler, more flexible approach where the standards body gave prescriptive advice and implementations were truly usable, she suggested “closed enough to support, but open enough that we respond to the industry.” She emphasized that was a difficult response from a regulation standpoint. Dr. Peters said, in principle, subspecialty societies were against tight regulation, believing it stifled innovation. But, noting concern about practice management and how variability allowed under X12 did not give efficiencies doctors expected in the office setting, she said regulation to move things forward might be preferred.

Ms. Miller noted the dearth of education on how to obtain ROI based on implementation. She pointed out that many began implementing HIPAA with the claim (rather than eligibility) and still had not reaped benefit and ROI. In the business model, eligibility began that encounter and everything was driven off that transaction. Providers implementing eligibility first would not have incurred the expense of creating the claim. Emphasizing that poor implementation practice diminished what might have been exponential ROI, Ms. Miller said the pilots would lead to ROI prescriptive advice.

Asked the best way to specify terminology for the ordered drug, Ms. Gilbertson said, once NCPDP knew the business cases, it would probably be a version upgrade of the SCRIPT Standard incorporating those new fields and guidance. The difficult part was implementation. Dr. Peters noted that SureScripts discretely maps SIG, converts it to a string, and generates an NCPDP SCRIPT message. An industry standard could be used, rather than an SDO standard, to get connectivity and finite data aggregation while giving what the pharmacist needed. Ken Whittemore clarified that SureScripts had a proprietary subscriber provider ID and algorithm for handling SIG codes, but not a standard.

Mr. Robertson explained that conversion could happen at any of three points in transmitting discharge medications from a hospital to a pharmacy. Depending on the systems’ sophistication, sender, receiver or an intermediary processor (e.g., RxHub, Surecripts) could translate. Sender or intermediary was preferable.

Ms. Miller noted the medical community had not implemented HIPAA as much as pharmacy did; the eligibility transaction’s capability was not fully utilized. Many had not implemented the mandated 270/271 transaction and remained in contingency. Providers could ask complex questions down to the procedure code, but answers were owned by responder who often could not give a verbose reply. The transaction’s ability to answer questions and ROI was lost. Ms. Miller said the e-prescribing initiative would reinforce industry use of the eligibility transaction and show another ROI. She urged NCVHS to include ancillary transactions stated in the 997 implementation guide when recommending eligibility.

Mr. Robertson reported that NCPDP-HL7 were mapping (field–by-field mapping or identified conduction pyramid) functions, data elements, and ensuring appropriate terminologies exist for identifying the medication. Asked if international harmonization problems would affect e-prescribing in the U.S. across the health care spectrum, Mr. Robertson said overall flows were similar and international cooperation might help everyone understand aspects of their own processes that had been taken for granted.

Dr. Peters said ASTM tried to standardize with the Internet. Date and time, date and signature and naming conventions were meant to be consistent with WC3. Most professional feedback on XML came from vendors or financial services. ASTM tried to harmonize health care particularities and looked at standardized vocabularies, nomenclatures, coding sets, SNOMED, ICD, CPT, LOINC, and other recommendations or requirements. Dr. Peters said development of SIG was an ideal area of harmonization for ASTM, NCPDP, HL7 and others to cooperate. Asked if any industry group was a natural focal point, Dr. Peters noted traditionally NCVHS would be that place, but EHR and e-prescribing vendors were the driving force for CCR. He supported NCPDP convening that group.

Mr. Robertson noted discussion in the NCPDP working group’s last meeting about SIG standard. HL7 and NCPDP agreed to converge their internal dialogues; at the moment, NCPDP was their focal point. Dr. Fitzmaurice suggested NCVHS recommend any consensus, but noted work had to be done quickly. Mr. Robertson clarified that SPL’s content included directions for use, but coded representation was limited by available terminologies and nebulous. Currently, SPL would not be a uniformly recognized source for that information. Collective efforts to standardize SIG would apply directly to the SPL and its representation. Dr. Peters cautioned that SIG from the provider to the pharmacist, product label, and how NDC identified the product were distinct entities. Information from the medication’s label that patients entered into their personal health records would not match. Ms. Gilbertson noted the working group discussed standardization of SIG and Mr. Robertson had pointed out that SDOs could only go so far – they had to reach out to the industry. Dr. Peters noted EHR and e-prescribing vendors wanted structured, detailed SIG and the route codified or enumerated that allowed automatically converting a prescription between medical and lay terminology.

Ms. Gilbertson clarified that the medication history, formulary and provider directory were transactions or functions currently performed with modified SCRIPT or other proprietary formats brought forward through NCPDP. Ms. Byrne said RxHub hoped to simultaneously use existing standards in the January 2006 pilots and take them through the NCPDP process.

Asked what had to be done with the messages for preauthorization, Ms. Gilbertson noted NCPDP prior authorization transactions already were in use between pharmacy, PBM or payer and there were X12 transactions for prior authorizations from prescriber-to-payer. It was not known whether these flowed together or if the business case MMA might introduce was part of flows that exist in the transaction.

Ms. Miller noted the 278 request response provided limited support for request for prior authorization of drugs. Short term, work-arounds existed; more were needed. The X-12 authorization workgroup had the capability and could move long term. X-12 had authorization transactions that could be utilized for this purpose. The registry was posted at WPC-EDI.COM. She noted it was difficult to make standards broad enough that everyone could use them, yet specific enough to convey the intent of that business content message. Trials and tribulations faced with the HIPAA implementation suggested how to make things better. X12 looked forward to NCPDP leading the way and proposed the DSMOs and Health Information Standards Board (HISB) as forums where issues could be brought forward for the benefit of the industry.

Ms. Miller said HIPAA transactions gave providers the opportunity but the message had not gotten out and they did not realize how those transactions empowered them. Contending that e-prescribing focused down to the provider, she said she wished she had the eligibility transaction when she was practicing and could have seen what the benefit package told about patients and their bigger picture. She recommended getting that message to providers by focusing pilots on ROI and the benefit.

