Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

March 3, 2004

Washington, D.C.

Meeting Minutes


The Subcommittee on Standards and Security of the NCVHS was convened on March 3, 2004 at the Washington Terrace Hotel in Washingon, D.C. The meeting was open to the public. Present:

Subcommittee members

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

Absent

  • John P. Houston, J.D.

Staff and liaisons

  • Maria Friedman, D.B.A., CMS, lead staff
  • Vivian Auld, NLM
  • J. Michael Fitzmaurice, Ph.D., AHRQ
  • Gail Graham, DVA
  • Marjorie S. Greenberg, CDC, NCHS
  • Donna Pickett, CDC, NCHS
  • Steve Steindel, Ph.D., CDC
  • Marietta Squire, CDC, NCHS

Others

  • Gary Beatty, X12N
  • Donald L. Bechtel, AFECHT
  • Theresa Doyle, Blue Cross/Blue Shield Association
  • Tom Hughes, National Electronic Attachment
  • Mitchell Icenhower, Health Care Data Exchange
  • Brett Kay, National Health Council
  • Frank A. Kyle, Jr. ADA
  • Tom Louder, AAHP/HIAA
  • Stanley Nachimson, CMS
  • Penny Sanchez, Electronic Data Systems
  • David R. Schinderle, AllHealthLogic
  • Robert Tennant, MGMA
  • Maria Ward, Health Level Seven
  • Kepa Zubeldia, Claredi

EXECUTIVE SUMMARY

ACTIONS

1. The Subcommittee approved a letter to the Secretary urging HHS to issue the NPRM on the claims attachment as soon as possible and provide pubic comment on the results of the demonstrations and pilots before promulgating a final rule.

2. The Subcommittee approved a letter of response to the DSMOs’ letter asking for closure on their request that the NCPDP standard be utilized by pharmacies for billable supplies, noting the matter was on the Subcommittee’s action list.

HIPAA UPDATE – Stanley Nachimson, CMS

Mr. Nachimson noted compliance dates for: most entities for the National Employer Identifier (July 30, 2004), the security regulation (April 21, 2005) and the National Provider Identifier (May 23, 2007). The proposed rule on the National Plan Identifier is expected this summer; proposed regulations on claims attachments and changes to transactions and code sets are also expected in 2004. Work continues on guidance papers for critical issues about the transactions and code set; a series of papers on security implementation for small providers will be published in 2004. CMS is working to ensure obstacles noted at a recent Workgroup for Electronic Data Interchange (WEDI) hearing about industry readiness and problems hindering full compliance can be eliminated. Two-thirds of Medicare claims are in HIPAA standard formats. As of July, non-HIPAA format and paper claims will be paid with a 27-day floor; HIPAA standard format claims will be considered electronic and paid with a 14-day floor. CMS received 53 transaction and code set complaints by February 25 and is investigating and aiming to help involved entities resolve those remaining open.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • Dr. Kepa Zubeldia, Claredi
  • Donald L. Bechtel, Chair, AFECHT
  • Gary Beatty, Chair, X12N Insurance Subcommittee
  • David R. Schinderle, President and Chief Executive Officer, AllHealthLogic
  • Mitchell Icenhower, Product Line Manager, Health Care Data Exchange, Siemens Health Services

Dr. Zubeldia noted issues linked to the claims attachment. He asked CMS to reconsider its policy preventing Medicare contractors using the Internet and he suggested the Subcommittee recommend standards for different purposes. Without clearly understood return on investment (ROI), he predicted implementations would focus on the minimum necessary. He cautioned that an NPRM might not have significant impact on implementations and attachments.

AFECHT recommended that: implementation allow time for organizations to understand and resolve issues prior to imposing deadlines for completion, the NPRM be issued soon in a way that completed round-one, consideration be given to work in progress, and the NPRM be released. Mr. Bechtel asked the SDOs and CMS to consider correcting findings prior to a final rule, and adjusting the timetable for national implementation after identifying the issues. AFECHT also advised NCVHS to issue the final rule with input from the beta trial, consider phased deployment, and find ways to fund pilot implementation for essential provider settings.

Mr. Beatty emphasized that, although CDA development was completed, the industry’s pilot testing still had to be completed prior to issuance of the NPRM and required broad volunteer participation, time and funding. X12 and AFECHT are preparing to facilitate testing and X12 and HL7 are determining development of a joint recommendation and timeline to migrate data content from the 837 health care claim to an attachment standard. X12 urged NCVHS to work with the Office of HIPAA Standards and industry representatives to ensure the attachments provide policy guidance to the industry on appropriate usage of health care claim attachments.

AllHealthLogic developed the Claims Attachment Document Exchange (CADE), an ASP-type Web-based service installed in two early adopter health plans where payers request, receive, sort, filter, scan, and upload routinely requested provider documents from electronic repositories. The California Medicaid program and Utah Health Information Network plan to implement pilots and AllHealthLogic intends to expand to other provider types. Mr. Schinderle urged publishing the attachment rule soon to achieve the transaction and code set’s fiscal goals. He advised that the proposed rule should support multiple approaches, the final rule uphold HL7’s recent changes, and the attachment rule permit alternate submission modes for the coordination of benefit transaction.

Mr. Icenhower said a pilot with feedback and input to the NPRM would increase the quality, understanding and credibility of the final rule. He called for a required trial implementation and feedback before developing the final rule and a realistic sense of what the industry needed to implement it, step-wise improvement with possible interim phases, time for each market segment to adopt it, and a deployment plan developed among industry players and maximized by organizations bringing the message to individual providers.

OPEN MICROPHONE

  • Theresa Doyle, Director of Legislative Policy, Blue Cross/Blue Shield Association
  • Maria Ward, Co-chair, Attachment Special Interest Group, Health Level Seven
  • Robert Tennant, Medical Group Management Association
  • Brett Kay, Director of Government Affairs, National Health Council

Ms. Doyle submitted Blue Cross/Blue Shield Association’s (BCBS) letter endorsing doing the pilots before the NPRM. She expressed concern that adding another standard could be detrimental to successful implementation and questioned whether the claim attachment standard “fit” goals for a shared EHR, urging NCVHS to consider alternatives.

Ms. Ward noted a national survey WEDI is conducting with HL7 and X12 asking about attachment needs: who needs them, when, why, and consequences of not having them. WEDI plans to have substantive information in several months.

Mr. Tennant supported having pilots before the NPRM to build momentum and identify data content issues. He emphasized building ROI with software vendors who had to begin developing systems before the 16-month window. He also noted a ROI for paper-based providers: their response might have to be mailed but receiving electronic requests for attachments sped up the process and lowered their AR.

