National Committee on Vital and Health Statistics Subcommittee on Standards and Security March 3, 2004 Washington D.C.

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1 National Committee on Vital and Health Statistics Subcommittee on Standards and Security March 3, 2004 Washington D.C. Testimony of Accredited Standards Committee X12 Gary Beatty Chair ASC X12N Insurance Subcommittee Phone: On behalf of X12 I would like to thank you for the opportunity to testify today regarding the health care claim attachments requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). X12 consists of approximately 370 member organizations developing standards in both X12 and XML formats for cross-industry electronic exchange of business information. Within the X12N Insurance Subcommittee there are approximately 140 member organizations as well as over 95 non-member organizations that represent payers, providers, software vendors, clearing houses, value added networks, sponsors, and consulting organizations. Below is a model for the transactions and implementation guides X12 has developed that fall under the requirements of HIPAA.

2 Providers Payers Sponsors Eligibility Enrollment Accounts Payable Managed Care Pre-Treatment Authorizations and Referrals /CDA Pre-Certification And Adjudication Service Billing/ Claim Submission /CDA Health Care Claim Acceptance Claim Status Inquiry Medical Records (EMR) /CDA Adjudication Accounts Receivable 835 Accounts Payable X12 has been working on health care claims attachments since the early 1990 s when we developed the 837 Health Care Claim transaction set. Contained within the 837 transaction set is the data content for several different attachments such as; durable medical equipment certification, ambulance certification, chiropractic certification, home health care information, home oxygen therapy information, and the ability to link to external documents, either electronic or paper based. This attachment information is still contained within the 837 Health Care Claim implementation guides currently mandated under HIPAA. Since 1997 X12 and Health Level 7 (HL7) have been working together to develop a national standard for health care claim attachments to meet the attachments requirement under HIPAA. By working together we are better able to meet the needs of the health care industry as we can incorporate both financial / administrative data content with clinical data content into a combined standard. This combined standard can take advantage of the same routing the health care industry has established for the administrative transactions. As a result of X12 / HL7 (Attachments SIG) coordination, X12 has developed several transactions

3 supporting health care claim attachments including the 275 Additional Information to Support a Health Care Claim or Encounter (004050X151) which can be used either as an unsolicited attachment to the 837 Health Care Claim submission or as a response to the 277 Health Care Claim Request for Additional Information (004050X150). Both of these transactions had their respective implementation guides approved for publication at the recent X12 trimester meeting (February 2004) and will be publicly available the 2 nd quarter of Within the 275 transaction is a binary segment which will contain the HL7 CDA document representing the clinical data needed for health care claim adjudication. The HL7 CDA document can be structured (codified) or unstructured (imaged) and it may be a complete document or a portion of a document. Originally HL7 developed six attachments based upon their version 2.4 which has a similar syntactical structure as X12 syntax. In 1998, the 277 transaction requesting attachments was pilot tested in coordination with HCFA and involved both payer and providers. This pilot however did not include the 275/HL7 version 2.4. Another pilot test was conducted in 2000 by Empire Blue Cross Blue Shield, HGSAdministrators, and CMS which did provide a limited proof of concept for these transactions (refer to NCVHS testimony provided by Empire on December 10, 2003). Given the capabilities of the health care industry and varied success, the length of time past since the pilot and the emergence of internet technologies, HL7 has evolved its standards to their Clinical Document Architecture (CDA) which is based upon extensible markup language (XML). HL7 has already provided testimony to this committee on their CDA approach on December 10 th, X12 is also looking to use a similar process for moving clinical data content to support the 278 transaction for pre-treatment authorizations and referrals. In April 2003, X12 and HL7 sent a letter to the Secretary of Health and Human services expressing concern over length of time that had elapsed since the original recommendation for attachments based upon HL7 version 2.4 and the need to provide HL7 enough time to

4 complete the CDA and pilot test the 277/275(CDA) prior to issuance of an NPRM for these transactions to ensure completeness, accuracy, and business process proof of concept. To date the CDA development has been completed, however the industry still needs to conduct pilot testing to verify the industries business needs will be met through the usage of the CDA and the flexibility it affords the health care industry for both structured and unstructured data content for health care claim attachments. This pilot testing must be completed prior to issuance of the health care claims attachments NPRM. Recommendations 1. Need for pilot testing X12, HL7, CMS gained valuable insight into the usage of the attachments transactions as part of the 1998 and 2000 pilot testing. The need for pilot testing was emphasized recently by those who testified at the WEDI hearing on implementation of the transactions and code sets (January 27 th, 2004). They stated that if tested early business and data content issues can be addressed prior to the HIPAA mandate. X12 supports the need for pilot testing the attachment transactions. However this requires broad volunteer participation from representatives of the health care industry user community including: Payers Commercial Governmental ERISA health plans (including their respective administrators) HMO & PPO Health Care Providers Hospitals Clinics, Individual physicians Clearinghouses Software vendors (for both payers and providers)

5 In addition, these pilot tests will require time and funding to be successful. WEDI and AFEHCT are in the early stages to facilitate pilot testing, and X12 work group members have participated in those early discussions. 2. Transition from X based attachments. X12 and HL7 need to develop a joint recommendation for the transition process and timeline to move the data content from the health care claim that will be contained within the attachments. In 1999 a cross work group team within X12 identified specific data elements that need to be migrated from the 837 health care claim to an attachment standard. Discussions are under way between X12 and HL7 on how we should move forward with the decisions from 1999, ensuring a current day plan is defined and agreed to and the appropriate communication and education is made available to the health care industry relative to these decisions and plans. 3. Usage of Health Care Claim Attachments X12 recommends the NCVHS work with the Office of HIPAA Standards (OHS) and health care industry representatives to ensure the attachments NPRM provide policy guidance to the health care industry on the appropriate usage of health care claim attachments. This includes but not limited to appropriate business situations where attachments should/should not be required, frequency of usage, and amount of clinical data required to satisfy health care claim adjudication. 4. Health Care Claim Attachments Education X12 and HL7 is developing an educational program for the June 2004 X12 trimester meeting in Chicago which will cover business process and usage of health care claims attachments including the 277, 275 and CDA documents, and perhaps their respective workflow and best practices. This educational program will be evaluated and presented in subsequent X12 trimester meetings depending on industry needs.

6 X12 believes that such education is crucial to the industry s success in the implementation of the claims attachments standard. Electronic claims attachments and specifically the combined use of X12 and HL7 standards are a new undertaking for the health care industry. As such, we believe that there needs to be a concerted effort to educate the health care industry on this issue as quickly as possible. At this stage, only education will provide for adequate preparation for the publication of the claims attachments NPRM, and the ensuing implementation of the proposed standard. X12 will support such education efforts where possible. X12 welcomes the information shared during this hearing as well as ongoing input to make the best EDI standards for the health care industry. Thank you Gary Beatty, Chair X12N Insurance Subcommittee

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