Mr. Robertson doubted it was significant whether any one organization took the lead, providing everyone was at the table and working together; it was more a matter of who had resources and was available. In order for prescribers to buy in, he contended the user interface had to be useful and one they could deal with. Prescribers did not want to deal with terminologies or care which codes were behind the scenes; but they would balk if expected to use unfamiliar NDC. Although the user interface became divorced from some discussions about standards, Mr. Robertson noted the relationship between them had to be addressed. It was important the prescriber community understood what e-prescribing bring them. There might be complications but, effectively introduced, it could benefit their workflow and ability to provide better care, rather than be viewed as regulations imposed by the government. Agreeing that the standards could be made to do about anything the industry asked, Ms. Gilbertson urged NCVHS to focus on benefits and improving information flow.

Dr. Peters agreed that doctors cared about what they could interact with and ease-of-use, not “what was under the covers.” Vendors in e-prescribing and electronic health records were confident they could provide that and sought uniformity but still had to deal with variability. He pointed out that 95-98 percent of retail and mail order pharmacies were automated and used NCPDP for all their connectivity on billing and claims. Doctors and vendors worried about siloing with only a prescribing application, not different standards. End users would just as soon have a uniform approach with EHR e-prescribing practice management integrated. They did not care if that came from one vendor, as long as vendors achieved interoperability. What they wanted was uniformity in terms of the back end.

Dr. Cohn recalled that MMA suggested existing commonly accepted standards did not require piloting; the Secretary could advise the industry earlier than 2009 about their applicability and use for e-prescribing. They heard NCPDP SCRIPT, while not having all necessary functionality, was probably usable. The 270/271, though not perfect or sleek and needing improvements for eligibility, had work-arounds for the message formats and could be used. Ms. Gilbertson agreed that standards currently in active use could jump immediately to CMS’s studies for the ROI environment. New prescriptions, refill requests, formulary, and eligibility checking provided models that were low hanging fruit. Medicare, new as a payer, had to be part of the 2006 demonstrations. Ms. Gilbertson confirmed that the refill transaction, which could go through relatively unmodified, was low hanging fruit.

Participants observed no one knew what Medicare would introduce into the PBM’s environments. PBMs, concerned with the drug spread and expense of managing that population, were not clamoring for Medicare business. Providers did not know what services PBMs would sell to the Federal Government or Medicare. Specialty pharmacy, DUR and audit would change requirements for messaging

Noting HIPAA’s struggle to meet Medicare’s needs in the standards because they required different data elements than other payers, Ms. Gilbertson cautioned that these could show up in the e-prescribing environment. Ms. Miller expressed concern with mandated implementation of the 4010 eligibility transaction that had the install base within the industry, when 4050 or 5010 implementation guides could be more eloquent in meeting new requirements. She urged that SDOs be enabled to move forward to the next versioning of their transactions that better met the environment’s changing needs.

Recalling earlier testimony that prescribers wanted an acknowledgement of receipt and noting NCPDP’s request for receipt was a VERIFY transaction concern was raised about the cost of these transactions, Ms. Amatayakul asked for perspectives. Dr. Peters remarked that doctors on the street were interested in fulfillment data, not the receipt. Ms. Gilbertson noted that the NCPDP SCRIPT transactions were request/response based with real-time bases. The VERIFY transaction, like the USPS return receipt had another functionality for a specialty situation and was not widely used. Real-time request and response handled what was needed. Ms. Miller suggested adding the 999 acknowledgement to an implementation along with TA1 and 997. She also noted that the proper response in real time to an eligibility was the 271, the informative answer. Dr. Cohn thanked everyone, observing that NCVHS worked best when everyone worked together to help drive industry consensus.

HL7/NCPDP Harmonization

  • Ross Martin, M.D., M.H.A., Senior Manager, Business Technology, Pfizer

Dr. Martin said HL7 and NCPDP acknowledged the need for coordination but until recently there had not been a compelling business need to drive a concerted effort. One driver was the path to MMA and business cases where HL7- and NCPDP-centric systems had to communicate. National Health Information Infrastructure (NHII) efforts and the appointment of Dr. Brailer as national coordinator for health information technology were other forces. Dr. Martin noted NCPDP and HL7 selected liaisons to facilitate communication. Conversations around these efforts focused on e-prescribing and the need for action. In April 2004 a draft proposal for accomplishing some of these tasks was distributed. Pfizer supported a stakeholder meeting on July 27.

Dr. Martin said a workspace had been created using Yahoo groups that was only available to participants, due to proprietary information. Anyone interested in participating actively in the process could join by contacting Dr. Martin at ross.martin@pfizer.com. Others could join the listserv (RxNCPDP@List.HL7.Org) by going to the web site www.hl7.org, clicking on “list servers” and following the instructions for joining this listserv. Observing that the project had sparked a broader process, he noted in August HL7 members attended for the first time an NCPDP workgroup meeting and actively participated.  Opportunities for mutual understanding, education, and collaboration include: mapping to HL7 v3, mapping HL7 to the NCPDP telecommunications standard primarily used for pharmacy claims adjudication, and bidirectional medication history information exchange.

Both boards made an addendum to their current MOU specific to this project. Dr. Martin said he saw real fellowship and opportunity-driven interactions. Stakeholders provided in-kind support. Pfizer was committed to providing ongoing functional support. Dr. Martin noted Pfizer belonged to ANSI HISB and concurred with the possibility of HISB as a forum for determining how overall harmonization went on between standards organizations.

Noting how hard it was for individuals or companies to volunteer to circle around their own standard, giving their time and proprietary information so communications could flow, Dr. Martin noted HHS and AHRQ could do much to facilitate efforts. Pfizer was looking at possibilities for grant money and in-kind services

Dr. Martin reflected that transforming health care was analogous to digging up the national highway system and putting it underground while not impeding traffic. He said the VA’s involvement in this project served as a model for how federal agencies could take a role-up-your-sleeves approach to participating in standards that was extremely helpful. NCVHS’s role as a facilitator was needed.

HL7/NCPDP Harmonization

  • Karen Eckert, RP.h., M.P.M., Medi-Span, WoltersKluwer Health

Dr. Eckert said the group identified discussion points: scope, resources, deliverables and inversion. Scope focused on goals for the first and subsequent phases and defined a specific, succinct and achievable goal. The group is identifying sources for expertise, project coordination and funding. Expectations about deliverables and the finished product must be firmly held internally with outside stakeholders as well as within the group. The group discussed which versions of the two standards should be targeted for mapping.