Mr. Kay expressed concern that any standard permitting an entire medical record to transfer across could undermine the minimum necessary protections in the privacy rule and urged NCVHS to consider policies and procedures to prevent wholesale sending.

OTHER STAKEHOLDER PERSPECTIVES

  • Frank Kyle, American Dental Association
  • Penny Sanchez, Co-chair, National Medicaid EDI HIPAA Workgroup
  • Tom Hughes, National Electronic Attachment

Dr. Kyle said usually all necessary information for claims adjudication could be included within the dental claim form. ADA proposed that the data content of a dental claim be reduced from a maximum to a minimum data set consistent with information on the ADA paper claim and sufficient for adjudication of most claims by most third-party payers. Additional information required in specific situations could be provided in a supplemental attachment.

Ms. Sanchez said absence of a standard way to electronically receive required supporting documentation for claims and prior authorization was a major gap for agencies implementing initial transactions and code sets rule. The National Medicaid Information Technology Architecture Framework CMS is developing encourages states to adopt common national IT standards to facilitate interoperability, improve data exchanges between trading partners and better use the Internet and emerging technology. A critical piece of that strategy is developing standard claims and prior approval attachments that can be uniformly understood and utilized. NMEH urged HHS to release the claims attachment NPRM and final rule as soon as possible. Ms. Sanchez encouraged HHS to develop a process to adopt future attachment types for use under HIPAA in a more timely way or choose an alternative other than the time-intensive NPRM process to adopt additional attachment types while allowing for an appropriate level of scrutiny and public comment. NMEH believed pilots should be conducted, but release of an NPRM or final rule should not be contingent on their completion.

Noting the National Electronic Attachment (NEA) had received an enterprise architecture approach and request for comments, Mr. Hughes suggested that CMS Medicare might be getting closer to using the Internet. He said attachments through the current network met the contemplated regulation’s approach supporting an imbedded scanned image in the X12 XML document. He expressed concerns about the complexity, cost, and the ability of payers and providers to technically implement and deploy systems essential to comply with the approach that might be proposed using X12. Mr. Hughes cautioned that payers would not spend the money to build in-house attachment receiving software until they saw the utilization would be there to justify the cost.

SUBCOMMITTEE DISCUSSION AND DEVELOPMENT OF A DRAFT RECOMMENDATION LETTER ON CLAIMS ATTACHMENT TO THE SECRETARY – Simon Cohn, M.D.

Members discussed how an incremental, staged approach, test pilots and the NPRM might address critical issues raised that day and the claims attachment letter. (See Actions, above.)

SUBCOMMITTEE DISCUSSION OF LETTER FROM DSMOS CONCERNING STANDARDS FOR BILLING FOR SUPPLIES – Simon Cohn, M.D.

Members reviewed and updated as necessary the letter of response to the DSMOs concerning standards for billing for supplies. (See Actions, above.)

SUBCOMMITTEE DISCUSSION OF E-PRESCRIBING WORK PLAN – Jeff Blair and Simon Cohn, M.D.

Members reviewed version seven of the draft E-prescribing plan. The Subcommittee blocked out two days testimony in May and four days over July and August. In late August questions will be developed for NCPDP and other major terminology developers invited to provide feedback at the September session. Members will draft an interim recommendation letter to for the full Committee’s approval in November.


DETAILED SUMMARY

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

HIPAA UPDATE – Stanley Nachimson, CMS

Mr. Nachimson said July 30, 2004 is the compliance date for most entities for the National Employer Identifier. Small health plans have an additional year. The compliance date for the security regulation is April 21, 2005. The National Provider Identifier was released January 23. The compliance date is May 23, 2007, providing time for CMS to build the system and ensure a two-year period between assigning the first identifier and compliance. A proposed rule on the National Plan Identifier is expected in the summer; proposed regulations on claims attachments and changes to transactions and code sets related to policy issues problematic to the industry during initial implementation of the transactions and code sets are also expected in 2004.

CMS’s Office of HIPAA Standards continues to work with industry and inform necessary parties of requirements for all HIPAA regulations. The office utilizes a toll free number and responds to individual questions about HIPAA standards and policy at HIPPA@CMS.HHS.gov. Work continues in the transactions and code set areas on more guidance papers for critical issues to the industry and a series of papers on security implementation for smaller providers will be published in 2004. CMS continues to monitor industry readiness to implement the transactions and code sets. Although the October 16th, 2003 date remained in effect, the optional contingency plan issued in July 2003 entitled covered entities to implement plans so payments could continue to flow in the health care industry in case either side in a transaction could not yet handle standard transactions. CMS continues to monitor industry readiness to move towards full compliance with transaction and code set standards hearings. A recent WEDI hearing elicited testimony about the readiness of segments of the industry and problems hindering full compliance. CMS is working with those organizations to ensure some obstacles can be resolved and removed.

While most covered entities can exchange some standard transactions, Mr. Nachimson doubted many could exchange all standard transactions. Medicare leads in claims; with 67 percent of Medicare claims in HIPAA standard formats. Medicare announced in February that, as of July 1, claims in the HIPAA standard format will continue to be considered electronic and paid using a 14-day floor; non-HIPAA format and paper claims will be paid with a 27-day floor.

The enforcement process for transactions and code sets is in response to non-compliance complaints. By February 25, CMS received 53 valid transaction and code set complaints: 16 against Medicaid, eight Medicare, 29 the private sector. Some 36 complainants felt a compliant transaction was rejected; 15 concerned code sets, one companion guides, another an NCPDP transaction. Thirteen complaints were closed at the request of complainants. CMS is investigating the others, intending to help the involved entities resolve them.

Discussion

Mr. Nachimson said Medicare considered claims that passed edits measuring compliance with the standard and implementation guide HIPAA-compliant. Medicare plans to allow limited access to individually identifiable Medicare information over the; he pointed out nothing in HIPAA prevented claims from being sent via email, assuming appropriate standards were met. Dr. Cohn noted the Subcommittee will hold a briefing on CMS’s use of the Internet. Mr. Nachimson said Medicare statistics indicated the number of submitters was relatively stable. Some plans reported increasing numbers of claims from third-party submitters and clearinghouses; others indicated more direct submissions from providers.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • Dr. Kepa Zubeldia, Claredi

Dr. Zubeldia defined claim attachments as added information provided payers to adjudicate a claim or for preauthorization or referral. Needs vary based on reimbursement practices, state laws and requirements for reimbursement and fiduciary duty. Attachments were time consuming and expensive to produce. Providers, uncertain what payers wanted and perceiving attachments as payment delay tactics, sometimes sent everything. Payers considered attachments time consuming, expensive to handle and administrate, and often difficult to understand. Most payers asked providers not to send them unless requested, but no adequate mechanism exist for requesting them. Dr. Zubeldia noted some attachments were: (1) required by law, regulation or business practice; (2) frequently required and proactively sent to avoid delays in reimbursement; and (3) responses to a request for additional information: part or (if providers could no make sense of the request) all of the medical record.