The project goal is to: (1) produce a guidance document outlining typical mapping requirements between HL7 and NCPDP SCRIPT standard messages, (2) conduct a working demonstration project of mappings resulting from this guidance document, (3) change both management process to ensure the guidance document continues to be updated, (4) create a future phase document of additional currently out-of-scope work for further collaborations.

Dr. Eckert said the project scenario focused on what they heard in previous testimony would bring the most benefit in the first phase: new prescriptions and renewals (e.g., upon hospital discharge, sending the prescription electronically to the retail pharmacy). A prescriber will initiate both a request for a new prescription and a response to a refill/renewal request from a pharmacy. Pharmacy will accept the request for a new prescription and initiate a request for a refill.

The group chose versions most readily available in the community in all implementations: HL7 v2.3 and NCPDP SCRIPT v4.2. Two tests early in 2005 (HIMS February in Dallas, NCPDP Annual Conference in March in Phoenix) will demonstrate messaging between a hospital or clinic CPOE system and community pharmacy. Demonstrations will be repeated for the pharmacy community. Participants will include SureScripts with their electronic prescription transmission, Cleveland Clinic using EPIC as their CPOE system vendor, and other pharmacy vendors. VA and their CPOE might participate. RxHub (and, if time allowed, the medication history) might also be included.

Discussion

Noting harmonization was critical, Dr. Cohn asked how to stabilize and align this effort and ensure messages were exchanged with fidelity. Noting exchange in the pilot was based on proprietary mapping and would only show a handshake was possible, not that mapping was useful long-term, Dr. Martin said the question was would the implementation guide be enough of a road map for anyone to translate. Contending that, in the world of HL7 Version 2X, there was so much variability in the implementations that only guidance could be given, Dr. Martin said the role of harmonization efforts was to show somebody could do the translations using the implementation guide. A mapping standard could be out there with v3 before it was in widespread use, avoiding some of that variability challenge

Dr. Eckert noted agreements that this document would be maintained and available through the separate SDOs. As people implemented, changes were needed or there was a new version of SCRIPT, the workgroup would maintain this document. It would then be handed back to the SDOs to maintain as versions were updated. Dr. Martin said the group’s most important work product was not the mapping exercise but the process by which HL7 and NCPDP would create guidelines for translation and continue to support them.

Mr. Robertson said HL7 and NCPDP had generally agreed on core messages and data elements for demonstrating moving a prescription from one entity to another. Near term, a focused set of pieces had to be mapped: the new prescription order, refill authorization request, refill authorization functions. Person, product, directions, quantity, provider and location had to be identified within those functions. The SDOs knew they could do them. Incorporating other things supported by SCRIPT beyond those in the first pass would bring up more terminology issues. Identification of the product would be a string name interpreted by visual inspection; the terminology did not yet exist. Parts of HL7 pharmacy messages not mappable into SCRIPT hopefully were beyond the scope required for e-prescribing. Dr. Martin noted this domain spoke to the need for a universal translator (e.g., RxNorm.) Dr. Eckert cautioned NCVHS to remember, when considering a standard requiring implementing RxNorm in the messaging and systems all end-user sites, Ms. Gilbertson’s discussion about ROI and ensuring a value proposition for system vendors.

Dr. Martin emphasized that project coordination was the key and that respecting volunteer’s time (e.g., grants providing for technical writers, project coordinators) was the best way to maintain momentum. Dr. Eckert noted the need to fund training as they moved towards v3, which was more difficult to understand. Most of what had been done was in kind and supported by the SDO. The rest would take monetary resources.

Mr. Steindel cautioned about cost overruns and the need for groundwork defining exactly what mapping did, results, and how organizations maintained it.

Dr. Cohn noted they were discussing moving this from project status to institutionalization. MMA was asking a lot from HL7, NCPDP and other SDOs, which historically worked on a voluntary basis, but he emphasized the opportunity to be successful in more than a single demonstration project. Dr. Martin said some volunteers saw the business case and felt giving time was in their organization’s best interest. He said he also saw a lot of passion and emphasized ensuring that volunteers did not do what could be done in a facilitative way.

Terminology Standards: Readiness for Adoption and Demo, Mapping to Drug Knowledge Bases

  • Randy Levin, M.D., Food & Drug Administration

Dr. Levin reported on FDA’s work with medication identifiers and terminologies for e-prescribing done in collaboration with NLM, the Department of Veterans Affairs, the Agency of Healthcare Quality and Research, drug manufacturers, repackers, relabelers distributors, and health information suppliers.

He noted three types of medication identifiers for ingredients; active (the unique ingredient identifier [UNII]) and inactive ingredients and active moiety. A number of codes were available. Active ingredients for most approved prescription drugs will be available early in 2005. Active ingredients for implementation in all marketed products will be available within three-to-four years, dependent on changes in FDA regulations. Active moiety (any portion of the active ingredient responsible for the effect) and inactive ingredients (components of the drug product other than active ingredients) also have UNII codes and will be available in that time frame.

Dr. Levin explained there were two identifiers for drug products (actual drug plus package drug product. Drug products are defined by the active ingredient, strength, manufactured dosage form, inactive ingredient, specific appearance of dosage form, proprietary name, manufacturer and distributor. A drug product might contain two-or-more drug products in one package. NDC labeler plus product code is the identifier for drug product. Most prescription drug products already have codes in FDA’s national drug code directory. Some other third-party vendors also have codes. The identifier for the packaged drug product is the labeler code from the NDC plus the product and package codes. Implementation for all marketed and packaged drug products is targeted for three-to-four years, dependent on changes in FDA regulations.

Noting problems with NDC were identified in previous discussions, Dr. Levin said FDA would improve NDC if the regulations were changed. Implementation would take three-to four years. He emphasized that codes were available for a pilot. RxNorm was positioned between active ingredient and drug product and would fill any gaps. Supplying this information to NLM will enable them to generate the correct form.

Medication terminology included ingredient, established drug product and proprietary drug product names; manufactured dosage form; route of administration; strength; appearance and package type. Ingredient and product names were available. Most prescription drug products were in the NDC directory. All marketed products would be up to date and comprehensive in three-to-four years. The manufactured dose form, route of administration, strength and package type were currently available in FDA’s data standards manual. FDA plans over time to harmonize (mapping, then blending to be the same) these as appropriate with HL7 and other groups, including international regulators. FDA is working to standardize medication information, evolving labeling section headings and associated content into a more highly structured format. A limited number of approved prescription drug products will be available in structured format late in 2005. All approved prescription products are expected by 2007; all marketed products are expected within three-to-four years, depending on changes in FDA regulations.

SPL is an HL7 standard in XML format with computer-readable tags dividing content labeling into sections defined by regulations that include medication identifiers and terminology standards. SPL is part of the drug description and provided as data elements to NLM for distribution in the Daily Med and support creating RxNorm. More information (e.g., mechanism of action, drug interactions food interactions, adverse events, indications and dosing) will be provided in the future based on new formatting regulations for structured elements. Some terminologies will be taken from the VA’s work with their terminology. Dr. Levin noted there is an SPL implementation guide for pharmaceutical companies submitting input for FDA content labeling as well as a style sheet for viewing labeling information. The FDA data standards manual and style sheet are on the FDA Web site (www.fda.gov/cder/dsm). NDC is on the CDER Web site (NDC/database default.XTDM data set). FDA data standards are in the Consolidated Health Informatics Web site (www.whitehouse.gov/omb/egov/gtob/health_informatics.htm). SPL information (including schema, implementation guide and style sheet) are on the HL7 Web site (SPL on www.hl7.org).

Terminology Standards: Readiness for Adoption and Demo, Mapping to Drug Knowledge Bases

  • Steve Brown, M.D., Department of Veterans Affairs

Dr. Brown explained that NDF-RT was a formal terminology with description logics based on VA’s NDF that interlinked with terminologies from other government organizations and at least one SDO with NLM, RxNorm, MESH, and coding systems from the FDA, including uni-codes. NDF-RT worked closely with the National Cancer Institute and HL7 dose forms, was published in the AB Metathesaurus (http://nciterms.nci.nih.gov), and NCI had the FRT as part of its browser (NCI.NIH.GOV).

Additions in terms and concepts related to pharmacogenomics have been added to NDF. Process integration included the new drug transaction, near-term rapid turnaround, the NDF maintenance environment, and lab and pharmacy reengineering initiatives.

VA was focused on integration and implementation rather than changes in concepts. MOA currently is 256 elements (in 2003 it was 232). P currently is 1,699 (24 higher than in 2003). Dr. Brown emphasized that changes had evolved in a controlled fashion. Decision support would not supplant a drug knowledge base in complexity. Basic modeling was done in a couple areas. VA worked with FDA, adding to roles and properties. Updates were done from NDC databases. Some 1,100 uni-codes were mapped into products. VA worked with NOM on RxNorms, drugs and components and had begun work with NCI. VA also had to solve issues with devices and supplies in NDF.

Terminology Standards: Readiness for Adoption and Demo, Mapping to Drug Knowledge Bases

  • Stuart Nelson, M.D., National Library of Medicine

Dr. Nelson clarified that the Daily Med would be a browsable and downloadable system hosted at NLM that contained SPL, RxNorm name, VA NDFRT information, and links to other sources (e.g., PubMed).  He said NLM will be ready and waiting for the first SPL from FDA late in 2005 that will form the core of Daily Med.

Asked what FDA needed from those terminologies for e-prescribing, Dr. Levin noted many codes were already available for piloting. UNII codes were not available until 2005 for active ingredients, but FDA could come out with certain ingredients earlier.

Dr. Nelson emphasized that RxNorm was built to facilitate interoperability between vocabularies and closely linked to UMLS, which NLM saw as an important vehicle for interoperability of many vocabularies, especially clinical vocabularies that might form the basis of an EPR.

Documentation was available. First updates to RxNorm separate from UMLS will be released in fall 2004. RxNorm will be synchronized with UMLS, but released more frequently in order to be useful in a clinical environment. UMLS may be issued quarterly. RxNorm will first have monthly, then weekly updates. RxNorm’s interim releases will use identifiers in the extant version of UMLS.

Dr. Nelson said current content included 110,000 concepts and over 95 percent of prescription drugs available with an RxNorm ID. Appelon mapped the version of RxNorm released with the 2004 AA version of the UMLS Metathesaurus against the thousand most common prescriptions written in DOD in 2002; 974 had an associated RxNorm form and ID. Gaps included kits that until then were not in RxNorm IDs and both durable and consumable orderable supplies. RxNorm does not address some problems with a prescription’s content, including SIG or routes of administration, but delineates administered form. NCPDP and NLM plan to test RxNorm with 100-200 commonly prescribed drugs.

Dr. Nelson noted three types of prescriptions: clinical drugs, drug/delivery (dispensing: paks, kits) device containing more than one drug (RxNorm will add codes for these), and compounded medication. NCPDP does not accommodate compounded meds because many states require paper script.

NLM has not tried to represent what is in its orange book of therapeutic equivalence and is considering whether to address the level of equivalence between brand names and generics.  NLM is willing to support a list of special ingredients, but could not support whether a particular drug contained those ingredients. FDA will do that. NLM will also support reimbursable common supplies (glucose test strips) orderable on a prescription form. Noting vocabulary was engineering, not science, Dr. Nelson emphasized the need for continual coordination over time.

Discussion

Dr. Nelson agreed that there needed to be a central point “where everything was put together in a workable fashion.” He noted UMLS was built to facilitate interoperation at different levels. He considered RxNorm a specialized case, though much the same. NLM’s goal was to facilitate interoperation of vocabularies. NLM had experience within the surrounding vocabulary and cooperated with pharmacy knowledge-based vendors for their drug vocabularies, with FDA for their drug vocabularies, and served as the core of the communication between FDA and VA.

Noting they heard the clinical drug (i.e., RxNorm) was the terminology clinicians wanted to use to order medication and that medications’ dispensed form was NDC, Mr. Steindel asked how NLM would convert RxNorm code into NDC code, especially with generic drugs. Dr. Nelson said NLM’s pilot with NCPDP would test the utility of RxNorm and e-prescribing to a pharmacy and its proprietary pharmacy knowledge base. He said NLM was taking quarterly FDA updates and including them as attributes to RxNorm forms. Many NDC codes might be associated with a specific RxNorm form. Emphasizing that NDC codes were an important, but not the sole level of abstraction,. Dr. Nelson pointed out that pharmacy might need more specific knowledge (e.g., lot numbers).