The transmission mechanism involves attachment content and how it is sent. No standard attachment, content, format, or method of transmission is in use today; the main transmission mechanism is paper. Some information that is part of the 837 implementation under HIPAA is on the standard 837. Electronic dental attachments are increasingly sent, but most are paper. Dr. Zubeldia said the 275 ORU HL7 message sending HL7 messages and other forwarding objects encapsulated inside a binary object in the 275 X12 transaction was “a shotgun wedding” satisfying an agreement between HL7 and X12 to use X12 for administrative transactions and HL7 for clinical messages. Syntax was inefficient, the message difficult to handle and unproven.

Issues included: (1) a standard attachment request (a 277 proposed transaction containing content clearly codified as LOINC codes) was needed for additional information: if all requests were codified, the list would “never be complete;” if not and one could request everything, what was the value of a standard request?; (2) some attachments were practically impossible to standardize; (3) uncertainty over whether HIPAA Privacy and the minimum necessary applied to unsolicited attachments; (4) claims were administrative transactions, most attachments clinical–the systems typically did not talk to each other; (5) linkage was required between the request and response to understand what attachment belonged to each request; (6) how would payers handle the attachment–was electronic automatic processing attainable and a goal for the first round of HIPAA attachments; were payers willing and ready and vendors and clearinghouses able to provide automation tools?; and (7) telecommunication and formatting issues.

Data format could be sent multiple ways: HL7 message without X12 wrapper or as 2.X or XML syntax; HL7 message encapsulated inside X12; free form text inside X12, an HL7 message or HL7 encapsulated inside X12; a scanned document (TIF or JPEG) codified as a DICOM image within an HL7 message contained in an X12 transaction.

Dr. Zubeldia asked CMS to reconsider its policy that did not allow Medicare contractors to use the Internet. He noted encryption and authentication issues in sending attachments over the Internet; components could be in standard format, codes, transmission mechanisms or combinations. Moving in steps towards automation, he suggested the Subcommittee recommend standards for different purposes. He noted CDA attachment documents explained how providers with automation could send the ORU message with everything codified, those lacking automation could send images.

Even with detailed standards, implementation varied. Payers had different companion documents specifying their requirements and generic interpretability was difficult or impossible. He advised living with differences, noting interpretability was the main problem. He emphasized the difficulty of process reengineering and value of moving incrementally. He cautioned that, without clearly understood ROI, implementations would focus on the minimum necessary. Noting implementers wait until the deadline, he said an NPRM might not have significant impact on implementations and attachments.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • Donald L. Bechtel, Chair, AFECHT

AFECHT recommended that implementation allow time for organizations to understand and resolve issues prior to imposing deadlines for completion. Mr. Bechtel urged industry to establish a project plan to coordinate validation and implementation schedules of covered entities and players, especially vendors. AFECHT is committed to assist in the identification and resolution of problems and conduct trial implementation in each effected health care segment.

Some clearinghouses and vendors in AFECHT had begun necessary enhancements to implement the claim attachment for certain attachments, namely DME and home health forms. Some participated in small pilots with earlier versions of the standards or developed prototypes demonstrated at the February HIMSS. Most work was preliminary and basic; none attempted to implement all functions. Vendors, payers and providers were occupied trying to implement the first round of HIPAA and still had a long way to go. The vendor community, apprehensive the claims attachment standard would be a complex transaction to implement with many issues and problems sought an industry study and education before developing solutions.

Work flows were the most serious concern. When a transaction enters a provider’s application it most likely hits a billing application; a decision mechanism must determine where to direct it; what, if any, system interface exists; and a routing table for directing requests. This could be complicated in sophisticated environments, requiring application logic, databases to store them and the information along with statuses for audit purposes and billing departments to manage their process. Policies and procedures also need to be modified for new work flows.

Generally, interfaces between financial and clinical systems do not exist. Interfaces in enterprise system between these systems are mostly “push” transactions, not the “request and pull” experienced with claims attachments. Developing work flows and associated interfaces will be complicated and require additional standards. Contained in one or multiple institutions, they can involve different systems, technologies, protocols, methods of storing data, coding systems and data structures. Vendors must develop application interface programs that work in a ubiquitous environment among disparate systems. Health care settings have issues that might make exchange of this data more complicated. Interoperability will be a key issue. Mr. Bechtel suggested considering coordination with EHR and noted concern about LOINC codes, which are not widely implemented outside of clinical systems, and interfaces with other code sets with documentation for consistent use and interpretation for mapping. Identifiers and issues around minimum necessary are concerns. Many systems do not fully utilize XML and infrastructure changes might be required. Competing standards are also an issue.

AFECHT recommended that the NPRM be issued soon in a way that round-one was completed and that consideration be given to work in progress, and the NPRM released. Mr. Bechtel urged the industry to develop a project plan with time for analysis, development of application codes, validating development, trial implementation, and documentation of issues and underlying problems needing resolution before implementing nationally with a mandated timeframe. He asked that findings be considered by the SDOs and CMS for correction prior to a final rule, and the timetable for national implementation be adjusted after identifying the issues. Mr. Bechtel said AFECHT, HL7, HIMSS, WEDI-SNIP, and others were collaborating on an implementation trial process with interested vendors, providers and payers. AFECHT recommended that the final rule should not be issued without input from the beta trial, that NCVHS consider phased deployment, and find a way to fund pilot implementation for essential provider settings that otherwise could not participate.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • Gary Beatty, Chair, X12N Insurance Subcommittee

Mr. Beatty noted X12 and HL7 collaborated since 1997 to incorporate both financial administrative data content with the 1997 clinical data content into a single national standard for health care claim attachments. Data content supporting different types of attachments is contained within the 837 transaction set and part of the mandated 837 required of the industry under HIPAA. This standard utilizes the routing the health care industry establishes with implementation of other administrative transactions.

With X12 and HL7’s attachment special group coordination, X12 developed several attachments supporting health care claim attachments including the 275, additional information to support a health care claim or encounter. The 275 can be used as an unsolicited attachment to the 837 health care claims submission and as the response to the 277 health care claim request for additional information. Both transactions had their implementation guides approved for publication at the February X12 trimester meeting and will be available in the second quarter.

A binary segment in the 275 transaction will contain the HL7 CDA document conveying clinical data for health care claim adjudication. The document can be structured/ codified, or unstructured/imaged and a complete or partial document. Originally HL7 developed six attachments based upon version 2.4 and a syntactical structure similar to X12 standards. The 277 transaction requesting attachments was pilot tested with payers and providers in 1998. Another pilot in 2000 by HGSA, CMS and Empire Blue Cross and Blue Shield provided limited proof of concept. HL7 has evolved its standards to the clinical document architecture, which is based upon extensible markup language XML. X12 intends to use a similar process for moving clinical data content to support the 278 transaction for pretreatment authorizations and referrals. X12 and HL7 jointly sent a letter to the Secretary in April 2003 expressing concern over time elapsed since the original recommendations for attachments and HL7’s need to for time to complete the CDA and pilot test the 277 and 275 prior to issuing of the NPRM for these transactions. CDA development is completed, however the industry still has to conduct pilot testing to verify business needs will be met. Testing must be completed prior to the issuance of the NPRM. X12 supports the need for pilot testing the attachment transactions however Mr. Beatty emphasized that this requires broad volunteer participation from representatives of the health care industry user community including payers at varying levels, commercial; federal, state and county governments; ERISA health plans and organizations; and PPOs. Pilot tests will require time and funding. X12 and AFECHT are preparing to facilitate testing.

Mr. Beatty said discussions were underway between X12 and HL7 on how to move forward and develop a joint recommendation and timeline for the transition from the X12 837 to migrate the data content from the 837 health care claim to an attachment standard.

X12 recommended that the NCVHS work with the Office of HIPAA Standards and health care industry representatives to ensure the attachments provide policy guidance to the health care industry on the appropriate usage of health care claim attachments. This includes but is not limited to appropriate business situations where attachments should or should not be required, frequency of usage, and amount of clinical data required to satisfy health care adjudication.

X12 and HL7 are developing an education program for their X12 trimester meetings covering business process and usage of the health care claim attachment, including 277, 275, CDA documents and, time permitting, prospective work flow and best practices.

Discussion

Dr. Zubeldia expressed concern about the flexibility of the government process to receive feedback from the pilot before a final rule. Ideally, he preferred a Notice of Intent that triggered pilots that resulted in an NPRM providing industry feedback. Less people would feel disenfranchised if another cycle provided feedback and comments on the NPRM before the final rule. Questioning whether one demonstration project would be enough, even for the six claim attachments originally considered by X12 and HL7, Mr. Blair asked for guidance on players and stakeholders as well as claim attachments that would be appropriate for parallel demonstration projects. Mr. Beatty agreed on gaining experience from varying levels and parties.

Mr. Beatty noted a value proposition to doing attachments related to the whole revenue cycle. Pointing out that many providers measure everything by how long revenue is outstanding and that process delays remittance by four-to-six weeks, he explained the intent to reduce delay while standardizing the information exchanged and asking specific, focused questions that move the process forward. Mr. Bechtel agreed, noting infrastructure issues and that state requirements call for information only obtainable through an attachment. In managed care the claim attachment is also associated to authorizations and referrals and an environment in which some medical is being provided through an attachment and the corresponding need to know why certain things are prescribed or ordered.

Dr. Zubeldia pointed out that the standard request for additional information sent electronically had a high ROI for both payers and providers. The ability to codify the attachment as a particular RU message inside a 275, allowing the whole process to be automated, had a more long-term and perhaps very high ROI. He doubted one could identify the ROI for the whole attachment puzzle: that depended on how one looked at different pieces. He cautioned that the pilot projects had to focus on what needed to be done and how; exploring solely for the sake of exploring might diffuse value. He emphasized getting large and small payers, providers and specialties, direct and clearinghouse submitters, and those with one or more vendors involved.

Dr. Fitzmaurice advised that NCVHS could supply a forum for getting suggestions for individual scenarios and communicate them to the Secretary, but he questioned whether this should be a government-funded pilot or a cooperative volunteer venture with industry. Mr. Bechtel said it was a combination. Forward-thinking organizations, payers with resources and the vendors who had to build and roll out these products would want to participate. Participants noted that resources were not available for many providers and certain segments of the payer side; both would need funding. Dr. Zubeldia suggested allowing or funding some Medicare or Medicaid contractors to participate and passing savings (at least during the pilot) to some small physicians. He noted quality improvement organizations had demonstration projects where hospitals that improved quality received additional funding or reimbursement from Medicare.

Dr. Huff said a spectrum of automation could be built slowly. He noted the flexibility CDA offered to contain an image or structured data allowed phasing and suggested supporting to the extent possible increasing sophistication through pilots and implementation. Mr. Beatty agreed that staging was important and that the model was viable. But he emphasized having volunteer implementation along with mandates so early adopters who could might move forward with CDA in a codified fashion. Dr. Zubeldia cautioned that people might stop with compliance and sending scanned images of medical records and not benefit from the long-term ROI that was mostly in the automated process with codified attachments that could be automated. Mr. Beatty noted CMS had begun to step transactions with contingency plans and setting dates for adjudication of payment,

Mr. Beatty and Mr. Bechtel supported the December proposal related to the HL7 X12 claims attachment. Dr. Zubeldia noted benefits and problems. The likely first step in deployment of the attachments, the scanned image included inside an XML structured had an X12 bin segment: a triple layering of a document he considered potentially problematic to manipulate with existing tools. The fact that a translator could process XML, HL7, and X12 did not necessarily mean it could process HL7 inside an X12 bin segment and an image inside that HL7 message. If the technical issue of nested syntax was resolved, he favored this approach that put structures in place for migration to the fully automated codified attachment. Mr. Bechtel advised considering the EHR and how that would allow doing segmented discreet data elements.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • David R. Schinderle, President and Chief Executive Officer, AllHealthLogic

AllHealthLogic developed the CADE, an ASP-type Web-based service where payers request, receive, sort, filter, scan, and upload provider documents routinely requested (transcribed dictation, itemization of charges, ER face sheets) already in electronic repositories. Documents are indexed by type and elements are built to be HIPAA compatible. CADE is installed in two early adopter health plans: PacifiCare and Health Net. Aetna, the California Medicaid program, and Utah Health Information Network plan to implement pilots. AllHealthLogic participated in a limited pilot exploring at the nursing level if nurses deal with images and reach the same clinical conclusions. Additional Medicare pilots are under discussion with the CMS Office of Program Integrity. Some 76 hospitals are live or committed and AllHealthLogic has begun to work in other states and plans to expand to other provider types (large medical groups, medical management companies).