Dr. Levin observed that the problem with NDCs was that they changed so much and on a daily basis. SPL would help passing to NLM and having an up-to-date linking between RxNorm and NDC. Extensively testing this conversion in the pilots would show people how that would work. The SPL standard was available, and pharmaceutical companies would start supplying example labeling. Implementing this system and process would continue through most of 2005; by then some products would be available to CMS for a pilot.

Asked the best source for the name of a brand substance (e.g., Valium), Dr. Nelson explained that updates will have CUIs. A new brand name on the market will have an RxNorm ID before it gets into the UMLS. He explained that RxNorm had IDs for everything from ingredient down to the level of the clinical drug

Noting two different use cases (using an orderable system to say independently in different fields Valium, 5 milligrams, and tablet compared to indicating one was allergic to Valium) Dr. Huff emphasized capturing information at the same level it was provided in statements. Dr. Nelson said the branded ingredients represented both the trade name and active generic ingredient.

Dr. Nelson explained the Daily Med will be available in 2005 (after NLM gets SPLs) as a browsable NLM database with some downloadable format (probably XML).

Identifier Standards

  • Karen Trudel, Acting Director, Office of HIPAA Standards, CMS

Ms. Trudel identified three types of health plans from the Medicare Part D perspective:

drug programs in Medicare Advantage plan, PDP plans, and fall-back plans contracted to provide choice. All were under HIPAA and could be enumerated. PlanID will not be ready for three-four years. For MMA, these plans could be an extension of the current process. However, Ms. Trudel noted different contracts and benefit packages in the private sector could impact development of NPRM. She urged SSS to recommend additional requirements for the PlanID structure.

She noted the Health Insurance Claim Number (HICN) used in Medicare Parts A, B, and C would be used in Part D. HICN (the security number of wage earner and suffix showing beneficiaries relationship to wage earner) did not include identity verification or personal representative. Interoperating would require either a master patient index (MPI) or a return to the concept of a HIPAA patient identifier.

The NPI compliance date is May 23, 2007; May 2005 is the effective date for the regulation and issuance of NPIs to providers. System build and enumeration contract were underway. Pilot testing is scheduled May through August; identifiers will be issued in August or September 2005. Ms. Trudel noted the NPI will enumerate many providers, but would not replace DEA, FEIN, enrollment of providers in a health plan, or certification. Both covered and non-covered providers and subparts of covered providers (including non-legal entities that furnish health care: e.g., location, hospital components, members of chains) can get NPIs. NPI is an all-numeric ten-position identifier with one check digit and does not convey provider or subpart information. Uniqueness is determined by collecting information about the provider, with different data elements for individuals and organizations. The state of licensure and license number would be collected for every taxonomy code type. There was no statutory requirement under HIPAA, but non-covered providers (e.g., physicians that do not bill independently, nurses) were encouraged to get NPIs. Service providers (e.g., carpenters, taxi drivers) were not enumerated. She noted they heard dispensers used the NCPDP identifier, but NPI was required on the claim and accommodated locations by subparts. Authorized agents and supervisors could receive an NPI, even if they were not a covered entity.

CMS initially proposed to enumerate locations but commenters contended location changed too often: obtaining an additional location identifier and providing all that information every time a practice moved would be nearly impossible. The location identifier was dropped from the final rule. She noted three possibilities: recommend use of the HIPAA standards and require a NPI, DEA and third number; recommend the HIPAA standards and fill gaps so a single identifier did everything for everyone; or adopt another standard that did it all. Ms. Trudel cautioned that the cost of rolling out a new identifier would have to be borne along with the cost of rolling out NPI. Prescribers would also bear the cost of maintaining another ID. She emphasized that in implementing any standard mapping (e.g., NPIs to HCIdea, ID to existing identifiers) would be critical.

Identifier Standards

  • Lee Ann Stember, President, National Council for Prescription Drug Programs

Ms. Stember explained that NCPDP is an ANSI-accredited SDO creating and promoting standards for transfer of data to and from the pharmacy services sector. In 1991, NCPDP identified a need for a unique prescriber identifier (UPI). Health plans needed to identify prescribers for utilization management. Pharmacies and processors/PBMs required a UPI across plans for prescribing, claims processing and utilization requirements. A significant portion of the prescription drug industry uses the DEA number to identify prescribers on prescription benefit claims. Problematic use and state legislation banning use of the number for any function other than DEA’s intended purposes of being a barrier to illegal controlled substance distribution led NCPDP to initiate a project to create an alternative prescriber identifier, which was vacated with announcement of the NPI in HIPAA.  Delay in the NPI led NCPDP to announce in 2002 joint development with NHIN of an NCPDP prescriber enumeration project where all prescribers (even those without ability to prescribe controlled substances), would be enumerated. Additional fields in HCIdea for each prescriber facilitate payment processing and more accurate prescriber identification. NCPDP envisioned HCIdea would mirror the success of NCPDP’s current pharmacy enumerator: the NCPDP pharmacy provider number.

With eventual implementation of NPI, NCPDP would create a crosswalk between the HCIdea identifier and the NCPDP provider ID number to NPI, facilitating the prescription drug industry’s transition to NPI. NCPDP entered into data supplier arrangements with various healthcare entities to supply prescriber data to NHIN for validation and population of the HCIdea database. The data was cleansed and each prescriber was assigned an HCIdea enumerator. The model provided ongoing updates of the HCIdea database.

NCPDP signed agreements with twelve data suppliers. Multiple data suppliers have passed all certifications: criteria have been met and data can flow between sources. DOD and other customers receive this data. The State of Utah Bureau of Medicaid Operations, in conjunction with NC and a major pharmacy chain, would begin testing transmission of HCIdea data between pharmacies and the Medicaid Bureau in the near future. Implementation throughout Utah was expected in 2005.

Ms. Stember emphasized that the HCIdea database was not a substitute for NPI, but a large subset of its providers. Noting they were still in a “soft launch” that ensured the integrity of the database, she said the current database contained only prescribers (e.g., MDs, DOs, advanced nurse practitioners, physician assistants, optometrists). The database contained 1.2 million or 86 percent of the records. Ms. Stember said the HCIdea identifier not only provided for the claim billing processing initially identified for the industry, but could serve as an enumerator for newly defined requirements of electronic prescriptions.