Mr. Schinderle reported a decrease in providers’ accounts receivable, primarily driven by a substantial reduction in cycle time ranging from six-to-18 days. Most requests were responded to within three-or-four days; some were processed and closed out by the health plan that same day. He noted a theoretical cost reduction of about $21 dollars per transaction, remarking it would take broader participation across a larger number of payers to realize those dollars.

He said this was more about standardized process and nomenclature than the off-the-shelf technology. He emphasized developing trust (will a provider who changes his business process get paid timely and efficiently by the payer), the work flow, and making sure that, if they “bet the farm,” the payer would support them and pay in a timely, efficient way. AllHealthLogic worked with their community of payers who provided additional clear guidelines on when and what type of attachments was needed.

Mr. Schinderle said LOINC codes did not reflect how folks worked today and required significant training. Those doing this work did not have the skill set to deal with manual coding complexities. AllHealthLogic supported going fully automated long term but questioned whether many were ready, even for baby steps. Payers and providers generally work on attachments at the document level. Payers typically based off information on a UB92 or HCFA 1500 and lacked sufficient information to drill down and ask data-element type questions beyond a missing data element on the UB. While he believed clinical documentation architecture using XML was a step in the right direction, Mr. Schinderle cautioned it would be challenging for smaller providers and payers for years. Providers preferred to submit attachments with billing when they knew what was needed. It was faster, more efficient and, they were still fearful of re-association problems and reluctant to separate claims from attachments.

One of the biggest communications problems was that many vendors of adjudication software and in-house teams that wrote and maintain it have not updated their software. The 837 COB transaction set remained problematic. Mr. Schinderle said providers and payers needed simple tools that worked with what they had today; EMS systems did not easily support today’s electronic claims. Some vendors have begun to modify their software to permit more activities. He suggested, short term, looking at exceptions for moving that data forward.

Mr. Schinderle urged publishing the attachment rule soon to achieve the transaction and code set’s fiscal goals. He said payers should provide clear guidelines on when, what and why. The proposed rule should support multiple approaches. The final rule should support HL7’s recent changes. LOINC codes should be used initially at the document-level for claims attachments to support claims adjudication and phasing in deeper adoption for greater clinical integration of systems. The attachment rule should permit alternate submission modes for the coordination of benefit transaction, enabling more to move electronically and addressing payers’ concerns. He endorsed American Hospital Association’s comments submitted earlier.

INDUSTRY PERSPECTIVE ON CLAIMS ATTACHMENT

  • Mitchell Icenhower, Product Line Manager, Health Care Data Exchange, Siemens Health Services

Mr. Icenhower said Siemens provides the revenue cycle solution for about 25 percent of the U.S. acute care provider market. One of the biggest challenges for their institutional customers is corralling their information and using it correctly. Siemens worked with all the TCS transaction. He emphasized that there was still much debate as to “the what and how” of claims attachments, noting it would require industry collaboration, forums and a collaborative plan to succeed. Siemens has been heavily involved in the analysis pieces, working with SDOs, but he cautioned that, like many software vendors, actual development work would not happen until an NPRM is published. Siemens laid groundwork, began incorporating the LOINC codes into their common vocabulary engine, but will need feedback and the final rule before development. One lesson learned from previous HIPAA implementation is that customers’ momentum can be destroyed if they are taken the wrong direction. Mr. Icenhower said a pilot period with feedback and input to the NPRM might take more time, but would increase the quality, understanding and credibility of that final rule for providers, boosting the adoption rate. WEDI, AFECHT, AMA and other industry organizations could work with vendors more effectively and spread that message to the provider. More collaboration between organizations on provider education was critical.

Challenges effecting institutional customers included data collection, storage, and access. Typically, acute care providers’ billing and clinical systems were separate. Usually a patient-type index pulls information together, but a request from a payer might be for different data, formats, systems, vendors and access control. Siemens believes the way to pull this together is in sync with the industry and the movement towards an EHR.

HCDE favored the initiative supporting the vocabulary and definitions to be used in the EHR. Mr. Icenhower acknowledged LOINC had great value, but noted its adoption rate was low and vendors had not yet fully supported the codes. LOINC codes were loaded in HCDE’s common vocabulary engine, but lacked widespread implementation among customers. Used in a manual UI-type approach, it was cumbersome. And there was an education issue. But the LOINC codes were key to automating, EHR, mapping, and relating requests to individual systems. Noting lagging adoption of the clinical document architecture, Mr. Icenhower urged the Subcommittee to include it as part of the pilot process.

The last challenge was a workflow issue (both proactive sending of the attachment because experience nudged it and ad hoc requests) vendors could help resolve. The process could be automated with a transaction standard and the LOINC codes; workflows could be defined and data pulled together from disparate systems with an EHR. Mr. Icenhower emphasized that alignment with EHR initiatives would give providers more incentive to get into an adoption mode, organizations more incentive to fund it, and bring everyone together with a common goal. Long term, alignment of the EHR and claims attachment initiatives would deliver a true ROI and workflow savings to providers.

Mr. Icenhower emphasized feedback through WEDI and AFECHT and staged implementation developed by the industry. He called for a required trial implementation and feedback before developing the final rule and a realistic sense of what the industry needed to implement it, step-wise improvement with possible interim phases, time for each market segment to adopt it, and a deployment plan developed among industry players and maximized by the organizations represented at the hearing bringing the message to individual providers.

Discussion

Mr. Schinderle explained that CADX stayed as close as possible to the data content and definitions in the X12 standard. CADX did predominantly HTML-type based transactions and had not fully incorporated LOINC codes behind the scenes or translated it in notes to an X12 envelope. CADX acted as a clearinghouse for some health plan partners; as business associates, putting these documents into their format and ready to go into their document workflow. Smaller organizations that lacked a place to store images wanted a Web-based interface. Mr. Schinderle said CADX could code things behind the scene, acting as a clearinghouse to move the transaction both ways. CADX could deliver in the X12 standard, but no one yet wanted to deal with it at that level. Mr. Icenhower noted the standard transaction delivered value to the vendor developing the workflow automation the providers need to pull this together and interface. In a very basic scenario, the LOINC codes would have reduced value, but long term they would enable interfacing back, understanding the request and pulling the right data from a myriad of vendor systems that were fronting into an EHR. Mr. Schinderle agreed. LOINC was a way to obtain standardized nomenclature, given good definitions. Without that, the focus was on pertinent chart information: a glossary of definitions the user base agreed on at the payer and provider level. Nomenclature tended to be a problem in the industry; one that would continue to plague everyone for a while.

Looking at just the six document types, Mr. Schinderle said if one followed the dollars and used that as a barometer the initial “sweet spot” uncovered in AllHealthLogic projects was in the automating of the request and delivery of the response. That transport layer sliced about $20 dollars off the cost. Considering all the provider types, the largest single group of attachments the California Medicaid program receives comes from hospital institutional providers; the next layer is DME. He said he did not have a global industry standard; without solid metrics and statistical counts, payers and providers could neither measure nor manage. Mr. Icenhower said the biggest savings depended on the provider, payer, and rules implemented in the region. He recommended that the pilot programs look at the cost savings associated as well as usability. He said he heard anecdotally that the savings might be closer to the “half-and-half savings one might expect” rather than $20 on the transport. Mr. Schinderle clarified that the provider cost numbers were a bell shaped curve with a high end of $33 and about $25 dollars in the middle. The net cost was about $4 to $5 dollars. He reiterated that it took broad adoption to achieve.

OPEN MICROPHONE

  • Theresa Doyle, Director of Legislative Policy, Blue Cross/Blue Shield Association

Ms. Doyle submitted BCBS’s letter supporting doing the pilots before the NPRM. She noted many BCBS plans still only received 25-to-50 percent HIPAA compliant transactions and expressed concern that adding another standard could be detrimental to successful implementation. She questioned whether the claim attachment standard “fit” their goals for a shared EHR and urged NCVHS to consider alternatives.

OPEN MICROPHONE

  • Maria Ward, Co-chair, Attachment Special Interest Group, Health Level Seven

Ms. Ward recounted how for nine years the group had determined the “low hanging fruit.” She noted a national survey WEDI is conducting with HL7 and X12 asking about attachment needs: who needs them, when, why, and consequences of not having them. Promoted through HL7, X12, WEDI, CMS – and NCVHS if it chooses, the survey hopefully will include everyone. Participants will log on the WEDI-SNIP Website, analyze trends and broad-based, diverse ideas. WEDI plans to have substantive information in several months.

OPEN MICROPHONE

  • Robert Tennant, Medical Group Management Association

Mr. Tennant supported having pilots before the NPRM to build momentum and identify data content issues. Noting the claim attachment standards were “the Rolls Royce” of transactions and would immediately effect only the highest level providers, he emphasized building ROI with software vendors who had to start developing systems before the 16-month window. He noted there also was an ROI for the majority of providers that were paper-based. emphasized that payers sending electronic requests for attachments sped up the process; the provider might have to mail the response but getting it quickly lowered their AR.

OPEN MICROPHONE

  • Brett Kay, Director of Government Affairs, National Health Council

Mr. Kay acknowledged that sometimes sending the entire record was required, but she expressed concern that any standard permitting an entire medical record to transfer across could undermine the minimum necessary protections in standard for the privacy rule. She urged NCVHS to consider policies and procedures to prevent wholesale sending of the entire record.

OTHER STAKEHOLDER PERSPECTIVES

  • Frank Kyle, American Dental Association

Dr. Kyle said the ADA’s policy was that attachments were not necessary in the majority of cases. Usually all necessary information for claims adjudication could be included within the dental claim form. ADA worked with payers, dental providers and vendors to develop electronic and paper claim forms meeting all interested parties’ needs. Many payers reduced requirements for attachment when dental claims were submitted electronically. Unfortunately there was no agreement on situations requiring attachments. Most dental offices submit far more attachments than required trying to avoid payment delays.

Most dental attachments were graphs; periodontal chartings or operative reports were increasingly requested for specialized treatment. Most attachments were submitted in the same envelope with the paper claim, but when dentists submitting electronic claims mailed attachments separately there was difficulty matching claim to attachments. This often required duplication of the attachment, delaying payment. Scanned attachments could be submitted to a repository for reviewing by a dental consultant, but current technology was proprietary and image quality lacked clinical quality. This too might require resubmission of the attachment, delaying payment.

ADA did not support this non-standards-based approach. ADA supported use of DICOM images for image transfer, dental plans however did not accept those images. ADA proposed that the data content of a dental claim be reduced from a maximum to a minimum data set. This set would be consistent with information on the ADA paper claim and sufficient for adjudication of most claims by most third-party payers. Additional information required in specific situations by payers under contract could be provided in a supplemental attachment. This would enable 90 percent of the claims to be processed expeditiously. The dentist would provide additional information upon request for the remaining ten percent of the dental. Dr. Kyle noted this approach was successfully used in the pharmacy industry. Further simplification would result if all payers agreed on clear and unambiguous criteria for attachments. ADA proposed working with the National Association of Dental Plans and Delta Dental Plans Association (DDPA) on this effort.

OTHER STAKEHOLDER PERSPECTIVES

  • Penny Sanchez, Co-chair, National Medicaid EDI HIPAA Workgroup

Ms. Sanchez noted Medicaid uses attachments for claims adjudication and meeting state and federal requirements and saw potential for using electronic attachments for prior authorization, managed care, adequately assessing prior authorization requests or the effectiveness of state and special programs, support case management clinical data collection, post payment review, and mitigating fraud and abuse.

Absence of a standard way to electronically receive required supporting documentation for claims and prior authorization was a major gap for agencies implementing initial transactions and code sets rule. Many agencies voluntarily implement electronic attachments in support of prior authorization. The National Medicaid Information Technology Architecture Framework CMS is developing encourages states to adopt common national IT standards to facilitate interoperability, improve data exchanges between trading partners and better use the Internet and emerging technology. A critical piece of that strategy is developing standard claims and prior approval attachments that can be uniformly understood and utilized. NMEH urged HHS to release the claims attachment NPRM and final rule as soon as possible.

NMEH supported HL7’s decision to move away from the fully codified HL7 traditional messaging structure to the more flexible XML-based HL7 clinical document architecture, Ms. Sanchez noted CDA’s capability to capture image documents, text data, or fully structured codified data allowed flexibility to determine which business model best met provider and agency needs. Due to state budget limitations and systems staff resource availability, most agencies anticipate limiting initial implementation for claims attachment to image documents and/or text data. As cost/benefit analysis on various attachment types is completed states might integrate fully codified capabilities in order to realize auto adjudication.

She agreed that X12 and HL7 models allowed providers to send attachments in an unsolicited manner when the plan or agency indicated the additional information was always needed and for requesting additional information in a solicited manner using the X12 277 request with appropriate LOINC value. But NMEH was concerned that the unsolicited model might result in the receipt of unnecessary attachments.

Some Medicaid agencies had begun development of Web portals and applications using XML; others expressed concern about ability to forge into an unfamiliar application language and technology. Concerns centered on whether agencies will have the knowledge base, system staff, and funding to support XML based applications and make appropriate business changes. Constraining file sizes is another issue. Many attachments will be image documents that can be quite large, even in compressed format. NMEH believes plans and agencies should be able to define file size limitations for each transmission.