CMS could use the Medicare ID number to identify prescribers for Medicare prescription drug benefits. But e-prescribing was being adopted by prescribers also serving private-pay and Medicaid recipients. Using a different number for each payer would add a level of complexity that impeded adoption.

NCPDP’s pharmacy identifier had been used since 1977and was included on over 4 billion transactions annually. Ms. Stember said it could be a way for prescribers to identify the patient’s choice of community pharmacies.

Discussion

Dr. Fitzmaurice asked if it was feasible to use existing data sets (e.g., UPIN, NCPDP) to fill blanks in enumerating prescribers and then verify the information. Ms. Trudel said CMS planned for the possibility of mass enumeration and always considered freeloading with existing high-quality data an option. She clarified that NPI included the state of licensure and number for any practitioner with a taxonomy code in the physician range. Phillip Scott, Senior Vice President of Health Care and Professional Development, NCPDP, said the HCIdea enumeration process took into consideration all available licensure; NCPDP could utilize UPINs and other identifications available through value-added fields, if necessary checking with a call center.

Noting that the principle advantage of HCIdea was that it identified multiple locations for a single prescriber, Mr. Blair asked what limitations there would be if NPI was used with separate direct indications, self locations or telephone number as proxy,        Mr. Scott said that depended on the business need. Pharmacy needed to verify physicians’ locations. Ms. Trudel confirmed that NPI will be required on HIPAA transactions, including the retail pharmacy drug claim, but not at this point on the prescription. NCPDP already arranged for mapping between HCIdea, NPI, and the NCPDP pharmacy provider identifier.

Ms. Stember clarified that HCIdea was a licensed product of NCPDP. Currently no fee was attached. Mr. Scott explained the initial purpose of HCIdea was to provide a unique identifier for pharmacy claims adjudication, eliminating the DEA number. As states sought to eliminate use of DEA numbers in any identification or financial transaction, it became apparent that prescribers also had a need for HCIdea. Mr. Steindel observed that neither DEA nor HCIdea was meant to be used for e-signature purposes and there could yet be a third identifier.

Remarking that they seemed to be on a track of multiple interim implementations, with NPI trying to be the end-game, Mr. Reynolds questioned whether the NPI database could contain all needed elements, He expressed hope they could focus on NPI and wrap all the numbers around it. Ms. Trudel said the sort of continuity CMS envisioned was mapping and the national provider system (NPS) collecting and holding other identifiers provided by the provider at the time of enumeration.

Asked about the HCIdea database’s structure, Mr. Scott explained that one number identified the individual prescriber and a dropdown in the database gave the multiple locations. A secondary field would hold an identifier (e.g., NPI if required). Ms. Trudel noted NPI only collected primary location and mailing address. A supplemental location code that could be added was only in the proposed, not final rule.

Ms. Trudel clarified that if NCVHS and the community decided they needed that correlation to location, an NPI with a location code could be repurposed or a proxy (e.g., phone number) could act as location. She urged NCVHS to weigh whether these requirements for e-prescribing should be imposed for all HIPAA transaction (e.g., claims).

She clarified that the NPI database had the ability to track state license numbers as one means of identification to eliminate duplicates, but could not identify using name, date of birth or other things. They would not provide the unique map to the NPI. Asked if, from a structural point of view, the database could be modified, Ms. Trudel said she did not see any regulatory reason preventing it. Ms. Stember and Ms. Trudel said they could not anticipate any problems resulting from including the HCIdea number as appropriate for prescribers with their NPI number.

Ms. Amatayakul questioned whether this meant HCIdea must be maintained to continuously populate NPI. Ms. Trudel explained that additional data would not be loaded from the HCIdea database; the identifier would be crosswalked and contained in the NPS database. She pictured the HCIdea database serving the purpose of a master prescriber index. It would continue to have a life and value of its own after everyone was assigned an NPI. Dr. Cohn agreed that HCIdea database was a value added and a valuable product for the industry. NPS or NPI did not have to solve every problem for everyone. Ms. Trudel noted that was the overwhelming flavor of the comments received in the final rule that caused CMS to cut back on some content. Dr. Cohn clarified that he thought NCPDP might help CMS with the enumeration process because they were ahead in identifying providers, but he said he was not certain NPS should include the HCIdea number or that its importance went beyond linking everything together as a value added product for NCPDP. Ms. Trudel said that, whatever NCVHS recommended to the Secretary (e.g., map to as many identifiers as possible), CMS would “figure out how to make it happen.”

Asked what had to be done to get that mapping and linkages to CMS, Mr. Scott said any collaboration between NPI and HCIdea was because the data was clean, not about the number. Participants noted that HCIdea and the NCPDP provider identification number were the same case with different types of providers. Potential bulk enumerations for CMS were available.

Standards for Formularies: Messages, Structure and Prior Authorization

  • Teri Byrne, Director, Trading Partner Integration, RxHub

Ms. Byrne presented RxHub’s plan for taking their proprietary standards through the NCPDP process to become accredited standards. She said her job has been to understand from a technology vendor’s, EMR’s, health plan’s, and PBM’s perspective the requirements and the data and information to be transferred in e-prescribing. RxHub developed and put out for public comment a set of standards, held workgroups over several years to modify and pilots to prove them. The standards were used in production applications including EMR, point-of-care technology, and electronic medical record vendors, PBMs/pharmacy benefit managers, health plans, hospitals and pharmacies/pharmacy networks. Twelve participants used RxHub standards or presented information to physicians. Ten others certified on RxHub transactions were ready to move into production as soon as they could roll out to their physicians. Eight more were currently certifying on RxHub transactions. RxHub also worked with others who had signed NDAs, received implementation guides and were developing flow transactions.

RxHub developed their MPI (proprietary software) to locate patients or their health plans. A proprietary file transfer loaded that data from the plans and PBMs.

The eligibility transaction utilized the X12 270, 271 inquiry response, thoroughly answering questions asked. RxHub developed a file transfer to preload formulary and benefit information provided by the plans and PBMs to the point-of-care application.