NMEH saw value in the six attachment types published by HL7’s Attachment Special Interest Group and expect they will cover many of Medicaid’s attachment needs. NMEH has defined data content for others that meet Medicaid needs and identified more that still require content definition. She noted many agencies had used local codes to accommodate changes in policy or accommodate new medical technologies; under HIPAA local codes were no longer an option. Attachments are an alternative. NMEH encouraged HHS to develop a process to adopt future attachment types for use under HIPAA in a more timely way or choose an alternative other than the time-intensive NPRM process to adopt additional attachment types while allowing for an appropriate level of scrutiny and public comment. Meanwhile Medicaid agencies might voluntarily use the published attachment specifications, but she cautioned it might not be possible to get trading partners to work with them without a rule mandating those attachments.

NMEH submitted a white paper in 2001 to CMS proposing options to improve efficiency of the physical consent process for documents for abortion, hysterectomy and sterilization. None were recommended due to cost and implementation difficulties. Unofficially CMS said it will allow an image of the consent form showing the wet signatures with the electronic attachment. NMEH continues to develop this attachment hoping to use it voluntarily or as a HIPAA standard.

NMEH believed pilots should be conducted, but release of an NPRM or final rule should not be contingent on completion of the pilot. Many states were concerned about any delay in ROI. Most could to participate in pilots at this time, however several states expressed interest. Others, concerned with the level of effort and costs, asked if enhanced funding or technical support was available for the pilot and coordination of trading partners and vending support.

OTHER STAKEHOLDER PERSPECTIVES

  • Tom Hughes, National Electronic Attachment

Mr. Hughes defined electronic attachments as anything needed to support an electronic claim. They were non-coded, non-imbedded in another transaction. Most were scanned images of paper documents or film. Noting FDIC insures banks that allow transfer in and out of bank accounts to pass information, he questioned the logic of Medicare’s rule prohibiting transmitting attachments or claims over the Internet. He contended that Medicaid fraud investigation was enhanced with ability to service attachments by doctor ID number and transmitting information over the Internet could result in millions of dollars in administrative savings to providers. Noting the NEA had received an enterprise architecture approach and request for comments, he suggested that CMS Medicare might be getting closer to using the Internet. NEA’s initial request for a CMS pilot for durable medical equipment claims was well received; two of four durable medical equipment payers expressed interest in participating.

Mr. Hughes said attachments through the current network met the contemplated regulation’s approach supporting an imbedded scanned image in the X12 XML document. Providers and payers already using scanned attachment products were on a migration path. He said he’d conveyed his concerns about the complexity, cost, and the ability of providers, let alone payers, to technically implement and deploy systems essential to comply with the approach that might be proposed using X12. His biggest concern was the impact on how business is conducted and major changes to work flow. He cautioned that final claims regulations were years away.

Mr. Hughes said only the six major players could afford to make the changes necessary for the contemplated X12 277 275 HL7 approach and that it was unlikely that major clearinghouses would spend the millions of dollars necessary or invest two-to-four years development time to support it. WebMD, PayerPath and Global HealthNet recommended systems already in place to their providers wanting to now send images and texts electronically. He noted providers could send attachments electronically from their office with a simple $100-$200 scanner and a monthly network connection fee of $20-$25 dollars. Training, technical support and customer service was included. The National Dental EDI Council estimated a savings of about $1.27 an attachment to providers and $1.46 for payers for every scanned attachment sent electronically. Recognizing this savings, some payers paid for providers’ registration fees and scanners. Mr. Hughes cautioned that payers would not spend the money to build in-house attachment receiving software until they saw the utilization would be there to justify the cost.

Discussion

Dr. Kyle said ADA’s policy was if at all possible not to have attachments; but they would rather have any required structured and simplified. Ms. Sanchez said NMEH supported standardized claims attachments and for three years on developing content for specific state Medicaid attachments. NMEH sought additional attachments specific to Medicaid’s unique needs and worked to get out and used by the industry. Mr. Hughes said NEA did not do the recommended attachments and had no problem with them being structured. Structured or not, he said the attachments should go electronically while the group worked on structure.

Ms. Sanchez said noted one state exchanged electronic attachments in a non-standard way. Medicaid had faced funding difficulties with the states in getting the basic and transactions and code sets rules running. Still, stakeholders in 23 states cited in NMEH conference calls a definite ROI by implementing attachments. She emphasized that attachments critical to Medicaid agencies were not yet developed fully. She also noted she had not seen resistance with the imaged version with the human decision variant that uses images but that some wanted to fully codify for specific attachments.

Ms. Ward explained that HL7 turned to a CDA approach primarily because of what they heard in WEDI, HIPAA summit and national presentations. She emphasized educating about what the recommendation was and did. HL7 reached out through WEDI-SNIP and AFECHT in conjunction with X12 and held educational summits focused on HIPAA and claims attachments. A series of national Web casts planned through WEDI-SNIP for payers and providers will begin at a fundamental level and build to business issues and processes.

She concurred with testing but cautioned that there would be little motivation without a regulation and questioned whether a Notice of Intent would move anyone to do a pilot. Payers told her unilaterally they would not invest in implementation of transactions without a proposed rule. She also cautioned that just a Medicare or Medicaid pilot would not provide a sense of the world of attachments. The pilot had to cover both the Medicare contractor and the diverse private payer with negotiated contracts based on employer groups. Ms. Ward noted in April 2003 Microsoft and Gorilla Logic held a demonstration at HL7 putting CDA inside a bin within an X12 segment. At HIMSS Epic and another vendor incorporated a CDA claims attachment as part of a HL7 IHE interoperability demonstration, creating, placing and sending a CDA.

Ms. Ward reported people mistakenly anticipated that implementers of claims attachments would suddenly have to support 40,000 LOINC code sets for attachments. She explained that with the majority of attachments, HL7 was simply identifying a question (e.g., what is the patient’s weight? with LOINC code. The answer was the value (e.g., 120 pounds); not a LOINC code value as it existed in the clinical and laboratory environment. She emphasized that, at least on the HL7 side, some of this fear about LOINC was unfounded fear of the unknown.

She assured there was no requirement that the entire medical record be sent by a provider in every situation. If a payer requested seeing the entire chart, the transmission vehicle allowed that to happen; but it was never intended that a provider do what the minimum necessary provisions of Privacy prohibited.