A formulary and benefit file transfer real-time transaction to the PBMs was designed as a physician application to ask PBMs or plans if a drug was covered; however technology vendors choose to preload this information. Multiple formats were developed using NCPDP SCRIPT standard for the patient medication history. The first format provided information from the PBM for health plans about medications paid for by that plan. RxHub also utilized HL7 formats. One, the ORU transaction or messaging format, reported receiving a request. An NCPDP-like transaction was then sent to the PBM to elicit information back, which was translated back into a report format of medication history for the physician. Vendors utilizing the discrete data rather than report format used the RDS message format to translate between NCPDP-like translation data format and an HL7-like data format. (RxHub was participating in mapping between NCPDP SCRIPT and HL7.)  The provider list indicates participating physicians and pharmacies; information received was shared back. NCPDP SCRIPT was used for prescription messages.

This batch file transfer included formulary data (formulary status, alternatives, non-listed drug indicators, and text messages), benefit data (drug requirements for coverage exclusions, prior authorization, step therapy, age, gender limits, quantity limits, text messages, and co-pay information. Prior authorization only indicated authorization was required; it did not enable sending an electronic request. Co-pay was added early in 2004; a pilot for utilization was nearly completed.

A task group open to everyone was formed to complete and submit this format to NCPDP for approval. After receiving feedback, the task group would hold a series of workgroups to include other formats. Ms. Byrne noted the time frame for approval (two years) depended on how well the RxHub format supported the rest of the industry’s needs. She estimated it would take a year for the group to reach consensus on the format, before taking it to Workgroup 11, the pharmacy workgroup, and then submitting it for the workgroup’s approval and for a vote or adjudication by the membership

At their November 2004 workgroup, RxHub would submit a data element request form (DERF) for changing the patient medication history. Time frame for approval is one year. Estimated completion was January 2006. RxHub hoped to work with ProxyMed and SURE Script to amend their different versions of the provider list transaction. Time frame for approval is one year from the time of submission, utilizing a DERF,

Ms. Byrne urged NCVHS to recommend utilization of the RxHub standards currently in use for demonstration projects in January 2006. She said RxHub would volunteer to be part of the demonstration projects. She recommended that HHS adopt the RxHub standards under MMA and that NCVHS stay involved in NCPDP’s consideration of the RxHub standards.

Standards for Formularies: Messages, Structure and Prior Authorization

  • Brian Bamberger, President, MediMedia Information Technologies

Mr. Bamberger noted that MediMedia’s health plan and PBM clients provided a variety of submission formats. MediMedia worked through the process and considered a submission standard desirable, but unnecessary. When making decisions on the P&T, MediMedia worked at the higher drug- rather than NDC-level.

Mr. Bamberger encouraged NCVHS to recommend CAQH submission formats as a starting point. MediMedia believed the submission format should allow for maximum flexibility and creativity on the part of the plan. He argued that the submission format should be developed and maintained by an ANSI-accredited SDO (e.g., NCPDP or HL7).

MediMedia collected, validated, aggregated and maintained weekly or monthly provision of formulary and, in some situations, tested real-time.

Mr. Bamberger advised NCVHS to consider the need for a wider data set and building in adequate time frames for vendors to reconfigure existing software. He noted that content and breadth of a formulary varied by plans, making difficulties for application vendors. Mr. Bamberger said developing formulary and messaging standards should be led by plans (e.g., AMCP) and an ANSI-accredited SDO.

He agreed with testimony at the July hearing about the difficulty of getting patient demographic information from the practice management system. However, he noted another barrier was linking formulary with the health plan card information obtained by the practice. Many patients ended up with two cards (for the pharmacy and health benefits) and the office staff only collected information on the health plan card. RxHub worked around this by creating MPI, but Mr. Bamberger questioned forcing PBMs and plans that felt it was not in their best interest to join RxHub. He suggested that identifying health plans and numbers on the plan cards would facilitate at an individual card level the linking of a specific plan and individual benefit to a formulary.

Approval criteria in plans developed by P&T committee varied greatly and the process of obtaining an approval for a prior authorization was onerous by design. Mr. Bamberger predicted prior authorization was likely to increase when PA was automated. Software solutions leveraging a formulary database would flag drugs requiring prior authorization Algorithm could run on the system or interactively, allowing physicians to document their judgment. Approval code could go to the dispenser. MediMedia volunteered to create a demonstration project with one of their software vendors and health plans to work through that process.

Discussion

Ms. Byrne expressed concern that technology vendors already using these transactions would have to redevelop to essentially new standards that still might not get approved. Ms. Gilbertson questioned that they could measure a fair ROI if the standards turned out different by the demonstration time frame, because the participants would want to wait until things were locked down.

Ms. Gilbertson reiterated that Medicare was a new payer in the prescription drug benefit environment; they could not assume Medicare rules would fit well. She suggested the pilot’s purpose was not to test what existed but ROI on investment, educational opportunities and studies that might be done as part of the demonstration. Ms. Byrne suggested the support might be to help technology vendors pay for implementation of new standards.

Mr. Bamberger said MediMedia was willing to participate in the development of the formulary exchange standards, but did not understand enough of the RxHub information and was cautious about not going backwards.

Ms. Byrne commented on the need to recommend one format, eliminating the need to develop multiple proprietary standards.  She noted the task group was open to members and non-members of NCPDP.

Phil Rothermich, ExpressScripts noted plan-, group- and member-level formularies had rising granularity. There was a place for each.

Ms. Byrne explained that the entire formulary was transferred to the point-of-care (POC) application in the formulary/benefit batch file. PBMs and health plans could distribute all or some of their formularies to particular technology vendors, depending on their needs.

Ms. Byrne clarified that patient medication history was a real-time request/response, but not during the prescribing process. She recalled PBMs testified in July about the RxHub model and downloading formulary information prior to the physician seeing the patient so information could be used during the prescribing process.

Members thanked RxHub for their decision to work with NCPDP to make these messages ANSI-accredited standards through the consensus process.

Open Microphone

Mr. Whittemore noted that the NCPDP standard had not been a “deal breaker” for SureScripts. Remarking that the dearth of unbiased, sound information about ROI for physicians or pharmacies heightened their reluctance to adopt the technology, he suggested CMS provide financial incentives to providers.

Noting there were numerous term types within RxNorm, Dr. Eckert cautioned the Subcommittee not use the umbrella “RxNorm” in making their recommendations when they meant specifics.

Jeff Brown, outside counsel to the Subcommittee, cautioned about implementing any standard for prior authorization other than the HIPAA-mandated 278 on the non-retail pharmacy side and NCPDP T Standard telecommunications on the retail side, which would have to go through the HIPAA modification process. He also noted the key words in the language delineating the 2006 demonstration project were not about testing to ensure technical workability, but to “show efficient implementation of the requirements.” He recalled a lesson learned from HIPAA: well-publicized pilots help implementation.

George Robinson, FirstDataBank, clarified that the only concept RxNorm linked to NDC and SPL was the semantic clinical drug (generic representation, not brand). Drug knowledge base vendors would have to link branded representation directly to NDC or the name base concept.

Recalling discussion in the July hearings about e-prescribing companies offering opportunities for commercial messaging within the e-prescribing process, Tony Schueth, Point-of-Care Partners, noted e-prescribing business models call for each individual receiving value from e-prescribing to pay a corresponding amount, some sources had stronger negotiating positions and reimbursements were not always equitable. He suggested funding to help companies adopt a formulary standard.

-DAY TWO-

Welcome and Introductions, Simon Cohn M.D.

Dr. Cohn announced hearing and meeting dates for the subcommittee. Hearings were scheduled for January 19 and 20, April 6 and 7, and July 26 and 27. February 1 and 2 was held open if needed. Dates will be established for May or early June.

Subcommittee Discussion, Draft Recommendation Letter – Simon Cohn M.D., Jeff Blair, Margaret Amatayakul

Mr. Blair noted the Subcommittee had added testifiers and examined additional issues. Testifiers at the March, May and July hearings identified standards available and in use, gaps and limitations. Members shared this input with developers of message format standards, identifiers and terminologies, asking to what extent they could address these limitations and gaps. Consensus still had to be reached on many points by September 1 and 2. Others would be deferred until October’s, December’s, January’s and possibly February’s meetings. Mr. Blair praised the industry’s and HHS’s cooperation and commended everyone who had been with the Subcommittee steadily for their loyalty, fortitude and steadfastness.

Mr. Robertson noted his written testimony stated NCPDP and HL7 should be accepted and acknowledged as standards. Responding to questions, he had said HL7 could support selection of a standard in a domain. But he noted the concept of domain was not clearly defined. He clarified that HL7 recommended that NCVHS state that the standard for e-prescribing communications between prescriber and pharmacy be conducted in NCPDP SCRIPT. Exceptions for HL7 would be allowed, but not required, in existing implementations already having e-prescribing functions working with HL7 messages and in new implementations in which prescribers and pharmacies were closely associated in a health care organization (e.g., where both were in the same physical location or different locations, within one health care organization). The test for a health care organization was that there was a recognized business and an organizational structure where at some point the prescriber and pharmacy were considered to be working for the same organization. In cases where the prescriber “could talk” HL7 and the pharmacy “spoke” PCRIPTNCPDB Script, neither should be penalized for the fact that they were not able to conform; bridging technology could allow them to adequately communicate.

Ms. Amatayakul captured and members discussed key observations relative to messages, terminology, identifiers, important related issues (policy or workflow issues outside the scope of standards) and other policy considerations, then considered observations describing the purpose and extent of industry experience regarding standards and issues and associated recommended actions that recognized identified standards and actions to address additions, development, and pilot testing necessary to meet MMA requirements.

Members reviewed the current prescribing environment and e-prescribing capabilities, noting lack of e-prescribing standards forced the industry to use workarounds. They considered the standards evaluation process and standards needed to support e-prescribing, standards gaps and limitations, and related issues exist that might affect implementation or acceptance of e-prescribing.

-DAY THREE-

Subcommittee Discussion, Draft Recommendation Letter – Simon Cohn M.D., Jeff Blair, Margaret Amatayakul

Utilizing the guiding principles and requirements identified in the MMA for selecting e-prescribing standards, the Subcommittee: (1) identified and evaluated three types of e-prescribing standards necessary to support e-prescribing: (a) message format standards that provide communication protocols and data content requirements (including those to support medication decision making), (b) terminologies to ensure data comparability and interoperability, and (c) identifiers for all relevant entities within the e-prescribing process; (2) some widely used standards might not need to be piloted in 2006, but could be adopted beforehand; (3) other standards with adequate industry experience had to be tested in pilots for the expanded functionality required by MMA.; (4) others with additional functionalities but lacking a business case and not widely used also had to be pilot tested; (5) standards should be vendor neutral and technology independent, preferably be developed by standards development organizations accredited by ANSI, and have suitable indications of market acceptance; (6) actions necessary to address gaps and limitations in standards in order for them to be available for the MMA demonstration projects beginning January 2006, including the fact that signaling the market about standards that did not meet all the needs of MMA but would be adopted could spur standards organizations to fill gaps. All observations and recommendations discussed can be found in the full transcript posted on the NCVHS Web site.

Ms. Amatayakul and Mr. Blair will draft the next version of the recommendation letter to the Secretary, conveying that industry had adequate experience with some standards, others needed piloting, and numerous process elements had to be put in place. Members will review that revision posted on the Web site and finalized during the August 24 12:00 EST conference call.  A second conference call will be held, if necessary, August 26 at 12:00 EST. The Subcommittee will present the draft to the full Committee September 1. It will be discussed and, hopefully, finalized September 2. Dr. Cohn and Ms. Friedman will deal offline with the e-health initiative document, adding a front letter to the executive summary and standards section for redistribution as pre-reading to the full Committee. Hearings are scheduled October 12 and 13 on e-signature and e-prescribing. A joint hearing between the Subcommittee and Privacy and Confidentiality on security, e-prescribing and privacy and confidentiality issues is scheduled November 18 and 19. Hearings December 8 and 9 will deal with additional e-prescribing issues. Hearings are scheduled January 19 and 20 for unresolved issues. Time is held in early February for an additional meeting. Dr. Cohn thanked the Subcommittee for its perseverance and the testifiers for providing expert input and guidance in moving forward what, hopefully, will be valuable, well-based recommendations.

Subcommittee on Standards & Security – August 17-19, 2004 – 28

I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

                                      /s/                                            1/10/05

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Chairman                                                                    Date