Dr. Carol Bickford expressed ANA’s concern. She asked how they might evaluate exactly what they were trying to move on and determine the data components. She suggested reducing the need for attachments by resolving more at the front end. Noting the focus had been on the financial components, she suggested looking at further use of the data being transmitted in the attachments and reporting structures to support evidence-based practice and better understand outcomes in diagnosis and interventions pieces. She encouraged them to set up a structure supporting essential research.

Ms. Sheila Frank from DDPA cautioned about the cost. She noted HIPAA did not mandate standardization of health insurance plan design, payment models, or payer operations. Some plans were dependent on the data in the attachments to operate their plans according to contractual obligations, government reporting requirements and sound business practices. This data (collected almost exclusively in hard copy) was also used for evidence-based practice research and improvement of payment models. DDPA was not convinced HL7’s solution was best for conveying attachment information but noted it was the only one serious considered and joined the Medicaid agencies in supporting it.

SUBCOMMITTEE DISCUSSION AND DEVELOPMENT OF A DRAFT RECOMMENDATION LETTER ON CLAIMS ATTACHMENT TO THE SECRETARY – Simon Cohn, M.D.

Mr. Nachimson noted an incremental, staged approach and the NPRM would address critical issues raised that day. CMS was working through AFECHT and other committees introducing vendors to the standard and seeking input about the standard, timing, cost and effort involved. CMS will look for pilot tests, research sources for funding, and assist in defining parameters and setting up pilots. If pilots indicate the approach in the NPRM is completely wrong, an amended NPRM will allow industry comment on any major change. The Committee will leave to the Secretary and HHS how to ensure comments are reflected in the process leading to a final rule

It was noted that the Subcommittee’s realization when first drafting the recommendation letter after the December 10 hearings that they did not yet have enough of a perspective from the industry that led to the day’s session. Several different claims attachment demonstration projects and pilots will now include a broad representation of effected stakeholders. The draft was amended to urge HHS to issue the NPRM as soon as possible so the industry would be willing to participate in the pilots and invest in the necessary infrastructure. HHS was encouraged to provide for public comment on the results of the demonstrations and pilot before promulgating a final rule. Members moved unanimously to bring the draft letter on the claims attachment to the full Committee the next morning with further possible wordsmithing.

SUBCOMMITTEE DISCUSSION OF LETTER FROM DSMOS CONCERNING STANDARDS FOR BILLING FOR SUPPLIES – Simon Cohn, M.D.

Dr. Cohn introduced a letter asking for closure on the DSMOs’ request for the NCPDP standard to be utilized by pharmacies for billable supplies. He noted two issues: (1) whether supplies should be billable using an NCPDP transaction, and (2) effectively accepting as part of the transaction two other medical code sets under HIPAA that members were not yet familiar. Tom Louder, speaking for AAHP/HIAA member companies and a coalition of pharmacy associations, urged the Subcommittee to consider the NCPDP request or put the issue on the agenda for discussion and resolution quickly.

Dr. Cohn explained that most retail pharmacies use the NCPDP standard (a real-time standard that permits almost instantaneous response from payers about covered benefits, co-payments and co-insurance requirements) to bill prescription drugs and supplies. Pharmacists were concerned that anyone who billed prescription drugs using the NCPDP standard would have to use the 837 professional claims (a batch transaction; not real time) to bill supply. Under contingency plans during the interim period, most members of the coalition continued to incorporate the NCPDP standard for supplies and prescription drug claims, but Mr. Louder emphasized the issue was huge and had to be resolved soon.

Dr. Cohn noted the DSMO’s letter did not mention use of the medical codes for billing of supplies within the standard; Mr. Louder said he did not know that they had investigated them yet. Mr. Nachimson explained the issue came after the proposed rule was published. The industry still had no consensus about how to go. NCPDP had expressed a sense of urgency and developed a white paper on the billing for supplies that might provide answers about current practices and using the code sets. Members noted that, devoid of any recommendation from the Committee, the industry could further testify during the NPRM public comment process. Dr. Cohn added the matter to their list of items, stressing that if the Subcommittee talked about this it had to be soon: members could comment on the NPRM, but could not hold hearings on topics brought up in an NPRM during a comment period. Members voted unanimously to approve an amended letter of response.

SUBCOMMITTEE DISCUSSION OF E-PRESCRIBING WORK PLAN – Jeff Blair and Simon Cohn, M.D.

Mr. Blair noted this draft E-prescribing plan was version seven of ongoing work, emphasizing there will be more versions and the Subcommittee’s commitment. He explained that the Medicare Prescription Drug Improvement and Modernization Act asked NCVHS for recommendations for e-prescribing standards, outlined stakeholders to listen to and issues to consider. The Subcommittee added current demonstration projects, implementations, networks under development, vendors and SDOs. The act included not only eligibility issues but whether they were eligible based on the formulary for particular prescriptions and other considerations.

Participants noted an urgency to produce interim recommendations as soon as possible. The Secretary is to report the initial standards recommendations to Congress by September of 2005. The Subcommittee must have final recommendations by June of 2005 and interim recommendations by the November 2004 full Committee meeting. E-prescribing demonstration projects are scheduled for 2006. Results will be reported by April 2007. The Secretary is to promulgate final e-prescribing standards on-or-before April 2008. Many want this earlier.

The work plan includes a list of priorities: the transaction and terminology standards, decision support and requirements of state and federal agencies. After spending four days at NCPDP, Mr. Blair noted there was much to e-prescribing that many members needed to learn as a foundation. Ms. Friedman will pull together a day of education for March 30. NCPDP will represent the industry with respect to different models of how prescriptions are conveyed, information requirements, constraints, and the overall market as well as how the scrip standard addresses and deals with these different models. Overviews of VA, HHS, FDA and DOD will provide a federal perspective. The Subcommittee will hear from DEA when the e-health initiative is handled separately later.

The plan lays out four of five priorities in the interim recommendations. Two days testimony is blocked out in May and four days over July and August to ensure that effected stakeholders have sufficient time and opportunity to testify. Members will hear from users prescribing, filling or providing formulary information or drug utilization review information and those regulating or accrediting it about how they use the standards, standards needed, gaps and other considerations and recommendations. In the late August session these issues, needs and gaps will be pulled into questions for NCPDP and other major terminology developers invited to indicate at the September session plans in place to address these additional requirements, how gaps will be addressed, and their recommendations. Members will then draft an interim recommendation letter that, hopefully, will be approved by the full Committee in November.

Mr. Blair said a number of networks rapidly moving forward with implementations in demonstration projects would provide real world feedback. Dr. Cohn noted that the next day members would negotiate ranges of dates for hearings. A pharmacy consultant will be hired to develop questions. Confirming that no other issues came before the Subcommittee that day, Dr. Cohn adjourned the meeting


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

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Chairman, Date